[Ip-health] Public health groups and experts write to PM over concerns with the US-India trade deal

prathibha sivasubramanian psa2m2020 at gmail.com
Fri Feb 7 21:04:48 PST 2020


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



*Endorsements:*

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,
www.accessibsa.org

Ms Indira Chakravarthi, Public Health Researcher, Delhi

Ms Mafruza Sultana, PhD candidate, South Asian University New Delh

Mr Prabhat Kumar Saha, Assistant Professor, Law School, Banaras Hindu
University



*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



*For further information, contact:*

Prathibha Sivasubramanian, 9968050357, pratsa2m007[at]gmail[dot]com
<pratsa2m007 at gmail.com>

Malini Aisola, 7838381185, malini.aisola[at]gmail[dot]com
<malini.aisola at gmail.com>
Attachments area

-- 
Jan Swasthya Abhiyan (JSA) is the Indian Chapter of the People's Health
Movement. JSA brings together organisations and individuals in India
working to promote health equity across all population groups. Also visit
our website: www.phmindia.org
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