HL Deb 05 May 2004 vol 660 cc1097-9

Baroness Knight of Collingtree asked Her Majesty's Government:

How The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), laid before the House on 1 April, will change the law in relation to the protection of patients and their right to decline to be used in clinical trials.

The Parliamentary Under-Secretary of State, Department of Health (Lord Warner)

My Lords, the regulations impose new legal requirements for the protection of patients in clinical trials of medicines, particularly incapacitated adults and children. Those conducting trials must obtain informed consent from all participants. Patients are provided with detailed information on the nature of the trial and have the right to withdraw at any time. The new statutory requirements are in line with existing good clinical practice in the UK.

Baroness Knight of Collingtree

My Lords, is the Minister aware, first, that I am grateful for what he has said and, secondly, that similar emollient assurances and promises of strict controls were made at the time of the passage of the Abortion Act 1967 and that every single one of those has been broken? Will he recall that the practice of using mentally handicapped people for experimentation and research without their permission, as now introduced in Statutory Instrument 2004/1031, was infamously pioneered by Nazi Germany and is abhorrent to all of us, in any circumstances whatever?

Lord Warner

My Lords, I understand the concerns expressed by noble Baroness. However, the regulations will help to ensure that the rights of all clinical trial subjects are protected and that the results of trials are reliable. They will produce powers of enforcement, which are lacking at the moment, when things are not satisfactory; and they will provide particular provision of a legal representative for people who are incapacitated.

Baroness Hayman

My Lords, does my noble friend the Minister accept that, while it is obviously extremely important to protect the rights of patients to consent, there are areas of research that are of grave importance that would not go ahead if we did not find ways in which to get ethical approval for research? For example, we need approval for those who are in intensive care and those who are mentally incapable of giving consent.

I remind the House of my interest as chairman of Cancer Research UK. Does my noble friend agree that the interests of patients have to be safeguarded in ensuring that clinical trials do go ahead to the benefit both of those participating and future patients?

Lord Warner

My Lords, before responding to my noble friend's question, I wish her and other Members of the House who are participating in this evening's charity event, Race for Life, the very best of wishes—and healthy contributions from all Members of the House.

I share my noble friend's concerns. That is why it is important that we do not deny people with incapacity the ability to participate in these trials, which will enable us to find cures and treatments that are effective for all people.

Baroness Carnegy of Lour

My Lords, having been some time ago chairman of a medical research ethics committee, my understanding was that all parts of the country and all research were covered by such committees and that patients were protected by them. Has that system been breaking down, so that the Government feel it necessary to legislate?

Lord Warner

My Lords, that system has not broken down. Indeed, it has actually been strengthened under this Government, with more money going in to support local ethical committees. The regulations ensure that we strengthen arrangements for clinical trials across the EU and provide powers of enforcement when there are breaches of the conditions.

Lord Carter

My Lords, is my noble friend the Minister aware that the Joint Select Committee on the draft Mental Incapacity Bill, which I chaired, considered the topic long and hard? We came to the conclusion that research on patients who lack capacity should be conducted, but under the strictest controls and protocols. To put it simply, how do we find a cure for Alzheimer's if we cannot do carefully controlled research on patients with that disease?

Lord Warner

My Lords, my noble friend is of course absolutely right. That is why we did not in any sense wish to rule out the participation of those with incapacity in clinical trials, but wished to ensure that there would be adequate controls to protect their interests through the regulations.

Earl Howe

My Lords, can the Minister confirm that under the regulations patients who lack mental capacity can be included in clinical trials if consent is given on their behalf by their "legal representative"? The definition of legal representative is extremely wide and includes not only family members and the doctor in charge of the patient's care but also anyone else from the hospital involved. Is not that last category of legal representative a cause for some concern?

Lord Warner

My Lords, there is need for flexibility in these areas. It may not always be possible in certain circumstances to gain access quickly to a patient's relatives. The regulations ensure that no one who is associated with the research and clinical trials can act as a legal representative.

Lord Elton

My Lords, do I understand from that last answer that any other medically qualified member of the staff of a hospital where such a patient is resident is entitled to give consent, regardless of what the rest of the family may feel because they are not there?

Lord Warner

My Lords, the first order of call will be on the relatives of the patients concerned. The other arrangements for a wider group of people who can serve as legal representatives are to ensure that incapacitated patients are not denied the opportunity to participate in these trials because one cannot get quick access to a relative.

Lord Campbell of Alloway

My Lords, is the Minister aware that in his previous responses he did not appear to accept any order of call and that, as drafted, the provision could be seen to be open to objection?

Lord Warner

My Lords, these arrangements are an extremely narrow part of the regulations. They are included in this form in order to ensure that incapacitated people are not denied the opportunity to participate in clinical trials that, on the whole, often provide better treatment as well as the research capability.