Appeal to sign on letter to Indian PMO on India-EU FTA
DNP+ | 20 September 2010
Appeal to sign on letter to the Indian PMO - India EU FTA negotiations can affect access to medicines
In the coming weeks India and European Commission are negotiating on the
provisions of a free trade agreement between the two countries. While the
chief negotiators will meet on 23rd September, key negotiations on IP will
be held in New Delhi in the first week of October.
European Commission has placed before India as part of the Intellectual
Property chapter TRIPS Plus provisions such as data exclusivity, patent term
extensions in addition to ACTA like IP enforcement provisions (injunctions,
third party liability, criminal remedies, damages, border measures). These
provisions if accepted by India will further undermine generic production
and supply of essential medicines to developing countries.
We request organizations and individuals across the world to join Delhi
Network of Positive People in a sign on letter to issue a appeal to the
Indian government to ’not sign on’ to any IP provisions in the FTA
negotiations. TO NOT TRADE AWAY OUR LIVES!
If you want to join the sign on letter, send your name, organization and
country to: Vikas Ahuja, DNP+ at vikas2contact@gmail.com and Leena Menghaney
at leenamenghaney@gmail.com by the 25th of September. THE LETTER IS COPIED
BELOW FOR YOUR REFERENCE.
In solidarity,
Loon Gangte & Vikas Ahuja
Delhi Network of Positive People (DNP+)
SIGN ON LETTER TO INDIAN PRIME MINISTER
Dr. Manmohan Singh
Hon’ble Prime Minister of India
The Prime Minister’s Office
South Block, Raisina Hill
New Delhi, India-110 011
Telephone: .
Fax: 91-11-23019545 / 91-11-23016857
New Delhi, October 1, 2010
Re: India’s central role in medicines supply is under threat Don’t sign on
to intellectual property provisions in the India-EU FTA
Dear Prime Minister,
We are writing on behalf of patient groups, of people living with HIV
(PLHIV) networks, HIV & public health organisations, medical organisations,
public interest NGOs and concerned individuals to express our concerns
before the next round of negotiations between India and the European Union
(EU) in the name of a bilateral free trade and investment agreement (FTA) to
be signed before the end of 2010.
India plays a key role in producing, registering and supplying essential
medicines - not only for Indian patients, but to all developing countries. A
study published recently in the International AIDS Society journal - "A
lifeline to treatment: the role of Indian generic manufacturers in supplying
antiretroviral medicines to developing countries," highlights the central
role that India’s generic production plays in AIDS treatment, concluding
that Indian generic manufacturers have supplied more than 80% of
donor-funded AIDS medicines to developing countries in the last seven years
.
We are alarmed that the Indian government may accept intellectual property
(IP) provisions that will undermine the production, registration and
worldwide availability of essential generic medicines.
This is not the first time. India through a series of legal amendments in
the last decade has already enforced the requirements for intellectual
property protection under international law. The TRIPS agreement - which has
bound India to introduce a product patent regime in 2005 - has already begun
to curtail the country’s ability to produce low-cost generic versions of
newer HIV, hepatitis and cancer medicines. Because India signed the TRIPS
Agreement, some new essential medicines have already been patented in India
and cannot be domestically produced, leaving patients in India and across
the developing world without access to affordable versions of these
medicines.
Trade agreements being currently discussed — particularly the one with the
European Commission — will further restrict this access. If India signs up
to the IP clauses therein which go significantly beyond TRIPS standards, it
will further reduce the country’s vital role as provider of essential
medicines.
As you know, the EU is trying hard in every forum to increase IP standards
that will benefit European pharmaceutical companies but will have a grave
impact on generic production and supply of medicines and ultimately access
to medicines for patients in the developing world.
Issues of Concern in EU India FTA that could affect access to medicines -
The EC is using these bilateral trade and investment agreement negotiations
with India to pursue IP provisions that goes significantly beyond the TRIPS
standards ("TRIPS-plus").
Patent term extension known as Supplementary Protection Certificates in the
negotiations is a straight-forward way to extend a pharmaceutical company’s
monopoly by extending the life patent on a medicine beyond 20 years. The
extra years added to the patent are extra years in which the patent holder
can maintain a monopoly position and continue to charge artificially high
prices for the drug, free from generic competition.
Exclusive rights over pharmaceutical test data (so called "data
exclusivity") figures prominently in the negotiations. The current text of
the IP chapter on pharmaceutical test data as proposed by the EU to India
essentially requires that India amend its drug regulatory legislation in a
manner that will not permit the placing of a generic pharmaceutical product
on the market if the originator has submitted any clinical trial data
relating to the medicine to the Indian DRA (Drug Controller General of
India).
If India accepts this clause, the DCGI will be legally prohibited from
registering a generic medicine as long as the exclusivity lasts over the
trial data (usually several years). Generic producers will have to submit
their own safety and efficacy data to register the generic. This will oblige
generic companies to repeat clinical and pre-clinical trials. The repetition
of trials raises grave ethical issues, as it would require withholding safe
and effective medicines from some patients (the control group), solely for
the purpose of proving something that is already known. This will not pass
the scrutiny of ethical committees, making it impossible for generic
companies to repeat the clinical trials. In addition, repetition of clinical
trials will take time and involve costs that the generic producers usually
cannot afford.
Intellectual property enforcement provisions include a number of different
measures (border measures, criminal sanctions for IPR infringement etc.) and
attempt to govern the way the disputes around patents and civil trademark
infringements will be managed by Indian courts. If India signs up to these
clauses, the Indian judiciary will have its hands tied and will no longer be
able to balance IP rights with the right to health of patients.
The investment chapter extends the definition of investment to include
intellectual property. If accepted by India, multinational drug companies
would then have the standing to sue the Indian government potentially in a
bid to block sovereign actions like compulsory licensing, price control and
regulation. It is critical to remove IP from the definition of investment so
that both the use of compulsory licensing, price regulation, as well as
refusal to provide exclusive rights over test data (data exclusivity) cannot
be linked to either the definition of investment or factored in the
consequences of expropriation.
Accepting the IP provisions will benefit European pharmaceutical companies -
but they will have a grave impact on generic production of medicines and
ultimately access to medicines for patients in the developing world. The
Indian government will be trading away our lives by agreeing to the EU’s
demands on intellectual property and enforcement in FTA negotiations.
We request India to not TRADE AWAY OUR LIVES and right to health in the name
of another trade agreement to be signed before the end of 2010.
As the Prime Minister of India, we urge you to refuse the IP provisions
outlined above. We request you to ensure that generic competition remains
possible in India. So many lives depend on it worldwide.
Signed by:
Delhi Network of Positive People (DNP+)
LOCOST (Low Cost Standard Therapeutics), India Medico Friends Circle (MFC),
India Drug Action Forum - Karnataka, India All India Drug Action Network
(AIDAN, India Nikhil Gurung, AAVASH SAMUHA, Nepal Bijay Pandey, Youth
Vision, Nepal Syaiful Brasila, PKNK (South Kalimantan of PUD), Indonesia
Paul Cawthorne, MSF Access Campaign, Thailand Rajesh Khongbantabam, ANPUD
