Opinion: WTO waiver is important, but so is fixing SA’s outdated patent laws

Opinion: WTO waiver is important, but so is fixing SA’s outdated patent lawsPHOTO: Cindy Shebley/Flickr
Comment & Analysis

Since 2020, South Africa has become the world’s champion in the call for equitable access to COVID-19 vaccines. On multilateral platforms the South African government has been clear in its call for equitable and universal access to COVID-19 medical products and treatments – not only for South Africa, but for the rest of the continent too.

The South African government has, at least in its rhetoric at high-level political gatherings, spoken out against vaccine nationalism and challenged the historically dominant power dynamics of pharmaceutical manufacturers. To support these statements, the South African government has together with India jointly proposed a patent waiver on COVID-19 health technologies at the World Trade Organisation’s (WTO) Trade-Related Aspects of Intellectual Property (TRIPS) Council. Along with the need for agreements to enable technology transfer and investment in local pharmaceutical production capacity, this patent waiver could allow countries to scale up the manufacturing of COVID-19 vaccines by issuing compulsory licenses to generic manufacturers.

The WTO TRIPS council will vote on the proposed intellectual property waiver on 10 or 11 March 2021.

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Opponents of the proposal including the European Union, United Kingdom, United States, Brazil, China, Switzerland, Australia and several other countries with strong local pharmaceutical lobbies – claim that voluntary licensing measures are a more appropriate measure to secure sufficient supply of vaccines. Voluntary licensing measures – where a pharmaceutical company who owns the intellectual property voluntarily licenses another company to produce a medicine – will not only respect the sanctity of intellectual property, the opponents argue, but these voluntary measures will enable sufficient supply of vaccines and medicines.

While voluntary licensing agreements between pharmaceutical companies (like the one negotiated between AstraZeneca and Serum Institute of India) may increase the supply of vaccines in part, it is unlikely that this will meet the huge global demand soon enough. Many pharmaceutical companies will not enter into voluntary licensing agreements, and even for those who may, voluntary licensing agreements tend to be geographically limited, or contain conditions to curb competition. Such clauses limit the ability of these agreements to achieve the widespread coverage needed to achieve global population immunity. Activists have also argued that relying on the charitability of pharmaceutical companies – who have already demonstrated their profit-seeking motives by allowing richer countries to buy up global supply – is unlikely to secure equitable access to COVID-19 vaccines and medicines.

Opponents of the proposal also state that existing provisions (known as TRIPS flexibilities) can be used for lower-income or middle-income countries to circumvent patents and get the vaccine doses that they need. TRIPS flexibilities among others allow states, in exceptional circumstances, to issue compulsory licenses to generic pharmaceutical manufacturers without the consent of patent holders. But TRIPS flexibilities are notoriously difficult and time consuming to implement, and are done on a case-by-case basis for specific medicines or manufacturers. Many countries have in the past undermined the use of these flexibilities by imposing restrictive trade agreements, or through blatant threats and political pressure. South Africa has never managed to successfully issue a compulsory license for any medicine.

But there seems to be a disjunct between promising and progressive commitments of the South African government on the international stage and the domestic legal framework on intellectual property.

South Africa has a painful history of patents obstructing access to medicines. Strides taken to improve access to medicine through challenging intellectual property (IP) rights have been ad hoc and limited to specific diseases or medicines. While the government’s international statements are important and necessary, more sustained change is needed at the domestic level to make sure that people can equitably access the medicines they need.

Multilateralism and international solidarity

Along with the patent waiver proposal at the WTO, South Africa has endorsed several high level commitments to fair, universal and equitable access to COVID-19 therapeutics, diagnostics, medicines and vaccines. Both President Cyril Ramaphosa and Minister of Health Dr Zweli Mkhize made statements in support of this at the World Health Organization’s World Health Assembly, an extraordinary summit of the G20, the UN General Assembly, UNAIDS, an extraordinary summit of the Organisation of African, Caribbean and Pacific States, a special gathering of the European Commission on the global response to COVID-19, and at a Virtual China-Africa Summit on COVID-19 – to name a few. While the patent waiver proposal would allow for compulsory licensing, South Africa was quick to join and participate in the leadership of international initiatives which pool patents and allow for voluntary license. These initiatives include the Access to COVID Tools (ACT) Accelerator, and the COVID-19 Technology Access Pool (C-TAP) – both frameworks facilitated by the WHO to share intellectual property, increase global partnership and collaboration, and secure financing for fair distribution of vaccines.

