TRIPS flexibilities: current and future use in the SADC region

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TRIPS flexibilities: current and future use in the SADC region

Generics/Research | Posted 13/09/2019 0 Post your comment

In response to the HIV/AIDS crisis of the late 1990s, several legal options were introduced to facilitate access to lower-cost treatments. These included flexibilities in the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, known as ‘TRIPS flexibilities’. In a recent review, authors ‘t Hoen, Kujinga and Boulet describe TRIPS flexibilities and discuss their current and future use in the Southern African Development Community (SADC) region [1].

In the SADC region, compulsory licensing of patents and the transition provisions for the least developed countries (LDCs) members of the WTO play a critical role in the procurement of lower-priced generic medicines. Between 2001 and 2016, eight of the 15 SADC Member States, of which six are LDCs, made use of a TRIPS flexibility, totalling 15 instances in the region. Of these 15 instances, six were compulsory licences or public non-commercial use while nine involved non-enforcement of patents using the LDC transition provision. All instances were related to the provision of HIV treatment, but four of the LDCs stated that they had invoked the measure for all medicines. Every case, except for one (South Africa), was executed.

In 2010, the global health initiative Unitaid established the Medicines Patent Pool (MPP) to safeguard the availability of generic HIV medicines by making patent licences available to generic producers. Today the MPP licences include all World Health Organization recommended HIV treatments, and all sub-Saharan African countries are part of the licensed territory. This makes TRIPS flexibilities for HIV medicines in the SADC region redundant; however, since this licensing practice does not yet exist for most other diseases, it remains important to ensure that TRIPS flexibilities can be invoked when required to protect public health.

For TRIPS flexibilities to be useful, they must be incorporated into national law. The SADC Pharmaceutical Business Plan 2007−2013 proposed to ‘coordinate the implementation of TRIPS flexibilities to improve access to essential medicines within the SADC region’. In 2012, the SADC Strategy for Pooled Procurement of Essential Medicines and Health Commodities proposed pooled procurement of medicines using the group-contracting model, delivered through a staged approach beginning with coordinated information exchange and work sharing. This pooled procurement was designed to reduce costs and establish reserves for further procurement. The updated SADC Pharmaceutical Business Plan 2015−2019 further proposed, among other actions, to:
• Collaborate with development partners to protect, include and take advantage of TRIPS flexibilities, and to assist countries in bilateral trade negotiations to conclude agreements that are not detrimental to public health;
• Strengthen the knowledge of Medicines Regulatory agencies, Intellectual Property officers and procurement agencies on issues of intellectual property and public health; and
• Facilitate local production for export; or importation for re-exportation within SADC as a regional bloc.

To conclude, experience from the SADC region demonstrates that TRIPS flexibilities have been used to effectively procure and supply lower-priced generic medicines for the treatment of HIV. TRIPS flexibilities may be needed for the procurement of lower-priced medicines for other diseases, including non-communicable diseases such as cancer, where patent-protected originator medicines are too costly.

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

Patent challenges in the SADC region

Reference
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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