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Lords Chamber

Volume 759: debated on Tuesday 24 February 2015

House of Lords

Tuesday, 24 February 2015.

Prayers—read by the Lord Bishop of Carlisle.

National Curriculum: Animal Welfare


Asked by

To ask Her Majesty’s Government whether they have any proposals to include animal welfare in the national curriculum in schools.

My Lords, the new primary science curriculum, introduced from September 2014, focuses on the essential scientific knowledge that young people need to be educated citizens. It teaches primary pupils about the requirements for animals to survive: appropriate habitat, food, water and air. Subjects such as citizenship and PSHE also provide opportunities for pupils to learn about animal welfare, and teachers are free to decide what further activities they offer on this subject.

I thank the Minister for that positive reply. As he says, it is important for young people to know about animals—not only domestic animals or farm animals, but wild animals and the environment. Is he aware that the RSPCA did a survey in 2014 of 800 teachers, 95% of whom thought that it ought to be taught to young people? Indeed, 83% thought it ought to be part of the national curriculum.

I am aware of the survey to which the noble Lord refers, and I know that the RSPCA teaches around 4,000 teachers about this every year. We feel that it is very helpful for young people to learn about animal welfare in the national curriculum, but we do not think it is right to include it, certainly not at this stage. We have a long way to go to make sure that the majority of pupils in this country have an education in core academic subjects first.

This year the Government are reviewing their codes on how to care for dogs, cats and horses. Does my noble friend agree that it is important that children are made aware of those new codes? If so, will the Government be offering any advice about their inclusion in school timetables?

As I said, I agree entirely that animal welfare is an important subject for pupils to learn about, but we have to recognise the low base from which we are starting education in this country. When we came to power, fewer than one in five pupils attending a comprehensive school was getting that core suite of academic subjects that would be a basic expectation in many countries, and certainly in any private school. We have recovered substantially from that position: now nearly 40% get that core suite, but the Question underestimates the low base from which we are starting.

My Lords, will the Minister commend those organisations that take the trouble to take animals, particularly dogs, into care establishments and schools for children with learning disabilities? It has been shown that those youngsters improve their behaviour on encountering animals. Maybe this is one area where we could increase attendance.

I agree entirely with the noble Baroness. Organisations such as Battersea Dogs & Cats Home, Blue Cross, Cats Protection, Dogs Trust and PDSA do excellent work. I am sure she will be interested to know that, under the Government’s successful free school programme, we will have the Milton Keynes special free school opening next year. It will be a 70-place alternative provision primary school for pupils with social, emotional and behavioural difficulties. It will incorporate a forest approach. They will keep chickens and will be taught by an experienced poultry keeper.

Does the Minister agree that hunting with dogs is a cruel and unnecessary sport? If so, how would he explain to young people in schools that the Tory party is threatening to repeal the hunting ban?

If we offer all our children a really good education, which we are trying to do, they can make their minds up on these issues for themselves.

Does my noble friend agree that when topics such as the use of animals in scientific experiments are dealt with in schools they should be dealt with in a balanced way, and that children should be able, as he has just said, to balance the various arguments on different sides?

I entirely agree. Children taught properly should be able to balance all these arguments. They should be taught about argument and they should have enough scientific knowledge to understand what is happening.

My Lords, would the noble Lord agree that it is slightly unfortunate that he chose to use this really quite innocuous Question to make a very crude party-political point? Would he also accept that, in doing so, he undermines the morale of teachers who have been working in the system for very many years and doing the very best they can, sometimes in quite difficult circumstances? Would he further he accept that the best primary schools have animals for the children to look after and that is how they learn about animal welfare?

As I think the noble Baroness has heard me say on a number of occasions, I regard teaching as the most noble of professions. It is certainly the most important profession at this time as far as the future of this country is concerned. But I think we just have to get real. Under the previous Government, the number of pupils getting a core suite of academic subjects in education slumped. We are recovering from that position, but until we start loading up the curriculum with extras on a compulsory basis we have to recover educationally to provide our pupils, particularly those from disadvantaged backgrounds, with that core cultural literacy that they need.

My Lords, the Minister gave a rather strange reply to an earlier question on the Hunting Act: that, somehow or other, properly educated pupils will be able to make up their own minds on the subject. It is not a question of making up one’s own mind on the subject. When a law of the land has been passed by both Houses of Parliament, the assumption is that people will obey it. I hope that he thoroughly agrees with that in relation to the Hunting Act.



Asked by

To ask Her Majesty’s Government what plans they have to celebrate the 200th anniversary of the Gurkha battalions and to acknowledge their service to the United Kingdom and their relationship with the British people.

My Lords, this year we mark the bicentenary of Gurkha service to the British Crown. Gurkhas hold a special place in the hearts of the British people and we will be celebrating our close and enduring relationship. The Brigade of Gurkhas will be holding many events over the year, including a parade and a memorial service in Whitehall in April, and Gurkha units will conduct public duties in London during May.

Does the Minister agree that the 200th anniversary of Gurkha service to this country provides an opportunity to mark the unique relationship forged in battle across the world by the Gurkha soldier and his British comrade? Is not the bicentenary of the Gurkha Brigade a reminder to us all that religious differences and diverse ethnic origins are no barrier to shared values and lasting friendships?

I agree wholeheartedly with the noble Baroness and I pay tribute to her work as an ambassador for the Gurkha Welfare Trust. Gurkhas within the British Army are proof that different religious and ethnic groups can work together in defence of a set of common values based on the mutual trust and respect that has grown over the last 200 years and I am immensely proud to have served alongside Gurkhas in Malaysia and Hong Kong.

We on this side also recognise the unique contribution made by the Gurkhas over the last 200 years. Do the Government agree that the best way to mark the 200th anniversary would be to ensure a clear and continuing role for the Gurkhas in Army 2020? Can the Minister say whether that is the Government’s objective and what that role might be?

My Lords, of course we are very keen on a proper role for the Gurkhas, and we feel that they have a proper role at the moment.

Is my noble friend aware that when we were conducting the Options for Change exercise and there was great competition among infantry regiments as to which should continue and which should disband, there was a suggestion that the Gurkhas should be stood down? Does my noble friend agree that one of the best decisions we took was not to listen to that advice and to ensure that the Gurkhas continued their service? Is not all the evidence that has emerged since from Afghanistan, Iraq and the various fields of activity in which the Gurkhas have been involved further tribute to the wonderful way in which they have served this nation over so many years?

My Lords, I agree with my noble friend. I think it was Prince Harry, who served alongside the Gurkhas in Afghanistan, who put it very well. He said that there was no safer place than by the side of a Gurkha.

My Lords, the Gurkhas have served our country with the greatest loyalty and bravery. I had the honour to serve, only for a few weeks, with the 2nd Goorkha Rifles. They spelt their name a different way from the other regiments and they were known as God’s own Gurkhas. They were, as always, fantastic fighting men and I hope my noble friend will agree that we owe the Gurkhas a debt of honour which we can never repay.

My Lords, I entirely agree with my noble friend. The Ministry of Defence is marking the celebration of 200 years of Gurkha service with a series of events in the UK and abroad.

I endorse absolutely the decision of the Government in this respect. Will my noble friend take account of the fact that on my visit to Pakistan about 25 years ago—the first visit from a Secretary of State of this country—I was welcomed by President Ghulam Ishaq Khan who told me that I should be able to find that country peopled with the noble ghosts of Britain’s past.

My Lords, that is a very interesting bit of information from my noble and learned friend. I am sorry that the noble Lord, Lord Slim, is not here; he served in the Indian Army and was on parade during the time of partition.

My Lords, I agree with all that has been said about the valour of the Gurkhas, but can my noble friend the Minister answer a question that is put by many people? Many veteran Gurkhas who have retired to this country live in poverty and receive only one-third of the standard pension of military pensioners. Have Her Majesty’s Government considered how, in the 200-year celebrations and commemorations, we should treat these valiant men? It should not be by paying them a pittance so that they need to go to food banks.

My Lords, Gurkhas of working age who have been discharged since the 1990s and who are resident in the UK have integrated well and contribute to society. On the question of pensions, since 1 April 2007, any Gurkha joining the British Army receives the same pay and pension benefits as their counterparts in the wider Army. Gurkhas serve on the same basis as the remainder of the Army, with some very small exceptions designed to satisfy the Government of Nepal.

My Lords, the Minister may be wondering why I am involved with the Gurkhas but does he have any plans to involve Joanna Lumley in the activities? She did a magnificent job with her Gurkha Justice Campaign, which was ably funded and supported by a person for whom I worked for 45 years, Sir Jack Hayward, who, sadly, died in January. I am sure that her involvement would be greatly appreciated by all Gurkhas and would be a tribute to the memory of Sir Jack Hayward.

I have listened very carefully to what my noble friend has said but I do not have any plans to meet Joanna Lumley.

Yarl’s Wood


Asked by

To ask Her Majesty’s Government what requirements were set in the contract for Yarl’s Wood Immigration Removal Centre recently reawarded to Serco regarding the dignity and privacy of women detained there.

My Lords, contracts for the operation of immigration removal centres require service providers to comply with the Detention Centre Rules 2001. This is in addition to the contracts’ operational specifications, which contain measures to ensure the dignity and privacy of women.

I thank the noble Lord for that Answer. In June last year Yarl’s Wood was the subject of 31 allegations of sexual misconduct. Those were investigated and a number of staff were dismissed. None the less, in November the Serco contract for Yarl’s Wood was extended for eight years. However, the harassment goes on. The January report by Women for Refugee Women documented inappropriate behaviour by male staff towards female inmates—themselves already the victims of sexual abuse. Can the Minister tell us when innocent women who have committed no crimes can expect to be treated with respect?

I think that the answer to the noble Baroness is: right now. I believe that the standards provided by Serco, the current operators of the scheme, are of a very high level. Yarl’s Wood was inspected by Her Majesty’s Inspectorate of Prisons and he found it to be a safe and secure place. In addition, there is an independent monitoring board. Just two weeks ago, my right honourable friend the Home Secretary set up a special review of all immigration removal centres to ensure that they are of the highest standard. I read the report by Women for Refugee Women very carefully and the most critical point was that it was felt that women’s privacy was invaded and that there were insufficient female staff. One of the key elements in the contract offered was that the proportion of female staff should increase. The proportion is going up from 42% to 60%, and that is a step in the right direction.

My Lords, my noble friend may have read the report by the Equality and Human Rights Commission about deaths in custody, published only recently. Does he accept that the organisations and institutions do not deliver the standards outlined and recommended in the EHRC report and that they are therefore at risk of being in breach of the European Convention on Human Rights? In the light of that, does he accept that it is time for HM Inspectorate of Prisons to carry out a thematic review of how these standards are being observed at the Yarl’s Wood centre?

Her Majesty’s inspectorate’s last visit was in June 2013. These are not planned visits; they are meant to be surprise visits to try to get an accurate picture of what is going on. They are meant to happen every two years, so we are expecting one fairly soon. Following the very serious allegations, some members of staff were suspended, and Bedfordshire Police is undertaking criminal investigations in that respect. The inspectorate returned to Yarl’s Wood to undertake 50 further interviews to make sure that its conclusion that it was a safe and respectful place could be upheld.

My Lords, I have visited Yarl’s Wood in recent years. Can the Minister confirm that no pregnant women are held there now? Will he agree that many detainees feel very cut off there and do not know when they will be released? Can he tell the House how many suicides or serious attempts at self-harm there have been in the past two years?

At Yarl’s Wood, in the past two years, the answer is, fortunately, none. These are very vulnerable people; we accept that totally. The noble Lord asked about pregnant women in particular. There is a limit which says that no women past the 24th week of pregnancy can be held or put into the detention fast track. The point is that they should be in Yarl’s Wood only for a very short time. They are people who are identified for quick return and their stays should be no more than a few weeks.

My Lords, I welcome the Secretary of State’s review of the welfare of detainees, but I am anxious to know whether it will include a review of whether the decision-making is to the appropriate standards. The evidence shows that victims of abuse in these centres feel greatly traumatised by the very fact of detention. Surely the reviewer should be encouraged to meet ex-detainees as present detainees might be reluctant to speak of some of the things that have happened to them. Would it not also be good if he met members of organisations that work closely with traumatised victims who have been detained—organisations such as the Helen Bamber Foundation, which deals with victims of torture; Freedom from Torture, and Women for Refugee Women? Will the reviewer meet those people, and will he review the very decision-making as to whether people should be detained at all?

It is, obviously, set up as an independent review, so it will be for Stephen Shaw to do that. However, as he is a former Prisons and Probation Ombudsman I would expect that his attention will be drawn not only to the current detainees but to former detainees and also to those excellent charitable organisations. To the list of excellent charitable organisations that the noble Baroness mentioned I would add Hibiscus, particularly at Yarl’s Wood. It does an outstanding job of providing humane care, advice and friendship to people in that situation.

My Lords, over the past two years Yarl’s Wood has developed a reputation, and not a very good one, for the way that it treats women in the centre. Can the Minister say a bit more about whether the number of girls under the age of 18 being detained there has gone down? The Minister rightly said that people should not be held there for great lengths of time. Can he tell us what the average length of stay is now?

Certainly; the latest statistic we have is that 92% of people are held for less than six months, and about 48% for less than 42 days. We want that to come down because, as I say, this is used very much as a last resort. In relation to children, as a result of action taken in your Lordships’ House children are, fortunately, no longer detained in immigration removal centres, and that is a good thing.

My Lords, in view of the concerns expressed only last Friday by the Joint Committee on Human Rights about women and girls who claim to have been victims of violence and are detained at Yarl’s Wood under the fast-track process, can the Minister tell us whether the Government have any plans for a screening process for people in that position?

This is subject to a very careful screening process, and the decision to send someone to Yarl’s Wood is not taken lightly. There are medical reviews by a GP and reports are provided to the caseworkers before any decision is made. The point is that these are people who have overstayed their stay, their asylum immigration applications have been denied and, therefore, they are about to be deported imminently. That is the reason they are there. However, that does not mean that they should be treated with anything less than the highest standards of dignity and respect.

My Lords, the review that has been announced is very welcome, as is what the Minister has said, but the terms of reference of the review do not explicitly include women generally; they refer just to pregnant women. The Minister himself has said that all the women about whom we have heard evidence from the noble Baroness, Lady Bakewell, are vulnerable. Will he now confirm that the review will look explicitly at the treatment of women, many of whom have fled gender-related violence in their home countries?

I would have thought that the noble Baroness might welcome the fact that the Shaw review will range much wider. Of the 30,000 people who are held in detention, around 80% are male, and it is important that their needs are reviewed as well. However, I am sure that the noble Baroness’s observation will be fed back to the review.

My Lords, is the Minister satisfied that there is no concern at all about any of the detention centres that we have in the UK, or is there any detention centre that is really causing a worry at the moment?

How do we define “worry at the present time”? We have rigorous systems of independent monitoring boards at every single centre. They consist of 12 independent people. We have the inspectorate carrying out its review. We have the independent review that we announced. We are happy that the places are safe and secure, but we are not complacent. These are vulnerable people and need to be protected.

Armed Forces: Baltic Defence


Asked by

To ask Her Majesty’s Government what is their assessment of the ability of the United Kingdom’s armed forces to participate fully in any NATO-led Baltic defence operations.

My Lords, NATO remains the cornerstone of UK defence. We are committed to Article 5 as a fundamental principle at the heart of NATO. An attack on one is an attack against all. We maintain a range of forces at the required readiness and standard and would respond to any NATO request to defend the Baltic states against external aggression. The level of our participation would depend on what requests NATO made of us.

My Lords, there is a saying that it is useless for the sheep to pass resolutions in favour of vegetarianism if the wolf is of another opinion. Is my noble friend not ashamed and embarrassed that, with clear Russian aggression in the Ukraine and major increases in Russian defence expenditure, all our major political leaders, ostrich-like, totally fail to spell out their respective positions on the levels of overall defence expenditure? Do we not need a clear commitment to maintain a 2% of GDP spend on defence and, indeed, probably more? Can my noble friend tell us why the Chief of the Defence Staff was gagged yesterday from speaking at Chatham House?

My Lords, we have met the NATO target since coming to office and will do so to the end of financial year 2016. NATO membership means equitable sharing of risks and responsibilities, so it is a case of comparing Russia not to the UK but to NATO, which spends 10 times more on defence than Russia. On my noble friend’s second question, the Defence Secretary decided that the Procurement Minister should speak, given the conference’s focus on relations between industry and government.

My Lords, four destroyers and frigates were lost in the Falklands; eight were very badly damaged. That is 12 destroyers and frigates. Today, if we lost 12 ships, we would have seven destroyers and frigates protecting this great maritime nation. Our defence forces have been cut too far. Will the Minister pass on to his right honourable friend the Prime Minister the message that, bearing in mind the world situation, with chaos in countries such as Iraq, Syria, Libya, Nigeria, Somalia and Ukraine, and risk of growing tension with Russia, we need to spend more money on defence and must not have a block to proper discussion of defence in the lead-up to this election?

My Lords, sufficient defence spending is particularly required in light of recent events. We need to be able to deal with multiple challenges and undertake a range of operations across the military spectrum, as well as maintain our standing commitments. This Government have consistently committed to spending 2% of GDP on defence and 20% on equipment, and, along with the US, we have been one of only two allies that currently meet the NATO guidelines.

In their present mood, the Russians are likely to be using a whole variety of hybrid and cyber forms of warfare, as they have in the recent past in the Baltic area. Are we fully prepared to meet that?

My Lords, NATO is working to tackle the challenge of hybrid attacks. There is little new in the tactics and techniques of hybrid warfare, such as subversion and the use of proxy forces, but the scale of sophistication of Russian activities, combined with the use of new instruments such as cyber, presents a new challenge and we are doing our best to get on top of it.

What assessment is being made by the British Government and Ministers of the impact on Russian public opinion of provocative NATO exercises on the border with Russia?

My Lords, the information given by my noble friend the Minister is to some extent reassuring, but perhaps it might be more reassuring if there were two aircraft carriers actually in service and if F-35B assault aircraft were actually working on those aircraft carriers. Will the Minister tell us what message we send out to our enemies, to whom we might seem somewhat unprepared?

My Lords, we are not unprepared. Our equipment programme represents a substantial investment: some £163 billion over 10 years on equipment and equipment support, ensuring that our Armed Forces retain a formidable range of cutting-edge capabilities, and the ability to project power across the globe, hence aircraft carriers. This investment is not only securing the best possible military capability; it is also helping to secure UK jobs and growth.

My Lords, does the Minister accept that there is in this House quite a mood of concern about the level of defence expenditure? We have also seen the concern expressed in the media. We are aware that there is a Bill currently going through your Lordships’ House to place 0.7% of GDP into the international development budget by law. Would the Minister consider a government amendment to that Bill, or an addition to that Bill, to link that to 2% of GDP for defence spending?

My Lords, I note the concern, but the defence budget this year is £33.8 billion. We have the second largest defence budget in the alliance—behind the US—and certainly the largest in the European Union. The UK remains a global power, making the second biggest contribution to the campaign against ISIL and sending 750 military personnel into Sierra Leone to help fight Ebola.

Specialist Printing Equipment and Materials (Offences) Bill

Order of Commitment Discharged

Moved by

My Lords, I understand that no amendments have been set down to this Bill, and that no noble Lord has indicated a wish to move a manuscript amendment or speak in Committee. Unless, therefore, any noble Lords object, I beg to move that the order of commitment be discharged.

Motion agreed.

Consumer Rights Bill

Commons Reason

Lords amendment

12: After Clause 32, insert the following new Clause—

Secondary ticketing platforms

Secondary ticketing platforms: seller profiles and ticket information

(1) Secondary ticketing operators must, on the website on which tickets are offered for sale or transfer, provide information concerning the sellers of tickets so that sellers may be easily identified.(2) Information provided by virtue of subsection (1) must include, but is not limited to—(a) the name of the seller;(b) if the seller is an undertaking, its registered number, jurisdiction of registration, registered office address, and if registered outside the United Kingdom, a valid address for service; and(c) the VAT registration number of the seller, if applicable.(3) Information provided under subsection (1) must be—(a) accurate; and(b) prominently displayed before a buyer is able to complete the purchase of the ticket.(4) Secondary ticketing operators must disclose clearly and prominently where the seller of a ticket is—(a) the secondary ticketing platform or a subsidiary undertaking or parent undertaking of the secondary ticketing platform;(b) a person or persons employed or engaged by the secondary ticketing platform;(c) other persons connected to employees, directors or shareholders of the secondary ticketing platform, or any of its subsidiary undertakings or parent undertakings;(d) the event organiser or an agent acting on its behalf;(e) any other party connected to the organisation of the event.(5) Where a ticket is offered for sale or transfer through a secondary ticketing platform—(a) the seller must provide all relevant information about the ticket;(b) the secondary ticketing operator must publish all relevant information about a ticket in a prominent and clear manner; and(c) the secondary ticket operator must immediately remove the ticket from sale when it is informed by the event organiser that the information provided is inaccurate or incomplete.(6) Information to be provided by the seller and published by the secondary ticketing operator for the purposes of subsection (1) must include, without limitation—(a) the face value of the ticket;(b) any age or other restrictions on the user of the ticket;(c) the designated location of the ticket including the stand, the block, the row and the seat number of the ticket, where applicable; and(d) the ticket booking identification or reference number.(7) Where tickets are being resold in contravention of the terms and conditions agreed to by the original purchaser, this must be stated prominently by the secondary ticketing platform at every stage of the purchasing process.(8) Information provided by virtue of this section must be— (a) accurate; and(b) prominently displayed before a buyer is able to complete the purchase of that ticket.(9) For the purposes of this section—“secondary ticketing platform” means an internet-based facility for the resale of tickets to events in the United Kingdom of Great Britain and Northern Ireland, regardless of the jurisdiction in which the owner of the service is registered;“secondary ticketing operator” means, in relation to a secondary ticketing platform, the person (whether incorporated or not) operating that secondary ticketing platform;“ticket” means anything which purports to be a ticket, including any item, tangible or intangible, which grants the holder the right to entry to an event;“event” means any sporting, music or cultural activity taking place at a specified time and place for which tickets are issued and required for entry or attendance;“event organiser” means the person responsible for organising and holding an event and receiving the revenue from the event;the term “undertaking” has the meanings given in section 1161 of the Companies Act 2006 (meaning of “undertaking” and related expressions);the terms “subsidiary undertaking” and “parent undertaking” have the meanings given in section 1162 of the Companies Act 2006 (parent and subsidiary undertakings);the term “person” refers to a natural person or a body corporate.(10) This section will come into force no later than six months after this Act is passed.”

Commons Disagreement and Reason

The Commons disagree to Lords Amendment No. 12 for the following reason—

12A: Because it would be inappropriate to require the provision of information relating to all categories of sellers when a ticket is resold, and because the amendment raises issues of compatibility with existing European Union law.

Motion A

Moved by

That this House do not insist on its Amendment 12, to which the Commons have disagreed for their Reason 12A, but do propose Amendments 12B to 12H in lieu—

12B: After Clause 86, insert the following new Clause—



Duty to report criminal activity

(1) This section applies where—

(a) an operator of a secondary ticketing facility knows that a person has used or is using the facility in such a way that an offence has been or is being committed, and

(b) the offence relates to the re-sale of a ticket for a recreational, sporting or cultural event in the United Kingdom.

(2) The operator must, as soon as the operator becomes aware that a person has used or is using the facility as mentioned in subsection (1), disclose the matters specified in subsection (3) to—

(a) an appropriate person, and

(b) an organiser of the event (subject to subsection (5)).

(3) Those matters are—

(a) the identity of the person mentioned in subsection (1), if this is known to the operator, and

(b) the fact that the operator knows that an offence has been or is being committed as mentioned in that subsection.

(4) The following are appropriate persons for the purposes of this section—

(a) a constable of a police force in England and Wales,

(b) a constable of the police service of Scotland, and

(c) a police officer within the meaning of the Police (Northern Ireland) Act 2000.

(5) This section does not require an operator to make a disclosure to an organiser of an event if the operator has reasonable grounds for believing that to do so will prejudice the investigation of any offence.

(6) References in this section to an offence are to an offence under the law of any part of the United Kingdom.

(7) This section applies only in relation to an offence of which an operator becomes aware after the coming into force of this section.”

12C: Insert the following new Clause—

“Enforcement of section (Duty to report criminal activity)

(1) A local weights and measures authority in Great Britain may enforce the provisions of section (Duty to report criminal activity) in its area.(2) The Department of Enterprise, Trade and Investment may enforce the provisions of section (Duty to report criminal activity) in Northern Ireland.(3) Each of the bodies referred to in subsections (1) and (2) is an “enforcement authority” for the purposes of this Chapter.(4) Where an enforcement authority is satisfied on the balance of probabilities that a person has breached the duty in section (Duty to report criminal activity), the authority may impose a financial penalty on the person in respect of that breach.(5) A local weights and measures authority in England and Wales may impose a penalty under this section in respect of a breach which occurs in England and Wales but outside that authority’s area (as well as in respect of a breach which occurs within that area).(6) A local weights and measures authority in Scotland may impose a penalty under this section in respect of a breach which occurs in Scotland but outside that authority’s area (as well as in respect of a breach which occurs within that area).(7) Only one penalty under this section may be imposed on the same person in respect of the same breach.(8) The amount of a financial penalty imposed under this section—(a) may be such as the enforcement authority imposing it determines, but(b) must not exceed £5,000.(9) Schedule (Secondary ticketing: financial penalties) (procedure for and appeals against financial penalties) has effect.”

12D: Insert the following new Clause—

“Duty to review measures relating to secondary ticketing

(1) The Secretary of State must—(a) review, or arrange for a review of, consumer protection measures applying to the re-sale of tickets for recreational, sporting or cultural events in the United Kingdom through secondary ticketing facilities,(b) prepare a report on the outcome of the review or arrange for such a report to be prepared, and(c) publish that report.(2) The report must be published before the end of the period of 12 months beginning with the day on which this section comes into force. (3) The Secretary of State must lay the report before Parliament.(4) In this section “consumer protection measures” includes such legislation, rules of law, codes of practice and guidance as the Secretary of State considers relate to the rights of consumers or the protection of their interests.”

