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EU: Healthcare

Volume 734: debated on Wednesday 11 January 2012

Question for Short Debate

Asked By

To ask Her Majesty’s Government what assessment they have made of the impact of the European Union on healthcare in the United Kingdom.

My Lords, I am very grateful for the opportunity to introduce this Question for Short Debate on the impact of the European Union on the delivery of healthcare in the United Kingdom—a subject on which I have spoken in your Lordships' House on a number of previous occasions. In doing so, I wish to draw noble Lords’ attention to my entry in the register of interests as a practising surgeon, professor of surgery at University College and active biomedical researcher. I would also like to take this opportunity to thank those noble Lords who have kindly added their names to the speakers list and who will make a contribution to this short, time-limited debate.

The impact of European Union directives and regulation on the delivery of healthcare in our country is an important issue. It is not primarily an issue of politics but of the well-being and safety of patients in our healthcare system. If there have been unintended consequences of the adoption of regulation and directives into domestic legislation, it is important for Governments to recognise this and ensure that appropriate measures are taken to overcome them.

We can consider the impact of legislation from Europe on the delivery of healthcare in our country in three broad areas. The first is directives and regulation that have already been incorporated into the laws of our country. The second concerns how directives and regulation that are under consideration should be incorporated into domestic legislation. The third covers areas of broader concern connected with potential consequences, particularly with regard to European Union competition law and the intended purpose of the Health and Social Care Bill.

As regards the first category, it is well recognised that the European working time regulation has had a detrimental impact on the training of our young doctors, particularly those who are training to pursue careers ultimately as independent practitioners at consultant level in the craft specialties, such as my own of general surgery. A restriction to 48 hours’ working per week has resulted in trainees feeling that they have insufficient experience at the end of their training to be certain that they can perform independent consultant practice in the way that it is envisaged in our country rather than models for the delivery of clinical practice in other European countries, to the extent that there is genuine concern that we may be producing generations of consultants less able to deliver the rigorous and demanding practice that we have always expected and have been fortunate enough to receive in our country.

There is also the question of the additional cost of providing locum cover to ensure that rotas are compliant with a 48-hour working week. In an important piece of work published last year, the Royal College of Surgeons identified an additional £200 million a year cost in providing locums to ensure that rotas were 48-hour compliant after the first year of the introduction of the final European working time regulation.

There has also been considerable concern about the problem of language and competence testing. I think most noble Lords would agree that the same standard should apply to every doctor and healthcare practitioner working in our country with regard to their ability to speak the English language and be able to communicate appropriately with patients. There is no doubt that the ability to communicate is a hugely important part of the delivery of healthcare. Equally, it is only right that patients in our healthcare systems are able to expect that all doctors and other healthcare professionals who have the privilege of treating them in our hospitals and other healthcare environments practise to the same level of competence. At the moment it is impossible for the national regulatory bodies in our country to ensure that doctors who are registered elsewhere in the European Union meet the same standards as we expect of our own graduates or graduates from elsewhere in the world.

There are real concerns that the first year after qualification from medical school—formerly known as the house job year, now known as foundation year 1 —which is an essential part of completing the process for full registration with the General Medical Council, has now been opened up to competition from medical graduates across Europe as part of the free mobility of labour in the European Union. However, this first year of clinical practice remains an important element of ensuring that our young medical graduates can complete their training and can ultimately register to practise in our country. The issue is very simple: if they are unable to take that year, they are unable to fully register and will not be able to practise in our country. This is a huge waste because these talented graduates should remain in our country and serve our nation, ensuring that the debt they have is repaid through practice in the National Health Service. In this year’s round of appointment to that first foundation year, some 52 potential graduates have not been given a foundation year 1 post and some 113 practitioners from the European Union have taken places on those foundation year 1 schemes. How do Her Majesty’s Government propose to ensure that this problem does not result in our graduates being unable to complete that essential first year after they have qualified from medical school?

