European Commission must stop attacking generic medicines, says ITPC

International Treatment Preparedness GroupDec 8 2010

European Commission must stop attacking generic medicines that are the lifeline of millions around the world

On International Human Rights Day, as the European Commission (EC) and the Government of India meet in Brussels to finalise a European Union (EU)-India free trade agreement, the International Treatment Preparedness Coalition (ITPC) calls on Indian negotiators to put the right to health of its citizens and of the fifteen million HIV-positive people worldwide needing treatment above the pharmaceutical companies' interests and profits. ITPC calls on all parties at the negotiating table to preserve and protect India's ability to produce and export affordable generic drugs that are the only HIV treatment option for millions of women, men and children.

"If India's ability to produce and export low cost generic drugs is curtailed, millions of people already developing resistance to current treatment will not have access to newer drug options that would be necessary to extend their lives," said Sarah Zaidi, Executive Director of the International Treatment Preparedness Coalition (ITPC).

"You may trade anything in this world, but you may NOT trade away our lives for intellectual property and profit," said Loon Gangte, representing International Treatment Preparedness Coalition (ITPC) and Delhi Network of Positive People (DNP+). "We will not be meek spectators when our lives are at stake."

Over the past decade, the price of antiretroviral treatment in developing countries has decreased from over US$10,000 per year to about US$70 per year.

Lower priced generic drugs have allowed for greatly expanded access to HIV treatment in low- and middle-income countries. Today, more than five million people around the world (but only a third of those in need) are receiving lifesaving HIV drugs, almost 80 percent of which are manufactured by Indian generic producers.

"Even as global leaders speak of scaling up access to HIV treatment and averting needless death, their economic policies, funding cut-backs and trade agreements tighten the noose on access to treatment and public health protections," Zaidi added.

ITPC's members around the world, many of whom rely on the generic HIV drugs, have joined Indian activists to call on the EC and the government of India to uphold the spirit of the 2001 Doha Declaration of the World Trade Organization (WTO) which supports the "rights of WTO Members' to take measures to protect public health and in particular to promote access to medicines for all".

"We call upon the heads of the World Health Organization, UNAIDS, the Global Fund to Fight AIDS, Malaria and Tuberculosis to join us and speak out for our right to health and make unequivocal public statements to support India's generic ARV production," said Rose Kaberia of the East African Treatment Access Movement (EATAM). "Around the world, thousands of HIV treatment activists and health campaigners are alive today because of the availability of cheap generic ARVs. This movement is speaking out for our right to live."

In May 2010, in response to campaigns by pressure groups including MSF's "Hand Off Our Meds" initiative, the European Commission stated that they are "fully committed to ensuring that people in the world's poorest countries can access affordable medicines" and indicated that nothing in the agreement would limit India's freedom to produce and export life-saving medicines. However, little information about the state of the agreement been provided to the Indian public, the Parliament or state governments.

Leaked texts of the negotiating documents moreover show that there is little cause for comfort with the EC's statements. The current working text of the agreement still contain clauses on intellectual property protection that go beyond India's obligations under the WTO TRIPS Agreement (Trade-related Aspects of Intellectual Property Rights). These clauses include: delaying the registration of generic medicines through 'data exclusivity'; stricter enforcement of intellectual property rules; and stopping of generic medicines in transit through customs regulations.

The European Commission is pursuing free trade agreements with similar provisions on intellectual property in other countries around the world including Malaysia, Indonesia, Thailand and the Philippines. ITPC is greatly concerned that apart from targeting countries like India that produce safe, effective and affordable generic medicines, the EC is also targeting the ability of other developing countries to import generic medicines or make these medicines themselves. ITPC calls on the EC to respect human rights and immediately remove all such provisions from all their free trade agreement negotiations.

ITPC demands that the European Commission remove the following clauses from the EU-India Free Trade Agreement and refrain from introducing them in other agreements:

1. DATA EXCLUSIVITY, as it delays the registration of generic medicines and will not permit the placing of affordable versions of pediatric doses and combinations of "off-patent" medicines on the market.

2. PATENT TERM EXTENSION, as it will extend patent life beyond 20 years.

3. INVESTMENT RULES, as it will enable foreign companies to take the Indian government to private courts over domestic health policies like measures to reduce prices of medicines.

4. BORDER MEASURES, as it will deny medicines to patients in other developing countries with custom officials seizing generic medicines in transit.

5. INJUNCTIONS, as it undermines the independence of the Indian judiciary to protect right to health of patients over the profits of drug companies.

6. OTHER INTELLECTUAL PROPERTY ENFORCEMENT MEASURES, as it puts third parties like treatment providers at risk of police actions and court cases.