12E: Insert the following new Clause—

“Interpretation of this Chapter

(1) In this Chapter—“enforcement authority” has the meaning given by section (Enforcement of section (Duty to report criminal activity))(3);“operator”, in relation to a secondary ticketing facility, means a person who—(a) exercises control over the operation of the facility, and(b) receives revenue from the facility,but this is subject to regulations under subsection (2);

“organiser”, in relation to an event, means a person who—(a) is responsible for organising or managing the event, or(b) receives some or all of the revenue from the event; “secondary ticketing facility” means an internet-based facility for the re-sale of tickets for recreational, sporting or cultural events.(2) The Secretary of State may by regulations provide that a person of a description specified in the regulations is or is not to be treated for the purposes of section (Duty to report criminal activity) as an operator in relation to a secondary ticketing facility.(3) Regulations under subsection (2)—(a) are to be made by statutory instrument;(b) may make different provision for different purposes;(c) may include incidental, supplementary, consequential, transitional, transitory or saving provision.(4) A statutory instrument containing regulations under subsection (2) is not to be made unless a draft of the instrument has been laid before, and approved by a resolution of, each House of Parliament.”

12F: Clause 91, page 48, line 18, at end insert—

“(1C) Chapter 3B of this Part comes into force at the end of the period of two months beginning with the day on which this Act is passed.”

12G: Schedule 5, page 72, line 8, at end insert—

“section (Enforcement of section (Duty to report criminal activity))(1) or (2) of this Act.”

12H: After Schedule 8, insert the following new Schedule—


Notice of intent1 (1) Before imposing a financial penalty on a person for a breach of the duty imposed by section (Duty to report criminal activity), an enforcement authority must serve a notice on the person of its proposal to do so (a “notice of intent”).

(2) The notice of intent must be served before the end of the period of 6 months beginning with the first day on which the authority has sufficient evidence of the person’s breach, subject to sub-paragraph (3).

(3) If the person is in breach of the duty on that day, and the breach continues beyond the end of that day, the notice of intent may be served—

(a) at any time when the breach is continuing, or

(b) within the period of 6 months beginning with the last day on which the breach occurs.

(4) The notice of intent must set out—

(a) the amount of the proposed financial penalty,

(b) the reasons for proposing to impose the penalty, and

(c) information about the right to make representations under paragraph 2.

Right to make representations2 A person on whom a notice of intent is served may, within the period of 28 days beginning with the day after that on which the notice was sent, make written representations to the enforcement authority about the proposal to impose a financial penalty on the person.

Final notice3 (1) After the end of the period mentioned in paragraph 2 the enforcement authority must—

(a) decide whether to impose a financial penalty on the person, and

(b) if it decides to do so, decide the amount of the penalty.

(2) If the authority decides to impose a financial penalty on the person, it must serve a notice on the person (a “final notice”) imposing that penalty.

(3) The final notice must require the penalty to be paid within the period of 28 days beginning with the day after that on which the notice was sent.

(4) The final notice must set out—

(a) the amount of the financial penalty,

(b) the reasons for imposing the penalty,

(c) information about how to pay the penalty,

(d) the period for payment of the penalty,

(e) information about rights of appeal, and

(f) the consequences of failure to comply with the notice.

Withdrawal or amendment of notice4 (1) The enforcement authority may at any time—

(a) withdraw a notice of intent or final notice, or

(b) reduce the amount specified in a notice of intent or final notice.

(2) The power in sub-paragraph (1) is to be exercised by giving notice in writing to the person on whom the notice was served.

Appeals5 (1) A person on whom a final notice is served may appeal against that notice—

(a) in England and Wales and Scotland, to the First-tier Tribunal;

(b) in Northern Ireland, to a county court.

(2) The grounds for an appeal under this paragraph are that—

(a) the decision to impose a financial penalty was based on an error of fact,

(b) the decision was wrong in law,

(c) the amount of the financial penalty is unreasonable, or

(d) the decision was unreasonable for any other reason.

(3) If a person appeals under this paragraph, the final notice is suspended until the appeal is finally determined or withdrawn.

(4) On an appeal under this paragraph the First-tier Tribunal or the court may quash, confirm or vary the final notice.

(5) The final notice may not be varied under sub-paragraph (4) so as to make it impose a financial penalty of more than £5,000.

Recovery of financial penalty6 (1) This paragraph applies if a person does not pay the whole or any part of a financial penalty which, in accordance with this Schedule, the person is liable to pay.

(2) In England and Wales the local weights and measures authority which imposed the financial penalty may recover the penalty or part on the order of the county court as if it were payable under an order of that court.

(3) In Scotland the penalty may be enforced in the same manner as an extract registered decree arbitral bearing a warrant for execution issued by the sheriff court of any sheriffdom in Scotland.

(4) In Northern Ireland the Department of Enterprise, Trade and Investment may recover the penalty or part on the order of a county court as if it were payable under an order of that court.

(5) In proceedings before the court for the recovery of a financial penalty or part of a financial penalty, a certificate which is—

(a) signed by the chief finance officer of the local weights and measures authority which imposed the penalty or (as the case may be) issued by the Department of Enterprise, Trade and Investment, and

(b) states that the amount due has not been received by a date specified in the certificate,

is conclusive evidence of that fact.

(6) A certificate to that effect and purporting to be so signed or issued is to be treated as being so signed or issued unless the contrary is proved.

(7) A local weights and measures authority may use the proceeds of a financial penalty for the purposes of any of its functions (whether or not the function is expressed to be a function of a local weights and measures authority).

(8) In this paragraph “chief finance officer” has the same meaning as in section 5 of the Local Government and Housing Act 1989.”

My Lords, we are coming to the final stages of the Consumer Rights Bill—an important reform of consumer law. I am looking forward to it receiving Royal Assent so that consumers have new, simplified rights when they buy goods, services or digital content and businesses can plan with certainty for the legislation to come into force.

The one remaining issue to resolve is the proposals for the secondary ticketing market. I would like to start by thanking those who have engaged in a really constructive dialogue with us over the past few weeks: the noble Lord, Lord Moynihan, and his team, other noble Lords, clerks of the House and the long-suffering departmental teams, both ministerial and official. It has been a long two months since we last debated the issue and I thought it would be helpful to give a summary of the issue and the Government’s proposals. Before I start, it may be helpful to make clear to noble Lords that I intend to support the amendment tabled by the noble Lord, Lord Moynihan, to facilitate the smooth passage of this important Bill.

The amendment to the Bill made by noble Lords at Report stage demonstrated the House’s concern about some aspects of the online secondary ticketing market. A range of issues were raised. The noble Lords, Lord Moynihan and Lord Grade, and others drew our attention to the level of fraud in the market, which was suggested by the National Fraud Authority to be £1.5 billion per year. The noble Baroness, Lady Grey-Thompson, and other noble Lords gave heart-wrenching examples of fans arriving at a venue looking forward to a wonderful evening only to be turned away because they had bought counterfeit tickets. They argued that the current rules in place to protect consumers were not effective enough.

The noble Baroness, Lady Heyhoe Flint, the noble Lords, Lord Clement-Jones and Lord Deben, and others had done their own research into tickets available on the secondary market and expressed concern about the lack of transparency. The noble Lords, Lord Holmes and Lord Moynihan, and others were concerned that alleged profiteering might be taking funding away from sports or cultural activity and reducing opportunities for genuine fans who could not afford high prices.

The noble Lord, Lord Stevenson, the noble Baroness, Lady Hayter, and the noble Lord, Lord Holmes, have been especially keen to resolve this issue as part of the Consumer Rights Bill, in order to allow fans to access events and have similar protection to that used for the London 2012 Olympics.

Of course, many of those who spoke, including the noble Lords, Lord Stoneham and Lord Borwick, the noble Viscount, Lord Younger, and the noble Baroness, Lady Wilcox, agreed with me about the importance of a thriving secondary ticket market and the need to ensure that the market remains open and competitive. I think that that sentiment is shared more widely across the House. The secondary marketplaces can provide a much safer environment for people to buy and sell tickets than other methods. If we can further increase confidence in the service that they can offer, I would hope to see their business flourish and grow.

The Government have been working hard to address the issues in the market. They are not easy issues, and we have been wary of unintended consequences at every turn. We have had to make some very difficult decisions, based on an uncomfortable evidence base. We have given the matter much attention and we now need to reach a conclusion.

The Government have tabled amendments to address some of these issues. The noble Lord, Lord Moynihan, has included our provisions in the most recent draft of his amendment. Our amendments are in two parts. First, we propose a statutory review of the secondary ticketing market. This will be a full review of consumer protection measures in the market. It will be independently led and it will be presented to Parliament. It will start this summer and must report within a year of the start date.

We need time to consult stakeholders and the individual leading the review before deciding on the detailed terms of reference and I know that noble Lords will want to express opinions on the matter. However, I can say that the review will broadly cover the following areas.

First, there will be an assessment of the current law and the changes we are making today. Noble Lords have rightly asked which laws apply to online ticket sales, and how effectively they are enforced. Secondly, it will cover business models in the market. Speakers in our debates have asked whether the market is dominated by consumer sellers or by traders; whether those in the market are seeking profits or mainly seeking to recoup their original costs; and whether national interests are supported. Thirdly, on access to tickets, I fully understand how frustrating it can be for tickets to sell out suspiciously quickly after release. The review will look at this, including the possibility that event organisers might deliberately restrict access to tickets to inflate prices artificially.

Alongside the review, the government amendments introduce a mandatory reporting requirement on the online ticketing marketplaces. Where they are aware of criminal activity they must report it to the police and the event organiser. Fraud is an underreported crime, so it is crucial to encourage those who are aware of fraud to report it so that law enforcement can be improved. This is a crucial step in eliminating some of the fraud that the National Fraud Authority found in the online ticketing market. The requirement mirrors regimes such as anti-money laundering rules and product legislation, where those who become aware of an issue must report it to the police and the relevant organiser.

Those are the two elements of the government amendments. I now turn to the amendment of the noble Lord, Lord Moynihan. In general this amendment balances the need to introduce transparency while allowing the secondary market to continue. Let me again stress that we want the secondary market to continue and we accept this amendment on the basis that it allows this. Our original instinct was that this market would flourish best without regulation. However, I have been persuaded to agree to some light-touch regulation.

The amendment of the noble Lord, Lord Moynihan, has two parts. The first part deals with transparency. This clause requires those selling tickets, and the marketplace where the ticket is resold, to provide the buyer with some basic information: the face value of the ticket; the seat number, where applicable; and any restrictions on the person who can use that ticket. Importantly, “buyer” is defined in the amendment as the person who buys the ticket—a change made yesterday by the noble Lord, Lord Moynihan. This will mean that consumers have enough information before they buy to make an informed choice and the right choice for them.

In addition, where the secondary market event organiser or certain other connected person—such as the parent company—is selling the ticket, rather than a simple consumer, they must continue to disclose their status as such.

I should make an important point here. The amendment which the other place rightly rejected included a requirement for individuals to give their name online and provide other unique identifiers, bringing with it the risk of identity theft. These provisions do not appear in the revised amendment of the noble Lord, Lord Moynihan.

As we have discussed at length in the House, transparency in this market could have awkward implications. Some comments made during our discussions have understandably raised concerns that event organisers would use the information provided to cancel tickets which are put up for resale, or blacklist the seller, preventing them from buying tickets in the future. This is definitely not what should happen. Our reading of these provisions, and the basis on which we accept them, is that cancelling tickets and blacklisting sellers is not fair or the right way to treat consumers.

I am therefore very pleased to see safeguards for sellers of tickets that will give consumers confidence to use the market. An event organiser will not be able to cancel a ticket or blacklist a seller merely because a ticket is resold or offered for resale unless there is a term in the original sales contract that allows for this and, more importantly, the term is fair. It is our firm view that terms which prohibit resale are not always fair and therefore will not be binding on the consumer. This includes terms which seek to prohibit resale at or above a particular price. These too are not always fair and should not be thought of as binding.

I am glad that at the end of the day we have found a compromise in the drafting of this clause. It will allow the secondary ticket market to continue to flourish. Fans who cannot attend an event will be able to resell their tickets. This will ensure that we have a lively and active resale market with numerous sellers competing for buyers, which will help to keep prices down.

There will of course be guidance on the new provision before it comes into force. Let me reassure the House that some guidance already exists and that enforcers are taking action in this sector, using a range of legislation. In that context, I would like to inform the House that the CMA has been conducting work into transparency in the secondary ticketing sector, including into some of the issues covered by these amendments. I am glad to say that it has already secured changes from the largest secondary ticketing platforms and expects to make an announcement in relation to this in the coming weeks.

These amendments address many of the points that your Lordships have raised in this House. Many more such points will be considered in the review. I therefore beg to move.

Motion A1

Moved by

As an amendment to Motion A, leave out “Amendments 12B to 12H” and insert “Amendments 12J to 12S”—

12J: After Clause 86, insert the following new Clause—



Duty to provide information about tickets

(1) This section applies where a person (“the seller”) re-sells a ticket for a recreational, sporting or cultural event in the United Kingdom through a secondary ticketing facility.

(2) The seller and each operator of the facility must ensure that the person who buys the ticket (“the buyer”) is given the information specified in subsection (3), where this is applicable to the ticket.

(3) That information is—

(a) where the ticket is for a particular seat or standing area at the venue for the event, the information necessary to enable the buyer to identify that seat or standing area,

(b) information about any restriction which limits use of the ticket to persons of a particular description, and

(c) the face value of the ticket.

(4) The reference in subsection (3)(a) to information necessary to enable the buyer to identify a seat or standing area at a venue includes, so far as applicable—

(a) the name of the area in the venue in which the seat or standing area is located (for example the name of the stand in which it is located),

(b) information necessary to enable the buyer to identify the part of the area in the venue in which the seat or standing area is located (for example the block of seats in which the seat is located),

(c) the number, letter or other distinguishing mark of the row in which the seat is located, and

(d) the number, letter or other distinguishing mark of the seat.

(5) The reference in subsection (3)(c) to the face value of the ticket is to the amount stated on the ticket as its price.

(6) The seller and each operator of the facility must ensure that the buyer is given the information specified in subsection (7), where the seller is—

(a) an operator of the secondary ticketing facility,

(b) a person who is a parent undertaking or a subsidiary undertaking in relation to an operator of the secondary ticketing facility,

(c) a person who is employed or engaged by an operator of the secondary ticketing facility,

(d) a person who is acting on behalf of a person within paragraph (c), or

(e) an organiser of the event or a person acting on behalf of an organiser of the event.

(7) That information is a statement that the seller of the ticket is a person within subsection (6) which specifies the ground on which the seller falls within that subsection.

(8) Information required by this section to be given to the buyer must be given—

(a) in a clear and comprehensible manner, and

(b) before the buyer is bound by the contract for the sale of the ticket.

(9) This section applies in relation to the re-sale of a ticket through a secondary ticketing facility only if the ticket is first offered for re-sale through the facility after the coming into force of this section.”

12K: Insert the following new Clause—

“Prohibition on cancellation or blacklisting

(1) This section applies where a person (“the seller”) re-sells, or offers for re- sale, a ticket for a recreational, sporting or cultural event in the United Kingdom through a secondary ticketing facility.

(2) An organiser of the event must not cancel the ticket merely because the seller has re-sold the ticket or offered it for re-sale unless—

(a) a term of the original contract for the sale of the ticket—

(i) provided for its cancellation if it was re-sold by the buyer under that contract,

(ii) provided for its cancellation if it was offered for re-sale by that buyer, or

(iii) provided as mentioned in sub-paragraph (i) and (ii), and

(b) that term was not unfair for the purposes of Part 2 (unfair terms).

(3) An organiser of the event must not blacklist the seller merely because the seller has re-sold the ticket or offered it for re-sale unless—

(a) a term of the original contract for the sale of the ticket—

(i) provided for the blacklisting of the buyer under that contract if it was re-sold by that buyer,

(ii) provided for the blacklisting of that buyer if it was offered for re-sale by that buyer, or

(iii) provided as mentioned in sub-paragraph (i) and (ii), and

(b) that term was not unfair for the purposes of Part 2 (unfair terms).

(4) In subsections (2) and (3) “the original contract” means the contract for the sale of the ticket by an organiser of the event to a person other than an organiser of the event.

(5) For the purposes of this section an organiser of an event cancels a ticket if the organiser takes steps which result in the holder for the time being of the ticket no longer being entitled to attend that event.

(6) For the purposes of this section an organiser of an event blacklists a person if the organiser takes steps—

(a) to prevent the person from acquiring a ticket for a recreational, sporting or cultural event in the United Kingdom, or

(b) to restrict the person’s opportunity to acquire such a ticket.

(7) Part 2 (unfair terms) may apply to a term of a contract which, apart from that Part, would permit the cancellation of a ticket for a recreational, sporting or cultural event in the United Kingdom, or the blacklisting of the seller of such a ticket, in circumstances other than those mentioned in subsection (2).

(8) Before the coming into force of Part 2, references to that Part in this section are to be read as references to the Unfair Terms in Consumer Contracts Regulations 1999 (SI 1999/2083).

(9) This section applies in relation to a ticket that is re-sold or offered for re-sale before or after the coming into force of this section; but the prohibition in this section applies only to things done after its coming into force.”

12L: Insert the following new Clause—

“Duty to report criminal activity

(1) This section applies where—

(a) an operator of a secondary ticketing facility knows that a person has used or is using the facility in such a way that an offence has been or is being committed, and

(b) the offence relates to the re-sale of a ticket for a recreational, sporting or cultural event in the United Kingdom.

(2) The operator must, as soon as the operator becomes aware that a person has used or is using the facility as mentioned in subsection (1), disclose the matters specified in subsection (3) to—

(a) an appropriate person, and

(b) an organiser of the event (subject to subsection (5)).

(3) Those matters are—

(a) the identity of the person mentioned in subsection (1), if this is known to the operator, and

(b) the fact that the operator knows that an offence has been or is being committed as mentioned in that subsection.

(4) The following are appropriate persons for the purposes of this section—

(a) a constable of a police force in England and Wales,

(b) a constable of the police service of Scotland, and

(c) a police officer within the meaning of the Police (Northern Ireland) Act 2000.

(5) This section does not require an operator to make a disclosure to an organiser of an event if the operator has reasonable grounds for believing that to do so will prejudice the investigation of any offence.

(6) References in this section to an offence are to an offence under the law of any part of the United Kingdom.

(7) This section applies only in relation to an offence of which an operator becomes aware after the coming into force of this section.”

12M: Insert the following new Clause—

“Enforcement of this Chapter

(1) A local weights and measures authority in Great Britain may enforce the provisions of this Chapter in its area.

(2) The Department of Enterprise, Trade and Investment may enforce the provisions of this Chapter in Northern Ireland.

(3) Each of the bodies referred to in subsections (1) and (2) is an “enforcement authority” for the purposes of this Chapter.

(4) Where an enforcement authority is satisfied on the balance of probabilities that a person has breached a duty or prohibition imposed by this Chapter, the authority may impose a financial penalty on the person in respect of that breach.

(5) But in the case of a breach of a duty in section (Duty to provide information about tickets) or a prohibition in section (Prohibition on cancellation or blacklisting) an enforcement authority may not impose a financial penalty on a person (“P”) if the authority is satisfied on the balance of probabilities that—

(a) the breach was due to—

(i) a mistake,

(ii) reliance on information supplied to P by another person,

(iii) the act or default of another person,

(iv) an accident, or

(v) another cause beyond P’s control, and

(b) P took all reasonable precautions and exercised all due diligence to avoid the breach.

(6) A local weights and measures authority in England and Wales may impose a penalty under this section in respect of a breach which occurs in England and Wales but outside that authority’s area (as well as in respect of a breach which occurs within that area).

(7) A local weights and measures authority in Scotland may impose a penalty under this section in respect of a breach which occurs in Scotland but outside that authority’s area (as well as in respect of a breach which occurs within that area).

(8) Only one penalty under this section may be imposed on the same person in respect of the same breach.

(9) The amount of a financial penalty imposed under this section—

(a) may be such as the enforcement authority imposing it determines, but

(b) must not exceed £5,000.

(10) Schedule (Secondary ticketing: financial penalties) (procedure for and appeals against financial penalties) has effect.

(11) References in this section to this Chapter do not include section (Duty to review measures relating to secondary ticketing).”

12N:Insert the following new Clause—

“Duty to review measures relating to secondary ticketing

(1) The Secretary of State must—

(a) review, or arrange for a review of, consumer protection measures applying to the re-sale of tickets for recreational, sporting or cultural events in the United Kingdom through secondary ticketing facilities,

(b) prepare a report on the outcome of the review or arrange for such a report to be prepared, and

(c) publish that report.

(2) The report must be published before the end of the period of 12 months beginning with the day on which this section comes into force.

(3) The Secretary of State must lay the report before Parliament.

(4) In this section “consumer protection measures” includes such legislation, rules of law, codes of practice and guidance as the Secretary of State considers relate to the rights of consumers or the protection of their interests.”

12P: Insert the following new Clause—

“Interpretation of this Chapter

(1) In this Chapter—

“enforcement authority” has the meaning given by section (Enforcement of this Chapter)(3);

“operator”, in relation to a secondary ticketing facility, means a person who—

(a) exercises control over the operation of the facility, and

(b) receives revenue from the facility,

but this is subject to regulations under subsection (2); “organiser”, in relation to an event, means a person who—

(a) is responsible for organising or managing the event, or

(b) receives some or all of the revenue from the event;

“parent undertaking” has the meaning given by section 1162 of the Companies Act 2006;

“secondary ticketing facility” means an internet-based facility for the re-sale of tickets for recreational, sporting or cultural events;

“subsidiary undertaking” has the meaning given by section 1162 of the Companies Act 2006;

“undertaking” has the meaning given by section 1162 of the Companies Act 2006.

(2) The Secretary of State may by regulations provide that a person of a description specified in the regulations is or is not to be treated for the purposes of this Chapter as an operator in relation to a secondary ticketing facility.

(3) Regulations under subsection (2)—

(a) are to be made by statutory instrument;

(b) may make different provision for different purposes;

(c) may include incidental, supplementary, consequential, transitional, transitory or saving provision.

(4) A statutory instrument containing regulations under subsection (2) is not to be made unless a draft of the instrument has been laid before, and approved by a resolution of, each House of Parliament.”

12Q: Clause 91, page 48, line 18, at end insert—

“(1C) Chapter 3B of this Part comes into force at the end of the period of two months beginning with the day on which this Act is passed.”

12R: Schedule 5, page 72, line 8, at end insert—

“section (Enforcement of this Chapter)(1) or (2) of this Act.”

12S: After Schedule 8, insert the following new Schedule—


Notice of intent1 (1) Before imposing a financial penalty on a person for a breach of a duty or prohibition imposed by Chapter 3B of Part 3, an enforcement authority must serve a notice on the person of its proposal to do so (a “notice of intent”).

(2) The notice of intent must be served before the end of the period of 6 months beginning with the first day on which the authority has sufficient evidence of the person’s breach, subject to sub-paragraph (3).

(3) If the person is in breach of the duty or prohibition on that day, and the breach continues beyond the end of that day, the notice of intent may be served—

(a) at any time when the breach is continuing, or

(b) within the period of 6 months beginning with the last day on which the breach occurs.

(4) The notice of intent must set out—

(a) the amount of the proposed financial penalty,

(b) the reasons for proposing to impose the penalty, and

(c) information about the right to make representations under paragraph 2.

Right to make representations2 A person on whom a notice of intent is served may, within the period of 28 days beginning with the day after that on which the notice was sent, make written representations to the enforcement authority about the proposal to impose a financial penalty on the person.

Final notice3 (1) After the end of the period mentioned in paragraph 2 the enforcement authority must—

(a) decide whether to impose a financial penalty on the person, and

(b) if it decides to do so, decide the amount of the penalty.

(2) If the authority decides to impose a financial penalty on the person, it must serve a notice on the person (a “final notice”) imposing that penalty.

(3) The final notice must require the penalty to be paid within the period of 28 days beginning with the day after that on which the notice was sent.

(4) The final notice must set out—

(a) the amount of the financial penalty,

(b) the reasons for imposing the penalty,

(c) information about how to pay the penalty,

(d) the period for payment of the penalty,

(e) information about rights of appeal, and

(f) the consequences of failure to comply with the notice.

Withdrawal or amendment of notice4 (1) The enforcement authority may at any time—

(a) withdraw a notice of intent or final notice, or

(b) reduce the amount specified in a notice of intent or final notice.

(2) The power in sub-paragraph (1) is to be exercised by giving notice in writing to the person on whom the notice was served.

Appeals5 (1) A person on whom a final notice is served may appeal against that notice—

(a) in England and Wales and Scotland, to the First-tier Tribunal;

(b) in Northern Ireland, to a county court.

(2) The grounds for an appeal under this paragraph are that—

(a) the decision to impose a financial penalty was based on an error of fact,

(b) the decision was wrong in law,

(c) the amount of the financial penalty is unreasonable, or

(d) the decision was unreasonable for any other reason.

(3) If a person appeals under this paragraph, the final notice is suspended until the appeal is finally determined or withdrawn.

(4) On an appeal under this paragraph the First-tier Tribunal or the court may quash, confirm or vary the final notice.

(5) The final notice may not be varied under sub-paragraph (4) so as to make it impose a financial penalty of more than £5,000.

Recovery of financial penalty6 (1) This paragraph applies if a person does not pay the whole or any part of a financial penalty which, in accordance with this Schedule, the person is liable to pay.

(2) In England and Wales the local weights and measures authority which imposed the financial penalty may recover the penalty or part on the order of the county court as if it were payable under an order of that court.

(3) In Scotland the penalty may be enforced in the same manner as an extract registered decree arbitral bearing a warrant for execution issued by the sheriff court of any sheriffdom in Scotland.

(4) In Northern Ireland the Department of Enterprise, Trade and Investment may recover the penalty or part on the order of a county court as if it were payable under an order of that court.

(5) In proceedings before the court for the recovery of a financial penalty or part of a financial penalty, a certificate which is—

(a) signed by the chief finance officer of the local weights and measures authority which imposed the penalty or (as the case may be) issued by the Department of Enterprise, Trade and Investment, and

(b) states that the amount due has not been received by a date specified in the certificate,

is conclusive evidence of that fact.

(6) A certificate to that effect and purporting to be so signed or issued is to be treated as being so signed or issued unless the contrary is proved.

(7) A local weights and measures authority may use the proceeds of a financial penalty for the purposes of any of its functions (whether or not the function is expressed to be a function of a local weights and measures authority).

(8) In this paragraph “chief finance officer” has the same meaning as in section 5 of the Local Government and Housing Act 1989.”

My Lords, I am very grateful to my noble friend the Minister for her careful consideration of the points that we made when we tabled the original amendment. We did so because we recognised that, based on the Government’s own figures, the level of online ticket fraud was of the order of £1.5 billion in 2012. That was of course a momentous year but that figure of £1.5 billion does not include the Olympic or Paralympic Games because, as your Lordships will recall, the opportunity was taken both in this House and in another place to criminalise the secondary market for that specific event. It is important to recognise that that figure of £1.5 billion was one where online ticket fraud occurred when victims purchased tickets for an event—such as music, sport, theatre or a performance—which did not materialise.

