Outcome of TRIPS waiver: National IP reform needed
The COVID-19 pandemic has highlighted the need for pandemic preparedness in low- and middle-income countries (LMICs) with vulnerable populations. LMICs face a double burden during pandemics as they are often the last to access available medicines and vaccines to reduce life-threatening illnesses. This does not bode well for LMICs whose public health systems are overburdened.
National intellectual property reform is necessary for pandemic preparedness to enable local production and manufacturing. It will also promote technology transfer. Most importantly, it will increase access to affordable medicines and realize people’s right to health services.
Why the TRIPS waiver is important
National intellectual property law reform is not limited to pandemics or access to medical technologies related to COVID-19. People in South Africa still struggle to access life-saving medicines for diseases like cancer due to high prices due in large part to intellectual property barriers and limited access options. For example, bendamustine is a cancer drug that treats lymphoma. It costs R4218 in South Africa but R752 in India. The drug’s patent exists in South Africa until 2031, which blocks entry of an affordable generic version.
Patents granted and maintained in South Africa include those withdrawn and refused in Europe, Israel and Colombia.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 cannot sell it due to patent blocks. Cases like this prevent local manufacturing from ensuring better and affordable access to medicines for people.
TRIPS waiver on the agenda of the WTO conference
The long-awaited Twelfth Ministerial Conference of the World Trade Organization (WTO) was held between 12e and 17e of June 2022. The hope was to find a solution to help increase the access of PRITIs to medical tools related to Covid-19.
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, especially for vulnerable LMIC communities.
After months of negotiations, the WTO has reached a disappointing ministerial decision that does not waive any intellectual property over COVID-19 medical tools. Instead, it clarifies existing public health flexibilities within the TRIPS Agreement, particularly on procedures for the use of compulsory licenses on patented products. He limited the decision to vaccines and excluded therapeutics and diagnostics that are crucial in the fight against COVID-19. The decision does not correspond to the current pandemic. It also sets a negative precedent for future responses to the pandemic.
The disappointing WTO result reinforces the urgency of reforming national intellectual property laws in the interest of public health and the realization of people’s constitutional right to access health services. In May 2018, the Department of Trade, Industry and Competition (DTIC), in its Intellectual Property Policy I, recognized the need for national reform in the interest of public health. But limited progress in starting legislative reforms.
The policy identified the introduction of Substantial Patent Search and Examination (SSE) as a critical step to ensure that the decision to grant patents is made after a rigorous review and examination process. The South African government has also started training its first generation of patent examiners. This opens up opportunities to integrate public health consideration into future review practices to ensure that the policy objective is being adequately met.
mRNA Technology Transfer Center Faces Intellectual Property Challenges
The World Health Organization (WHO) mRNA Technology Transfer Center faces various intellectual property challenges. Based in South Africa, the hub has responded to global inequalities 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 such as Brazil and China. Introducing substantive review would be key to dismissing patents as broad as Moderna’s mRNA patent, which poses a legal risk to the mRNA Hub and thus creates obstacles to the introduction of the vaccine on the South African market.
South African patent laws have not changed since the 1970s and are not constitutional. The Constitution obliges the State to realize the right of people to access health services. Moreover, stagnating laws perpetuate a lack of generic competition, driving up the price of life-saving drugs. The COVID-19 pandemic has 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 starting point for maximizing our use of TRIPS flexibilities to help solve long-standing problems of access to medicines. There has never been a more urgent time than now to release the patent bill. – e-Health News