The COVID-19 pandemic highlighted the need for pandemic preparedness in low- and middle-income countries (LMICs) with vulnerable populations. LMICs face a double burden during pandemics because they are often last in line to access available medicines and vaccines, which can reduce life-threatening diseases. This does not bode well for LMICs with overburdened public healthcare systems.
Domestic intellectual property reform is necessary for pandemic preparedness, to enable local production and manufacturing, to aid access to and transfer of technology, and most importantly, for increasing access to affordable medicine and realizing people’s right to access healthcare services.
The need for domestic intellectual property law reform is not just limited to pandemic preparedness and access to COVID-19 medical technologies. People in South Africa still struggle to access life-saving medicines for diseases like cancer due to high prices, mainly driven by intellectual property barriers and limited access options because of patents. For instance, Bendamustine is a cancer drug which treats people with Lymphoma and is priced at R4218 in South Africa versus R752 in India. The drug is patented in South Africa until 2031, blocking any more affordable generic version entry.
People in South Africa still struggle to access life-saving medicines for diseases like cancer due to high prices, mainly driven by intellectual property barriers and limited access options because of patents.Candice Sehoma and Baone Twala
Minister Ebrahim Patel @the_dti, keep your promises and publish amendments to the Patents Act without delay! It's time to #FixPatentLaws to put patients over the profits of pharma #PeopleOverProfit @SECTION27— MSF Southern Africa (@MSF_southafrica) September 6, 2022
Patents granted and upheld in South Africa include those that were withdrawn and refused in other jurisdictions, including Europe, Israel and Colombia. Adcock Ingram, a South African manufacturer, has a registered generic of Bendamustine, but they cannot sell it because of patent blockages. Instances like this prevent local manufacturing from ensuring better and affordable access to medicines for people. The long-anticipated World Trade Organisation (WTO) twelfth ministerial conference happened between the 12th and 17th of June 2022. The hope was that a solution would be reached to help increase access for LMICs for COVID-19-related medical tools.
On the agenda was the TRIPS waiver, which sought to remove intellectual property protections on COVID-19 medical tools. The waiver would allow for increased production and supply of COVID-19 vaccines, therapeutics and diagnostics worldwide, particularly for vulnerable communities in LMICs. After months of negotiations, the WTO reached a disappointing ministerial decision that does not waive any intellectual property on COVID-19 medical tools. Instead, it clarifies existing public health flexibilities within TRIPS, particularly on the procedures of using compulsory licenses on patented products. It has narrowed the decision to vaccines and excludes therapeutics and diagnostics, which are crucial in combatting COVID-19. Therefore, the decision is not to fit for responding to the current pandemic and creates a negative precedent for future pandemic responses.
The disappointing WTO outcome increases the urgency for domestic intellectual property law reform in the interests of public health and the realisation of people’s constitutional right to access healthcare services. In May 2018, the Department of Trade, Industry and Competition (DTIC), in its Intellectual Property Policy I, recognised the need for domestic reform in the interests of public health, and limited progress has been made to kickstart law reforms.
The Policy has identified the introduction of substantive patent searching and examination (SSE) as a critical step to ensure that the decision to grant patents is made upon rigorous scrutiny and procedure of examination. The South African Government has also started training for its first generation of patent examiners: this opens opportunities to integrate the consideration of public health into future examination practices to ensure the objective of the Policy is adequately achieved.
After months of negotiations, the WTO reached a disappointing ministerial decision that does not waive any intellectual property on COVID-19 medical tools. Instead, it clarifies existing public health flexibilities within TRIPS, particularly on the procedures of using compulsory licenses on patented products.Canide Sehoma and Baone Twala
The Constitution obligates the state to realise people’s right to access healthcare services. South Africa’s patent laws have not changed since the 1970s, which means the laws have not been updated in line with the Constitution.Canide Sehuma and Baone Twala
The World Health Organisation (WHO) mRNA Technology Transfer Hub, headquartered in South Africa, was established to respond to global inequities in COVID-19 vaccine access. The hub faces various intellectual property challenges, including Moderna’s patents on mRNA technology that have been filed and granted in South Africa yet rejected in other countries such as Brazil and China. The introduction of substantive examination would be critical in rejecting such broad patents like the Moderna mRNA patent, which poses a legal risk for the mRNA hub and thus creates barriers for introducing the vaccine to people in the South African market.
The Constitution obligates the state to realize people’s right to access healthcare services. South Africa’s patent laws have not changed since the 1970s, which means the laws have not been updated in line with the Constitution. Additionally, the stagnancy of the laws perpetuates a lack of generic competition, thus driving up the price of life-saving medicines. The COVID-19 pandemic highlighted a more pressing threat and the need for us to strengthen local response mechanisms for future health emergencies. Reforming our patent laws is a good place to start in order to maximize our use of TRIPS flexibilities to help resolve long-standing access to medicine issues. There has never been a time more urgent than now to release the Patents Amendment Bill.