In the many hours of negotiation and debate, we have sought to address the causes of our concerns: that there is a very significant volume of counterfeit and invalid tickets sold to the public through the secondary sites. As 85% to 90% of resale now takes place through the four platforms, which are owned by three companies, the overwhelming majority of these invalid tickets come through those sites. The biggest problem in this day and age is not the old-fashioned tout. It is the wholesale harvesting of tickets by touts from their computers, with specialised software. They are incentivised by these four platforms, not least through power seller programmes. This harvesting is now out of control and volumes of tickets are acquired on such a scale that it is proving difficult, if not impossible, for genuine music and sports fans to purchase a ticket at face value for high-demand events. In the time when you are typing in your name, address and details, the specialised software is sweeping the volume of tickets available to the general public and within a matter of minutes, sometimes, those tickets are appearing on the secondary websites. The sheer number of tickets for high-demand events going on to the platforms is sufficient to facilitate price manipulation, to the detriment of the public.

Against that background, I would like to address a number of points that my noble friend the Minister has made. I say straight away that it is really important that anyone considering the position we are taking on this Motion recognises that there has been universal support throughout the proceedings in your Lordships’ House for a secondary market to thrive. But that secondary market needs to be effective; it needs to be transparent and accountable. That is the really important point. To use the words of my noble friend the Minister, we are seeking light-touch regulation to ensure that we can absolutely guarantee to individuals who want to go online the right level of information, from which they can then make a decision to purchase.

In the past, we have not had the legal support for consumers to have that information available. As the Minister rightly points out, the four key elements are information, face value, seat number and row number. It is absolutely right and proper that someone who is disabled or in a wheelchair knows that they can have access to that seat before they make that purchase. At the moment, that is not the case. Following this legislation, if your Lordships agree to the Motion in my name, all those details and information will be available before a decision is made and before the purchase takes place—not after the purchase has taken place. That is in subsection (8)(b) of the proposed new clause. It is an exceptionally important point for the secondary ticket operators to recognise when they implement this legislation, as I hope they do.

The second point is that for too long the terms and conditions set by the original event organisers have not taken full legal precedence. If you are the event organiser and you are putting on Glastonbury, for example, and request pre-registration to ensure that the person who is buying the ticket is pre-registered and, in the case of Glastonbury, that there is a photo—that is what the organisers want—it must be right that those terms and conditions take precedence. They do so because Glastonbury does not want touting. They do so because in many cases there are law and order issues. It should be right for theatres to decide whether they want children under the age of four, for example, to come to a performance when they might possibly disturb other people’s enjoyment of the evening. Those terms and conditions, however, must meet the fairness test and they must be legal. That is on the face of the Motion. That is vital, so that there is no avoidance of doubt: the action taken by event organisers in setting terms and conditions must meet the fairness test and must be legal.

The two Motions that were originally tabled by the Minister covered a duty to report criminal activity and the review. I am most grateful to her for her consideration of the many aspects of these tickets and the information that we wish to see provided on them. The matter has been considered in full by her team and, indeed, by her. I give one case in point. The movers of the original amendment were very keen to see a booking reference on the ticket. This would enable an individual to check with the event organisers whether that ticket was valid. Apparently, neither a booking reference number nor a ticket ID number falls within the “main characteristics” of a ticket and, therefore, under EU law, we cannot require that information to be provided. There are different legal opinions on that. There are many lawyers who believe that an essential characteristic —indeed, a main characteristic—of a ticket is its original ID number. We recognise, however, that government advice was that this is not the case. This is a compromise amendment and the result of many hours of negotiation. I hope that, when we come to the review, that issue will be looked at in more detail.

It is also important that, while we are putting the responsibility on the secondary market through this Motion to take a whole series of steps, at the same time we recognise that the event organisers need to reflect during the review on how they can improve the opportunities for resale. Resale is a difficult and sensitive subject, but to have good relationships with your consumers and your fans, looking at resale under certain circumstances is a very important priority for the event organisers. Wimbledon’s policy on non-transferable tickets is that, provided that the ticket is returned before the start of play, the buyer gets a full refund. The ECB allows face-value resale to family and friends; it will not cancel face-value on the secondary market. The Oval and Lord’s offer full refunds and ticket exchanges. The 2015 Rugby World Cup will have a full ticket exchange. So event organisers are very much aware of the importance of keeping good relationships with their fans and recognising that sometimes it is not possible to go to an event, maybe due to a family crisis, and that where possible resale policies should be put in place. I very much hope that, during the process of the very important review that the Minister has announced today, the question of resale will also be considered in detail.

It is right that when the Secretary of State at the DCMS, who has policy responsibility for this subject, appoints the chair of the review, he considers in detail the points raised in both Houses before proposing the final terms of reference. It has become clear from your Lordships’ interventions on all sides of the House, and from the excellent work of the all-party group on this subject led by Sharon Hodgson and Mike Weatherley, that a thorough investigation of the operation of the secondary market is essential. We need to understand why that £1.5 billion of fraud has taken place and to address it; we need to look carefully at the business models employed.

I also hope that the review will research the impact of touting on fans and events and the effect of excessive profiteering on the objectives set for event organisers. This is not just about sport and the arts; it is about the church, charities and events that reach out to the public, where anyone organising that event wants to ensure that the information is available to them. We need to research the impact on those individuals and what they may get if they have a counterfeit ticket. At the moment, if you have a counterfeit ticket, after much deliberation you may get back from the secondary site what you paid for it—but you have missed the experience. You may have travelled down from Glasgow with your family. Ultimately, many of the people who are reimbursed are reimbursed by their credit card companies, not by the secondary market. These are issues that need to be looked at carefully in the review.

Above all, we need to look at how technology is developing—how the website is being used to maximise the opportunity for touts to sweep tickets and then sell them at a high profit. We need to look at the effectiveness or otherwise of existing legislation and the ability of enforcement to tackle international platforms, working offshore in this sector. In this context, it is international co-operation by law enforcement officers and legislators that is important, as in the gambling market, and the co-operation undertaken in this context during the London Olympic and Paralympic Games would be a useful case study.

I hope that the review will look at the need for better enforcement of the Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013, particularly in defining what constitutes a trader. We need to look at what non-legislative measures can be taken by event organisers to prevent the unauthorised resale of tickets. I hope that we will look at model terms and conditions for ticket sales, and then ticket sale arrangements by primary event organisers and the relationship between event organisers, the contractual relationships with primary organisers and ways of putting the interests of the consumers—in this case, the true fans—first. I have mentioned that I very much hope that the review will explore with the European Commission what precisely constitutes a main characteristic of a ticket; it is only recently that the directive has been published and implemented, and we need clarity on the issue. The review will give us the opportunity to look into it in detail. Above all, there are two case studies within the timeframe of the proposed review: we will have the chance of reviewing the Ashes test and the Rugby World Cup.

For those who are writing, or about to write, manifestos, it would be worth while reflecting on a Populus opinion poll on this subject. There has been a lively campaign of emails to many of your Lordships on the unpopularity of these measures. I can bring the House up to date: in that Populus poll, the question was put whether there should be more government regulation of ticket sales, and 68% of the public agreed while 8% disagreed. Then of course there were the categories of “somewhat disagree”, “strongly disagree” and so on. On the question of whether ticket sellers should be made to disclose the ticket row and seat number—basic information that any consumer should have before making a decision to purchase—76% of the public supported the intent of the Motion that we are laying before the House today, and a mere 3% disagreed. If noble Lords want a populist measure that is also the right one for consumers in their manifestos, whichever party they represent, I cannot imagine a stronger level of public support than they would find for the measures that we have worked so hard for. My noble friend Lady Heyhoe Flint has been second to no one in the amount of work that she has put in to secure the consensual agreement that we have reached with the Government today.

It will not have escaped noble Lords’ attention that the Secretary of State in the Department for Culture, Media and Sport has clear views on this subject, which I very much respect. I want to thank him and his team for their engagement in the lengthy negotiations and their courtesy in staying heavily involved. When I was Member of Parliament for Lewisham East, as one of the only two Conservatives in the history of that seat—the other being Christopher Chataway, whose passion for sport knew no bounds—Sajid Javid was an impressive officer of that association, before he embarked on his successful career both inside and outside Parliament. I consider him a friend and I think very highly of him. I thank him again and wish him well with implementing in full the statutory review.

I have no doubt that the measures taken today will in due course strengthen the secondary market, address the excessive profiteering which has been the product of an unregulated, web-driven market, and consequently enable the Secretary of State to strengthen further his support for this industry. In the mean time, my thanks go out to the BIS team. As I have said, there are strong views on both sides of this debate and it is not without humility that, having recently seen the wonderful film “Testament of Youth”, I am reminded of the passage in Vera Brittain’s book Testament of Friendship, in which an epitaph on a gravestone erected by a certain Major Milner to his wife Dorothy in 1826 reads:

“What faults you’ve seen in me, strive to avoid. Search your own hearts, and you’ll be well employed”.

On this occasion, the faults that they have seen in me have dominated proceedings. They have been patient, professional, calm and understanding during two months of almost daily negotiation, either on the phone or in person, including every single day of last week’s recess. I offer my special thanks to them and to the Public Bill Office, and to Ashley Lumsden, the special adviser from BIS, who has commanded the highest respect from everyone who has been involved in these negotiations for his indefatigable work.

This Motion is only the beginning. I look to the Government, the secondary market and primary event organisers to make sure that it works. In so doing, I congratulate my noble friend the Minister on securing what I hope will be the safe passage of this excellent Bill. I beg to move.

My Lords, as a signatory to the original amendment and a member of the All-Party Group on Ticket Abuse, I very much support Motion A1 and I am absolutely delighted that the Government do as well. To say the least, this has been a cliff-hanger. I hope that my noble friend Lord Moynihan, Sharon Hodgson MP, Mike Weatherley MP, and of course my noble friend Lady Heyhoe Flint, all get roles in a remake of “Chariots of Fire” for their efforts in securing this agreement, which will benefit music and sports fans immensely. My noble friend Lord Moynihan in particular has been incredibly tenacious in his pursuit of the right solution and I pay strong tribute to him. I also pay tribute to my right honourable friend Vince Cable, my noble friend Lady Neville-Rolfe, my honourable friend Jo Swinson and their adviser Ashley Lumsden, who have been instrumental in forging a deal in BIS and in convincing their colleagues in the DCMS to adopt the solution before us today.

When our amendment came before the House of Commons in January, my honourable friend Jo Swinson said:

“A careful balancing act is needed. We want to make sure that as many people as possible can access events, whatever their means. We want sports and entertainment in the UK to flourish. We … want to protect consumers and allow the ticket resale market to work as well as it can”.—[Official Report, Commons, 12/1/15; col. 657.]

I believe that these clauses will do all this. My honourable friend also criticised the previous amendment, which was passed by this House. She said that there were,

“difficulties involved in Lords amendment 12”.—[Official Report, Commons, 12/1/15; col. 658.]

She said that it would require sellers to provide their name, that it would enable event organisers to cancel tickets put up for resale and that,

“more stringent information requirements would go beyond the provisions set out in the consumer rights directive”.—[Official Report, Commons, 12/1/15; col. 660.]

Again, I believe that these clauses meet those objectives. These safeguards now set out in the Bill will be much more reliable than the assurances belatedly given by the secondary sellers or the information on their websites.

To be clear, this is not about closing down the secondary market. A secondary market that works in the interests of fans buying and selling tickets is reasonable; an opaque stock exchange with links to criminal activity is not. I hope that this amendment will ensure that the secondary market is the former. These transparency measures are good news for fans looking to buy tickets, and do not impose an unfair burden on sellers. It is also good to see that Ministers will support measures which uphold fair and reasonable ticket terms and conditions. Ticket terms and conditions must be fair in law, and the new Motion recognises this.

Just as a reminder, serious money is involved in ticket touting. A single Rugby World Cup final ticket is on sale on StubHub today for £59,000. No tax is being paid; the seller is anonymous, and may even work for the secondary platform; and the buyer has no guarantee about where the seat is. These amendments will introduce some much needed transparency, and then we will also have the statutory review, to which my noble friend referred, to ensure that the market is operating fairly.

I welcome that the review of the law and its effectiveness and what can be done to improve it, in particular as regards enforcement, is enshrined in today’s amendments. There are a number of questions for review, which my noble friend went through, such as: will this stop speculative sales? Rugby World Cup tickets were on sale on secondary websites before the organising body had even set the ticket prices and launched the application process. Is the £5,000 fine adequate? I hope that all this will include looking at how to tackle bulk-selling and how effectively to enforce the law against traders impersonating consumers to evade consumer law. However, that is an ongoing matter. We have come today to the right conclusion, and I congratulate all those involved.

My Lords, it gives me great pleasure to briefly say a few words on this good news day for sports fans. It is fair to say that it has been a long time coming, but in the measures that we are adding to the Bill today we are giving greater choice and information to sports fans to help in the fight against those who commit fraud or seek to exploit the pockets of hard-working families.

My own role in this battle dates back two decades to 1994, when I led from the Labour Benches in the other place a campaign to have the then Government extend the provisions they were introducing to ban ticket touting at football events to other sports in the Criminal Justice and Public Order Act 1994. We were partly successful in that we had reserve powers added to that Bill to allow the Home Secretary of the day to designate other sporting events.

Ever since then, together with other Members of both Houses, from all parties, I have called for more effective action as the problem has grown and grown, especially with the introduction of the internet, which created a fertile new environment for the problems we have heard explained so well by the proposer of this Motion. I therefore wholeheartedly endorse the measures being added to the Bill. Most of all, I pay tribute, as others have done, to the noble Lord, Lord Moynihan. He was battling 21 years ago in support of the kind of measure we have here now, and is still fighting as hard as ever to protect the sports that he loves.

I have spoken to some sports governing bodies today, and I know that they are hugely grateful for the enormous amount of time and effort that the noble Lord has put into this issue ever since the amendment was voted for by this House in November. There have been many hours of meetings with Ministers, Bill teams, lawyers and experts, and that shows in the well balanced and fair proposals that have addressed the concerns raised by the House. Certainly on this issue, I think that the House will respond favourably to the words of the noble Lord and the amendments. Through his grasp of how the sports sector works and of the way to get things done in this place, we now have an effective improvement in the law and, alongside it, a review that allows the matter to be considered in greater detail. I hope that the noble Lord’s expertise will remain on tap for the review; he will certainly add weight to it.

One reason why the noble Lord, Lord Moynihan, was committed to this cause was that he saw how the London Olympics benefited from a touting ban. He was determined that what was right for that showpiece event would work for other sporting events. It is an example of using the legacy from London for the wider good. I wish only that the Department for Culture, Media and Sport would put as much effort into securing improvements in participation in sport as a legacy as the noble Lord has—I could say “my noble friend”, because in this context he certainly is a noble friend of mine because of his love of sport.

That brings me to a final point and a question for the Minister. The Rugby World Cup 2015 starts in just six months’ time. Can she confirm that the measures that we are passing today will be operational for that event? If she cannot give that commitment today, will she work hard to see that that is brought about? I will end as I began, in saying that it is a good news day for literally thousands of loyal sports fans, and also for major sports organisations, which wish to sell tickets to real fans, not to investors who wish to make quick profits. These measures are all about putting limits on “Rip-off Britain” for the public benefit.

My Lords, this Bill, as the name suggests, is supposed to be about protecting consumers—indeed, most of it does. However, this recently tabled amendment, which places new duties on ticket sellers in secondary markets, could actually allow consumers to be ripped off under the guise of protecting them. All the tickets which the sports and music bodies are concerned about will now go back to being sold in pubs, clubs and car parks, where no consumer protection exists, so this amendment could increase fraud by forcing customers to buy tickets on the street. It is no surprise that the amendment is completely out of step with public opinion.

I am sure that I can trade polling statistics with my noble friend. Polling by ComRes shows that 80% of the public support the right to resell tickets, 64% believe that they should be allowed to pay more than the face value of a ticket to get into a sold-out event, and 66% believe that event organisers should not be allowed to restrict what happens to a ticket once they have sold it. We could see thousands of fans criminalised if they do not provide the right information on their listings. The reality is that a seller will not provide the right information if they think that their ticket could be cancelled. They could provide adjacent seat numbers, for instance, and other fans could then see their tickets cancelled, causing havoc at the event.

The treatment of the secondary market in ticketing is completely out of step with other online markets. Is there a need to declare where what you are selling comes from when you are selling goods on Amazon, for example? These proposed new clauses try to deal with an issue that does not exist. The wording of the amendment is clever in that it seems to provide a protection against ticket cancellation, but this protection is meaningless as it does not apply where there are terms and conditions which state that tickets will be cancelled if they are resold. The wording makes it clear that terms and conditions used to enforce cancellation should not be unfair terms under the Unfair Terms in Consumer Contracts Regulations. This is because certain restrictions such as terms and conditions which allow resale at face value have been judged as not in breach of these regulations. This means that event organisers will be able to impose a de facto price cap on resale. Event organisers will be able to use the law to enforce their own commercial terms and conditions. We are about to give event organisers total control over tickets after they have been sold. This is a carefully constructed legal monopoly. Will my noble friend the Minister assure me that one of the subjects to be looked at in the review is how the number of people employed in the secondary ticket market has changed, and how the market share of the ticket issuers has changed?

My Lords, following the debates on the subject of secondary ticketing in Committee and on Report, which caused considerable polarisation of views across party lines, I am pleased that today there appears to be good agreement on the way forward. I know that my noble friend the Minister has worked assiduously to find common ground. Reaching this point today is an example not just of how effective this House can be in spending the necessary time discussing the detail, analysing the issues with all those concerned, reviewing and scrutinising the law and moving forward, but also of how many company boards work with much interaction on challenging issues, which takes place initially behind the scenes, enabling the final decisions to be made in situ with relative accord and rapidity. To that extent, it would have been interesting to have secured my ticket to be a fly on the wall at some of these discussions, in which case there would have been no pillar impeding my view and I would not have needed the guarantee of a seat number. However, I would have needed a guarantee from the event organiser that there were no spiders’ webs—real or political, perhaps.

Although I welcome the Government’s willingness to act to address many of the strong concerns expressed on the secondary ticketing market through their Amendments 12B to 12H laid today, and their agreement to the amendments tabled by my noble friend Lord Moynihan, this is the beginning of a journey, as my noble friend said. First, there were clarion calls from some quarters for the secondary ticketing market to be banned. It is pleasing that there is now a general view that the secondary ticketing market has a necessary place in allowing fans to purchase seats for cultural and sporting events. A corollary of this is that it makes it more likely that seats at events will be filled—a frustration often expressed by observers and would-be fans.

It is now also accepted that the issue under debate, described generically as secondary ticketing, is much more complex. However, there is a main concern over sharp practice at best and fraud at worst. The victims are those, of course, who buy bona fide tickets and find that they are invalid. Along with some other noble Lords, I am adamant that there is legislation in place to protect against fraud but that it has to be made to work, with prosecutions, recompense for victims in relation to detriment suffered and with deterrents to putative fraudulent activity. I have also mentioned the need for more transparent and detailed guidelines for ticket operators and consumers, which is very much in the spirit of the Consumer Rights Bill, but without creating any unnecessary new bureaucracy.

Therefore, I welcome the move to make it mandatory for online ticket marketplaces to have to report criminal activity to both the police and the event organiser. Many of the persistent secondary ticketing troubles emanate from illegal websites, so the Action Fraud initiative as a national reporting centre for fraud and internet crime is to be welcomed. Of course, with the emergence globally of millions of websites, the question of how to regulate, monitor and harness the web is a matter for all Governments in all countries across most sectors. Therefore, my first question to my noble friend the Minister is: how proactive will this Action Fraud unit be, or is it merely a reception centre for reporting such crime?

The House may like to be reminded of the success of PIPCU—the Police Intellectual Property Crime Unit. Deep in the City of London some highly effective work is being carried out to identify fraud proactively, to intercept and to prosecute the owners of websites who are effecting and facilitating the transit of counterfeit and pirated goods into this country. In terms of the work it does, to what extent could the Action Fraud unit link up with, or learn from, PIPCU’s experience?

My main question about the statutory duty to report is: how can we know if the online marketplace is not reporting crime? Subsection (3)(b) of the new clause proposed in Amendment 12B states that the duty to report applies when,

“the operator knows that an offence has been or is being committed”.

Surely it should additionally apply to operators who suspect that an offence might be committed. Do we not seek the early tip-off? How proactive a role is the enforcement authority expected to have? To borrow a phrase used in an earlier debate by my noble friend Lord Clement-Jones, “Not a clue, guv”. There is a danger that a market operator will be able to turn a blind eye to a criminal activity, where he can legitimately say that he was not aware or could not have known. The enforcement authority will have the leeway of needing to be satisfied that on the balance of probabilities a person has breached the duty—but will the onus of proof be too difficult to establish, and too costly to work effectively, to achieve prosecution and for a fine to be imposed?

Finally on the duty to report, I wonder whether the cap of £5,000 provides an adequate deterrent for failing to report. The Minister may reply that she thinks it proportionate. However, I suggest that the stakes could be raised by doubling the maximum fine—on the basis that a fine is payable only if a suspected crime, which turns out to be an actual crime, is not reported. Your Lordships may be interested to be reminded that, for example, a fine of up to £20,000 is payable by employers for not paying the minimum wage.

I turn now to the second, welcome, element of the Government’s amendment—the statutory review. I welcome it because it will start as soon as possible and will have a tight reporting period. The purpose of the review is to address many of the complex issues relating to ticket sales, but it is as yet unclear what the terms of reference will be, and what such a seemingly catch-all review will cover. I have heard that it should encompass some aspects of the operation of the primary market—such as the sensible and proportionate block-booking of tickets by the RFU or the ECB for rugby or cricket events where clubs or schools are the beneficiaries. The review should also cover unscrupulous block-bookers who seek to make an unhealthy profit by selling on.

As my noble friend Lord Moynihan said, there is the question of who is defined as a consumer and who as a trader. Conversely, there is also the need not to have a chilling effect on the secondary marketplace. There is the issue of guidelines for contracts for ticketing for myriad events, and also the question of how to protect UK sports, theatre or concert fans who choose to book tickets for UK events through operators or sites overseas. I am pleased to hear from the Minister that the CMA is playing an active role and is taking some action. I ask the Minister for reassurance that the Government know that the review needs to be particularly wide ranging, but also tightly worded, to be effective and useful for taking the several steps forward that are needed in 2016. I note her encouraging comments today.

Finally, in repeating my support for the Government in acknowledging the valuable role of the secondary market, I add that the amendment would have been improved by the inclusion of a sunset provision for the review, perhaps at the point when it reports its recommendations. I ask my noble friend to comment on that. There will always be persistent fraudsters, but I welcome the consensus today that the review, while not providing all the solutions that some seek now, does provide us with a sensible platform from which to establish some concrete facts and to analyse the different elements of a complex landscape.

My Lords, I do not wish to detain the House long, as I understand the real reason why everybody is here. However, I wish to make one or two points, particularly as I disagreed with the proposers of the amendment at earlier stages of the Bill.

First, I congratulate my noble friend Lord Moynihan on his persistence and cheerfulness as the long-distance runner on this issue. I congratulate both him and the Minister, my noble friend Lady Neville-Rolfe, on having worked so hard in the last few weeks to arrive at a workable compromise. I have enjoyed working on this Bill with them, with my noble friends Lady Jolly and Lady Bakewell, and with the noble Baroness, Lady Hayter, and her colleagues on the Opposition Benches. I acknowledge the mutual courtesy and constructiveness that have been displayed at all times.

I accept that this compromise can provide more transparency in the marketplace in the interests of consumers, but we have always maintained that that must not be at the expense of the recognised and reputable operators in the secondary ticketing market. I am pleased that my noble friend Lord Moynihan acknowledged that these proposed changes have been designed to protect the reputable secondary ticketing market. He recognises that there is public support for greater regulation, but there is also wide public support for having a system of secondary ticketing. This proposal is better than encouraging people to go back to the ticket touts at events—or, indeed, using online and offline classified advertising.

On this side particularly we welcome the 12-month review of consumer protection issues relating to secondary ticketing. I reiterate the points that my noble friend Lord Moynihan made. I hope that the review will cover the wider issue of wholesale ticketing harvesting—the computer programs designed to circumvent procedures designed to contain sales to individuals, and how they can be best countered. I hope it will also examine and promote best practice techniques and the phasing of ticket sales, which maximise the chances of real fans obtaining the tickets.

There is, however, one final concern that should be expressed. I was glad to have the Minister’s reassurance on this matter; I hope that she can speak again on it without reservations. We welcome the compromise restricting event organisers’ ability to cancel the tickets that have been legitimately sold if they are identified in the secondary ticket market. However, the proposed new clause permits cancellation if the resale terms flout the terms and conditions of the ticket. That could cause confusion. I understand that it is right that the original seller should apply a cancellation if, for example, an adult was sold a child’s ticket. Can the Minister repeat that it will be completely unacceptable to have a blanket condition in ticket terms and conditions banning all resales—and, indeed, resale at a higher value? If either of these conditions prevailed it would drive a coach and horses through what we assume are the good intentions of this compromise. It would appear to be an unreasonable and unfair restraint for consumers in the ticketing market.

Apart from that, I welcome this compromise. I look forward to seeing it properly implemented.

My Lords, the A1 is a beautiful road linking north and south. Motion A1 is a beautiful Motion, linking the sports fan back to the sport and the music fan back to the gig. It goes to the heart of a problem that has dogged sport, music and live entertainment for decades in this country. It is a great day for the sports fan and a fantastically bad day for the fraudster. Let the fraudster—the cyber, sheepskin-clad fraudsters—begone. This will make a tremendous difference to anybody who truly has sport, music, art, cultural and creative events in their hearts in this country.

There will be much to discuss in the review—many minutiae and details need to be bottomed out. I also believe there is still much that sport and music promoters can do to further protect their product and truly drive the primary market in tickets for their events. This is a great amendment and a great day across sport and music. It is testament to my noble friend Lord Moynihan, who has shown dogged determination over months to get us to this stage. The man from Monmouth has coxed this amendment to a successful and superb conclusion.

My Lords, I thank my noble friend Lord Holmes for bringing such a smile to my face. I love the word “dogged” here; I know he has a beast of a similar persuasion at his feet. The vision of a sheepskin-clad fraudster outside Lord’s when it is 75 degrees in the summer trying to get rid of his tickets brought a wonderful degree of levity to the occasion.

As I have spoken at every stage of the Bill on this issue, I hope the House realises how strongly I have felt about seeking to establish a fair market for sport and entertainment. I hope by the time the Minister has stood up there will have been reassurance to my noble friends Lord Borwick and Lord Stoneham for the slight concerns they have in certain areas. Secondary selling has now had an enormous amount of scrutiny and I am convinced that we have got to the right point in the Bill, crafted with so much ability and long-life energy by my noble friend Lord Moynihan. He has worked so enormously hard that he deserves to sit down in a darkened room after this and have a break. It really has been quite remarkable.

