EU: Legislation

Lord Kakkar Excerpts

Monday 4th February 2013 Lords Chamber

[Baroness Warsi]

I am not aware of what specific representation has been received in relation to that matter, but I will make sure that I write to the noble Lord and give him a full answer.

[Lord Kakkar]

My Lords, I declare my interests as professor of surgery at UCL and a member of the General Medical Council. Despite assurances given at the time of its introduction that the imposition of the working-time regulation on junior doctors’ rotas would improve patient safety, we learnt last week from the president of the Royal College of Surgeons that the regulation has actually undermined the training of future generations of hospital consultants. Recently at least two coroners’ verdicts have cited the regulation as part of their narratives. What progress have Her Majesty’s Government made in the negotiations on this issue that were started in early 2011 by the then Health Secretary and the Business Secretary?

[Baroness Warsi]

It is exactly because of specific issues such as this that we believe improvements can be made and that we can negotiate with Europe on a way forward that is in our best interests and works clearly in terms of, for example, our hospitals—the example given by the noble Lord. It is for that reason that the Prime Minister has laid out that certainly in the next Conservative manifesto there will be a clear provision for us to go to Europe, to negotiate and to get that better deal.

UK Industry: International Competitiveness

Lord Kakkar Excerpts

Thursday 5th July 2012 Lords Chamber

[Lord Kakkar]

My Lords, I, too, congratulate the noble Lord, Lord Jenkin of Roding, on having secured this important debate. I would like to focus my comments on something that he said in his introductory remarks around the issue of the life sciences industry. In doing so, I remind noble Lords of my entry in the register of interests as professor of surgery at University College London; as chair of quality at University College London Partners, one of the five designated academic health science centres in our country; and of my collaborative activities with the life sciences industry, focused on the area of thrombosis research, my own particular science interest.

The life sciences industry—pharmaceuticals, medical technology and medical and industrial biotechnology—is described as being exceedingly important to our country, and second only to financial services in the contribution that it makes to our economy. The industry generates in excess of £50 billion a year in revenue and employs some 166,000 people. In the pharmaceutical industry, the export of medicines in 2009 generated £7 billion in excess revenues compared to our importation of medicines. Over the past 30 years the pharmaceutical industry, through sales of medicines and medicinal products, has been a net contributor to our economy.

The pharmaceutical industry employs some 72,000 of our fellow citizens in this country. The medical technology industry has a turnover of some £15 billion a year and employs in excess of 60,000 of our fellow citizens. As to the value of public expenditure in medical research, every pound spent brings a contribution of 39p in extra economic activity in perpetuity. To a simple surgeon that suggests that when we invest in biomedical research we get a 39% return on our investment for ever—which is very impressive. Conversely, it is also well noted that if we were to remove from research council funding £1 billion of annual investment in the sciences and medical research, we would lose some £10 billion of gross domestic product. It is hugely important that public investment should continue to drive this important area of economic activity.

On the broader contributions beyond public expenditure, one-third of all the investment in biomedical research comes from charities. That is really quite impressive. Some 40% of investment in research and development in this area of activity comes from foreign multinational companies. Of all the G8 countries, we receive the largest proportion of investment in our R and D from foreign multinationals, which is tremendously impressive. It is something on which we should focus and that we should bring to the heart of any policy-making.

The Government are to be congratulated on having recognised this and on having made this a particular area of focus and attention over the past two years, not only because there is huge opportunity for economic growth and development associated with investment in the life sciences industry, but because investing in this area has the important benefit of improving our ability to deliver healthcare, improving the technologies and innovations that we can provide to patients and our fellow citizens and therefore improving clinical outcomes. It is striking to see how contributions from research in the United Kingdom play across the world. Our population represents less than 1% of the global population, but 12% of all citations in biomedical sciences around the world are citations of research undertaken in our country. This demonstrates that our impact across the world remains hugely important.

The noble Lord, Lord Jenkin of Roding, mentioned the life sciences strategy that was announced by the Prime Minister on 5 December 2011. It is an important strategy that has the capacity to do a huge amount to drive forward the development of the life sciences industry in our country and also to ensure that biomedical research in the academic arena, in our universities and in the NHS, continues to grow and prosper for the benefit of patients.

