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Pharmaceutical products

No progress

by Tillmann Elliesen

In brief

Tanzanian AIDS patient

Tanzanian AIDS patient

The European Parliament has adopted a WTO rule that intends to make it easier for poor countries to import cheap pharmaceutical products. In practice, however, pharma experts reckon not much is likely to change.

In 2005, the World Trade Organisation (WTO) members adopted an amendment to the agreement on intellectual property rights (TRIPS Agreement) which allows poor countries with no pharmaceutical industries of their own to commission other countries to produce and export generic copies of patented drugs. Both sides – the importing country that places the order as well as the country that makes and exports the pharmaceutical product – need to issue a compulsory licence that sets aside the patent protection.

In actual fact, the TRIPS amendment was supposed to come into force at the beginning of 2008. By November, however, the protocol had been ratified by only 11 countries, which is well short of the 100 ratifications required (two-thirds of WTO members). The TRIPS Council thus extended the deadline by two years, to the end of 2009. With the European Parliament’s approval at the end of October, the 27 EU member states now have the go-ahead to incorporate the rule into national law.

The TRIPS amendment goes back to the so-called Doha Declaration on intellectual property and public health adopted at the 2001 WTO Ministerial Conference in the capital of Qatar. In 2003, because the Doha Declaration made no arrangement for countries without pharmaceutical manufacturing capacities, the WTO members decided on compulsory licensing as an exemption to the TRIPS Agreement. Two years later, the TRIPS Council decided to integrate that exemption into the TRIPS Agreement. Ratification will seal the deal.

But experts do not believe the revised rules will give poor countries better access to medicines. The process is seen as extremely long-winded and fraught with red tape. Since 2003, only two countries have availed themselves of it. In summer 2007, Rwanda asked Canada to manufacture a generic version of an AIDS drug. The government in Ottawa thereupon authorised a Canadian company to copy the patented pharmaceutical product and supply the required quantity to Rwanda.

Organisations such as Médecins Sans Frontières or the German BUKO Pharma Campaign have long called for the process to be simplified. That, they claim, is vital if it is to be effective in helping to improve pharmaceutical supply in countries with no production capacities of their own. Oliver Moldenhauer of Médecins Sans Frontières is thus in two minds about the ratification of the agreement: exemption from patent protection would finally be established, he says, but corrections to the rules would probably also be off the agenda for good. (ell)