I declare an interest as a board member of the England and Wales Cricket Board and I hope I do not offend any Scots when I say thank goodness that England managed to beat Scotland in the World Cup a few days ago. No disrespect to the Scots but I might not have been able to walk through the door had that not happened.

The amendment before the House is not as comprehensive as the one we voted for just before Christmas but after lengthy negotiations, as mentioned by my noble friend, it addresses the key concerns raised and introduces—in that wonderful phrase—some new light-touch regulation. Alongside this it introduces the statutory review which many of my noble friends have complimented, and it is hugely welcome.

I too thank the Minister for the enormous amount of time she has spent considering this issue with all of us championing the cause, and for making her officials so available. That is so important and they helped us to drive through and draft this Motion. It will benefit fans of sport and entertainment across the country and up and down the A1—this is an A1 Bill, we must not forget that—and it has been greeted with huge congratulations from hundreds and thousands of people within the worlds of sports and entertainment. I almost feel that we should break out into a Mexican wave when we reach the conclusion of today’s discussions.

As we have heard, the Motion protects the consumer on the reselling of tickets by introducing the basic information we have so desperately wanted. Crucially, it does not in any way prohibit or ban the resale of the tickets. Concern was voiced before during the passage of the Bill about what information should be required and it is clear that we have sought to protect privacy issues by neither the name nor the address of the seller being given.

The information reporting set out in the Motion is important. It provides a way of detecting fraud and misleading selling. Indeed only last week, as my noble friend Lord Moynihan mentioned, the DCMS acknowledged that it was important that information was provided at the point of sale so that both consumers and event organisers could be certain whether listings were of genuine tickets. This will help to eradicate the curious practice used by many sites of tickets being listed for sale before they have even gone on sale officially by the event organisers and the venues. It is quite remarkable. The review to be established will assess if any further information is required or whether we have got the balance right first time. I hope it is the latter.

When this measure becomes law, those who buy a ticket from a secondary seller will receive exactly the same information and protection when they make the purchase as they would expect to receive when purchasing directly from the event organiser. They will know the value that the event holder has placed on the ticket—its face value—and the exact location of the seat. They will also have the option of checking with the event organiser that it is a genuine ticket. It is simple and effective.

Let us reassure the House about how this amendment would work in relation to the rights of the consumer. It is clear that event organisers will be able to uphold only terms and conditions which are fair and which have been communicated to the public when they buy the tickets. Nothing will come as a great surprise to the purchaser of the tickets. It will not have an adverse impact on the ordinary fan who wants to sell on a ticket if he or she cannot attend. All major sporting events—and, we assume, entertainment—either have exchange mechanisms or allow some form of resale at face value. It is hoped that this will encourage the best practice already identified by my noble friend Lord Moynihan concerning the theatre ticket and the terms and conditions on the back of it. Presumably no four year-olds are allowed to go and watch “Fifty Shades of Grey”, as that might contravene the terms and conditions.

Nowadays, for example, the ECB has no intent to cancel tickets sold on at face value, and it already allows the transfer of tickets. This is a form of governance that should be imitated and copied by any event organiser or governing body. It will not cancel those tickets if sold on the secondary market, and why on earth should it? That would cause reputational damage and would no doubt lead to investigation and complaint, as well as turn away and turn off genuine fans.

With the security of this amendment, event organisers will be empowered to take action against the worst abusers of ticket terms and conditions, as has already been mentioned. This covers issues such as fraudulent sales, bulk ticket sales by professional touts—not always in sheepskin jackets—and the use of bots to purchase tickets. To the uninitiated, a bot is a computer program that repeatedly logs in to buy tickets automatically. My noble friend referred to it as “harvesting” tickets; I refer to it as “hoovering up” tickets, but perhaps harvesting is more his scene and hoovering may occasionally be mine. It also covers the advance selling of tickets not yet on sale, as I have already mentioned, exploitative touting, and concession tickets sold to the wrong people in the wrong place, which can lead to embarrassment and discomfort.

The passage of this Bill will play a role in helping the UK to maintain our position as an open and honest showcase for international sports and entertainment events in this country, attracting millions of fans to our venues annually.

Cricket venues are doing everything they can to keep prices affordable, to encourage family audiences and not to overprice the market. However, visiting one or two of the websites referred to and looking at Ashes test match ticket sales, one can see that an averagely priced ticket costing £100 is currently on offer at at least £600. It is possible to get a ticket with a full hospitality package in one of the stands costing £1,950. I thought, “That must be a very expensive meat pie that they sell at Lord’s”, but it just shows what an amazing, incredible and dishonest mark-up is put on these tickets. It is completely unfair to supporters, who are denied the opportunity to attend major international events.

We have provided much needed protection to fans who spend their hard-earned money watching the sport they love. Those fans or consumers deserve our protection. I do not wish to sound triumphant but I know that there is a collective huge sigh of relief that common sense has prevailed. Now, hundreds and thousands—nay, millions—of fans can give a standing ovation to my noble friend the Minister and her team, as well as to my noble friend Lord Moynihan, for helping to protect the hard-working fan.

My Lords, I see no reason why the noble Baroness, Lady Heyhoe Flint, should not feel triumphant. I think that is the right approach, and I join her and others in thanking the noble Lord, Lord Moynihan, who has done so much to bring us here, and also, as others have said, the Bill team; the sports and arts bodies; my colleague Nicola Jayawickreme, who has seen us through this; my noble friend Lord Stevenson, who alas is in a jungle today and cannot be with us; my gig-attending honourable friend Stella Creasy, who fought this much more alone, I have to say, in the other place; and also, if rather at the wire, the Government.

However, given that this will affect some of our premier sports, perhaps that final spurt, the holding of our collective breath till the very last moment when the line was crossed, and the smiles and cheers at the Minister’s words are particularly appropriate. Indeed, had the Minister sung her speech, that would have reflected as well the arts world’s relief that sense has prevailed and that genuine fans of music or sports will have access to the best without having to witness only those with the deepest pockets being able to pay to see the best of British performers, whether on the track or on the stage.

Furthermore, the money paid by fans will now, we hope, go to the promoters or the performers but will not be skimmed off by those who buy tickets purely to make excess rent, in the economic jargon. This was never an issue of individual fans wanting to sell the odd ticket they could no longer use. It is, as has been said, about industrial-scale touting—the buying up of sheaves of tickets to make a quick bang—and it is that that Motion A1 seeks to address.

We know that the Government had strongly resisted until almost the very last moment Motion A1 and all attempts to tackle an industry that makes a few people very rich but sucks money not just from fans but from sports and arts bodies—those that want to keep prices within the reach of all, not just the rich, so that ordinary rugby club members can go to Twickenham, tennis players to Wimbledon and music fans to their favourite gigs.

I remember that some years ago Paul Hamlyn opened the opera house—I think to celebrate his wife’s birthday—simply to groups of young people or community groups. I took 20 people there who would never have gone into the opera house without this. I will remember their faces, I think, for as long as I live, and the delight they had. I think they paid £10 a seat. In today’s world, with today’s methods, all those tickets would have been hoovered up and all those people denied that wonderful chance to go there.

Today the Government have accepted that it is time to deal with that industry, and we are delighted. There are of course issues not yet covered by the Motion, but these can fall to the review to consider. I hope the Minister can assure us that both sporting and arts representatives will be consulted on the choice of chair as well as on the terms of reference so that we learn from other inquiries. To add to the mix that has already been mentioned, I also ask that the Government consider for the review research into the impact of touting on fans and events, the effects it has in terms of pricing out ordinary fans and the wider reputation damage to events. They should also consider actions on bots, which have been explained to us, and enforcement of existing legislation; also, what constitutes a ticket—is it a piece of paper or is it the right to attend an event? Finally, they should consider whether the ticket identification number needs to be added to those tickets where there is no block, row or seat number.

Today, as the noble Viscount, Lord Younger, suggested, shows a job well done by your Lordships’ House. This final change will strengthen the Consumer Rights Bill. I think it is a triumph for the rights of consumers, in this case in the guise of fans and supporters. We wish the whole Bill well as it gets its final sign-off from the other place.

Before the noble Lord, Lord Moynihan, responds, perhaps, rather than repeating them, I will say that I share the many tributes that have been made during this debate to and by the noble Lord, Lord Moynihan. They have been made by the noble Lords, Lord Clement-Jones, Lord Stoneham and Lord Holmes, the noble Baronesses, Lady Heyhoe Flint and Lady Hayter, and the noble Lord, Lord Pendry, with his deep knowledge of the football world. On his question, the Bill provides for the measure to come into force two months after Royal Assent—so ahead of the Ashes and the Rugby World Cup, I hope.

I am also grateful for the points made by my predecessor, my noble friend Lord Younger, who did so much for enforcement of IP and the battle against counterfeiting. I will take away his various ideas, notably for dealing with fraud, and look forward to discussing his questions with him and feeding them into the review. I was also interested in his reference to sunsetting, which is one of the ideas that we look at in our Better Regulation work in the business department.

My noble friend Lord Borwick raised two important issues relating to how the amendments affect the secondary market in terms of employment and market share. As has been said, we have yet to set the terms of reference for the review, but I assure him that those issues will be considered for inclusion. He also expressed the concern that the amendment might criminalise consumers who give incorrect information. I reassure him that it will not introduce any criminal offences; the enforcement is but by civil penalties.

I can confirm that the blanket protection on ticket resale of the kind cited by the noble Lord, Lord Stoneham, is not provided for in the amendment. I reiterate what I said earlier on this important point: terms that prohibit or restrict resale above a particular price are assessable for fairness. They are not always fair and are not binding on the consumer if that is the case.

This is, of course, a compromise provision. The Government were not willing to jeopardise the passage of the Consumer Rights Bill. Therefore, while we share some of the concerns raised about how the industry could interpret the new legislation, it is up to it to show that it treats all fans fairly and to make these changes a success. We have a statutory review, which will be an opportunity to look at this matter and at many of the issues debated today. I know that this House will be very interested in the results of the review and that many noble Lords will feed in their thoughts and ideas. I should make it clear, as the noble Lord, Lord Moynihan, touched on the subject, that the review is a joint one between the DCMS and BIS—the reviewer is to be appointed jointly by the two Secretaries of State. I note the various points made by the noble Baroness, Lady Hayter, and will take them away to ensure that we have the right independent chair and the right terms of reference.

I thank noble Lords for their expert scrutiny of the Bill, and in particular for the provisions we are discussing today. I look forward to the Bill receiving Royal Assent.

My Lords, I express my further thanks to all noble Lords who have participated in this debate on what is, as has been rightly pointed out, a compromise provision. For the avoidance of doubt on the part of one or two speakers who may not have fully appreciated it, all those who have spoken in favour of this Motion reiterated that it is very important for a secondary market to thrive. We are looking through this Motion for an effective, transparent and accountable secondary market. I appreciate in all humility the generous personal comments that have been made and ask the House to agree to the Motion standing in my name.

Motion A1, as an amendment to Motion A, agreed.

Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

Motion to Approve

Moved by

That the draft regulations laid before the House on 17 December 2014 be approved.

Relevant documents: 23rd Report from the Secondary Legislation Scrutiny Committee and 17th Report from the Joint Committee on Statutory Instruments

My Lords, the purpose of the regulations is to enable women to have their own genetic children, free of terrible disease caused by disorders in their mitochondrial DNA. The regulations do so by allowing healthy mitochondria from a donor to replace the unhealthy mitochondria in a woman’s egg or embryo.

Mitochondria are present in almost every cell in the body and produce the energy that we need to function. This is why they are often referred to as the “powerhouse” of the cell. Unhealthy mitochondria can cause severe medical disorders known as mitochondrial disease, for which there is no cure. There are 37 genes in the mitochondrial DNA, compared with more than 20,000 in the nuclear DNA. This represents less than 0.1% of the total genetic make-up. The techniques provided for by these regulations offer the only hope for some women who carry the disease to have healthy, genetically related children who will not suffer from the devastating and often fatal consequences of serious mitochondrial disease.

Provision to make these regulations was introduced by Parliament into the Human Fertilisation and Embryology Act 2008. It followed an amendment that recognised the progress being made in research. In 2010, researchers at Newcastle asked the Department of Health to take forward steps to develop regulations. Over the last five years, there has been extensive engagement and consultation with the public on this issue, including, first, an ethical assessment by the Nuffield Council on Bioethics in 2012; secondly, a highly commended, respected and wide-ranging public dialogue and consultation exercise carried out by the HFEA in 2012-13; and, thirdly, a public consultation on draft regulations carried out by the Department of Health in 2014. There have been three separate reports into the safety and efficacy of these mitochondrial donation techniques by an expert panel convened by the HFEA, published in 2011, 2013 and 2014. The expert panel members were selected for their broad-ranging scientific and clinical expertise, and for having no direct or commercial interest in the outcome of the review.

This process was commended in a recent letter to the Guardian from eminent scientists and Nobel Prize winners from the UK and across the world. The letter included this sentence:

“the UK has run an exemplary and internationally admired process for considering benefits, risks, ethical issues and public consent, which must properly precede a change in the law”.

Given the extensive scrutiny given to this issue during the life of this Parliament, I believe it is appropriate to allow this Parliament to decide whether to take the next step for mitochondrial donation, which can make meaningful progress to actually help families only with the passing of these regulations. The two proposed techniques that would be allowed under these regulations are maternal spindle transfer and pronuclear transfer. These replace the mitochondrial DNA, which contains a small number of unhealthy genes, with healthy mitochondrial DNA. Mitochondrial DNA is just 0.054% of our overall DNA. One important point to emphasise here is that none of the nuclear DNA, which determines our personal characteristics and traits, is altered by mitochondrial donation.

I know that many noble Lords will have their own tributes to pay, but I would like to make my own acknowledgment of the ground-breaking work that the scientists at Newcastle University have led, which is world-leading in the development of these new techniques. It is also very important to praise the Lily Foundation, a charity founded by families who have lost their children to serious mitochondrial disease, which has reminded us about the human story that inspired this scientific advance.

I turn now to the detail of the regulations made under powers in the 1990 Act which, as I said, were added in 2008, with Parliament’s express agreement, in anticipation of the advancement of science to this point. These powers would permit mitochondrial donation in order to prevent the transmission of serious mitochondrial disease.

Regulations 3 to 5 set out the circumstances for mitochondrial donation techniques using eggs. Regulations 6 to 8 set out the circumstances for mitochondrial donation using embryos. That would allow the two techniques that have been the subject of extensive UK-wide review and consultation: maternal spindle transfer and pronuclear transfer.

Regulations 11 to 15 and 19 set out the information that can be provided about a mitochondrial donor to any child born from the donation and information to that donor. Regulations 16 and 17 set out special provisions for consent, which were identified through the public consultation process. These regulations apply UK-wide, and the devolved Administrations have been kept informed of development and progress.

Concerns have been raised in advance of this debate by some noble Lords about both compliance of the regulations with European Union law and how the regulation-making powers were originally drawn in the 2008 Act. Those are complex issues, and I have taken care to write to noble Lords about them before the debate. In doing so, I set out the Government’s clear view that we are acting within EU law and that the legislation is sound and robust.

As I have set out in recent parliamentary replies to the noble Baroness, Lady Hollins, the clinical trials directive does not cover treatment services, which is what would be allowed under the terms of the regulations. Furthermore, to be clear, the clinical trials directive relates to medicines and therefore has no relevance in the context of mitochondrial donation.

There has also been much discussion of the safety of these mitochondrial donation techniques, and, as I have outlined, there have been three reports by the HFEA-convened expert panel during this Parliament. On each occasion, the expert panel has concluded that there is nothing at all to indicate that the two donation techniques are unsafe. Although the expert panel has recommended that further experiments should take place, the panel has said that it expects such research to support the conclusions that it has reached so far.

In public discussion, there has been some misunderstanding of the term “critical” when used by the expert panel. This point was helpfully clarified in the HFEA briefing note, which has been endorsed by the expert panel. It clarifies that these experiments could take place before or after the approval of regulations by Parliament.

We have said that it is our view that this Parliament should be given the opportunity to consider these regulations, as the key developments and reviews have taken place during the lifetime of this Parliament. We cannot be certain about what priorities the future Administration will have and whether, in the event that the regulations were deferred, there may be an extended delay in considering them further.

My position on this, shared by my ministerial colleagues, is very simple. Families can see that the technology is there to help them and are keen to take it up. They have noted the conclusions of the expert panel. It would be cruel and perverse, in my judgment, to deny them that opportunity for any longer than absolutely necessary.

Let me explain further the safeguards that would apply here. If these regulations are passed by Parliament, the HFEA would put in place a robust regulatory process, as it has in other areas of fertility treatment. The regulations would also bring into being important safeguards through the HFEA’s own licensing procedures. For a licence to be issued to a provider of mitochondrial donation, it would first have to demonstrate that it could carry out the procedure safely and effectively. Each provider would need to be authorised, and treatment for each patient would be approved on a case-by-case basis.

Every such decision would be based on the scientific evidence, including: information on the safety and efficacy of the techniques at the time of the application; advice submitted to the licensing committee by the clinic; and an assessment of each individual patient. The HFEA is highly respected across the globe as a model for the regulation of fertility and embryology treatments and research. Many other countries do not have this framework in place.

In setting out the purpose and effect of these regulations I hope I have been able to offer reassurance to noble Lords that the long process of consideration of mitochondrial donation has been rigorous, sensible and inclusive. The UK is admired across for the world for the approach that it takes on matters such as this. I recognise that some noble Lords will be opposed in principle to mitochondrial donation. While I respect their point of view, I cannot agree with it. The Government’s view is that it is right that we bring this matter to this Parliament to ask parliamentarians to make an informed decision about what happens next.

I end by emphasising what, to me, is the ethical heart of this issue. This House now has the opportunity to give real hope to families and the chance for doctors to offer more to those families carrying serious mitochondrial disease than yet another generation of avoidable suffering and shortened lives. The UK can offer this world-leading science within a robust regulatory regime and, in so doing, the chance to make a real difference to families. I commend these regulations to the House and beg to move.

Amendment to the Motion

Moved by

To leave out from “that” to the end and insert “this House declines to approve the draft Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 laid before the House on 17 December 2014 and calls on Her Majesty’s Government not to lay new draft regulations until a joint committee of both Houses has been established and has reported on (1) the safety of the procedures permitted by the draft regulations, (2) the compliance of the draft regulations with European Union and domestic law, and (3) the key definitions used in the draft regulations”

My Lords, first, I have to say that I am in favour of mitochondrial donation. I am not opposed to it in principle. I tabled this amendment because otherwise it would have passed through this House—in the Moses Room—without the kind of concern that we now have. The numbers present show it to have been right to discuss this matter very carefully. It is right because we are dealing with something of incredible importance to the families concerned: the fathers and mothers who can produce children but cannot, because those children will, almost certainly, carry this terrible disease. They deserve all the care that we have expended on them. The fact that some suggest that there are not that many of them is nothing: if there were but one we should be as concerned about this as we are.

I yield to no one in my determination to try to do what is right in this area and I do so for a personal reason, which is that I am thankful every day that my wife and I produced four children who in that sense—though perhaps in no other—are perfect. Those of us in this situation have a particular need to be concerned. We should be concerned with the parents; we should be concerned with the wider community; and we should be concerned with the children who would be born in these circumstances. My concern is that the Government have approached this in a way that is very unhappy. Because there are so many of us who would find the movement of a spindle from a non-diseased egg to a diseased egg something that we could accept, there was a basis for a commonality of understanding and support. That was there. All we needed, therefore, was to be assured that the procedure was safe and legal.

My noble friend—and he is a noble friend; he was one of my Ministers, and we worked closely together—has carefully covered his view of the law. I think that the law is very often an ass. I am certainly not one who would demand that lawyers should decide what we should want. I say sorry to the noble Lord, Lord Pannick, who looks unhappy at that comment. However, I believe that we should obey the law and it is quite clear that there is considerable disagreement—I put it simply like that—about whether this action is legal under European law. Although my noble friend gave the best account that he could, it is worth saying that many others take a different view. What is more, the two law officers, the Attorney-General and the Lord Chancellor, voted against these regulations. The Attorney-General has said clearly that he did so on legal grounds, so it cannot be said that those of us who suggest that the legal arguments are at least uncertain have an entirely unreasonable position.

Many who are present will have been sitting through the last part of the previous debate on ticketing. I had taken a particular view on that but felt that the House had heard enough of me without intervening on that occasion. But it may be within the memory of the House that the Government fought very hard not to take action on ticketing until they were absolutely sure about the legality, under European law, of what was being proposed and that there was a proper investigation of it. I had expected my noble friend to say that he had been to outside experts and to the European Union itself to be assured that he was not going to find himself in court were this passed. He has not done so. The only legal advice that has been presented to this House is the internal advice of the Department of Health. I do not find that satisfactory.

I am grateful to my noble friend for giving way. Does he accept that the Wellcome Trust has published and given to all Members a legal position which has all the authority of its own lawyers and which backs up the position of the Minister?

The Wellcome Trust has certainly done that but I was referring at that moment to the ministry and the Minister. However, the Wellcome Trust has not gone to experts in European law; it went to an expert that it chose. I am perfectly happy about that but it is only one of a series of opinions, which are contrary one to another.

I started with this point because of my concern about the families. It seems that it would not be a good beginning for this change if, immediately afterwards, the large number of Members of the European Parliament —from the right to the far left—who have said that they would see this as so clearly contrary to European law seek to refer it to the courts. That would not start this off very well. The real question is why the Government have not taken the steps which would enable us all to accept that this was legal. I do not understand why they have not done that, so my first questions to my noble friend are: why was that not done and why, even after we asked for it, did the ministry not go out and see that it had exterior and clear European advice, so that we would know where we were?

That is of course only the first part of it; the second is a question of safety. I have said that if we talked about transferring the spindle from one egg to another, I would not have any ethical objection. Indeed, it would be the opposite; I would want to support it. I ought to say that, because one noble Lord, who I know is going to speak later on, at an earlier meeting said, “Well, he only says all those things because he’s a Roman Catholic”. I think I will face that. Those Members of your Lordships’ House who took part in the proceedings on the Marriage (Same Sex Couples) Bill will remember that I spent a good deal of time supporting the Government’s position on that.

I do not think anyone can complain that I am somehow in the thrall of some exterior power. I do not think anybody should suggest that I was other than willing to rebel on those things that I thought right. If there is any doubt about that, the Chief Whip will say that that is rather a wider rebellion on many other issues. So I hope no one will say that I am putting this case for any reason other than the one that I put forward. I put it forward because I believe that this House has a parliamentary duty to ensure that the legislation stands up. I do not accept the argument of some that this is a matter for only the experts and the scientists.

Many will remember that, as Minister for Agriculture, I dealt for four years with the BSE crisis. I spent a great deal of time listening to the scientists, standing up for the scientists and getting it in the neck almost every day by refusing to do the unscientific, which I was asked to do. It gave me a great respect for scientists, but it was my responsibility as a Minister to ensure that Parliament made the fundamental decisions. It is not up to anybody—even an organisation as distinguished as the one that will have this responsibility—to make the final decision about safety. That is, as Dr Harris, an old opponent in the other House, made quite clear, for Parliament to decide.

I come to this problem by saying that Parliament very nearly did not get much of a decision here anyway, because we were going to do it around the corner. So there would have been no contribution. That is why I am sorry we called it a killing Motion. It is not that at all: it is intended to give us this debate.

Parliament, however, must recognise that there are real doubts about safety. At the very last moment, we heard some information today. There has been, of course, an attempt to use one of these two mechanisms. It took place in China. The result was an abortion, a stillbirth and a child who died immediately: three—all dead. As a result, China banned the procedure. I discovered today, in answer to a Question, that the Human Fertilisation and Embryology Authority has not even asked for the evidence from China about how that happened, why it happened, why that decision was taken and whether what those who do not wish this matter to be raised say is true: that it was nothing to do with the technique but was to do with other exterior matters. It is not acceptable to tell the country that this is safe when we have not even asked for the evidence from the one occasion on which it has been used, and upon which three babies died.

Secondly, there has been a lot of usage of words. I try not to get myself into any of those difficulties, but it is quite clear that most people expected that there would be a complete test on at least one set of animals that were rather closer to human beings than mice. Of the two techniques, the one that gives me some problems has been performed only on mice. However, there is a test under way at this moment on more advanced animals, if we are allowed to use such a phrase. Macaques have been given the technique and it appears to have worked and produced healthy babies. However, we do not yet know whether those babies themselves can reproduce. We will not have a long period to wait but we do not know the answer yet.

We have a huge responsibility to these mothers who cannot bear a well baby, but we also have a responsibility to the baby that they bear. What a terrible comment it would be if those who longed to have a baby and were therefore able to have it gave birth to a child who could not have a baby. That would be unacceptable. Yet when we had discussions with those who wanted to convince me—this is the thing that appals me—the scientist concerned said, and I quote, “Well, what’s wrong with sterility anyway? I’m sterile”. The public out there do not realise it is being seriously suggested that it does not matter whether these children are sterile. I am sorry, but that is not what the public think. They think we will ensure that the children and the mothers are properly protected.

I am very concerned about this. In the end, if it all goes wrong, it will be no use for us to say, “I took the opposite view”. I was one of the 16 Conservative Members of Parliament who voted against the Iraq war. I want to tell the House that there is no satisfaction in being able to say, “I was right”, or, “I proved you wrong”. The same is true here. I do not want to say at the end, “I was right to ask for a bit more care”.

What I am asking for is very simple. The Minister says, perfect reasonably, that we must not hold this up as some future Government may not be as enthusiastic about it as we are. I must say to him that I can think of no Government who, if a Joint Committee of the two Houses recommended that we should go ahead, would do anything other than put it before the House. Already, he has had a chance to get much more support by allowing the House what it ought to have: some ability to choose between these two techniques. I have asked why we cannot choose the technique that is ethically acceptable to so many but must have them bundled up in this way. The answer, I am afraid, is about money. Because some people have been investing in one technique and others in another, we want to ensure that both will be able to be used. I do not find that acceptable as an answer but it is the only one that I have had so far. It is tied up in a very careful phrase: that it will enable the authority to decide which of the techniques is “most appropriate in the circumstances of the woman concerned”. There is no appropriateness in the circumstances of the woman concerned; the appropriateness is about whether this or that laboratory is available to do it and has invested the resources to make it possible.

We ought to have been able to make a choice in this House. We were denied that, even though we asked for it. The Government seem determined to ensure that these things are not decided by this House but are packaged in a way that means we are not able to choose.