A number of important initiatives are described in the life sciences strategy, one of the most interesting of which is the commitment to the development of telemedicine to ensure that we can better manage patients with chronic diseases in their own homes, along with a commitment to ensure that 3 million patients with chronic diseases will be provided with the opportunity to access telemedicine so that their condition can be monitored at home rather than needing to avail hospital facilities for the management of their care. There is also the commitment to a £180-million catalyst fund to help identify and provide early investment into the potential breakthroughs of the future, those that will have the greatest clinical impact and thus encourage investment into our country.

We also have what at the time was a somewhat controversial commitment to ensure that across the National Health Service as a whole, the great store of data on clinical conditions that we hold is better aligned to research opportunities and therefore able to attract greater investment into the health service for research. There is, too, the important commitment to ensure early access into the NHS and therefore early access for patients to innovations and new drugs. This will be particularly attractive to the biopharmaceutical industry in terms of ensuring that it targets its research activities in the United Kingdom because it will be better able to access rapidly the potential markets for its innovations.

In addition to the life sciences strategy, we recently saw the publication of the innovation review by the chief executive of the NHS which looks specifically at how the health service can better adopt innovation, diffuse it widely across the entire NHS and, what is particularly important, ensure that the health service is outward-looking in terms of its relationship with the life sciences industry so that in addition to achieving its primary objective of providing the best healthcare for the people of our country, it is able to contribute to the broader generation of wealth creation, thus promoting the interests of UK plc, as the chief executive puts it in this document.

However, there are also some problems. Although investment in our life sciences industry by foreign multinational companies remains substantial, over the past 10 to 12 years there has been a considerable reduction in the contribution we make to global clinical trials, the important phase 2 and phase 3 research studies that allow us to evaluate novel interventions and new drug therapies. Before the introduction of the European clinical trials directive in 2003, some 6% of all patients going into clinical research globally came from our country. By 2006 the percentage had fallen to just 2%, and by 2010 to 1.4%. That is a very worrying trend. The European Commission has recognised that this is a problem not only for our own country but throughout Europe, and is now looking at how the directive might be revised. What position have Her Majesty’s Government taken in these negotiations, in particular to ensure that, when the directive is re-presented, it is much more flexible in allowing for recognition of the national standards that apply to clinical research, which are particularly high in our country, and that any competitive edge which had inadvertently been lost in the past can be regained once again?

Some 23% of those who work in the sciences and biomedical sciences departments in our academic institutions come from outside the United Kingdom. One of the great concerns is the potential impact of the changes made to visa requirements on the ability to attract top-rate clinical and basic scientists to come and work in our country. Is the Minister able to confirm that Her Majesty’s Government remain sympathetic to the need to attract top basic and clinical scientists so as to ensure that our life sciences, and particularly our academic research institutions, are able to compete at the highest levels globally?

Finally, there is the broader question of how we can build on the initiatives of Her Majesty’s Government to drive forward the life sciences industry. There is concern that the generous settlements which have been provided in the current spending round for the research councils and for medical research in particular may not be sustainable in the next spending round. However, it is vitally important that they are maintained. As I have said, investment in medical research provides remarkable long-term returns to the wider economy. Is the Minister able to confirm that Her Majesty’s Government remain sympathetic to investment in research and innovation?

There is also a need to look at tax incentives to better ensure that this country encourages venture capital investment at the very early stage in translational medical research. We need to develop a system of adaptive licensing, combined with the advances we are going to see in genomic medicine and stratified medicine, to ensure that new innovations can come to the market quickly and benefit patients. We also need to look at the way that the National Institute for Clinical Excellence judges value in terms of innovation, looking not only at the quality of life improvement but also at the economic and broader social impact of innovation.

Finally, there must always be a careful, measured approach towards regulation of research, ensuring that patients are always protected but also that the environment for research in our country remains competitive and attractive.

EU: Recent Developments

Lord Kakkar Excerpts

Thursday 16th February 2012 Lords Chamber

[Lord Kakkar]

My Lords, as is quite right, this debate has focused principally on questions related to the economic crisis facing the eurozone and on questions concerning the negotiation of the ongoing treaty. I should like to seek further information and guidance from Her Majesty’s Government on how they are currently dealing with the unintended consequences of previous European regulation as it applies to the delivery of healthcare in our country. In so doing, I remind noble Lords of my entry in the declaration of interests as professor of surgery at University College, London, consultant surgeon at University College Hospital and an active biomedical researcher.

