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.
South Africa to allow parallel imports and compulsory licensing
Home/Policies & Legislation | Posted 15/11/2013 0 Post your comment
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.
Related articles
South African HCPs told to ‘get their facts straight’ on generics
Increased use of generics could save South Africa millions
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
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2013 Pro Pharma Communications International. All Rights Reserved.
Source: Business Day, DTI
Guidelines
Regulatory update for post-registration of biological products in Brazil
New regulations in Brazil for the registration of biosimilars
Reports
Top nine biological drugs by sales in 2023
New findings of semaglutide in managing hidradenitis suppurativa
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Global biosimilars guideline development – EGA’s perspective
Comments (0)
Post your comment