TWN Info Service on Intellectual Property Issues (Jan09/02)
19 January 2009
Third World Network

Health: WHO/Big Pharma counterfeit plans receive harsh criticism
Published in SUNS #6620 dated 19 January 2009

Geneva, 16 Jan (Riaz K. Tayob) -- Small pharmaceutical manufacturers and civil society groups that support access to medicines have joined hands in their opposition to the World Health Organization's International Medical Products Anti-Counterfeit Taskforce (IMPACT).

The next session of the Executive Board of the WHO (19 to 27 January) is to consider a report and draft resolution on "Counterfeit Medicines" driven mainly by the work of WHO's partnership with IMPACT task force on counterfeits (WHO EB124/14 - see also SUNS #6618 dated 15 January 2009).

In a 15 January letter to Indian Prime Minister Man Mohan Singh, the Small and Medium Enterprise Pharma Confederation of India (small-scale pharmaceutical producers) calls for the total rejection of the work of IMPACT. It regards the WHO Secretariat proposal on Counterfeit Medicines a serious move at the international level which threatens exports from India particularly to developing countries.

Neither IMPACT, the task force partnership between WHO and "stakeholders", nor its work is acceptable, the letter from the Indian small-scale pharmaceutical producers says. It advises that India should not fall into the trap of negotiating any definition of the term counterfeiting as it is driven by multinational pharmaceutical industry interests.

Under the garb of coining a new definition, multinational companies should not be allowed to bring in issues of quality, adulterated and spurious drugs, solely to muddle facts and surreptitiously use it to curtail Indian exports.

First, it cites the dominant influence of multinational pharmaceutical companies in IMPACT. The International Federation of Pharmaceutical Manufacturers Association (IFPMA) has and is playing a leading role, it is the head of IMPACT's technology working group and more importantly is a part of the planning group, the main decision-making body of IMPACT.

Second, through leadership and funding, the European Union is pushing its own agenda to promote its own pharmaceutical industry via intellectual property rules. The EU is trying to translate their national policy into an international norm through IMPACT.

Specifically, the letter states, the EU has given significant funds to IMPACT and particularly to the promotion of IMPACT's "Principles and Elements for National Legislation against Counterfeit Medical Products" which proposes an international criminal regime for so-called "counterfeit" drugs for enforcement by both customs officials and drug regulatory authorities.

The letter refers to cases of shipments seized by EU customs officials, under their laws, even though the drugs are safe and efficacious. Multinational pharmaceutical companies could try and raise complaints about intellectual property rights infringement to effectively stop the supply of medicines from India.

According to the Mint newspaper, a $500,000 consignment from Dr. Reddy's Laboratories to Brazil was seized while in transit in the Netherlands recently. This follows previous seizures of the exports of small manufacturers.

The Mint reports that India's Commerce Secretary G. K. Pillai said the department has taken up the matter with the European Commission (EC) and that "this is an act of piracy by the European Union. The consignment was going to Latin America and was seized in Europe... This is a dangerous thing happening, which is totally uncalled for. It is part of the strategy by these countries to target generic drugs from India."

According to Zee News, India's Commerce Secretary has said yesterday that "we may have to take the issue to the WTO and challenge it ... we would be seeking consultation with the EU."

The Mint reports that Leena Menghaney of Medecins Sans Frontieres (MSF) in India said that the EC regulations that have led to the seizure of Indian generic drugs in transit to Brazil have created barriers to the export of affordable, quality, low-cost generic drugs from India to other developing countries. This is part of the IP (intellectual property) enforcement agenda, she said.

The letter also charges that IMPACT "has taken shelter behind the WHO Secretariat which has given them the cloak of legitimacy when it is actually nothing more than a multinational industry and developed country agenda to stop exports of medicines."

The letter also refers to a national initiative at the behest Big Pharma that burdened local industry with several measures but which lead to no extra purity of medicines. It noted the multinational takeover is imminent as India is the biggest market in the world. It called on the government to take immediate action if affordable medicines are to be made continuously available in the country in the future.

In another letter from the New Delhi non-profit think tank CENTAD to the Indian Ministry of Health, it states that there are grave concerns presented by conflicts of interest in the constitution and processes of IMPACT.

It states that many developed country pharmaceutical industry organisations have actively participated in formulating the definition. IMPACT promotes stringent intellectual property enforcement to circumvent fair competition in generic pharmaceuticals trade in and from developing countries.

The consequences that flow from the IMPACT definition, which conflates issues and has many ambiguities, may have serious legal and economic implications and could undermine flexibilities prevailing in current international IPR agreements, CENTAD states.

The concern regarding falsifying medicinal products is limited to the issue of spurious and sub-standard drugs. It proposes that both the draft report and the resolution be opposed. The Secretariat should be requested to start the process afresh by adopting a legitimate member-state-driven agenda. +