Baroness Gardner of Parkes
To ask Her Majesty’s Government whether they will enable the use of new experimental drugs by terminally ill patients who are prepared to waive their right to sue pharmaceutical companies in order to assist the development of new drugs and ease their own condition.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
My Lords, there are existing provisions under medicines legislation for access to unlicensed medicines without requiring changes to the law. The Government are committed to ensuring access to new and promising medicines for patients while ensuring that medicines continue to meet high standards of safety, efficacy and quality. This is why the Government have been taking forward work on an early access scheme, adaptive licensing and promotion of clinical trials in the UK.
Baroness Gardner of Parkes
I welcome that Answer as it means that many valuable drugs might come to the market much earlier and be available for patients. Does the Minister agree that many elderly patients with a terminal condition will definitely get treatment that they may not particularly want themselves but that hope is terribly important in all our lives? Any of the new, experimental drugs can provide this valuable ingredient of hope to such patients.
Baroness Finlay of Llandaff
My Lords, in light of the proposed EU directive that is being led by MEP Glenis Willmott to facilitate clinical trials and the work done by Empower: Access to Medicine, led by Les Halpin, are the Government working with the Halpin protocol, which aims to overcome the legal barriers—real or perceived—to early access to, and development of, medicine in the UK?
Earl Howe
My Lords, the Medicine and Healthcare Products Regulatory Agency is at the forefront of the negotiations at European level to ensure that the new clinical trials regulation, which will replace the current directive, is much more conducive to companies directing their clinical trials towards Europe, in particular, we hope, the United Kingdom. This needs to happen. The trend over the past 10 years has been in the wrong direction and we want our own market share to increase; there are already signs that it is doing so.
Lord Taverne
The Minister’s Answer is encouraging. Does he agree that if one looks at the possible benefits to patients and the public from avoiding delays and extra costs, to press on with it is a no-brainer?
Lord Campbell-Savours
The Question refers to waiving the right to sue pharmaceutical companies. What is the Minister’s response to that?
Earl Howe
My Lords, there is no need to think in those terms. There are many routes by which patients can access medicines lawfully and maintain their legal rights. We want to make sure that ethics and patient protection continue to be at the forefront of drug development. It would be wrong to give an indication to drug companies that they can throw caution to the winds in that sense.
Baroness Oppenheim-Barnes
It often takes as long as five or six years to develop a new drug. Sometimes, even after that period, when permission has been given, something is found late in the day. Therefore, does the Minister agree that we need to know what sort of period he is thinking of in accepting drugs that have not yet been approved?
Earl Howe
My Lords, this will very much depend on a case-by-case analysis of the drug in question. If there is a very promising new drug that is a breakthrough medicine, where there is no alternative treatment, there may be a case for considering that more favourably than a drug for which there is a readily suitable alternative. As I mentioned earlier, the menu of options available to us, such as an early access scheme for unlicensed medicines and an adaptive licensing scheme within European Union rules for licensed medicines, can perhaps be tailor-made to suit the drug in question.
Lord Patel
Does the Minister agree that there are two separate issues: one is doctors’ and nurses’ ability to prescribe off-label drugs, which is allowed, and for which the doctor takes responsibility; and the second is using a drug that might be promising for treatment and doing research on it, which requires research protocol to be followed? Neither is permissible under current regulations.
Earl Howe
My Lords, the noble Lord is right that the two issues are distinct. It has always been the case that a doctor can, under his or her own professional responsibility, in certain circumstances, prescribe an unlicensed medicine. However, he is also correct that clinical trials need to take place within a framework of proper ethical and organisational approval.
Lord Hunt of Kings Heath
My Lords, I refer to my health interests in the register. Will the introduction of value-based pricing inhibit or encourage early access to new medicines?
Earl Howe
My Lords, the noble Lord will have to wait, I am afraid, for the results of the current discussions that are going on with the pharmaceutical industry about what value-based pricing will look like in the end. Certainly, it is our ambition that the price of a medicine should more fairly reflect its benefit to the patient and society. Therefore, if doctors have greater confidence that those two things apply when they are made aware of the price of the medicine, we certainly hope that uptake will follow.