Africa’s Aids patients biggest losers if India/EU drugs deal sails through

By IN2EASTAFRICA - Sun Feb 27, 6:09 pm

Jimmy Gideyi has been on free antiretroviral generic drugs manufactured in India since 2004, when he was confirmed HIV positive.

In the past decade, the 56-year-old man has received a constant supply of the drugs, which are almost 10 times cheaper than branded ones, thanks to the humanitarian organisation, MSF (Doctors Without Borders).

However, Gideyi, like other HIV positive patients in East Africa, fears all that might come to an end, if the controversial Free Trade Agreement between the European Union and India goes through.

“I pray the trade talks fail as HIV/Aids patients in poor countries will be the biggest losers. Getting cheap drugs will be very difficult,” he says.

The agreement, expected to be finalised mid this year, has sparked fury among human rights activists who accuse the EU of scheming to elbow out developing countries producing generic drugs.

Demonstrations have been held in Nairobi, Brussels, Bangkok, New Delhi, Paris, Jakarta, Kathmandu and Manipur in North East India, all demanding the deal be abandoned.

Top on the list of concerns is the “data exclusivity” clause, which humanitarian organisations argue if retained, monopolies on medicines could be extended and production of affordable, quality generic versions could be delayed for years.

“With such a clause, India would agree to grant a period of exclusivity over clinical trial data for that medicine, which would prevent the Drugs Controller General of India (the body responsible for approving drugs) from registering a generic medicine for that period,” says Michelle Childs, policy director at MSF’s Campaign for Access to Essential Medicines. She says multinational companies in Europe want the exclusivity period to be 10 years.

The health sector in Africa relies heavily on generic drugs not only for treating Aids, but also other ailments. The bulk are imports from India.

The concerns have received support from the United Nations.

Last year, UN Special Rapporteur, Anand Grover, said the agreement, as it was, placed trade interests over human rights.

“Millions in the developing world depend on India for generic medicines at affordable costs. Restriction of generic drug production in India will have a devastating public health impact around the world and adversely affect the right to health of millions of patients,” Mr Grover warned.

However, EU dismisses the fears as unfounded, insisting data exclusivity is a tool that recognises the development and marketing of a new medicine, allowing the originator to conduct extensive research and testing.

“Our concern is to ensure long-term access to generic medicines. Hence, we need innovation in the world of pharmaceuticals and that simply won’t happen if companies invest millions in research only to see all their work handed-over to competitors,” says John Clancy, spokesperson of EU Trade Commissioner Karel de Gucht.

Mr Clancy says the EU Commissioner for Trade has on numerous occasions given his personal assurance that “nothing in this agreement will prevent India from using compulsory licensing including for the manufacture and export of medicines to other developing countries in need.”

Compulsory licensing is when a government allows someone else to produce the patented product without necessarily having the consent of the patent owner.

It is one of the flexibilities on patent protection included in the World Trade Organisation’s agreement on intellectual property — the Trips (Trade-Related Aspects of Intellectual Property Rights) Agreement).

According to the official, the European Commission has even proposed to include language to this effect in the FTA text itself, as well as an explicit reference to the Doha Declaration on the Trips Agreement and Public Health, “to ensure that the flexibilities granted by the Trips Agreement, especially as regards patents on medicines, can be fully used by India.”

Since the talks began, the Indian government has continued playing its cards close to its chest, only insisting nothing has been agreed and that discussions are still on-going.

Last year India’s Commerce and Industry Minister Anand Sharma, responding to a query in Parliament, said: “Final positions have not emerged and therefore no agreement has been reached in any sector including Intellectual Property Rights (IPRs).”

A leaked draft document on the talks, reflect India’s rejection or hesitation on a range of proposals namely data exclusivity, radical enforcement on liability of intermediary service providers and tighter controls on goods in transit among others.

In brief, according to the leaked document on the July talks, last year, India reiterated its refusal to go beyond Trips and also discuss issues that require changes to Indian law.

By JEFF OTIENO, The East African