Ensuring a Sustainable and Resilient Response to COVID-19 and Emerging Infectious Diseases through Local Production
On the 6th of July the South Centre together with ReAct – Action on Antibiotic Resistance and Innovation+Design Enabling Access (IDEA) Initiative at Johns Hopkins Bloomberg School of Public Health co-organized a side event at the United Nations High-level Political Forum.
The virtual event aimed to highlight how a sustainable and resilient recovery from COVID-19 will require an effective way of boosting local or regional production of health products, from face masks to vaccines, needed to respond to the challenge. The panel provided perspectives on the importance of expanding local production and harnessing regional pooled procurement.
A summary of the presentations by all speakers is provided below.
Carlos Correa, Executive Director of the South Centre (moderator):
COVID-19 has shown that there is a need to rapidly increase the manufacturing of vaccines and other health products in the context of a pandemic, but this is also true for the products needed for treating other infectious diseases. There is a need for equitable access, particularly for vaccines. Currently there is an unfair distribution of vaccines at the multilateral level and companies that developed them have not been willing to share the respective technologies. There has not been decisive action internationally to expand manufacturing capacity even though capacity exists, which has not been used.
Earlier this year, the World Health Assembly adopted a resolution on strengthening manufacturing capacity and access to health products. This resolution is welcome; it should lead to more action at the international level to expand access to vaccines and other medical products, particularly for developing countries. The current research and development (R&D) model for pharmaceuticals revolves around big companies that dominate and control the market. Changing the industry’s structure by promoting local production is crucial to achieve a fair access to such products.
Anthony So, Founding Director of the IDEA Initiative at the Johns Hopkins Bloomberg School of Public Health and Director of the Strategic Policy Program of ReAct North America:
Local production can be understood as the strategic localization of the pharmaceutical value chain, particularly by locating the value chain in low- and middle-income countries. Local production could help meet the demands of vaccines for COVID-19 and prevent the surge of deadlier variants and this should motivate the global community to invest in such efforts.
There are different expectations on what local production may deliver—for example, increasing R&D and receiving technology transfer. This process would allow low- and middle-income countries to gain access to the building blocks of knowledge and follow-on innovation, increase national control and bolster other capabilities such as increasing their regulatory capacity to ensure the quality of products and ensure affordable prices, and placing the technologies closer to those in need to help remedy the mismatch between supply and demand based on public health priorities.
There are mechanisms that can help increase equitable access. These include placing conditions for access on public financing; the pooling of intellectual property, such as the World Health Organization (WHO) COVID-19 Technology Access Pool (C-TAP), the Medicines Patent Pool (MPP) which has helped deliver treatments for HIV/AIDS; establishment of technology innovation hubs; and the proposal at the World Trade Organization (WTO) on an Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver that could facilitate technology transfer and enable local manufacturers to proceed.
To end this pandemic, there needs to be vaccine equity. The current global health infrastructure has not been able to deliver. Post World War II, the international system was built from a place of camaraderie and global cooperation that seems to be missing now.
Public sector manufacturing could also scale-up what the private sector has not been able to deliver including production of active pharmaceutical ingredients (API) and could also help to expand collaborative registration procedures to ensure that local production is also supported by effective demand and affordable prices through pooled procurement.
Issues of sustainability and affordability need to be addressed and it should be emphasized that local production could help to narrow the gulf between the marginal cost of manufacturing and the price paid for the marketed cost of a product. The current picture for COVID-19 vaccines is less promising. Availability is even a more significant issue than affordability though both are a problem, and therefore there is a need to find a new pathway to achieve health equity. The current disparity of vaccine distribution stems from how high-income countries have reserved COVID-19 vaccines while the rest of the world has access problems.
Furthermore, scaling up production for vaccines, medicines and diagnostics follow different paths. The near-universal market for COVID-19 is very different from other products such as for orphan drugs or antibiotics. Therefore, issues of incentives for private markets need to be considered as well as right-sizing what local production can do in managing expectations and returns on investment, be it public or private.
