THIS NEWS STORY is designed to help the public understand developments in the WTO. While every effort has been made to ensure the contents are accurate, it does not prejudice member governments’ positions.
TWO DOHA DECLARATIONS
The WTO Ministerial Conference in Doha, Qatar produced two declarations. The main declaration, more commonly known simply as the “Doha Declaration”, covers the work programme for negotiations, unofficially called the Doha Development Agenda or the Doha Round, and some other issues.
The ministers also issued a separate Doha Declaration on TRIPS and Public health. One provision, paragraph 6, required decisions on a specific issue, which were taken in 2003 and 2005. The resulting “Par.6 system” removes an intellectual property obstacle that would have prevented countries from using compulsory licences to manufacture generic medicines exclusively for export to countries unable to make them themselves. But the declaration as a whole is more than that.
The view was shared by participants from a range of diverse organizations in the symposium on Global Health Diplomacy to mark the declaration’s 10th anniversary, organized by the Geneva Graduate Institute of International and Development Studies, and held at the WTO.
Mr Lamy was speaking in a session chaired by former Swiss President Ruth Dreifuss, who is also the former chairperson of the WHO Commission on Intellectual Property Rights, Innovation and Public Health. Also on the podium were WHO Director-General Margaret Chan and WIPO Director-General Francis Gurry.
The November 2001 Doha ministerial Declaration on TRIPS (trade-related aspects of intellectual property rights) and Public Healthwas a political turning point in the way public health is governed globally, Mr Lamy said.
Before the declaration was issued, intellectual property protection (patent protection for drugs and medical products, in particular) and the WTO’s TRIPS Agreement were often considered simply to be an obstacle to public health, Mr Lamy recalled.
Now, the perception has changed: the declaration affirmed that the two are not contradictory. Mr Lamy quoted from it: “We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health.”
An important result has been a shift in focus from the “compatibility” of trade, intellectual property and health to the more dynamic and constructive “coherence” between them, he said. It has allowed a partnership to develop between the World Health Organization (WHO), World Intellectual Property Organization (WIPO) and WTO.
Mr Lamy added that the main responsibility for ensuring coherence is within national governments, including how intellectual property is handled in bilateral or regional free trade agreements. If governments accept tougher standards for intellectual property protection than required in the TRIPS Agreement (known as “TRIPS-plus”), then governments are accountable to their critics not to the WTO, he said.
One area of cooperation between the three organizations has been the examination of the relationships between incentives for innovation, access to medicines and trade. WTO Intellectual Property Division Director Antony Taubman told the meeting that a forthcoming product will be a study that draws on a range of facts and figures to create a guide for policy-makers to choose among the complex options available to them to provide better health services to their poorer populations through improved access to the medical technologies and medicines that are needed.
Before and after
The 2001 Doha Declaration on TRIPS and Public Health was genuine a turning point, changing the reality of the situation, Mr Lamy said.
Changing the rules. The declaration allowed WTO member governments to tackle a problem that existed in the TRIPS Agreement at that time: they altered the agreement's provision to remove an obstacle that prevented countries from using compulsory licences to manufacture generic medicines exclusively for export to countries unable to make them themselves — creating the “Paragraph 6” system.
This was a considerable achievement showing that member governments considered it to be a political priority, Mr Lamy said, because securing a consensus to change WTO rules is difficult at any time.
(Compulsory licensing is when a government authorizes a manufacturer to make a medicine or other product without the permission of the patent-owner.)
The “Paragraph 6” debate. He noted the current debate about whether the system is working. One side argues that it is working, because it has been used once (for generics exported from Canada to Rwanda) and that the existence of the system helps countries bargain more effectively to lower medicines’ prices.
The other side argues that the fact it has only been used once shows it is too complicated, and that prices are lower for other reasons such as the increased scale of purchases.
“It’s not for me to take sides,” Mr Lamy said. “We can only hope that we can have, as much as possible, an informed debate.”
Joint technical assistance. The declaration also led the WTO to beef up the technical assistance it is giving to developing countries on understanding various flexibilities (such as compulsory licensing and parallel importing) in the TRIPS Agreement and on using them as appropriate. A number of the programmes were designed and carried out in collaboration with WHO and WIPO. The result is better informed policy-makers who no longer see the flexibilities as an abstract “theory”, he said.
Mr Lamy said this decision was taken even though it “ruffled feathers” among those who felt it is not the WTO’s role to promote the flexibilities.
The future. For the future, experience shows that access to medicines has many aspects, and involves many players. This emphasises the need to continue to work together even when agencies have limited resources and have different cultures, Mr Lamy said.
The way innovation and invention lead to economic and social benefits is also changing, he went on. For example the Medicines Patent pool (multiple patents “pooled” and licensed out by one entity in order to cut transaction costs for all concerned) was not feasible 10 years ago, he observed.
WHO, WIPO, WTO study
One of the results of the Doha Declaration on TRIPS and Public Health has been closer work between the WHO, WIPO and WTO. Their objectives and areas of responsibility differ, but collaboration means the three areas are better understood and policies can be developed to meet shared objectives in health, intellectual property and trade.
WTO Intellectual Property Division Director Antony Taubman outlined the preliminary findings of a study to be published in 2012. Ensuring poorer patients are able to access medicines and other health products involves proper (“rational”) use of the products, affordable prices, properly designed health systems, suitable financing, and carefully selecting strategies for procuring the products. Intellectual property is only part of the picture.
The study’s purpose is to guide policy-makers through an area of complex policy options, without making any recommendations. It looks at access to medicines and innovation together and the effect they have on each other over time, rather than taking a static approach or looking at them separately.
He highlighted three themes that have developed in the on-going work:
Illumination — the rules need to be transparent and clear. Better factual information is now available on the burden of disease, on access to medicines and prices, and on what patents cover and where.
Coordination — public health cannot be tackled in isolation. Coherence is needed for broader objectives, particularly human rights, public health and the multilateral trade and intellectual property systems. It is also needed on the ground, for instance, in technical assistance and the trilateral cooperation between WHO, WIPO and the WTO.
Implementation — the rules and their flexibilities only deliver expected results when practical choices are taken by governments in their own countries. Illumination and coordination help clear the way, but are not substitutes for action. Practical initiatives will ensure that medicines are more accessible and innovation fulfils unmet health needs.
The study looks at the relationship between innovation, access to medicines and trade in the light of a number of developments over the past decade and discusses some of the challenges ahead.
Manufacturing and product development. Public-private partnerships are increasingly emphasized and partnerships for developing health products are “coming of age”. Research and development in the pharmaceutical industry is evolving, including in a larger number of developing countries through increasingly diverse ways of developing products.
National health systems and policies. More attention is being paid to strengthening national health systems. More funding is available for developing vaccines and for immunization. The impact of non-communicable diseases in developing countries is receiving more attention globally.
Intellectual property and incentives. The relationship between public health, the intellectual property system, and ways to promote innovation and access to medical technologies are better understood. This is accompanied by a policy debate about ways of promoting innovation in medical research, and for financing research and development, particularly for neglected diseases.Better information, better debate. Discussions on international public policy are better informed, and more soundly based on facts because more data are available, covering a wider range of subjects. As a result, policies are more coherent internationally, with more practical cooperation on health policies that cut across a range of related issues — health policy, trade and intellectual property.