There are also important concerns about the impact of the European clinical trials directive in terms of reducing the competitiveness of the biomedical science and research science output of our country. It is estimated that in the year 2000, 6 per cent of all patients who entered clinical trials around the world came from our country. Soon after that, in 2003, the clinical trials directive was incorporated into our domestic legislation, and the problems associated with its bureaucracy have resulted in a reduction in this country to just 2 per cent in 2006 and 1.4 per cent in 2010 of the number of patients included in clinical trials around the world.

These are all well proven areas where Her Majesty's Government need to develop a strategy to address the problems that have been experienced. However, there are also important matters relating to directives that are currently being considered by the Department of Health for inclusion in domestic legislation. There is a directive on transplantation which, if incorporated, will add bureaucracy to the delivery of transplantation services in our country, resulting in added cost. Those responsible for the delivery of these services believe that our standards that are highly regarded throughout the world are of sufficient quality and that any potential European directive must not be gold-plated and undermine an already successful service.

With regard to energy efficiency, a directive that is currently under regulation has caused considerable concern to the NHS Federation. This directive requires the building stock of all public bodies, including the National Health Service, to be improved on an annual basis, and for 3 per cent of floor space to be addressed each year. This will cost some £70 million a year, and the NHS, given the severe financial constraints it is facing, can hardly afford this.

Then there is the ongoing concern that European competition law may inadvertently be applied and in some way affect the proposals of Her Majesty's Government in the Health and Social Care Bill. Clinical commissioning groups, in wishing to take forward the development of new services to improve the clinical outcomes and care of our patients, could be disrupted in doing that through the application of European competition law.

In October last year, the Prime Minister indicated that all government departments should look at European regulation to determine how it might be adversely impacting on the work of those departments and the life of our country. There is no doubt that in the area of healthcare, the training of our young doctors, the innovation and delivery of biomedical research, and the delivery of healthcare itself have been detrimentally affected. It is absolutely essential that Her Majesty's Government are sensitive to the concerns—repeated on several occasions by those with responsibility for the delivery of healthcare in our country—and act as a matter of priority.

I remind noble Lords that this is a time-limited debate and that all speakers, except for the Minister, have two minutes. When the clock displays two minutes, noble Lords have had their two minutes. I note that we are without at least one speaker in this debate.

My Lords, I congratulate the noble Lord, Lord Kakkar, on opening his debate with such clarity and force.

I am chairman of the Institute of Cancer Research, a college of the University of London. We are now regarded as the leading cancer research organisation in the world and are judged on the discovery and development of drugs. The clinical trials directive has harmed us. It lacks harmonisation across and even within countries. What is called a clinical trial in country A may be an observational study in country B. Sometimes drugs within a protocol are deemed investigational medicinal products instead of supportive medication or routine therapy. Red tape abounds, inspections are inconsistent and heavy-handed, and high-quality clinical trials are stifled by the directive. It handicaps innovation, causes delays with new trials, obstructs our competitive edge over the USA and other countries, and renders us a less attractive location for trials. It damages our pharmaceutical industry—Britain’s most successful manufacturing sector. The Americans are counting their good fortune, and soon the Chinese and the Indians will be accumulating theirs.

Trials are cornerstones of the work with our sister organisation, the Royal Marsden Hospital. The blame for the follies inflicted on us radiates at the feet of the EU, and I urge the Government to press harder for revisions to the directive.

My Lords, I wish to focus on the mutual recognition of professional qualifications directive, which provides the framework within which healthcare professionals move around within the EU.

I am entirely supportive of the notion of free movement across the Union and I have no doubts about the benefits that the mobility of healthcare professionals can bring to patients and to the medical profession. However, a number of high-profile cases have called the workings of the directive into question, and all UK regulators have expressed strong concerns that the current system forces them to admit individuals who do not meet the standards that would be required of UK or non-EU professionals.

Professional mobility should never be at the expense of patient safety. There is evidence that, as it currently stands, the directive is striking the wrong balance. The requirements as currently set out are not sufficient to ensure that qualifications and skills are adequate and up to date. We need a competence-based approach, rather than a one-off qualification, fixed at a particular point in time and hard to compare across jurisdictions. Knowing that an individual who has not practised for years has had to take steps to come up to date is essential.

