On 14 December 2021, the South Centre and the Brazilian Institute of Consumer Rights (IDEC) co-organized a webinar to debate local manufacturing and equitable access to vaccines and treatments for COVID-19.
To watch the first session, see: https://www.youtube.com/watch?v=VkjEBtlybc8.
To watch the second session, see https://www.youtube.com/watch?v=awVykAQ1ahs.
The event was opened by Ms. Carlota Aquina, Executive Director of IDEC, and Dr. Viviana Muñoz-Tellez, Coordinator of the Health, Intellectual Property and Biodiversity Programme of the South Centre, who highlighted the importance of the collaboration between the institutions and the continued relevance of access to health in current times.
The first session, entitled The Race for Accessible Medicines: New Promises and Treatments for COVID-19, was moderated by Mr. Matheus Falcão, Coordinator at IDEC.
Dr. Gabriela Costa Chaves, Independent Consultant on Public Health, described some of the main prospects for COVID-19 treatments, noting the sanitary relevance of such new treatments, including new anti-viral medicines for early stages of infections, particularly for those who cannot be vaccinated or do not have access, and in cases of potential lack of efficacy of vaccines in light of variants. In this context, Brazil is a huge pharmaceutical market for sales (potentially the 5th biggest world market). The national market is shared by transnational pharmaceutical companies, national pharmaceutical companies (generics producers) and public laboratories: there is however a high technological dependency. As such, the challenges to the public health system include shortages of essential medicines (many off-patent ones), high prices of new medicines (protected by patent rights), and lack of technologies for tropical neglected diseases. Under COVID-19, there was initially shortage of intubation kits and other needed products, while Brazil was excluded from most voluntary licenses. She delineated the historical reasons and industrial policies which enabled Brazil to manufacture many medicines, including the exclusion from patent protection of pharmaceutical products and processes in 1971 (to stimulate national production), tied to efforts to centralize medicines needs and use a list of essential medicines. Within this agenda, some production of active pharmaceutical ingredients (APIs) in the 1970s-1980s took place, which were later discouraged after the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and neoliberal reforms in the 1990s (including deregulation of medicines’ prices). However, in 1988, the universal health system (SUS) was created and a strong public response to HIV took place, including efforts for local manufacturing and investments for national generics policies and companies. In the 2000s, industrial policies included pharmaceuticals under the idea of the Industrial Complex of Health, and subsequently of partnerships for productive development (PPDs) which allow for technology transfers to local companies. Responses to patent barriers, including the compulsory licensing for Efavirenz in 2007, took place. Dr. Chaves mentioned some of the main challenges of public manufacturers, including the challenge of coordination, stability of public demand, portfolio updates, investments in innovation, among others. The centrality of public laboratories was highlighted in relation to the regulation of medicines’ prices and supplies via local manufacturing (e.g. Butantan and Fiocruz for COVID-19 vaccines). In this landscape, limitations to patent protection, coordination within the health sector, the adoption of a priority medicines list, and guaranteeing public demand have been important incentives for local manufacturing. However, Brazil continues to be technologically dependent, and the consequences of the TRIPS Agreement in this regard were clear. She concluded by noting that having an established technological and manufacturing capacity is necessary, including to conduct technological prospective analyses and clinical trials, and stressed the need for an enabling legal framework and adequate regulatory pathways for the marketing approval of pharmaceutical products.
Dr. Pedro Villardi, Coordinator of GTPI/ABIA, shared the updates from the recently approved (by a huge majority) Brazilian Bill on compulsory licensing for Covid-19 health technologies. The original draft bill proposed a total suspension of intellectual property rights (a ‘mini TRIPS waiver’), but it later turned into the current bill after multiple consultations with different groups. He situated the current discussions in the broader historical efforts by civil society and public institutions in Brazil to ensure broader access to medicines, including through reducing IP barriers. In this context, there was a necessity to address monopolies as a structural element to discuss local manufacturing, as reflected in the approved Bill. However, the Bill was partly vetoed by the president, and there are ongoing discussions at the Congress to override or accept it. The vetoed points referred to the obligations on pharmaceutical companies to share all necessary knowledge for the manufacturing of the technology subject to the compulsory licensing (patent applications also included), going beyond what is described in the patent/patent application, and to share biological materials (relevant for the production of vaccines). He concluded by noting the need for such a law to include these obligations in order to allow for local manufacturing in Brazil of, among others, mRNA vaccines.