There are many people in this House who do not have a worry about the use of embryos. I recognise that. However, I also recognise that we have a duty to take with us the majority of people if that is humanly possible. To do that, certain simple things are required.

Clearly, the public are worried. I know that it is fashionable to be rude about public opinion polls. Indeed, so rude were some officials that they ran rather close to the libel laws. However, the truth is that in the ComRes test of public opinion, which was a direct test asking questions that the public would understand about things that they have read in the newspapers, the majority of people were unhappy about this; up to 90% said that it should not go ahead unless the tests had been completed. So far, the Government have not convinced the public of the sense of this.

Nor have the Government given us the opportunity to make a proper choice. The Government are presenting this today only because they were forced to do so after a 90-minute discussion in the House of Commons; otherwise this would have been gone through in the Moses Room, in a technique that is very convenient for the Executive.

So why should we ask for this to be fought over again? Your Lordships will know that I am an enthusiastic supporter of genetic modification of food. I am very unpopular among many environmentalists on this matter. Many of the modifications that we want involve very, very small amounts of genetic change, yet out there, there are marchers and campaigns. I think they are wrong because the testing and the science are clear. If the testing and the science in this case were as clear, complete and total, I believe that I would be able to vote for one of these two proposals. However, it is not.

Therefore I say to the Government that it is unacceptable to use a series of words that make it sound as though all is okay. I am fascinated by the refusal to use the phrase “genetic modification”. When it was asked whether one of these two techniques would be genetic modification if it were used on weasels, the Government accepted that it would. So it is genetic modification when it concerns weasels but not when it concerns human beings. All the way through, the arguments that could have won us over and got many more of this House on side have been refused. I say this with great pain because, in my view, this is the best Minister in this House and the man whom we most respect. I am sorry that we have not been able to join him in accepting this.

The proposal that I put forward is that we should have a committee that would be responsible for ensuring that this is legal and safe. I hope that it would also ensure that this House would have a proper choice about the ethical question. I am not raising that on this occasion, but there is a difference between the two proposals that are put forward. I hope that this House will take seriously this issue as we must protect three sets of people: the families—mothers and fathers—the children and the wider society. We would be the first country in the world to allow this. We have to be very careful that we do so with full and wholehearted support, and that we have fulfilled the safety needs.

No one is more aware that there is no such thing as absolute safety. I refer to the arguments over BSE. All you can do is make it as safe as possible by doing all the things that are necessary to see that you have covered every eventuality, and then you have to step out. My own family motto is “Duc in altum”: “launch out into the deep”. However, you do not launch out into the deep unless you have made absolutely sure that you have taken all the possible different issues into account.

The reason I ask this House to reject the Government’s proposition, and to insist that safety and law be looked at again and that the terms also be reconsidered, is not because I do not want to help these men and women who are so affected or because I have an ethical objection to one of the two proposals before us, but because I want this to work. I want it to work in a way that will enable other countries to follow us and to provide this for women who need it so much.

Is it too much to ask that we complete the tests, that we learn from the Chinese why the only time one of these two techniques has been used, they were so appalled by the results that they banned them—they had very clear evidence, which we can have—and that we have absolute assurance on the matter of the European law? We can then all do what is best, and if it goes wrong, we can say, honestly, that we took the best steps and did what was right at the time. That is the only thing human beings can ever do. If we are wrong then, that is due to the wrongness of human nature, and not the wrongness of avoiding what it is necessary to do to make us as safe as is humanly possible. I therefore hope that this House will accept that what could be the shortest of delays is a necessary part of making sure that none of us comes back and says, “We allowed something to happen that should never have happened”.

My Lords, I am sorry for rushing in, but the noble Lord, Lord Deben, excited me so much with the comments he made that I have to answer some of his points, particularly on safety. I hope that noble Lords will have patience, because I need to go through each of the points he has made on safety, as I have no doubt that they will come back again in subsequent debate.

It is important that I put down some ground work. What are we talking about? We are talking about a mitochondrial DNA disease that commonly affects multiple different organs. Symptoms include severe muscle weakness, diabetes, heart problems, cardiac failure and sudden cardiac death, as well as central nervous system problems, which include dementia, epilepsy, stroke and such other horrible conditions. It results in death, which can occur early in childhood or after a prolonged period of incapacity and pain that can last for years.

It is important to have some facts about mitochondrial DNA genetics and inheritance. Mitochondrial DNA is strictly inherited maternally, via the egg. The mitochondrial DNA copy number and the number of mitochondria vary between cell types, with more than 200,000 in the egg and early embryo down to perhaps as few as 10 to 20 in many cells of the two to three-week old embryo, and hundreds to thousands in most cell types in adults, where the number tends to correlate with energy demand. Cells can have a mixture of two or more types of mitochondrial DNA sequence, a condition referred to as heteroplasmy, in contrast to homoplasmy, where each copy has the same sequence. More than 300 distinct mutations of mitochondrial DNA have been found in patients with mitochondrial disease. Although some mutations are far more common than others, if an individual is heteroplasmic, with a mixture of mutant and normal mitochondrial DNA, the proportion of the former determines whether they show symptoms of mitochondrial disease. Some women at risk of transmitting mitochondrial disease to their children are heteroplasmic and may have levels considerably below the disease threshold, but their eggs can have very high levels of mutant mitochondrial DNA or even be homoplasmic. This can be explained by the so-called bottleneck, which I will not go into in detail, but, during the development of the egg, only a certain number of mitochondria go into fertilisation, and that causes a bottleneck that sometimes results in only the mutant mitochondria getting through.

It is estimated that at least one in 200 children in the UK is born with some faulty mitochondrial DNA—so quite a lot of them may well have some faulty mitochondrial DNA. It is estimated that one in 6,500 babies goes on to develop serious mitochondrial disorders. The severity varies from mild to extremely debilitating and may result in early childhood death. Almost 2,500 women of child-bearing age in the UK are at risk of transmitting mitochondrial disease to their children. Estimates based on this figure suggest that between 100 and 150 births a year in the UK risk passing on mitochondrial disease to the child. If today we were discussing cancer or dementia, and how we could modify those diseases with some form of genetic or mitochondrial manipulation so that people would not get it, everybody would be in favour of it; but as mitochondrial disease affects 100 to 150 people a year, we do not take it so seriously—or so it seems.

I will now go on to what the noble Lord, Lord Deben, said about the two techniques that we are likely to be discussing—the maternal spindle transfer, which the noble Lord prefers, and pronuclear transfer—and I will say why I believe it is necessary that currently the HFEA, as a regulator, is allowed to decide which method might be appropriate for a given patient in a given centre. We do not know which technique is the more efficient and safer, despite what some others may believe. In fact, they may not be equally efficacious in every woman.

Pronuclear transfer has been used successfully in animals for more than 30 years with no evidence of adverse effects. On the other hand, maternal spindle transfer is a newer technique, which is likely to result in less carryover of mitochondria but has a higher risk of chromosomal abnormalities. That is an important point: pronuclear transfer may have more carryover of mitochondria but maternal spindle transfer has a higher risk of chromosomal abnormality. Maternal spindle transfers are very sensitive to manipulation. The embryo is less sensitive in its early stage to such manipulation.

Furthermore, both techniques have been found to be variable for avoiding mitochondrial disease. Which technique will be used for each individual patient will be a decision for the patient, based on their informed consent, their clinicians, the evidence from research and the safety aspects. In my view, it would be inappropriate for Parliament to make a scientific judgment as to which technique should be able to be used. One thing is certain: the scientists and the clinicians will go with whichever method is the safest and most efficacious. If it turns out, through research that is currently going on, that we can make maternal spindle transfer safer and less likely to lead to chromosomal abnormalities, that is the method that the scientists and the clinicians will choose. Research is going on to make that process safer. There are many ways of doing this. I am not being flippant when I say that one of the methods that has been tried is to use a small amount of caffeine to make the maternal spindle transfer more stable. Eventually, we will get that research right and whatever method is safest will be used. However, it would be wrong to opt now for one method which is not as successful as others.

Issues have been raised about the health and safety risks of some of the techniques. I agree with the noble Lord, Lord Deben, that it is never possible to be certain that new medical procedures will be 100% safe or effective. That applies to the whole of medicine—drugs, devices or surgery. Risks have been assessed in detail. As the Minister said, there have been three separate reviews of the scientific evidence on the technique’s safety by a specially convened independent panel of experts. It would be wrong to suggest that these experts might be biased when none of them has any financial interest in mitochondrial research or treatment, or that they might not have understood the issues and that we in this Parliament are more likely to understand the science which underpins this research, which has led to the point where it is now possible to use this technique to help women to have normal babies.

Decisions on safety and efficacy should be taken by the statutory regulatory authority created to do this—the HFEA. Risks must be balanced. Evidence suggests that any risks of mitochondrial donation are proportionately less than the significant risk that children will continue to be born who will develop severe mitochondrial disease if these techniques are not used. Ultimately, it will be up to affected families to judge the balance of these risks. They are the ones who will take the risks.

I would like to explore some of the health risks that the noble Lord, Lord Deben, mentioned, although he did not mention that of the potential effects of the donated mitochondrial DNA on the rest of the cell. I turn first to traits attributed to mitochondrial DNA. On variations in the 37 well studied genes, a whole mitochondrial genome has been sequenced for all these genes and they have all been found to have one function in expressing the protein that produces energy. No other trait has been identified from the sequencing of the whole mitochondrial genome. Therefore, the variations have been well studied. Although this is still contentious among mitochondrial experts, theoretically—I admit—it is possible that a child born after mitochondrial donation might have a slightly different energy metabolism compared with his or her female ancestors. However, none of this has resulted in devastating mitochondrial disease.

Evidence has also been cited that a mismatch between the DNA in the donor’s mitochondria and the mother’s nuclear DNA might have a negative impact, namely sterility and impaired growth—the noble Lord mentioned sterility—in the resulting child, as well as slow metabolism. This issue was considered in great detail by the HFEA scientific panel. In normal human populations the mixing of nuclear DNA during sexual reproduction means that there can be a complete exchange of nuclear and mitochondrial DNA type over a few generations—I calculate it to be about six generations. Given that I married an English lady, the mitochondria of my children have changed dramatically. My ancestors’ mitochondria are no longer in my children—they have English mitochondria. However, I am glad to say that they have produced terrific children. Evidence of mismatch between nucleus and mitochondrial genomes has come mostly from research where new combinations have been made experimentally across animal species that have been separated for many hundreds of thousands of years or longer—for example, rats and mice. Within species, such as in some experiments involving mice or fruit flies, evidence of mismatch is seen only when particular sub-strains of a species have been reproductively isolated from each other and each inbred. The one species, the human race, is the most outbred species there is. Some of us are examples of that.

Some scientists who support the idea that the science currently is not safe cite examples of that kind, involving experiments done on fruit flies and inbred mice. But let me pose a question. Suggestions that more animal experiments are required to test the consequences of disrupting co-evolved mito-nuclear interactions are reasonable if we want to understand the importance of these interactions in the animals used. I agree with that. However, they are unlikely to be relevant to humans, precisely because the specific interactions will have evolved to be different in humans compared with other animals.

In humans, it is possible that the future work to which the noble Lord, Lord Deben, referred, on embryonic stem cells derived from human embryos created by either maternal spindle cell or pronuclear transfer, where very different mitochondrial haplotypes—characteristics within the mitochondrion—are exchanged, might reveal issues. But any effect is likely to be subtle. If people are asking for these experiments to be done, if the view of some scientists now is that it is not necessary to take the next step of offering this treatment to mothers and fathers, it would require—

Would the noble Lord comment on the HFEA’s recommendation that, as available data are limited, an extensive range of pre-clinical research should be carried out before proceeding?

The data that the report suggested were not available were actually presented to the committee. They have not been published because, as any scientist would know, if you publish—

I wonder whether I can help my noble friend Lord Patel. Does he agree with me that there were very few available data for the first in vitro fertilisation babies, and that that was a step in the dark, as were pre-implantation diagnosis and sperm microinjection? Before he concludes his speech, would my noble friend be kind enough to answer an important question asked by the noble Lord, Lord Deben, about the possibility that we might be making infertile children? Was that not the accusation made when infertility was treated by in vitro fertilisation, and was there not a widespread fear at that time, too, that we would be making infertile children?

I thank my noble friend for that interruption. It was worse than that: it was suggested not only that those children might be infertile, but that they might be half monsters of some kind. To answer the question raised earlier about the HFEA’s evidence—yes, it did ask, and the evidence was verbally produced. The reason why it is not published is that anything that is published, even in the form of an extract, cannot then be published in a reputable journal. I know that that evidence has now been sent for publication.

To go back to the subject of the evidence requested, if we were to go down that road and do those experiments, what would be required in the human population is the deliberate creation and destruction of many hundreds, if not thousands, of embryos—to prove a point that does not require proving. Hundreds and thousands of human embryos have already been tested and found to go to a blastocyst state, and I hope my noble friend Lord Winston will agree that if we see them in that state, the embryo will be satisfactory. He nods slightly.

The alternative would be human population genetic studies to fulfil that requirement for evidence. What that shows is that exchange of mitochondrial DNA haplotypes by normal reproduction should reveal combinations that are deleterious. Human population genetic studies will do that. Such studies include genome-wide association studies and whole genome sequencing projects looking at many specific diseases and syndromes. Those kinds of studies will be required. They do not require embryos to be created, nor is it necessary to do these studies before this treatment is available.

I know I am going on a bit, but other points were made. If there are points about epigenetics et cetera, those are also spurious and have no basis in science.

Let me go now to something that the noble Lord, Lord Deben, mentioned twice: the Chinese example. The technique that was used in the United States and in this Chinese example is called cytoplasmic injection. No doubt the noble Lord, Lord Winston, is more familiar with it from his work than I am. It is a technique that is not allowed in the United Kingdom. That is the first point. It is completely different in design and intent from what we are talking about in mitochondrial replacement; it is nothing to do with it.

What was done in China was a cytoplasmic injection not for replacing mitochondria, but for infertility treatment in older women. That was also the case in the United States; it was an extra cytoplasm with possible mitochondria in older women, where both are at risk of producing chromosomal abnormality. In China it was used in only one study, which was conducted by an American, Professor Grifo. They inserted five embryos. We do not allow that in the United Kingdom because of the risk of multiple pregnancy. It resulted in a multiple pregnancy. They then tried to reduce the number of foetuses by injecting one of them to reduce the number of foetuses from three to two. I do not know what kind of technique they used—

“Dangerous”, my noble friend says. It killed the other two and resulted in a premature birth. They never published this, despite being asked if there was a publication. It is wrong to say that the HFEA did not ask them; the review panel did. Professor Grifo sent a letter saying that, in his view, all the foetuses were normal but they died of prematurity. What they died of was an obstetric botch-up. It had nothing to do with what we are talking about today. It was a completely different technique. We should dismiss it completely. It would be wrong to put any credence on it and say that it is a good reason why we should not do this.

I could go on about other safety aspects that were brought up, but let me close by saying that hitherto the science has gone as far as it can in thousands of animal experiments that have resulted in normal pups. In human embryos it has gone as far as it can to produce normal embryos, which, if implanted, there is no reason to believe would not develop into normal, healthy babies who would not carry the defective mitochondria. All we are doing today is allowing the regulator henceforth to decide, on a case-by-case basis, to issue a licence to those clinics for those mothers who request this treatment, and which are allowed to use both techniques that we currently know are safe while further research goes on. None of us stops researching: the noble Lord, Lord Winston, still carries on researching; the noble Lord, Lord Kakkar, still carries on researching. If a chance was given, the noble Lord, Lord Walton, would still carry on researching. We do not stop researching; that is the nature of medicine and of academic medical science. I hope that we will pass these regulations.

My Lords, I am extremely grateful to be able to follow the noble Lord, Lord Patel. I am also grateful to the noble Earl for setting out the issues so carefully at the beginning. I listened with great attention to the eloquent and persuasive speech from the noble Lord, Lord Deben, but I am afraid I was not persuaded. I cannot go along with the idea that we should put this regulation on hold for the time being. My reason is the awful position parents find themselves in when they have a child severely affected by one of these dreadful mitochondrial diseases. They are desperate to avoid having more children with the same disease. The noble Lord, Lord Deben, started from the same position but I believe that we are now in a position to move forward.

We have all been bombarded with information about mitochondria to the extent that few of us can be entirely ignorant of what they are and what they do. Yet there is still considerable room for confusion, at least according to some of the correspondence I have received. References to GM crops and cloned animals are way out of line. Suggestions that mitochondrial transfer techniques are a form of cloning when they are nothing of the sort, or that they are on the slippery slope to genetic manipulation and designer babies when there is no conceivable link between them, are very unhelpful and not part of any reasoned discussion about the issues. I could elaborate on that but will leave it for the moment to concentrate on what I think are the more rational arguments that have been and will be made today.

The noble Earl discussed the safety issues, as did the noble Lord, Lord Patel. The suggestion has been made that the techniques may not yet be safe enough. Let me take this a little further. The basic animal experiments have been going on since the 1980s and the specifics of maternal spindle and pronuclear transfer have been very fully researched for the last seven years. We have heard about the three thorough scientific reviews by expert panels set up by the HFEA. In each, further research that needed doing was suggested and each time the research has been actively and successfully pursued. On the last occasion, in 2014, they clearly stated that there were no major safety issues remaining. It is true that they suggested some further tests—and they are all under way, as we have heard—but they pointed to the fact that at the end of the day there will be no substitute for trying it in humans who carry the abnormal mitochondria.

In vitro studies in the test tube with human embryos after mitochondrial replacement have revealed no problems, and experiments with macaque monkeys—yes, they have been done—and maternal spindle transfer are all reassuring. It is interesting that monkeys are not suitable models for pronuclear transfer techniques because research shows that pronuclear transfer in vitro fails in monkeys but works perfectly well in human studies. The only way in which safety can be finally tested is in humans since no procedure or drug can be certainly safe without that. We have gone almost as far as we possibly can before that step is taken. We have heard some issues about the China syndrome, which I believe the noble Lord, Lord Patel, has dealt with perfectly well. Clearly, that was quite something else and not relevant to our discussions today.

Equally important is that these regulations do not simply allow human trials to start now—they do not; they allow the HFEA only to examine applications made to it for full assessment. It will then decide if the science is persuasive enough, that those proposing to do it have sufficient experience and capacity, and that the patients being put forward are clearly those likely to benefit. Remember that the HFEA is no pushover. It has in its membership not just three scientists and a clinical geneticist but three patients who have gone through IVF, a barrister, a professor of philosophy, a bishop and a national security adviser. That is quite an interesting mix but not one likely to be easily moved by faulty argument. It is they and their scientific advisory panel who will be assessing applications when these regulations come into force in October.

Other anxieties have been expressed that we will be disrupting the relationship between the nuclear and mitochondrial genes: the nuclear genes carry the information that determines all the characteristics that make us human, and the mitochondrial genes provide the energy supply for cells. This argument was discussed at great length in the HFEA’s scientific report in 2014 and was found wanting, not least because half the genes in a fertilised egg are derived from the father and are therefore already foreign to the mitochondria, yet they do not interfere with each other. Furthermore, mitochondrial genes are pretty well conserved between different individuals because they perform a limited number of functions, while there are large differences between the nuclear genes of different people, each of whom is made up of a mixture of DNA from a mother and a father.

You might expect problems to occur all the time in normal people if there was a problem of interrupted communication between nuclear and mitochondrial genes, but the fact is that we do not see any miscommunication problems arising. On top of all that, there is no detectable direct interaction between the genes or the DNA in the nucleus and the mitochondria—only indirect actions through protein products and RNA, as between any cell activities. Nor, incidentally, is there any evidence whatever that mitochondrial genes contribute to any of the features that one might consider to be human characteristics.

The worry is sometimes expressed that we are messing with the germ cell line and that what we do to the first offspring will be handed on to her daughters and so on. However, what will be handed on will be only normal mitochondria and none of the egg donor nuclear genes. The mitochondrial donor does not contribute anything to the nuclear genetic pool, which is all derived from the original mother and father. The next daughter after that will have a quarter each of what will then be the original genes of the grandmother and grandfather—I hope that noble Lords are keeping up—and half from her new father, but she will still have normal mitochondria despite this dilution of her nuclear gene pool down the generations.

A number of questions have been raised about the legality of pressing ahead with these regulations, as the noble Lord, Lord Deben, said—most notably by my noble friend Lord Brennan, who I know is sitting behind me. I would not dream of crossing legal swords with my noble friend but I have to say that I have been convinced by the Department of Health’s legal opinion and more recently by the opinion obtained by the Wellcome Trust from Mr Thomas de la Mare QC. These reassure me that the regulations do not in fact contravene any of the provisions of the EU clinical trials directive, the human tissue directive, the HFE Act or the EU charter or European Convention on Human Rights. It is worth noting, incidentally, that the Nuffield Council on Bioethics could find no ethical reasons to object to mitochondrial transfer techniques being used. Both it and the HFEA confirmed that their public opinion exercises had revealed considerable support among the general public.

Finally, there is a most difficult question which has not been raised: the religious conviction of some that manipulation of embryos is basically wrong and against God’s will. I am afraid I have no answer to that; I am not privy to God’s will. However, I know that parents who have watched affected children suffer and in turn have suffered themselves are hoping and praying—yes, they are praying—that they will be able, some day, to have a child who is normal. What a boon that would be, and I very much look forward to us passing these regulations today.

My Lords, for those among us—and I include myself—who are not scientists, this is a demanding topic. In fact, I guess that even those who are scientists do not always find it exactly straight- forward. A significant part of that complexity derives not from the difficulty of the science itself but from the different—sometimes diametrically opposite—things that we are told by people who have been studying and researching mitochondrial transfer for many years.

Like many others in your Lordships’ House, I have recently attended a number of presentations, drop-ins and seminars on this subject. I have also read through the many written representations that have been referred to and which most of us will have received. They mirror the speeches being made in this debate.

On the one hand, we are assured, as we have been today, that scientists are clear about both the safety and the efficacy of mitochondrial transfer. It is no different from giving a blood transfusion or changing the batteries, so there is no problem there. On the other hand, we are warned by scientists—not just the correspondents to whom my noble friend Lord Turnberg referred—that mitochondrial transfer is a form of genetic modification which does affect the germ line, albeit not the nucleus, and could have a potential impact on the traits of any children, and their children, born as a result of this procedure. Some suggest that this would involve crossing a key bioethical threshold that we could later regret, and we are all aware of the pressure that is being brought to bear on us from elsewhere in the world.

In addition to all that, from a purely ethical point of view, as my noble friend Lord Deben mentioned, one form of treatment, maternal spindle transfer, is for many people clearly preferable to the other type—pronuclear transfer. Unfortunately, as my noble friend Lord Patel pointed out, the spindle method is currently less stable, although that may change.

The so-called “genius” of the Church of England has always been its via media—the middle way—and that is where I find myself today. Over the last few years, we have consistently taken a fairly nuanced position on this subject. Despite some misleading press reports, we are not in principle opposed to mitochondrial transfer, and it makes a pleasant change for the church not to be against something. Indeed, I explained this to the Minister, Jane Ellison, before the debate in the other place and she referred to our conversation in her comments there. But, at the same time, we have always counselled a degree of caution, given the potential implications of this development. In particular, we have always argued that the research tests into safety—set out quite clearly as essential before any further move is made by no less than the HFEA expert panel in 2011— should be completed and reported before these regulations are approved. That has not yet happened. We are therefore disappointed by the element of rush now, which I guess could be occasioned by the forthcoming election. I was talking this morning with a GP friend, who said that she could not imagine any drug or treatment being authorised before all the necessary tests had been undertaken and reported. In this case, that clearly, according to the HFEA’s own recommendations, has not been achieved, even though, as we have been reminded, the research has of course been taking place for several years.

Like every other Member of your Lordships’ House, I am very keen to see help offered to couples who face the terrible prospect of a child born with mitochondrial disease. I also know which of the conflicting scientific viewpoints I would rather believe. To reiterate, both personally and as a representative of the Church of England I am basically very much in favour of this development. However, I cannot ignore the compelling arguments against pushing this through in haste, and for that reason I am minded to vote for the amendment proposed by the noble Lord, Lord Deben. I know that it is regarded by some as a wrecking amendment. I do not see, read or hear it in that way. I would hope that any Joint Committee’s work could be completed without undue delay. For the same reason, if we reach a Division on the initial Motion before us, I will feel compelled to abstain.

My Lords, I must declare an interest in that much of the groundbreaking science of mitochondrial donation has happened at Newcastle University, where my wife also works, although in a different field. Also, some of the relevant work has taken place on the premises of the International Centre for Life in Newcastle, of which I am honorary president. I am also a fellow of the Academy of Medical Sciences.

I shall be as brief as I can. We have a duty to consider five simple questions. Is it legal? Is it safe? Is it necessary? Is it ethical? Is it rushed? It seems to me that, as the noble Lord, Lord Turnberg, said, we have clear evidence that it is legal for Parliament to enact these regulations. They are explicitly foreshadowed in the Human Fertilisation and Embryology Act 2008. They are not covered by the clinical trials directive. They are not eugenic, and therefore not in conflict with the EU Charter of Fundamental Rights.

Is it safe? We have heard that the safety and efficacy of both techniques have been established as far as is possible by exhaustive study, independent scrutiny and public consultation. The case of the Chinese example, as the noble Lord, Lord Patel, has said, is simply not relevant to this case. This was an obstetric disaster that happened to one woman and was a technique that was intended to cure infertility and had nothing to do with mitochondria anyway. As far as we can tell, the mitochondrial transplant element of that technique worked.

As for the infertility question, I have to say that I think my noble friend Lord Deben has misquoted a very distinguished scientist, Professor Robin Lovell-Badge. I was in the same meeting and I did not hear him say the words that the noble Lord said. He made the point that some techniques that are already legal and used probably perpetuate some forms of infertility. We therefore already accept that some techniques that are used may produce children who lead very happy lives but will themselves require assisted reproduction.

Incidentally, I completely agree with my noble friend Lord Deben that we should not argue from authority, that the consensus of scientists may sometimes be wrong and that we should make up our own minds. As always in science, however, it is the evidence, not the existence of a consensus, that convinces me that this is efficacious and safe.

Is mitochondrial donation necessary? If there is one thing that we have learnt from 30 years of in vitro fertilisation, it is that adoption is not a full alternative to conception. Were we right to give women assisted reproduction so that they could have their own children? Yes. Millions of happy mothers bear witness to that.

Is pre-implantation genetic diagnosis an alternative in this case? Often it is not, because it is more likely, as we have heard from the noble Lord, Lord Patel, because of heteroplasmy, to produce an afflicted child. I was also surprised to hear the noble Lord, Lord Deben, say that the reason we are going ahead with the techniques of maternal spindle transfer and pronuclear transfer is “about money”. I just do not think that is the case. It is very clear, as we have heard from the noble Lord, Lord Patel, and others, that there are very good reasons to go ahead with both these techniques.