There are three important areas where there is consensus with regard to concerns about the application of European regulation and its incorporation into United Kingdom domestic legislation. The first is with regard to the ability of our national regulator, the General Medical Council, to assess the competence and language skills of doctors registered elsewhere in the European Union who come to work here in the United Kingdom. The General Medical Council currently has on its register 22,542 doctors registered elsewhere in the European Union who automatically have the right to be registered in our country by the General Medical Council because they have been registered elsewhere in the European Union.

The General Medical Council is not entitled to make any assessment of their competence, their skills to practise medicine and their ability to communicate in the English language as a result of the way in which the European regulation has been interpreted and incorporated into UK domestic legislation. Clearly that is not appropriate. We have seen unintended consequences with the result that doctors have come to practise in our country, have been unable to communicate appropriately and have not been subjected to the same tests and safeguards as any other doctor would be prior to registering with the General Medical Council. As a result, patients in our country have been put in jeopardy and their safety has been compromised.

I had the privilege of introducing a Question for Short Debate on 11 January in your Lordships’ House when this matter was discussed at some length. Following that debate and the subsequent media coverage, the European Union Commissioner for Internal Market and Services wrote an article for the Daily Telegraph in which he stated that it was an overinterpretation of current European regulation, with regard to the position which previous UK Governments have taken, that had resulted in an inability of the General Medical Council to perform the language, competence and skills testing that our citizens would reasonably expect our national regulatory body would perform for any doctor registered to work in our country.

I ask Her Majesty's Government what plans they have to redress that issue. In particular I know it is not normal practice or convention to pre-announce any measures that might be dealt with in the gracious Speech, but is there an opportunity in the forthcoming Session to redress that issue and to deal with an amendment to the legislation to ensure that, in the future, the General Medical Council is able to undertake this type of competence, skills and language testing that is so very important to ensure that all doctors and healthcare professionals in our country practise to a high standard? I emphasise healthcare professionals because there is a similar problem with regard to the ability of the Nursing and Midwifery Council to undertake such competence and skills testing.

The second area is the application of the European working time regulation with regard to certain disciplines and specialties in the broader area of medicine. Here I speak to the craft specialties, such as my own of general surgery, where it is generally agreed that a 48-hour working week is an insufficient period in which to provide appropriate training for our young doctors who wish to go on eventually to practise as independent consultant practitioners in our healthcare system. Very recently, two narrative verdicts by coroners in London identified the application of the working time regulation as a contributory cause to the deaths of two patients, one after an elective surgical procedure.

The imposition of the Working Time Regulations with the restriction to a 48-hour working week has made it impossible for our healthcare system, in the way in which it is currently delivered, to organise rotas that allow continuity of care for patients in hospitals. Clearly, that cannot have been an intended consequence of the working time directive when it was adopted into UK domestic legislation. It is vital that we overcome that problem and ensure that our patients remain safe and properly cared for in our hospital system.

The third area is the adoption of the clinical trials directive into domestic legislation. When the clinical trials directive from Europe was originally proposed, it was proposed with very good reasons to try to improve the standards of clinical research across Europe. An unintended consequence of the clinical trial directive has been excessive bureaucracy, which has undermined the competitiveness of clinical research in our country. In 2000, 6 per cent of all patients in the world who entered into clinical trials came from the United Kingdom. The clinical trials directive was adopted in our country in 2003, and by 2006 that level of participation fell to just 2 per cent of all patients entered into clinical trials coming from our country; in 2010, the figure was 1.4 per cent.

That has had a serious impact on the competitiveness and the standing of our life sciences industry and our academic contribution to biomedical research globally. That is hugely important because research drives innovation in our healthcare system; it improves standards; and it allows us to become more effective and more efficient in terms of delivering higher standards of healthcare. However, the Prime Minister announced on 5 December last year a life sciences strategy for our country, recognising that life sciences represent the second most important industry to our economy after financial services. It is well recognised that unless the problem of our competitiveness in terms of being able to undertake clinical research is addressed, the broader ambition of promoting our country as an inward investment centre for life sciences will not be achieved.

It cannot be right that unintended consequences of European regulations, and the way in which they have been interpreted and incorporated into UK domestic legislation, should be allowed to undermine the training of our young doctors, which ensures that future generations of healthcare professionals provide the highest standards that the people of our country have rightly come to expect; that that incorporation of regulation is allowed to undermine such a vital area of economic and academic activity as life sciences and biomedical research; and, most importantly, that it puts the safety of patients in our healthcare system unintentionally in jeopardy. I very much hope that in the coming Session, and in answering the debate, the Minister may be able to provide some reassurance that, despite all the other problems and challenges that Her Majesty's Government face with regard to negotiations in Europe currently, they will continue to address actively these three important areas.

