Pharmaceutical Services and global health governance in times of COVID-19

Alane Andrelino Ribeiro Luciani Martins Ricardi Marcela Amaral Pontes Silvana Nair Leite About the authors

RESUMO

Este ensaio aborda como e em que níveis a Assistência Farmacêutica é atravessada pela dinâmica da governança global da saúde, e como se relaciona com aspectos geopolíticos e socioeconômicos. Tenta-se ir além do acesso a medicamentos e produtos para saúde, abordando também o uso racional de medicamentos, seu impacto na resistência aos antimicrobianos e na saúde dos povos. Além disso, discute como a Assistência Farmacêutica pode ser vista nesse contexto.

PALAVRAS-CHAVE
Assistência Farmacêutica; Saúde global; Covid-19

ABSTRACT

This essay addresses how and at what levels Pharmaceutical Services is affected by the dynamics of global health governance, and how it correlates with geopolitical and socioeconomic aspects. It attempts to go beyond access to medicines and health products, as well as to address the rational use of medicines, the impact in antimicrobial resistance and in people’s health. Furthermore, it debates how Pharmaceutical Services can be seen in this context.

KEYWORDS
Pharmaceutical Services; Global health; COVID-19

Introduction

Global health governance can act through different types of regulatory instruments. The hard law, with legally binding instruments, restricts the practices of countries and transnational corporations through treaties, conventions, sanctions, among others. One of the examples of hard law in the health area, at a global level, is the Framework Convention on Tobacco Control of the World Health Organization (WHO), which has 182 countries and a series of binding commitments11 World Health Organization. Framework Convention on Tobacco Control. Geneva: WHO; 2021. [acesso em 2021 jan 1]. Disponível em: https://www.who.int/fctc/cop/about/en/.
https://www.who.int/fctc/cop/about/en/...
. Soft law is more flexible, does not have a mandatory character and is implemented through resolutions, directives, intergovernmental policies, among other things. The WHO List of Essential Medicines22 World Health Organization. WHO model list of essential medicines - 22nd list, 2021. Geneva: WHO; 2021. [acesso em 2021 jan 1]. Disponível em: https://www.who.int/publications/i/item/WHO-MHP-HPS--EML-2021.02.
https://www.who.int/publications/i/item/...
is an example of soft law.

In addition, global health governance also takes place in other ways, strongly influenced by the economic and political powers of non-state actors, who often ignore the multilateral system and place forums such as the WHO on the sidelines of the process. These actors include large transnational biopharmaceutical corporations, which are able to influence, directly or indirectly, the definition of global research priorities, the configuration of standards and the establishment of rules for their activities in the global market. As examples, there are the rules on trade of products and Intellectual Property (IP) – in particular, within the scope of the World Trade Organization (WTO) and the World Intellectual Property Organization (WIPO) –, ISO certifications and the standardization of nomenclatures. Additionally, increasingly, public-private partnerships, large philanthropic institutions and United Nations (UN) donors are driving global policy through funding organizations, governments, projects and studies that gain strategic political influence in the health area33 Gleckman H. Where we are now with the global governance of TNCS. Series of Three Visual Presentations – Part 1. [acesso em 2021 jan 1]. Disponível em: https://www.tni.org/files/article-downloads/13_msismvisualpresentations-overningtncsbymultilate-ralism_stateofplay.pdf.
https://www.tni.org/files/article-downlo...
, 44 Gleckman H. Where we are now with the emergence of multistakeholderism. Series of Three Visual Presentations – Part 2.2020. [acesso em 2021 jan 1]. Disponível em: https://www.tni.org/files/article-downloads/23_msismvisualpresentations-_what_is_msism.pdf.
https://www.tni.org/files/article-downlo...
.

The focus of this essay’s analysis is on the asymmetries between transnational biopharmaceutical corporations, governments and civil society. The first section deals with recent documents related to policy formulation, normative guiding principles and WHO guidance documents that interface with Pharmaceutical Services (PS) actions. Then, a cut is made on the initiatives of multiple actors linked to the COVID-19 pandemic scenario, such as COVID-19 Technology Access Pool (C-TAP), Access to COVID-19 Tools (ACT) Accelerator, COVID-19 Vaccines Global Access (Covax Facility) and the proposal filed by India and South Africa at the WTO with the aim of temporarily exempting certain obligations of the Agreement on Trade-Related Aspects of IP Rights (TRIPS Agreement) in relation to prevention, containment or treatment of COVID-19 (TRIPS Waiver).

