Shri Narendra Modi
Hon’ble Prime Minister of India
South Block, Raisina Hill
New Delhi 110011
6 February, 2020
Dear Prime Minister Shri Narendra Modi ji,
Concerns regarding review of India’s intellectual property Acts and access to affordable medical devices, in the context of the US -India Trade Deal
The undersigned organisations and experts working on access to healthcare and medicines are writing to share our concerns regarding the proposed US-India trade deal and its potential implications for public health in India. This is further to our letter sent on 20 September 2019.
In particular, 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. In this regard, we note that the Department for Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce and Industry, 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 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 etc.
The recently announced US-China economic and trade agreement requires China to provide for measures that will result in extending the IP protections for medicines and confer longer monopolies, which exceed 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. Because India does not provide for data exclusivity in its laws, the US could even ask for data exclusivity to be adopted.
News reports have suggested that the mini trade deal is a precursor to an FTA between the US and India. The United States has been the biggest critique of the public-health friendly provisions enshrined in the Indian IP laws and had, in the past, threatened India with serious consequences for the Government’s act of granting a compulsory license for sorafenib, a kidney cancer drug. We urge that if India accepts the “TRIPS-plus” demands of the USA, 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.
Another demand of the US is to do away with the price controls on medical devices and regulate only trade margins. Such a move will allow the 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.
In fact, trade margin rationalisation is a much weaker form of regulation that if applied in the absence of price caps will leave retail prices unchecked, will not correct serious market distortion in medical devices and exclude manufacturers and importers from the ambit of regulation. The attempt to secure trade margin rationalisation is a backdoor attempt to neutralize the price caps, which remain simply the most effective way to make critical medical devices accessible to patients.
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’. In fact it has repeatedly been held by the Government’s Expert committees that there is no evidence of any superiority linked to better clinical outcomes for any of these stents
There is no precedent of India negotiating price control policies in trade and it is critical that policies meant to protect public health are kept outside the purview of trade agreements.
Therefore, we call upon you to uphold Gandhi ji’s Talisman and consider the concerns of teeming millions of ordinary people in India, as you did in the case of RCEP and reject the United States’ demands for India to adopt “TRIPS-plus” intellectual property provisions and to do away with the price caps on medical devices.
Sincerely,
Prathibha Sivasubramanian
Campaign for Access to Medicines-India
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Jan Swasthya Abhiyan (JSA) is the Indian Chapter of the People’s Health
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