Medicine bar

Last week, cancer sufferer Barbara Clark won her fight to be prescribed the drug Herceptin. Clark could have died within the year if she had not received the drug, but the Primary Care Trust (PCT) had initially refused to give it her on the basis that it was currently licensed only to be used on NHS patients whose breast cancer was at a more advanced stage than hers. The PCT said that in withholding the drug it was operating within national guidelines, issued by the National Institute for Clinical Excellence (Nice).

The legitimacy of Clark’s request was fuelled by the preliminary results of an international trial involving approximately 5,100 patients in the use of Herceptin in early stage breast cancer, which were announced in May this year and showed that the drug can reduce the risk of breast cancer recurrence by up to 46 per cent.

Since the results were announced, PCTs have come under increased pressure to use the drug. Clark’s PCT decided to allow it to be prescribed to her. The trust’s chief executive Alan Carpenter said that given her circumstances it was in Clark’s “best interests” to receive Herceptin at the early stage of her treatment.

It is unclear if this decision will open the floodgates. The drug remains unlicensed, and Nice can only consider issuing a guidance for a wider use of the drug once the European Agency for the Evaluation of Medicinal Products (Emea) has deemed it safe for use in early stage breast cancer. The Emea will become involved only when manufacturers make an application to license the drug for this use. No such application has been made and the manufacturers have indicated that an application may not be made until 2006.

Legal remedies
In the absence of formal licensing it is likely that other individual requests for Herceptin will continue to be dealt with on a case by case basis. However, is it possible to force a trust to prescribe the drug either through a common law negligence claim or an action claiming breach of Articles 2 or 3 of the Human Rights Act (HRA) 1998?
A claim of negligence appears difficult but not impossible. The trust would have to be shown to be unreasonable in refusing to make available a drug that is unlicensed for the use to which a claimant would put it. The trust could argue that its actions appear to have the backing of the Department of Health/Nice and that Herceptin itself carries certain health risks. The manufacturers list a number of severe side effects, including potential heart and lung damage, the extent of which have not yet been fully evaluated. However, the PCT in Clark’s case was aware of these factors and still found it to be in her best interests to be prescribed the drug. This will operate as a powerful argument to suggest that failing to prescribe the drug amounts to a lack of reasonable care and a breach of duty.

Despite this conclusion in light of Clark’s case, a claimant is still burdened with proving causation of loss. While a claimant may have little problem proving that the delay in prescribing the drug caused a reduction in her prospects of ultimate survival, this may not provide a remedy in damages, as has been recently reaffirmed by Gregg v Scott (2005). A claimant would only succeed in establishing causation if they were able to show that their prospects of survival were better than 50 per cent at the point at which the court finds that the drug should have been provided and that they have been diminished by the delay in its provision to less than 50 per cent.

Claim for breach of the HRA
An action under Article 2 of the HRA may provide better prospects to a claimant. Article 2 both prohibits the state from taking life and places on it a positive duty to protect life. The European Commission has held that the state must “not only refrain from taking life ‘intentionally’ but, further, take appropriate steps to safeguard life” (X v UK (1978), and confirmed in Osman v UK (1998)). Under Article 6, public authorities are to comply with the requirements of the European Convention on Human Rights wherever possible.

But would the provision of the drug to the claimant constitute an ‘appropriate step to safeguard life’? It is suggested that the evidence as to the efficacy of the drug would need to be compelling to persuade the court that it was.

Further reliance may be placed upon Article 3 of the convention, which enshrines a person’s right to the protection of their physical and human integrity. Article 3 was considered in Pretty v UK (2002), where it was argued that suffering attributable to the progression of a disease may amount to prohibited treatment if the state can prevent or ameliorate such suffering and does not do so. Whether or not the withholding of Herceptin, which could alleviate a suffering in early stage breast cancer, is ‘prohibited treatment’ would be a question for the court. In its defence, the Secretary of State in Pretty argued that the lengths to which the state should go in discharging its positive obligation to protect individuals from prohibited treatment is within a member state’s margin of appreciation.

Possible defences to breaches of Articles 2 and 3
Potentially, even if a breach of Articles 2 or 3 could be established, the PCT could rely on the resources defence established by R v Cambridgeshire District Health Authority ex parte B (1995). In that case, the court was asked to consider the merit of the health authority’s decision to withhold treatment for non-Hodgkins lymphoma in a 10-year-old girl on the basis that it was costly and the prospects of it being successful were not well established. Sir Thomas Bingham stated: “Difficult and agonising judgments have to be made as to how a limited budget is best allocated to the maximum advantage of the maximum number of patients. That is not a judgment which the court can make. In my judgment, it is not something that a health authority, such as this authority, can be fairly criticised for not advancing before the court.”

PCTs provide appropriate funding for recommended treatments subject to issues of “clinical and cost effectiveness”. Herceptin is not a cheap drug. In 2001, Nice estimated that the cost per patient of a 38-week course of combination therapy was approximately £15,500 for the Herceptin element alone.

While R v Cambridgeshire was a judicial review case, a similar conclusion might be anticipated in a case under the HRA. It is to be hoped that the issue of resources does not dictate the outcome if other patients than Clark were to litigate under the HRA.

Barbara Clark won her fight to be prescribed cancer drug Herceptin. What does this mean for future cases? Christian Beadell and Adam Korn report