Post-Trial Acces to Treatment

News

16 February 2015

The paper ‘Post-Trial Acces To Treatment’ gives an overview of corporate best practices related to the provision of Post-Trial Access to Treatment (PTA) in low and middle income countries (LMICs).

SOMO analysed the policies of the biggest pharmaceutical on PTA, analysed the strong elements regarding PTA in international ethical guidelines, and reviewed the academic debate on this topic. The aim of this paper is to fill the knowledge gap about how the pharmaceutical industry currently deals with PTA in practice and to contribute to a high yet realistic standard of PTA in low- and middle-income countries (LMICs).

Post-trial access to treatment

Medicines for the European market are increasingly being tested by pharmaceutical companies on clinical trial participants in LMICs, where most participants are poor and have limited access to health care. Against this backdrop, the right to PTA after the trial has ended becomes increasingly important to avoid the exploitation of vulnerable participants. Since the national health-care systems in LMICs are often not able to provide follow-up treatment after the trial, it happens that beneficial treatments experienced by clinical trial participants are not continued. This is an unwanted and unethical situation which places a greater appeal for pharmaceutical companies to take responsibility for providing PTA.

The difficulty SOMO experienced in collecting good PTA examples from the companies in question and the absence of examples in the academic literature confirms the highly exceptional nature of PTA. The scarcity of access to treatment provided by commercial sponsors after a trial in LMICs is concerning. In those exceptional circumstances where a company decides to arrange post-trial access to an unlicensed drug, it is done through an Open Label Extension Study or a Compassionate Use Programme.One of the recommendations is that pharmaceutical companies should act with ‘due diligence’ in relation to the issue of PTA in line with the UN Guiding Principles on Business and Human Rights. Companies should have an adequate policy commitment on PTA and show more activity in identifying and assessing the negative impacts of conducting clinical trial in LMICs, including access to treatment and appropriate care during and after the trial.