European Union Membership (Economic Implications) Bill [HL]

Lord Kakkar Excerpts

Friday 25th November 2011 Lords Chamber

[Lord Kakkar]

My Lords, I join other noble Lords in congratulating the noble Lord, Lord Pearson of Rannoch, on securing this important debate on the Second Reading of his Bill. I will confine my comments to the area of healthcare and the impact that the European Union is having on the delivery of healthcare and biomedical research in our country. I remind noble Lords of my interests as a practising surgeon, professor of surgery and active biomedical researcher.

I will concentrate on two areas: the European working time regulation and its impact on the training of young doctors and other healthcare professionals in our country; and the impact of the clinical trials and data protection directives on our ability to conduct high-quality clinical research. On the European working time regulation, there has been extensive review and discussion about its potential implications. Its purpose is well recognised, but the unintended consequences with regard to the practice of medicine are not always so well recognised.

If the working time regulation had provided demonstrable evidence of an improvement in clinical quality, the safety of patients and the training of our young doctors and other healthcare professionals, it would be a very reasonable regulation to adopt and apply to the practice of medicine in our country. However, there is little evidence that the regulation restricting hours of work to 48 per week and applying to medical practitioners in training has achieved those objectives.

Clearly there are differences between different disciplines in medicine. The craft disciplines of surgical practice such as my own require a high level of exposure to large numbers of cases in order to develop technical skills, and also a broad ongoing continuity of management of patients to develop the judgment necessary for ultimate independent consultant practice.

The Royal College of Surgeons has taken a keen interest in the potential impacts of the working time regulation on surgical training in our country. In 2010 it produced a report that looked at the potential cost implications of the application of the working time regulation with regard to surgical training. In the two years prior to the introduction of the working time regulation, it collected data using freedom of information requests that were responded to by 96 acute NHS trusts, and extrapolated the findings to the 160 acute trusts where surgical training takes place. It concluded that in the year of introduction of the working time regulation, expenditure on locum costs to cover rotas as a result of the regulation increased from some £540 million a year to £750 million—an increase of more than £200 million.

That was across the board. When the royal college looked at surgical locums, it concluded that costs increased from £170 million a year to £230 million—an extra £60 million spent on locums as a result of the application of the working time regulation restricting surgical trainees to working 48 hours a week. It also tried to determine the number of surgical hours lost per month as a result of the restriction to a 48-hour working week and concluded that some 400,000 surgical hours a month were lost as a result of the restriction. If we were paying this price for achieving an improvement in clinical care or in training, it might be completely justifiable. However, the Royal College of Surgeons and the Association of Surgeons in Training concluded that that was not the case.

The second area is the impact of European directives and regulations on the conduct of clinical research in our country. Twelve per cent of the global citations in clinical and healthcare research are of publications from United Kingdom institutions and nearly one-quarter of the 100 leading medicines in the world have been developed in our country. Biomedical research is therefore hugely important to our economy and in terms of what we can do for our own people as well as for others around the world. In January a working group at the Academy of Medical Sciences chaired by Sir Michael Rawlins published a report, entitled A new Pathway for the Regulation and Governance of Health Research, which looked at ways of ensuring that we remain competitive. It concluded that the European clinical research directive has had a detrimental impact on the conduct of clinical research in our country. The directive was introduced for good reasons—to improve ethical standards and to ensure consistency of data and, ultimately, to ensure that patients are strongly protected in all clinical research—but there have been unintended consequences which have made the approval of clinical trials much slower and the conduct of clinical trials less effective. It has also increased the cost of doing clinical trials, so much so that, in 2000, 6 per cent of all patients going into clinical trials globally came from our country while, by 2006, the number had fallen to only 2 per cent of patients going into clinical trials. That has a very serious impact on our ability to function in that area.

These conclusions were also confirmed by your Lordships’ Science and Technology Committee in its second report for Session 2008-09, on genomic medicine, chaired by my noble friend Lord Patel. It also concluded that it would be important for Her Majesty's Government to review the working of the clinical trial directive and the data protection directive, which were having a detrimental impact on the conduct of clinical research in our country. I know that the Government are keenly aware of these important issues and that they are trying to address them. If a committee were established to look at the benefits and costs of our membership of European Union, consideration of the impact of European regulation on the conduct of research and the training of our doctors are important topics that should be considered.