FIX THE PATENT LAWS CAMPAIGN SUPPORTS EFFORTS TO INCREASE ACCESS TO MEDICINES THROUGH INTELLECTUAL PROPERTY REFORMS AT INTERNATIONAL AND DOMESTIC LEVELS
12 June 2022 — As the World Trade Organisation again meets to debate South Africa and India’s proposed Waiver on intellectual property for COVID-19 medical technologies this week, Fix the Patent Laws Campaign adds its voice in support of increased access to COVID-19 medical tools for the African continent. FTPL also welcomes domestic commitments to patent law reform for all medicines. We welcome the announcement by the Minister of Trade, Industry and Competition Ebrahim Patel before Parliament on 20 May 2022 that a draft Patents Amendment Bill would be sent to Cabinet by October 2022. Fix The Patent Laws Campaign looks forward to the opportunity to make submissions on this important draft law, which is critical for improved access to medicines and the fulfilment of the right to access healthcare for all living in South Africa.
Domestic patent law reform
For people living in South Africa, patent reform would mean improved access to medicines which is guaranteed as part of the Constitutional right to access healthcare services. However, the realisation of this right is currently compromised by South Africa’s outdated patent legal regime. The promised Patents Amendments Bill is a long awaited legislative step following the Department of Trade, Industry and Competition’s release of the Intellectual Property Policy Phase I in 2018. SECTION27 and FTPL have long advocated for domestic reform and welcomed the Policy and agreed with many of the promised reforms that directly affected public health. These public health related reforms proposed moving away from a depository patent system, whereby patents are automatically granted on medicines when fees are paid, towards a Substantive Search and Examination system where patentability criteria are checked prior to the granting of 20-year monopoly patents. The effect of addressing these issues would reduce unsubstantiated, superficial patent applications. Consequently, this would prevent patent evergreening and result in a more open medicines market thereby allowing more generics to compete in the market.
Patented medicine case study
Bendamustine is recommended as an essential treatment for chronic lymphocytic leukemia and follicular lymphoma by the World Health Organisation. In South Africa bendamustine is indicated for the treatment of chronic lymphocytic leukemia, non-Hodgkin’s lymphoma, and multiple myeloma – but is not included on South Africa’s essential medicines list mainly due to affordability. A typical full-course of bendamustine involves intravenous dosing of 100mg for two days in row in a 28-day cycle for 6 cycles, is available in the private sector at ZAR21,868.40 per treatment. By comparison a full course of generic bendamustine in India was priced at approximately ZAR16,800. Because bendamustine is patented in South Africa, generics of the drug will be unavailable until after 2032. Patents that have been granted and upheld in South Africa have been revoked and withdrawn in Europe, and refused in South Korea, because of how they limit affordable access to this life-saving drug. More affordable generic or biosimilar competitor drugs to bendamustine have been prevented from being distributed in South Africa through 2021 court action from patent holders. Many people living with HIV are diagnosed with non-Hodgkin’s lymphoma. But because bendamustine is unavailable to public sector patients – and generics are blocked from entering the market to reduce the price of the drug and increase supply of alternatives – patients are being denied access to potentially life-saving medicines.
After an unexplained five-year delay in introducing reforms to the Patents Act, and many attempts to engage the Minister on progress on the introduction of the Patents Bill in parliament, the Minister announced that the Bill will be introduced by October 2022 during the Trade, Industry and Competition budget vote on 20 May 2022. We welcome this announcement and look forward to engaging with the Patents Bill by October 2022.
Delays in patent law reform may have had negative impacts on access to a range of medicines, as well as South Africa’s efforts to improve access COVID-19 vaccines through the World Health Organisation’s mRNA technology transfer hub in collaboration with Aspen in Cape Town. The current patent system allowed Moderna to register patents on the mRNA technology, whereas many other countries had rejected Moderna’s mRNA patent applications. Substantive Search and Examination would likely have mitigated the Moderna’s successful registration of these patents.
FTPL supports the TRIPS Waiver at the World Trade Organisation’s Twelfth Ministerial Conference
Internationally, South Africa, together with India, has led the charge for improving access to COVID-19 diagnostics, vaccines and therapeutics through the TRIPS Waiver Proposal. The Waiver was first proposed in October 2020 and called for a temporary waiver of intellectual property on COVID-19 diagnostics, vaccines and therapeutics for the duration of the pandemic. It is supported by over 100 countries. However, the European Union and high income countries like Switzerland, the United Kingdom of Great Britain and Northern Ireland have strongly resisted the Waiver; while countries like the United States of America have supported the Waiver partially, calling for a waiver to support access to COVID-19 vaccines. Members of the World Trade Organisation have been negotiating the terms of the Waiver in order to move to text-based negotiations. On 10 June 2022, the World Trade Organisation released a draft decision text on the TRIPS Waiver Proposal that is supposed to be finalised. This text is a far cry from the TRIPS Waiver Proposal and does not achieve the objectives of the proposed waiver: increasing access to a range of COVID-19 medical tools for countries in the global South. Rather it adopts a so-called ‘TRIPS plus’ approach which means that the draft text only broadens the scope of and eases the bureaucracy of some TRIPS compulsory licensing procedures. These flexibilities are already available in the TRIPS agreement and do not address how IP protections negatively affect production and supply of COVID-19 vaccines, medicines and therapeutics in a pandemic. The decision text only applies to patents on vaccines and only commits to returning to the question of diagnostics and therapeutics in six months. While the decision text waives the limitation of the use of compulsory licensing only for the domestic market thus allowing for some exportation. The decision text is drastically different from the proposed Waiver and It has also been criticised for making the use of existing flexibility measures to promote public health even more complex to navigate.
Pre-existing TRIPS flexibilities allow countries to use compulsory licensing for example, to force companies to license their medicines in the said country. This type of licensing would allow domestic manufacturing of the licensed drug. However, historically, the efficacy of this mechanism has proved limited and contingent on countries’ domestic legislation and implementation. In South Africa, no compulsory license has ever successfully been granted and easing the process for compulsory licensing was also promised as part of patent reform. On 25 April the United Nations Committee on the Elimination of Racial Discrimination’s (CERD) released a damning statement on the lack of equitable and non-discriminatory access to COVID-19 vaccines. The statement acknowledged the bias against vulnerable and marginalised communities based on identity markers such as race (people of mainly African and Asian descent) and ethnic identity in both the Global South and North. The statement calls on States to ensure effective and non-discriminatory access to COVID vaccines and treatment, taking into account the situation and needs of marginalised groups subjected to discrimination. Importantly, it called on Germany, Switzerland, the United Kingdom of Great Britain and Northern Ireland and the United States of America to support a broader temporary waiver on intellectual property rights pertaining to COVID
The 12th Ministerial Conference of the World Trade Organisation begins today in Geneva, Switzerland. Negotiations on the draft text will also be underway during the conference. We support South Africa and India and the 100 other countries that support the TRIPS Waiver proposal. We call on countries currently opposing the Waiver to support the Waiver to improve access to COVID-19 diagnostics, vaccines and therapeutics and increase access to medicines overall. We also call on South Africa to reject the current decision text and pursue a text more reflective of a real TRIPS Waiver
FTPL lauds the efforts of the South African government to increase international access to COVID-19 medical tools through the TRIPS Waiver proposal and urges domestic actors to expedite the process of law reform locally so that everyone living in South Africa can have equal and equitable access to affordable medicines.
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