David Lock: Who has a legal duty to fund post-trial treatment?

If someone has been in a clinical trial, do they have a legal right to ongoing treatment for as long as treatment is clinically appropriate where the clinical trial was a success for that patient? I wrestled with this problem on an individual case recently where a patient got fantastic results from an expensive drug during a trial but it was likely that there would be no NHS funding to continue the treatment after the trial ended. The question was this “was it supposed to work like this?” and if not, does the patient have a legal right to demand that the treatment is continued. Although the matter is far from straightforward, it seems to me that the answers to those questions are respectively (and probably) “No, it was not supposed to work like this” and “Yes, the patient does have a legal remedy.”

The authors of the 1996 version of the World Medical Assembly (WMA), who adopted a statement of best practice about how clinical trials should be conducted throughout the world, clearly thought that trial patients should get on going treatment as a quid pro quo of putting themselves through the trial. The 1996 version of the Declaration of Helsinki included the following paragraph:

“At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic, or therapeutic methods identified by the study.”

Critics might say, adopting the words of the late Mandy Rice-Davies, “well they would say that wouldn’t they.” The WMA view could be characterised as the opinion of a group of well-meaning doctors who lived far away from the economic realities of the commercial world of drug trials and pharmaceutical companies. Whilst that may well be true, it’s only half the story because the 1996 version of the Declaration of Helsinki was adopted as setting the standards for running clinical trials by the EU in its 2001 Clinical Trials Directive. Article 4 of the 2005 EU Commission Directive on Clinical Trials provides:

“Clinical trials shall be conducted in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the General Assembly of the World Medical Association (1996)”

It is therefore not surprising that the duty to apply the principles of Declaration of Helsinki is also set out clearly in the Medicines for Human Use (Clinical Trials) Regulations 2004 which defines “good clinical practice” as acting in accordance with the practices set out in the Declaration of Helsinki. So it seems, although as far as I know this has not been tested in any court of law, the statements of good practice in the Declaration of Helsinki are part of both EU and domestic UK law. If that is right, patients may well have a legal right to continue successful treatment.

But this does not answer the difficult question about who should fund post trial treatment” Should the primary duty be on the drug company who sponsor the trial, the investigators who conduct the trial, the NHS or is there a legal duty on the Research Ethics Committee to impose conditions which ensure post-trial treatment is securely funded and if not, approval is not given? And crucially what is the legal position if a patient gets to the end of the trial and no one agrees to pay for on-going treatment. If the Research Ethics Committee have signed off the trial without requiring the sponsor to pay for on-going treatment, who should pick up the cost? There is no clear answer to this question except that if there is a legal duty to fund, one or other party (and ultimately the Secretary of State) has to fund. The patient cannot be left in the position where everyone points to someone else and the patient is sold short.

In 2008 the National Patient Safety Agency (now the Health Research Authority) published a guidance letter which said, “There is no legal or policy requirement to provide continued treatment to participants once they have completed a clinical trial.” That letter may well have appeared reasonable from the perspective of those conducting clinical trials and the pharmaceutical industry, but it made no reference to the Declaration of Helsinki, the 2001 and 2005 Directives or the Medicines for Human Use (Clinical Trials) Regulations 2004. I doubt that this is an accurate statement of the law but it has not been tested in a court case. However guidance cannot override primary EU and UK law requirements, but a mis-statement of the law might get the drug companies, who are not part of government, off the hook.

The expansion of scientific possibilities and the squeeze on NHS resources perhaps means that it is inevitable that more patients will be left without on-going treatment at the end of a clinical trial. Sooner or later someone will start to ask the difficult questions as to whether this is either morally acceptable or lawful, and then there may be some very difficult issues to confront.

David Lock is a barrister and QC at Landmark Chambers, London. He is the senior independent director and a non-executive board member of Heart of England NHS Foundation Trust, is a member of the BMA Ethics Committee and chairs Innovation Birmingham which runs the Science Park in Birmingham. He has set up a website www.gplaw.co.uk, which pulls together law, guidance, and practice that affect general practitioners.

Competing interests: He is a member of the Labour Party, is a supporter of Amnesty International and his wife is a doctor who is employed by the charity, Freedom From Torture. He provides legal advice to a wide range of NHS bodies on a variety of health law issues and provides legal advice and representation for patients, charities, pressure groups and commercial organisations concerned about or involved in the NHS.