Authorities in host member states must be able to access adequate information regarding the professional history of an individual and to seek answers to any queries they may have. Use of the Internal Market Information System is likely to represent a simpler and more cost-effective option than the proposed European professional card. There is currently no alert system to inform member states when a fitness-to-practise case is brought against an individual. If such a system were to be introduced in some member states, it would be hindered by the use of domestic data-protection legislation.

The ability to communicate effectively in the language of the host member state is critical to safe and effective practice and is the most obvious cause of concern to patients. The directive fails to ensure that professionals meet the necessary standards.

My Lords, I live in a rural area where patients with serious conditions are now treated many miles away. The local population has become reliant on the voluntary air ambulance. This is the most popular charity in the north. It can be a life-or-death situation. The lifeboats that also save lives and do an equally important voluntary job do not have to pay VAT on fuel, but the ambulances do. A Question was therefore tabled asking whether air ambulances could have equal exemption from VAT. The noble Lord, Lord Sassoon, answered:

“EU law provides a specific exemption from VAT for the supply of certain equipment and services used for sea rescue. There is no equivalent provision for air ambulance rescue services”.—[Official Report, 16/6/11; col. WA 202.]

Is it not time that the EU helped all charities that save lives throughout the EU and allowed VAT exemption on fuel?

I ask the Minister, is there a problem of medication being sold to EU countries for a better price than in the UK? Are we running short of some drugs in some areas? I declare an interest: I have used CoAprovel for some time. My surgery in north Yorkshire can no longer obtain it, and I therefore take the prescription to London, where the drug is still available. The UK should maintain adequate supplies of medication so that patients are never left in a situation where they must wait for their treatment. I hope that safeguards will be put in place.

My Lords, I join other noble Lords in congratulating the Lord, Lord Kakkar, on his masterly overview of the subject.

In the short time available, I have to record cautiously encouraging news. Your Lordships will recall a debate on 8 September in which attention was drawn to the problems with language testing of health professionals from the EEA. My noble friend Lord Howe gave an encouraging reply at the time and, following a constructive Green Paper issued by the Commission, a draft directive was issued in December which includes three significant proposals.

The first is that a warning system is to be introduced so that regulatory bodies must warn each other if, for example, a doctor or nurse has been struck off or suspended from a register and attempts to register in another member state. The second is that there will be updated minimum training requirements for doctors, dentists, pharmacists, nurses and midwives to reflect the evolution of those professions and of education in those fields. That is particularly important with some of the newer accession states, where there is a very different culture and practice. The third is the right for regulatory bodies to check the language skills of health professionals—something for which UK health organisations have been pressing. On that point, does the department’s reading of Article 38 of the directive, especially its second paragraph, give a blanket power for a competent authority routinely to examine all applicant health professionals for knowledge of the language, which I understand to be a common aim among those authorities?

Those three proposals will have a major impact in remedying the shortcomings affecting health professions which were thrown up by the original directive. I remind your Lordships that the healthcare regulatory organisations in England, and those covering devolved Administrations where they have responsibility, played a major role in discussion on the Green Paper. Finally, I pay tribute to the Minister and his department for working with the Commission to achieve what I am confident will be a favourable and constructive development.

My Lords, I was hoping that the noble Lord, Lord Owen, would be taking part in this debate, as I believe that he was going to be talking about competition law, but this is an opportunity to intervene briefly on the issue. I think the noble Lord, Lord Kakkar, for giving us the opportunity.

The main arguments given by the department for there being a low risk of application of EU competition are that, for commissioners, healthcare is provided on a universal basis on the principle of solidarity and, for providers, that they will not be regarded as undertakings unless the particular economic activity in which they are engaged is part of a market.