Commonwealth Parliamentary Association

Lord Kakkar Excerpts

Thursday 8th September 2011 Lords Chamber

[Lord Kakkar]

My Lords, I join noble Lords in congratulating the noble Baroness, Lady Hooper, on having secured this important debate. I wish to confine my comments to the continuing role of the Commonwealth, particularly with regard to healthcare and biomedical research. In so doing, I remind noble Lords of my declarations of interest, particularly my role as Professor of Surgery at University College London.

There is a distinguished heritage with regard to health and the provision of postgraduate medical education and training associated with the Commonwealth. For many decades, medical trainees, graduates and other healthcare professionals from Commonwealth countries have come to our country and made a vital contribution to the establishment of the National Health Service and ensured that that service was sustained over many years. Many of them returned to their own Commonwealth countries, having benefited from training in the United Kingdom, and went on to become leaders of disciplines in the profession of medicine in their own countries, contributing to the development of healthcare systems in many nations based on the provision of healthcare in the United Kingdom. In so doing, they brought great credit to our country and increased the influence of the United Kingdom in those countries because the provision of healthcare is so very important in every nation.

Equally, our own trainees had the opportunity to practise in many Commonwealth countries, making important contributions, learning an awful lot and having their own careers enriched as a result. The contributions in this two-way relationship have been substantial. In our own country the development of primary care, acute hospital practice, mental health and biomedical research have been hugely enriched by the relationships between Commonwealth countries. However, in the past 10 to 15 years, that emphasis on encouraging links with regard to healthcare and biomedical research across Commonwealth countries has become somewhat less important to our nation as we have looked to other regions to deal with the provision of staff and medical professionals to help in the delivery of healthcare in the United Kingdom. That is a great pity because one of the important by-products of these close links in healthcare and biomedical research has been the promotion of our own healthcare and biopharmaceutical industry in Commonwealth countries. We often hear that this area of economic activity and endeavour in health and biomedicine is the second most important industry for our nation after financial services in terms of its economic value.

Moving forward, there are important opportunities for us to refocus on the Commonwealth. As we have heard, one-third of the world’s population are citizens of Commonwealth countries. Many of these nations are seeing substantial economic development. As nations develop there is increasing emphasis on the provision of healthcare and the training of healthcare professionals. Our universities, National Health Service, healthcare industries and biopharmaceutical industry could all benefit from a renewed focus on the opportunities available if there were greater collaboration and co-operation in healthcare provision across Commonwealth nations. Equally, those nations could benefit from the very fine industries, knowledge, technology and innovation that we have developing in our own country in our universities and their associated industries.

I have four questions for the Minister with regard to health and training of healthcare professionals in relation to the Commonwealth. First, do Her Majesty’s Government have a specific strategy for ensuring that we can once again encourage some of the most able and capable medical trainees from Commonwealth countries to spend some of their postgraduate training time here in the United Kingdom rather than go to other countries, such as the United States, or other European countries? Secondly, can we facilitate our own trainees to take advantage of the wonderful opportunities existing in Commonwealth countries to enrich their own careers and training opportunities? Thirdly, is there a specific strategy to promote our healthcare and biopharmaceutical industries in Commonwealth countries, so that they can improve and increase their export opportunities and in so doing, ensure that the innovation and discovery from our own universities, and within those industries, can be used to improve healthcare delivery and health in Commonwealth countries? Fourthly, and finally, might there be opportunities for us to build on the concept of Commonwealth learning to develop a virtual Commonwealth postgraduate medical federation or university to promote continuing medical education driven from the United Kingdom to assist the development of healthcare in Commonwealth countries?

European Union Bill

Lord Kakkar Excerpts

Tuesday 22nd March 2011 Lords Chamber

[Lord Kakkar]

My Lords, from the outset I declare an interest as a practising surgeon and professor of surgery at University College. The matters that I wish to deal with are not as grand as the overall principles of this important Bill—I am grateful to the Minister for having outlined its important purpose in establishing an opportunity to reconnect our people with the European Union—but on matters of unintended consequences of past European legislation and regulation and how this or future legislation might better protect against these problems. I shall do so by giving examples from my own discipline and area of practice, that of medicine and healthcare.

