EU: Reform

Lord Kakkar Excerpts

Thursday 9th January 2014 Lords Chamber

[Lord Kakkar (CB)]

My Lords, I join in thanking the noble Lord, Lord Dykes, for having secured this important debate, and, in so doing, declare my own interests as professor of surgery at University College London and a member of the General Medical Council.

The area of health and delivery of healthcare was not an area originally anticipated as having any competence at European Union level, specifically in the treaties. The delivery of healthcare and the allocation of healthcare resources along with the development of health policy were described as an area in which member states and national governments maintained absolute competence. The Department of Health balance of competence review, necessitated by the fact that, inadvertently, much European legislation and many directives have impacted on the delivery of healthcare, determined broadly that, in those areas where European regulation and directives have impacted on the delivery, it was positive. However, it identified a number of important areas where there were unintended detrimental consequences resulting from European regulation.

I shall concentrate on two areas that were highlighted in that competence review and in the third report of Session 2013-14 of the Science and Technology Committee of the other place. The first is the question of the European working time directive, which has been debated extensively in your Lordships’ House. I return to that because the directive continues to have a very important impact on the way that we are able to organise and deliver healthcare in our country and because the unintended consequences of its impact have been substantial.

The working time regulations have affected the quality of care. Although initially it was anticipated that restricting working time to 48 hours per week for trainees would promote patient safety and improve quality, regrettably that has not been the case in this country. Indeed, where the question of the duration of working hours for junior doctors has been studied carefully, particularly in the United States, it is clear from prospective evaluations that have been undertaken over a period of time that such a restricted period of working each week has a detrimental impact on patient safety.

There has clearly also been a detrimental impact on our ability to train junior doctors.

[Lord Davies of Stamford]

I am most grateful to the noble Lord for giving way. I greatly recognise and admire his expertise and experience in this area, but can he perhaps tell the House why our continental partners, in France and Germany and so on, do not seem to have had the same problem with the delivery of healthcare that he suggests we have had as a result of the directive?

[Lord Kakkar]

I thank the noble Lord for his intervention. That is because the application of the working time directive in those countries has been different from our rather fastidious application of the directive here in the United Kingdom. It is also due to the fact that the organisational structure for the delivery of healthcare is very different in France and Germany from the way that we deliver healthcare in our country.

Particularly in the craft specialties, such as my own specialty of surgery, trainees have found it increasingly difficult, within the restriction of 48 hours and the restricted period of time now available for specialist training, to develop the skills necessary to deliver independent consulting practice, which is very much a feature of the delivery of healthcare in our NHS but is rather different from countries such as France and Germany, where they tend to have larger departments with a much more hierarchical structure.

There has also been a substantial cost impact from the adoption of the working time regulations. In the first full year after their application across the National Health Service, an extra £200 million was spent on the provision of locums to fill rotas necessary to cover the provision of out-of-hours care within the NHS. Indeed, just for surgical specialties, the Royal College of Surgeons has assessed that an additional £60 million was spent to provide locums to cover surgical rotas. The Royal College of Surgeons estimates that, because of the application of the working time regulations, some 40,000 surgical hours are lost per month. Again, that has had a detrimental impact on ensuring that access to services can be adequately delivered to meet workload demands. Most worrying is the fact that, on a number of occasions, coroners have included in their narrative verdicts reference to the working time regulations as having had a detrimental impact on the care of individual patients.

Her Majesty’s Government recognise that this is an important challenge. Indeed, in 2010, the then Health Secretary and the Business Secretary announced that they were to initiate negotiations with our European partners not on withdrawing from the working time directive as it applies to healthcare but on ensuring greater flexibility, which would allow us to develop training schemes to meet the specific needs of the NHS in England in the training of our trainees. That resulted in the process being pursued through the mechanism of the social partners, but regrettably that negotiation has failed and the question has now been returned to the European Commission.

Clearly, this is an important area where action is required. As I have said, we need not to withdraw from the working time directive but to allow the necessary flexibility to allow working hours to increase from the current level of 48 hours to 56 or 65 hours, depending on what point trainees are at in their training and on what specialty or discipline they are training in. Can the Minister confirm that this might be a priority area in any further negotiations with our European partners?

The second area is the question of clinical research. Our country has a very distinguished heritage in terms of its contribution to biomedical research globally. The citations for research undertaken in our country are substantial. Some 12% of global citations for biomedical research are derived from research conducted in our country, a substantially greater proportion than in any other country in the world. Much of this is based on our distinguished history in delivering important clinical research. In 2001 6% of all patients entering clinical trials in the world came from the United Kingdom. By 2006, after application of the clinical trials directive, that had fallen to 1.4% and in the period 2007-11 there was a further 22% decline in the number of patients entered into clinical trials from our country.

The clinical trials directive has not only impacted on clinical research in our own country, it has affected all other European member states in terms of their competitiveness globally to deliver clinical research. The Medicines and Healthcare Products Regulatory Agency, which registers new clinical trials, identified in 2007 some 1,207 new trials registered. By 2011 it was down to 943. Clearly, the clinical trials directive is having a detrimental impact. It has, indeed, been renegotiated and a clinical trials regulation was agreed in 2012 by the European Parliament, due for application in 2016. The third report of the Science and Technology Committee of the other place identified ongoing concerns even about the newly drafted clinical trials regulation, concerns that were raised in evidence the committee received from the Academy of Medical Sciences and from the Wellcome Trust, a major funder of clinical research in our country.

In the area of clinical research, I suggest not that we withdraw from the clinical trials directive or the future clinical trials regulation, because there are important benefits to having a certain standard across the European Union, but that we should be able to ensure that flexibility provides for the specific environment in which we undertake and deliver clinical research in our country, with the strong national clinical governance mechanisms that we have in place, rather than find that the directive and the future regulation have had a detrimental impact on our ability to remain competitive in the life sciences area. The life sciences are an important feature of national activity, both in terms of ensuring excellence in our health service and in terms of the economic impact that life science industries have for our country.