Subsequently, the limits and possibilities of the initiatives are discussed in the light of barriers and facilitators of global governance, analyzing the predominance of these initiatives within the cases and contexts analyzed. The text is supported by institutional information and data and scientific literature. It is hypothesized that changes in the dynamics of global health governance related to corporate capture deepen the asymmetry of PS offer and people’s health status.

Aspects of Pharmaceutical Services in Global Health Governance

The PS crosses aspects related to integrated care, guarantee of access and rational use of medicines. An important challenge for PS policies is the inequity of access to medicines, especially due to high prices and the lack of research into therapeutic options for certain diseases. This challenge has increased since the advent of the TRIPS Agreement, signed in 1994 within the scope of the WTO, guaranteeing, among others, patent protection for pharmaceutical products for a minimum period of 20 years. Under the justification of contributing to the promotion of technological innovation, the transfer and diffusion of technology, the implementation of the TRIPS Agreement resulted in an increase in costs and dependence on the purchase of inputs from transnational laboratories holding patents, creating barriers to access and favoring the marketing of counterfeit and substandard products as a result of inaccessibility55 Moraes RV. A atuação internacional do Ministério da Saúde no tema de acesso a medicamentos. In: Brasil. Ministério da Saúde. Assessoria de Assuntos Internacionais de Saúde. Saúde e Política Externa: os 20 anos da Assessoria de Assuntos Internacionais de Saúde (1998-2018). Brasília, DF: Ministério da Saúde; 2018..

However, the first WHO Resolution specifically focused on ‘Intellectual Property Rights, Innovation and Public Health’ was only adopted in 200366 World Health Assembly. Resolution WHA 56.27. Intellectual property rights, innovation and public health Resolution. Geneva: WHA; 2003., many years after the TRIPS Agreement. From that point onwards, the WHO became yet another forum for discussion and analysis of the issue of the impact of IP on public health, under a different prism from that practiced within the scope of the WTO until then55 Moraes RV. A atuação internacional do Ministério da Saúde no tema de acesso a medicamentos. In: Brasil. Ministério da Saúde. Assessoria de Assuntos Internacionais de Saúde. Saúde e Política Externa: os 20 anos da Assessoria de Assuntos Internacionais de Saúde (1998-2018). Brasília, DF: Ministério da Saúde; 2018.. In this sense, in 2006, the Resolution ‘Public health, innovation, essential health research and intellectual property rights: towards a global strategy and plan of action’77 World Health Assembly. Resolution WHA59.24.Public health, innovation, essential health research and intellectual property rights: towards a global strategy and plan of action. Geneva: WHA; 2006. was adopted; and, in 2008, the Resolution8 that culminated in the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA)99 World Health Organization. Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. Geneva: WHO; 2011., with the objective of promoting innovation in health and access to medicines. However, the GSPA has not yet been fully implemented, especially due to vehement opposition from high-income countries, which could be interpreted as a way of protecting the interests of the biopharmaceutical industry.

Convened by the UN Secretary-General in 2015, a High Level Panel on Access to Medicines was launched and clarified the discussion on the requirement for clear information on how much it costs to innovate and bring a certain health technology to market1010 United Nations. Report of The United Nations Secretary-General’s High-Level Panel on Access to Medicines. [acesso em 2021 jan 1]. Disponível em: http://www.unsgaccessmeds.org/reports-documents.
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. This analysis may also have influenced WHO instruments that are strategic for access to medicines and other technologies, such as the documents presented in table 1.

Table 1
Recent United Nations documents in interface with Pharmaceutical Services. 2021

Subsequently, the 41st session of the United Nations Human Rights Council approved the Resolution on access to medicines and vaccines in the context of the right to the highest possible standard of physical and mental health, of which Brazil was one of the proponent countries1111 United Nations. General Assembly. Forty-first session Human Rights Council. Resolution A/HRC/41/L.13. 8 July 2019a. Access to medicines and vaccines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. 2019a. [acesso em 2021 jan 1]. Disponível em: https://www.healthpolicy-watch.org/wp-content/uploads/2019/07/HRC-Resolution-L.13-Access-to--Medicines-and-Vaccines-English.pdf.
https://www.healthpolicy-watch.org/wp-co...
. In the same field, the signatories of the political declaration adopted during the High Level meeting on universal health coverage, within the scope of the UN General Assembly, commit to making efforts to promote a range of incentive mechanisms that separate the cost from the investment in Research and Development (R&D) of price and sales volume, facilitating equitable and affordable access to new tools and other results to be obtained through R&D. However, in the following paragraph, it only supports the role played by the private sector in R&D of innovative medicines, leaving aside the important role of universities and other public institutions in R&D1212 United Nations. Follow-up to the political declaration of the high-level meeting of the General Assembly on antimicrobial resistance. Report A/73/869. 2019b. [acesso em 2021 jan 1]. Disponível em: https://un-docs.org/en/A/73/869.
https://un-docs.org/en/A/73/869...
.

