'Protect our medicines, our health, our lives'

The EU-India Summit in February touched off protests by health activists and civil society groups both in India and around the world against the free trade agreement currently being negotiated between these parties. Ranja Sengupta reports.

OVER 1,500 protesters took to the Delhi streets on 10 February, crying 'Europe, hands off our medicine' as they voiced their opposition to the  Bilateral Trade and Investment Agreement (BTIA) that is currently being negotiated between the European Union and India.

The BTIA, or free trade agreement (FTA) in common usage, has been under negotiation since 2007; while voices of analysts, activists and people whose lives will be directly affected have risen in protest, the determination on both sides to reach 'an ambitious agreement' continues unabated. The EU-India Summit, held on 10 February, was to see the culmination of these ambitions, activists feared.

Protesters carried a giant medicine pill through the streets of Central New Delhi, the powerful visual imagery highlighting India's role as the 'pharmacy of the developing world' which faces a severe challenge from the EU's demands to include harmful intellectual property (IP) provisions in the FTA. 'No pyar with IPR' (no love with intellectual property rights), rhymed some of the banners.

Affordable medicines produced in India have played a major role in scaling up HIV treatment to more than 6.6 million people across Asia, Africa and Latin America. By 2008, Indian generic antiretrovirals (ARVs) catered to 65% of total ARV purchases globally and 80% of donor-funded AIDS medicines. According to a 2011 policy brief issued by the Joint UN Programme on HIV/AIDS (UNAIDS), the UN Development Programme (UNDP) and the World Health Organisation (WHO), 'increased availability of sources for generic medicines has drastically reduced the annual price of first-line antiretroviral drugs from over $10,000 per person in 2000 to less than $116 for the cheapest WHO-recommended first-line antiretroviral regimen in the first quarter of 2010, a reduction of nearly 99%'.

The EU has repeatedly asked for IPR commitments that go way beyond India's TRIPS commitments. This, analysts feel, will severely undermine the producing and marketing capabilities of the generic medicine industry in India and will threaten the access to cheap medicines worldwide. In a 10 February press release by several health groups, data exclusivity on medicines, intellectual property enforcement measures and investment protection are cited as some of the most damaging provisions that threaten access to medicines in India and the world. In addition, the EU also wants patent terms to be extended from the current 20 years to 25 years. These provisions stand to further undermine access to medicines, which is already threatened by the current rules of international trade, the release pointed out.

Data exclusivity (DE), a key demand of the EU in this FTA, imposes strict restrictions on the use of trial data submitted by a company, notwithstanding whether a patent is granted to the company or not. In India, marketing regulators refer to such trial data to grant marketing licences to smaller generic companies for similar drugs. But DE, if agreed to, will imply that regulators cannot refer to trial data submitted by the original applicant to grant marketing rights to a generic producer for a certain period of time, usually 5-10 years or slightly more. So generic producers would have to repeat clinical trials and submit their own data if they want to enter the market within this period. This is costly and often unaffordable for small producers and would in effect defer the introduction of cheap generics into the market. This also involves unethical wastage of resources in repeating trials of already established treatment. In Jordan, data exclusivity as a part of the US-Jordan FTA has raised medicine prices by 2 to 6 times, says a 2007 Oxfam study.

IP enforcement is another area of the FTA negotiations where the EU is demanding stringent provisions. According to a brief released by medical charity Medecins Sans Frontieres, the IP enforcement measures 'would widen the scope of actors that could have penalties brought against them and also increase the likelihood that wrongful searches, seizures and legal actions against legitimate suppliers of generic medicines will be carried out'.1 First of all, the proposals in the FTA may extend stringent enforcement measures to cover 'patent infringements' (much more complex and difficult to determine) which were not covered under TRIPS. Second, the EU's proposed text also contains provisions that include third parties, and active pharmaceutical ingredient (API) manufacturers, drug distributors and treatment providers can be exposed to the risk of patent enforcement. The EU wants what are termed 'provisional injunctions', where courts are given powers to issue orders to prevent suspected but not yet proven infringement. Such threat of legal proceedings will deter many third parties from working with generic producers. The proposal also allows the possibility of issuing injunctions and seizing medicines on a mere suspicion or allegation of patent or trademark infringement and goes far beyond the provisions under the TRIPS Agreement. This can work as a major block for generic producers.

Such enforcement mechanisms also cover border measures which apparently establish stringency of IP standards of even goods in transit. This has recently become a highly controversial issue with the EU's repeated seizures of generic medicines which were being transported from India to Brazil and other Third World countries through the Netherlands. The EU's border authorities seized these under EU Regulation 1383/2003 on grounds of 'patent infringement' - a charge strongly refuted by India - even though these were not meant for European citizens.

