[Ip-health] Letter to the PM : Don’t sign on to intellectual property provisions in the India-EU FTA

prathibha siva prathibha.siva at gmail.com
Wed Oct 13 05:42:00 PDT 2010

From: "napn" <napn at wlink.com.np>

Date: October 13, 2010 12:34:14 GMT+05:45

To: "'basantachettri'" <basantachettri at yahoo.com>

Subject: letter to indian embassy

13 / 10 2010

Don’t sign on to intellectual property provisions in the India-EU FTA


His Excellency Mr. Rakesh Sood


Embassy of the Republic of India

336 Kapurdhara Marg, Kathmandu, Nepal


Dr. Manmohan Singh

Hon’ble Prime Minister of India

The Prime Minister’s Office

South Block, Raisina Hill

New Delhi, India-110 011

Tel: 91-11-23012312

Fax: 91-11-23016857

New Delhi, September 28, 2010

Re: India’s central role in medicines supply is under threat

Dear Prime Minister,

We are writing on behalf of patient groups, people living with HIV (PLHIV)
networks, HIV & public health organizations, medical organizations, public
interest groups and individuals, to express our concerns before the next
round of negotiations on the EU-India bilateral free trade and investment
agreement (FTA), which is 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 and concludes
that about four million people started treatment between 2003 and 2008,
largely due to India’s ability to produce low cost quality medicines. The
report documents that Indian generic producers supplied the majority of ARVs
in developing countries. Indian-produced generic antiretrovirals (AIDS
drugs) comprised 87 per cent of ARV purchase volumes and accounted for 91
per cent of pediatric ARV volumes in 2008. The report raises the concern
that trade agreements being currently discussed may further reduce India’s
vital role as provider of life-saving treatments1.

We are therefore concerned 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 Union (EU) – will further restrict
this access. If India signs up to the IP clauses demanded by the EU, which
go significantly beyond TRIPS standards (TRIPS Plus), it will further reduce
the country’s ability to provide affordable 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. The EU is also using the
FTA negotiations with India to pursue ‘TRIPS Plus’ IP provisions and
enforcement rules that will hinder the production and flow of life-saving
generic medicines.

Issues of Concern in EU-India FTA that could affect access to medicines:-
Patent term extension known as “Supplementary Protection Certificates” in
the negotiations, is a straightforward way to extend a pharmaceutical
company’s monopoly by extending the patent life on a medicine

beyond 20 years. If India accepts this clause, the years added to the patent
in India are extra years in which the company 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 drug regulatory authority (Drug
Controller General of India). If India accepts this clause, India’s drug
regulator 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 may not pass the scrutiny of ethical
committees, making it difficult 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.

A study on the impact of data exclusivity in Jordan found that of 103
medicines registered and launched since 2001 that currently have no patent
protection in Jordan, at least 79 per cent have  no competition from a
generic equivalent as a consequence of data exclusivity.2 Data exclusivity
in Jordan was introduced as a result of the US-Jordan FTA.

Intellectual property enforcement provisions include a number of different
measures (criminal sanctions for IPR infringement, evidence, injunctions
etc.) that 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. In
addition, the impact of border enforcement measures is clear from the
seizure of generic medicines by the EU that were on their way from India to
Africa and Latin America.

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 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 so
called “expropriation”. Even labeling requirements in the interests of
public health can be questioned under such provisions as a recent investment
dispute3 filed by Phillip Morris, the tobacco company against Uruguay
demonstrates. Philip Morris has alleged that Uruguay’s requirement to
increase the size of pictorial warnings of the effects of tobacco on
cigarette packets violate their trademark rights. A clear example of how
companies can use a bilateral investment treaty to challenge government
decisions related to public health on grounds of IP infringement.

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 call upon India to NOT TRADE AWAY OUR LIVES and right to health in the
name of another trade agreement. 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

Best Regards

 Rajiv Kafle


National Association of People Living with HIV in Nepal

Tel: 4373910, 9803862107

 In solidarity,
Prathibha Sivasubramanian

Prathibha Sivasubramanian

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