In good news for patients, the government has set up an expert panel to frame rules for compensation in case of an adverse event due to a faulty or unsafe medical device. Health ministry’s apex panel — Drugs Technical Advisory Board (DTAB) — has cleared formation of the sub-committee to amend Medical Devices Rules, 2017, to include provisions for compensation on the grounds of a malfunction in the device, or it being unsafe or non-compliant. This would help plug a loophole in the rules, as under the existing dispensation, the government initially found itself helpless in handling the Johnson & Johnson hip implant case. However, it may be noted that the proposed rules will cover all future cases of negligence in medical devices sector, and not the ongoing J&J case. J&J recently legally challenged government’s compensation formula, with patients also expressing their concerns regarding the lack of transparency.
The development assumes significance as it would be the first such law which would provide teeth to the government to prosecute medical device companies in case of an adverse event or death. The proposed amendments will help cases filed on the grounds of negligence and have been languishing in consumer courts. The DTAB, in its recent meeting, had recommended constitution of a sub-committee to be headed by Directorate General of Health Services principal consultant BD Athani, official sources told TOI. The 10-member panel has representation from medical devices industry (Rajiv Nath from Aimed and Pavan Choudary MTal), consumers (Bejon Misra), and doctors (Rajesh Malhotra and Ramesh Chander), besides the regulators. The chairperson has the option of including experts from relevant field if required, they added.
The decision to bring in separate rules has been taken to simplify the legal process, cut down time and multiple stages. A case of an adverse event due to a medical implant is difficult to prove in the existing system and lacks clarity in law, experts said earlier. It may be pointed out that the expert committee headed by Dr Arun Agarwal, formed by Union ministry of health, to study the issue of faulty J&J hip implants also recommended including the provision relating to compensation. The need for a legal provision for compensation is especially important for India with its socio-economic demographics, which may not have the strength to fight against powerful corporates in courts, sources said. The compensation will have to be given in the case where an adverse event or death is reported only for already approved devices, and not those which are under clinical trials. – TOI