This case is under dispute settlement at the WTO and Canada, China, Ecuador, Brazil, Japan and Turkey have now joined the consultations.2 India has alleged that 'such measures are inconsistent as such and as applied, with the obligations of the European Union and the Netherlands under Articles V and X of GATT [General Agreement on Tariffs and Trade] 1994 and under various provisions of the TRIPS Agreement, namely, Article 28 read together with Article 2, Articles 41 and 42, and Article 31 read together with the provisions of the August 2003 Decision on TRIPS and Public Health.' But such measures are often provided for in EU FTAs and undermine the supply of genuine and cheap medicines for treatment of critical diseases. The EU is very keen to include such measures under the FTA with India because it will give it considerable control over the movement of India's generic medicines.

Though the Indian government has announced it will not give in to TRIPS-plus demands from the EU, such demands seem to be very much on the table at the FTA negotiations.

Further, the EU also wants market access for its investors and investment protection at very high standards. India currently has bilateral investment treaties (BITs) with 22 EU member countries. Of these, the BIT with Germany offers the highest level of protection for foreign investors. The EU wants this level of protection for all member states under this FTA.

This will allow EU pharmaceutical companies to sue the Indian government in secret arbitration cases in international tribunals for huge sums of money under the investor-to-state clause. In the field of medicines, the definition of 'investment' will also compel the Indian government to recognise IPRs as an investment and therefore protect EU companies' IPRs (including data) under the investment protection clauses. This will erode the government's policy space and deter regulation of aggressive use of such IPRs in the interest of public health and access to medicines. The Uruguay government, for example, has been sued by Philip Morris, the tobacco company, when it tried to bring in legislation to allow more space for pictorial warnings on cigarette packages. In addition, if market access is given to European companies under the investment chapter, they will be free to invest in the Indian pharmaceutical industry without any performance requirements such as the need to incorporate local content in their production, and this will threaten the very existence of the Indian generic pharmaceutical industry.

Summit talks

The EU-India Summit on 10 February was expected to announce some kind of an understanding or perhaps set the broad terms of the FTA. Not surprisingly, protests by patients' groups reached a crescendo on the day. Demonstrations took place not only in Delhi but across the world, in Malaysia, South Korea, Thailand and in several African countries, all of which fear loss of access to crucial and cheap medicine supplies from India. A day earlier, activists had delivered coffins to the office of the European delegation to India.

The patients' groups were joined by farmers' groups from northern India, dairy farmers from south India, small retailers, students and activists from all over, all of whom are severely worried about the impact of this FTA on the lives of ordinary people, including on their access to jobs, incomes, medicines, food, finance and natural resources... - the list seems endless but these concerns seem to be increasingly validated by the numerous reports and analyses pouring in.3

Apart from TRIPS-plus commitments in the IP chapter and a strong investment chapter, provisions in this FTA also include liberalisation of India's goods and services sectors including sensitive sectors like agriculture, retail, banking and key industries such as cars, as well as access to India's government procurement market. The vast multitude of the EU's demands in sensitive segments can severely threaten India's policy space and its development policy instruments. 

During the Summit itself, however, leaders gave out no more than a broadly optimistic statement without going into specifics. India's Prime Minister Manmohan Singh said, 'There are obviously some problems but we are confident that those problems can be resolved and will be resolved. Both of us have reaffirmed our commitment to an agreement as early as possible.' The President of the European Council, Herman Van Rompuy, said the negotiations are going well but also mentioned, 'We value substance over speed.' The European Commission President Jos‚ Manuel Barroso seemed more optimistic and named Autumn 2012 as the target period to seal the deal. Leaders from both sides are now to supervise the negotiations closely so that an early agreement can be reached.

With global consciousness on critical development concerns around this FTA rising rapidly, there is increasing pressure on India and the EU not to make monumental mistakes that will threaten the health of people in India and the world. But in spite of the apparent show of understanding and reassurances, the EU is yet to give any substantial and lasting commitment that the provisions highlighted above will not be included in the FTA. It is clear that the people must continue to voice their strong concerns if the world is not to be deprived of affordable medicines. If global society does not play its role in protesting against such provisions, then in this labyrinth of shadowy deals and aggressive bargaining, the patients' voice may be lost forever.                       

Ranja Sengupta is a senior researcher with the Third World Network.

Endnotes

1 http://www.msfaccess.org/sites/default/files/MSF_assets/Access/Docs/Access_Briefing_FTAEnfor

      cementProvisions_ENG_2012.pdf

2 The EU has recently offered a settlement and India and the EU have reached an 'understanding' and the EU has confirmed the detailed principles agreed in the understanding to guide border enforcement of intellectual property in the EU. The European Commission has also adopted a proposal for a new Regulation to replace Regulation 1383/2003 but India has not yet withdrawn the WTO case without making sure what the impacts of such legal changes will be. In any case, even after this 'understanding' Indian drugs were seized again by the EU.

3 For some of these, see http://www.bilaterals.org and http://donttradeourlivesaway.wordpress.com/

*Third World Resurgence No. 259, March 2012, pp 20-22