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 to 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. It will also aid the transfer of technology. Most importantly, it will increase access to affordable medicine and realise people’s right to healthcare services.

Why TRIPS waiver is important

Domestic intellectual property law reform is not limited to pandemics or COVID-19 medical technologies access. People in South Africa still struggle to access life-saving medicines for diseases like cancer due to high prices driven largely by intellectual property barriers and limited access options. For instance, bendamustine is a cancer drug that treats Lymphoma. It costs R4218 in South Africa but R752 in India. The drug patent exists in South Africa until 2031, which blocks the entry of an affordable generic version. 

Patents granted and upheld in South Africa include those withdrawn and refused in Europe, Israel and Colombia.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. 

TRIPS  waiver on WTO conference agenda

The long-anticipated World Trade Organisation (WTO) twelfth ministerial conference happened between the 12th and 17th of June  2022. The hope was for a solution to help increase access for LMICs to 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. The decision does not fit the current pandemic. It also 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. But limited progress in kickstarting 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 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. 

mRNA technology transfer hub  faces intellectual property challenges

The World Health Organisation (WHO) mRNA Technology Transfer Hub faces various intellectual property challenges. Based in South Africa, the hub responded to global inequities in access to COVID-19 vaccines. The hub
faces various intellectual property challenges. These include Moderna’s patents on mRNA technology,
granted in South Africa but rejected in countries like 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 to introducing the vaccine to people in the South African market. 

South Africa’s patent laws haven’t changed since the 1970s and aren’t in line with the Constitution. The Constitution obligates the state to realise people’s right to access healthcare services. 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 to maximise our use of TRIPS flexibilities to help resolve long-standing access to medicine issues. There has never been a time more urgent time than now to release the Patents Bill. – Health-e News