The topic of access to health technologies returned to the agenda at the 148th meeting of the WHO Executive Board, a forum for discussion and negotiation in preparation for the 2021 World Health Assembly. A report presented on the topic of social determinants of health states that

advances in technology, increasing urbanization and the risks of climate change consolidate existing inequalities and further increase gaps in health outcomes1313 World Health Organization. Executive Board. Report EB 148/24. Social determinants of health. Geneva: WHO; 2021. [acesso em 2021 jan 1]. Disponível em: https://apps.who.int/gb/ebwha/pdf_files/EB148/B148_24-en.pdf.
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(1).

Furthermore, the report reaffirms the uneven distribution of gains in health status over the past century, within and across countries. However, the document does not address the need to enable a health care and wellness economy and to redistribute power and resources, currently concentrated in unfair trade agreements, privatizations, environmental racism stemming from extractive capitalism and other forms of exploitation and spoliation of life.

Themes related to PS – such as integrated care, antimicrobial resistance, guarantee of access, rational use of medicines and patient safety in medication – have been recurrent in global health governance forums, receiving special attention in the context of coping with the COVID-19 pandemic, as barriers and inequities in access to health technologies have been highlighted, pointing out that private interests have suffocated public health interests in decision-making.

Initiatives linked to COVID-19

In May 2020, the WHO, in partnership with several Member States, launched the C-TAP, aimed at encouraging the global community to voluntarily share knowledge, data and IP, with a view to accelerating the development of products necessary to combat the disease pandemic. Unfortunately, Member States seem reluctant to require the sharing of knowledge and IPs as a condition for companies to receive public funding mobilized to support relevant research. In January 2021, the People’s Vaccine Alliance and Health Action International (HAI) sent an open letter to the WHO Director-General expressing concern regarding the progress of C-TAP, as well as making recommendations regarding the publication of periodic monitoring reports, data transparency and information on technology transfer agreements1414 Oxfam International. The People´s Vaccine. Health Action International. Letter to Dr. Tedros Adhanom Ghebreyesus. 2021. [acesso em 2021 jan 1]. Disponível em: https://www.keionline.org/wp-content/uploads/HE-Dr-Tedros-Letter-from-Peoples-Vac-cine-Alliance-and-Health-Action-International.pdf.
https://www.keionline.org/wp-content/upl...
.

On the other hand, the Covax Facility initiative, which is restricted to funding large pharmaceutical companies in exchange for providing limited doses of COVID-19 vaccine to previously identified countries, has received greater support from countries, organizations and companies. However, the initiative does not antecipate agreements for the transfer of technology, maintaining the knowledge gap of technological development, as well as it does not provide for the sharing of IP or transparency in agreements with other countries.

Considering that emerging patent disputes may affect the manufacturing and supply of medical products, and in light of the need for a rapid and truly global response to COVID-19, in October 2020, India and South Africa made joint submission to the WTO TRIPS Agreement Council, which became known as the ‘TRIPS Waiver’1515 World Trade Organization. IP/C/W/669. Waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of Co-vid-19. 2020 out 20. [acesso em 2021 jan 1]. Disponível em: https://docs.wto.org/dol2fe/Pages/SS/direc-tdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True.
https://docs.wto.org/dol2fe/Pages/SS/dir...
. The proposal sought to obtain a temporary exemption from the implementation, application and compliance of provisions of the TRIPS Agreement related to copyright, industrial design, patents and protection of undisclosed information, in order to ensure the prevention, containment and treatment of COVID-19. It should be noted that, in the presentation of the proposal, while most low and middle-income countries (including China) supported or abstained, some high and upper-middle-income countries (including Brazil) were opposed. In a statement on the TRIPS Waiver proposal, the European Union (EU) stated that “there is no indication that IP rights issues are a genuine barrier to COVID-19 related technologies”1616 Knowledge Ecology International. WTO TRIPS Council (October 2020): European Union dismisses concerns that IPRs are a barrier to Covid-19 medicines and technologies. 2020 out 20. [acesso em 2021 jan 1]. Disponível em: https://www.keionline.org/34275.
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.

