Improving access to medicines: the Doha Declaration on the TRIPS Agreement

Generics/Research | Posted 06/09/2019 post-comment0 Post your comment

In a recent review, authors ‘t Hoen, Kujinga and Boulet describe the role of the Doha Declaration on the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in improving access to essential medicines [1].

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The HIV/AIDS crisis of the late 1990s brought the international community together in developing a plan to facilitate access to low-cost HIV treatment. In 1999, the World Health Assembly (WHA), the decision-making body of the World Health Organization (WHO), reinforced the role of WHO in intellectual property ‘to ensure that public health interests are paramount in pharmaceutical and health policies’. This WHA resolution encouraged countries to assess their options to safeguard access to essential medicines and requested that WHO assess the health implications of international trade agreements, such as TRIPS, with a view to assisting countries in mitigating any negative implications. This resolution, coupled with public pressure to introduce greater flexibility into international patent rules, led in 2001 to the adoption of the Declaration on TRIPS and Public Health by the WTO Ministerial Conference in Doha. The Doha Declaration was a significant development in international policy designed to rebalance the rights of patent holders with the rights and duties of governments to protect public health. Paragraph four of the declaration reads: ‘We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.’

The Doha Declaration clarified legal tools known as ‘TRIPS flexibilities’ that countries can use to ensure access to medicines. Specifically, it clarified the right of countries to issue compulsory licences and to permit parallel importation. A compulsory licence allows a patent to be used without the consent of the patent holder for a reasonable royalty payment. When a government uses a compulsory licence, this is called ‘public non-commercial use’ or ‘government use’. Public non-commercial use can be extremely useful in the procurement of medicines to supply the healthcare system when the patent-holder offers the product at an unaffordable price. In these instances, governments can permit local generic drug production or import.

The Doha Declaration also established new transition provisions specifically for least developed countries (LDCs) members of the WTO relating to the grant and enforcement of patents and test data protection. These transition provisions permit LDCs to postpone the implementation of certain intellectual property protection provisions. Transition provisions facilitate medicines manufacturing as some LDCs have significant pharmaceutical production capacity and offer the possibility to further develop manufacturing capacity.

Southern African Development Community (SADC) Member States can also benefit from the regional exception of TRIPS Article 31bis, an additional flexibility available to some regional groups facilitating trade in generic medicines within such groups to channel economies of scale.

Conflict of interest
The authors of the research paper [1] declared that there was no conflict of interest.

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TRIPS flexibilities: current and future use in the SADC region

Patent challenges in the SADC region

1. ‘t Hoen E, Kujinga T, Boulet P. Patent challenges in the procurement and supply of generic new essential medicines and lessons from HIV in the southern African development community (SADC) region. J Pharm Policy Pract. 2018;11:31.

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Source: Gedeon Richter

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