A right to medicines for all?

Trade gone wrong

The EU's ongoing negotiations on a bilateral trade agreement with Peru have already become a legendary case study for medicines campaigners, as a warning about what developing countries should look out for when they discuss trade in medicines. The EU's initial demands on data exclusivity and supplementary patent protection were so steep that they threatened to drive Peru's total pharmaceutical expenditure upwards to $1,267 million dollars by 2025, just to maintain current consumption levels, according to a report published by Health Action International.

Campaigners say the exercise provides “insight into how the EU's intellectual property trade agenda affects access to medicines”. The report calculates the number of active pharmaceutical ingredients protected by patents would have risen by more than 10% (and the national drug bill by bill by 26%) if the EU (and drug firms) had succeeded in imposing the rights conferred by the EU supplementary protection certificate – the mechanism that the EU introduced in the 1980s to extend patent protection for medicines. And if Peru had agreed to the EU provision giving innovator firms a ten-year period of exclusivity on test data, an even more dramatic increase in costs would have resulted. As things stand at present, the two sides have initialled a compromise with no patent extension and a five-year data exclusivity period.

The problem of excessive EU demands in trade deals has not been raised just by health activists. The World Health Organization and the Pan-American Health Organization have produced a guide for estimating the impact on access to medicines of changes in intellectual property rights. It has been used in studies conducted in partnership with organisations including the United Nations Development Programme, the World Bank Institute, and the International Center for Trade and Sustainable Development.

Now campaigning groups are demanding that EU member states and the European Parliament “take on their rightful role of holding the European Commission to account and ensuring that the incoming Commission's policies on trade respect long-standing European commitments on health and development”. They claim that it is inconsistent for the EU to be acting to promote cheaper medicines within the member states – as it did with the recent competition inquiry into the pharmaceutical sector – while defending high prices in poor countries.

Branded medicines

Big manufacturers of branded medicines are increasingly concerned about the risks from illicit parallel trade in products that they have agreed to supply to poorer countries at reduced cost, and from other linked trade distortions. In September, a criminal investigation was triggered in Germany when cheap HIV treatments that Glaxo had despatched to African markets appeared in German pharmacies, in counterfeit packaging. Meanwhile, a complex dispute between India and the EU is only now approaching resolution, a year after Dutch customs officials impounded consignments of Bombay-manufactured generic medicines in transit at Rotterdam and bound for Brazil, not because they were counterfeit but because of allegations that they infringed patents belonging to Merck Sharp & Dohme. The subject threatened to precipitate action by India and Brazil against the EU, and was one of the irritants at the recent EU-India summit.