Need your signature: Letter to Indian Prime Minister: Don't Trade Away or Lives

[Guest guest]

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@... and Leena Menghaney at

leenamenghaney@... 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+)

e-mail: <dnpplus@...>

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: 91-11-23012312.

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

Nikhil Gurung,

AAVASH SAMUHA,

Nepal Bijay Pandey,

Youth Vision,

Nepal Syaiful Brasila,

PKNK (South Kalimantan of PUD), Indonesia

Cawthorne, MSF Access Campaign, Thailand

Rajesh Khongbantabam, ANPUD

Asian people's Alliance for Combating HIV & AIDS (APACHA)