Earlier this week, I was in Mumbai to chair a session on patents in a conference on risks and liabilities in the pharmaceutical and FMCG sectors organised by the Insurance and Hospitals Committee of Bombay Chamber of Commerce and Industry (BCCI) and sponsored by the Organisation of Pharmaceutical Producers of India (OPPI).
Among the various panel discussions organized in the conference, the one which I found most interesting was the one titled “Clinical Trials and Responsible Strategies". This session was extremely educative thanks to practical insights from Dr.R.H.Jani of Cadila Healthcare Limited, Ms.Suneela Thatte of Quintiles Limited, and Ms. Deepika Mathur of HDFC-ERGO General Insurance Ltd.
One of the issues discussed between these panellists was that of compensation awarded to participants of clinical trials for any trial-related injury or death in light of:
1. the amended Schedule Y of the Drugs and Cosmetics Rules, 1945,
2. the guidelines on Good Clinical Practices (GCP) issued by the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act, 1940,
3. the guidelines for biomedical research on human participants issued by the Indian Council of Medical Research (ICMR) and
4. the Guidelines for Determining Quantum of Financial Compensation to be paid in case of clinical trial-related injury or death (the draft guidelines were notified in August 2012 for comments and suggestions by stakeholders and members of the public)
Under the GCP guidelines of the CDSCO, compensation awarded to participants for disability or death caused by a clinical trial stands distinguished from compensation/consideration provided to the participant for participation in the trial.
Clause 2.4.5 lays down the guidelines for compensation for participation, which must be submitted to the Institutional Ethics Committee (IEC) as part of the application for clinical trial by a researcher/investigator. This is clearly reflected in Clause 18.104.22.168 which requires the researcher to submit “Proposed compensation and reimbursement of incidental expenses” as part of the application.
Clause 2.4.7 provides for compensation to be provided by the Sponsor of the trial for accidental physical injury caused as a result of participation in the trial. Instead of compensation, the Sponsor may also provide for insurance coverage for an “unforeseen injury”.
Clause 22.214.171.124 requires the investigator to clearly inform potential trial subjects of the compensation that they are entitled to in the event of disability or death which is cause by a research-related injury.
Until January 2013, the compensation in case of injury or death during clinical trial was governed by a notification of the Ministry of Health and Family Welfare dated G.S.R. 821(E) which was notified on November 18, 2011.
Subsequently, draft guidelines were issued in August 2012 with a view to improve on the 2011 notification. Finally, on January 30, 2013, new guidelines were notified vide G.S.R.53(E) which currently govern compensation to be awarded to a subject in case of death or injury during trial. This has been inserted as Rule 122DAB of Drugs and Cosmetics Rules, 1945. It is this notification that appears to give sleepless nights to Contract/Clinical Research organizations (CROs).
According to the Panelists, Sub-rules 1 and 2 of the new Rule 122DAB in particular appear to expand the scope of situations where a clinical trial subject is entitled to compensation even in situations or injuries which are not related to the clinical trial. Following are the relevant provisions:
122DAB. Compensation in case of injury or death during clinical trial:
(1) In the case of an injury occurring to the clinical trial subject, he or she shall be given free medical management as long as required.
(2) In case the injury occurring to the trial subject is related to the clinical trial, such subject shall also be entitled for financial compensation as per order of the Licensing Authority defined under Clause (b) of Rule 21, and the financial compensation will be over and above any expenses incurred on the medical management of the subject.
An initial reading of sub-Rules 1 and 2 of Rule 122DAB clearly suggests that the scope of sub-Rule 1 is wider than that of sub-Rule 2. The former appears to cover any injury suffered by the trial subject, even if such injury is not related to the clinical trial. This could mean that if the trial subject meets with a road accident, the Sponsor of the clinical trial is expected to bear the expenses for life-long medical management of the subject which are incurred to treat such an extraneous injury.
However, sub-Rule 2 states “such subject shall also be entitled for financial compensation.............and the financial compensation will be over and above any expenses incurred on the medical management of the subject”. The use of “also” along with reference to “any expenses incurred on medical management” could mean that the sub-Rule 2 is a continuum from sub-rule 1, and intends to provide for a compensation which is distinct from “free medical management” referred to in sub-rule 1.
Further, a purposive reading of the very object of these Rules could lead one to conclude that these Rules are meant to secure the interest of a trial subject with respect to trial-related injuries, and are not meant to provide him with a carte blanche for extraneous injuries which have no connection whatsoever with the clinical trial. Also, neither the GCP guidelines nor the ICMR guidelines seem to require such broad compensation for non-trial related injuries.
I will continue with a discussion on the notification in the next post. In the meantime, comments and corrections are welcome!