Committee of Mercosur countries discusses the expansion of the production capacity of medicines at Fiocruz

Over a year after the last in-person meeting, representatives of Brazil, Argentina, Uruguay and Paraguay in the Ad Hoc Committee to Promote the Expansion of the Regional Productive Capacity of Medecines, Immunizations and Health Technologies (CAHECPR) met last Thursday (2/16), at Fiocruz, in search of strategic actions for common problems. The event was not limited to discussing the shortcomings that became clear during the COVID-19 pandemic: it showed that joint action could strengthen countries and bear fruit beyond their borders; the need to incorporate the issue of drugs, sera and vaccines for neglected diseases into the group's initiatives; and the importance of scale production.

Representatives of Uruguay, Brazil, Argentina and Paraguay in the Ad Hoc Committee to Promote the Expansion of the Regional Productive Capacity of Medicines met at Fiocruz (photo: Peter Ilicciev)

Created in 2021, the CAHECPR seeks to analyze and map the production, research and development capacities of the four countries, in addition to proposing initiatives to improve the access to medicines, vaccines and technologies. The holding of the 6th Global Conference on Science, Technology and Innovation (G-Stic Rio) provided the opportunity to organize a satellite meeting and draw up “a path” for action. Representative of Brazil on the committee, the Vice President of Production and Innovation in Health at Fiocruz (VPPIS), Marco Krieger, highlighted the favorable moment to discuss the matter: Combining the learnings from the pandemic and a resumption of the strength of Mercosur itself.

“We should leave this meeting with a list of important products for our countries so that we are able to organize our work based on a strategic perspective of this demand”, stated Krieger, who was still Acting President in the absence of Mario Moreira. “And we are expanding the discussion that we started with synthetic drugs to other inputs, vaccines and diagnostic kits”, he added in the CDHS auditorium.

Diseases Without Borders

Representing Argentina, which occupies the pro-tempore presidency of Mercosur, Pascual Fidelio reinforced that, in the bloc, “there are no small or major” and that “problems have no borders”. He highlighted that the production of drugs and inputs is not something new in the region, remembering the 122 years of Fiocruz and the work that, in Argentina, goes back to the 40s and 50s of the last century. Like other members, he highlighted the need to develop medium and long-term works that are able to resist political changes. “Governments and politicians may come and go, investments may decrease, but I believe we will have results to show. As Krieger said at G-Stic, many talk about problems. We are here to talk about solutions”, stated Fidelio, who manages the National Administration of Laboratories and Institutes of Health “Dr. Carlos G. Malbrán” (Anlis).

Daniel Perez, from the Health Surveillance Division of Paraguay, highlighted the need for his country to participate in the committee, although it does not yet have public production laboratories. “Our participation is important both from the regulatory point of view and from that of strengthening of human capital. We hope to have public production laboratories in the future. Being here and exchanging experiences with vaccine-producing countries and APIs is an enriching experience”, he stated.

Isabel Slepak – who spoke on behalf of the Uruguayan Representative, Leticia Perdomo, who was unable to attend – stressed the need to promote the regional strengthening of vaccine production. “For all that we have experienced in the pandemic, the work of this group is essential, it is key to share experiences. I hope this meeting bears fruit”, said the Director of the Department of Medicines of the Uruguayan Ministry of Public Health.

Sustainable Model

The event was divided into panels, followed by a meeting of committee members at the end of the day. Kleber Barros brought the perspective of the Brazilian Ministry of Health. He emphasized that there is a window of opportunity, but that it transits in a complex field that involves regulatory issues, the need for high-level training and technology development. “An industrial strategy takes time. We need to see the advances we have made and what we can improve to make them effective”. Barros pointed out challenges such as dependence on foreign production, identifying the best cooperation models, discussing intellectual property and the geographical redistribution of production capacities. “We need to prepare the region to provide our countries with rapid and effective responses to pandemics and emergencies”, he stated. “A project that is sustainable even in non-pandemic times”.

Present at the meeting, the Pan American Health Organization (PAHO) offered support. Tomas Pippo, Regional Advisor for Pharmaceutical Policies and Innovation, highlighted the inequalities in COVID-19. “The pandemic has shown Latin America's high dependence on an issue where technology is in the hands of a few. In the vaccine market, three companies hold more than 50% of the market, and the first has over 10%.” Pippo highlighted that it is important to remedy the shortage of medicines, such as those for intensive care, and restore trust in the healthcare system. “It is particularly serious when there is immunization and the population does not accept being vaccinated”. Regarding the COVID-19 mRNA vaccine, which Fiocruz and the Argentine company Sinergium Biotech will provide hubs for the region, he highlighted the collaborative model adopted, of transfer of technology that is different from the traditional one, not aimed at profit.

