The separate Doha Declaration explained
WTO member governments adopted the Declaration on the TRIPS Agreement
and Public Health by consensus at the WTO’s Fourth Ministerial
Conference in Doha, Qatar, on 14 November 2001.
Its purpose is to respond to the concerns that have been expressed that the TRIPS Agreement might make some drugs difficult to obtain for patients in poor countries.
Inventors are allowed patent rights in order to promote research and development. That includes the creation of new drugs. The TRIPS Agreement, which has been in force since 1995, also enshrines in public international law, governments’ right to take various kinds of measures that qualify or limit intellectual property rights, including for public health purposes.
However, some members and public interest groups queried whether the flexibility written into the TRIPS Agreement was sufficient to ensure that it supports public health, especially in promoting affordable access to existing medicines while also promoting research and development into new ones.
Different views were expressed about the nature and scope of the flexibility in the TRIPS Agreement, for example about compulsory licensing or parallel imports (see explanation in fact sheet).
Questions were asked as to whether this flexibility would be interpreted by the WTO and its members in a broad, pro-public-health way.
There was concern about whether governments would feel free to use this flexibility to the full, without fearing pressure from trading partners or industry.
The special declaration responds to these concerns in a number of ways.
First, it emphasizes that the TRIPS Agreement does not and should not prevent WTO members governments from taking measures to protect public health. It reaffirms the members’ rights to use fully the provisions of the TRIPS Agreement, which provide flexibility for this purpose.
These important statements are a signal from all WTO members: they will not try to prevent each other from using these provisions.
Second, the declaration makes it clear that the TRIPS Agreement should be interpreted and implemented in a manner that supports WTO members’ right to protect public health and, in particular, to promote access to medicines for all.
It also highlights the importance of the objectives and principles of the TRIPS Agreement for interpreting its provisions. Although the declaration does not refer specifically to Articles 7 (“Objectives”) and 8 (“Principles”) of the TRIPS Agreement, developing country members attach particular importance to these provisions.
These statements therefore provide important guidance both to individual members and — in the event of disputes — to WTO dispute settlement bodies.
Third, the declaration contains a number of important clarifications of some of the flexibilities contained in the TRIPS Agreement. It does this while maintaining members’ commitments under the TRIPS Agreement.
On compulsory licensing, the declaration makes it clear that each member is free to determine the grounds upon which the licences are granted. This, for example, is a useful corrective to the view sometimes expressed that some form of emergency is a pre condition for compulsory licensing.
The TRIPS Agreement does refer to national emergencies or other circumstances of extreme urgency in connection with compulsory licensing. But this is only to indicate that in these circumstances there is no need to try to obtain a voluntary licence before resorting to compulsory licensing.
The declaration makes it clear that each member has the right to determine what constitutes a national emergency or other circumstance of extreme urgency, and that public health crises can fit the bill, including HIV/AIDS, tuberculosis, malaria and other epidemics.
The declaration also refers to the “exhaustion” of intellectual property rights, and therefore a member’s right to allow parallel imports (for an explanation see fact sheet.
The TRIPS Agreement says that a member government’s practices in this
area cannot be challenged under the WTO dispute settlement system.
The declaration makes it clear that the TRIPS Agreement’s provisions on exhaustion in effect leave each member free to establish its own regime without challenge — subject to the general TRIPS provisions prohibiting discrimination on the basis of a person’s nationality.
While WTO members have clarified the flexibility in the TRIPS Agreement and their right to use it to the full, the story does not end there. It is a country’s domestic law that has direct legal force within that country. Therefore, the declaration does not remove the need for each country to take the necessary steps domestically to use this flexibility where necessary if it wants to ensure that medicines are available at affordable prices.
For least-developed country members of the WTO, the declaration says they do not have to protect patents and undisclosed information rights for pharmaceuticals until 2016. For these rights, the least-developed countries therefore have 10 years added to their transition period for applying the TRIPS provisions.
An issue which arose in the work on the declaration was the question of countries with limited manufacturing capacities and how they could make effective use of compulsory licensing.
It is not in dispute that members can issue compulsory licences to import as well as for domestic production. The concern that has been expressed is about whether supplies of generic medicines made in other countries will be available for importing, particularly in the light of the provision of Article 31(f) of the TRIPS Agreement.
This states that any compulsory licences granted to generic producers in those other countries shall be “predominantly for the supply of the domestic market of the Member” granting the compulsory licence.
This concern may become greater as countries with important generic industries, such as India, are obliged to provide patent protection for pharmaceutical products from 2005. In this regard, the declaration recognizes the problem and instructs the TRIPS Council to find an expeditious solution to it and to report on this before the end of 2002. (Members failed to reach consensus by that deadline. In the preparations for the Cancún Ministerial Conference, attempts are underway to try to break the deadlock.)
While emphasizing the scope that the TRIPS Agreement gives to governments to take measures to promote access to medicines, the declaration also recognizes the importance of intellectual property protection for developing new medicines. It also reaffirms WTO members’ commitments under the TRIPS Agreement.