Joint submission authored by Yousuf Vawda, Andrew Rens, Andrew Rens, Brook Baker, Tobias Schonwetter, and Achal Prabhala; and co-submitted by 44 other academics, experts, scholars and advocates. The full submission is available here as a printable PDF.
The introduction follows.
The Department of Trade and Industry’s (the dti) Intellectual Property Consultative Framework (the Framework) identifies the intersection between intellectual property (IP) and public health as a priority area that requires immediate domestic review. Thus, the focus of this submission is on this priority area.
In crafting an IP policy framework affecting, among other things, medical technologies, policy and lawmakers must address the tension that exists between the protection of IP rights and human rights – the rights of the public to have access to medicines and other health technologies necessary for their well-being. If there had been any doubt about how to resolve this tension, then the issue must surely have been settled with the release of the Report of the UN Secretary-General’s High Level Panel on Access to Medicines on 14 September 2016 (the Panel Report). The Panel Report states:
“Human rights are fundamental, universal entitlements that people inherently acquire by virtue of their birth. In comparison, intellectual property rights are ‘one policy tool among many for encouraging innovation and technological research and development.’ Intellectual property rights are temporary, revocable, transferable privileges granted by states and can be suspended or revoked under certain conditions laid out in the TRIPS Agreement when it is in the interest of the state or society.”
Yet the primacy of the right to health is not obvious from a reading of the Department of Trade and Industry’s IP Consultative Framework (the Framework). The Framework recognises the ‘intersection between IP and public health’ and proposes to prioritise public health measures in implementing the policy. While we welcome this statement of intent and several of the dti’s positive proposals, it is disconcerting that the Framework fails to reference the human rights paradigm in its approach to policy-making. This is a key theme which recurs in our submission.
The Framework extols IP rights protection as a key driver of innovation, but the evidence for that proposition is less convincing. In addition to the considerable scholarly literature suggesting a thin connection between IP and innovation, the experience of India, and the proposed policies of Brazil, suggest that stringent patent standards better serve the pursuit of innovation than weaker standards, such as they exist in the US and EU. While the latter standards have led to a crisis in pharmaceutical innovation and in pricing of new medicines, rendering essential medicines inaccessible, more stringent patent standards have the potential to rescue pharmaceutical innovation, as well as increase access to medicines. In this regard the Panel Report states in Recommendation 2.6.1(a)
“WTO Members must make full use of the policy space available in Article 27 of the TRIPS Agreement by adopting and applying rigorous definitions of invention and patentability that curtail the evergreening to ensure that patents are only awarded when genuine innovation has occurred.”
In addressing the requirement that countries adopt stringent patent standards, the Panel Report deliberated on the existing model for financing research and development (R&D) into health technologies namely, rewarding innovative activity with patent monopolies, and concluded that it has produced impediments to access and innovation:
“it also has created important tensions because of high prices, and fueled policy incoherencies through the application of exclusivity-driven business models. Because this system is predicated on the ability to generate profit, governments and the biomedical industry have often failed to deliver new health technologies for diseases that do not, and cannot, promise high returns—those that mostly afflict the poor regardless of where they may live.”
In general, well-designed IP policies and legislation can be a useful but imperfect policy instrument in promoting innovation, technology transfer, R&D, industrial development and – more broadly – economic growth, but only if anti-competitive risks are avoided and if IP standards, exceptions and exemptions allow for mutual benefits of IP rights holders and users in the public interest.
The correct framing of a well-tailored IP policy does not relate to innovation and development objectives only, as is acknowledged in the Framework. The Constitution and South Africa’s accession to various international and regional human rights conventions impose human rights obligations on the state, including the right to access health care and the corresponding right of access to essential medicines. In addition, South Africa’s population is entitled, under relevant human rights norms, to share in the benefits of scientific advancement. These human rights principles ought to have been directly addressed in the Framework.
It would be appropriate that the development of IP policy begins with reference to the Bill of Rights, the most relevant and urgent of which are the right to access health care, including medicines, the right to education, including the right to educational materials, and the right to just administrative action.
This framing must inform the objectives of the policy which, we suggest, should seek to: engender the ethos of the Constitution, most particularly human rights obligations pertaining to health; strike a balance between the creators and the users of IP and the public at large; stimulate innovation, including incremental innovation and adaption appropriate to national needs; promote public health and the right to health and of access to medicines more broadly; and promote access to knowledge.
Our approach is thus to engage with the Framework in a sympathetic and constructive yet critical manner. In the following submission we make comments on the provisions of the Framework and, where appropriate, offer recommendations.
In sum, we recommend that:
- The Government should set strict guidelines and time frames for the finalisation of policy in this area and the drafting of relevant implementing legislation.
- In the meantime, the dti should initiate regulatory and sub-regulatory reforms, including pharmaceutical patent examination guidelines, that would clarify and tighten patentability criteria for pharmaceuticals, and allow for immediate patent examination in this area of vital national interest.
- The implementation of a substantive search and examination system should be prioritised, and the relevant legislation promulgated to facilitate substantive examination beyond mere formalities. Clarifying this issue would, for example, allow the dti to take forward examination of pharmaceutical and other health technology-related patents as a matter of urgency, especially as it has already hired and is training a cadre of patent examiners.
- Legislation should be written incorporating all public health flexibilities, including:
- The immediate amendment/repeal of Patent Regulations 40 and 41, in order to facilitate substantive examination of patent applications and to fully comply with the intent of section 34 of the Patents Act;
- The introduction of examination guidelines linked to strict patentability standards with proscription on minor modifications to or variations of known substances, new use and new formulation patents to prevent ever-greening;
- Full disclosure in patent applications including their foreign status and, when available, the International Non-proprietary name (INN) of pharmaceutical-related patents;
- Pre- and post-grant opposition procedures, accessible to all interested parties (widely defined);
- Parallel importation under an explicit international exhaustion regime;
- Expansive compulsory licensing and government use provisions, including simplified procedures, expanded (including public health) grounds for grant, and remuneration guidelines for low percentage royalties;
- Compulsory licences to remedy anti-competitive conduct;
- Extensive early working exceptions, as well as other exceptions for educational, scientific and research purposes; and
- Exclusion of diagnostic, therapeutic and surgical methods; plants, animals and genetic material.
We submit that these measures are all compliant with the TRIPS Agreement and, further, have long been proposed by various international expert panels, including the most recent UN Secretary-General’s High Level Panel.
The process of reforming South Africa’s IP laws has been an inordinately long one. Given the critical public health and public interest issues at stake, we cannot over-emphasise the need to move with utmost urgency to finalise the policy.
The remainder of this document provides detailed comments for many of the sections contained in the IP Consultative Framework document. We will be available to elaborate on our submission if required.