30 August 2003
Decision removes final patent obstacle to cheap drug imports
WTO member governments broke their deadlock over intellectual property protection and public health today (30 August 2003). They agreed on legal changes that will make it easier for poorer countries to import cheaper generics made under compulsory licensing if they are unable to manufacture the medicines themselves.
public health notifications
> Dedicated webpage on the decision of 30 August 2003, with details of notifications
The decision settles the one remaining piece of unfinished business on intellectual property and health that was left over from the WTO Ministerial Conference in Doha in November 2001.
“This is a historic agreement for the WTO,” said Director-General Supachai Panitchpakdi. “The final piece of the jigsaw has fallen into place, allowing poorer countries to make full use of the flexibilities in the WTO’s intellectual property rules in order to deal with the diseases that ravage their people.
“It proves once and for all that the organization can handle humanitarian as well as trade concerns,” he went on. “This particular question has been specially difficult. The fact that WTO members have managed to find a compromise in such a complex issue bears testimony to their goodwill.
“It also gives WTO members a good momentum to take to the Ministerial Conference in Cancún. I sincerely hope ministers can work together to reach agreement on the other outstanding issues that they will deal with in Cancún,” he said.
The decision waives countries’ obligations under a provision of the
WTO’s intellectual property agreement. Article 31(f) of the
Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement
says that production under compulsory licensing must be predominantly
for the domestic market. This effectively limited the ability of
countries that cannot make pharmaceutical products from importing
cheaper generics from countries where pharmaceuticals are patented.
In the decision, WTO member governments have agreed that the waiver will last until the article is amended.
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Flexibilities such as “compulsory licensing” are written into the TRIPS
Agreement — governments can issue compulsory licenses to allow other
companies to make a patented product or use a patented process under licence without
the consent of the patent owner, but only under certain conditions aimed
at safeguarding the legitimate interests of the patent holder.
But some governments were unsure of how these flexibilities would be interpreted, and how far their right to use them would be respected. The African Group (all the African members of the WTO) were among the members pushing for clarification.
A large part of this was settled at the Doha Ministerial Conference in November 2001.
In the main Doha Ministerial Declaration of 14 November 2001, ministers stressed that it is important to implement and interpret the TRIPS Agreement in a way that supports public health — by promoting both access to existing medicines and the creation of new medicines.
They therefore adopted a separate declaration on TRIPS and Public Health. They agreed that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health.
They underscored countries’ ability to use the flexibilities that are built into the TRIPS Agreement, including compulsory licensing and parallel importing.
And they agreed to extend exemptions on pharmaceutical patent protection for least-developed countries until 2016. (The TRIPS Council completed the legal drafting task on this in mid-2002, see press release 301.
On one remaining question, they assigned further work to the TRIPS Council — to sort out how to provide extra flexibility, so that countries unable to produce pharmaceuticals domestically can import patented drugs made under compulsory licensing. (This is sometimes called the “Paragraph 6” issue, because it comes under that paragraph in the separate Doha declaration on TRIPS and health.)
Article 31(f) of the TRIPS Agreement says products made under compulsory licensing must be “predominantly for the supply of the domestic market”. This applies directly to countries that can manufacture drugs — it limits the amount they can export when the drug is made under compulsory licence. And it has an indirect impact on countries unable to make medicines and therefore wanting to import generics. They would find it difficult to find countries that can supply them with drugs made under compulsory licensing.
Members were deadlocked over how to resolve this question, and the original deadline of 31 December 2002 was missed.
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This 30 August 2003 agreement allows any member country to export
pharmaceutical products made under compulsory licences within the terms
set out in the decision (text below). All WTO member countries are
eligible to import under this decision, but 23 developed countries are
listed in the decision as announcing voluntarily that they will not use
the system to import.
A separate statement by General Council chairperson Carlos Pérez del Castillo, Uruguay’s ambassador, is designed to provide comfort to those who feared that the decision might be abused and undermine patent protection. The statement (see below) describes members’ “shared understanding” on how the decision is interpreted and implemented. It says the decision will be used in good faith in order to deal with public health problems and not for industrial or commercial policy objectives, and that issues such as preventing the medicines getting into the wrong hands are important.
A number of other countries announced separately that if they use the system it would only be for emergencies or extremely urgent situations. They are: Hong Kong China, Israel, Korea, Kuwait, Macao China, Mexico, Qatar, Singapore, Chinese Taipei, Turkey and United Arab Emirates
The decision covers patented products or products made using patented processes in the pharmaceutical sector, including active ingredients and diagnostic kits.
It is designed to address the public health problems recognized in Paragraph 1 of the Doha Declaration on TRIPS and Public Health, which says that WTO ministers “recognize the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.”
The decision takes the form of an interim waiver, which allows countries producing generic copies of patented products under compulsory licences to export the products to eligible importing countries. The waiver would last until the WTO’s intellectual property agreement is amended.
The negotiations on the decision were conducted by the chairpersons of the TRIPS Council: Ambassador Eduardo Pérez Motta of Mexico (2002) and Ambassador Vanu Gopala Menon of Singapore (2003).
The text of the decision and the General Council chairperson’s statement follow.