Government officials, businesses and civil society groups alike are this week commemorating the fifth anniversary of the adoption of the Doha Declaration on the WTO TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2).

Signed by WTO Members on 14 November 2001 at the global trade body's fourth Ministerial Conference in Doha, Qatar, the declaration aimed to address concerns that the patent protections and other rules set out in the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) could raise the price of pharmaceuticals. Hailed at the time as "a giant victory" for access to affordable medicine, it was said to be proof that the multilateral trading system could respond to global public health concerns.

Five years down the road, although most concur that the declaration was an important milestone, many remain deeply concerned about the impact of intellectual property rules on access to medicine.

"The Doha Declaration said all the right things but to date has delivered virtually nothing to poor patients," said Celine Chaveriat of Oxfam International. "We've gone backwards in five years." Guy Willis of the International Federation of Pharmaceutical Manufacturers & Associations disagreed. He told Bridges that that the "Doha Declaration represents a balanced approach" and that developments over the last five years have "helped to clarify the declaration."

Adopted in conjunction with the launch of the Doha Round trade talks, the declaration marked international consensus just two months after the terrorist attacks of 11 September 2001. It came at a time when concern over intellectual property rights' effects on access to medicines was higher than ever before. Fears of a possible outbreak had rich country governments threatening to override patents on anthrax drugs. Major legal battles over South Africa and Brazil's attempts to make treatment more affordable for their millions of HIV/AIDS patients had thrust the issue to the forefront of the WTO agenda.

In the declaration, government agreed that the "TRIPS Agreement does not and should not prevent Members from taking measures to protect public health." Recognising "the gravity of public health problems" that poor countries face, especially due to epidemics such as HIV/AIDS, tuberculosis, and malaria, they stressed that the agreement "can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and . . . promote access to medicines for all."

The declaration aimed to clarify ambiguities in WTO intellectual property rules about countries' ability to produce and import affordable drugs. It reaffirmed Members' rights to "determine what constitutes a national emergency or other circumstances of extreme urgency," and to "to determine the grounds" for granting 'compulsory licences' authorising the production of patented medicines without the consent of the patent holder.

Although the TRIPS Agreement permitted governments to use compulsory licences, Article 31(f) specified that the generic copies of patented drugs thus produced could only be sold on a country's domestic market. This rendered compulsory licensing useless for countries lacking sufficient pharmaceutical manufacturing capacity, no matter how severe their public health problems. The declaration instructed Members to find "an expeditious solution to this problem" by the end of 2002.

In addition, the Doha declaration reaffirmed Members' right to export and import legitimate medicines at lower prices. Known as 'parallel trade' or parallel import/export," the legitimacy of this practice had been questioned by some countries.

Finally, it specified that least developed countries could delay implementation of the TRIPS agreement with respect to pharmaceuticals until January 2016.

Speaking in 2001, James Love of Consumer Project on Technology called the declaration the "strongest and most important international statement yet on the need to refashion national patent laws to protect public health interests." Oxfam's Michael Bailey added that the principles set out within the document would make it "much harder for the US and drug companies to bully poor countries over their patent policies."

However, five years later, the struggle to improve countries' access to medicines continues.

It took WTO Members until August 2003 -- long after the 2002 deadline in the Doha declaration -- to reach an accord on helping countries lacking manufacturing capacity to make use of compulsory licenses. The so-called '30 August 2003 decision' was effectively a temporary waiver of the requirement that medicines produced under compulsory licence be restricted to the domestic market, pending an amendment of the TRIPS agreement (see BRIDGES Weekly, 4 September 2003). Even at the time, critics charged that its numerous requirements set an impracticably high bar for the legal importation of drugs produced under compulsory licences.

So far, not a single country has used the waiver. Nevertheless, in December 2005, WTO Members agreed to make the 30 August 2003 decision a permanent amendment to the TRIPS agreement. The amendment will enter into force when two-thirds of the WTO's 150 Members ratify it. To date, three countries have ratified the amendment: the US, Switzerland, and El Salvador. In the meantime, the waiver decision remains in effect.

Some have explained that since developing countries were allowed to delay patent protection for pharmaceutical products until January 2005, the full effect of the agreement has not been realised. The mechanism "hasn't been used because it's too early," clarified one WTO official. "It will come up when there is a single supplier in the market," which will be the case once developing countries and LDCs fully implement their TRIPS commitments.

At a 14 November meeting in Geneva to commemorate the fifth anniversary of the declaration, Ellen 't Hoen of the Campaign for Access to Essential Medicines suggested that since some major generics producers such as India are now providing patent protection for newer medicines, their prices are being driven up. "It should alarm us," she said. "We're getting back to where we were five years ago."

Third World Network's Sangeeta Shashikant said that five years after Doha, WTO rules were far from the only trade-related threat to access to medicine. She pointed to the impact of bilateral and regional free trade agreements (FTAs) on "limiting the grounds on which governments can issue compulsory licences," for example, to cases of national emergency, government non-commercial use, and to address anti-competitive practices. She also warned that new protections for clinical test data in FTAs delay generics from coming to market. Added Oxfam's Jennifer Brant, "What's the point in having the Doha declaration if it's being chipped away?"

"The Doha declaration was of politically symbolic importance by making people stop and think about it," said Guilherme de Aguiar Patriota, a Brazilian trade diplomat. Since then, however, multinational corporations had steadily engaged in "damage control," quietly eroding the impact of the declaration. He added that dissatisfaction with the WTO process had motivated countries such as Brazil and Kenya to propose setting up a global framework for research and development in the World Health Organization.

One trade expert suggested that the declaration had served to open the eyes of the WHO to the effects of intellectual property rules. In recent years, the WHO has commissioned high-level investigations into the relationship between intellectual property, innovation, and public health.

ICTSD reporting; "Views on the Draft Declaration on the TRIPS Agreement and Public Health," CONSUMER PROJECT ON TECHNOLOGY, 13 November 2001; "Views on the TRIPS Agreement and Public Health: 5 Years down the Road," CONSUMER PROJECT ON TECHNOLOGY, 14 November 2006.