The Department of Pharmaceuticals (DoP) has started discussions with the stakeholders to garner views on various compulsory licensing provisions under the intellectual property laws, after the Department of Industrial Policy and Promotion (DIPP) released the discussion paper sometime back.

The DoP officials recently met the leading pharmaceutical organisations and a couple NGOs to gather their views on the issue after the DIPP circulated the discussion paper among the concerned departments for feedback. DoP sought the views of the stakeholders through detailed representations and met each organisation separately.

“The mandate of the DoP is to collect and compile the views of the stakeholders related to pharma and submit to the DIPP. We are doing that and the comments of the department will also be forwarded along with that,” sources said, without specifying more about the issue.

“The task of the Department is to make available quality medicines at reasonable prices to the masses. In order to see how this mandate could be fulfilled through the issue of compulsory license under the Patent Act, the meeting with the stakeholders was held,” sources said.

Leading associations like IDMA, IPA, FICCI, FOPE and NGOs like Medicins Sans Frontieres (MSF) reportedly submitted their views, a mixed bag of responses, on the CL provisions. The Department officials, without conveying DoP stand or committing specifically on any point, told the stakeholders that it would forward them to the DIPP.

The DIPP had come out with the paper in the backdrop of increasing acquisition of domestic pharmaceutical companies by foreign players and the concerns expressed by the Parliamentary panel on health over the availability of life-saving medicines at affordable prices in its report sometime back. DIPP sought the views of the stakeholders to know if new guidelines were necessary with regard to the CL provisions.

The paper mainly dealt on points like should CL provisions be confined to public health emergencies, should government be sole distributor of drugs made under the CL provisions, whether CLs can be issued on the basis of anti-competition law, and what should be the royalty payments to compensate for CL. Using CL, the government can allow third parties (other than the patent holder) to produce and market a patented product or process without the consent of the patent owner.