South Africa can and must demand better deals for drug clinical trials — lives depend on it
Clinical trials are a fundamental pillar of the research and development (R&D) process for any new drug or vaccine. South Africa’s involvement in several recent trials has been essential to international pharmaceutical companies’ global rollouts — but, argue Candice Sehoma and Lebohang Kobola, the government needs to stand firm and negotiate more shrewdly for access to these medicines.
Clinical trials remain the most expensive part of the process to develop a new drug or vaccine, costing between tens and hundreds of million dollars and some requiring thousands of people to participate. It is deeply unethical then if the treatment, vaccine or diagnostic trialled in people in South Africa is subsequently kept out of reach of millions through high prices, intellectual property monopolies or inadequate supply.
The South African government has been involved in numerous COVID-19 vaccine trials. The latest is the Moderna vaccine clinical trial under the Sherpa phase II and III trials in collaboration with the South African Medical Research Council, which is expected to enroll at least 14,000 participants across East and Southern Africa.
To ensure a robust understanding and effectiveness of the vaccine being tested, the South African government’s participation in these clinical trials is imperative to evaluate the suitability of these vaccines in its diverse patient population. This is a crucial bargaining chip which is currently underplayed by the South African government when dealing with pharmaceutical corporations.
The South African government’s participation in these trials is not delivering a direct return on investment for the people involved or for the State. The government should make better use of opportunities and its capacity to hold pharmaceutical corporations like Moderna accountable for using taxpayer-funded clinical trial resources to advance their private research knowledge.
The South African government should demand access to Moderna’s mRNA technology for the locally based mRNA Hub, established to develop mRNA vaccines to mitigate access inequities. Currently Moderna’s patents pose a legal risk for the mRNA Hub and could potentially block the mRNA Hub from supplying their vaccine.
Patients volunteering for clinical trials make a significant contribution to the research and development (R&D) process. They deserve to have their voices heard in decisions made about data and results sharing — especially with whom the data is shared and under which terms access to the trialled health technology will be given.
The clinical trial guidelines of the South African Health Products Regulatory Authority (SAHPRA) include a section on post-trial access, ensuring guaranteed access of the trialled products to participants or patients involved in the study. However, South African health authorities in the National Department of Health must push the envelope further by attaching stronger conditions that would ensure improved access for all people in South Africa when it hosts clinical trials.
Pharmaceutical corporations have an ethical duty to ensure access to the medical products being trialled for participants but also to the general population given the public investments and resources injected by taxpayers to enable these research trials. History, however, has taught us that we cannot rely on the generosity of pharma corporations.
In the battle for access to TB and HIV medicines we have witnessed just how narrow the conversation around access is — often limited to only allowing a portioned number of doses to clinical trial participants or access via donation programmes.
This was the case with the TB drug delamanid and its developer, the pharmaceutical corporation Otsuka, during clinical trials in South Africa in 2011. Otsuka initially availed its drug for 400 patients through the clinical access programme — essentially a donation programme limiting access to only a small number of patients in need. Further to that, the price at which delamanid was sold by Viatris, the licensee of Otsuka, to South Africa — R19000 for a 6-month treatment course — is incredibly high for a country like South Africa, considering the massive needs to treat patients.
Take the example of long-acting cabotegravir (CAB-LA) for instance, the antiretroviral injection given every two months, that was trialled in South Africa as part of phase III multicountry trials (HPTN 083 and HPTN 084), and approved in the United States for HIV pre-exposure prophylaxis (PrEP).
CAB-LA is yet to be registered by the South Africa regulator (SAHPRA) and hence it is not yet available to the general South African population; however, there is limited availability to former clinical trial participants. Otherwise, CAB-LA is priced at $240–270 per person per year in low-income countries, and this may make it unaffordable for the South African government to roll it out more widely. Viiv’s delays in licensing and sharing technology with generic manufacturers has delayed the entry of generics to the market by 4–5 years.
ViiV must make CAB-LA available at an affordable price in South Africa given their involvement in the clinical trials; it is not sufficient for ViiV to provide it only for trial participants given the greater investment by the country. SAHPRA also has a responsibility to ensure that CAB-LA is registered expeditiously to enable greater availability.
The term “access” is hardly ever viewed through the lens of affordability and availability via the sharing of technology that ensures a larger manufacturing footprint. These should rather be informed and guided by sustainability to benefit not only a few but the larger population — especially in places where the disease burdens are heavy.
South Africa hosted the Johnson & Johnson (J&J) COVID-19 vaccine clinical trials and subsequently had a manufacturing agreement with generic manufacturer Aspen to do the ‘fill and finish’ of the J&J vaccine locally. However, this deal sparked controversy when Aspen exported the locally filled vaccines to the European Union despite the African continent’s vaccination rates of less than 3% at the time. Aspen had no power to decide how the vaccines would be distributed because of the nature of the agreement, which was a contract manufacturing agreement prior to it being transformed into a license agreement. This highlights the limiting nature of some of these contracts where powerful corporations like J&J can impose restrictive conditions that stifle the independence of smaller manufacturers.
It is imperative to stop these kinds of access agreements only being offered on an ad-hoc basis. Instead, it should be a standard requirement in government regulations for agreements around clinical trials to routinely include strengthened access provisions.
The South African government must embed progressive and sustainable approaches to access as early as possible into the R&D life cycle, especially for clinical trials, to ensure that the fruits of innovation are benefitting the greatest number of people. South Africa must also learn from its recent experience and carefully consider its policy options to ensure increased access to research and innovation trialled locally, or risk selling short the people and public funds involved.
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