Concerns regarding review of India’s intellectual property Acts and access to affordable medical devices, in the context of the US -India Trade Deal

Letter to the Prime Minister of India from organisations and experts working on access to healthcare and medicines

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.


Prathibha Sivasubramanian
Campaign for Access to Medicines-India

Campaign for Access to Medicines-India
All India Drug Action Network (AIDAN)
Initiative for Health & Equity in Society (IHES)
International Treatment Preparedness Coalition, South Asia
Delhi Network of Positive People
Lawyers Collective
Cure SMA Foundation of India
Dr. Subodh Sharan Gupta, Public Health Expert
Ms. Surbhi Shrivastava
Prof Dr Biswajit Dhar, JNU
Dr. Mira Shiva (Public Health Physician)
Dr. Mohan Rao, former professor, Centre of Social Medicine and Community
Health, JNU, New Delhi.
Dr. Amar Jesani, Independent Researcher and Teacher (Bioethics, Public
Health, Mumbai
Mr. Vinay Kumar Jha, Independent Researcher, Jharkhand
Mr. Nachiket Udupa, Concerned Indian
Ms. Kapila Gureja, Activist
Ms. Shirin Syed, IP Faculty, North Maharashtra University
Ms. Lakshmi Menon, Research Scholar, IUCIPR
Dr. Gopal Dabade, President, Drug Action Forum-Karnatak
Dr. Prashanth N S, Public health researcher, Bangalore (India)
Ms Vikash Prakash, Ekjut, India
Dr. Shakeel, CHARM
Mr. Ganesh Acharya TB ACTIVIST Mumbai.
Mr. Reji K. Joseph, Associate Professor, ISID.
Mr. Rupal Panchal, Advocacy for Rare Genetic Disease
Dr. Srividhya Ragavan, Professor of Law, Texas A&M University School of Law
Dr. Kriti Shukla, Public Health Activist
Mr. Achal Prabhala, Coordinator of the AccessIBSA project,
Ms Indira Chakravarthi, Public Health Researcher, Delhi
Ms Mafruza Sultana, PhD candidate, South Asian University New Delhi
Mr Prabhat Kumar Saha, Assistant Professor, Law School, Banaras Hindu

Copy to
Shri D. V. Sadananda Gowda, Minister of Chemicals and Fertilizers
Dr. Harsh Vardhan, Hon’ble Minister, Ministry of Health and Family Welfare
Shri Piyush Goyal, Hon’ble Minister, Ministry of Commerce and Industry
Dr. Subrahmanyam Jaishankar, Hon’ble Minister, Ministry of External Affairs
Dr. P K Mishra, Principal Secretary to Prime Minister, PMO
Shri P. K. Sinha, Principal Advisor to Prime Minister, PMO
Dr. P. D. Vaghela, Secretary, DOP, Ministry of Chemicals and Fertilizers
Smt. Preeti Sudan, Secretary, Ministry of Health and Family Welfare
Dr. Anup Wadhawan, Commerce Secretary, Ministry of Commerce and Industry
Shri Vijay Gokhle, Foreign Secretary, Ministry of External Affairs
Smt. Shubhra Singh, Chairperson, NPPA, Ministry of Chemicals and Fertilizers

Jan Swasthya Abhiyan (JSA) is the Indian Chapter of the People’s Health

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