We have heard mention of the European working time regulation, for instance. It is an important piece of legislation, designed to improve the safety of workers in the workplace and their rights overall by restricting working time to 48 hours. However, its application to the practice of medicine has led—in an unintended way, I believe—to detrimental effects on the training of our junior doctors. We hear stories continuously about the way, and I have experience of this, that it has eroded the training of those particularly in craft specialities, such as those like myself in general surgery, to the extent now that the training offered within a 48-hour week is quite inadequate and we are producing generations of doctors who potentially might not feel sufficiently confident in the structure of the way that we deliver healthcare in our country, compared with the delivery of healthcare in other European systems, to practise independently and provide the standard of service and care to patients in the National Health Service in future. That is clearly an unintended consequence but it could have serious implications.

Another example is the application of employment law, driven by the principles in legislation derived from Europe. It is good in many ways to ensure that there is a free movement of labour across the European Union, and that has brought many advantages to our country. However, it has created a serious and important problem regarding the end of medical school undergraduate education. By tradition, the first year of employment after graduating from medical school—the so-called “house job”, now known as the foundation 1 year—is a year where junior doctors take up a post under the continued supervision of the dean of their medical school. They have to complete that post before they can be fully registered with the General Medical Council and be in a position to practise independently in our country. However, because that first year is a year of employment, it must now be open to competition throughout the EU for applicant doctors from anywhere in Europe. As a result, we now run an increasing risk of our successful graduates being unable to find posts in their first foundation year because they have been taken by others. They will therefore not be able effectively to complete their undergraduate education, and will never be able to register with the General Medical Council and serve the people of our country. Again, this is an unintended consequence of previous legislation and regulation from Europe that has had a detrimental effect.

I turn now to the primacy of our regulatory body for medical practice in the United Kingdom—the General Medical Council. There is a European medical directive and it is a requirement that the Medical Act passed by this Parliament be consistent with the requirements of that directive. The directive covers several areas, such as defining what specialties exist in the European Union with regard to medicine, surgery and so on. It deals with the number of hours that are required for a recognised undergraduate medical course. It deals with the question of the duration of postgraduate training for doctors, surgeons and others. However, it also ensures that an EU national—a qualified doctor registered anywhere in the European Union—has the right to practise here, in the United Kingdom, by seeking registration with the General Medical Council. That, in itself, is fine. However, it also therefore prevents the General Medical Council determining the quality and content of the training schemes that those doctors have been subjected to. It prevents something that we all well recognise the importance of now—the ability to test the English language skills of those doctors before they come to practise in our country. As a result of that, there have been some serious problems—unfortunate events where our own citizens have died as a result of poor medical practice that could have been avoided if these unintended consequences had been foreseen. It is interesting that the General Medical Council is able to deal—

[Lord Teverson]

Can I just clarify that? Surely it is the responsibility of the employer to make sure that the person is competent to speak English and carry out their duty. They have the right to do that. It is surely a primary responsibility of any employer to make sure that the people they employ meet the standards of that organisation or business.

[Lord Kakkar]

Indeed it is but it is not always done. I was coming to the point that the General Medical Council has the obligation to do this for doctors who come from outside the European Union. It must ensure that they have the language skills, that they have sufficient competence in skills, and that their training programmes and undergraduate medical education are of a sufficient standard and quality.

[Baroness Nicholson of Winterbourne]

Will the noble Lord reinforce his point by endorsing the FAB exam, which has resulted in more than 2,000 Iraqi medical professionals staffing the National Health Service very successfully? Could the FAB exam be transferred to European Union member state applicants who come to the General Medical Council?

[Lord Kakkar]

Indeed it could. There should be consistency in the standards that are required for doctors to practise in our country. There is another point: if a practitioner registered in another European Union country is struck off, suspended or undergoing investigation by that country’s regulator, those regulatory authorities have no obligation to inform our own—the General Medical Council—that it has happened. A doctor from elsewhere in Europe, having qualified there and been registered here, could continue to practise while not being able to do so in their original member country. This, again, is unacceptable.

I make these points just to reiterate that, in trying to achieve the objective of reconnecting the people of our country with the European Union, the proposals outlined in the Bill are very important. However, it is also important to ensure that we protect the standing of the European Union in areas such as the practice of medicine and healthcare by ensuring that the problems we have experienced so far are not repeated in the future; and that, as a country, we overcome these problems so that the purpose of the General Medical Council—to protect our patients and ensure the highest standards—is not inadvertently frustrated by European legislation.