TWN Info Service on WTO and Trade Issues (March
Concerns over EU-India FTA’s impact on drugs
Health organisations have voiced their concerns
over negotiations between India and the European Union towards a bilateral
free trade agreement which if signed threatens to impose even higher
standards of intellectual property protection above and beyond the provisions
required under the WTO agreement on Trade Related aspects of Intellectual
Property Rights (TRIPS). This could further restrict access to life
saving drugs in
With best wishes
Health: Concerns over EU-India FTA's impact
on access to drugs
Serious concerns have been voiced by non-governmental organizations this week over the negotiations on a bilateral free trade agreement (FTA) between the 27-member European Union and India, which if signed, "could further compromise access to life-saving medicines" in India and elsewhere in the developing world.
According to the international medical humanitarian
organization Medecins Sans Frontieres (MSF), the European Union (EU)
According to MSF, the final round of informal
talks between the EU and
The EU has said that it wants to conclude the FTA negotiations ahead of the EU-India summit scheduled for October 2010.
In a media release Friday, MSF said that people living with HIV/AIDS are protesting to ensure that Indian negotiators do not give in to pressure to accept terms that will seriously hamper access to medicines for millions of people living in the developing world.
"As the source of 92% of the AIDS medicines
used in developing countries today,
"In recent free trade agreements signed with
the EU or the US, developing countries agreed to introduce very strict
intellectual property rules that drastically restrict [the] ability
to produce or trade in affordable generic medicines. If
"This FTA is the latest step in a long attack
According to MSF, in 2005, in order to comply with international trade rules (under the WTO TRIPS Agreement), India was obliged to grant patents on medicines, but the country also introduced measures to protect public health and limit abusive patenting.
But the bilateral trade agreement negotiated with the EU now threatens to impose even higher standards of intellectual property protection, enabling companies to maintain prohibitively high prices on medicines.
MSF pointed out that specific measures that
In addition, after multiple incidents of seizing
Indian generic medicines in transit to other developing countries in
Latin America and Africa, the EU is now seeking to legitimize such measures
(At a meeting of the WTO TRIPS Council last week,
On Friday, MSF sent a letter to Indian Prime Minister
Dr Manmohan Singh, in which it voiced concern that the EU-India FTA
may contain provisions that further restrict access to medicines in
Such provisions will have drastic consequences with regard to access to medicines, said the letter, pointing out that these provisions will strengthen and extend the monopoly rights of multinational pharmaceutical manufacturers at the expense of patients in India and beyond.
More specifically, said the letter, these provisions will seek to limit, and in some cases, completely block, what remains of generic competition. Generic competition has proven to be key in lowering the prices of medicines, thereby improving access to medicines, the letter added.
The MSF letter urged the Indian premier to reject any intellectual property proposals that go beyond the requirements of the TRIPS Agreement.
"We are marching to call on the Indian government not to trade away our lives," said Loon Gangte, president of the Delhi Network of Positive People (DNP+).
"Lifelong treatment for people living with
HIV depends on continued access to newer AIDS medicines. Because of
international trade rules that
DNP+ is an Indian support group for people living with HIV/AIDS.
On 10 March, DNP+ sent a letter to Members of the Indian Parliament, expressing alarm that the government "is trading away our lives and right to health", in the name of a free trade agreement to be signed before the end of 2010.
As patients relying on life-long treatment, the group representing people living with HIV/AIDS said that it was intimately familiar with provisions on intellectual property in such trade agreements and their impact on access to treatment.
The letter noted that new AIDS medicines have
been patented in
According to the letter, the EU is trying hard in every forum to increase intellectual property standards that will benefit European pharmaceutical companies but will have a grave impact on the domestic production of medicines and ultimately, access to medicines.
"The Indian government will be trading away our lives by agreeing to the EU's demands on intellectual property and enforcement in FTA negotiations," the letter warned.
The group also complained to the Parliamentarians about the lack of public debate or consultation with the people most affected.
In its letter, the group said that it has been asking the Indian government since 2008 to be transparent in these negotiations. "However, there has been no answer from the government."
"It is not only our lives that are at stake
but those of millions around the developing world in Asia, Africa and
Latin America that rely on
Noting that the Indian Parliament since 2005 has
secured a space for access to affordable medicines by ensuring that
the right to health is predominant over multinational companies' profits,
the letter said that yet, the India-EU FTA is now undermining everything
that the Indian Parliament has done to ensure access to medicines in
The FTA is a binding legal obligation that the government is signing without any discussions or permission from Parliament, said the letter, adding that while the European Parliament is heavily involved in these negotiations and are discussing them, Indian MPs have been bypassed by the government.
The letter called on the Members of Parliament to immediately ask the Indian government to stop all FTA negotiations until there is public consultation. No FTAs are to be signed without Parliament and State Legislatures' approval.
The letter further called for the immediate release of all information, studies and negotiations on all FTAs by the government.
Meanwhile, in a related development, MSF earlier on 9 February welcomed a decision by the Delhi High Court to reject an appeal filed by Bayer Corporation, a German pharmaceutical company, against an earlier court order that had rejected the implementation of a drug regulatory system that essentially linked registration of medicines to their patent status.
According to MSF in a press release issued following the ruling, the Delhi High Court had in August 2009 rejected a petition filed by Bayer aimed at stopping the Drug Controller General of India (DCGI) from granting marketing approval to a generic version of an anti-cancer drug (sorafenib tosylate) patented by the multinational.
Explaining the concept of "patent linkage", MSF said that Bayer was seeking to ensure that the Indian drug regulatory authorities did not start the registration process of a drug, if it was covered by a patent and the patent-holder did not consent.
MSF pointed out that the role of a drug regulatory authority is to ensure that medicines marketed in a country are of quality, and are safe and effective, and not to deal with the patent status of the medicines, which is the role of a country's patent office.
"We are delighted with this decision - at the moment in India, we are seeing a number of multinational pharmaceutical companies trying to use litigation to stifle generic competition," the MSF press release of 9 February quoted Dr. Tido von Schoen-Angerer of MSF's Campaign for Access to Essential Medicines as saying.
"By rejecting Bayer's attempts to introduce
patent linkage, the Indian courts have ensured that public health safeguards
like compulsory licensing can be used to open up generic production
of life-saving medicines including antiretrovirals for millions in
Anand Grover, counsel for Cancer Patients Aid
Association, was quoted as saying in the MSF press release: "In
"We hope that Bayer and other pharmaceutical
companies respect this fact. A patent holder cannot use the DCGI, a
government agency, to enforce its private rights. This was an attempt
to introduce a TRIPS-plus requirement in
Noting that the Bayer case is the second case
that has been brought by pharmaceutical companies against the Indian
government in an attempt to enforce greater patent protection in the
country, MSF also pointed to a separate case where Novartis is challenging
another public health safeguard in
The pharmaceutical company based in
In what was viewed as a landmark ruling, the Madras
High Court in August 2007 dismissed a petition filed by Novartis challenging
the constitutional validity of Section 3 (d) of
In dismissing the petition, the High Court held that it was not the proper forum to decide whether the Act was in compliance or not with the WTO TRIPS Agreement, and deferred to the World Trade Organization to decide on the matter. (See SUNS #6308 and #6310, dated 7 August 2007 and 9 August 2007.)