Patents and patients – can EU protect both?

Date: 31/03/05

India has just introduced legislation to permit patent protection for pharmaceutical products.

Since India, along with Brazil, is a significant manufacturer of medicines, this development has aroused concern among anti-poverty campaigners that life-saving drugs might no longer be available at prices that people in poor countries can afford.

Because there has not up to now been patent protection for medicines in India, it has become a centre for manufacturing 'generics', essentially cheaper copies derived from patented originals.

But the World Trade Organization (WTO) now requires all its members to comply fully with the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement, though an exception has been given for the Least Developed Countries, who have until 2016 to introduce the TRIPS standards on pharmaceuticals.

While India's legislation is necessary to bring it into line with WTO rules, the timing of its introduction is unfortunate. It came just before World Tuberculosis Day (24 March). At nearly two million, the number of people who perished from TB in 2004 was more than those killed by wars, tsunamis, airline accidents and murder. It is a leading killer of people whose immune systems have been ravaged by AIDS.

Anti-TRIPS campaigners argue that the extension of patent protection will affect the access of poor countries to medicines.

Pharmaceutical companies counter that most medicines identified as essential do not enjoy patent protection. They contend that although India has been without patent protection and has a strong generics industry, the Indian population's access to essential medicines is no better than Africa's.

The pharmaceutical companies were hoping that the controversy over patents would be reduced by an agreement at the WTO in August 2003 to use loopholes in TRIPS to make the provision of cheap medicines easier.

The EU has since been trying to put that WTO agreement into law. Presenting the Commission's draft legislation, the then trade commissioner Pascal Lamy said: "The EU leads the way in ensuring access to affordable medicines." It was proof, he said, that the EU was delivering on its commitments to make the Doha round of world trade talks a tool for alleviating poverty.

The Commission's draft regulation would allow makers of generic medicines to manufacture patented products for export to developing nations that lack the means to make the drugs themselves.

The European Parliament's international trade committee has been analysing the text and commissioned studies from two academics.

Both Carlos Correa, an Argentine lawyer and economist, and Katharina Gamharter, of the Vienna University of Economics and Business Administration and Harvard Law School, question why only WTO members will be able to benefit from the scheme, unlike a similar one drawn up by Canada.

"Whether a country is a WTO member or not does not constitute a valid criterion for allowing or not exports of low-priced drugs to address public health needs," writes Correa. "Threats to public health do not recognise such arbitrary legal distinction."

Correa concludes that the impact of the proposal in ameliorating public health problems "will probably be modest".

Discrimination between countries could flout international human rights law, he said and could leave non-WTO member Russia without adequate means to tackle its mushrooming AIDS crisis.

Correa also suggests that the generic drug industry would be reluctant to take part in the scheme.

Gamharter argues that changes must be made to the draft regulation "to reflect the close link between EU trade and development policies".

The importing country should have the right to determine autonomously what constitutes a national emergency or other circumstances of extreme urgency that would be grounds for waiving the requirement to obtain a licence to manufacture.

The regulation should be re-phrased so as explicitly to allow for authorised procurement of medicines by non-governmental organisations and public tendering, she says.

Correa said that the lack of any predictability about what fee should be paid to the patent holder for a licence to manufacture created "considerable uncertainty" both for importing countries and generic companies.

He said it would "probably not attract significant interest from the generics industry" and was "unlikely to dramatically increase the supply" of cheap medicines in countries needing them.

Seco Gerard, of relief agency Médecins Sans Frontières, said: "Who will use a mechanism that is so complicated?" she asks. "You would need to be very motivated to do that. Industry may have good intentions but its main responsibility is to be profitable. If you are to have a profitable business, are you going to invest in something with no certainty?"

A Commission official said that compulsory licensing was part of the solution but not in itself sufficient. What was needed to address global diseases was, he said, successful research and development (encouraged by patent protection), affordable drug prices for developing countries, efficient healthcare systems in developing countries and sufficient funding for purchasing drugs.

Analysis feature on the introduction of patent protection for pharmaceutical products, following the World Trade Organisation's TRIPS agreement (Trade Related Aspects of Intellectual Property Rights). A draft regulation put forward by the European Commission addressed the problem of access to affordable medicines for developing countries, providing for exemptions from patent rules.