Inside the push to make intellectual property work for African pharma

Africa’s leadership aims to significantly scale up the amount of pharmaceutical manufacturing happening on the continent, which could help create greater levels of health security for the population. But there are myriad challenges. Access to licenses to manufacture products is one because pharmaceutical patent holders are largely overseas. And there aren’t enough partnerships where foreign companies guide local producers on how to make their products. There are also gaps in the amount of trained workers needed, inadequate levels of infrastructure, not enough research and development happening locally, weak regulatory systems, and financial risks to investors. But the tides are slowly turning and a lot of effort is being funneled into making this happen. As part of this push, experts gathered in Addis Ababa, Ethiopia, for the first International Conference on Innovation, Intellectual Property and Technology Transfer in Africa’s Pharmaceutical Sector — hosted by the new African Pharmaceutical Technology Foundation, launched by the African Development Bank. There are no silver bullets and many things must fall into place, participants said. But while the power is largely held outside the continent — in the hands of multinational pharmaceutical companies — there are some levers of power African nations can use to change the status quo. “We are in a defining moment. We really need to make sure that we will not miss the opportunity,” said Michel Sidibé, the African Union special envoy for the African Medicines Agency. “We really need a paradigm shift … from a privilege-centered approach to a people-centered approach.” It’s the moment to craft a “different vision” on how innovation, intellectual property, and access to pharmaceutical products will play out on the African continent, said Brook Baker, professor at Northeastern University School of Law, who specializes in access to medicines. “African countries really need to devise an intellectual property strategy that is fit for their own needs, not necessarily copy the IP strategy that you would find in high-income countries,” said Pascale Boulet, intellectual property expert at the Drugs for Neglected Diseases Initiative, or DNDi. Volunteerism One option is voluntary licenses — where companies voluntarily grant licenses to companies to manufacture their products. But this comes with limitations. The Medicines Patent Pool, or MPP, is a mechanism that works with patent holders to agree to license out their products to other manufacturers to expand access in low- and middle-income countries. “I think, in many respects, for what we’ve done, we’ve been quite successful. But we’re still having a lot of problems really expanding this model,” said Charles Gore, MPP’s executive director. MPP has signed 35 licenses and by the end of 2022 had facilitated access to 35 billion doses of treatment, according to a spokesperson. He said that one of the reasons they haven’t reached more agreements is because the industry doesn’t understand the agreements are bespoke. “They think it’s some kind of fixed model,” Gore said. “It’s so flexible. There’s so much we can do with it — if people sit down and want to discuss.” Greg Perry, assistant director-general of the International Federation of Pharmaceutical Manufacturers, said voluntary licensing is a good “meeting point” for global pharmaceutical companies and African manufacturers. He added that this model has had success, for example, with expanding access to HIV treatment, and during the COVID-19 pandemic, Oxford AstraZeneca issued voluntary licenses to manufacture its vaccine. But a leading criticism of the MPP model is that the onus is on the companies to decide which countries to include and exclude in agreements. “We’re in a very difficult situation. … We’re a very small organization with no real leverage ourselves,” Gore said. “In terms of pushing a company to give us an expanded geography, it’s really difficult — and naming and shaming is not maybe the way to get the next license.” He said MPP leans on governments and civil society to push companies to create broader access. Not everyone agrees that voluntary licenses are effective in broadening access. Too many important products aren’t licensed, Northeastern University’s Baker said. “To suggest that voluntary licenses are the total solution to the dilemmas of expanding manufacturing capacity for all the products that are needed in Africa, I think is disingenuous,” he said. “How can we have trust in promises of voluntary efforts?” Oxford AstraZeneca issuing voluntary licenses during the pandemic was the exception, not the rule — as many companies didn’t make that decision, said Ken Shadlen, a pharmaceutical patent expert at the London School of Economics and Political Science. “In an ideal world, the entire international community should be saying: ‘This is wrong, this is a critical product, everybody should have access, and this is the way access should be structured,’” said Anban Pillay, deputy director-general