Developing countries are not making the most of TRIPS flexibilities because of political pressure

BMJ 2011; 343 doi: (Published 02 December 2011) Cite this as: BMJ 2011;343:d7706
  1. Rachel Marusak Hermann
  1. 1Geneva

The flexibility given to developing countries to provide medicines more cheaply to those in need is not being exploited to its full capacity, a legal expert on public health has said.

While the Declaration on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and Public Health, signed in Doha in 2001, reinforced several types of flexibilities to boost access to medicines, developing countries are not taking full advantage of them, Frederick Abbott, professor of international law at Florida State University College of Law, told the BMJ.

He gave an interview to the BMJ at the 5th High-Level Symposium on Global Health Diplomacy, which was held on 23 November at the World Trade Organization in Geneva.

Professor Abbott, who was also a symposium panellist, said that only one country, for example, had used the flexible import-export mechanism allowed under the TRIPS agreement. Rwanda had used it to import a generic fixed dose combination antiretroviral drug from a Canadian company under compulsory licence.

Limited implementation of TRIPS flexibilities was caused by various factors, he said, but one of the greatest challenges that developing countries face is political pressure, increasingly manifested in bilateral and regional agreements that restrict flexibilities.

“Developing countries have found that if they attempt to issue government use or compulsory licences, even on AIDS medicines, they come under intense political pressure, from the home country of the originator pharmaceutical company, and this has had a substantial dampening effect on use of TRIPS flexibilities,” he said.

The conference, which was called Ten Years After the Doha Declaration: The Future Agenda at the Interface of Public Health, Innovation and Trade, considered what could be done by health, trade, and intellectual property authorities to meet the world’s most pressing health problems.

“Access to essential medicine has improved tremendously in the first decade of this century,” Margaret Chan, director general of the World Health Organization (WHO), told the conference, in which other high level policy makers participated, including Pascal Lamy, director of the World Trade Organization (WTO), Francis Gurry, director of the World Intellectual Property Organization (WIPO), and Ruth Dreifuss, former chairwoman of the WHO Commission on Intellectual Property, Innovation and Public Health.

“At the same time,” she continued, “The poorest of the poor still have no access to affordable, quality medicine. That is the challenge.”

Although key advances in medicine access have been made since the signing of the 2001 Doha Declaration, persisting access limitations coupled with the current political and economic landscape has pushed policy makers to take a more innovative approach to global health challenges. Many agencies, for example, are now engaging in “public private partnerships,” combining capabilities from different sectors to improve global health outcomes.

Signed with the backdrop of the HIV/AIDS crisis, the Doha Declaration marked a political turning point. While recognising the importance of intellectual property protection to spur the development of new medicines, it also recognised the impact that intellectual property had on medicine prices and reaffirmed that developing countries had a right, in certain circumstances, to change licensing rules if it was necessary to protect public health.

Since then, access to medicines, especially antiretroviral therapy, has improved. Michel Sidibé, executive director of UNAIDS, said during the symposium that the AIDS case demonstrates the potential of TRIPS. According to a report recently released by UNAIDS, 47% of people living in low and middle income countries had access to antiretroviral therapy in 2010 compared to 2.7% in 2002.

UNAIDS attributes the effective scaling-up in large part to the fall of treatment prices, indicating that many developing countries had used TRIPS flexibilities to produce and purchase generic antiretroviral medications.

Professor Abbott said that while implementation has been limited, TRIPS flexibilities have also served as a bargaining chip. “Part of the principle of these flexibilities is that they are in the background of negotiations. One of the reasons why companies will issue voluntary licences is because of the threat of compulsory licences.”

But many challenges remain, the delegates agreed. More than 7.6 million people from low and middle income countries who need HIV/AIDS treatment are not receiving it. About 97% of patients receiving treatment in low and middle income countries, excluding the Americas, are on first line treatment therapies. As their resistance grows, more and more patients will need to move to more expensive second and third line regimens. According to Mr Sidibé, second line treatments are selling at three times the price of first line treatments and third line treatments are even more expensive.

As well as issues surrounding the next stage of antiretroviral therapy scale-up, delegates called attention to a wide range of other increasingly urgent global health issues. From the lack of sufficient research and development in areas such as neglected diseases and antibiotics to the growing problem of non-communicable diseases and substandard medications, the list of innovation and access challenges is long.

Beyond the changing political landscape, the global economic crisis is already affecting essential funding programmes. The Global Fund, the world’s largest backer of national programmes to fight HIV/AIDS, tuberculosis and malaria, confirmed at the symposium that it will be making no new grants or funding until 2014.

Tido Von Schoen-Angerer, executive director of the Campaign for Access to Essential Medicines for Médecins Sans Frontières (MSF, Doctors Without Borders), said that these cuts would have grave consequences. “There is an incongruence between what policymakers say about the need for treatment and the funding gaps that we are facing” (BMJ 2011;343:1124, doi:10.1136/bmj.d7755).

In this complicated, even precarious, context, policy makers from traditionally disparate worlds are joining forces to promote public health solutions together. They are also moving beyond traditional policy making strategies to enact change. “We don’t need treaties to take action,” said Mr Gurry, WIPO head. He emphasised that today, although important to keep their distance from private entities, international agencies cannot be effective working in their own isolated spheres.

The agencies have already begun to collaborate with private partners. WIPO Re:Search is a collaboration of public and private sector stakeholders for the research and development of medicines to treat neglected tropical diseases (NTDs), malaria, and tuberculosis. WHO will also collaborate with private partners within the Pandemic Influenza Preparedness Framework. According to the framework, influenza vaccine, diagnostic, and pharmaceutical manufacturers “will make an annual partnership contribution to the WHO for improving global pandemic influenza preparedness and response.”

Several other initiatives were evoked during the symposium as important elements in the evolving global public health system. The Medicines Patent Pool, which seeks to improve access to affordable HIV medicines in developing countries through voluntary licensing, provides another avenue toward affordable medicines. A binding research and development convention is under discussion at WHO for the creation of a global mechanism that would de-link medicine development from medicine cost with the aim of increasing innovation in disease areas most affecting developing countries.


Cite this as: BMJ 2011;343:d7706

View Abstract