South African President Lays Down Gauntlet to Europe: Approve IP Waiver And Procure Vaccines from African Manufacturers Drug & Diagnostics Development 18/02/2022 • Elaine Ruth Fletcher Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) South African President Cyril Ramaphosa at announcement of six African countries to receive mRNA vaccine technology South African President Cyril Ramaphosa Friday called on Gavi, The Vaccine Alliance, and COVAX, the global COVID vaccine consortium to begin procuring African-made versions of vaccines for COVID and other diseases, as soon as a network of new African manufacturing facilities, now in the making, are in full production. He spoke in Brussels at an event where WHO announced that Egypt, Kenya, Nigeria, Senegal and Tunisia, as well as South African manufacturers, are to receive technology and training in mRNA vaccine manufacturing from the new WHO-supported Technology Transfer Hub in Cape Town South Africa, where scientists at Afrigen Biologics and Vaccines say they have replicated the Moderna mRNA vaccine formulation. WHO Director General Dr Tedros Adhanom Ghebreyesus named the new partner countries at a ceremony hosted by the European Union-African Union Summit, and attended by all six recipient countries, as well as European Commission President Ursula Von der Leyen, European Council President, Charles Michel, and French President Emmanuel Macron, who holds the rotating EU Council Presidency. Ramaphosa said that the new hub-and-spoke system of of vaccine R&D development and tech transfer should change the way vaccines are procured in Africa – as well as produced. COVAX vaccine deliveries in Africa – stark supply shortages and dependency on imports from India, the US and Europe were key features of the 2021 vaccine rollout. “Organizations such as COVAX and Gavi need to commit to buying vaccines from local manufacturers,” Ramaphosa declared, “Instead of going outside of those hubs, they need to buy from the locally-produced hubs once they get going.” Gavi, established in 2000 by the Bill and Melinda Gates Foundation, has been procuring vaccines in bulk for over 90 low income countries for over two decades. COVAX, the ambitious global COVID vaccine facility that was co-founded by WHO and managed by Gavi, UNICEF, and others has been the procurement and distribution channel for vaccines during the pandemic. But those giant Geneva-based agencies and their partners, like the Global Fund, traditionally have raced after the bottom dollar in bulk purchases from big generic producers in Asia, from Europe and the United States. And their procurement preferences, in turn, have actually driven more industry consolidation and monopoly control over not only vaccines, but a range of much more basic health products from PPE to insecticide treated malaria bednets, UN insiders say – making it difficult for African manufacturers to even get a foothold. Now, Ramaphosa and other African leaders are beginning to call that out. They say that a shift in procurement preferences among the big UN and donor-funded procurement agencies is critical to enable African producers to be sustainable; it would also stimulate African R&D and economies, and eventually reduce the net cost of products that must now be imported. “This would enhance the spirit of Africa’s determination to enhance biotech sovereignty” said Ramaphosa, and end the era of “Africa being consumers of medical countermeasures for disease produced at high prices that are not affordable to our country.” Left to right: EC President Ursula von der Leyen, South Africa’s Cyril Ramaphosa, EU Council President Charles Michel, French President Emannuel Macron and WHO’s Tedros Adhanom Ghebreyesus at today’s announcement of six African countries to receive mRNA vaccine technology. South Africa – approve IP waiver Ramaphosa also called upon European countries to approve an intellectual property waiver on COVID technology – a so-called “TRIPS waiver” that was proposed by South Africa and India over a year ago at the World Trade Organization. “Now I come to an uncomfortable point,” said Ramaphosa, “Governments that are really serious about ensuring that the world has access to vacccines should ensure that we approve the TRIPS waiver as we’ve put it forward rather than hide behind IP an the profitability of the originators,” he asserted. ” When we are talking about the lives of hundreds of milllions of people, rather than the profitability of a few companies, it is not acceptable that Africa is consistently at the back of the queue in relation to access to medicines. “While we appreciate the donations, they are never a sustainable way or mechanism to build resilience,” said Ramaphosa, adding, “I’m been amazed plesantly at the number of scientists we’ve got on the African continent. They have just come out of the woodwork, and they are demonstrating enormous capability. And those are the people whose energy we need to unleash… “And all we need to do that is to approve the TRIPS waiver to empower them, and just give them the energy and that oxygen so that they can surge forward.” His comments led to some awkward moments on the stage with European Commssion President von der Leyen and other EU officials struggling to respond. Ursula von der Leyen, president of the European Commission Directing her reply to Ramaphosa, von der Leyen suggested that the EU sees the mRNA Tech Transfer initiative as a countervailing force in the industry landscape – limiting “the profitability of the IP owners. That is the companies, that …you were blaming – while protecting a very precious good, and this is the intellectual property, what