Tuesday 28 May

The Patent Amendments Bill: The negative impact of half a decade of delays

patent bill opinion


Umunyana Rugege and Baone Twala 

Currently, South Africa’s compulsory licensing laws are so stringent that they make it very difficult to use compulsory licensing and require law reform to make them useful and accessible, writes Baone Twala and Umunyana Rugege.

During his Budget Vote speech on 20 May 2022, Minister Ebrahim Patel laid out several “concrete actions” to be undertaken during the course of 2022. Specifically, he undertook to submit the Patents Amendment Bill to Cabinet for approval by October 2022 and thereafter table it in Parliament.

With Cabinet’s final meeting having taken place on 30 November 2022 without a decision on the draft Bill, we are disappointed that the finalisation of the draft Bill continues to be delayed.

In 2018, the Department of Trade, Industry and Competition released the Cabinet-approved Intellectual Property Policy of South Africa Phase I (the policy). This followed a decade-long process after the DTIC initiated a plan to reform intellectual property laws in 2009. What happened between 2009 and 2018 is a story for another day.

The 2018 policy recognised the shortcomings of South Africa’s current legal framework and acknowledged the negative impacts of outdated intellectual property legislation and regulations on public health and access to medicines in particular. The policy commits to enact key amendments “that will promote a holistic, balanced and coordinated approach to intellectual property that is mindful of the many obligations mandated under the South African Constitution”. Importantly, the policy undertook to urgently implement the reforms envisaged in the policy.

The Minister’s announcement in Parliament eight months ago indicates the readiness of the Bill for engagement beyond the department. It is frustrating that the public is forced to wait, even after a decade-long process to get a policy, and a further four years of waiting for a Bill to be published. Any further delay is unacceptable.  

TRIPS requirements for compulsory licensing eased

Since the Minister’s promise to release the draft Patents Amendment Bill in May 2022, the World Trade Organisation made a decision on South Africa’s proposal for a TRIPS Waiver for Covid-19 vaccines, diagnostics and therapeutics. The decision relates specifically to vaccines, and a decision on diagnostics and therapeutics will be determined at a later stage. The decision essentially improves the utility of existing TRIPS flexibilities by slightly easing requirements for use of compulsory licensing. But this decision does not equate to a true TRIPS waiver as proposed by South Africa and India in 2020. The decision effectively emphasises the importance of maximising TRIPS flexibilities and focusing on domestic law reform to improve people’s access to medicines.

On 15 November 2022, the Minister tabled a report to the Portfolio Committee on Trade, Industry and Competition titled “Report on South Africa’s Trade Portfolio: World Trade Organisation” on South Africa’s trade portfolio regarding the WTO. In his report, the Minister highlighted the TRIPS decision as a victory, demonstrating the clear link between the work on the international stage and the importance and urgency of patent law reform and the possibilities for compulsory licensing. The slides stated, “SA’s Patent Bill is intended to also give domestic effect to all available TRIPS flexibilities”.

South Africa must reflect the same political will for domestic reform as it has done for the TRIPS Waiver Proposal and decision. Currently, South Africa’s compulsory licensing laws are so stringent that they make it very difficult to use compulsory licensing and require law reform to make them useful and accessible. South Africa’s patent laws can make better use of TRIPS flexibilities and has been promising to do so for almost five years. The TRIPS decision presents a small amendment to TRIPS flexibilities but it will only be meaningful for South Africa if incorporated into legislation through amendments to patent laws. So, the process must come full circle. Domestic patent law reform is necessary and urgent.

South Africa hosts the World Health Organisation Hub

The National Health Research Summit, organised by the National Health Research Committee, took place in November 2022, a week after the Minister’s presentation. A key theme emerging from the summit was the opportunities presented by emerging health technologies like mRNA (the technology used in some Covid-19 vaccines, including Pfizer and Moderna). South Africa hosts the World Health Organisation mRNA Vaccine Technology Transfer Hub, which aims to improve health and health security by establishing sustainable, locally-owned mRNA manufacturing capabilities in low and middle-income countries. The hub has created an mRNA Covid-19 vaccine, which will begin clinical trials by June 2023. A successful vaccine provides opportunities for preventing Covid-19 and potential advancements for HIV and TB and other diseases.

The success of the Technology Transfer Hub relies on an enabling legal framework, which currently does not exist in South Africa. Without a strong legal framework, it will be difficult to use the outcomes of the Technology Transfer Hub in the medicines market or make them accessible