Life Sciences

Baroness Thornton Excerpts

Tuesday 6th December 2011 Lords Chamber

[Baroness Thornton]

My Lords, I thank the Minister for repeating the Statement. I, for one, certainly believed it was important that we took this Statement in the House, even if it is a day later than we might normally have done, because our great panoply of scientists, doctors and experts should have an opportunity to respond to it. It is likely that we can see the Minister’s hand in this initiative as research is one of his responsibilities and, indeed, one of his passions.

I share the Minister’s pride in Britain’s strength in life sciences. We all agree in the House that the industry needs government support and focus if its potential to contribute to the country’s industrial future and to its people is to be maximised. I also think the whole House will agree that there are huge potential benefits to British patients from closer collaboration between the NHS and the industry. We all want patients to have the quickest possible access to the latest life-saving and life-enhancing treatments. Indeed, it was for those two principal reasons that when we were in government we prioritised the life sciences sector and established the Office for Life Sciences to support an industry that employs more than 100,000 people. Indeed, we created a Life Sciences Minister—a contact point for the industry and someone of huge experience and real personal commitment to it. It has to be said that one of our criticisms of this Government is we believe that they have allowed the momentum that we established behind promoting this industry to fall away. Indeed, the unexpected closure of Pfizer earlier this year exposed the Government asleep at the wheel and was a wake-up call. Therefore, to some extent we see this as the Government playing catch-up but it is nevertheless an extremely welcome development and we wish it well.

Although the Minister is concerned about the need to lift a regulatory burden from industry, I think we all agree that proper regulation on the use of patient data is most certainly not a burden that we want to lift. We want that properly addressed. My questions are around those issues. Some patient groups have already expressed concern about the media-briefed statement from the Government and the lack of accompanying detail, so I hope that the Government will be able to give some reassurance here. Will all patients have the ability to opt out of sharing their data, even in anonymised form? Will the fundamental principle of consent form the bedrock of any new system as control of data should be possible in today’s information age? I understand that the patients’ representatives walked away from the Department of Health working group on these important matters. If that is the case, why did they do so? Does the Minister accept that he needs to work harder to uphold public confidence in this process or risk undermining trust in the whole principle? Therefore, the safeguards are very important. What safeguards will there be to ensure that patient data are stored securely? What precisely are the changes that the RHG plans to make to the NHS constitution?

Is it the case that the anonymity of data cannot always be guaranteed? If that is the case, what are these circumstances, and why not? The Minister is very familiar with this issue, as, indeed, is his noble friend Lady Northover, because in May 2002 both of them were involved in a debate on precisely this issue. It was a debate on the safeguarding of patient data. It was said in the debate:

“For example, the Gulf War-related research and the research relating to leukaemia in the area of Sellafield could not have been carried out with purely anonymised data. There has also been recognition of new variant CJD and its relation to the BSE epidemic”.

It is not appropriate to use anonymised data in that context either. It was also stated, in my view very wisely:

“Apart from the medical profession, who else will be subject to the contractual duty of confidentiality? What type of contract does the Minister envisage will be entered into by, for example, civil servants and those who act with the various agencies which may process that information? What review process for the regulations will be followed by the Secretary of State in 12 months' time? Will it be an open and transparent process? Will there be an opportunity for debate? There is also the very important issue of informing patients that their information has been processed. I believe that the Minister should spend some moments explaining how patients—or, at least, doctors—will be able to tag their medical notes in some shape or form so that it is clear that their information has been processed by researchers”.—[Official Report, 21/5/02; col. 750.]

I could not have put those questions better myself, and they are the ones that the Minister needs to address in this case.

Who will judge which companies will receive this information when they are in competition with each other? The Statement assumes a very prettily organised and co-operative world but that is not the world out there in the pharmaceutical industry. Companies are competing with each other for the research they do, its outcomes, availability and how you make it available. How will the Government judge which companies they make this information available to and what criteria will they use under those circumstances?

I wish to ask the Minister a specific question about one of our great institutions which is involved in this research—Cambridge University. It seems to me that the Government need to manage these sorts of challenges, and this is a very serious one. I have given the Minister notice that I was going to raise this question. In October 2011, the European Court of Justice, responding to a reference from a German court about the interpretation of the European directive on the legal protection of biotechnological inventions, made a judgment which will have the effect of banning the issuing of patents for embryonic stem cell research. The ruling means that existing patents involving the use of embryonic stem cells are no longer valid and that future patent applications will not be considered. Many researchers at Cambridge are concerned that the ruling could damage the entire field of research and drive much of it abroad. The ruling could act as a huge disincentive for investment as patents are important if pharmaceutical companies are to recoup their investment in clinical trials and turn a profit. It could therefore set back possible new treatments for a range of disorders from heart disease and diabetes to blindness and Parkinson’s. The ruling also leaves scientists in the contradictory position where they are funded to do research for the public good yet prevented from taking discoveries to the marketplace where they could be developed into new medicines. It would be a tragedy if our great institution of Cambridge University had to take this research abroad because of a ruling of the European Court of Justice. I would like to know what the Government intend to do about that.

I am afraid that I cannot resist making this final point. It is a great irony that while Ministers are happy to offer up other people’s data, they continue to withhold the risk register on their own reforms despite a clear ruling from the Information Commissioner to publish.