Ensuring Universal COVID-19 Vaccine Access Requires Political Will & Scaling Production Medicines & Vaccines 29/05/2020 • Grace Ren 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) As the COVID-19 pandemic continues to ravage the world, hope has been pinned on the development and roll-out of an effective vaccine. But in a global crisis where demand for the vaccine will be everywhere, how can fair and equitable distribution be ensured? Panelists from the World Health Organization; the Coalition for Epidemic Preparedness Innovations (CEPI); Medicines Law and Policy, the Shuttleworth Foundation, and a former Brazilian diplomat tackled this question in the second webinar in the ‘Global Pandemics in an Unequal World’ series, cosponsored by the New School and Health Policy Watch. “How do we turn the commitment to a universal vaccine from rhetoric to an implementation plan?” posed Sakiko Fukuda Parr, moderator of the discussion and director of the Julien Studley Graduate Programs in International Affairs at the New School. “What we have now is not only a health crisis, but a crisis that shakes your world order. We can’t separate what is going to happen in health from what happens in the global geopolitical situation,” said Celso Amorim, former Brazilian Minister for External Relations. In the midst of redefining the world order, a new paradigm for ensuring access must emerge in order to roll-out any successful COVID-19 vaccines in an equitable fashion, said other panelists. “The supply of any successful and safe and efficient vaccine will be limited for several years…[because] the global demand will be everywhere at the same time,” said Elen Høeg, policy manager at the Coalition for Epidemic Preparedness and Innovation (CEPI), which is supporting the development of at least three different vaccine candidates. Fair allocation of any vaccine should then be based on public health need, rather than countries’ ability to pay, said Mariângela Simão, assistant director-general for Access to Medicines & Vaccines at the World Health Organization. “We are bound to establish new [allocation] criteria that are unprecedented in the world, based on ethical and moral values. And then we need to make these products accessible and affordable,” she added. To do that requires the buy-in of major Heads of States, says Amorim, who proposed a United Nations General Assembly Session to put pandemic preparedness and response on the agenda for all Member States. “Like it or not, people are represented internationally by governments and I think we have to have a very broad discussion in the United Nations in a political body,” he said. But another looming issue is the problem of scale – manufacturing capacity will have to ramp up significantly to meet the global demand, even with equitable access conditions in place. One solution is to tie access requirements into funding agreements for vaccine development, said Achal Prabhala, Shuttleworth Foundation fellow. “The EU, the US and the UK could attach some access conditions to the billions of dollars being given to vaccine developers,” Prabhala explained. But he also lamented that this is “the solution that will probably not be implemented.” Other solutions may be on the horizon. The panelists spoke just a day before the official launch of the World Health Organization’s COVID-19 Technology pool, which aims to pool all data, technology, and other research necessary to speed development and scale manufacturing of any COVID-19 treatments, diagnostics, and vaccines. “What this whole initiative will do, is create a place where donors can put conditions on spending so that research and development funding comes with conditions regarding sharing technologies that are needed to scale up production worldwide,” said Ellen t’Hoen, director of Medicines, Law & Policy. “I hope that this crisis will lead to increased multilateralism and collaboration, and then we can move away from the kind of vaccine nationalism that we now see around the world.” (top, left-right) Sakiko Fukuda-Parr, Achal Prabhala, Celso Amorim (bottom, left-right) Elen Høeg, Mariângela Simão, Ellen t’Hoen) Here are some key remarks from the featured speakers: Sakiko Fukuda-Parr, director, Julien J. Studley Graduate Programs in International Affairs, The New School We need a global public good vaccine for COVID-19 that is effective and safe, but also mass produced, priced affordably and distributed widely and equitably. And that would reach all people, especially vulnerable populations and developing countries. There’s an overwhelming support for this idea as an objective, and it’s been endorsed by political and religious and intellectual leaders around the world such as presidents and prime ministers of France, Germany, Canada, China, China, South Africa and others. And there’s also a broad consensus that this is not only an ethical imperative, but an urgent public health priority and that there is a need for international cooperation and multi stakeholder partnership. But there is much greater difficulty in achieving agreement on how to get there. How do we go from the business as usual market model upon pharma research and development, financed by charging