By William New
A panel of key Geneva actors on policy related to intellectual property rights and public health on 14 November gave a range of views on the World Trade Organization Doha Declaration five years after its agreement.

Several nongovernmental groups and a developing country official saw some benefits but raised concerns about future access to medicines and about the health impact of bilateral free-trade agreements being negotiated between large and small economies.

Representatives of two key intergovernmental bodies, the WTO and the World Health Organization, meanwhile, highlighted work being done to improve access to medicines, especially through technical cooperation.

The declaration was an outcome of the 2001 WTO ministerial in Doha, Qatar which launched the now-stalled round of trade-liberalisation negotiations that were intended to focus on ensuring developing countries benefit equally from the global trading system.

In December 2005, WTO members adopted a public health amendment to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The amendment instituted an August 2003 WTO agreement on a draft waiver to TRIPS for public health reasons, which was called for under paragraph six of the Doha Declaration to allow more export of medicines under compulsory license to countries without sufficient production capabilities. A compulsory licence forces the sharing of patented information on a medicine to allow generic production.

On the panel, Adrian Otten of the WTO Intellectual Property Division indicated the positive contribution to public health that the Doha Declaration has made. The paragraph six solution is to be reviewed every year, but so far has not elicited concerns from member states, he said. It was most recently reviewed at the October meeting of the TRIPS Council. An overall review of the Doha Declaration has not been sought, he said.

On concerns about bilateral free-trade agreements, Otten said there are a number of ways for concerns to be raised within the WTO context, such as in talks about preferential treatment for smaller economies, and through strengthened monitoring of regional trade agreements. The issue also arises in countries’ regular trade policy reviews, he said.

The Roles of WTO, WHO

On the roles of the WTO and WHO, Otten said there is cooperation and that the WHO has followed the WTO process, providing technical information.

Howard Zucker, the assistant WHO director general for health technology and pharmaceuticals, and head of a new WHO working group on intellectual property rights and public health, discussed the WHO’s work since TRIPS. He said WHO has focused on policy, training and technical support to help increase global access to medicines. He cited a number of WHO publications, including one forthcoming on the implications of WHO decisions related to TRIPS and public health, and another looking at government use of compulsory licensing.

The WHO has helped with local production of medicines, and collected and provided data, Zucker said. It also monitors all discussions on health at the WTO. In addition, WHO is working with the European Patent Office and the World Intellectual Property Organization (WIPO) to identify what drugs are on patent and when they will come off patent, he said.

Zucker said the WHO works with the WTO on trade issues and in the field looks at the use of TRIPS flexibilities. On the IP working group, he said some member states had not wanted trade issues on the table, and the issues are “open to discussion” by the member state-led group. He added that the working group is not just about intellectual property but also about innovation and development, with an eye on how to address neglected diseases. Guilherme Patriota of the Brazilian mission flagged a concern that the working group not be overly focused on innovation issues but rather look at the impact of intellectual property on public health.

Otten said the WTO is invited as an observer to the WHO working group process, the first meeting of which is 4-8 December. The WTO also invites the WHO to participate in its technical cooperation activities, and works with other agencies such as WIPO, the World Bank and nongovernmental organisations, he said.

Pressure Not to Use TRIPS Flexibilities?

Patriota shared several nongovernmental groups’ view that developed countries have pressured developing countries politically and economically to agree to weaker terms on health than the WTO agreements.

Patriota and others also noted that no country has yet used the draft waiver after three years, “a clear indication of its usefulness,” he said. “Countries are discouraged from using these flexibilities,” he said.

In addition, Patriota drew a link to efforts by some developing countries including Brazil to change the mandate of WIPO to make it more oriented toward a balance between public and private rights. He said WIPO generally states that it is focused on the protection of rights. He said WHO should not “become a WIPO-plus or WTO-plus institution” or be captured by private-sector interests.

He also said there is an inconsistency between intellectual property rights, which grant a monopoly to the right holder, and trade principles, which are based on competition. Developing countries are in a “very difficult environment,” Patriota said, adding that if one tries to use flexibilities, “you will be coerced not to use them.”

There were no developed country or industry representatives on the panel.

New Oxfam Study Critical of Doha Declaration

Oxfam issued a new study at the event entitled, “Patents versus Patients: Five years after the Doha Declaration.” The report is critical, arguing that “little has changed” since the signing of the declaration as patented medicines continue to be priced too high for the world’s poorest populations, trade rules continue to block access to generic medicines, and serious diseases continue to rise in developing nations. “Urgent action is needed,” the report asserts.

The report calls for: a WTO review of TRIPS; the United States to stop pressuring countries adopt stricter intellectual property rules; clarification by the European Union that it will not push for TRIPS-plus measures; and political and technical support from wealthy countries use safeguards under TRIPS. It also urges developing countries to summon the political will to implement public health safeguards, and calls for an end to lawsuits by pharmaceutical companies Novartis and Pfizer challenging developing countries’ IP laws.

An Oxfam representative at the meeting said national governments have the right to their own interpretation of the TRIPS agreement when implementing it into national law, and said that India’s interpretation is under attack.

Ellen ‘t Hoen of Médicins Sans Frontières said under WTO rules the right to use compulsory licensing for public health reasons is left up to the national government and that it does not have to be for health emergencies only.

She also said that while no country has used the paragraph 6 solution. There are about 15 countries that have used Doha Declaration paragraphs 4, 5 and 7. These all relate to a national government’s right to use the flexibilities in TRIPS.

Generics Pipeline Seen Drying Up

The good news, ‘t Hoen said, is that countries that need lower-priced generic medicines are increasingly able to get them. But the concern is for the future, she said, as sources are drying up for these medicines, such as for HIV/AIDS. This is particularly the case with India’s 2005 implementation of the TRIPS agreement, which will lead to patents on drugs. “Generic pipelines are empty for these products,” she said.

Dr. Tido von Schoen-Angerer, director of MSF’s Campaign for Access to Essential Medicines, said in a statement, “We’re seeing many countries make use of the Doha Declaration to import medicines, but what is the use if soon there are no generics to buy?”

In particular, ‘t Hoen said, those who need to switch drugs after a failed first course to “second-line” drugs are still seeing high prices due to lack of competition. “We’re getting back to where we were five years ago,” she said. “That should really alarm us.”

She also raised the possibility that TRIPS is “a bad bargain” since it has not kick-started research on neglected diseases, for which product development is not seen as profitable, and which often occur in developing countries. The WHO has a key role in addressing the problem areas, and WIPO also should do more, ‘t Hoen added.

Sangeeta Shashikant of the Third World Network said there are “very mixed feelings” after five years as there have been gains but also pressure to adopt national laws and practices that are more restrictive than TRIPS.

Shashikant cited cases of developing countries effectively using TRIPS flexibilities to significantly lower drug prices and increase access. But she said countries are being pushed in bilateral trade negotiations to adopt TRIPS-plus rules, such as limiting government use of compulsory licences, or data exclusivity requirements that block the registration of generic products even if a compulsory licence is issued. “It is definitely not the time to be complacent,” she said.

Thiru Balasubramaniam of the Consumer Project on Technology said it is too soon to judge the utility of the TRIPS amendment. He also praised India’s implementation of TRIPS as it enforced the ability to use compulsory licences for export of patented pharmaceuticals. In addition, he praised a 2002 amendment adopted by the European Parliament on manufacturing for export under compulsory licence when requested by the country in need. But he also cited flaws in the TRIPS amendment such as a prohibition on export to high-income countries.

Otten said that “presumably,” India will become a regular user of compulsory licences to export as drugs come under patent.

William New may be reached at wnew@ip-watch.ch.