South Africa to allow parallel imports and compulsory licensing

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South Africa to allow parallel imports and compulsory licensing

Home/Policies & Legislation | Posted 15/11/2013 0 Post your comment

Just two months after releasing a draft policy on intellectual property, South Africa has announced that it will also amend its patent legislation to allow parallel imports and compulsory licensing.

The National Policy on Intellectual Property was released for comment on 4 September 2013 by the South African Government’s Department of Trade and Industry [1]. The aim of the health-related provisions in the policy, according to Health Minister Rob Davies, are to bring South Africa’s laws in line with international agreements, including the World Trade Organization’s (WTO’s) Trade Related Aspects of Intellectual Property Rights (TRIPS), which has legal flexibility measures that effectively allow countries to break patents on medicines in a public health emergency. TRIPS allows countries to use compulsory licensing as an option to make patented drugs more affordable for citizens by allowing generics manufacturers to bring generics to the market before the expiry of patents in a public health emergency.

South Africa is the world capital of HIV/AIDS, according to Mr Davies, and has a serious burden of tuberculosis linked to that. He adds that the country has ‘to have the freedom and ability to use the policy space that’s been made available to us under TRIPS and public health for us to take that option’.

In its announcement of 5 November 2013, the Department of Trade and Industry says that the Patents Act as it stands does not address issues of pricing of medicines, despite the fact that the National Policy on Intellectual Property seeks to address such matters. The department therefore states that ‘South Africa will amend its legislation to address issues of parallel importation and compulsory licensing in line with the Doha Decision of the WTO on Intellectual Property and public health.’

In South Africa there is no patent extension or restoration despite the fact that the country is under pressure to introduce such measures. However, since there is no international harmonization on such matters the country has no plans to introduce any such measures.

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. South Africa introduces new patent policy [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 15]. Available from: www.gabionline.net/Policies-Legislation/South-Africa-introduces-new-patent-policy

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Source: Business Day, DTI