John Crown (Independent) | Oireachtas source

I request the Leader to consider having a debate on medical and biomedical research, which is a very important sector of the economy. I spoke a little about some aspects of it yesterday. Not only does it increase the standards of science and medicine, and the standards of research, but it also improves clinical outcomes for patients and has positive and beneficial effects for the economy. My concern is that one aspect of the system ? I am sorry for getting a little bit technical ? which has worked relatively well looks like it is about to undergo a substantial change. It is probably putting it too strongly to say I am troubled but I am a little in the dark about it, namely, the situation with respect to the ethical research committees which exist in hospitals. Every hospital must have an ethical research committee. In this country when a new trial involving a new drug or medication of a research nature is being introduced it must have the approval of a statutorily constituted ethics committee.

The 2004 European clinical trials directive had many negative features but it had one positive one, namely, that the verdict of any legally constituted ethical research committee in a hospital applied in every other hospital in the country. One does not have to apply individually. We have a two-step process for the approval of clinical trials in this country, which is correct. There is a national regulatory approval system conducted by the Irish Medicines Board and a second layer of approval is conducted on an ethical level. The remit of ethics committees is to ensure the research is ethical. That constrains the enthusiasm of doctors who have an academic self-interest and sometimes of companies that have a financial self-interest. Until now, the ethical research committees, which operate in response to statute and are regulated, answer to the Minister for Health, but apparently as part of the new health information Bill there is a suggestion that they will in some sense be answerable to the Health Information and Quality Authority, HIQA. Not alone would that not be optimal, it would not be appropriate because HIQA is also the body which has direct responsibility for assessing the cost of treatment in this country and directly or indirectly makes critical decisions and gives the Minister advice on which drug should be used on the grounds of health economics. It is a colossal conflict of interest for it to be responsible also for clinical research and I believe we need to have a different structure for it.

At present I run international research trials which recruit patients across different countries. Ireland has an extremely good reputation for having a professional and efficient clinical trials approval process which is streamlined and works relatively quickly. The United Kingdom in contrast, from where much of the intellectual inspiration for HIQA has come, has perhaps the worst reputation in Europe and as a result my British colleagues are exasperated at their inability to make high quality clinical trials and new treatments available to patients who are often in desperate situations.

The baby and bathwater spring to mind here but the more appropriate way to look at this is to ensure we do not develop an unnecessary solution to a problem that does not exist. The Minister should keep his eye firmly on this. This is the sort of thing people think is very technical and people in the Department will be able to handle this but it really needs careful consideration and consultation. I propose that in this Chamber we would schedule a debate on this critically important sector of the economy and health sector, biomedical research.