The World Trade Organisation's executive has finally broken deadlock in a deal to give some of the world's poorest countries access to cheap drugs.
The 146 WTO members have agreed to a deal that could see millions of people around the world gain access to drugs for infectious diseases such as HIV and also other serious conditions such as asthma and diabetes.
The program to make drugs accessible to the world's poorer countries was agreed at the WTO two years ago, but implementation has been dogged by disagreement over the details and industry concerns that it will become vulnerable to patent breaking.
After considerable negotiation, the countries most worried about this issue, including the USA, reached agreement on a major sticking point - that patents could be relaxed but must not be exploited by organisations in developing countries for commercial gain. Specifically, there must be efforts to insure that parallel trade of exports to richer countries does not come about.
The new agreement centres on legal changes that will make it easier for poorer countries to import cheaper generics made under compulsory licensing if they are unable to manufacture the medicines themselves.
"This is a historic agreement for the WTO," said director-general Supachai Panitchpakdi. "The final piece of the jigsaw has fallen into place, allowing poorer countries to make full use of the flexibilities in the WTO's intellectual property rules in order to deal with the diseases that ravage their people.
"It proves once and for all that the organization can handle humanitarian as well as trade concerns," he went on.
The decision waives countries' obligations under a provision of the WTO's intellectual property agreement. Article 31(f) of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement says that production under compulsory licensing must be predominantly for the domestic market. This effectively limited the ability of countries that cannot make pharmaceutical products from importing cheaper generics from countries where pharmaceuticals are patented.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) said that the agreement struck at WTO to make the existing flexibilities of the TRIPS agreement accessible to members lacking domestic manufacturing capacity demonstrates the value of the multilateral trading system.
"The negotiators have sought a balance between the recourse to compulsory licensing and the damaging effect that its indiscriminate use would have on the development of new medicines," it said, while cautioning: "It remains to be seen if that balance has been successfully achieved."
Rather than compulsory licensing, EFPIA would rather see access achieved via initiatives undertaken by the industry, often in partnership with other groups. "We believe that international support for the expansion of these efforts will provide greater and more immediate benefits than the uncertainties of compulsory licensing,"it said.
EFPIA director-general Brian Ager commented: "Now it is time to focus on the real access barriers such as the lack of healthcare infrastructure, financing and education in developing countries in order to find sustainable solutions to the lack of access to healthcare in developing countries.
"As poverty is at the root of inadequate access to medicines, the developing world needs to pursue economic growth as the main tool with which to improve public health."