Concerned about the US push to do away with price controls for medical devices and drugs, up to 30 academics and researchers have written an open letter to Prime Minister Narendra Modi, ahead of a possible Indo-US trade deal, stating that this will be detrimental to the rights of the patients.

“We are also apprehensive of the US pressure on India, which has been exerted continuously and will surely intensify following the deal, for increased intellectual property (IP) protections through amendments to the IP Acts. There is no precedent of India negotiating price control polices in trade and it is critical that polices meant to protect public health are kept outside the purview of trade agreements,” the letter stated.

The Department of Promotion of Industry and Internal Trade (DPIIT) recently held a meeting with stakeholders to review India’s existing IP Acts.

“During the meeting, participants from law firms representing their foreign multinational pharmaceutical companies insisted on removing public interest safeguards in the Patents Act such as provisions restricting the scope of patentability, local working as a ground for granting of a compulsory license, pre-grant oppositions etc,” the letter further stated.

Experts have stressed that India may be going the China way if it bows down to US demands. The recently-announced US-China economic and trade agreement requires China to provide for measures that will result in extending IP protections for medicines and confer longer monopolies, such extending duration of a patent beyond 20 years to compensate for delays in granting marketing approvals or patents) and so on.

“Similar demands may be placed on India,” said Prathibha Sivasubramanian of the Campaign for Access to Medicines – India.

From repeated pushes to do away with price control on cardiac stents to threatening the government with serious consequences for granting of compulsory license for Sorafenib (a kidney cancer drug), the US has been very critical of India’s public-health friendly IP provisions.

The government can invoke a compulsory license and ask a brand which holds patents to share it with generic companies to afford production of larger quantities of the life-saving drugs at cheaper rates.

The US is also urging India to do away with price controls and regulate only trade margins. “Such a move will allow the companies to fix very high introductory prices. Your welcome steps to cap ceiling prices of cardiac stents and knee implants checked exploitation of patients by hospitals. The regulation of trade margins in the absence of ceiling price caps will shift exploitation of patients from the hospital to the manufacturer,” Sivasubramanian adds.

Rajiv Nath, Forum Co-ordinator for Association of Indian Medical Device Industry (AiMeD), said, “We agree that healthcare delivery policy discussions are an internal matter of a sovereign nation whether the US or India and should not be part of any bilateral trade discussions.”

“Price caps are needed as an over rider on an initial consumer protection safety net of trade margins capping over the import landed prices or Indian manufacturers’ Ex-Factory price (on which GST is applied for the first time as they enter the supply chain). Businesses need profits to grow and serve their clients adequately but profiteering is a no-no in healthcare delivery. At AiMeD we encourage our members to manufacture responsibly,” Nath said.

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