With the COVID-19 pandemic, there has been a renewed interest in regional collective action to support local production. However, at the global level, the COVAX initiative has come short in its response to the equitable distribution of vaccines, and therefore, it is essential to ask whether more equitable foundations for regional collective action for local production can be built. Other issues to consider is whether to divide production stages between regions ensuring national production in one country and access across countries, what should be the system’s thinking in the architecture of interdependency to sustain efforts at the regional level and the need for an end-to-end approach to bringing health technologies to the market.
Historical examples can help illustrate critical components of local manufacturing and scale-up, such as the development and scale-up of penicillin in the 1940s and 1950s. Over a decade after Fleming's discovery of penicillin and given the slow progress in Britain to produce penicillin, Howard Florey travelled to the United States, where the Government Office of Scientific Research and Development and its Committee on Medical Research assisted in the development of penicillin. The Government's Committee on Medical Research helped the scale up of penicillin in critical ways. First, it introduced Florey to the U.S. Department of Agricultural research laboratory that was looking for an economic use for corn-steep liquor, which turned out to be the ideal culture medium for penicillin. Second, to scale up production, the Committee on Medical Research got appropriate waivers to overcome industry concerns of antitrust if firms cooperated in developing the drug. Lastly, to offset the risk that firms investing in the production of natural penicillin would lose their monopoly, the government subsidized its production, investing US$75 million, a substantial sum at the time.
Furthermore, Pfizer possessed the critical process that was needed for the scale-up of penicillin production. And in 1941, Pfizer entered into an agreement with Merck and Squibb that included full exchange of research and production information. This provided Merck with the access to technology that was later used for its own work on streptomycin.
Additionally, a proposal and grant from WHO and the United Nations Children’s Fund (UNICEF) was taken by the Indian government to create penicillin production through a publicly owned facility in India. Prime Minister Nehru accepted the proposal recognizing the importance that such capacity had to be owned and grown. For their part, UNICEF and WHO envisioned developing an antibiotic R&D training center tied to the facility and sharing technical know-how developed there as part of a global network of such centers. Critical lessons can be learned from these historical examples worth repeating.
Ayoade Olatunbosun-Alakija, Co-Chair of the Africa Union Africa Vaccine Delivery Alliance for COVID-19 (AVDA) – speaking on personal capacity:
The value of a regional approach to vaccine production is exemplified by the situation in the Pacific region, where for instance, Fiji has had some of the worse surges of COVID-19 per capita, and what has prevented increases in mortality has been the availability of the vaccine through local/regional production. The AstraZeneca vaccine is being produced in Australia and has been brought to Fiji, even if at a slow pace, yet people are being vaccinated. Fiji was supposed to receive the vaccines from COVAX. This is one example of why local and regional production is needed.
It is critical to start building the capacity now, including research and development, and increase technology transfer, but it is important to understand the complexity of the supply chain. She provided examples of different COVID-19 vaccines and how their components are manufactured in various sites and different countries. The challenge is to start building the capacity in Africa and other regions even as negotiations on the TRIPS waiver continue.
This is not an issue that can be addressed only from a health perspective but from other sectors as well, including finance, trade and investment, to help determine how vaccine production can take place in our countries. Even though many countries in Africa have tried to procure vaccines, high-income countries have bought them all. There is a need to share more doses of vaccines with Africa, Latin America, and countries that are experiencing huge surges in the immediate term. In the medium-long term, local vaccine production is the only way to end this inequity, and right now, the focus can’t be on profit-making, it needs to be on saving lives.
A good starting point could be for countries to start evaluating the work of the Access to COVID-19 Tools (ACT) Accelerator and the work of COVAX to ensure that in the future these initiatives are more inclusive and will indeed, serve all the people and not leave the majority of the world behind.
Patrick Tippoo, Executive Director of the African Vaccine Manufacturing Initiative (AVMI) and Head of Science and Innovation at Biovac, South Africa:
The aim of AVMI is to establish sustainable vaccine manufacturing in Africa. This plan began ten years ago, and the pandemic has made it even more important to have a local vaccine manufacturing capacity.