scientists have developed. “And here I think we can find the bridge,” she added, saying that both sides share the same goal but have different ways of reaching it. “The goal is really to make sure that the technology is transferred and dismantled and shown in full scope,” she said in her remarks. “And for that, we think that compulsory licensing with limited, deeply-cut profits might be a bridge we go together” said Von der Leyen pressing, in live time, an EU alternative to the IP waiver that major European countries have sought to advance in the World Trade Organization, where the issue has been debated behind closed doors for over a year. African-European friction on intellectual property measures evident at opening mRNA hub – South Africa: Lab technicians work in laboratories in Afrigen, a Cape Town R&D firm that is part of the WHO mRNA Vaccine Hub Ramaphosa also charged that “full operationalization of [South Africa’s ] mRNA hub has been hampered by intellectual property barriers. This could occur in other countries,” he added, referring to the designated recipients of the vaccine technology that South Africa’s has been developing. There has been a “failure to transfer technology to the hub through non-exclusive licenses to produce, as well as to export and distribute, the COVID-19 vaccines in low- and middle-income countries, including through the COVAX facility,” he added, referring to Moderna’s refusal to share know-how with the hub, which is seeking to replicate their version of an mRNA COVID vaccine. This, Ramaphosa said, is important to ensuring that the South African hub teams “have all the necessary operating procedures and know-how to manufacture mRNA vaccines at scale and according to international standards…. to support manufacturers in low- and middle-income countries to produce their own vaccines. ” Two weeks ago, scientists at Afrigen in South African’s tech hub said they believed they had replicated the Moderna jab, based on publicly accessible data. However, they said that scaling up manufacturing would take much longer without Moderna’s assistance. Moderna has so far pledged to not enforce patents during the pandemic – but it also has not proffered a hand to Afrigen. “Publicly available information, this is not enough,” agreed von der Leyen, in her reply back to the South African leader. “There needs to be in-depth information about a technology. So we have a common goal,” adding that the EC aims to “create the regulatory frame that is really necesssary to make it happen.” WHO Sidesteps IP Issue In his remarks at the Belgium ceremony WHO’s Dr Tedros sidestepped the delicate and unresolved IP issues around the hub, saying: “The aim of the hub is so that manufacturers can receive training in how to produce certain vaccines and the license to do so.” Primarily set up to address the COVID-19 emergency, the hub – as well as the “spokes” in the six country network, announced today, offer the potential to expand manufacturing capacity for other vaccine products as well, “putting countries in the driver’s seat when it comes to the kinds of vaccines and other products they need to address their health priorities,” said WHO in a press release. “Depending on the infrastructure, workforce and clinical research and regulatory capacity in place, WHO and partners will work with the beneficiary countries to develop a roadmap and put in place the necessary training and support so that they can start producing vaccines as soon as possible,” WHO said. Earlier this week, BioNTech announced another major initiative in Africa, shipping ready-made vaccine production facilities in containers to Rwanda and Senegal. BioNTech it would collaborate with the WHO hub in the employment of trained personnel at its facilities. But it remains unclear about how BioNTech, which is producing its own proprietary Pfizer-BioNTech vaccine, will collaborate with the WHO-supported mRNA hub, which aims to develop and produce vaccines using a competitor’s technology (Moderna) and one that can be freely licensed to boot. Asked by Health Policy Watch, how the WHO-supported mRNA network is being funded, a WHO spokesperson said, “We need €100 million over 5 years, and we have secured 80% of that from the countries Dr Tedros mentioned in his speech,” without elaborating further. In her remarks, meanwhile, Von der leyen said that the European Commission, together with Germany, France and Belgium, are investing €40 million in the mRNA technology transfer network, “because we are deeply convinced that it’s the right way to go… It’s a major step forward in Africa’s strategic sovereignty when it comes to vaccines. “We all know the state of play today. Today of all the vaccines applied in Africa. 1% is produced in Africa, of all the vaccines, and rightly so the goal is in 2040 to have reached a level of 60% of vaccines produced in Africa that are administered in Africa. And this is the precondition. Turning to Ramaphosa she added, “And here indeed, dear Cyril, I think it is important that, as you said, we limit with this technology transfer, the profitability of the IP owners. ” In a closing statement Friday, afternoon von der Leyen said that the African Union Commission and the European Union Commission would organize a “college to college meeting” this spring in Brussels with WTO Director General Dr. Ngozi Okonjo-Iweala, to try to define a way forward on the IP issue, adding that the two sides “share the same goal” but have “different ways to reach the goal – there must be a bridge between the two ways.” Image Credits: UNICEF, Rodger Bosch for MPP/WHO. 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