My Lords, I suspect that the amendment has a similar purpose to Amendment 63, in the names of the noble Lords, Lord Turnberg and Lord Patel. The purpose is to ensure that in exercising its functions the HRA not only promotes the interests of research participants and those of the wider public in facilitating research but, in doing so, has to ensure that the publication of research findings takes place fairly and frankly. I tabled the amendment because there was concern in the Joint Select Committee, of which I was a member, about whether those responsible for conducting research were tempted on occasion to shield from public view the downside findings of a piece of research, for commercial or even professional, reputational reasons.
The Joint Committee’s discussions of that issue are set out in paragraphs 328 to 336 of its report to the Government. There was a lot of support in principle for greater transparency around research findings, and
particularly clinical trials data, but there was some ambivalence in the discussions of witnesses in front of us, including the Minister, about prescribing this requirement in primary legislation. Tucked away in the discussion was a concern that this kind of approach would cause pharmaceutical companies to take clinical trials away from the UK. That was the implication, I think, of some of the remarks passed to the Joint Committee, which rightly in my view took a more robust view. In paragraph 335 of its report, it recommended that the Bill should be amended,
“so that promoting transparency in research and ensuring full publication of the results of research, consistently with preservation of patient confidentiality, becomes a statutory objective of the HRA”.
That is what my amendment aims to do.
My views on this issue have been shaped over time, but particularly by my experience as the Department of Health Minister responsible for the pharmaceutical industry and its regulation as well as for NHS R&D. In those roles, I did my bit to promote that industry and secure UK jobs in it, and I know the arguments about securing clinical trials. However, they have to be balanced with other considerations, when deliberate concealment of adverse research data has taken place. This is in nobody’s interests, including those of the company where it has taken place, because eventually it usually gets found out.
To illustrate my concerns, I want to detain the House a little longer with a brief account of what came up in my time as a Minister, when there was concealment. “Panorama” revealed, in 2003, what was happening with an anti-depressant called Seroxat, which was being given to about half a million people a year. Some of the people taking higher doses of the drug experienced suicidal feelings, and there were a number of cases of younger patients committing suicide. There was widespread concern among patient groups, and the MHRA had to launch a review, which included a small subset of younger patients under 18, for whom Seroxat was not licensed but for whom it was being prescribed by doctors. At that time, about 8,000 young people a year were being prescribed this drug, and the Committee on Safety of Medicines advised me that children taking this drug were more likely to self-harm or have suicidal thoughts. That finding was not then available to the regulators, but the public fuss caused by the media caused the company—and I want to mention it; it was GSK—to end up passing the information in its files to the regulators in the UK, Europe and the US. I took the view, in 2004, that there was a respectable case for prosecuting GSK, because it had failed to inform the MHRA in a timely fashion of the information on adverse reactions in juveniles.
The whole affair limped on after my time as a Minister and became the largest investigation of its kind. Over 1 million pages of evidence were scrutinised, with GSK challenging matters all the way. Matters were only concluded in March 2008 when the decision was taken not to prosecute GSK, which received a slap on the wrist. The then MHRA chief executive said in a press release:
“I remain concerned that GSK could and should have reported this information earlier than they did”.
This case—and there are others which I know of—illustrates why we should put in the Bill a clear requirement that research information is put into the public arena in a timely way when there is a downside as well as when there is an upside so that people can have a fuller picture of what is actually going on. If noble Lords want a fuller account of the Seroxat saga, they can find it in my book, A Suitable Case for Treatment, which is available in the Library. I beg to move.