at South Africa’s National Department of Health. Discretion Patent offices have a role to play in changing the narrative on the continent. Patents are handed out to foreign companies too liberally in many African countries. “It just cannot continue,” said Mustaqeem de Gama, an intellectual property expert at Afrigen Biologics. “Most of our jurisdictions are nonexamining jurisdictions, which means that anyone can come and register a patent as long as they comply with the formalities.” If countries want to build up innovation at the local level, patent offices have to use more discretion, he added. And incentives for patent offices must change, said Peter Drahos, professor emeritus at the European University Institute and the Australian National University. While these offices are intended to represent the public, they are highly dependent on the fees they receive from the patent holders. “Governments actually need to think hard about how to make sure that their patent offices are really working in ways that fulfill the patent-social contract,” Drahos said. “You’ve got to change the mindset of patent offices.” Patents that Moderna filed in South Africa have complicated the work of the messenger RNA technology transfer hub. The hub did not receive a technology transfer to create an mRNA vaccine during the pandemic, so it had to develop its own vaccine. “The messenger RNA hub is still under threat of Moderna as it … has to invent around existing patents in place in South Africa,” Northeastern University’s Baker said. A regional approach to compulsory licenses? The Trade-Related Aspects of Intellectual Property Rights, or TRIPS, is the international agreement that governs intellectual property rights. But within it, there are flexibilities. African nations need to use these flexibilities to the fullest extent and include them in national law, said Erika Dueñas Loayza, a technical officer at the World Health Organization. “Are you sure that you have all these different flexibilities included in your legislation? That is what you need to check — and I think it’s very important,” she said. This includes the ability of countries to issue compulsory licenses, which allows for production without the consent of the patent owner, among other flexibilities, including those around research and defining what constitutes an invention. Compulsory licensing should be part of every country’s toolbox, said Pillay of South Africa’s National Department of Health. “Even if you don’t use it, at least it’s available to you to use when you are denied access. And that’s sometimes the case when companies are just very difficult,” he said. Compulsory licenses can also serve as leverage, Boulet said. For example, in 2017 Malaysia’s government issued a compulsory license for Gilead Sciences’ hepatitis C treatment sofosbuvir after its efforts to be included in a voluntary license failed. In response, Gilead then included Malaysia in its voluntary license agreement. “Why can’t Africa talk about regional approaches to compulsory licenses?” Northeastern University’s Baker asked. “It makes total sense.” Historically, low- and middle-income countries have been discouraged from issuing compulsory licenses due to pressure from trading partners and pharmaceutical companies, according to Médecins Sans Frontières’ Access Campaign. Additionally, competition laws and policies have been important in promoting access and innovation in countries such as South Africa. “Are you sure that in each African country, you already have a good competition law that can help you in these different situations?” WHO’s Dueñas asked. ‘Trickle down’ innovation There’s not enough pharmaceutical research and innovation happening on the African continent — so many patents aren’t held locally. This has led to “trickle-down” innovation, European University Institute’s Drahos said. “Innovation begins in rich people’s countries and then maybe it trickles down eventually to other countries, maybe it trickles down to poor people,” he said. “All the evidence shows that in times of crisis, that trickle stops.” The ways in which the world engages with science should be reenvisioned, he said, and Africa should take on a leadership role in doing that. “That seems to me an area where we desperately need leadership, and we are not getting it from the West,” Drahos said. “We do have to come up with an alternative model to ‘trickle down’ innovation.” In that vein, language should be included in funding agreements for innovators, which include strong language around access to the product that results from the innovation — and to ensure this is properly implemented, participants said. And African governments should invest more in research and development. And all of these efforts should be careful to avoid the creation of new imbalances of power, Northeastern University’s Baker said. “I don’t think the ultimate goal for public health … is to create a subclass of successful African monopolists who abuse their rights to exclude, to charge high prices to underserved, needed populations,” he said. One