§ Baroness HaymanMy Lords, I beg leave to ask the Question standing in my name on the Order Paper. In so doing, I remind the House of my non-financial interest as chairman of Cancer Research UK.
The Question was as follows:
To ask Her Majesty's Government what progress they have made in resolving the problems highlighted by medical charities and National Health Service clinicians in relation to the implementation of the European Union Directive on Good Clinical Practice in Clinical Trials.
§ Lord Davies of OldhamMy Lords, a joint Medical Research Council/Department of Health project is exploring in depth the challenges identified by those undertaking publicly funded trials in the consultation on the draft implementing regulations. The Government are considering changes based on all the responses to the consultation. My noble friend Lord Warner has written to my noble friend Lady Hayman.
§ Baroness HaymanMy Lords, I thank my noble friend for that encouraging reply, particularly given the seriousness of the situation before the intervention of my noble friend Lord Warner. Will my noble friend confirm that the Government recognise the crucial role that non-industry funded clinical trials play in this country as distinct from the rest of the EU? Will he give an undertaking that the extended timetable that I believe is now available will be used to ensure that high quality publicly funded or charitably funded clinical trials, which have been of such benefit to patients in this country, will be safeguarded?
§ Lord Davies of OldhamMy Lords, I recognise the importance of non-industry-funded health research carried out in this country. There is now a somewhat deferred timetable with regard to work on the directive. That provides additional time to take on board the very forceful representations made by Cancer Research UK and, indeed, by other bodies, and to get the matter right.
§ Lord Clement-JonesMy Lords, clearly very great concern has been expressed by the medical and research community, not least by Cancer Research UK and the MRC. This is yet another example of an EU directive where the Department of Health has been 288 caught on the hop. Is it not high time that the Department of Health got a rather better radar screen so that it can pick up these directives when they come through via UK representation in Brussels and make representations while a directive is going through, not afterwards?
§ Lord Davies of OldhamMy Lords, I do not accept that the Department of Health is not sufficiently sensitive to issues as they arise in respect of European Union directives. A directive that seeks to protect patients across Europe, and is highly desirable in those terms, is relatively straightforward in the majority of countries where most research is carried out by commercial organisations. As my noble friend indicated in her Question, the directive has particular implications and difficulties for the very substantial amount of research that is carried out by non-commercial organisations in this country. Therefore. we have a particular interest in the matter and have made forceful representations on it. In the additional time that is now available we are taking on board the representations that we have received. We are extremely hopeful that we shall arrive at a directive which is fully consistent with the needs of this country.
§ Baroness GreengrossMy Lords, recognising the justified excellent reputation of non-industry funded clinical trials in this country, will the Minister assure us that in future all clinical trials, whether publicly or industry-funded, will include all age groups because at the moment many exclude people of 65 and over with terrible results?
§ Lord Davies of OldhamMy Lords, that is an important point. We are aware that research can be skewed if not all age groups are represented. I fully take on board the point that the noble Baroness makes.
§ Earl HoweMy Lords, despite what the Minister said, is this not a prime example of an EU directive hat brings with it massive burdens for those who carry out clinical trials and no benefit whatever for patients? Will the Minister explain what the point is of a harmonisation measure if it adds nothing either to the validity of trials or, indeed, to patient safety?
§ Lord Davies of OldhamMy Lords, I contest the noble Earl's point that the directive fails to add to patient safety. The directive is driven by the needs of patients. As has been indicated, in other countries the need for the directive may be even more pressing than in this country. However, we do not wish to be complacent about research in this country. We have the most excellent record. The noble Earl will recognise that ID per cent of the world's advanced medical research is carried out in this country. It is a very important part of our provision. But that does not mean that in all forms of medical research we do not make the needs of the patient a priority. The measure we are discussing will help in that regard.
§ Lord TebbitMy Lords, if the Minister noticed that there are defects in our system that may endanger patients and if he was aware of that, why on earth did not the Government bring forward domestic legislation to deal with it instead of waiting to be bossed around by people in Brussels who are mostly concerned with defects in other countries?
§ Lord Davies of OldhamMy Lords, when a defect, as the noble Lord identified it, occurred with regard to our own circumstances in the case in North Staffordshire some two years or so ago, we took appropriate measures to rectify it. But, as he will recognise, research is carried out on a European-wide basis, and other countries too have enviable records with regard to their work. It is appropriate that we should have harmonisation across Europe, given the fact that the medical profession contributes to European-wide medical advance through such research.
§ Baroness Carnegy of LourMy Lords, will the noble Lord remember that every clinical trial in this country is looked at by local medical research ethics committees, which approach it from the point of view of the people who will take part in the trials? Have the Government pointed that out to the European Union—because I do not think that every country in the EU has that type of protection? I should have thought that that alone should make us exempt from the directive.
§ Lord Davies of OldhamMy Lords, I cannot go quite so far as the noble Baroness wants in assuring her that such a contribution would then make us exempt from the directive. But she is absolutely right: our concern about ethics, through the local control that she has identified, is an enormous strength in our provision of medical research. We have presented to Europe, in the discussions on the directive, all those facets of our outstanding record with regard to medical research.
§ Baroness Finlay of LlandaffMy Lords, given the rigours with which clinical trials are conducted in this country, and the evidence that patients in trials do better overall than those who are not entered into trials, are the Government taking on board the representations from intensivists and others dealing with critically ill patients, where there are very real problems in obtaining consent to entrance into a trial by routes other than the conventional one; namely, the prior consent of patients? That group of patients, if not included in clinical trials, may well not receive advances in care in the long term.
§ Lord Davies of OldhamMy Lords, the noble Baroness has introduced an additional point of considerable importance. It is not directly covered by the directive; nevertheless, she is right—we do need to pay particular regard to that group of patients. I can assure her that the department does so.