However, a number of questions arise. What if providers collaborate, as they do in the post-acute care and enablement programme, which is a collaborative model? What if other providers who are excluded from a consortium object to that? It could be alleged that there is anti-competitive behaviour. What if commissioning bodies create a market, as we have done with elective surgery and ISTCs? There are also question marks over the criteria for mergers, in particular when foundation trusts merge. Why cannot we also temper the application of EU law by referring specifically to Article 106 of the TFEU in terms of the task of integration assigned to commissioners, and mitigate the Competition Commission’s exercise of its duties regarding tariffs, Monitor’s duties, and so on, by praying in aid the need to have regard to the interests of patients?

My Lords, I want to speak about the data protection directive. It regulates the processing of any personal information, and has been transposed in the UK as the Data Protection Act. That legislation covers any activities that involve data processing. They are as diverse as marketing and internet transactions, routine administrative data collection and the use of health records for research and clinical practice.

Health research is therefore only one small aspect of the directive, but that complex legislation has had a major impact on how health data are used in studies. Properly controlled access to individuals’ health records is essential for health research. Health records enable researchers to identify patients to take part in clinical trials and to provide data for observational studies, such as those looking for associations between particular lifestyle choices and ill health. Researchers find the legislative framework for the use of health data complex and confusing. For example, they are uncertain how much protection now offered by exemptions for research on how they handle anonymised data, where the identity of individuals is masked.

The European Commission will put forward a new legislative proposal to replace the data protection directive at the end of January. That is expected to increase the rights of individuals, and it is highly likely that that will have an impact on how we use health data in research, even if that is unintended.

The Government recognise the importance of the use of patient data in research. I welcome the recent commitment to consult on changes to the NHS Constitution to create a system that will enable patients’ records to be used in research unless they opt out. This is therefore an exciting but also anxious time for the use of health data in research. We must make sure that changes to EU data protection legislation do not inadvertently hamper those plans. I am sure that the noble Earl will liaise with the Justice Department to ensure that that is not the case.

My Lords, in the 1970s, when I was chairman of the education committee of the General Medical Council, before I became its president, I was for five years a member of a European advisory committee on medical education, which produced a number of reports on basic and clinical education. It had the effect of improving medical education in many parts of the EU. That remains somewhat uneven. At the same time, we introduced a Professional Linguistic Assessments Board exam for doctors from outside the European Union coming to work in the UK to assess their clinical competence and their ability to understand English. When we tried to do that for European incoming doctors, we were threatened with being taken to the European Court because that was contrary to the Treaty of Rome. At that time, we persuaded the Department of Health that it was essential that it should impose a language test on incoming doctors from the EU as a condition of employment. That has been done very unevenly. What action are the Government taking to improve that situation? Do they propose to try to renegotiate the European working time directive, which has had such an adverse effect on the training of many junior doctors?

Secondly, does the noble Earl think it likely that the Human Tissue Authority will be the competent authority to deal with the transplantation directive in the UK at a time when the Government propose either to abolish or to merge that organisation? Finally, is the European directive on clinical trials being considered by the newly established Research Regulatory Authority?

My Lords, there can be no doubt about the importance of the issues which my noble friend Lord Kakkar raised for debate and introduced with his customary eloquence.

As is well known, where the European Union is concerned, the tendency is often for difficult practical issues to be subordinated to well intended political ideals. As the Social Policies and Consumer Protection Sub-Committee, of which I am a member, pointed out in its report on the mobility of healthcare professionals last year, nowhere is it more important for this tendency to be resisted than in matters relating to patient safety.

The sub-committee concluded that the mutual recognition of professional qualifications directive,

“fails to command the confidence of patients and professionals”,

and that the increased desire for mobility, which we all share, was nevertheless resulting in the admittance of individuals who do not meet standards required to be considered to practise in the United Kingdom. We should keep the sub-committee's conclusions firmly in mind and continue to push for the development of a competence-based approach for the recognition of qualifications across the EU.

More positive, to my mind, are EU proposals for enhancing cross-border access to healthcare—proposals that do more justice to the principles of open markets and free movement. The proposals have the potential to reduce waiting times for patients facing unduly long delays. The principle that patient reimbursement should not exceed the value of the cost of the same or equivalent treatments on the NHS should exert pressure to keep the new directive’s costs under control.

