WHO Drug Information Vol. 20, No. 1, 2006 - World Health ...

Access to MedicinesWHO Drug Information Vol 20, No. 1, 2006Production and export of generic medicinesunder the TRIPS AgreementAt the WTO Ministerial Conference in Doha, November 2001, WTO Members adopted the MinisterialDeclaration on the TRIPS Agreement and Public Health (the Doha Declaration). The DohaDeclaration confirmed, amongst others, the right of WTO Members to use safeguard measures,such as compulsory licensing and parallel imports, to protect public health and promote access tomedicines.However, WTO Members failed to resolve a key issue at Doha: how countries which have insufficientor no manufacturing capacity in the pharmaceutical sector can effectively exercise the right touse compulsory licensing? The TRIPS Agreement permits the grant of compulsory licences forlocal production of generic versions of patented medicines in the interest of facilitating access toaffordable medicines. But countries with insufficient or no manufacturing capacity cannot takeadvantage of this measure.One option for these countries is to grant a compulsory licence to enable the import of genericmedicines produced by foreign manufacturers. The problem is that where generic versions ofpatented drugs are produced under a compulsory licence, the TRIPS Agreement (Article 31f) requiresthat such production shall be predominantly for the supply of the domestic market. This hasraised concerns that exporting countries may have difficulties exporting sufficient quantities tomeet the needs of those countries with insufficient or no manufacturing capacity. The Doha Declarationhighlighted this problem in Paragraph 6 and WTO Members were instructed to find an expeditioussolution.On 30 August 2003, the WTO General Council established, as an interim measure, a system topermit the export of pharmaceutical products manufactured under compulsory licence. This systemwas finally adopted on 6 December 2005 as an amendment (subject to ratification) to theTRIPS Agreement.Can the system work?Whilst the proposed amendment has been hailedby some as an important breakthrough in thedebate on patents and access to medicines, thisoptimism may be a little premature. No countryhas yet to make use of the system even though itwas adopted in 2003. Since the final 2005amendment will essentially incorporate the samesystem (and the same conditions), the workabilityof the system remains to be proven.The system permits countries wishing to importgeneric medicines to do so from a foreign producer.Whilst least-developed countries areautomatically eligible, developing countries haveto establish either that they have no manufacturingcapacity or the current capacity is insufficientto meet their needs. Countries make the determinationthemselves; and the WHO guide onimplementing the Decision observes that this is amatter of self-assessment that is not challengeableby other Members. The system requires theimporting country to notify the TRIPS Council.Where the needed medicine is patent protected inthe importing country, the government will have togrant a compulsory licence for the import of thegeneric version of the medicine. Where no patentis in force, the importing country has to providenotification of its intention to use the system.Whilst much has been made about the amendmentallowing least-developed countries to importgeneric medicines, the most significant aspect ofthe system is the ability of generic-producingcountries to export generic medicines without thequantitative restrictions. The generic manufacturerhas to obtain a compulsory licence toproduce and export, which will only permit theproduction and export of the quantity required bythe importing country. The compulsory licence willalso require the manufacturer to make theproducts clearly identifiable through labelling ormarking, and notify the TRIPS Council of thequantities supplied to the importing countries andthe distinguishing features of product. But willgeneric manufacturers be willing and able toproduce and export the needed medicines underthe system?22