Is it ethical? We do not, in the 21st century, have the luxury of deciding these things in a theological way. If we block an advance of this kind and it turns out that it could have eliminated suffering safely, then it is on our consciences in a way that it would not have been 30 years ago, when we could do nothing. In losing our impotence, we also lose our innocence. In other countries, this decision would be up to the regulator already. Here, uniquely, we have explicitly said that Parliament should first decide whether the regulator can take such cases, which is what we are deciding today.

Once Parliament has decided that mitochondrial donation is not likely to be unsafe, and the HFEA has judged that it is safe, it should be up to families to decide whether they wish to use it. It would be unethical for the state to deny them that choice.

We may become the first country to do mitochondrial donation, but there is nothing wrong with that. Britain has been the first with most biological breakthroughs, from natural selection to the double helix, from monoclonal antibodies to in vitro fertilisation. In every case, we look back and see that we did more good than bad as a result.

In this House, we have been deluged with off-the-shelf emails from people overseas demanding that we support my noble friend Lord Deben’s amendment to stop so-called GM babies. However, I am afraid the senders have been misinformed, as the noble Lord, Lord Turnberg, said. Describing mitochondrial donation as producing GM babies or, indeed, three-parent babies is using phrases that are wildly misleading. You cannot call someone with 0.1% of their genes and 0.054% of their DNA donated from somebody else the child of three parents. That is a misuse of the English language.

The reason it is not genetic modification, as the term is understood by most people, is simple: this is therapeutic, not eugenic. It is germline only for female babies. As the noble Lord, Lord Patel, said, this is a dead end in males. I do not, however, hear the opponents arguing that we should license this technology for male babies, even though that would be perfectly logical if that is their real concern.

Finally, is it rushed? Far from being hurried, it has been under development for more than 30 years, under debate for 15 and under scrutiny for five. There is nothing slippery about this slope. There has been no rush. Now, however, that we have reached this stage there jolly well should be some reasonable haste on behalf of the women whose reproductive life is running out and who desperately want their own child, people such as Claire Wright, who is now 40 and who had to watch her son Jacob lose his smile on the way to a cruel death. Yes, there is understandable urgency. We would have to have very good reasons to argue that the ethical thing to do is to prolong her suffering and that of others like her. I cannot see those reasons.

My Lords, I very much support the Motion that has been tabled by the noble Lord, Lord Deben, for the reasons he very articulately expressed. The Minister has reassured us significantly about these regulations, but he did express many of the uncertainties that remain. In moving his Motion, the noble Lord, Lord Deben, talked about uncertainty. The noble Lord, Lord Patel, gave us graphic details of the uncertainties of the two processes that are proposed, which may result in increased risk of chromosomal defects. In the light of all that uncertainty, how can it be right that your Lordships’ House be asked to make a decision of this magnitude before the conclusion of all the necessary research?

I want to talk briefly about one issue that relates to the protection of women’s health. We are told that these proposals are all about advancing women’s rights, and yet it seems to me that we are at risk of overlooking one very important matter in relation to which these procedures plainly do not advance women’s rights. That is the repercussions of the increased demand for donor eggs for the women who donate the eggs. The requirement for more eggs is a consequence of scientific development, and that is widely accepted. A Nuffield Council on Bioethics report looked into the ethical issues around mitochondrial donation and stated:

“One of the major barriers mentioned by scientists when assessing the potential for cell reconstruction techniques to become treatments is the fact that many more egg donors will need to be found to undertake the research required in order for the safety and efficacy of PNT and MST to be established, and if therapies are to be provided in future. A shortage of egg donors is an acknowledged problem in respect of donations for reproduction, and it is not yet clear whether egg donors would be more likely to come forward”.

I am grateful to the noble Baroness for giving way, but I do not think that she speaks from experience. Sadly, I have to say that I do speak from experience. I have run a very large infertility practice for a very long time, and we found donors very easily when it was concerned with these sorts of serious conditions. There was never a problem about finding donor eggs for this kind of problem.

I thank the noble Lord for that intervention. However, the research shows that there is a shortage of women donors.

Eggs used have to be extracted from women’s ovaries by a process known as controlled ovarian hyperstimulation, which can lead to complications for women. According to the Royal College of Obstetricians and Gynaecologists, it affects up to one in three women to some degree. It says that between 3% and 8% of IVF cycles are complicated by either moderate or severe OHSS, which can cause a variety of painful and upsetting symptoms such as abdominal pain, nausea, diarrhoea, haemoconcentration, thrombosis, pleural effusion and respiratory distress. It can be further complicated by ovarian rupture and renal insufficiency. In some cases, it can be life-threatening.

The Newcastle Centre for Life conducted research on the prevalence of OHSS and published the results. It found that the risk of hospitalisation increased massively if more than 20 eggs were collected. We do not know whether the pattern that it established is repeated at other research centres because the data have not been compiled. There is a gap in the evidence base. The really important point is that, as I understand it, the collection of 20 or more eggs is very common in the UK. Tens of thousands of women have been through the process, so there is a substantially increased risk of a serious medical condition.

Mitochondrial donation is impossible without a supply of donor eggs. The procedures rely on the willingness of women to undergo a process which may bear serious health risks and about whose safety there are not extensive data. Two Answers were given in Parliament last summer which suggested that the monitoring of the incidence of ovarian hyperstimulation syndrome is inadequate. On 9 July, the Health Minister in another place said:

“The HFEA does not, therefore, hold definitive data on the number of women admitted to hospital with OHSS, including non-patient egg donors and egg-share donors”.—[Official Report, Commons, 9/7/14; col. 313W.]

On another occasion, it was said that,

“licensed fertility clinics are only required to report instances of OHSS to the authority that require a hospital admission with a severe grading”.—[Official Report, Commons, 24/6/14; col. 157W.]

It was stated that other cases were reported as well. I do not think that the Government have given enough consideration to the effects of the legalisation of mitochondrial donation on the donor’s health. There is a possibility that it will lead to further problems.

This concern is underlined very effectively by the fact that the Newcastle scientists pressed Parliament very hard to sanction legislation to permit the creation of animal hybrid embryos. Parliamentarians who recall that debate will remember that the principal justification for changing the law was to allow the creation of admixed human embryos in order for research to be conducted without it being dependent on human eggs because of their limited availability. The legislation was passed; the research is dead.

I thank the noble Baroness for giving way. It is important to clarify that point, particularly as it was crucial in the debate on that amendment. Admixed embryos were required for the research to be carried out then in order to study the diseases in embryonic stem cell lines without using human eggs. She is correct in saying that. On why that research has been abandoned, as the noble Lord, Lord Alton, may well remember, I made the comment in closing that the utopian dream of the scientist would be that, one day, we might reach a point where we were able to take a skin fibroblast and down-regulate it so that it behaved like a pluripotent cell. That dream came true two weeks after that legislation was passed, when Yamanaka in Japan published an article saying how it could be done. That is why the research stopped; it was not because it could not be done.

I thank the noble Lord for his intervention. It remains the case that there is a shortage of donated eggs. My concern is for the women who are asked to donate eggs.

I am sorry to interrupt my noble friend, but, given that my noble friend Lord Patel mentioned this case, perhaps I might reinforce what she is saying, because Newcastle is not offering to provide donation opportunities for women but is asking them whether they will sell their eggs, at £500 per cycle. We all know that that can lead to hyperovulation syndrome, an issue which I raised in your Lordships’ House last week and which I know concerns many of us from all sides of this argument. So there is another dimension involved in this. My noble friend Lord Patel was also right to say to my noble friend Lady O’Loan that when we debated these issues in 2009 many of us pointed to things like adult stem cells and the work being done by Professor Shinya Yamanaka. We said then that arguing for animal/human hybrids was a diversion when much more important work, like that which the noble Lord, Lord Patel, has just mentioned, could have been undertaken.

I thank the noble Lord for that intervention. I am not arguing against this process; I am arguing against the introduction of these regulations at this time in the absence of sufficient knowledge and protection. We have to look at the factors, as the noble Lord, Lord Alton, said. Being paid to donate one’s eggs constitutes a very serious issue for women who are in poverty and who will do it as a way of raising money, possibly even to look after their own children. We need to provide protection for such women.

In conclusion, we should not hasten ahead without putting in place clear and comprehensive systems for monitoring the outcomes of all controlled ovarian hyperstimulation treatments, including those treatments that would result in the generation of eggs to facilitate PNT and MST. In this context, I simply ask that we proceed more carefully and that we back the Motion moved today by the noble Lord, Lord Deben.

My Lords, I declare an interest in that it was my scientific group which started pre-implantation diagnosis—the first attempts to diagnose genetic diseases in embryos in families who have these fatal, sad genetic flaws in them. I congratulate the Minister on his absolutely balanced and fair speech. From time to time, we have not agreed, but I think that his care, compassion and courtesy are deeply appreciated by the whole House. I also congratulate the noble Lord, Lord Deben, on his very clever speech. I do not agree with what he said and I hope that, at other times, we can see why we disagree. I accept that he is talking with deep conviction, but I think that we have already sorted out most of his objections, both the legal and the difficulties of side-effects.

My Lords, before my noble friend goes any further, I say to him that there are real differences in legal opinion. I do not think that we have quite sorted them out yet.

I am very grateful to my noble and learned friend for that.

I want to do something which I have done previously in debates of this kind, which is to talk from personal experience. I may be one of the few people in the House who have sat with an endless number of parents who have a genetic disease in the family, have listened to their problems and have seen the kind of dilemma that they face. I am reminded of the child Jeremy “Martinez”—forgive me if I change the surname, but I do not have approval to give the surname of that patient from some time ago. We were doing in vitro fertilisation and pre-implantation genetic diagnosis in the 1980s, and the first babies, who are now 25, were born in 1990. At that time, we were looking at the very common genetic disorders. It is interesting to consider that there is a vast number—too many, some of us think—of Members of this House. At least 40 of you, on mathematical probability, will carry the fatal genetic mutation for cystic fibrosis. That is very common indeed and much more common than the problem with mitochondrial disease, even though we are beginning to see that it is becoming rather more common as we get better molecular techniques.

What is very clear, and it is very important because it has not been stated, is that the number of families who will be of child-bearing age when a mitochondrial disease is diagnosed will be very few. That is important because we are not talking about a large number of people; we are talking about a small number, but they have a definite problem for which they need some desperate solution. They are prepared to do whatever they think is best for their families, with informed consent.

In the case of Jeremy, he was a bit slow to grow, but by nine months he could not lift his head. He started to vomit; he had diarrhoea; he then progressively developed muscular weakness and started to get epileptic fits. These fits would often go on all night; this child screamed with pain and was uncontrollable; eventually, having gone both blind and deaf, with severe mental problems with his brain, he died at the age of two. There was no treatment. His mother came to see me to ask if there was any possibility that she might have some screening of her embryos in the future. This was in 1989. Certainly, Alan Handyside and I had discussed the possibility of looking at mitochondrial disease, but we did not have the molecular techniques at that time to have any chance of being able to screen an embryo. It is true that that screening has now happened and can be done; indeed, there is a very interesting report from Newcastle University showing how that can be done in some cases. However, it is not always satisfactory, for the reasons that the noble Lord, Lord Patel, stated.

We could not do pre-implantation genetic diagnosis; the lady had another problem. Interestingly, I will say this to the noble Lord, Lord Deben: this lady had had two stillbirths. She had also had a couple of miscarriages. It is quite probable that those losses of life from within her were a result of undiagnosed mitochondrial disease. Of course, we will never know, but these people have reproductive failure rather more often. She therefore had only one choice: her choice was to have antenatal testing, which has become increasingly possible, and now can be rather more reliable than it was then, with either chorionic villus sampling or sampling the fluid from around the baby. Amniocentesis is now done. Of course, if the diagnosis is made, this woman would then be left with the decision whether or not to have an abortion.

I must tell the noble Lord, Lord Deben—because I understand that he is very much against abortion, and I respect that deeply and appreciate that stance that he has made repeatedly—that the reason why women go for pre-implantation genetic diagnosis is mostly because they want to avoid the chance of having an abortion of their pregnancy. That has been the consistent reason with all the cases that we tackled in the early stages of this technology. The other interesting thing is that, although cystic fibrosis is so very common, in fact in the first 10 years of our treatment of this disease, we had only about 12 births, because very few people want to go through with this technology in any case because it is so complicated. We were not charging; it is not an expensive treatment but it was a question of whether they really wanted to go through it.

I remember the first patient, Mrs Edwards, whom I can talk about. She was adamant that she was not prepared to consider another termination of pregnancy because it was so damaging, and she felt that it was morally wrong. I say that facing the right reverend Prelates opposite, because they will understand how clearly that ethical issue is something that these patients consider. I want to make that absolutely clear from the start.

Ultimately, in a pluralistic, democratic society, we have certain ethical principles. We have the principle to try to do good, not to do harm; to arrive at a just solution wherever possible, as doctors; and to respect the autonomy of the individual in front of us. That respect for autonomy means making sure that you discuss the difficulties of the treatment, the possible side-effects, and the risks that you might get the diagnosis wrong. By the way, we made a pre-implantation misdiagnosis. I remember one family that ended up with an affected child in spite of our diagnosis; mistakes can happen medically. That child, remarkably, is still alive, which is very surprising. The family came to terms with that mistake and fully understood that we had taken all possible due care, so there was never a massive issue about that. That was a very remarkable family.

None the less, we have to accept that there is nothing worse than losing your child except one thing: I do not know of a worse injury than losing your child after watching a gradual deterioration and devastating death in pain and discomfort, with the disruption that that means for the rest of that family. That is something that these families do not get over easily; they have to try to find some way out of this. Therefore, I beg your Lordships to understand that we need to consider the autonomy of individual patients who might not share precisely the same values that we have, who may not have the same religious views that we have. I speak very clearly about this, because I understand absolutely that our ethical principles are based on respect for human life. That is something that I absolutely share: we understand from the chapters in Genesis that we are created in the image of God. We understand also that sometimes we are accused of playing God. I say to the right reverend Prelates opposite—and this is perhaps very presumptuous of me—that playing God is something that we do very properly; it is something that we do by imitatio Dei. We do not try to supplant God, but to augment His works because we feel that that is one way of improving and supporting life and nurturing it. Let us be clear: it is not so much about what we do; it is about having the wisdom and the judgment to make certain that we are doing the best we can in these individual cases. We have come to the point now with this particular diagnosis that it is absolutely right to go ahead with the technology that the noble Earl, Lord Howe, talked about in his speech.

Finally, I do not believe—in spite of what we have heard this evening—that this technology threatens the fabric of our society in the slightest bit. It does not threaten the fabric of our society; on the contrary, in a way it protects it because what we are doing is recognising our limits by accepting regulation. We have not said that we are going to go ahead with this; we will have to see what the regulatory authority wants. The noble Earl knows perfectly well that I have some misgivings about regulation in certain areas, but none at all about this. I think that will be shared universally by my colleagues, some of whom are listening to this debate.

My Lords, the noble Lord and I agree on much of what he has been saying today. However, in 2013—just two years ago—when he spoke at the Intelligence Squared debate, he said:

“And it’s worth bearing in mind that abnormal children have been born as a result of mitochondrial transfer. This has been completely unpredictable”.

I wonder what, if anything, has happened to change his mind about that. I suspect that he and I are agreed that there obviously are dangers involved in this and safety questions that he will want to address. May I also ask him—and I will not intervene again—whether he agrees with what my noble friend Lord Patel said earlier about the situation in China? I have with me the document Fertility and Sterility 2003, vol. 80, published on 3 September 2003, which was written by Zhang and others, who looked at the procedure that was used in China. Although we were told that this was not cytoplasmic transfer, does he agree with my noble friend Lord Patel, or does he agree with what is here in the statement that this was a pregnancy derived from human nuclear transfer?

I think that the noble Lord was asking him to reply to my comment. He is quite right that China has used pronuclear transfer techniques, but the disaster was upsetting to me.

I am very concerned that the noble Lord, Lord Patel, might get into trouble with the Whip sitting on the Front Bench. I am always in her bad books, and I would not want to allow him to be in her bad books as well.

Let me answer the noble Lord, Lord Alton. It is true that, two years ago, I said that it was unpredictable; of course, these things are unpredictable. In the context in which I was speaking, that was correct. To be fair, however, the noble Lord, Lord Alton, knows that, with the case of Jacques Cohen in New Jersey, 17 babies were born after mitochondrial transfer. Therefore, there has been some other evidence—other than that evidence from China—that suggests that this is not quite as daft as proposed. Added to which, of course, in two years, a huge amount of research has been done by our colleagues in Newcastle. They have been working flat out on a whole range of tests which, I think, have made a very big difference. Since the statement that I made in the House, three different committees have looked at the safety.

Science does not have the truth; we have a version of the truth. We have to interpret what we can as best we can.

I deeply respect the noble Lord, Lord Alton, as he knows very well. We both come from a very strong view about what is the right thing to try to do wherever possible. However, I feel here that, apart from the issue of preserving healthy life, if we decide not to vote for the amendment of the noble Lord, Lord Deben, we are doing something really important. We are expressing our concern—our compassion—as a House for people who are faced with an invidious and horrendous choice.

Under those circumstances, given that this will be a limited procedure affecting very few people, it would be utterly wrong for this House to turn down the democratically elected Chamber and not to support what the Government propose.

My Lords, at the outset, I have to declare two interests. First, I am the honorary life president of Muscular Dystrophy UK, which, along with the Wellcome Trust and other organisations, has been sponsoring and funding some of this research. Secondly, I have to say that I have an avuncular interest in the department in Newcastle upon Tyne, because Professor Douglas Turnbull, who now holds the chair of neurology in that university, holds the chair which I held 32 years ago.

I say just in passing to the noble Lord, Lord Deben, to whom I listened with the greatest possible interest, that he may not remember that I was the neurologist on the Southwood working party, which advised his department on BSE and produced a report which ultimately led to the disappearance of BSE and its human form, Creutzfeldt-Jakob disease, so he does not need to lecture me about the precautionary principle.

There is one sensitive matter which I feel that I must raise at this stage. I am a lifelong member of the Methodist Church, although I at present attend an Anglican church. I know full well that from the very first day that the whole issue of human fertilisation and embryology came before this House, it was bitterly opposed by the Roman Catholic Church. I do not suggest to either the noble Lord, Lord Deben, or my noble friend Lord Alton that their adherence to and strong faith in the Roman Catholic principles has in any way influenced their attitude to the regulations; but at every stage from the first regulations to allow human fertilisation and embryology to take place, they have been bitterly opposed.

I must confess that I did discuss the whole issue of the status of the human embryo with an old friend, the late Cardinal Hume, whose father was a professor of medicine in Newcastle, Sir William Hume, who taught me briefly when I was a medical student in the early 1940s. Cardinal Hume and I discussed the whole issue, and I told him that I simply could not accept what the Roman Catholic Church has now decreed. Many, many years ago, St Thomas Aquinas said that life did not begin until the foetus was capable of independent existence outside the womb. It was a Pope in the 19th century who decreed that life began at the moment that the sperm entered the egg.

I said to Cardinal Hume that I really could not believe that a small bundle of cells carries the same status in society as a mature adult, and that that was something with which I profoundly disagreed. We discussed it and regularly went on to have a powerful exchange of views and then to decide that we could not agree, but then moved on to discuss a matter of much more mutual concern: the fortunes of Newcastle United Football Club. When, in 1980, the city of Newcastle decided to create a number of new honorary freemen to celebrate its 900th anniversary, among them were me as dean of medicine, Cardinal Hume and Jackie Milburn, the former England and Newcastle centre forward. Cardinal Hume said that it was the greatest day of his life: all his life he had been waiting to meet Jackie Milburn.

I move on from that to say that the whole issue of human fertilisation and embryology and each of the amendments to the Act and new Acts all came under attack from the Roman Catholic Church and its adherents throughout the process. They opposed the whole question of preimplantation diagnosis of serious diseases, such as Duchenne muscular dystrophy, in which I had a particular research interest. They opposed the development of stem cells based on human embryos—bearing in mind, of course, that many of the eggs that were later to be produced from those human embryos were donated voluntarily by the women from whom they were obtained, just as the eggs that are used in mitochondrial transfer have been voluntarily and willingly donated by the women when they were surplus in in vitro fertilisation programmes.

I need to remind the House that in 2008, when we discussed the new regulations and what became the Human Fertilisation and Embryology Act 2008, one of the plain purposes of the Act was to permit regulation-making powers to amend the definition of a permitted egg and a permitted embryo for the purposes of preventing the transmission of serious mitochondrial disease. That was a decision by this House in 2008, and I was heavily involved in the debates at the time and discussed the whole process by which mitochondrial transfer, as carried out by pronuclear transfer in Newcastle, could be used to prevent the birth of children with those devastating diseases.

They are devastating diseases. I diagnosed many such patients in my time as a neurologist in Newcastle and elsewhere. Epilepsy, muscular paralysis, dementia, blindness and deafness can result from mitochondrial mutations. The problem always was that women carrying those mutations would pass them on to all their children of either sex. Of course, the results were variable, and still are. Some of those diseases are devastating and produce death in infancy. Some are much less serious, but none of them is treatable, except by supportive treatment. None of them can be cured by any form of treatment.

In 2008, I tabled an amendment stating that “a licence may provide”, with the intention at the time of seeing whether we could accept that the HFEA could at that stage issue a licence to legalise the process. It was made clear to me that it was premature, and that much more research was necessary. That research has been done over the succeeding seven years in Newcastle and elsewhere. The researchers have worked tirelessly and produced a substantial number of embryos by pronuclear transfer, embryos which gave every evidence of being totally normal—the only problem being that, until regulations such as these are passed, it is illegal to implant them into a uterus to allow children without mitochondrial disease to be born.

I believe that the time has come. I talked to so many of the women who carried the mutations. I talked to so many of their families. The agony and distress that they experienced, knowing that any children that they had would carry those devastating diseases, was pitiful and caused me very great concern. I have to say that I now firmly believe that the work has been done: all the research has been done, the consultations have been widespread. The Nuffield Council on Bioethics, along with the expert committees, has issued a series of completely positive reports. All the organisations in the medical profession, starting with the BMA, the royal colleges, the Medical Research Council and the Association of Medical Research Charities, are universally in favour of accepting the regulations at this stage, because they believe that the consultation, along with the research, has probably been the widest, most comprehensive and most detailed that has happened in the case of any medical procedure in history. I believe that very strongly, and I cannot stand the thought of now extinguishing the hope of these women and families, who believe that this procedure will allow them and their offspring to have normal children without mitochondrial disease. For that reason it is crucial that these regulations should now be passed. It is not the end of the story, because once the regulations are passed in this House no procedure to implant these embryos can be carried out except under a licence from the HFEA. Every individual case will be considered. That process will be there to provide the protection that many doctors and Members of this House appear to need. However, the time has come when we must move forward.

My Lords, this has been an extraordinary debate. We have had a feast from the best in the medical profession on all sides. It is clear that there is real agreement and empathy about the need to make a difference for those women who suffer so perniciously in relation to mitochondrial difficulties. There is also consensus on the need to do something to relieve that suffering and pain. There is no dissonance between any of those who spoke, although they differed on what we should do about it. Perhaps the calm voice of reason, if I may respectfully say so, came from the very balanced intervention of the right reverend Prelate, who, with great modesty, rejoiced in the fact that for once the Church of England could agree with the noble Earl, Lord Howe, about something of real importance. Therefore, there is no disagreement about the need to do something.

I congratulate the noble Lord, Lord Deben, on giving us the opportunity for this debate. He is right to say that had he not tabled the amendment, which has exercised so much of our attention, we would not have been able to take advantage of the House’s wisdom. The real question raised by the amendment of the noble Lord, Lord Deben, is one of timing. I listened with great care to the very fair, very balanced and exemplary introduction of the noble Earl, Lord Howe. It came to this. We have now all worked extremely hard, the election is upon us and we have no idea of the complexion of the next Government. Therefore, carpe diem—do this now. The right reverend Prelate the Bishop of Carlisle fairly raised this question. But for that election, would we now be in such haste? The concluded results of the research would normally be waited for. An opportunity for real debate would be seized.

I, like all Members of the House, have been bombarded by emails and letters of all complexions on this issue. What surprised me as a former law officer was to see who agreed and who disagreed. There is a view that if you have three law officers in a room you might get five different results. Therefore, it was with real surprise, and a little concern, that I noted that both of my successors in title, the right honourable Dominic Grieve and Her Majesty’s current Attorney-General, did not agree that this regulation should go through now. That gave me—I do not know about any other noble Lord—real pause. Why would my two successors in title disagree on the timing? I therefore looked first at the explanation that the current Attorney-General gave to his constituents. It is probably fair that this House should have the benefit of it. He said:

“This week the House of Commons debated and decided to approve regulations allowing mitochondrial donation, a process of replacing a small amount of DNA in cells in an egg or embryo to avoid the child which will later be born suffering from genetically inherited mitochondrial disease”.

He went on to say:

“First let me set out where I think there has been general agreement. This is a difficult decision to take. Everyone will have huge sympathy for parents who know their children will inherit this severe disease and are desperate to pursue treatments which can help them to have a healthy baby. They have every right to make their case for this change. Similarly, we all admire the hard work and ingenuity of scientists who have developed these techniques with intention of combating genetic disease”.

I warmly agree with that statement. We have scientists in our country who are second to none. He continued:

“However, legislators have to consider not just individual interests but the interests of our society more broadly and should consider too what precedents are set and what lines are crossed by the laws and regulations we make. Different legislators will of course reach different conclusions on these questions and views may change, but I am not persuaded this would be the right thing to do now”.

That view was clearly shared by Dominic Grieve, because both voted against the Motion in another place. That is why I was worried. Why did my two colleagues disagree? Why were they not comfortable with this position? I looked at the science and had the most wonderful explanation—I will not call it a lecture because it was a delight—from my noble friend Lord Patel when we were in Doha of the differences that made this such a safe and necessary option. Here, on our Benches—they now sit together—are two of the best members, I respectfully suggest, of the medical profession. They, too, are urging us to go on. Why, therefore, were my two legal colleagues so concerned? I looked for myself. Did they have a point? Was there a legal problem that was not being faced? I regret to say that there is.