As ever, though, we must be vigilant. As the NHS devolves increased local powers to patients and professionals, the importance of thorough and transparent pricing structures becomes greater. It is easy to imagine a situation in which two patients receive differing levels of reimbursement for the same treatment, performed at the same hospital abroad, based on differences in British local costs. It will be hard to justify such differences to the electorate. As we seek improvements in service, we must always be alert to practical difficulties that may arise.

My Lords, I should like to raise three unrelated issues and ask three simple questions. The first builds on the issues raised by the noble Lord, Lord Kakkar, in his opening remarks and picked up by the noble Lord, Lord Walton, about the working time directive. I understand that the recent attempts to revise the directive have failed but that discussion is under way with what are called the EU “social partners”, which are essentially the trade unions and employers organisations. I ask a simple question: if those discussions raise it in this fashion, will the Government support the opt-out from the EU working time directive proposed by the surgeons, which would allow them to work up to 65 hours a week?

The second unrelated issue is that one of the unintended consequences of opening our doors to Europe in this way—very positive as that is—is that it has tended to exclude those from other parts of the world who have made such an enormous contribution to the UK, particularly those from Commonwealth countries. Will the Minister confirm that the Government will continue to support the international medical training schemes for people from the Commonwealth and beyond? Indeed, will he promote them further? At the moment they are not being picked up in any great numbers.

My third point picks up on the issue raised by the noble Lord, Lord Lexden, concerning the cross-border healthcare initiative. It seems to me from everything that I have read that it is very uncertain what the numbers will be in practice. Can the Minister let us know what the Government’s own assessment is of the likely impact of introducing that directive later this year or next year?

My Lords, I basically support many of the aims of the working time directive. None of us wants to see junior doctors exploited or working until they are so tired that they are a danger to the patients for whom they care.

The two judgments in SiMAP and Jaeger were most unfortunate and in fact skewed the working time directive in a very bad way. The result has perhaps been damaging to one very large group of patients—frail older people, who form a quarter of the patients in our hospitals. As we know, some tasks previously carried out by doctors were understandably handed over to nursing staff. This can be a good thing, but in many cases what was previously carried out by nurses has been handed on to healthcare assistants. Healthcare assistants are largely untrained, are not regulated and do not always have the competences that are needed. We know, sadly, that much basic care, such as help with feeding, adequate nutrition and hydration, and even basic toileting, has not been carried out well and has had dreadful consequences, which unfortunately we read about in the press all the time.

These very frail patients—a quarter of the patients whom we treat—often suffer from some form of cognitive loss or dementia. They need to be cared for by people whom they understand and feel they can trust, and language is very important in this. We must be certain that these patients feel safe with the people who are caring for them. Therefore, we need language testing by regulators to make sure that the standard of care that our frail patients receive respects their dignity and human rights, and we must work towards that.

My Lords, I apologise to the noble Lord, Lord Kakkar, for missing the beginning of his speech, and I thank him for bringing this debate to your Lordships’ House.

“The European working time directive is destroying surgical training”. This was a comment from a surgical trainee responding to the General Medical Council’s national training survey of 2010. It echoes warnings made by the Royal College of Surgeons since 2004, when the 58-hour maximum working week was introduced. In 2011, the Association of Surgeons in Training and the British Orthopaedic Trainees Association surveyed 1,887 trainees on the impact of the working time regulation, which introduced the 48-hour limit in 2009. Sixty-six per cent reported a deterioration in surgical training, only 1.6 per cent reported an improvement, and 67 per cent had to attend work when off duty to maintain their operative training and learning.

The GMC repeated that survey again in 2011. While showing an improvement in some specialties, it found no change in surgery, with 80 per cent of trainees working beyond their rostered hours. It found 60 per cent of trainees in obstetrics and gynaecology and surgery taking longer to achieve the required educational competences as a result of the working time regulation. In America, trainees are allowed to work up to a maximum of 80 hours, and in some specialties this can be increased to 88 hours.

