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Draft Human Fertilisation and Embryology (Amendment) Regulations 2018

Draft Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018
31 January 2018

The Committee consisted of the following Members:

Chair: Sir Henry Bellingham

† Cartlidge, James (South Suffolk) (Con)

† Debbonaire, Thangam (Bristol West) (Lab)

† Doyle-Price, Jackie (Parliamentary Under-Secretary of State for Health)

† Green, Kate (Stretford and Urmston) (Lab)

† Henderson, Gordon (Sittingbourne and Sheppey) (Con)

† Hodgson, Mrs Sharon (Washington and Sunderland West) (Lab)

† Howell, John (Henley) (Con)

Kyle, Peter (Hove) (Lab)

† Letwin, Sir Oliver (West Dorset) (Con)

† Moore, Damien (Southport) (Con)

† Morris, James (Halesowen and Rowley Regis) (Con)

† Morton, Wendy (Aldridge-Brownhills) (Con)

† Norris, Alex (Nottingham North) (Lab/Co-op)

† Pawsey, Mark (Rugby) (Con)

† Slaughter, Andy (Hammersmith) (Lab)

† Whitford, Dr Philippa (Central Ayrshire) (SNP)

† Woodcock, John (Barrow and Furness) (Lab/Co-op)

Mike Everett, Committee Clerk

† attended the Committee

Third Delegated Legislation Committee

Wednesday 31 January 2018

[Sir Henry Bellingham in the Chair]

Draft Human Fertilisation and Embryology (Amendment) Regulations 2018

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I beg to move,

That the Committee has considered the draft Human Fertilisation and Embryology (Amendment) Regulations 2018.

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With this it will be convenient to consider the draft Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018.

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It is a great pleasure to serve under your chairmanship, Sir Henry.

The draft regulations are part of a wider set of measures to implement European Union directives that set quality and safety standards for donated human tissues and cells used in treatments for patients. They will amend UK legislation to strengthen requirements relating to tracing tissues and cells from donor to patient, and imports from countries outside the European economic area. They establish a standardised EU-wide coding system to ensure the traceability of all human tissues and cells and set out what licensed establishments need to do to demonstrate that tissues and cells imported from countries outside the EU meet high safety standards.

I am sure the Committee agrees that UK patients should have every opportunity to access the life-changing therapies and treatments covered by the draft regulations, such as stem cells to treat blood cancers, corneas to restore sight, heart valves to treat heart conditions, and skin grafts to treat burns, to name but a few. Such tissues and cells may be donated in the UK, in European countries or anywhere in the world, so we need to know that they are safe to use. The group of directives is underpinned by a simple aim: to ensure that tissues and cells used in treatment meet high standards, wherever they come from.

Being able to trace tissues and cells from their original donor to their final use in patients’ treatment, and back again, is important for identification purposes, so that if a patient suffers a serious adverse reaction, donors and other recipients can be traced quickly to minimise the risk of further harm. It is also important for patient safety that tissues and cells imported from countries around the world meet the same quality and safety standards as those from within the EU. The draft regulations will achieve that.

As the world leader in tissue banking, the UK has welcomed the proposal to introduce a European tissues and cells directive since it was first made in 2002. We were already taking action to ensure high standards of quality and safety for human tissues and cells, but we supported the directive because it meant that the voluntary tissue bank scheme already in operation would be made statutory, improving confidence that all tissue banks would meet the highest standards across the EU.

Although I am pleased to say that the UK has not experienced any major incidents involving problems with identification or traceability, the draft regulations will guarantee that no such problems will arise in future. It should also be noted that tissues and cells regularly move between licensed establishments and across international borders, which makes an internationally recognised identification code necessary.

Although UK legislation largely achieves the aims of the coding and import directives, it does not yet meet all their specific requirements. The regulations will transpose the directives’ provisions into UK law and make us consistent with the EU. Our priority is to maintain the same high standards of safety and quality after our exit from the EU. Regardless of our future relationship, the draft regulations are important for the safety of all patients.

Requirements for reproductive cells are set out in the draft Human Fertilisation and Embryology (Amendment) Regulations, which amend the Human Fertilisation and Embryology Act 1990. Requirements for all other human tissues and cells—other than organs and blood, which have their own legislation—are set out in the draft Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations, which amend the Human Tissue (Quality and Safety for Human Application) Regulations 2007. We intend both draft regulations to come into effect on 1 April.

A range of consultation activities have taken place to consider how the provisions of the draft regulations will work and to assess their impact on licensed establishments. I am aware that the competent authorities have done a lot to prepare licensed establishments for the regulations’ implementation, and I am grateful to them for that work.