This issue is complex and difficult because it is an issue that is not just centred on ourselves. The European dimension is also important. One of the reasons why I understand this issue so painfully well is that I had the advantage of being the UK’s advocate when we were arguing about the charter between 2001 and 2003. I therefore looked again at the regulations. I wanted to understand them better. I must ask the noble Earl, Lord Howe, why he is so certain that these rules comply with the European legislation and why the Government are confident that the concerns expressed by both the current—

I am very grateful to the noble and learned Baroness for giving way. Can she explain to the House what advantage there would be in referring the matter to which she is now addressing her remarks to a Joint Committee? Take, for example, compliance with the statute that already exists where the regulations are ultra vires. Surely that is a matter for determination by a judge and nothing that your Lordships can say in the House today, or indeed that a Joint Committee could say in its report, would resolve that issue in a way that would tie the hands of a court. I rather suspect, although her knowledge is greater than mine, that the position is exactly the same in Europe. Therefore, I cannot see that referring the matter to a Joint Committee, as the noble Lord, Lord Deben, asks us to do, would advance it except simply to delay the decision on the issue, which would ultimately have to be taken by a court.

My Lords, the issues in relation to how the charter impacts upon the legislation that we are discussing have not been sought out, have not been argued and have not been developed. One of the essential issues, if we are to do something which everyone agrees is novel, different and important internationally, is that we have to be confident that we are on solid ground because if we are not, we give a disservice. There are two things. One is that the research that is still awaited and, as was mentioned by the right reverend Prelate, is to be forthcoming should be available. The second is that these issues in relation to the charter could be properly articulated. I looked quite carefully to see whether this has already been done. Had that already been looked at, and was there an answer in the letter of the 17th that the noble Lord issued? Were all the worries that I have—I am afraid that there are about 20 pages of them—dealt with? However, they have not been. So the question comes back: why the haste?

Everybody agrees that we have to get this right and having worked so hard and so long, and knowing of the pain that many have already spoken about, what a cruel thing it would be to do this and then say that the legal basis upon which it was founded was flawed. The noble and learned Lord, Lord Hope, is right that if in the final analysis the arguments we articulate and which go through the Select Committee are not sufficiently sound, the only way in which the sagacity and value of these legal principles can be tested would be in a court. That is what would happen.

Does the noble and learned Baroness also agree that until the regulations are made, the matter cannot be tested because courts do not deal with hypothetical arguments? The regulations have to be made, so if this issue is to be properly tested in a court the first step is to make the regulations.

My Lords, there are two steps. I would argue that the first step is that if a Select Committee is able to deal with all these matters in the proposal currently before us in draft, and which would today go into regulations, would be the basis of the Select Committee’s examination. If that basis is found to need some minor alteration or amendment, it would be that amended version which would then come before this House and form part of the regulations. That would be the issue that would likely be tested if there was still disagreement.

My hope would be that the concerns that have properly been raised could be dealt with by the Select Committee, particularly if we were to persuade some of the noble and learned Lords who had perhaps served in the Supreme Court in the past to lend us some of their expertise on that Select Committee. One of the advantages that we have in this House is of having that level of expertise. That is why we could do this in rather a short compass. First, I do not agree with those who think that this issue should be kicked into the long grass. It should not. Secondly, I do not believe that a Government of any complexion, as has been said in this debate, who had a very well reasoned and consensual Select Committee report would hesitate from implementing it.

Does the noble and learned Baroness agree that if the regulations were agreed today, and therefore passed, the HFEA itself would have the opportunity to test the legal opinion? It certainly did that with the cytoplasmic hybrid embryos, if we go back to 2007. The HFEA then took a series of legal opinions to inform it in its opinion against the Government at that time. Why cannot that process go on at the same time?

The real issue is whether we are going to abrogate our own responsibility. Is this something which we should ask an outside agency to do? Should we make a decision where we cannot come to a fully informed and articulated decision ourselves? If we are left in the position of saying, “I am not entirely sure about the research or the sagacity of the legal principles being advanced that enable me to pass this”, surely we should wait until that is clarified. If the House believes that it wishes to abrogate that responsibility because the nature of the issues we are dealing with are such that we feel comfortable about doing that, then of course that is always a matter for us. But I simply argue that what is being asked for is what I hope to be a relatively short period for these matters to be fully considered and fully put to rest.

I am very conscious of time but there are a number of arguments that we could put forward on the law, which would help to further exemplify that this matter is not easy. It is complex. The reason I emphasise that the law officers are disagreeing is the following. All law officers are in the same position. We are not here to tell people what they want to hear; we are here to tell them what they need to know. That should be valued by the House and I am sure that the House would want to be confident that doing this, which everyone hopes would be a good thing, should be lawfully done, too.

My Lords, one of the bases of my noble friend Lord Deben’s amendment to the Motion is this question of whether these regulations are lawful. I have studied quite carefully the opinion of the noble Lord, Lord Brennan, with a junior. I have seen other opinion as well but I am thinking now only of my own analysis of what the noble Lord and his junior said.

The first point is: is this lawful under the domestic law of the United Kingdom? My answer is that it is clearly lawful because, in 2008, this Parliament passed an amendment for the purpose of allowing such regulations to be made. That is as clear as it can be, and you do not need to be a lawyer to think that it is possibly quite a good point. The result of the opinion that the noble Lord, Lord Brennan, has given on this point is that that amendment would be held to be pointless. The courts are not very keen on reaching a conclusion that a deliberate action of Parliament is without point, so I feel very strongly that these regulations in draft are lawful, within the domestic law of the United Kingdom.

Now we come on to the complexities of the European law. Like the noble and learned Baroness, I have had some experience, now long past, of appearing before the Court of Justice in Luxembourg. Masters of complexity are very difficult to find at a greater level than it has. The essential point about this, however, is very clear. If the noble Lord, Lord Brennan, is right, it is not a question of these regulations being wrong; it is that the whole procedure that they are aiming to do is unlawful according to European law. That is fundamental. I do not believe that it is correct, because I do not think that the European Union has a treaty basis if we are dealing with medical procedures in the member states. The regulations that are referred to in great detail—huge definitions and all the rest of it—are intended to deal with the furtherance of the common market. Therefore, if you get a tablet in Germany that is supposed to be suitable for you, then it would be equally suitable in this country—

Can I just help the noble and learned Lord by saying that the thing that concerns me is Article 6.3 of the treaty and the way in which the charter has been incorporated to consolidate all the other European laws that were there before the making of the charter? It was the charter itself, and the way in which it has changed things, which makes the difference. I am not focusing primarily on the issues that have been referred to by my noble friend Lord Brennan in his opinion. I am really looking at those issues that arise as a result of the charter. I do not believe that their proper interpretation has been dealt with. I know that the House will not like me very much if I go through the whole charter, but I am very happy to share the issues which really concern me with the noble Earl, Lord Howe.

So far as I have understood the European treaties, they do not confer an authority as yet to interfere in the medical procedures within the member states. That is basic, and means that they cannot interfere or render unlawful a medical procedure such as the one proposed in these regulations. I could go into the detail of it—I am sure that would not be very acceptable—but I have two principal reasons for thinking that that is right. The first is that no challenge, so far as I know, has been offered by the European Commission to the provisions in the 2008 Act—which of course would be the right place to challenge this, if it were unlawful. This provision was definitely intended to make these regulations possible. The second reason that I advance is that in the opinion of the noble Lord, Lord Brennan, a reference is cited to a treaty dealing with these matters which is outside the European Union. It has a number of members of the European Union as signatories, but it has not been signed by the United Kingdom, nor ratified of course by the United Kingdom, so it is not part of our law. That is the kind of law that deals with embryology in a way that might have been difficult for us if it had been part of the European Union.

These are simple reasons why I think this situation is reasonably clear. Of course, I accept that the law officers have taken a different view. We have not had a chance of discussing it in detail with them. The other point I have to make is that no amount of discussion in a Joint Committee can settle this matter. The only place it can be settled is in a court of law, either the domestic courts of the United Kingdom or, if necessary, the Court of Justice of the European Union in Luxembourg. In a sense, if that is a real point, the sooner the regulations are passed the better so that they can be tested.

So far as the point made by the right reverend Prelate is concerned, I understood that the research that the HFEA was asking for has been done and is in the process of publication. It just does not happen to have completed publication. As he was speaking I was reminded that when I had the responsibility of taking the 1990 Act—the original Act in this area—through this House, the then Bishop of London took quite a prominent part in the discussions. His watchword was caution—and he thought that that amount of caution had been built into the procedure by having the HFEA examine individual cases and be in charge of the licensing.

My Lords, I take a rather different view from some of my eminent medical colleagues. I have worked for over 30 years with families of severely disabled children. As a psychiatrist—and as the mother myself of a child born with a severe developmental disability—my heart goes out to those parents facing the prospect of inherited mitochondrial disorders. As a mother, I understand what is called the moral imperative to try to help. However, our first responsibility must be to the children who may be created through these proposed interventions: the most important moral imperative must be to do no harm.

A new technology of such potential importance must take as long as is needed to be as sure as possible of its safety. Being first is not always best. I have carefully read the HFEA 2014 review of scientific methods. It has been implied that the scientific reviews have not raised any concerns, but in paragraph 3.7.25 the review states,

“although the results with the two techniques continue to be promising, further experiments need to be carried out before introducing either into clinical practice to provide further reassurance about efficiency and safety”.

I asked a Written Question in December asking whether clinical trials were being planned and I am grateful for the helpful reply from the Minister and the mention he made of it in his opening remarks—although I disagree with his interpretation of medicine, which is defined much more broadly in the European directive. The Minister also explained that,

“for any new IVF technique there will need to be careful monitoring of the procedure and, subsequently, any pregnancies”.

But we are not talking about pregnancies primarily; this is me as the psychiatrist talking now. As the noble Lord, Lord Deben, pointed out, we are talking about children—children who will, we hope, grow up to be healthy human beings, and who will themselves be able to have healthy children. But what if they do not?

In paragraph 3.7.29 the HFEA expert panel said:

“Until knowledge has built up that suggests otherwise, the panel recommends that any female born following MST or PNT”—

maternal spindle transfer or pronuclear transfer—

“should be advised, when old enough, that she may herself be at risk of having a child with a significant level of mutant mtDNA, putting her child, and if female, subsequent generations at risk of mitochondrial disease”.

The science is complicated, but there is apparently a real possibility that resulting embryos from a woman born after MST or PNT could be heteroplasmic—

May I ask the noble Baroness what experiments she would propose to determine that the children born through this procedure will be healthy in every way, including reproduction-wise?

My Lords, I do not think that intervention is very helpful as it is not relevant to the point I am making. The issue of heteroplasmy was spoken about earlier, and it simply means two or more different mitochondrial DNA types coexisting in a single cell. The review panel concluded:

“These levels may still not be sufficient to cause her children to have a problem, but subsequent generations could be affected”.

In paragraph 4.3 the panel stresses that,

“it should be accepted that there will always be some risk and unknowns associated with the use of MST or PMT in humans until it is tried in practice”.

I understand that and agree with it.

One argument for agreeing the recommendations now is to enable the HFEA to license these techniques as soon as it is convinced that there is sufficient evidence of safety without then having to seek parliamentary approval, thus possibly delaying implementation. In 2008, Dr Evan Harris, the former Member for Oxford West and Abingdon, a champion of the 2008 Act, said:

“Safety is clearly a concern… If Parliament decides that it is not safe enough to allow the HFEA to consider licensing something, Parliament would not draft, confirm or pass the regulations”.—[Official Report, Commons, Human Fertilisation and Embryology Bill Committee, 3/6/08; col. 35.]

Agreeing the recommendations now seems to be putting the chicken before the egg. Supporters of the techniques—

The noble Baroness made the point that heteroplasmy, and therefore the carryover of the diseased mitochondria, is possible under this technique. Does she agree that experiments show that the likelihood is less than 5%, whereas pre-implantation genetic diagnosis has it at up to 40%? That is a legal procedure, so we are talking about trying to legalise a safer procedure than something that is currently legal.

Again, I do not think that is the point that I am trying to make. Maybe I am not being quite clear enough.

Would the noble Baroness not agree that there is only one absolutely safe way to ensure that this disease is not handed down from generation to generation, and that is for those women who are carriers of the genetic fault not to have children? That may be an appalling thing for me to have said, many people would think, but there are many people who for various reasons cannot have children.

That is a good point.

Supporters of the techniques simplify the impact of these proposed procedures by saying that mitochondrial donation is like changing a battery. Their argument runs that mitochondrial DNA relates only to power production in the cell but does not affect the DNA, which encodes our characteristics, and therefore that exchanging mitochondria should not be seen as ethically significant. In a debate last September, the honourable Member for Havant in another place summed up this position well when he said that the techniques represented,

“a change in the membrane of the cell so that the battery function continues, but it does not affect human identity even by 0.1%. That is why I do not believe that there is an issue of dignity or integrity of the individual”.—[Official Report, Commons, 1/7/14; col. 98.]

The Government underlined how important this point was to their policy in their consultation response when they said:

“Most importantly, mitochondrial donation techniques do not alter personal characteristics and traits”,

of the person, the implication being that if this technology were to affect personal characteristics then the Government would withdraw their support.

So the ethics and the safety of the science are inextricably linked. Unfortunately, it seems that we are still at the beginning of understanding the complex interactions between mitochondrial and nuclear DNA. Some recent empirical studies on animals have suggested that mitochondria indeed affect characteristics, and that there is a relationship between mitochondria and memory, temperament and behaviour. As a psychiatrist, I see temperament as a personal characteristic, and I think it was for that reason that the New Scientist withdrew its support for the techniques. In an editorial last year it said that,

“we may have seriously underestimated the influence that mitochondria have. Recent research suggests that they play a key role in some of the most important features of human life”.

I note that the Government’s own consultation document acknowledged the diversity of problems associated with mitochondrial disease, including learning disabilities, neurological problems, autonomic dysfunction and dementia, and that every person’s symptoms are different. The Government’s response to the consultation concluded that they do not alter personal characteristics. One problem that I have with the current proposals is the idea that mitochondria are mere batteries, which is what has been quoted in so many of the papers that have been circulated to Peers. The New Scientist leader comment in September last year said that most debate around the issue had worked on the assumption that mitochondria were simply cellular powerhouses. However, given their newfound influence over our bodies, the implications of this technology may be far more radical than we have assumed. The leader made the point that it seems that mitochondria, far from being passive power plants, influence some of the most important aspects of human life, from memory and ageing to combating stress and disease. They even have influence over the DNA in your cell nuclei and change and evolve during your lifetime.

I have been inundated by emails, as I am sure we all have, from people who are concerned. I had an email from a cell biologist working in California, Professor Paul Knoepfler, who contributed to the HFEA’s call for evidence. He said that,

“mitochondrial transfer might be proven safe, but then again it might not. From my perspective as an impartial (scientific) observer … putting myself at some risk by publicly opposing this technology … its approval at this time would be a … risky gamble with children’s health and lives”.

He says that many scientists have told him that privately they share his concern.

I have one question for the Minister: would he withdraw his support for the regulations if he thought that the role of mitochondria was more than mere power production? Would he then support the amendment of the noble Lord, Lord Deben, for further consideration of this matter?

Until recently, the Wellcome Trust had on its website a statement suggesting that the procedure would be able to go ahead in late 2014, when the science was ready. But is the science ready? I am not quite convinced yet. As noble Lords may be aware, I chair the BMA board of science, which has not yet discussed this matter. I have discussed my support for the noble Lord’s amendments with senior officers of the BMA, and perhaps I may clarify the BMA’s position. Its support for the principle of such reproductive technologies has been expressed as an ethical principle to allow the cautious exploration and development of such technologies. I have concerns about the timing of these regulations, and for that reason I welcome the opportunity to debate them presented by the noble Lord, Lord Deben.

My Lords, we have heard from legal and medical experts. I am happy to say that I am not an academic and I know very little about the subject. However, it strikes me that if we look at the practicalities from the point of view of the parents who are afflicted by this condition, and we turn back to 1978 when baby Louise Brown was born as a result of the in vitro fertilisation undertaken by Steptoe and Edwards—

In Oldham—quite right. From that one invention, nearly 5 million children have been born who otherwise would not have been because their parents were infertile. There was a strong religious lobby against it at the time; indeed, a lot of people were against it because it was interfering with the genesis of life. This fatal Motion seems to carry some of that feeling with it.

I am a mere surgeon. I had the opportunity to visit the Lister Fertility Clinic with a parliamentary group to learn a bit more about IVF and how it was carried out. I watched the technicians—not the doctors—who had gained expertise in intracytoplasmic sperm injection. That is the technique whereby you isolate the egg, find a lively sperm and then inject it straight into the cytoplasm. The technique that has been suggested for mitochondrial donation is not dissimilar from that. A lot of expertise has been gained over the years when that has been done. I heard the noble Baroness, Lady O’Loan, and, I think, my noble friend Lord Elton refer to the situation of donors.

The noble Lord seems to be saying that there is no difference between IVF and the mitochondrial process. However, IVF does not require the genetic modification of human eggs and embryos, or tampering with the contents of the egg or embryo itself. This technology requires both.

I take the noble Lord’s point. If I wanted to, I could explain why this is not an issue. One point that arises is that it is illegal to tamper with the nucleus. The technique that we are discussing relates specifically to mitochondria.

I will move on. Having seen this technique at work in the clinic, I am absolutely reassured that the expertise is there and, therefore, that the technique of mitochondrial donation, if allowed, could be carried out successfully.

I will speak briefly about the families who are currently facing the prospect of having children with severe mitochondrial disease. We are told that the numbers of those who will have severe disease is in the order of 10 or 20 per year. This technique can be fully utilised only after the regulations have passed, the HFEA has ensured that it is safe and each unit has demonstrated that it can do it safely. Only then will these families be able to have this done.

Informed consent is a prerequisite in any medical procedure. Informed consent is important because patients have to be sure that what they are having done is in their best interest. They have a choice of whether to accept what the doctor is offering or to reject it. My noble friend Lord Ridley referred to Claire Wright, a mother who lost a baby at 18 months. I was fortunate to meet her yesterday and to hear her story. What she said to me was very moving and touching. If she had the opportunity to have mitochondrial donation done, her concern was that the clock was ticking and that she may have reached the point where she would no longer be able to undergo the procedure. Yes, she could remain childless. Yes, she could adopt. But she would like to have a child that bears some of her genetic characteristics. I think that this technology will allow that to happen.

Nothing that we have in medicine at the moment can provide 100% safety—

I am grateful to the noble Lord. Before he moves on, I want to speak to his point about adoption. Your Lordships will have seen the recent parliamentary reply on this. In the past five years, around 5,000 newborn babies have been available for adoption. That is all, compared with more than 1 million babies that have been aborted during that period. Does he not think that we should be much more interested in seeing if we can put right that imbalance?

Does he also recognise that there is a difference between the two techniques that are being offered to the House today, maternal spindle transfer and pronuclear transfer, in that one requires the destruction of human embryos, 2 million of which have been destroyed since the original legislation was enacted in 1990, and the other does not? On the basis of what I think he believes and says, is it therefore not only more prudent but more ethical to use the technique that does not result in the destruction of human embryos?

It was made very clear by the noble Lord, Lord Patel, and others that the need for the two techniques is to allow the HFEA to make a decision on which is the preferable technique. We have a situation at the moment where many of the embryos that are produced are discarded after the 14 days or so that are allowed. I will not go into the question of adoption. It is a matter of choice. If the family would prefer to have a child without this affliction, that is their choice, and they may not choose to go down the adoption route.

Returning to the subject of safety, as has been stated, no procedure can guarantee 100% safety. Even the natural birth that we all go through will produce children with defective genes and abnormalities; even nature cannot get it 100% right. To expect a situation where we have to demonstrate to all and sundry that this procedure is 100% safe is impossible.

Finally, it is important to recognise that passing this regulation is not opening Pandora’s box. We are not going down the route of eugenics and we will not create monsters. We must trust the scientists. We must recognise that we have regulation in this country—one of the most regulated countries in the world in the health field—and I believe that we must leave it to them to make the case. As was said by my noble and learned friend Lord Mackay of Clashfern, the decision was already made in 1990, when he was responsible for taking the Bill through Parliament. In 2008, it was modified with the full understanding that this type of technique might well be brought into use.

The day has come, the time has come and, frankly, we must just get on with it.

My Lords, I come to this debate without any expert legal or medical experience or perspective. As a former chair of the Human Tissue Authority, I worked closely with the Human Fertilisation and Embryology Authority, the well established regulator in this area. I came to know the way in which it regulated and certainly had confidence in it, as indeed Parliament has. As a former chief executive of Universities UK, I am also familiar with the research trials that are rigorously and vigorously undertaken in health research before any change or new technique is introduced into clinical practice. I have come to know the bodies which speak for science and for medical research, such as the MRC and the Royal Society, and the Association of Medical Research Charities, of which my noble friend Lord Turnberg has been a scientific adviser, as well as the Nuffield Council and the Wellcome Trust. I realise how fortunate we are in this country to have pre-eminent organisations, respected around the world, the main aim of which is to ensure that research is rigorous, honest, thorough and ethical. I say all this because I take great comfort in the fact that, where there are complex areas of science or new techniques, particularly where they might be controversial—as with fertility and genetics—we have the knowledgeable, forensic and wise guidance of these bodies to help us in Parliament to arrive at secure solutions.

Mitochondrial DNA disease is severe. In most cases, we are told, it causes early infant death, and the few children who survive suffer multiple health problems. Mitochondrial donation, a new reproductive technology developed by our world-leading scientists in Newcastle, is important because it enables families affected to have a healthy child. Our decision today will be immensely important to those families.

A key question has been raised about the safety of the procedure. As others have said, while no medical procedure can be guaranteed to be 100% safe, a huge amount of testing has been done to establish the relative safety of this particular procedure.

I have no professional expertise in this or in any other area of disease. So, like most other women and men in the street, I rely on the rigour and competence of our regulators, ethicists and clinical testing systems to provide the best possible guidance on new techniques and procedures, to enable me to make up my mind—even if some of the evidence is contradictory. All the bodies that I referred to earlier, and others which represent the families of those tragically affected by the disease, favour this regulation to permit mitochondrial donation. They have provided excellent briefings, and there was a hugely helpful seminar yesterday where experts on different aspects of this issue addressed a range of concerns. They have pointed to seven years of intensive scrutiny, three separate reviews of the scientific evidence on the technique’s safety, independent ethical reviews and an extensive public consultation. Currently, the law allows for these techniques to be used only in research. It is up to us in Parliament to decide whether these techniques are ethical and whether they may, with safeguards, be used in patients.

The Nuffield Council on Bioethics found that, given the benefits to individuals if shown to be sufficiently safe, the techniques are ethical for families to use. The public, during consultation, concurred. The Wellcome Trust has helpfully set out the scientific evidence and detailed reasons why the procedure cannot be seen as genetic modification. What is very clear is that scientists throughout the lengthy period of research have been open and transparent. Nothing has been hidden, including their disagreements. There has been no conspiracy, as some of the critics seem to have suggested.

I found that I had a lot of sympathy with my noble friend Lord Turnberg and the noble Viscount, Lord Ridley. All the evidence I have seen and the arguments I have heard reassure me that this is not a slippery slope or an open door, or any other cliché. Nuclear DNA is not altered, so donation will not affect the child’s appearance or personality, or its uniqueness. It will simply allow parents to choose to have children who are genetically related to them but who are free from potentially devastating disease. I trust that the House will support these regulations.

My Lords, it is a rule of this House that only one person speaks at one time. I ask noble Lords to be seated, please. We are in some difficulty. A number of noble Lords still want to speak. I understand that; this is a serious matter. Perhaps I might suggest to them that they will attract the approval of the House if they keep their remarks brief. Most noble Lords have come here with contributions to make, and they are speaking from extensive notes. It would help us all if we could move this debate to a conclusion; many noble Lords have indicated that to me. Therefore, while I do not for a moment suggest that we move to that stage now, I ask noble Lords to be orderly in allowing others to speak and to be brief.

My Lords, I am grateful to the House. Although of course I have ethical objections to the regulations, which are well founded and have been pretty well rehearsed on previous occasions, the Motion in the name of the noble Lord, Lord Deben, does not invite us to vote on the ethics. Therefore, accepting what the noble Lord, Lord Taylor, has just said to the House, I will not explore those ethical issues today but will stick to the points that the noble Lord, Lord Deben, raised earlier on, which concentrate on safety, legality and definitions. In supporting the Motion I want to address three points: procedure, pertinent questions and the specific issues posed by pronuclear transfer—one of the techniques made legal by these inappropriately combined regulations. It is worth saying in parenthesis that there is a third technique, polar body transfer, which was referred to during the discussions that the noble Earl was good enough to arrange for a group of us to have. That is being explored at this time, and will require yet more regulations to come before your Lordships’ House.

Yes, and so it should, as the noble Baroness says. However, why are they not being taken together, why is there a hurry, and why are we not considering them all at the same time? Some raise particular issues, and others raise different issues, so many of us find that being asked to take it or leave it today is very difficult.

Some 41 Members from all sides of the House of Commons have written to your Lordships asking us to provide the opportunity for further consideration to be given to these regulations. For 18 years I served in another place. I would have been appalled if only 90 minutes had been provided during my time there, when we discussed in 1990 the original legislation or subsequent changes to it—90 minutes on unamendable regulations. Half the House of Commons—300 compared with 350—either voted against or abstained: 128 voted against, 172 abstained, and 300 voted for. As the noble and learned Baroness, Lady Scotland, said to us earlier on, the Lord Chancellor—and we have heard from an eminent and very learned noble Lord today, a former Lord Chancellor—and the Attorney-General both voted against the regulations. Subsequently, we have received representations from 50 Members of the European Parliament—I say to my noble friend Lord Walton that they were not all Roman Catholics—including Socialists, Christian Democrats, Communists, Greens and others, and internationally respected scientists, challenging the safety and the legality of what we are being asked to approve. Last week Professor Christopher Exley, a British scientist, described these procedures as,

“a genetic experiment which could have disastrous consequences for generations”.

That is not a religious view. This requires us to take the moderated view that the right reverend Prelate the Bishop of Carlisle commended to us earlier on. Yet, procedures permitted only a 90-minute debate in the Commons on an unamendable order, and if it were not for the noble Lord, Lord Deben, today, we would not have the opportunity to be discussing these complex questions—

As a point of fact—and I hope that the government Chief Whip will agree with me—we would have debated this order in this Chamber under the normal procedures of this House with or without the amendment that was put down, because that is the practice of this House. I can see the government Chief Whip nodding and the noble Baroness who chairs the Delegated Powers Committee agreeing.

I am glad to hear what the noble Baroness, Lady Farrington, has said to us today. It is important that it should be on the Floor of this House, therefore we are all agreed. I contrast the 90 minutes given to the House of Commons to discuss this with the 90 hours that Parliament spent discussing fox hunting. I ask noble Lords to contrast those things. We are required to show due diligence and scrutiny, especially over controversial legislation.

