Do South African Patent laws pose a barrier to access to Medication?
The short answer is yes. South African patent laws, according to the author, tend to favour pharmaceutical companies rather than the public that needs lifesaving drugs.
Introduction
South Africa as a member of the World Trade Organization (WTO) is required to uphold minimum standards of Intellectual Property (IP) protection as defined by the international agreement on Trade-Related Aspects of Intellectual Property Rights (the ‘TRIPS’ agreement). The TRIPS agreement requires its signatories including SA to grant 20 years of patent protection on products and processes that meet SA’s patentability criteria. [1]
The criteria for patentability in the Patents Act are:
1. Novelty (New);
2. Involves an inventive step;
3. Is capable of being used in trade, industry or agriculture.[2]
The criteria mentioned above seems straightforward and fair; however, South Africa does not technically use it. South Africa uses a depository system for granting patents, meaning that instead of examining whether the claims set out in the patent applications are true, the South African patent office grants patent applications if the applicant meets the procedural requirement. The procedural requirement involves the prescribed form being filled out correctly and the prescribed fees being paid.
The use of a depository system causes a few problems namely:
1. It enables patent applications that do not meet the criteria to be granted.
2. It enables the “evergreening”.
Evergreening: can be described as an act where pharmaceutical companies make minor modifications to existing drugs to get multiple patents on a single medicine. The act of evergreening prevents medicine from going into the public domain, which results in the delay or blockage of the generic versions of that medication, and thus limits the access to pharmaceutical medicine. Pharmaceutical companies get away with such practices due to the non-examination of patent claims.[3]
Under the TRIPS agreement, SA has the flexibility to set stricter patentability criteria to prevent evergreening amongst other things and to make medication more accessible. Flexibilities such as compulsory licensing and parallel importation.
Compulsory licensing: under the TRIPS agreement, WTO members can grant compulsory licensing without the consent of the patent holders, on the grounds defined by the country’s national laws, to use an invention or allow its use by a third party.
The granting of compulsory licenses is to protect the health and safety of citizens, and the Doha Declaration affirms the freedom of countries to determine the grounds for issuing compulsory licenses.
Through compulsory licensing, the price of medicines can be lowered to ensure an increased supply of medicines in the market, where the patentee has not or will not provide a sufficient supply at the right price. Compulsory licensing is an important instrument in emergencies where a patentee cannot respond to an urgent situation.
It is important to note that South Africa to date has never issued a compulsory license.
Parallel Importation: occurs when a genuine good is bought from another country and imported to South Africa without the consent of the patent holder.
South Africa fails to make use of parallel importations; which enables countries to import patented medicines from other countries in which they are sold at lower prices.
Conclusion
South Africa currently does not take full advantages of the legal flexibilities permitted under the TRIPS Agreement. Hopefully, in the light of the circumstances, we find ourselves under South Africa might start to fully utilize the abovementioned flexibilities.
[1] https://www.fixthepatentlaws.org/wp-content/uploads/2016/09/MSF-FTPL-report-FINAL-VERSION.pdf
[2] 25 (1) of the Patents Act
[3] Why South Africa should Examine Pharmaceutical Patents, MEDICINS SANS FRONTIERES ACCESS CAMPAIGN 11–12 (2013), http://www.msfaccess.org/content/why-south-africashould-examine-pharmaceutical-patents
