Health experts raise concerns over price controls, patent law clauses in Indo-US trade deal

Ahead of the likely visit of United States Trade Representative Robert Lighthizer this week, health experts and organisations have flagged their concerns about the potential public health implications of the US-India trade deal in a letter to Prime Minister Narendra Modi.

The concerns centre around two issues—patent laws that will affect the production of affordable generic medicines, and the issue of price controls for medical devices (coronary stents and knee implants) that are a crucial part of the trade deal between the two countries.

“We are concerned with demands of the United States to do away with the price controls on medical devices as part of the ongoing negotiations on US India trade deal. 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,” experts said in a letter.

The letter points to the recent meeting between officials from the department for promotion of industry and internal trade (DPIIT), ministry of commerce and industry, and stakeholders to review India’s existing IP Acts.

“During the meeting, participants from law firms representing their foreign multinational pharmaceutical companies have 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,” the letter stated.

Experts have cited the recent US-China economic and trade agreement where China has agreed to extending the IP protections for medicines and confer longer monopolies, exceeding the international obligations under the Agreement on Trade-Related Aspects of Intellectual Property Right (TRIPS) such as patent term extensions (i.e. extending the duration of a patent beyond 20 years to compensate for delays in granting marketing approval or patents), patent linkage (i.e., linking the marketing approval of generic medicines to the patent status of the drug and denying marketing approval to generics), and heightened enforcement provisions. “Similar demands may be placed on India, too,” they said. “If India accepts the “TRIPS-plus” demands of the US, it would seriously undermine the availability of affordable generic medicines in India and result in pushing more people below the poverty line due to out-of-pocket expenditure on medicines and increased costs of healthcare. Conceding to US demands for “TRIPS-plus” provisions would have a devastating impact on all the national health programs,” they added.

On the issue of doing away with price controls on medical devices and regulating only trade margins, public health experts said such a move will allow companies to fix “very high introductory prices” and compromise access to medical devices. “Your much welcome steps to cap ceiling prices of medical devices like cardiac stents and knee implants made them affordable to the common man, and also checked exploitation of patients by hospitals. The regulation of trade margins in the absence of ceiling price caps will only shift the exploitation of patients from the hospital to the manufacturer,” they said. Even under the current regime of ceiling price caps on cardiac stents, the United States, representing the interests of US-based medical devices companies, has been demanding higher prices for foreign-made stents on the basis of claims of ‘incremental innovation,” they stated in the letter.

Expert committees set up by the government have held that there is no evidence of any superiority linked to better clinical outcomes for any of these stents.