At the African Union (AU), South Africa has also developed regional frameworks for the continent not to “be left behind” in the race for vaccines and their distribution, “Call[ing] for an equitable and timely distribution of vaccine supply within the African continent”. President Cyril Ramaphosa presided over a digital conference on Africa’s role in vaccine development and access between 24 and 25 June 2020, where the Africa Centre for Disease Control and Prevention (Africa CDC) Consortium for COVID-19 Vaccine Clinical Trial (CONCVACT) was launched and a continental strategy for a COVID-19 vaccine was adopted. The strategy “recognis[ed] the barriers that intellectual property, including patents, trade secrets and other technological know-how has posed to timely introduction of affordable vaccines in developing countries in the past” and “not[ed] that there is an urgent need for countries to make full use of legal and policy measures… to ensure monopolies do not stand in the way of access to COVID-19 vaccines”.

As a central player in the drafting of this strategy and in the rollout of vaccines to the whole continent, South Africa is clearly “talking the talk” about equitable access to vaccines and medicines in the global arena. But more work needs to be done domestically to give these promising statements substance.

Domestic landscape not conducive to equitable access to medicines

Fix the Patent Laws – a coalition of over 40 patient advocacy groups and health-based civil society organisations – has written twice to the Presidency and the Department of Trade and Industry and Competition (DTIC) since the start of the COVID-19 pandemic to highlight concerns with South Africa’s current IP system and the implications for COVID-19 vaccines and other medicines.

The history of the battle for antiretrovirals to treat HIV has shown that patent regimes can either be crucial in realising the right to access healthcare and health products, or act as barriers to equitable, affordable access to medicines. As it stands, our patent system does not examine patent applications to determine whether they meet strong patentability criteria, and simply grant patents on application. This has resulted in many patents being unwarranted: some drugs under patent here are not patented anywhere else in the world. Our patent system allows ‘patent evergreening’ – where the period of patent protection is extended and keeps the prices of medicines artificially high for extended periods of time, which has limited access to life-saving medicines. Activists are adamant that government must reform our patent system.

The coalition has urged the Presidency and DTIC to publish new legislation adhering to the recommendations of the Intellectual Property Policy Phase I which was adopted by Cabinet in 2018. This policy aligns with global public health policies and best practice, but the DTIC seems to drag its feet when with publishing new legislation. It is critical that Bills be published for public comment and expedited into law not only to strengthen South Africa’s efforts to make sure that COVID-19 vaccines and treatments can reach all the people but importantly also to increase access to medicines generally at home.

Concretizing gains made now and the future of access to medicines in South Africa

The South African government has acknowledged, through its joint-proposal at the WTO, that special measures are needed to facilitate access to medicines, prevent deaths and relieve pressure on the health system. But COVID-19 is not the only health crisis to which these measures should apply. While the patent waiver at the WTO is a bold move from the South African government for our country and others in the Global South, the waiver would only exist for the duration of the pandemic, and only in relation to COVID-19 medicines. Real patent law reform domestically would save lives in South Africa now and for years to come.

Patent law reform could help to give cancer patients affordable and equitable access to medicines, people living with HIV greater access to second or third line antiretrovirals, increase the supply of contraceptives and push down the prices of drugs for drug-resistant tuberculosis. Not only is this possible, but it is a constitutional imperative. Over and above promoting the rights to equality, dignity and access to healthcare and medicines, new legislation would save lives, relieve pressure on healthcare workers and ease the strain on our public health system. And it cannot wait any longer.

*Chaskalson is a Communications Officer at SECTION27. SECTION27 is a member of the Fix the Patent Laws coalition.

 Note: This opinion piece is written by an employee of SECTION27. Spotlight is published by SECTION27 and the Treatment Action Campaign, but is editorially independent, an independence that the editors guard jealously. Spotlight does not endorse or reject the views expressed in this article.