Countries need to plead to have access to vaccines if there is no manufacturing capacity. The easiest way to have access is to make it. This has been clear with what has been happening with the COVID-19 pandemic. However, all the efforts for local manufacturing capacity need to consider the critical issue of sustainability, so it is not only built for pandemics. Critical issues in the African continent include understanding the procurement channels and the way markets are shaped.
There are five active manufacturing entities in the continent and therefore, this capacity can already be used. Several other countries and companies are planning or have the ability to build capacity over the next few years not only in vaccines but also in therapeutics.
Difficulties in manufacturing capacity have existed for many years. In 2011 there was concern on influenza vaccine manufacturing capacity and the lack of capacity in Africa, and still there remains no capacity for influenza vaccine production.
The Africa Centres for Disease Control and Prevention (CDC) and the African Union held a virtual conference on expanding Africa’s vaccine manufacturing. The conference had two major outcomes: launching the partnership for African vaccine manufacturing (PAVM) and the framework for action with milestones. The vision from the conference is to ensure Africa has timely access to vaccines to protect public health security by establishing a sustainable vaccine development and manufacturing ecosystem in Africa. The focus should be on manufacturing and the development aspect to ensure the whole value chain from start to finish, not just formulation or filling, packaging, and labeling.
The research and development component is very important because, without it, the development of scientific know-how and the ability to receive technology transfer could be compromised. If there is no local development of products, there will be a dependency on outside partners to provide products. For example, he noted that 99% of vaccines are imported in Africa today, and the goal will be to produce at least 60% in Africa by 2040.
The PAVM initiative aims to help coordination efforts, establish regional hubs, resource mobilization and financing, strengthen regional vaccine regulatory capacity, and focus on technology transfer and skills development. He said that the aspirations for the development of products include COVID-19 vaccines (including fill/finish), vaccines for African-specific pathogens, vaccines for unknown global pathogens, and routine immunization.
Akira Homma, Director of Bio-Manguinhos/Fiocruz and President of DCVMN (Developing Countries Vaccine Manufacturing Network):
Most developing countries are highly dependent on importation of hospital and laboratory inputs, including equipment and vaccines. There are current inequalities in the application of vaccines against COVID-19 and an urgent need to increase the world’s vaccine production capacity.
Governments in high-income countries made enormous and unprecedented investments in research, technology, and production of COVID-19 vaccines. Intellectual property, technology and production are concentrated in a few high-income countries.
Local vaccine production is a long-time expectation. WHO initiatives since the 90s and in the Pan American Health Organization (PAHO) have held many discussions on childhood vaccination and vaccine programs, including the importance of local production, technology transfer and the need to improve access locally. However, there are many challenges for local production, including the complexity of the production and the multiple steps needed, and the need to comply with international standards for manufacturing, quality, and biosafety. The inputs required for the production also need to be of high quality, and in most cases, they are imported. Building facilities and starting production operation take time but are critical to prepare for the next pandemic. Experts and qualified human resources are also required for management, production process,, quality control and administration. Solid technical and management coordination and governance are needed, and a tremendous amount of investment is required.
Some other critical challenges are the specificity of the technology platform of vaccines for COVID-19 but also for other vaccines, the need to ensure sustainable long-term operation, including the economic feasibility, technology capacity, and competitiveness. Governments’ long-term financing and their political support through policies are critical.
Brazil has extensive experience in local production, including in setting up the federal research institutions in the 1900s. The work on smallpox eradication was done through the local production of the vaccine in 1975. There has been continued government support to strengthen local production capacity.
Analía Porrás, Chief of Medicines and Health Technologies Unit at the Department of Health Systems and Services (HSS/MT) at the Pan American Health Organization (PAHO):
COVID-19 has shown, particularly for the Latin America region and the Caribbean, the high dependency on the importation of health technologies outside the region, the vulnerability of supply chains during emergencies and the high geographical concentration of COVID-19 vaccines.
PAHO has produced vital policy documents on increasing production capacity for essential medicines and health technologies in line with WHO proposals to foster local production, improve the resilience of health systems during emergencies and contribute to economic development.
