#PharmaGate: South Africa’s Push for Patent Law Reforms Exposes Both Government and Drug Companies
The Mail and Guardian (M&G) newspaper in South Africa published a story titled: “Motsoaledi: Big pharma’s ‘satanic’ plot is genocide” where it is reported that Health minister Aaron Motsoaledi is livid about a pharmaceutical company campaign he says will restrict access to crucial drugs.
It is reported that the South African drug companies’ umbrella body, the Innovative Pharmaceutical Association of South Africa (Ipasa), selected a Washington, DC-based, lobbying firm Public Affairs Engagement (PAE) to lead the charge against South Africa’s Draft National Intellectual Property Policy (DNPIP).
PAE, in turn, put forward a nine-page plan titled “Campaign to Prevent Damage to Innovation from the Proposed Draft National IP Policy in South Africa”. This plan which was leaked to the press is now at the heart of the so-called #PharmaGate scandal which has received widespread condemnation.
To recap, the DNPIP published for comment in September 2013 makes two key recommendations in relation to institutional reform of patent law namely the combination of the depository and substantive examination systems; and the introduction of pre-grant and post-grant opposition procedures. The cumulative effect of these two recommendations is that the evergreening of patents in South Africa would become a thing of the past. In other words, pharmaceutical companies would not be granted patents for minor adjustments to patented compounds just prior to expiry.
It has been argued, quite convincingly, that evergreening locks generic drugs from competing with patented drugs and leaves needy patients unable to afford vital drugs such as HIV/AIDS treatments. Therefore Health rights groups in South Africa have supported the DNIPP arguing that it will facilitate the production of cheaper, generic medicines which will increase competition in the pharmaceutical sector and lower the price of medicines in South Africa.
At Chapter 2 on page 23, the DNPIP recommends that:
“South African legislation should allow strict rules to apply to patenting as competition principles may be undermined. This should exclude diagnostic, therapeutic and surgical methods from patentability, including new uses of known products, as is the case under the TRIPS Agreement.”
However many have noted that the DNIPP does not make any reference to the amendments to the Medicines and Related Substances Control Act intended to reduce drug prices by allowing generic substitution of off-patent drugs, the parallel importation of on patent drugs as well as price transparency. In addition, it is noted that the DNIPP is silent on the provisions of compulsory licensing in terms of S56 of the Patents Act. In the case of both pieces of legislation, the DNIPP is faulted for not addressing the issues of implementation and enforcement in the context of access to essential medicines.
With respect to patent search and examination, the DNPIP makes several recommendations relating to the introduction of a “search and examination” system for patents:
“There is an outcry by users of the patent system that South Africa needs strong patents that can survive the test of competitiveness throughout the world. This can be achieved if a substantive Search and Examination of Patents system is followed.” – pg. 8.
“Cabinet should consider approving the establishment of a substantive Search and Examination of Patents to have strong technologies.” – pg. 8
“This also means that South Africa may need to create a Substantive Search and Examination since it is using a depository system that inherently grants weak patents.” – pg. 12
“Cabinet should consider approving the establishment of a Search and Examination Office to have strong technologies.” – pg. 15
Currently, South Africa’s patent prosecution system is a deposit based system in which patent applications are only examined as to their formalities i.e. patent applications are not examined for novelty, inventive step and utility, if a patent application complies with the required formalities, the application can proceed to grant. Thus the risk exists that this system is likely to result in grant of multiple patents on e.g. a single medicine, and to allow evergreening to occur.
With respect to pre-and post-grant oppositions, IP commentators have argued that the DNIPP appears to confuse the pre- and post-grant opposition proceedings with the search and examination proceedings which are not formally part of the prosecution of the patent. More fundamentally, it has been noted that the DNIPP fails to provide any empirical data or particular country’s model that was considered in coming up with the recommendations with respect to patent search and examination as well as pre-and post-grant oppositions.
All in all, this blogger submits that #PharmaGate exposes the South Africa government’s criticized track record with regard to implementation of existing laws relating to access to medicines. In addition, the Trade and Industry’s Ministry unsatisfactory drafting of the DNIPP is exposed once more. Therefore the Health Minister’s latest sensationalist remarks reported by the M&G appear to be intend to deflect attention from the above issues of poor implementation and drafting by the Executive branch. As for the drug companies, #PharmaGate only exposes the capitalist and pro-intellectual property (IP) ownership stance of Big Pharma, aptly captured in the critically acclaimed documentary, “Fire in The Blood”, whose trailer is featured above.