Set up panel to examine unethical pharma marketing practices: SC to Government

The Supreme Court on Thursday directed the Centre to constitute a committee within two weeks to undertake a holistic and comprehensive examination of issues relating to unethical pharmaceutical marketing practices.

The apex court directed that the committee would endeavour to complete the exercise in a time-bound manner and submit its recommendations to the Centre within two months from the date of its first meeting, after duly undertaking the consultative process and considering the material and suggestions placed before it.

A bench of Justices Vikram Nath and Sandeep Mehta passed the order on a plea concerning alleged prevalence of unethical marketing and promotional practices by pharmaceutical companies in their dealings with healthcare professionals.

The petitioners claimed that such practices include direct or indirect monetary benefits, gifts, hospitality, sponsored travel, entertainment and other inducements extended to medical practitioners with a view to influence their drug prescribing practices.

The bench noted that the Centre has proposed to constitute a three-member committee to examine the issue and make recommendations as to the appropriate statutory and regulatory framework for regulating the conduct of pharmaceutical companies.

“In view of the aforesaid discussion, and having regard to the constitutional obligation to protect the right to health as well as the continuing need for an effective and enforceable framework to regulate pharmaceutical marketing practices, we consider it appropriate to exercise our jurisdiction under Articles 32 and 142 of the Constitution,” the bench said.

It said the directions issued by the court are intended to secure effective implementation of the existing framework and to facilitate the ongoing exercise of the Centre towards evolving an appropriate regulatory mechanism.

“The Union of India shall, if not already constituted, constitute the committee proposed by it within a period of two weeks from the date of this order,” it said.

The bench said the committee would undertake a comprehensive examination of all issues relating to unethical pharmaceutical marketing practices, including the adequacy of existing statutory and regulatory framework, the efficacy of mechanisms presently in place for monitoring, oversight and enforcement, and the measures required to ensure greater transparency, accountability and effective compliance.

It said the committee would take into consideration the material already placed on record by the petitioners and the intervenors, and afford them a reasonable opportunity to place before it their respective views, suggestions and concerns.

The bench said the committee would make its recommendations to the Centre regarding appropriate regulatory and/or statutory framework for effectively regulating pharmaceutical marketing practices, keeping in view the need for transparency, accountability and effective enforcement.

It said the committee would be at liberty to seek assistance of such technical, professional and domain experts, institutions or bodies as it may consider necessary, and may obtain such expert inputs as may be required for a proper appreciation of the regulatory, medical, pharmaceutical and other relevant aspects.    

“The Union of India shall, upon receipt of the recommendations of the committee, duly consider the same and take an appropriate and reasoned decision at the earliest, having regard to the constitutional mandate under Article 21 of the Constitution of India and the larger public interest involved in ensuring ethical, transparent and accountable pharmaceutical marketing practices,” it said.

The bench asked the Centre to file a compliance affidavit before it.

It said the issues arising in the proceedings are of considerable public importance and the matter concerns the adequacy of existing statutory and regulatory framework governing pharmaceutical marketing practices and the mechanisms for their implementation, monitoring and enforcement.

“In a sector which has a direct bearing upon the health and well-being of citizens, the efficacy of the regulatory framework cannot be assessed merely by the existence of prescribed norms; it must also be judged by their efficacy, implementation and enforcement,” it said.

The bench said it is necessary to ensure that safeguards incorporated in the regulatory framework are capable of being meaningfully enforced in practice, and that appropriate measures are available to identify, address and prevent violations.

“Such a framework must, ultimately, ensure that the legitimate interests of the pharmaceutical industry are balanced with the paramount consideration of protecting patients and safeguarding the larger public interest in ethical, accessible and affordable healthcare,” it said.

The bench said regulation of pharmaceutical marketing practices entails questions of legislative and executive policy.

It said these matters fall primarily within the domain of the Centre and its authorities. 

It said the court must remain mindful of the doctrine of separation of powers and cannot substitute its own policy determination for that of the executive.

“At the same time, judicial restraint cannot be understood as requiring this court to remain indifferent where the material before it discloses concerns having a direct bearing upon public health and the right to health,” the bench said.

It posted the matter for January 29 for consideration of the compliance affidavit.