Although there are gains for the UK in transposing these directives, there will of course be a cost to those establishments, including those in the NHS, in implementing the regulations. For some it will involve investment in new IT software, but the regulations will be drafted to ensure that there are no unnecessary administrative burdens or costs placed on these licensing establishments. They transpose the directives while avoiding any element of gold-plating, which we have done to minimise the cost to the NHS.

In conclusion, the regulations fulfil a UK obligation as a current member of the European Union. More importantly, they bring into UK law provisions to enhance our already robust controls that ensure that donated human tissues and cells used in the treatment of others meet the highest quality and safety standards. We recognise that these tissues and cells are increasingly travelling between countries, so we all want a safety system that protects patients and also supports wide access to treatment. I commend the regulations to the Committee.

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It is a pleasure to serve under your chairmanship, Sir Henry. I want to make it clear from the outset that the Opposition welcome the amendments to the regulations. As the trade in and use of human cells and tissues becomes more complex, it is important that any risks are premeditatedly addressed, and the regulations will help us take a step in the right direction towards achieving that aim.

However, it is important that we never miss an opportunity to press the Minister on points worthy of being raised. We agreed with the chief executive of the Human Tissue Authority, Allan Marriott-Smith, when he said:

“These objectives support our aim to make sure human tissue is stored and used safely, ethically, and with proper consent.”

He went on to say:

“We are committed to working with our stakeholders to ensure a smooth transition and proportionate approach to implementation.”

That is a crucial point that I am sure the Minister will keep a close eye on, as the regulations are implemented. She will be aware that I will also be keeping a close eye on them in my Front-Bench role. I am especially interested to know how she expects to mitigate the high cost of implementation of these changes, as was highlighted in the consultation that preceded the draft regulations.

With those brief remarks, I will conclude. I look forward to hearing the hon. Member for Central Ayrshire and to the Minister’s closing remarks.

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I, too, support the regulations. It will be important that the UK, as it becomes a third country, matches the regulations and is able to export human cells and tissues into the EEA, as well as being able to import them now.

Two matters have been referred to: the need to have a single code that is traceable right across Europe and to have clear standards for countries that are outside the EEA. All of us would welcome that. I have a little concern about what is referred to as the one-off exemptions. That implies that for certain patients there could be repeated one-off exemptions. I would urge the Government to look at that to ensure that it does not become a loophole that would allow repeated import of something substandard, even if it were designated for a single patient, which is how it is identified.

Although organs and blood are obviously outwith this measure, we are well aware of the CJD––Creutzfeldt-Jakob disease—and infected blood scandals. Those happened at the time when we imported blood products from America and people were not thinking about it. It is important to think ahead, so that if there is an issue, it is identified and traced quickly and the supplier shut down.

I welcome both the importing controls from third countries, particularly when we hear of some quite frightening trades in stem cells, organs and tissues in parts of Asia, and also the traceability of having a single code. I echo the point that that will obviously require a little bit of investment.

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I thank both Front-Bench speakers for the constructive way they have engaged with the regulations. It is testament to the fact that we are all interested in one goal, which is improving safety and standards for patients. It is absolutely right that we probe the important issues that have been raised here.

With regard to the one-off exemptions, what we are trying to do with the coding is for tissues and materials that are stored. The one-offs that we have referred to tend to be when we find a match. They are not stored and are unlikely to be between different countries. However, things can change and we need to future-proof all these regulations to ensure that patient safety is guaranteed.

The hon. Member for Central Ayrshire rightly reminded us of CJD and contaminated blood. Those issues illustrate powerfully what can happen when things go wrong or we do not maintain those standards. I assure her that within the Department we will be keeping an eye on changing standards internationally. These regulations have come from the European Union, but we are always keen to learn from international experience about how we can improve safety standards. We should never stop being vigilant in pursuit of that.

The hon. Member for Washington and Sunderland West also mentioned the issue of costs, which is a fair concern. I appreciate that with the implementation of any regulation there will be a cost to establishments, and that includes the NHS. We have done everything we can to keep those costs to a minimum. We have avoided any gold-plating, which Governments of all colours have often been criticised for in the past. We have been keen not to create additional significant costs for establishments.

We think that the biggest cost will be within the fertility sector. There will be 92 establishments that will have to implement the regulations. We believe that the costs will apply only to special kinds of printers, staff training and the upgrading of IT systems. We do not expect that that will be very onerous, but we will keep an eye on it. With that, I thank the Front Benchers and commend the regulations to the Committee.

Question put and agreed to.

DRAFT HUMAN TISSUE (QUALITY AND SAFETY FOR HUMAN APPLICATION) (AMENDMENT) REGULATIONS 2018

Resolved,

That the Committee has considered the draft Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018.—(Jackie Doyle-Price.)

Committee rose.