On the other hand, the representative of South Africa stated in a formal meeting of the TRIPS Council in February 2021 that:

Regardless of how much money any donor country can throw at the problem, the philanthropic donation and convenience model cannot resolve the fundamental disconnect between the monopoly model it underwrites, and the problem with philanthropy is that it cannot buy equality1717 World Trade Organization. TRIPS Council regular meetings. [acesso em 2021 fev 20]. Disponível em: https://www.wto.org/english/tratop_e/trips_e/intel6_e.htm.
https://www.wto.org/english/tratop_e/tri...
.

If the exemption was granted, important barriers that exist today for better access to essential products related to COVID-19 would be eliminated, making it possible to diversify production through technology transfer, stimulating innovation and lowering product prices. It should be noted that countries that have used TRIPS flexibilities, such as compulsory licensing, are under intense intimidation and persuasion by high-income countries in international trade and diplomacy1818 World Trade Organization. IP/C/W/672. Waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of Covid-19. 2021. [acesso em 2021 jan 1]. Disponível em: https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W672.pdf&Open=True.
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, 1919 South Centre. Alcance de la licencia obligatoria y el uso gubernamental de medicamentos patentados en el contexto de la pandemia de Covid-19. 2020. [acesso em 2021 jan 1]. Disponível em: https://www.sou-thcentre.int/wp-content/uploads/2020/04/Covid-19--CL-Table-ES.pdf.
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. The argument that IP rights are necessary to finance innovation is not consistent and loses even more strength when one sees the dependence on donor funding and early purchase agreements in R&D for COVID-19.

Countries such as the United States of America (USA) and EU members have managed to create financial conditions for the rapid development of vaccines, not with the objective of collective or even individual well-being, but with the priority of putting their economies back on track, reproducing the objectification of life and placing the disease in the center of attention.

The annual meeting of the World Economic Forum (WEF), held in June 2020, entitled ‘Great Reset’, pointed to COVID-19 as an opportunity that created conditions for a new ‘green’ deal and a ‘reset’ of the system. For this Forum, terms such as sustainability, fourth industrial revolution, climate change, biotechnology and artificial intelligence are considered catalysts for the capitalization of life and recovery factors from yet another cyclical crisis of capital2020 World Economic Forum. The Great Reset. [acesso em 2021 jan 30]. Disponível em: https://www.wefo-rum.org/great-reset/.
https://www.wefo-rum.org/great-reset/...
. These terms are in the public interest, however, they are not designed to achieve the structural changes needed to transform everyone’s health. It’s no wonder that major biopharmaceutical corporations, major health philanthropists, and even the UN are partners with the WEF.

With the pandemic, the need for sufficient production of equipment and inputs, supply and affordable prices in all regions is even more evident. Trade statistics show that only a small fraction of the world’s additional production of COVID-19-related supplies reached low-income countries2121 United Nations. United Nations Conference on Trade and Development. Global trade: a frail recovery in the second half of 2020. [acesso em 2021 jan 1]. Disponível em: https://unctad.org/system/files/official--document/ditcinf2020d4_en.pdf.
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. The WHO Director-General, during the 148th meeting of the Executive Committee, warned the world that, on the “border of catastrophic moral failure, the price of this failure will be paid with lives and livelihoods in the world’s poorest countries”2222 World Health Organization. WHO Director-General’s opening remarks at 148th session of the Executive Board. 2021. [acesso em 2021 jan 1]. Disponível em: https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-148th--session-of-the-executive-board.
https://www.who.int/director-general/spe...
(1)
.

For Sunyoto et al.2323 Sunyoto T, Vieira M, Moon S, et al. Research Synthesis: Biosecurity Research and Development (R&D). KNOWLEDGE PORTAL on innovation and access to medicines. 2020. [acesso em 2021 jan 1]. Disponível em: https://www.knowledgeportalia.org/biose-curityrd.
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(27), “the COVID-19 pandemic is likely to have profound impacts on national and global approaches to R&D in biosafety”, such as the US national strategy for responding to COVID-19 through operation ‘ Warp Speed’ and the priorities listed by the ‘NIH-Wide Strategic Plan for COVID-19 Research’2424 Leineweber FV, Bermudez JAZ. A influência da resposta dos EUA à Covid-19 no contexto da Saúde Global. Ciênc. Saúde Colet. No prelo 2021. [acesso em 2021 jan 1]. Disponível em: http://www.cienciae-saudecoletiva.com.br/artigos/a-influencia-da-res-posta-dos-eua-a-covid19-no-contexto-da-saude--global/17832?id=17832.
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. This situation can also be influenced by the political effects of the use of war narratives against COVID-19 by countries and the WHO, which reinforces the discourse of “guilty countries”, that is, “external sources of guilt” or “enemies”2525 Wright India. Are We at War? The Politics of Securitizing the Coronavirus. 2021 jan 10. [acesso em 2021 jun 1]. Disponível em: https://www.e-ir.info/pdf/89284.
https://www.e-ir.info/pdf/89284...
(3). For Wright2525 Wright India. Are We at War? The Politics of Securitizing the Coronavirus. 2021 jan 10. [acesso em 2021 jun 1]. Disponível em: https://www.e-ir.info/pdf/89284.
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(4), COVID-19 securitization policies “increase tensions and insecurities within and between states, increasing inequalities and hampering a coordinated global response”. The author also points out that

