The policy has been adopted by cabinet and as such represents official government policy, and has the potential to herald a new era in access to medicines for South Africa
JOHANNESBURG, South Africa, June 1, 2018,-/African Media Agency (AMA)/- Yesterday (30 May 2018), after nine years of development, the Department of Trade and Industry (the dti) finally published the Intellectual Property Policy of the Republic of South Africa, Phase I. The policy has been adopted by cabinet and as such represents official government policy, and has the potential to herald a new era in access to medicines for South Africa.
While we welcome the finalisation and adoption of this policy, we stress that it has not yet changed anything in the lives of people in South Africa who right now need medicines that remain unaffordable, and that it will not do so until key elements of the policy become law. As a matter of urgency, the dti must produce a thorough and far-reaching bill to amend the relevant Acts and parliament must prioritise the passing of this bill. Those aspects of the policy that can be implemented without legislative changes must be implemented right away. Whether the state can deliver the required legislative changes will be a key test of its commitment to the health of the people.
The harsh reality is that this law reform process in South Africa has already taken too long. It has taken too long for two of our comrades who have passed away in recent years, Tobeka Daki and Sue Johnson. At critical times in their illnesses, both Tobeka and Sue could not access the medicines they needed due to high prices. We will remember these comrades as we continue to advocate for more just and humane patent laws.
Comment on the content of the policy
As the Fix the Patent Laws coalition, we welcome the publication of the new policy and we are broadly in agreement with its content. The policy addresses most of the critical health-related policy and legislative changes that we have been campaigning for since 2011. We are disappointed though that certain critical sections of the policy are lacking in detail – in particular the sections on patentability criteria and on compulsory licensing.
That said, we welcome the policy’s framing in terms of the Constitution of South Africa and its acknowledgement of the importance of considering the public health impact of economic policy. We also welcome the policy’s acknowledgement that South Africa requires an intellectual property framework appropriate to its phase of development and that a patent maximalist approach is not in the best interest of our economy. In this regard, the policy implicitly rejects the incorrect view that trade-offs have to be made between the right to health and economic development
We make the following specific comments:
1. We support the introduction of a substantive patent search and examination system for patents in South Africa – something we have been advocating for, for years. The policy recognises that the current depositary system, in which patent applications are granted if they meet procedural formalities (paperwork and filing fee), leads to an excessive number of poor quality patents being granted in comparison to other countries. Patent examination guidelines must now be published for public input and the examination of patent applications for pharmaceutical products must start as soon as possible.
2. We welcome the commitment to develop patentability criteria to “promote genuine innovation” – although we are disappointed that the policy does not go further to discourage specific evergreening practices. Ideally, the policy would have explicitly stated that South Africa will no longer grant patents for new uses, new forms, new formulations, combinations and other minor modifications of existing medicines. To improve the system, it is vital that South Africa develop rigorous patentability criteria and examination guidelines, following international best practices in countries of a similar developmental status, such as Argentina and India. By ensuring that only patents that meet rigorous criteria for novelty and inventiveness are granted, the government can curb excessive and secondary patenting, and ensure that only genuine innovation is rewarded. This will facilitate earlier introduction of more affordable generic medicines, ensuring that more people can access medicines earlier. Raising the bar for patentability is also necessary to incentivise R&D expenditure and efforts towards the development of meaningful health innovations that address unmet health needs, rather than perpetuating the pursuit of minor modifications and me-too versions of existing profitable products.
3. We welcome the long-term commitment to introducing pre- and post-grant patent opposition procedures that could help ensure that only those inventions that represent genuine innovation are granted patent protection. This has been another key ask of our campaign. However, we are concerned that the interim solution proposed by the policy—a third-party observation system and administrative law procedures—will not permit sufficient participation by third-parties. We instead encourage the rapid introduction of simplified opposition procedures, and greater transparency concerning patent applications to allow third parties, such as civil society groups and other pharmaceutical companies, to intervene.
4. We support the commitment to introduce a “more effective and efficient” system to obtain compulsory licenses for medicines – another key ask of our campaign in recent years. Compulsory licenses are a vital tool to ensure medicine access and must be available on a wide variety of grounds and in such a way that they can be granted quickly and effectively when needed for public health purposes. We urge government to withstand the industry pressure that will no doubt oppose this policy commitment, even though this commitment is entirely in line with World Trade Organisation rules.
We remain committed to engaging constructively with the DTI, the inter-ministerial committee on IP, and wider government to ensure rapid reforms to our patent laws to improve access to medicines in line with the state’s Constitutional obligations. We cannot wait another nine years for this policy to be turned into law.
Distributed by African Media Agency (AMA) on behalf of Médecins sans frontières (MSF).
