TWN Info Service on Intellectual Property Issues (March 10/09)
22 March 2010
Third World Network

Concerns over EU-India FTA’s impact on drugs access

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 India and the developing countries. The following article outlines the problem.

The article is reproduced with permission from South-North Development Monitor SUNS #6883, 15 March 2010.

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Evelyne Hong
TWN

Health: Concerns over EU-India FTA's impact on access to drugs
By Kanaga Raja, Geneva, 12 March 2010

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) is pressuring India to adopt measures that will impact severely on India's ability to produce and export affordable medicines.

According to MSF, the final round of informal talks between the EU and India are reportedly beginning in New Delhi this week, before formal talks take place in Brussels in April.

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, India is the pharmacy of the developing world. So, the impact of this also stretches far beyond India," said MSF Campaigner Leena Menghaney.

"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 India also gives in, access to treatment for people living with HIV/AIDS and other patients will have been sacrificed in the negotiation process," she added.

"This FTA is the latest step in a long attack by the US and the EU to shut down India's generic industry," said Dr Amit Sen Gupta of Jan Swasthya Abhiyan.

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 Europe is pushing such as data exclusivity (which delays the registration of generic medicines), and an extension of the patent term beyond 20 years, are unnecessary under international rules.

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 by forcing India to adopt them in the FTA, said MSF.

(At a meeting of the WTO TRIPS Council last week, both India and Brazil reiterated their concerns over the actions of customs authorities in the European Union member-states in detaining generic medicines whist in transit to other developing countries. Both complained that they have not seen any concrete measures or significant progress to date on the part of the EU in reviewing its related regulation. See SUNS #6877 dated 5 March 2010.)

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 India and the rest of the developing world.

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 India has already signed in the past, some of our newer AIDS medicines are already patented and completely unaffordable," added Gangte.

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 India and cannot be domestically produced because India signed the WTO TRIPS Agreement.

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 India as a source of affordable generic medicines."

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 India.

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 India and beyond. We hope this judicial precedent of safeguarding public health in patent disputes will continue, as matters such as these, and the forthcoming Novartis case go up to the Supreme Court," he added.

Anand Grover, counsel for Cancer Patients Aid Association, was quoted as saying in the MSF press release: "In India, we do not have a patent linkage system. The patent system and the drug regulatory system are two separate and independent mechanisms and this is Parliament's intent."

"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 India, which has been rejected."

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 India's Patents Act.

The pharmaceutical company based in Switzerland has appealed to the Indian Supreme Court, following its loss in a case before the Madras High Court in 2007.

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 India's Patents Act of 2005. The provisions in Section 3 (d) of the Patents Act are aimed at preventing the ever-greening and granting of frivolous patents.

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.)