designating the virus as a security issue is a political move that frames global health debates in ways that do not help with the ultimate goal of international health cooperation2525 Wright India. Are We at War? The Politics of Securitizing the Coronavirus. 2021 jan 10. [acesso em 2021 jun 1]. Disponível em: https://www.e-ir.info/pdf/89284.
https://www.e-ir.info/pdf/89284...
(4).

We emphasize the need to recognize that COVID-19 deepens individual, community and structural vulnerabilities of our time, and reveals the effects of the health-environment relationship, in addition to the precariousness of health systems.

Are these global health governance initiatives serving all countries?

Global health diplomacy can be understood as a set of practices through which various actors try to coordinate and orchestrate global policy solutions with the argument of global health2626 Ruckert A, Labonté R, Lencucha R, et al. Global health diplomacy: A critical review of the literature. Soc Sci Med. 2016 [acesso em 2021 jun 1]; (155):61-72. Disponível em: 10.1016/j.socscimed.2016.03.004.
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, through negotiation of strategies and alliances, management of donors and stakeholders, acting in the relations between countries2727 Martins P, Aguiar ASW, Mesquita CAM, et al. Diplomacia da saúde global: proposta de modelo concei-tual. Saude soc. 2017; 26(1):229-239.. On the other hand, for Basile2828 Basile G. Clacso. La salud internacional Sur Sur: ha-cia un giro decolonial y epistemológico. [acesso em 2021 jun 1]. Disponível em: http://biblioteca.clacso.edu.ar/clacso/gt/20190320033726/II_DOSSIERS_DE_SALUD_INT_SUR_SUR_GT2019.pdf.
http://biblioteca.clacso.edu.ar/clacso/g...
(16), this global health is understood as “the path between globalization, neoliberal hegemony and global commodification of life”. Thus, it is necessary to analyze in its entirety how diplomacy in global health affects the landscape of policies and the global biopharmaceutical market and its implications for the health of people from the local to the global level.

Strategies for accessing medicines and other health products need to be aligned with the quest to reduce the profound asymmetries in the production and access to these technologies among the people of central and peripheral countries2929 OXFAM International. Small group of rich nations have bought up more than half the future supply of leading Covid-19 vaccine contenders. 2020. [acesso em 2021 jun 1]. Disponível em: https://www.oxfam.org/en/press-releases/small-group-rich-nations-ha-ve-bought-more-half-future-supply-leading-covid-19.
https://www.oxfam.org/en/press-releases/...
, 3030 Callaway E. The unequal scramble for coronavirus vaccines - by the numbers. Nature. 2020 [acesso em 2021 jun 1]; (584):506-507. Disponível em: https://doi.org/10.1038/d41586-020-02450-x.
https://doi.org/10.1038/d41586-020-02450...
. However, in these times of a pandemic, national protectionism in the acquisition of vaccines, masks, respirators, reagent tests and workforce stood out, to the detriment of diplomacy of comprehensive care and global health, with an emergency routine that can put even more at the end of the queue other relevant health issues3131 Sanahuja JA. Covid-19: riesgo, pandemia y crisis de gobernanza global. Anuário CEIPAZ, 2019-2020. Madrid: Ceipaz; 2020..

To Almeira3232 Almeida C. Saúde, política externa e cooperação sul--sul em saúde: elementos para a reflexão sobre o caso do Brasil. In: Fundação Oswaldo Cruz. A saúde no Brasil em 2030 - prospecção estratégica do sistema de saúde brasileiro: desenvolvimento, Estado e políticas de saúde. Rio de Janeiro: Fiocruz; Ipea; Ministério da Saúde; Secretaria de Assuntos Estratégicos da Presidência da República; 2013. vol. 1. p. 233-327.(273),

The central premise that guides the WTO system is that human well-being will increase with economic growth based on trade liberalization in a context of non-discriminatory and transparent rules.