Dr. Viviana Muñoz-Tellez, South Centre, highlighted the importance of expanding diagnostic testing, presented an overview of the new potential and approved treatments for COVID-19 in a global perspective, including monoclonal antibodies, and explored avenues for scaling up manufacturing of therapeutics for COVID-19 in developing countries. In relation to inequity in diagnostics, she noted that timely identifying who is infected is pivotal, but low and middle income countries are way below in terms of testing capacity. One of the issues is that to increase affordability. PCR tests are very costly and expanding production of generics would allow lower costs. Also, capacity to evaluate diagnostics is concentrated in developed countries and China. With respect to treatments, some early potential treatments did not prove efficacious (e.g. HCQ and convalescent plasma), while others have been proved relevant, such as some monoclonal antibodies, tocilizumab, and others. There are also various potential treatments under investigation, including the anti-viral molnupiravir. There is therefore still a lot in the pipeline and there might be supply constraints. Another issue is how to deal with voluntary licensing which exclude jurisdictions such as Brazil (such as Merck’s molnupiravir MPP license which includes many other countries) – since the technologies are IP-protected and held by private companies (despite the public investments). Many patents are already being filed, including in Brazil. Therefore, dealing with such patent applications would be an important element in the policy to ensure generic availability. In addition, the trials remain restricted to a few countries. The focus on therapeutics has also been very limited as compared to vaccines at the multilateral level, such as the insufficient budget allocated to the Access to COVID-19 Tools (ACT) Accelerator, leading to a very clear funding gap. Therefore, in terms of scaling up access, issues of concern include: effectiveness, need for broad scale randomized controlled trials (RCTs), high prices especially for biologics, patent barriers and limited voluntary licensing, production issues (logistic and supply constraints), and market entry challenges for biosimilars. In terms of recommendations, sustainable innovation and investment plans are needed (at national and regional levels), support to domestic producers, notably for the development of biosimilars, avoidance of IP barriers (avoiding the granting of frivolous applications via robust patentability criteria) and full use of TRIPS flexibilities such as compulsory licensing and government use, regulation of anti-competitive practices and the potential IP waiver at the WTO. At the regional and multilateral level, more emphasis on diagnostics and treatments is needed, and a pandemic framework for collaborative and coordinated research and development without IP barriers more supportive of local and regional production capacity and transfer of technology. And, finally, the new negotiations on a WHO pandemic treaty is an opportunity to include some of these measures.
The second session, entitled Brazil: Inequalities and Obstacles in the Path of Vaccines and Treatments, was moderated by Ms. Ana Carolina Navarrete, Director of the Health Program at IDEC.
Prof. Claudia Chamas, Center for Technological Development in Health (CDTS) at the Oswaldo Cruz Foundation (Fiocruz), presented the structural and specific conditions which enabled a successful partnership between Fiocruz and AstraZeneca, including the importation and subsequent local manufacturing of APIs. The contract between the parties contains industrial secrets and a record timeline for incorporation of technology by Fiocruz. More broadly, she focused on the issues to achieve further successful models. This includes capacity to evaluate the impact of pandemics and assess technological options, experience in processes of international technology transfer, state support, manufacturing capacity at the local level, experienced staff, conducive legal framework, good relations with the partner, and regulatory capacity, among others. She then established a link between the local issues with the broader global discussions on global health, highlighting the need for manufacturing and the distribution of essential products under a principle of equitable access. She concluded with a reminder that there is no development without solidarity.
Mr. Tiago Rocca, Manager of Strategic Partnerships and New Businesses, Butantan Institute, highlighted that the issue of technological risk in emerging vaccines is a matter of concern, which makes private entities refrain from investment. This explains the role of public institutions such as Fiocruz and Butantan, who undertake investments and assume the risk, also due to their prior experience. However, there is need for further participation of the private sector (similarly to the experiences of India and China), in diffusing technologies and enlarging the manufacturing capacity in the country, while also sharing technological risks. In addition, Mr. Rocca noted the actions taken by Butantan to respond to the pandemic, including the successful partnership between Butantan and the Chinese company Sinovac, and the ongoing development of its national Butantanvac vaccine for COVID-19 – the latter enabling full manufacturing in Brazil. The importance of diversity of technological platforms was highlighted. There was also investment in anti-COVID serums currently in clinical trials – based on platforms which are already available at Butantan, including those for rabies.
Ms. Judit Rius Sanjuan, Policy Specialist on Health Technologies, Innovation and Access at the United Nations Development Programme (UNDP), noted that local production and technology transfer are an important intervention within the ecosystems of tools available to strengthen access and supply capacity for health technologies. Fiocruz and Butantan show different successful models (North-South and South-South), she said, further adding a third example: the announcement in November of the first transparent, global, non-exclusive license for a COVID-19 health tool between the WHO and Medicines Patent Pool (MPP)’s COVID-19 Technology Access Pool (C-TAP) and the Spanish National Research Council (CSIC), for a COVID-19 serological antibody technology. Ms. Rius recalled that voluntary agreements are not all the same, and it is important that their geographical scope does not exclude countries such as Brazil. She noted the importance of transparency (of investments on R&D, manufacturing cost and terms of the contractual agreements, including technology transfer and advance purchase agreements) for parties negotiating contracts but also for the wider public at large. She also recalled the various policy tools being deployed by various countries, including competition law, procurement and regulatory provisions, and stressed the importance of an enabling ecosystem. In this regard, it is important to ensure an enabling and coherent legal and regulatory environment and global policy coherence, including in discussions at the WHO on preparedness to pandemics and the WTO discussion on a TRIPS waiver. She recalled UN Secretary-General António Guterres’ call for vaccines to be considered global public goods.
Author: Vitor Henrique Pinto Ido is Programme Officer of the Health, Intellectual Property and Biodiversity Programme (HIPB) of the South Centre.