Human rights vs principles of science

The new rules on compensation for death/ injury during clinical trials once again highlight the tough choices faced by our policy makers: how do they uphold human rights while safeguarding the principles of science governing clinical trials?

The process of framing compensation guidelines for volunteers on clinical trials conducted in India took a little more than a year. It started out with a draft published in November 2011, was followed by meetings with stakeholders to get their views and by January 30 this year a Gazette notification announced the contours of Rule 122-DAB to be added to the Drugs & Cosmetics Rules 1945, as the First Amendment (2013).

But was the consensus building just a smoke screen? Industry was in for a bit of a rude shock by the final notification published on January 30. (See report: http://bit.ly/1215poK). The amendment gives the Drug Controller General (India) the final say on which cases merit compensation as well as the amount, under advice from expert committees.

Global CROs conducting trials in India have in fact paid compensation for trial-related deaths in other jurisdictions so this would seem to be a business risk they live with. What they object to is the fact that the new rules do not seem to have any safeguards or are silent on crucial details. For instance, there is no clarity on the composition of the expert committees, so how can bias not be ruled out? There is no appeals process as well so the DCGI’s decision to stop a trial cannot be appealed.

Industry bodies like ISCR point out that not differentiating between trial-related and trial non related injuries when deciding compensation could in fact be seen as an inducement. Similarly, ISCR feels that a sponsor should not be held responsible for injury or death arising out of misconduct or negligence by an investigator as this eventuality should be covered by the laws of medical negligence.

ISCR also contends that the new rules contradict the definition of a clinical trial when they call for compensation for injury or death due to the failure of the investigational product to provide ‘intended therapeutic effect’, because this is just what the trial is trying to observe. Similarly, the use of a placebo in placebo controlled trials is central to the scientific base of a clinical trial and hence compensation cannot be given to a patient/volunteer who may have got the placebo.

Sources see the hand of ministries other than the Ministry of Health & Family Welfare, in some of the deviations between the final draft approved by all stakeholders and the one finally published on the CDSCO’s website on January 30. For instance, given the medico-legal aspects of deaths during clinical trials, sources surmise that the law ministry would have definitely weighed in to crack down on what is seen as the industry’s attempt to pass off responsibility. And since the Gazette Notification comes into force from the date of release, there can be no changes unless it is legally challenged, which is sure to be a long painful process.

There is no doubt that patients/ volunteers need to have a legal safety net, particularly in a country like India, where low levels of rural literacy and economic factors have created a class of professional patients for whom clinical trials are a livelihood. At the other end of the spectrum, we have patients who do not even realise they were enrolled in trials.

In the clash of human rights and the principles of science, (as well as business interests and political posturing) are we in danger of missing the wood for the trees? Yes, we need to protect the rights and safety of patients and volunteers on clinical trials but if the rules are so stringent that industry decides to take clinical trials elsewhere, India runs the risk of not having access to new generation drugs tested on our populations. Policy makers will have to ensure that while they focus on getting it right today, they do not lose sight of their responsibility to future generations of patients in the country.

Viveka Roychowdhury
Editor

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