Sonia Damasceno, from the Ministry of Health's Special Advisory for International Affairs (Aisa), spoke about the importance of the committee and this second in-person meeting as a space for cooperation, further suggesting going beyond Mercosur. Mediating said table, Jorge Costa, Advisor to the VPPIS, emphasized that the first door that opened for this strategy for the strengthening of the production base and technological development was Mercosur, but that it is not restricted to the bloc, and can be expanded to Latin America and the Caribbean.

The panel on the technological and production capacities of Brazil and Argentina brought together not only Fidelio, but also Mauricio Zuma, Director of the Immunobiological Technology Institute (Bio-Manguinhos/Fiocruz), and Ricardo Neves Oliveira, Production Manager at the Butantan Institute. Zuma stressed that the pandemic showed the importance of local production so as not to be left in the hands of multinational companies. He highlighted that the production of biologicals is complex, one that involves training and an ecosystem of education, science and technology for which partnerships are essential. “We find highly qualified professionals, but they are not always ready for our needs. That is why we have a master's degree in immunobiological technology, with excellent results. These are fundamental projects, but with long-term results”.

Zuma also recalled that the biological industry needs production scale due to high costs. In addition to meeting 41% of the needs of the National Vaccination Program (PNI), Bio-Manguinhos exports vaccines, such as yellow fever vaccines, through the United Nations to Latin America, Africa and some African countries. “The scale is not always ensured only by the Ministry of Health. We have to seek to serve other markets, especially in our region”.

The director of Bio-Manguinhos pointed out that “there is no point in developing what has already been developed, risking that the product “reaches the market already obsolete”. “The private pharmaceutical industry is further ahead. That is why technology transfer contracts are worth being made”, he added. The Institute produces 13 vaccines, of which 210 million doses of COVID-19 were delivered to the Ministry of Health, in addition to tests and reagents. Fiocruz's capacity should increase when the Industrial Complex for Biotechnology in Health is ready, on the Santa Cruz Campus, with a capacity to produce 120 million vials of vaccines and biopharmaceuticals per year.

Butantan brought its experience in sera, vaccines and education. Oliveira showed interest in contributing not only to actions in the bloc, but also to Latin America and Africa. The Institute produced 124 million vaccines in 2022, in addition to more than 600,000 vials of serum. It is also developing vaccines for dengue and chikungunya, with registration being expected within two years. In what he classified as “the pains of the pandemic”, Oliveira recalled Brazil's dependence on developed countries to obtain equipment such as filters, bags, hoses. Another problem is the retention of highly qualified labor that, after being trained, often goes to the private sector or abroad. Oliveira also suggested a regulatory alignment between countries to facilitate regional collaboration.

Fidelio, on the other hand, pointed out that Argentina has four COVID-19 vaccine applications being developed by public and private laboratories, and that only 10% of local laboratories produce API. He also highlighted the need to work on strategic drugs for cancer, degenerative and neglected diseases, such as leishmaniasis. Ana Lia Allemand, Director of the National Agency of Public Laboratories (Anlap) in Argentina, stated that the country has also invested in doctoral and postdoctoral scholarships in strategic lines in health, such as neglected diseases and cannabis.

Fright and Opportunity

In the last panel, representatives of the Brazilian Association of the Industry of Pharmaceutical Inputs (Abiquife) and the Brazilian Association of the Industries of Fine Chemicals, Biotechnology and Specialties (Abifina) spoke about the capacity of the sector. Norberto Prestes, Executive President of Abiquife, said that the API market moves US$ 200 billion and tends to grow 60% until 2028. “When you look at the scenario, there seems to be no way out for us. Seven percent of global API consumption is in the region, while only 1.6% of the pharmaco-chemical industry is here. There are 13 in Brazil, 16 in Argentina, 834 in China and 107 in the USA. In the 1990s, we had eight companies producing antibiotics. Today, there are zero. The numbers are frightening, but studying the map more deeply, we see the possibility of producing in Latin America with lower numbers. It is time to discuss as a group and seek solutions”. As an advantage, he indicated that the friction between the USA/China and the war between Ukraine and Russia could make Europe starts looking at the region.

Soalheiro, from Abifina, highlighted the need to build State policies, not government ones, that are able to resist political changes. A study by Fiocruz with Abifina showed that 77% of strategic products for Brazil do not have domestic input manufacturers. Based on the study, a basket of molecules was created taking into account patents about to expire, the best-selling APIs, essential drugs, the ordinance on strategic inputs and the production feasibility.

For Krieger, the CAHECPR meeting leaves guidelines to be followed. In the field of immunobiologicals, the mRNA Hub projects and the transfer of the yellow fever vaccine to Anlis will be prioritized. As for the production of APIs, some complementary work opportunities were prioritized based on surveys led by Fiocruz, Abifina and Abiquifi, and the list of strategic drugs is also being revised. The idea is to present the joint work plan in June this year at the meeting of the Health Ministers of Mercosur.

The region's effort is beginning to be noticed abroad. “We were approached at G-Stic to talk about the possibility of a partnership with Europe, as a potential support for our initiatives. It is important to show the world that our work is serious”, said Krieger.