It is not just the absence of the preclinical tests recommended by the HFEA that suggests that the cart has been placed before the horse, but the disingenuous decision by the clinic promoting these regulations—even before your Lordships have debated, let alone approved, these regulations—to offer women money, as we heard from my noble friend Lady O’Loan earlier on, to sell their eggs for these procedures, a practice which itself can be injurious to their health, while telling us:

“It was never about politicians voting on whether it was safe or not”.

That seems almost a contempt of Parliament, and is certainly an extraordinary dismissal of health and safety considerations, which everyone has admitted this afternoon are a consequence of what we are being asked to agree. We have a duty to satisfy ourselves about questions of public safety.

I have experienced this afternoon something of a sense of déjà vu on the arguments, which are so reminiscent of those which persuaded your Lordships to vote for animal/human hybrid embryos in 2007. Although my noble friend Lord Patel, who I think is about to intervene on me again, said earlier on that there was a significant breakthrough by Professor Shinya Yamanaka just two weeks after the Bill passed, that is not entirely accurate. The Yamanaka breakthrough came in 2006 in the journal Cell, not after the Bill passed but before it was even published. If you look back at the Hansard, as I hope Members will, I argued repeatedly that the proposal was redundant because of the Yamanaka breakthrough and that we should not have voted for it. However, despite the Yamanaka breakthrough, many argued that animal/human hybrid embryos were necessary.

Before we rush pell-mell into authorising something which the rest of the world—from the federal agency in the United States to the People’s Republic of China—has prohibited, may I ask the Minister to answer some pertinent questions? First, what regard has he had to the increasing demand for women to give up their eggs for these techniques, the failure of the HFEA to monitor the drugs and dosages used for ovarian stimulation, and published data by Newcastle indicating an incidence of hospitalisation due to such stimulation due to the frequent collection of more than 20 eggs per cycle? Does he regard it as ethical to ask women to sell their eggs for £500?

Secondly, what is the cost of these regulations, both human and financial, when pronuclear transfer—the second of the procedures that have been referred to— requires the destruction of at least two and in some cases 10 healthy embryos for every procedure? Contrast the financial cost, too, of an issue I have raised regularly on the Floor of your Lordships’ House; namely, the failure to provide vital and much needed public funding into finding a cure for diseases such as mesothelioma, which will take the lives of 60,000 British people in the next 30 years.

Thirdly, and more specifically, why have the Government not waited for the outcome of the HFEA’s recommended preclinical experiments before proceeding? Fourthly, like noble Lords today, Dame Sally Davies, the Chief Medical Officer, said at a meeting that I attended with the noble Earl:

“No one will guarantee that it is safe”.

That being so, and given the absence of safety trials, how much has the National Health Service set aside for compensation if safety fears are realised? One recent payment to the parents of a baby damaged at a hospital reached a staggering £10 million.

Finally, I turn to the specific issue of pronuclear transfer. These regulations have bundled together two different procedures. As I said, pronuclear transfer—PNT—unlike maternal spindle transfer, requires the destruction of human embryos. It is a technique that has been specifically advocated by researchers at Newcastle. To date, most applications of this technique have been in mice. However, the Weatherall report of 2006, sponsored by the Academy of Medical Sciences, the Royal Society, the Wellcome Trust and the Medical Research Council, on page 85 stated the following:

“Humans and non-human primates share many features of reproductive biology that are not present in other mammals … Hence, rodents and other non-human primates have only limited usefulness as models of human reproductive physiology”.

Consistent with this, the report of the HFEA’s expert panel in April 2011 said that before the technique could be considered safe to use clinically, it was critical to undertake,

“PNT in a non-human primate model, with the demonstration that the offspring derived are normal”.

Has this been done? Nearly four years later, the answer is still no—even though most postgraduate researchers would have already completed a doctorate within this timeframe.

Strikingly, a news article for the journal Nature stated on 19 January 2012:

“The Newcastle researchers do not have plans to determine whether primates conceived through pronuclear transfer come to term and are healthy”.

Remarkably, the HFEA’s expert panel then changed its mind about preclinical experimentation in primates being critical for pronuclear transfer, in its ensuing report in 2013. The only explanation provided was exceptionally brief and far from compelling. It said that:

“Current research using PNT in Macaques has yet to be shown to be successful. From unpublished data it appears that Macaque zygotes do not survive the PNT process well”.

The panel now believes that the macaque may not be a sufficiently good model for the human. If macaque embryos do not have a good record of surviving pronuclear transfer, and human eggs are even more sensitive, are not problems with human embryos more likely? Surely this suggests the need for proceeding even more cautiously, not less.

The Joint Committee proposed by the noble Lord, Lord Deben, should reflect on the HFEA expert panel’s minutes of 12 February 2013, in which Dr Dieter Egli, of the New York Stem Cell Foundation, explains that he was,

“sceptical about the clinical application of PNT”,

because a structure known as the centrosome may be left behind, and that,

“the consequences of this need to be investigated”.

The proposed Joint Committee should also consider the minutes of the HFEA teleconference with Dr Shoukhrat Mitalipov on 30 January 2013, which reported:

“Dr Mitalipov expressed the view that development of MST or PNT embryos to blastocyst was not in itself enough to give confidence that the techniques are safe and effective”,

and the recent remarks of Professor Justin St John, a geneticist at Monash University in Australia with considerable expertise on the behaviour of mitochondria in nuclear transfer, who said:

“As well as analysing foetal development in a non-human primate model, it is essential to analyse offspring to determine that no abnormalities appear at least during early life”.

Not only have the researchers at Newcastle refused to perform such preclinical research in non-human primates, I have been unable to find evidence of their own prior experience in obtaining healthy offspring of any species following pronuclear transfer, or even in taking any such embryos past the blastocyst stage.

Clearly, I am not going to get to speak this evening, so I ask the noble Lord a very simple question. Does he have any faith at all in the HFEA to do what it actually says on this tin? If the regulations are passed today it will then have the job of deciding when it will be safe to go ahead and grant a licence. If he does not have that faith in the HFEA, will he please say that? Because I do.

I serve on my own university’s ethics committee, which looks at the use of animals in experiments. Apparently, one of my roles on that committee is to be, as it were, the animals’ friend and to ask whether the experiment is repetitive, whether it is necessary to do such things and what it is going to lead to. There is no one on the HFEA who is the friend of the human embryo. That is a bizarre situation and one I would like to see rectified. But to take the noble Lord at his word, of course I think the HFEA often does a good job, and I admire many of its members.

I will simply say one other thing to the noble Lord. The HFEA is a regulator, not a legislator. That is our duty here today and that is why we are having this discussion. I am conscious that others wish to intervene and I am grateful for the patience of your Lordships’ House in allowing me to put these points. As we ponder on these serious issues revolving around public safety and questions of definition and legality, they deserve far better consideration and scrutiny than has been provided thus far. Surely we should remember the wise advice that those who legislate in haste repent at leisure. Therefore, the proposal of the noble Lord, Lord Deben, for a Joint Committee of both Houses to examine the safety and legality of these regulations deserves our support.

My Lords, since 1990, this Parliament, and, in particular, this House, has shown the rest of the world how these matters should be dealt with. It is for that reason that I hope that we will pass these regulations today.

In 1990, the noble Baroness, Lady Warnock, set down the ethical framework within which we make decisions and within which scientists must do their work and regulators must regulate. In 2008, as the noble Lord, Lord Walton, the noble and learned Lord, Lord Mackay, and others will remember, we debated these and related issues at considerable length. At that time, the scientists came to us and said, “We believe that very shortly it will be possible for mitochondrial transfer to happen”. At that point, Parliament sat and listened to the scientists and said, “Not yet. Not yet”. That is why we passed the permissive legislation that we did, which has led to these regulations.

The noble Lord, Lord Deben, in putting forward his very cogent and persuasive argument, missed out one crucial fact that undermines his argument: research is not linear. Researchers do research and it takes them to places that they had not imagined or they hit obstacles that they did not anticipate. Things change radically, as they did in the case of animal hybrids. That is why we operate as we do, within a system whereby Parliament sets out the principles and the ethics. We require the scientists to come back to us again and again and we are dependent on the information that they give to us.

I went to the same meeting as the noble Lord, Lord Deben, and I formed a very different impression of the scientists. Our top scientists have been making themselves available to Members of Parliament for all of the past year to explain as clearly as they can this science as it is emerging. I do not think that we should abrogate our responsibility in this House. I think we should continue to listen to the scientists. I like the fact that I live in the United Kingdom where we debate these matters. We have the involvement of people from the church and from different faiths and walks of life. We also listen to contributions from people such as the noble Lord, Lord Alton, who are consistently and wholly opposed to this issue. However, it is important that his voice is heard. I do not want the ethical decisions to be sent off to the courts as they are in the United States.

Noble Lords have talked a lot about the emotional issue of meeting the needs of families but they have also discussed the safety of these issues. However, I simply put before the House the response of parents to the suggestion that they might have a child who proved to be infertile. When they were asked how they would feel about that, they gave the clear response, “We love our children as they are and we would not have not had them. However, if we could have had a child who did not have the illnesses that they have, we would have opted to have such a child, even if that child proved to be infertile”.

The scientists have been absolutely straight with us and have given us the relevant information. They have not said that this process is safe or guaranteed because they cannot do so. The noble Lord, Lord Alton, is right—they will have to come back to us if techniques developed in the future prove to be better and safer than those we are discussing. However, given the information that we have, I for one feel that this Parliament has been fully informed and that we can make a decision—and I hope that we do.

My Lords, I sense that the House wants to come to a decision.

Just over 14 years ago, I asked the House to agree that embryology research could be extended to cover diseases such as Parkinson’s disease, Alzheimer’s disease, cancer and diabetes. This provision had been anticipated and included as a regulation-making power in the Human Fertilisation and Embryology Act 1990, which had allowed embryology research but only for conditions such as infertility and congenital diseases.

The 2001 regulations were passed following a Motion moved by the noble Lord, Lord Alton, to whom I pay tribute for his integrity and perseverance. However, his Motion to establish a Select Committee prior to the regulations being approved was defeated by 212 votes to 92.

The 1990 Act followed the work of a committee led by the noble Baroness, Lady Warnock, which made recommendations on developments in science and medicine in relation to human fertilisation and embryology. I pay tribute to the noble Baroness for her outstanding work in helping us get the balance right between the respect owed to human embryos and the potential for the use of embryos in research and treatment for devastating illnesses.

The 1990 Act was a model in the regulation of certain infertility treatments and embryo research. It reflected the need to have a strict framework in which regulation could be conducted to take account of the advances in medicine anticipated by both the noble Baroness, Lady Warnock, and Parliament in 1990.

Since 1990, the science and research have developed, just as has the need for Parliament to keep up and anticipate further developments. Thus, in 2001, we passed emergency legislation to put it beyond doubt that human reproductive cloning could not take place in the UK. In 2004, we passed regulations in which the identity of the donor of eggs, sperm or embryos could be given to the adult donor-conceived person under certain circumstances.

We have heard about the 2008 Act, which amended the 1990 Act to include restrictions on the types of embryos that may be placed inside a woman. Importantly, the 2008 Act amended the 1990 Act to insert a regulation-making power to enable techniques which were under development at that time to be used in treatment to prevent a child being born with serious mitochondrial disease. Surely, the noble Viscount, Lord Ridley, and the noble Lord, Lord Walton, are right—at every significant stage of embryology research and potential treatment, Parliament has been asked to give its approval and thus ensure public confidence in our scrutiny of these most difficult decisions. My view is that Parliament has discharged that responsibility thoroughly and well. However, I am glad that the noble Lord, Lord Deben, has given us the opportunity to have this debate. Of course, we would have had a debate but the noble Lord has served a great purpose in encapsulating the core argument and I am grateful to him for so doing.

We find ourselves asked to make a crucially important decision, with powerful contributions having been made on both sides of the argument. On the one hand, we celebrate the triumph of science that these new techniques represent. We have within our reach the possibility of eradicating mitochondrial disease from families who have been blighted by it for generations. On the other hand, we are grappling with serious moral, legal and ethical questions that are raised by the proposed introduction of such techniques for treatment. We on this side of the House have a free vote. Speaking for myself, and myself alone, I will vote in favour of the regulations.

The noble Earl, Lord Howe, will respond to many important points that have been raised, but I ask him to focus on a number of very important considerations that have also been raised. On the question of continuing research and the comments of the expert panel, will he confirm that the panel said there was no evidence to suggest that the techniques proposed in the regulations are unsafe? Will he also confirm that the panel has agreed that further research and reviews could take place either before or after the regulations are approved?

As regards whether this matter is being rushed through Parliament and would benefit from further scrutiny by a Select Committee, the question here is: what would be gained by delay? Will the noble Earl confirm that the principles that we are discussing were approved by Parliament in 2008 after thorough debate? I do not need to go over the work of the Nuffield Council on Bioethics or that of the HFEA and its expert panel because noble Lords have mentioned that, but I should comment on the 90-minute debate that took place in the House of Commons. I agree with the noble Lord, Lord Alton, that 90 minutes is too short. However, I have read that debate and it seems to me that it was thorough and well informed and that the points on both sides were put forcefully and interventions were made. My honourable friend Luciana Berger was asked a number of very tough questions, as was the Minister. Could anyone say that at the end of those 90 minutes MPs were not in a position to come to a conclusion? Indeed, can anyone say that we are not in a position to come to a conclusion following a debate which has lasted at least three and a half hours?

We have heard from eminent lawyers on both sides of the argument on the legal questions. We have had written submissions from the Department of Health and the legal advice of the Wellcome Trust, and other legal propositions have been put to us. However, you reach a point when it is time to make a decision. I think that we are in a position to make such a judgment.

A number of noble Lords, including the noble Lord, Lord Alton, referred to the two techniques and how one should be considered in relation to the other. I understand the point that the noble Lord, Lord Alton, made. However, will the noble Earl, Lord Howe, confirm that the panel believes that at present there is insufficient evidence to choose between the two techniques? Does he consider that that is still the Government’s position? The noble Lord, Lord Deben, said that this was a question of resources. I have not seen evidence to suggest that that is the case. The important question is: can the Minister refute that? Can he say that the sole issue is that at the moment we are not in a position to judge which technique is likely to be more effective, and that it is solely for that reason that we are permitting the two techniques to be in the regulations?

Finally, we come to the position of the HFEA. At every point of our debates—this goes back to 2001—we have relied on the robustness of that body. The robustness of the HFEA is absolutely essential. There have been discussions and debates about how effective it is; my noble friend Lord Winston is a well known critic of some of its activities. Fair enough—but I believe that the HFEA has proved itself a highly effective and robust regulator over 20 years. I ask the Minister to confirm that it is the Government’s intention to continue to support the robustness of that regulatory approach.

As for the Chinese experience, will the Minister confirm that, although there are issues in connection with the techniques used, one big difference between the UK and the Chinese position is the regulatory framework and the robustness of the HFEA? I suspect that that was not the case in China years ago when those developments took place.

The question is whether the benefits of trying to eradicate this dreadful disease by preventing the transmission of mitochondrial disease, in view of the likelihood that otherwise children will continue to be born who will die in infancy, outweighs the risks of the techniques, which some noble Lords have described tonight. The scientific community—on the basis not of some kind of cosy consensus but of hard evidence—and the families experiencing this disease are clear that we are right to support the regulations. It is now up to us individually to decide whether we agree them. I, for one, am convinced that it is the right thing to do.

My Lords, before the noble Earl starts his speech, may I apologise to the House? The noble Lord, Lord Alton, has clarified the fact that it was the Lord Chancellor and the current Attorney-General who voted against this measure in the House of Commons. I was told that two Law Officers had voted against, and I assumed that the two Law Officers must have been the right honourable Dominic Grieve and the current Attorney-General. It was not: it was the Lord Chancellor and the current Attorney-General. I should apologise for that; it was a misunderstanding of the information that I was given.

My Lords, that is why, having been told that it was the two Law Officers, I came to the conclusion that the Lord Chancellor was not among them.

My Lords, as I fully expected, this has been a debate of very high quality, with a range of views, both for and against the regulations, eloquently expressed. My principal job now is to respond to the Motion moved by my noble friend Lord Deben and to some of the additional points raised by other speakers.

My noble friend’s Motion covers three main points—safety, compliance with EU and UK law, and the key definitions in the draft regulations. My noble friend and the noble Lord, Lord Brennan, in his legal opinion, argued that there was some doubt about whether the regulations were compliant with EU law, in particular the EU directive on clinical trials. With respect to both noble Lords, the Government do not agree. The EU clinical trials directive does not apply here because it is concerned with medicinal products, and mitochondrial donation techniques simply do not fall under that definition.

My noble friend asked whether we had checked our position with the European Union. The simple answer is no. Within a framework of subsidiarity, it is entirely the responsibility of each member state to ensure that its own legislation is consistent with EU law. That is what we have done. The EU would be inundated with extensive queries from member states if a “legal advice” facility existed, and there is no such facility.

Is the noble Earl equally confident that the regulations are compliant with the European directive that is due to come into force in 2016, and which might explain the timing?

My Lords, I think I can make an unequivocal statement that all the legal advice I have received is that the regulations we are considering are fully compliant with European law.

As has been said, any legislation agreed in Parliament could be subject to challenge, and it would be up to the Government at the time of challenge to defend their position. The noble and learned Lord, Lord Hope, made that point. Let me reassure noble Lords that we have considered these issues very carefully, and we are confident that the regulations are compliant. I am pleased that other noble Lords who have spoken agree with that.

The noble and learned Baroness, Lady Scotland, cited the European charter. The EU charter does not apply in this context, because Article 51 says that it applies to member states,

“only when they are implementing Union law”.

This means that a state must be either directly implementing an EU law obligation or acting within the scope of EU law. The regulations do not do either of those things.

We have considered the issues raised and, as I have said, we are very confident that these regulations do not contravene European law. The issue comes back to whether the clinical trials directive is engaged here. It is not. Our view, incidentally, was agreed with independent legal advice commissioned by the Wellcome Trust from Thomas de la Mare QC: mitochondrial donation simply does not come within the definition of medicinal products, to which the directive applies.

In the context of the horizontal articles of the charter, Articles 51 and 52, have the Government considered how Article 6.3 changes things, because it consolidates what the law was then? There is a difficulty, and I do not know whether the noble Earl has had specific advice on those matters. I know that this was not contained in the opinions that were promulgated earlier.

I can only say again that the legal advice I have had is that the charter cuts in only when there is an issue of European law. We do not consider that treatment services, which are what we are talking about here, are covered by EU law. The noble Baroness made a point of saying that my right honourable friend the Attorney-General did not vote in favour of the regulations, but it is difficult for me to comment on that. There was, rightly, a free vote in the other place, just as there is here. I cannot comment on the personal view of the Attorney-General—and I have to say that I do not think that anything said or quoted by the noble and learned Baroness threw much light on that issue.

I repeat that my department is confident that these regulations are necessary and have a sound legislative base in the Human Fertilisation and Embryology Act 1990, as amended. As my noble and learned friend Lord Mackay rightly pointed out, it was the clear intention of Parliament that this provision would enable mitochondrial donation to take place in a clinical setting.

On the issue of safety, my noble friend Lord Deben urges us to delay until further research is carried out. However, we could wait indefinitely for research and follow-up and still not have a 100% assurance about safety, because that is the nature of science and research. The standards of assurance that some are seeking are considerably higher than those for cancer treatment or heart disease. As far as the expert panel convened by the HFEA is concerned, there is no evidence to suggest that these techniques are unsafe. The critical experiments are progressing positively.

As I said, the mitochondrial donation regulations require the HFEA to assess each application for mitochondrial donation on a case-by-case basis. That will include consideration of the evidence on safety and effectiveness. As a statutory independent regulator, it is for the HFEA to determine its own procedures for assessing applications to carry out treatment regulated by the 1990 Act. Applications to provide mitochondrial donation treatment are no exception to this rule but, clearly, the HFEA will not authorise the treatment if it does not consider it safe to do so.

It is never possible to answer every safety question before new medical procedures are used in people for the first time. New techniques can be refined and reviewed. Even the most exhaustive research can establish only that a technique is sufficiently likely to be safe to justify “first in human” treatment. However, if medicine is to progress, clinicians should in my submission be permitted to use new techniques when evidence suggests these are sufficiently safe and effective. It is the Government’s view that medical knowledge in the field of mitochondrial disease and donation has now reached this stage and it is time to progress. The legislative framework of the HFE Act provides for Parliament to endorse the Government’s view before proceeding and, following the extensive process of consideration that I have already set out, we have properly brought this to Parliament for debate on affirmative regulations.

I listened with care to the noble Baroness, Lady Hollins. I absolutely concede that there is a balance of risks to be considered. As I have said, it is not possible to be certain that new medical procedures will be 100% safe or effective. These risks must be balanced with the risk of ongoing suffering for families with mitochondrial disease. For me, the simple point is this: scientific evidence suggests that any risks of mitochondrial donation are proportionately less than the significant risk that children will continue to be born who will develop severe mitochondrial disease if these techniques are not used. As the noble Lord, Lord Patel, pointed out, ultimately it will be up to affected families to judge the balance of these risks with advice from their clinicians and then to decide whether they choose to proceed with treatment, subject to authorisation by the HFEA.

My noble friend Lord Deben mentioned the Chinese study. That study has not been published and we understand that it will not be. It concerns one pregnancy, using an earlier form of pronuclear transfer. One of the clinicians involved gave a full interview to the Independent recently and explained that the complications that occurred related to multiple pregnancies from multiple embryo transfer, rather than from the mitochondrial donation process. As I understand it, there were no genetic abnormalities in the foetuses.

Turning again to the speech by the noble Baroness, Lady Hollins, the HFEA-convened expert panel considered the issues that she raised: if the patient and the donor have different mitochondria, known as haplotypes, the donor’s mitochondria may not, as it were, “talk properly” to the patient’s nuclear DNA, causing health problems. The panel considered that as part of its third scientific review. However, it was of the view that the data submitted to it about this potential problem were not relevant enough to raise safety concerns. However, the panel has recommended, as a purely precautionary step, that consideration be given to the mitochondria haplotype when matching donors to patients, even though the risks of not doing so are assessed to be very low.

The noble Baroness questioned whether successive generations, particularly girls, could have the same problems arise from unhealthy mitochondria. The principle behind the treatment is that the mitochondrial DNA that the child will inherit will be the disease-free mitochondrial DNA of the donor, not the faulty mitochondrial DNA of the mother, although there is a small risk that the low level of unhealthy mitochondria may be carried over when the patient’s nuclear DNA is moved from her egg or embryo to the donor’s. Evidence continues to be reassuring that carryover after mitochondrial replacement is very low and unlikely to be problematic. The risk of mitochondrial disease being present in these generations will, we believe, be low.

The noble Baroness also said that we still do not know enough about the relationship mitochondria have with the human body. This is true of many aspects of human physiology, not just mitochondrial DNA. The majority of the evidence indicates that mitochondria are primarily concerned with generating the power that every cell in the body needs to function. It is generally accepted that, as vital as the function of the mitochondria undoubtedly is to the human body, they do not play a role in developing a person’s physical appearance or personality traits, which are derived solely from nuclear DNA.

Before my noble friend leaves the question of risk, may I ask him to close a little chink in the reassuring curtain that he is drawing before us? We are assured by the HFEA that there is no evidence of risk in what is proposed, but it also proposes quite a large phalanx of experiments that should be completed before proceeding. First, there appears to be a slight logical discontinuity there. Secondly, can we be reassured that, in the Minister’s view, the HFEA will not proceed to licensing anybody until they have completed that programme of experiments?

My Lords, I can confirm to my noble friend, and to the noble Lord, Lord Hunt, who asked a similar question, that the expert panel stated that the further experiments that it recommended could take place either before or after the passing of these regulations. However, they must be done before treatment can take place. I hope that that is sufficient reassurance.

The noble Lord, Lord Alton, and the noble Baroness, Lady O’Loan, spoke about the risk of ovarian hyperstimulation syndrome. OHSS is a well recognised side-effect of the drugs used to stimulate a patient’s or donor’s ovaries to collect multiple eggs for use in fertility treatments. The risks of OHSS are very well understood, with patients and egg donors carefully monitored. The HFEA’s code of practice requires women undergoing ovarian stimulation to be given information about the possible side effects and risks, including OHSS. Women are informed of the symptoms to look out for and are warned to contact their clinic if they feel unwell. Women donating eggs for use in mitochondrial donation will not be at any increased risk of developing OHSS.

The noble Lord and the noble Baroness both questioned the practice of paying for donated eggs. I submit that there is nothing sinister in that. Within the legal framework of the HFE Act, the HFEA sets the rates for compensation to donors of eggs or sperm; £500 for an egg donor is well within those limits. It certainly is not a sign that Newcastle University is anticipating the introduction of the regulations to allow mitochondrial donation. It is continuing its research and has an ongoing need for donated eggs for that purpose.

I turn now to the issue of definitions. In making the regulations, the Government have been clear about their approach, the definitions used and the source of their material. The Government’s consultation on the detail of the regulations set out very clearly: the definitions of scientific terms; the detail of the techniques that the draft regulations would cover; the terms that others might use, such as “genetic modification”; and the proposed approach to information for donors and those conceived through mitochondrial donation.

My noble friend questioned why we do not consider these techniques to amount to genetic modification. Mitochondrial donation does not alter the nuclear DNA which defines personal characteristics and therefore, in our view, does not constitute genetic modification. In the absence of a universally agreed definition of genetic modification in humans, the working definition was developed with the Chief Medical Officer in order to bring some clarity to the discussion about these processes. Opponents have not been able to offer a scientifically based alternative and the British Fertility Society, among others, has been happy to adopt the Chief Medical Officer’s working definition.

My noble friend also asked why we have not separated the two techniques in these regulations. I say to him and to the noble Lord, Lord Hunt, that the expert panel convened by the HFEA stated in its 2014 report that,

“based on 2014 considerations the panel still believes that there is at present insufficient evidence to choose between PNT and MST as a preferred technique”.

The Government are therefore satisfied that there is sufficient scientific evidence to justify Parliament being asked to consider regulations to enable the use of two mitochondrial donation techniques in clinical practice. As I have said, it will be for clinicians in consultation with families to decide which technique would be best in each case. It is worth noting that the HFEA’s public dialogue showed a considerable level of public acceptability for both techniques.

My noble friend also referred to the ComRes poll and suggested that we had somehow unfairly dismissed it. The ComRes poll was commissioned by the CARE organisation—Christian Action Research and Education—which I understand opposes the introduction of mitochondrial donation. An evaluation of the survey was conducted by Pier Logistics and Gene Rowe Evaluations. The evaluators considered the survey to be a deeply flawed piece of work. They criticised the intentional use of what they described as,

“sensationalist, inflammatory and misleading language to characterize the debate”.

There was also considered to be:

“An unreasonable degree of selectivity within respondents