In this context, the author argues that there is no link between the benefits of global trade and sound social policies, nor in the application of public health principles and methods in the formulation and implementation of trade policies. Biopharmaceutical technologies, in addition to being under IP rights of several patents on the same product, may also be under the rights of supplementary protection certificates, trade secrets, and numerous evergreening strategies as a way to postpone the patent, among other mechanisms.

Commercial decision-making has a direct impact on health and takes place within the framework of the WTO, in which the WHO has a superficial role and influence, and low and middle-income countries have little voice and influence in decisions. The IP system has reproduced artificial scarcity and deprivation, in which price and production capacity are manipulated as sources of wealth for the few and deprivation for the many, reinforcing structural inequality. For Thambisetty3333 Thambisetty S. Vaccines and patents: how self-interest and artificial scarcity weaken human solidarity. London School of Economics and Political Science. 2021. [acesso em 2021 jun 1]. Disponível em: https://www.printfriendly.com/p/g/LKnS8y.
https://www.printfriendly.com/p/g/LKnS8y...
(2), the patents:

They rely on self-interested behavior to drive innovation, and in doing so, undermine altruism, collaboration, and any notion of intellectual work to advance the common good.

Compulsory licenses, despite the importance of their use, have proved to be insufficient to minimize these asymmetries, as, among other weaknesses, the terms and conditions that limit competition and the absence of a legal obligation of broad transparency make R&D difficult and compose a restrictive geographic scope. Another example of the overlap between the right to health and commercial rights is the growing financialization of the biopharmaceutical sector, mergers and acquisitions of startups that, over time, gain market value, which influences the lack of detailing of the R&D costs of the product. This lack of transparency gives biopharmaceutical companies an advantage in price and competitiveness negotiations, especially those with monopoly technologies3434 Bermudez J. Os medicamentos e tecnologias farmacêuticas como uma questão estratégica para a viabilidade do Sistema Único de Saúde. Physis. 2018 [acesso em 2021 jun 1]; 28(1):e280102. Disponível em: http://dx.doi.org/10.1590/s0103-73312018280102.
http://dx.doi.org/10.1590/s0103-73312018...
.

As reported by Sarpatwari et al.3535 Sarpatwari A, Avorn J, Kesselheim AS. State Initiatives to Control Medication Costs - Can Transparency Legislation Help? N Engl J Med. 2016; 374(24):2301-2304. Disponível em: doi:10.1056/NEJMp1605100.
https://doi.org/10.1056/NEJMp1605100...
(2303),

Broader knowledge of the cost of drug development can lead to better incentives to drive innovation in areas of high public health importance.

In this context, transparency is a core value for access to medicines, as a human rights issue3636 Harvard. FXB Center for Health and Human Rights. Access to medicines and human rights. In: Health and Human Rights Resource Guide. Chapter 10. [acesso em 2021 jun 1]. Disponível em: https://www.hhrguide.org/2017/06/09/access-to-medicines-and-human-rights/.
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, 3737 Perehudoff K, T Hoen E. Human Rights and Intellectual Property for Universal Access to New Essential Medicines. In: Equitable Access to High-Cost Pharmaceuticals. [s.l.]: Elsevier; 2018. p. 67-87.
and must be aligned with the principles of open science, such as Open data, Open access, Open methods, Open peer review, Open source and Open resources3838 Gallagher RV, Falster DS, Maitner BS. et al. Open Science principles for accelerating trait-based science across the Tree of Life. Nat Ecol Evol. 2020 [acesso em 2022 abr 25]; (4):294-303. Disponível em: https://doi.org/10.1038/s41559-020-1109-6.
https://doi.org/10.1038/s41559-020-1109-...
.

Such a scenario of opacity implies barriers for R&D and public production in peripheral countries. For Ido3939 Ido VHP. Transparência no setor farmacêutico: uma nova dimensão do debate internacional sobre acesso a medicamentos?. Trab. educ. saúde. 2019 [acesso em 2022 abr 25]; 17(3):e0022656. Disponível em: https://doi.org/10.1590/1981-7746-sol00226.
https://doi.org/10.1590/1981-7746-sol002...
(3),

Even if the transparency of the pharmaceutical sector increases, and governments take steps to do so [...]. In this sense, it is also necessary that this agenda allows a broader reflection on the persistence of conflict of interests in the health field, especially in the undue lobby of certain private actors in the determination of public policies and international negotiations.

