The South African government is calling for comments on its proposed National Policy on Intellectual Property, which supporters say will, if implemented, curb patent evergreening and expand production of generics.
A central issue identified in the draft policy, which the Department of Trade and Industry (DTI) has put out for consultation until October 4, is that, at present, South Africa does not examine patent applications. Instead, the system allows drugmakers to obtain multiple patents on the same drug, even for inventions which do not fall under the country’s definition of innovation, allowing firms to extend the lives of their patents, blocking competition and charging inflated prices, say critics.
To remedy this, the policy says South Africa should set “a higher standard for innovation,” so that patents are not granted simply for combining existing medicines or registering new uses for previously-patented products.
The document also points to the need for a substantive patent examination system, and this has been warmly welcomed by health groups the Treatment Action Campaign (TAC), Medecins Sans Frontieres (MSF) and SECTION27, who have long campaigned for intellectual property reform.
South Africa hands out an excessive number of pharmaceutical patents - 2,442 in 2008 alone, compared to Brazil which granted just 278 during 2003-08 - without examining applications to determine their validity, they point out, and call on the DTI to limit the number of drug patents granted.
It should do this, they say, by: - ensuring that all applications are substantively examined; - strengthening patentability criteria to prevent evergreening; - enhancing the Patents Office’s public transparency concerning patent applications and the status of granted patents; - allowing a broad range of third parties to file pre-grant and post-grant patent oppositions - currently, the only way to challenge a patent in South Africa is through lengthy court proceedings; and - broadening the grounds and facilitating the procedures for issuing a compulsory license.
The health groups note while that the consultation is only the start of the legislative process, and the reform process has already been considerably delayed, “the principles in the document set the stage for changes that promise to increase competition in the pharmaceutical sector and lower the price of medicines in the sector.”
They also welcome the draft policy’s strong statement that South Africa should not be party to trade agreements with provisions that would undermine the right to health.