Lord Kakkar
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.
Baroness Northover
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.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
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.