NGOs Ask Govt To Reject US’ Demand To Adopt
“TRIPS-Plus” IP Provisions And To Do Away With Price Caps On Medical Devices
A large number of NGOs working in the health and related
fields in the country have demanded to the Indian government to reject the
United States’ demands for India to adopt “TRIPSplus” intellectual property
provisions and to do away with the price caps on medical devices.
In a letter to Prime Minister Narendra Modi, these NGOs have
stated that they 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 NGOs said.
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 “TRIPSplus” 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-ofpocket 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 said.
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
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 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, the