Furthermore, transparency must also ensure that investors’ contributions and their risks are detailed4040 Torreele E. Business-as-Usual will not Deliver the Covid-19 Vaccines We Need. Development (Rome). 2020 [acesso em 2022 abr 25]; 63(2-4):191-199. Disponível em: https://doi:10.1057/s41301-020-00261-1.
https://doi:10.1057/s41301-020-00261-1...
.

In central countries, there is a concentration of biotechnology and IP, while in peripheral countries, dependence and technological vulnerability are reproduced, deepened by the loss in international purchases due to the devaluation of other currencies in relation to the dollar and the euro. In this sense, measures of restrictions or temporary liberalization of trade in health products that took place during the pandemic may have different reflexes in northern and southern countries4141 Ismail F. WTO reform and the crisis of multilateralism: A Developing Country Perspective. Geneva: South Centre; 2020. [acesso em 2022 abr 25]. Disponível em: https://www.southcentre.int/wp-content/uploads/2020/09/Bk_2020_WTO-reform-and-the--crisis-of-multilateralism_EN.pdf.
https://www.southcentre.int/wp-content/u...
. For Velasquez4242 Velásquez G. Rethinking R&D for Pharmaceutical Products After the Novel Coronavirus COVID-19 Shock. Geneva: South Centre. (Policy Brief. nº 75) 2020. [acesso em 2022 abr 25]. Disponível em: https://www.southcentre.int/wp-content/uploads/2020/04/PB-75-Rethinking-RD-after-COVID-19-Shock-REV.pdf.
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(3):

A binding global treaty or convention, negotiated at the WHO, could allow sustainable funding of research and development of useful and safe medicines at affordable prices for the population and public social security systems. The adoption of such a convention within the WHO, based on article 19 of its constitution, could also make it possible to review the way in which the WHO acts in a broader sense.

For this to happen, it is necessary to require political and technical involvement on the part of Member States and civil society for the proper consideration of regulatory or fiscal strategies that subsidize gradual limits and targets to be agreed with private sector entities, as occurred, for example, in the Framework Convention on Tobacco Control. Furthermore, issues such as real-world evidence, drug pricing, new curative therapies, value-based alternative payment models, price transparency, digital technologies, precision medicine, population aging, and universal health care need to be discussed critically, in particular, regarding the link with the logic of financialization and the need to be guided by the public health perspective.

The initiatives pointed out in the previous section have limitations in that they still privilege the cosmovision of the hegemonic health of the contemporary world system. Among the constraints are: a) flight of human talent from the south to the global north; b) IP rights regime for corporate profit, not global access; c) trade policies that sanction the reduction of tariff protection and export taxes in peripheral countries; d) disconnection from the social determinations of local health; e) fragmented and commodified health systems4343 Global Health Watch. O que é o WHO Watch?. 2021. [acesso em 2022 abr 25]. Disponível em: https://www.ghwatch.org/who-watch/about.
https://www.ghwatch.org/who-watch/about...
.

The WHO has taken timid actions on the components of the rational use of medicines. Meanwhile, the standardization of nomenclature for biological and biosimilar medicines has advanced and is a topic of great business interest, as it impacts competition between these products4444 World Health Organization. WHO Expert Committee on Biological Standardization. 2021. [acesso em 2022 abr 25]. Disponível em: https://www.who.int/biologicals/expert_committee/en/.
https://www.who.int/biologicals/expert_c...
. This situation is aggravated by the actions of corporations and influential countries in the maintenance of structural asymmetries in the international system, such as the supremacy of economic power in influencing multilateral arenas, both in terms of final decisions and in the construction of rules and guidelines, as well as in emptying out initiatives that are not of their interest. The ongoing international cooperation initiatives and their stakeholders have not minimized these asymmetries.

Importance of rebuilding multilateral forums

Multilateralism is defined as arrangements involving more than two states, while multilateral institutions are understood as multilateral arrangements with a set of rules4545 Keohane R. Multilateralism: an agenda for research. Inter. J. 1990; 45(4):731-764.. Ruggie4646 Ruggie J. Multilateralism: the anatomy of an institution. Inter Org. 1992; 48(3):561-598. goes further, pointing out that these arrangements between three or more States are coordinated by certain general principles and conduct, in a more qualitative approach.