Local production is a crucial area for access issues in the region and it is essential to have an end-to-end approach, throughout the lifecycle of the product. There is an ongoing lack of availability and affordability of health technologies in many developing countries that deepens in emergencies and today, the manufacturing of such health technologies is concentrated in only a few countries.
The international supply chain could be vulnerable and more so in an emergency context. This created an unprecedented shortage of critical health goods, including personal protective equipment. Once the vaccines became available, high-income countries could secure supply before others. Countries with local capacity then do better, but it is not sustainable for all countries to develop such a capacity. Few countries are large enough to reach scale. Furthermore, it is crucial to ensure sustainability not only in periods of emergency. Industrial development policies are critical in this regard and require strengthening governance mechanisms.
There is a need to strengthen regulatory systems to guarantee the quality of goods, to support institutions in increasing their research and production capacity and to ensure that intellectual property policies are consistent with policies for industrial development. For this, we need countries to work together, decentralize and diversify value chains, and counteract the urge of governments to impose export restrictions. With a regional approach, it is possible to create sustainable investment and have adequate policies. PAHO pooled procurement and the strategic fund for medicines could also help ensure sustainability, long-term planning for demand and access at the right price and time.
Jean-Michel Piedagnel, Director of South-East Asia for Drugs for Neglected Diseases initiative (DNDi):
In Malaysia, DNDi has developed a new chemical entity as part of combination treatment for Hepatitis C (HCV), ravidasvir in combination with sofosbuvir.
He noted three key points on this collaboration:
- Clinical trials: clinical trials were developed in Malaysia and Thailand to register the chemical entity – this is already a success since DNDi is not a big pharmaceutical company.
- The model: South- South collaboration. This was the most significant success of the initiative. Collaboration from the governments, pharmaceutical companies, and non-governmental organizations (NGOs) and on financing came from Egypt and Malaysia.
- The Journey: started with a clinical trial, but it turned into an access strategy at the Ministry of Health of Malaysia. The clinical trial became less important for the Ministry, and technology transfer, simplification, access strategy, use of the TRIPS agreement to have access to Sofosbuvir (use of compulsory license) were crucial.
Critical elements in a successful partnership include that the decision-making process is with the countries where the health need is based, and there is a need to understand where know-how and expertise are located. It is vital to work with the government to highlight why this is beneficial to their development, create value in the value chain, have strong ownership, and share the risk. The Minister of Health of Malaysia took risk-taking decisions that supported the project and also provided financing.
After the panel presentations, discussion was opened with the participants.
It was noted that access to vaccine technology for local production required overcoming barriers such as intellectual property, in addition to ensuring transfer of know-how, in particular to expand capacity for mRNA vaccine production for COVID-19. There is already some capacity in selected developing countries to use this novel platform. It was also suggested that the TRIPS waiver could support access to the building blocks for vaccine production.
The need to leverage public funding to increase access and affordability was also discussed. Given that many companies producing the vaccines have received significant public funds, there should be demands made on providing access outside business as usual.
Recognizing the importance of scaling up global vaccine manufacturing, it was suggested that more facilities around the work need to be involved. Incentives for increased collaboration should also be envisaged.
The need for equity in distributing vaccines and ensuring access to humanitarian settings and conflict areas were also highlighted.
To support local production, the government’s role was deemed critical, as well as to leverage its purchasing power. The important role of regional procurement was noted, such as the PAHO revolving fund and how it has helped maintain access to treatments for HIV and Tuberculosis (TB) and safe and quality vaccines. This model has helped to ensure the sustainability of production and access to affordable products.
Strengthening regional production capacity, regional supply chains, harnessing regional markets and regional procurement to support local production were also mentioned as important elements to increase access to vaccines and other medical products in the future.
It was also noted that access considerations needs to be embedded in the research and development process, considering different models for R&D.
Increasing South-South cooperation was highlighted as an important enabler.
In his closing remarks, Carlos Correa noted the importance of cooperation, engineering the value chain and ensuring demand together with availability and affordability. There is a need to look at supply and demand, with stronger South-South cooperation and universal access to health products – beyond vaccines.
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