Developing countries allowed to import generic medicines under a new protocol ratified by MEPs

Two years of EU brinkmanship came to an end on 24 October when the European Parliament cleared arrangements for giving poor countries access to patent-protected medicines at affordable prices.

MEPs belatedly approved EU ratification of a 2005 World Trade Organization protocol on compulsory licensing - potentially paving the way for developing countries to order generic drugs from manufacturers abroad without infringing patent rights.

The Parliament had been holding out for promises that EU negotiators will not seek to neutralise the WTO concessions through intellectual property clauses in trade agreements. MEPs also wanted a declaration of EU support for healthcare systems and pharmaceutical infrastructure in beneficiary states through funding, technology transfer, and research into drugs relevant to developing countries.

The vote went ahead after Trade Commissioner Peter Mandelson and Portugal’s minister for EU affairs Manuel Lobo Antunes, speaking for the Council of Ministers, gave assurances on both counts.

The new protocol amends the existing WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs).

The current agreement allows developing countries to produce their own generic medicines but not to import them. The new protocol would allow countries lacking domestic production faculties to order generic versions of vital drugs from overseas suppliers.

But the European pharmaceutical industry says that the protocol will make little difference to poor countries.

Christophe de Callatay, spokesman for the European Federation of Pharmaceutical Industries Associations (EFPIA) told Chemistry World that transitional WTO arrangements adopted in 2003 already encourage drug companies to supply medicines to poor countries at discounted prices.

’It’s not an IP issue,’ he said, pointing out that 95 per cent of the 300 products on the World Health Organization’s list of ’essential’ drugs are out of patent - which means that anybody in the world can copy them at no cost. ’The lack of healthcare in, say, Africa is due mainly due to problems over which we have no control. poor infrastructure, lack of sanitation, no nursing, no syringes, no diagnostics, nothing. A myopic focus on intellectual property issues - suggesting that reducing IP protection will somehow improve access to medicines - is misleading.’

"A myopic focus on intellectual property issues - suggesting that reducing IP protection will somehow improve access to medicines - is misleading" - Christophe de Callatay

The industry has already moved to make cheap drugs available to the developing world, de Callatay added. ’For years, decades even in some cases, companies have voluntarily taken steps through partnerships with non-governmental organisations, governments and other stakeholders to make drugs available at discounted or not-for-profit prices.’

Shortly before the Strasbourg vote, nations party to TRIPs agreed in Geneva to extend the deadline for ratification from 1 December this year to 31 December 2009.

However, the 27 signatures provided by EU ratification will give a boost to the protocol which must be ratified by two thirds of the WTO’s 151 members. The 11 previous signatories include major pharmaceutical producers including the US, Switzerland, Israel and Japan.

Arthur Rogers