I believe that a more flexible approach is needed to allow senior trainees on the verge of consultant practice to work longer hours if needed, as in the United States. A return to an average of 56 hours for craft specialties would allow new trainees, starting at 48 hours, the time to develop their skills as they progressed through their training to a maximum of 65 hours for senior trainees, as allowed by the opt-out clause of the EU and as noted by the noble Lord, Lord Crisp. A one-size-fits-all solution is not appropriate, and the feedback from trainees suggests that it is damaging their training. Will the Minister identify what steps the Government intend to take to ensure greater flexibility, and will the Government consider overturning the SiMAP and Jaeger judgments and revising the new deal and the WTR?

My Lords, I, too, congratulate the noble Lord on initiating this debate, and I also congratulate other noble Lords who have very comprehensively covered the wide range of important EU healthcare issues currently in the process of discussion, development or implementation in the UK. Considering these issues as a whole in the one debate, rather than tending to debate them separately as various reports or new proposals or directives come up, has been invaluable. It provides us with an overview of the key issues, how they impact on each other and how they can reach into every aspect of the NHS care and treatment of patients, research, and the working lives and training of healthcare professionals.

The cross-border health directive, which we are required to enact by October 2013, the draft directive on the mobility of health professionals, and the implications for our NHS of the EU’s proposals for revising the energy efficiency directive—with the prospect of huge expenditure and further upheaval for our NHS if, as a public body, it is to become a major driver in achieving EU energy efficiency targets—all present major challenges for the NHS, and one does wonder how well equipped it is to meet them in its current state of uncertainty and upheaval.

In view of the short time available, I want to focus on four questions to the Minister. First, on the clinical trials directive, I echo the concern of noble Lords who have pointed to the UK’s steadily diminishing global share of clinical trials. I look forward to hearing from the Minister how the Government are addressing this decline. How will the new NHS architecture impact on this, and when might we expect our share to start rising again?

Secondly, on EU procurement law, the question we need to address when we come to it in the next stage of the Health and Social Care Bill is the proper balance between planning and the social solidarity that is expressed by the NHS. We also need to consider the effect of EU procurement law on commissioning and the progressive effect of the EU procurement regime to the point where commissioning decisions and planning become victims of court cases. What is the Minister’s opinion of where the balance lies? Will he expedite the meeting that he promised with noble Lords, including my noble friend Lady Thornton, to discuss ways forward on this matter?

Thirdly, how is EU work progressing on tackling health inequalities across EU countries? What initiatives are being undertaken or supported by the Government and what are the timescales for report and development? Finally, I note that last year the UK NHS was owed more than £38 million from EU member states for healthcare treatment for their nationals, so it would be helpful if the Minister could update the House on the progress and systems that are in place to ensure that this money is collected.

My Lords, I begin by thanking the noble Lord, Lord Kakkar, for calling this debate and, indeed, all noble Lords who have spoken and contributed so eloquently and, I may say, succinctly. The Government are determined that the NHS achieves results for patients that are consistently among the best in the world. One way to do that is to compare our experience with those of other European countries. There are many areas where we can learn from each other—for example, where we have worked closely with counterparts in Spain, which has the highest organ donation rate anywhere in the world, to improve donation rates here.

In assessing the impact of the EU on healthcare in the UK, we should start by recognising that the Treaty on the Functioning of the European Union respects the right of member states to organise and manage their own health services. Much of the activity of the European Union on health is therefore designed to complement national policies. However, various areas of European legislation, as noble Lords have pointed out, can have an impact on healthcare in the UK. One such area is social policy. Every year, many millions of UK citizens travel within the EU knowing that, should the need arise, they can access immediately necessary healthcare for free, or at a substantially reduced cost, by using their European health insurance card as a temporary visitor. Many UK state pensioners prefer to live in the warmer climate of countries like Spain or France, and do so knowing that their healthcare costs are covered. Of course, if they were to live here in the UK, they would be entitled to treatment under the NHS.

