The World Trade Organisation (WTO) has ratified measures that will allow generic manufacturers to circumvent patent protection and export life-saving medicines to developing countries facing public health crises.
The agreement makes permanent an earlier waiver system for the WTO’s Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement, designed to help countries which lack the infrastructure to make their own medicines.
The waiver system was implemented in 2003, in no small part because of the desperate need to provide access to affordable antiretroviral drugs to combat the AIDS epidemic. Ahead of the meeting, there had been concerns, particularly among countries affected by HIV and other diseases such as malaria and tuberculosis, that the waiver would be revoked.
WTO representatives from developed countries stressed that safeguards must be put in place to protect the drug industry from parallel imports. The pharmaceutical industry has long argued that parallel trade - in which a trader sources lower-priced products from one country and imports them for sale in another where prices are higher - damages its profitability and ability to carry out R&D, introduces a risk of mislabelling as goods are re-packaged and serves as an entry point for counterfeit drugs.
The amendment will be formally built into the TRIPS Agreement when two thirds of the WTO members have ratified it. The WTO said members have set themselves until December 1, 2007 to do this. The waiver remains in force until then.
"The agreement to amend the TRIPS provisions confirms once again that members are determined to ensure the WTO trading system contributes to humanitarian and development goals as they prepare for the Hong Kong Ministerial Conference," said WTO Director-General Pascal Lamy.
The latest decision comes a week after WTO members agreed to extend the transition period for least-developed countries, allowing them until July 1, 2013, to provide protection for trademarks, copyright, patents and other intellectual property under the WTO’s agreement. Least-developed countries had already been given until 2016 to protect pharmaceutical patents.
The Pharmaceutical Research and Manufacturers of America (PhRMA) said in a statement that it welcomed the move. “These safeguards will be critical in ensuring that medicines produced and exported under the solution reach the intended countries, and it is significant that WTO Members agreed in Geneva to implement those safeguards."