• 01616 966 229
  • Request a callback
Stephensons Solicitors LLP Banner Image

News and Events

A medical experiment or life saving treatment?

  • Posted
Sepsis - new guidelines being published for doctors on how to deal with this deadly condition

In the recently reported case of University College London Hospitals v KG [2018] EWCOP 29, the court ruled that it was in the best interests of a person lacking capacity to receive a medical treatment that has never been tested on or administered to any human being.

The middle-aged man from the east of England, referred to as “P” throughout proceedings, suffers from sporadic CJD which is invariably fatal. The average lifespan from diagnosis is six weeks, meaning P’s expected lifespan would be to the end of October 2018. Mr Justice Cohen confirmed that P does not have the capacity to make an informed decision himself.

The University College London Hospitals NHS Foundation Trust sought the court's authority to administer a treatment known as PRN100 to their patient, P. PRN100 has never been tested on or administered to any person anywhere, it is a completely novel treatment. P, the official solicitor on his behalf, his family and the trust all asked for the court's approval for the treatment to be administered.

The National Prion Clinic has been working on the development of PRN100, a humanised monoclonal antibody, from 2007 through to 2013. Unfortunately, the substantial cost of such study, together with the rarity of CJD and the high-risk nature of drug development, has meant that is has not been possible to raise the funding needed for a formal clinical trial. The precise side effects on a human are not known because, of course, they have never been tested. They may or may not be reversible.

The administration of a new and untested treatment is referred to in the Code of Practice to the Mental Capacity Act 2005 in several material passages. At paragraph 6.18, it says:

"Some treatment decisions are so serious that the court has to make them ...". 

This includes "cases where there is a dispute about whether a particular treatment will be in a person's best interests" 

Then at 6.19 this category is explained further and

"... may include cases that introduce ethical dilemmas concerning untested or innovative treatments where it is not known if the treatment will be effective..."

Professor Mead highlighted the positives of administering the untested treatment at paragraph 13 of the judgment, commenting that “there is no alternative treatment available for their condition. It is hoped that PRN100 may delay the progression of the disease. Other possible benefits may be the stabilisation of the disease, a decreased rate of decline or even an improvement in the patient's condition.”

In his judgement, Mr Justice Cohen explained that in reaching his decision, he had applied “a best interest test which requires taking into account a large number of factors. Broadly speaking they can be broken down into the nature of the treatment that is proposed, what is involved and what its prospects of success are. Secondly, what are the views of the patient, what does he want and what do his nearest and dearest want? Thirdly, how do I feed into the thought process the fact that this is a novel and experimental treatment.”

Mr Justice Cohen firstly commented on the nature of the treatment at paragraph 18 of his judgment, whereby “the actual treatment in itself is not especially invasive. It involves the administration of medication into the vein and will be gradually titrated upwards… It is, of course, essential to keep the effect of the treatment under very close review so that it can be adjusted or stopped if required.”

Secondly, Mr Justice Cohen dealt with the fact that this is a novel treatment. In considering this at paragraph 19 of his judgment, Mr Justice Cohen commented that “I have to be and am satisfied that the highest standards of monitoring will be maintained.” Furthermore, he expands on this at  paragraph 20, when he acknowledges that “the team has developed a detailed treatment plan and obviously is fully aware of its duties to promote and safeguard the health, well-being and rights of the patient.

Thirdly, Mr Justice Cohen considered the views of P and his family, commenting that “It is clear that he wants the treatment… His wife and family have all confirmed that this is his as well as their genuine wish.”

Applying all these considerations, Mr Justice Cohen approved the administration of PNR100, concluding that “It seems to me plainly in his best interests that P should have the treatment and accordingly I approve it.

Stephensons have a specialist team of Court of Protection solicitors covering cases nationwide and have the benefit of a legal aid contract (subject to eligibility). Should you require any assistance or advice on any matter which may relate to the Court of Protection or community care, please do not hesitate to contact us on 01616 966 229.

By  Megan Taylor, graduate paralegal in the Court of Protection and community care department.