Right on Post-trial Access to Investigational Treatment

Abstract

The article explores the modern condition of the legal regulation of post-trial access to investigational treatment. The author has determined main arguments concerning the necessity of foreseeing such a right and the problematic issues that arise in case of its implementation. On the one hand, a subject can legitimately expect that s/he will continue to have access to beneficial treatment after the end of trial, for example, if it alleviates the symptoms of a chronic illness, depriving a trial subject from the beneficial post-trial access would defeat the basic principle of medical ethics. At the same time, this provision may have a large financial burden on the sponsor of the trial; it is difficult to control the occurrence of serious adverse reactions; providing post-trial access only to the subjects of the trial and denying others create disparity among patients.

The particular attention is paid to international standards and experience of foreign countries in this field. The legal and regulatory acts of Ukraine do not have any provisions on post-trial access to investigational treatment. The main international ethical guidelines, such as Declaration of Helsinki, CIOMS/WHO Guidelines, contain such a right, but they have different formulations and volumes that only intensify professional discussions. The most common norm is as follows: «a responsibility of sponsor to supply details of the plan for treatment or care of subjects once their participation in the trial has ended», which, in contradistinction to the Ukrainian legislation, is not connected with the causing damage to the subject. The author also has researched a unique case of Brazil, where the post-trial drug access program must make the medication available and free of charge to the subjects of the research in the cases of concluding the trial or after the patients’ participation in the study.

On this base, the author offered to provide in the legislation of Ukraine requirements to inform in advance subjects about the presence or absence of post-trial access and to evaluate these provisions by ethics committees before and at the end of all trials in order to determine its real need in each individual case. The scope of the right on post-trial access to investigational treatment must be reasonably weighed in order to avoid, on the one hand, becoming an excessive stimulus for the subjects, and, on the other hand, not leading to a situation where on such regulation conducting of clinical trials in the country will no longer be appropriate.