high prices under 20 year patents and other intellectual property exclusivity with limited distribution focusing on high income countries first, and from that to a people’s vaccine that is patent free mass produced accessible in the global south? Who will have early priority access to the vaccines or other necessary technologies, who will bear the financial burden, who will benefit from the investments and who will receive the treatments? How can the values of solidarity and multilateralism prevail over nationalism? How can 21st century capitalism address market failures by creating innovative social institutions to protect public health priorities that do not align with just a maximum profit, private profit and revenues? How do we turn the commitment to a universal vaccine from rhetoric to an implementation plan? And in particular, how will low-income people and countries in the Global South have access to vaccines and other treatments so that we can actually end the pandemic? Mariângela Simão, assistant director-general for Access to Medicines & Vaccines, World Health Organization First we live in a globalized world, so anything that happens in one country affects others. Secondly, it’s also shown that the countries are not prepared, no matter how many resolutions were approved in the World Health Assembly. On the other hand, this has been a very democratic virus… It raised an enormous, collaborative effort to try to sort it out, because no one is safe as long as someone else is vulnerable to this virus. We cannot let low and middle income countries end up with an unfair allocation of the leftovers. The market cannot work the same way it worked in the past pandemics and it cannot work the same way. We think we should be all applying at least to five principles; transparency, because we have right now we have a situation where you have companies trying to sell products that we don’t have yet to countries in, we have some countries trying to buy products that are not there yet. We are talking about a new normal, where income should not play a role anymore. We also need flexible regulatory in procurement approaches, we need collaboration among the different stakeholders to produce a safe and effective product in the shortest time possible. But we also need these products to be allocated to address public health needs, with ethical rules informing the allocation. So it’s really super important that we have agreed criteria to allocate products that will enable equitable access. We’ll need to take into account the vulnerability. For example, the Bahamas, a high income country. Suddenly last year, they were devastated by a hurricane. And now they get COVID, so their ability to pay is very limited. So income doesn’t play the same role anymore. So we are bound to establish new criteria that are unprecedented in the world, based on ethical and moral values. And then we need to make these products accessible and affordable. Achal Prabhala, Shuttleworth Fellow in advancing innovation and access to medicines The thing that strikes me the most over the last 20 years is that access to treatments and vaccines is no longer an afterthought.The model that we followed right through something like one year ago was develop the drug first, get a treatment, and then let’s figure out how to give people access to it. That’s not the model here. But having said that, there are two big threats that confront us. And the first is intellectual property, private monopolies that are owned by corporations. And to provide one quick example of how IP remains a threat, I think one can do no better than to look to Gilead’s license for remdesivir, which is the first US FDA approved emergency use treatment for COVID-19. They released an access agreement that allows a few production facilities in India to sell generic versions of the drug in 127 countries. But about half the world is left out – every middle income country, so every country in Latin America including Brazil, which is particularly severely hit by the coronavirus. Many of the former Soviet Union countries are completely left out. The second trait, however, is nationalism. And I think the perfect example of how nationalism is playing out is when the CEO of Sanofi, which is registered in France, suggested that the US would have first dibs on its vaccine. And of course, this raised a fly in France. Since the French President intervened, and then the chairman of Sanofi had to backtrack those comments. When it comes to vaccines, there are very, very few production facilities around the world that can even make a generic vaccine. There are solutions that countries are advocating for themselves. Brazil, Chile, Germany, Canada, Ecuador, have begun taking actions to suspend monopolies around Coronavirus related treatments, vaccines and diagnostics, should that be necessary. There are multilateral solutions that have been discussed like the WHO COVID-19 Technology pool. And then finally, we have the solution that probably will not be implemented, which is having the EU, the US and the UK attach some access conditions to the billions of dollars being given to vaccine developers. Elen Høeg, Policy Manager, Coalition for