An amendment to a World Trade Organization agreement for public health purposes was harshly criticised by non-governmental organisations and greeted with caution by the pharmaceutical industry.

NGOs said the access-to-medicines deal that was reached by WTO members on 6 December was hastily agreed and would make permanent a flawed agreement. It would make “access to affordable medicines even more bleak,” said Médecins Sans Frontières (MSF) in a statement.

The amendment agreed to at the WTO will permanently incorporate a waiver into the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), allowing countries to export affordable medicines produced under compulsory license to countries requesting the products (IPW, WTO/TRIPS, 5 December). The temporary waiver adopted on 30 August 2003 has so far not been used.

The pharmaceutical industry welcomed the amendment, particularly the safeguards incorporated in the deal to avoid medicines produced under compulsory licenses reaching unintended markets.

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) said the agreement included safeguards that would make sure that export under compulsory license would not be used for commercial ends. IFPMA also emphasised that WTO members had “committed” to preventing diversion of products away from the intended markets, and that the amendment “should ensure” that only countries that “truly lack pharmaceutical manufacturing capacity” would use the waiver.

MSF expressed alarm at the decision to amend the TRIPS agreement “based on a mechanism that has failed to prove it can increase access to medicines.”

It said the 30 August decision is “overly cumbersome and inefficient” because it is based on a “drug-by-drug, country-by-country decision-making process,” and in adopting it the WTO was “ignoring the day-to-day reality of drug production and procurement.”

MSF called on the WTO to demonstrate by the end of 2006 that this deal can do away with the negative effects it said full TRIPS implementation has on access to medicines.

Consumer Project on Technology (CPTech) Director James Love echoed this, calling the decision “anti-consumer, anti-competition and anti-free trade.” Love especially focused on countries that have opted out of the waiver, saying they will never use it or only in times of emergency.

CPTech said the WTO rule is “protectionist by design” as these opt-out countries can bar imports from developing countries. For the opt-out countries this was a “irresponsible decision coming in the middle of concern over an avian flu pandemic.”

CPTech said the developing countries were pressured to accept the deal by “big pharmaceutical companies and the European Union,” and they should have “put up more resistance.”

Meanwhile, Chairperson Amina Mohamed of the WTO General Council that formally adopted the amendment said at a press conference afterwards that it was principally the African countries that had driven the process to reach a deal on TRIPS and public health.

Robert Weissman of Essential Action also criticised the decision, and said that the key question is “whether efficient generic suppliers will be able to export drugs globally and achieve economies of scale that will drive down prices and promote access.”

The Pharmaceutical Research and Manufacturers of America (PhRMA) particularly welcomed the agreement to maintain “anti-diversion measures and other aspects of the ‘chairman’s statement’,” negotiated in 2003.

“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,” said PhRMA chief executive officer, Billy Tauzin.

EU Joins the Implementation Countries

Some countries have implemented the 2003 waiver into national law, which is necessary in order to export under this agreement.

So far Norway, Canada and India have implemented the waiver, while the Republic of Korea and the EU “have said their new laws are on the verge of coming into force,” the WTO says.

On 1 December the European Parliament agreed to adopt, with some amendments, the European Commission’s “proposal for a regulation allowing companies to produce copies of patented medicines under license for export to developing countries,” according to the EU.

“Europe has sent an important signal ahead of the Hong Kong ministerial,” EU Trade Commissioner Peter Mandelson said in a statement. “Europe urges other potential exporters of drugs to implement the WTO Decision as soon as possible to allow their generic manufacturers to produce medicines for export to countries in need.”