Noble Lords will be aware—some have mentioned it—of the European Union directive on cross-border patient mobility. Until relatively recently, there was little discussion of the issue of patient mobility at a European level. However, a new generation of Europeans, accustomed to crossing borders with ease and able to purchase goods and services from any part of the European Union, are proving less willing to accept constraints on where they can obtain their healthcare. The new directive brings together several years’ worth of case law established by the European Court of Justice. It makes clear the rules that apply when EU citizens wish to access treatment in another member state. The directive sets out the arrangements under which member states are obliged to accept citizens from other EU states, and explains the rules for refusing such treatment. It also sets out the systems that a state must provide to allow its own citizens to access their rights to cross-border healthcare. I say to my noble friend Lord Lexden that we do not expect an influx of patients rushing to take advantage of NHS services. The NHS does attract some overseas visitors, including many from outside Europe, who pay for their treatment. EU citizens, entitled to treatment under the directive, would be reimbursed by their home system but only up to the cost of providing the treatment in their home state.

There is also a substantial body of European legislation regulating medicines and medical devices. This legislation, harmonising requirements for allowing medicines and devices into the EU, has reduced burdens on pharmaceutical and medical device companies in accessing the whole European market. The UK plays a prominent role in shaping the regulatory frameworks for medicines and devices with the Medicines and Healthcare products Regulatory Agency, which is one of the leading regulators in Europe.

My noble friend Lord Ryder and my noble friend Lady Wheeler—I apologise for calling the noble Baroness, Lady Wheeler, my noble friend, although of course she is—spoke of the clinical trials directive, as did other noble Lords. That directive is designed specifically to harmonise clinical trial practice across Europe. In recent years, there has been a decline in the number of clinical trials conducted in the EU and the UK. That cannot be attributed only to the introduction of the clinical trials directive as international competition for attracting clinical research has increased dramatically in recent years.

However, the Government consider the revision of this directive to be a priority to ensure that the UK remains an attractive place for the conduct of clinical trials. The European Commission is also committed to revising the directive. A scheme was introduced in April this year for the notification of low-risk national trials, replacing the traditional authorisation process, and more risk-proportionate monitoring has been introduced, taking a targeted approach to monitoring that depends on the level of risk a trial represents to patients and data credibility. I should say to my noble friend Lord Ryder that one of the Government’s aims for the revision of the clinical trials directive is to harmonise its implementation across Europe. The Government have been influencing the Commission so that the revision of the directive ensures that the EU becomes an attractive place for the conduct of clinical trials once again.

Another priority for the Government is the revision of the directive on the mutual recognition of professional qualifications. We have made it clear that we want to stop foreign healthcare professionals working in the NHS unless they have passed robust language and competence tests. The proposal published by the European Commission last month contains some welcome amendments, such as a new proactive alert mechanism. This should contribute significantly to tightening the European regulatory framework and improving patient and public safety. While the proposal would not allow language checks by a competent authority before recognition of the qualification of a professional, they do make it clear that controls on language checks would be permissible and could be undertaken before a professional was able to practise. I should say to my noble friend Lord Bridgeman that the Government are currently analysing the proposals in detail to formulate a UK negotiating position. As usual with EU proposals, part of this process will involve consulting the devolved Administrations. I say to my noble friend Lady Scott and the noble Lord, Lord Kakkar, that the Commission’s proposal does contain some welcome amendments, such as that proactive alert mechanism and negotiations on the text are due to begin at the end of January 2012, with the aim of reaching an agreed directive in the autumn of this year.

With regard to the European professional card, which was raised by my noble friend Lady Scott, the Commission has worked with stakeholders to develop proposals for the card. There have been some positive developments in the proposals and it seems that what is now proposed will be underpinned by use of the internal market information system, but we need to seek views from competent authorities about the administrative implications of the proposals before we can finalise our position. The Government have made clear that mobility should not be at the expense of patient safety. The Commission’s proposals recognise the unique position of healthcare professionals and they build additional safeguards into the directive for healthcare professionals in certain areas—for example, in the case of that alert mechanism. Provided that the necessary safeguards are built in for healthcare professionals, we see no reason for a conflict between the joint aims of facilitating patient safety and freedom of movement.