example of a new vision of knowledge-sharing is South Africa’s mRNA technology transfer hub. The host company, Afrigen Biologics, will train other entities on their mRNA platform. The mRNA technology is flexible and a company that has this platform at their facility can pivot to developing and producing new products for vaccines and therapeutics. And in return for being part of this network, those entities must share with MPP any intellectual property they develop on this platform so that MPP can share it more broadly. “This is a very nice model and what we hope is that possibly this model could be used elsewhere,” MPP’s Gore said. The hub is “product agnostic” because it is teaching the platform that can spur further innovations, Afrigen Biologics’s de Gama said. “I think that is really the type of knowledge sharing that we need on the continent,” he said. Intellectual property isn’t everything Local manufacturers accessing intellectual property to operate doesn’t solve all the problems of Africa’s nascent African manufacturing sector. Many African manufacturers aren’t at the required levels of expertise, with the right infrastructure, and skilled staff, nor have they met the needed quality control certifications. “IP is important,” Afrigen’s de Gama said “But it’s not the most important thing. It goes together with other things.” The African continent doesn’t produce enough drug substances, active pharmaceutical ingredients, and excipients, said Pillay of South Africa's National Department of Health. This leaves manufacturers dependent on importation — and the largest value of a pharmaceutical product lies in the cost of the active pharmaceutical ingredient and excipients. In the vaccine space, much of manufacturing in Africa has been “fill and finish,” which is the final packaging stage — a type of manufacturing that does little to ensure health security during a crisis. Fully producing vaccines end-to-end is complicated and requires a technology transfer, said Everest Okeakpu, chief operating officer at Biovaccines Nigeria Ltd. This is where a company transfers the know-how on how to produce their product to a local manufacturer. For these complicated products, compulsory licenses are impractical — because a local manufacturer can’t move forward without that guidance. Tech transfers are an arrangement that requires a lot of trust between the two companies and the expertise to absorb the technology,” said Rajinder Kumar Suri, chief executive officer of the Developing Countries Vaccine Manufacturers Network International. But global companies aren’t always interested in doing technology transfers. “There’s a lot of suggestions that are out there about ways to make more originators interested to incentivize, or to compel them to act more like AstraZeneca did,” Shadlen said. The new African Pharmaceutical Technology Foundation is working to create the conditions that will build more of these relationships. And often African manufacturers aren’t equipped to take on this role. “What single thing should Africa concentrate on?” Gore asked. “Education, because you need this workforce. It’s absolutely critical.” A number of generic manufacturers that set up shop in South Africa needed to bring in teams from elsewhere because there weren’t enough skilled people locally, said Pillay of South Africa’s National Department of Health. And there are very few African manufacturers that apply for the MPP’s expressions of interest to receive licenses, MPP’s Gore said. For example, during the pandemic, an African API manufacturer was offered a license for Pfizer’s drug Paxlovid. “They said: ‘This is a bit too complicated for us at the moment to develop, so unfortunately, we’re going to have to refuse it,’” Gore said. The limited number of applications is also partly due to requirements around quality assurance from what’s known as a stringent regulatory authority, such as pre-qualification by the World Health Organization. But this can be a costly process, Gore said. MPP is considering having Africa-specific calls for expression of interest, he said, which may include offering licenses conditionally — if a manufacturer reaches the required thresholds of quality, the license then becomes theirs. This could help give assurances to investors that their investments will pay off. Gavi, the Vaccine Alliance’s new African Vaccines Manufacturing Accelerator is also working to ensure there are more local partners available to take on technology transfers. National policies that favor local production, or even require it, are also crucial to building up the industry — but they must clearly define what qualifies as African manufacturing, MPP’s Gore said. “The subsidiary of a foreign company is not necessarily what I would call African manufacturing. And we’ve seen this where the control … is outside of Africa, and you lose that sovereignty,” he said. Dig into Roots of Change, a series examining the push toward locally led development. This is an editorially independent piece produced as part of our Roots of Change series. Click here to learn more.