Epidemic Preparedness and Innovation (CEPI) The challenge of ensuring access in a pandemic is fundamentally different from an epidemic in that the global demand will be everywhere at the same time. Hence, the supply of any successful and safe and efficient vaccine will be limited for several years. So, as pointed out, then there’s this balance between the national interests and global solidarity, because I do think we all recognize this is a global challenge that requires a global solution. There will be both development challenges and access challenges. One thing that has become evident is the need to step up and very urgently get in place large scale manufacturing across many geographies to cover the global demand. So we must put in place mechanisms for a global procurement and ordering system, both to give predictability for manufacturing and security of investments as well as addressing the regulatory measures. A fair allocation mechanism, which will be led by the WHO, will be established. We see great will from partners to commit to having doses secured for a global pool of vaccines to serve a fair global allocation model. Celso Amorim, Minister of External Relations of Brazil (1993-94; 2003-2010), and Minister of Defense of Brazil (2011-2014) What we have now is the biggest crisis that’s not only a health crisis, but a crisis that shakes your world order. We can’t separate what is going to happen in health from what happens in the global geopolitical situation. I think there are changes that are going to help. I hope it doesn’t lead to conflict at some point; I hope it can lead to new kinds of cooperation in the world which are multipolar in which developing countries can help. I think this is basically a political question. Even the Doha Provision only was able to pass because rich countries also saw they needed it. Of course, technical expertise has to come from the WHO. But we really need the involvement of the United States. That’s why we have been proposing the idea of a special session of the General Assembly where all countries would participate. Like it or not, people are represented internationally by governments and I think we have to have a very broad discussion in the United Nations in a political body. You need a big, international conference, Heads of State in order to push for better replies to world problems. The WHO simply is not enough. We have to have big political support – the General Assembly of the United Nations is the only place where you can have really a big impulse. Ellen t’Hoen, director, Medicines, Law & Policy If a vaccine becomes available, the demand will be immediate, it will be global, and it will be enormous. And we need to plan for this. Now, if there’s one thing that we’ve learned from the HIV crisis, it’s the danger of having no plan. The drugs were developed, but it took about a decade before they became available in low and middle income countries. One lesson-learned from that is that you need to sort out the ownership issue. And this is not only about patterns with HIV, there were barriers to the low cost, generic production of drugs on a large scale, and that was largely solved through the Doha Declaration and the establishment of the Medicines Patent Pool (MPP), where patents for antiretrovirals (ARVS) could be pooled [and licensed to generics manufacturers]. All the patent licenses for all WHO-recommended antiretrovirals are available through the MPP. In mid-March, Costa Rica, proposed to the WTO to establish a COVID-19 technology pool that brings together all the necessary intellectual property – data, cell lines, know-how, technology – in order for that to be freely shared to advance science and future large scale production of vaccines ,therapeutics and diagnostics. The pooling of such knowledge was endorsed by the World Health Assembly and tomorrow, there will be an announcement with the president of Costa Rica, WHO, and a number of other member states to launch this initiative. What this whole initiative will do, is create a place where the donors funding the research and development of vaccines, drugs, and diagnostics, can put conditions on that spending regarding sharing technologies that are needed to scale up production worldwide. I hope that this crisis will lead to increased multilateralism and collaboration, and then we can move away from the kind of vaccine nationalism that we now see around the world. The people first in line for a vaccine should be the health care workers of the world, but you need to have agreements for making that happen. Upcoming Webinars in ‘Global Pandemics in an Unequal World’ The Tuesday event was the second in a series of four webinars, co-sponsored by The New School and Health Policy Watch, with the Centre for Development and Environment at the University of Oslo joining as a partner. Join us in June and July for the next two webinars, covering these themes: 24 June – Digital technology and Inequality in the COVID-19 response 22 July – COVID-19 inequalities and the environment This story was updated 2 June 2020 to amend a quote by Ellen t’Hoen. 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) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.