In relation to EEA migrants having access to the vocational year’s training as part of the directive proposals, which was an issue raised by the noble Lord, Lord Kakkar, the proposals were only recently published by the Commission, which was undertaking a detailed analysis to better understand the impact on healthcare professionals and patient safety. A number of aspects of the proposals require further clarification. A key priority for the Government going forward is to ensure that freedom of movement by professionals is balanced by safety considerations.

I move now to the working time directive, which was an issue raised by many noble Lords, including the noble Lords, Lord Kakkar, Lord Walton and Lord Crisp, the noble Baroness, Lady Greengross, and my noble friend Lord Ribeiro. We are committed in the coalition agreement to limit the application of the working time directive in the UK. The agreed government position is that retention of an individual’s right to opt out of the limit on weekly working time must be the UK’s clear overall priority in any renegotiation of the directive. The UK would welcome changes to increase flexibility on on-call time and compensatory rest, but not at the expense of losing the opt-out.

The noble Lord, Lord Crisp, mentioned the opt-out in particular, and my noble friend Lord Ribeiro asked about flexibilities. The directive at the moment affords all doctors the choice to opt out and work more than 48 hours a week. Doctors who opt out can work up to 56 hours—the maximum outlined in the new deal. But breaching that limit would be very costly for the NHS. The opt-out gives working people, including doctors, the choice over their working hours. They are better off because of that choice, we believe. Therefore, it is a Government priority that individuals should continue to enjoy the right to opt out if they wish. The 48 hours is measured over the reference period of six months. Therefore, doctors may in any week work more than 48 hours; there is flexibility. In response to the Temple report, my right honourable friend the Secretary of State asked Medical Education England to advise NHS employers on ways to realign and simplify the new deal. The Department of Health has received its report and is considering the recommendations very carefully, including the case for negotiating a new contract.

I move to organ donation, which was raised by the noble Lords, Lord Walton and Lord Kakkar. The Government are fully committed to supporting action across the EU to increase the number of safe, high-quality organs available for transplant. We are working with the Commission and other member states to help ensure that any legislative framework will not prove to be a disincentive to organ donation and transplantation. I am sure that all noble Lords will agree that having more safe, high-quality organs available for transplant across Europe would benefit all member states alike.

The noble Lord, Lord Kakkar, and my noble friend Lord Clement-Jones, raised the issue of the potential consequences of the application of EU competition law to the NHS under the Health and Social Care Bill. Competition law could already potentially be applied to the provision of NHS services. The relevant treaty provisions have already been incorporated into UK law. The purpose would be to protect patients' interests from abuses. The potential consequences would extend to remedies and sanctions to address abuses in individual cases. However, European case law makes clear that commissioners of NHS services would not be subject to competition in respect of their purchasing activities, so under the Health and Social Care Bill clinical commissioning groups would not be constrained by EU competition law in their decisions on how best to improve services. I have more to say on competition law but unfortunately time is against me.

The noble Baroness, Lady Masham, asked me about the exemption from VAT for air ambulances. I will write to her on that as I do not have the answer in my brief.

The noble Lord, Lord Patel, asked about the data protection directive. The Commission is in the process of reviewing the existing directive and will publish a draft for consultation, which we expect by the end of the month. We will then have an opportunity to comment and give our views. The department is well sighted on this. We are involved in the discussions to ensure that UK researchers are not affected by proposals covering data protection in respect of research.

The noble Lord, Lord Walton, asked about the role that the new Health Research Authority might have in clinical trials. The HRA will not take over the role of the MHRA in assessing and inspecting clinical trials but will be involved in streamlining the processes, as the noble Lord is aware. On 1 December the HRA issued proposals for the further development of its national research ethics service.

Time has moved on. In closing, I will highlight the positive impact that the EU has had on healthcare in the UK. We are able to share experience and expertise with other member states to improve quality and standards and to encourage innovation, and we are determined to ensure that the United Kingdom continues to play a key role in shaping the European health agenda.

Sitting suspended.