Julia Manning is Chief Executive of 2020Health.
Following the Prime Minister’s Downing Street Business Summit yesterday it can’t be a complete coincidence that Sir Michael Rawlins (Chairman of NICE and Senior Fellow of the Academy of Medical Sciences) review of the regulation and governance of UK clinical research was published today. Scientific research is central to economic growth in the UK. Although it fits in neatly with the Conservative’s pre-election plans to have a bonfire of regulation, it was actually instigated by Andy Burnham when he was at the Department of Health in March 2010. It was a response to the fact that the UK global share of clinical trials had fallen from 6% in 2002 to 2% in 2007 (and is now lower still) and successive reports had detailed just how much regulation was strangling the setting up of clinical trials. My report on Emerging Technologies published in October last year included a one page chart on page 80 on just how many hurdles researchers have to jump before they can conduct a clinical trial in the UK.
In 2007, the UK pharmaceutical industry alone invested £4.2 billion in R&D, employed 73,000 people and was ranked first for its contribution to the UK’s trade surplus (£4.3Bn). At a time when we are battling the trend for research going East it is vital that we ensure scientific research can flourish here, and having universal NHS provision should make this much easier, as recognised by Sir David Cooksey’s report of 2006.
However streamlining governance is only one part of the equation. There are two other key factors. One is that in order to conduct a medicine trial in the UK we have to already be using the best ‘gold standard’ medicine to compare the new agent against it. For a whole variety of reasons we have fallen behind in the uptake of new medicines in the UK, meaning that when wanting to test a new drug for an improved response, we literally don’t have enough or sometimes any patients on the existing ‘gold standard’ medicines with whom to compare.
The other is public confidence. The brilliant true story ‘The immortal life of Henrietta Lacks’ which was published late last year is the most recent book to raise the question of informed consent and benefits of research to the person or family from whom cells or tissue are taken. In this case the family of Henrietta, whose malignant cells were the first to grow successfully in a test-tube and be available for thousands of researchers and medicine development, continued to live in ignorance, poverty and illness, receiving no benefit from their relative’s “donation”. This is not the only example, but as the public become more aware that it can be their cells and tissues that turn into multi-million pound cash-cows for researchers and industry there will rightly be more questions about ownership and shared benefits. Andrew Wakefield’s MMR fraud doesn’t help confidence either.
Colin Blakemore has used this moment to call again for ‘assumed’ consent for both organ donation and tissue donation. I argued against this when Gordon Brown argued the case for ‘presumed’ consent back in 2008 but I think this government’s plans to ‘prompt’ choice on consent when people reapply for a driving licence is a better idea. However the complexity of ‘informed consent’ should not be underestimated and this is the other aspect of confidence we need to consider. Knowledge is dynamic and people need to know that tests will be developed in the future that will tell us an awful lot more about our health and wellbeing than we may want researchers to know. It’s one thing to sign over our organs and tissues once we are dead (tho’ even then there are our relations to consider); it’s another to give a way carte-blanche rights on the tissues of the living.
I am sure that Sir Michael will have found a way to streamline clinical trials governance that will release some if not all of the grip of regulation on pharmaceutical research in the UK. But at the same time we can’t ignore the continuing lack of adoption of new medicines and the need to keep the public’s confidence with research if we want to see economic growth from UK clinical trials.