Furthermore, Ruggie4646 Ruggie J. Multilateralism: the anatomy of an institution. Inter Org. 1992; 48(3):561-598.(571) considers that, unlike multilateralism, “imperialism is another way of coordinating relations between three or more States, however, denying the sovereignty of the subject States”. This internationalization of States is articulated with the so-called ‘American informal empire’, in which it coordinates the other powers of the global North in an integrated way and even China does not pose major challenges to this mechanism4747 Garcia A, Bugiato CM. Repensando o estado e imperialismo nas relações internacionais: as contribuições teóricas de Leo Panitch. Rev Est. Intern. 2019; (10):3-18., even with the current competition between the USA and China. This context can be elucidated by the criticism that the WTO has received for allegedly not incorporating and addressing the concerns and notes of developing countries regarding the TRIPS Waiver, placing these countries on the sidelines of decision-making4848 Geneva Health Files. Is the ‘Walker Process’ at the WTO undermining the TRIPS Waiver? Newsletter Edition. 2021 [acesso em 2022 abr 25]; (108). Disponível em: https://genevahealthfiles.substack.com/p/is-the-walker-process-at-the-wto?justPublished=true.
https://genevahealthfiles.substack.com/p...
, 4949 Global civil society protest against. WTO pushing ‘Walker text’, sidelining TRIPS waiver. [acesso em 2022 abr 25]. Disponível em: https://www.thehindubusinessline.com/news/national/global-civil-so-ciety-protest-against-wto-pushing-walker-text-side-lining-trips-waiver/article37596283.ece.
https://www.thehindubusinessline.com/new...
.

For Lima and Albuquerque5050 Lima MRS, Albuquerque M. Reordenamento global, crise do multilateralismo e implicações para o Brasil. Rio de Janeiro: Centro Brasileiro de Relações Internacionais; Policy Note; 2020. p. 4-12. [acesso em 2022 abr 25]. Disponível em: https://www.cebri.org/br/doc/6/reordenamento-global-crise-do-multilate-ralismo-e-implicacoes-para-o-brasil.
https://www.cebri.org/br/doc/6/reordenam...
, international organizations promise to guarantee coordination between unequals, through mechanisms such as reciprocity, transparency, plurality of opinions and identities, and legitimacy. However, the transformational incapacity of these mechanisms is verified, which is reflected in a crisis of legitimacy of multilateralism and its institutions. The authors suggest “increasing cultural diversity and national representation”5050 Lima MRS, Albuquerque M. Reordenamento global, crise do multilateralismo e implicações para o Brasil. Rio de Janeiro: Centro Brasileiro de Relações Internacionais; Policy Note; 2020. p. 4-12. [acesso em 2022 abr 25]. Disponível em: https://www.cebri.org/br/doc/6/reordenamento-global-crise-do-multilate-ralismo-e-implicacoes-para-o-brasil.
https://www.cebri.org/br/doc/6/reordenam...
(10) as an anti-status quo strategy of power asymmetry in multilateral arenas, but there are limits to this strategy.

On the other hand, the so-called ‘multistakeholderism’ is defined by Raymond and DeNardis5151 Raymond M, DeNardis L. Multistakeholderism: anatomy of an inchoate global institution. Inter. Theory. 2015 [acesso em 2022 abr 25]; 7(3):572. Disponível em: https://doi.org/10.1017/S1752971915000081.
https://doi.org/10.1017/S175297191500008...
(573) as the engagement between two or more categories of actors, such as the State, intergovernmental organizations, companies and civil society, involved in issues involving important values and public interest and by “polyarchic relations of authority constituted by procedural rules” and that spend some effort to influence the management of public affairs.

In the field of health, despite the harmful permeability of the WHO, it is still important to insist on governance based on principles of cooperation and solidarity and on the constitutional role of the WHO as a leading and coordinating authority on global health, defining public health rules and concrete solutions in global level and with co-responsibility at the local level, not only in emergencies. For this, it is necessary: social participation and participatory governance with transparency and without conflict of interest or corporate capture; incorporation of actors that have been left out of the negotiations, such as specialists and non-governmental institutions from peripheral countries5252 Geneva Global Health Hub. The politics of a WHO pandemic treaty in a disenchanted world. Conference version of the G2H2. 2021. [acesso em 2022 abr 25]. Disponível em: https://g2h2.org/wp-content/uplo-ads/2021/11/G2H2-Politics-of-a-WHO-Pandemic--Treaty-Conference-version.pdf.
https://g2h2.org/wp-content/uplo-ads/202...
; and support for the WHO, disputing it in common collective interests and truly feasible cooperation.

In addition, its Member States need to act beyond the colonial mentality, moral rhetoric, fragile negotiations, self-promotion and permeability to corporations5353 Almeida C, Campos RP. Multilateralismo, ordem mundial e Covid-19: questões atuais e desafios futuros para a OMS. Saúde debate. 2021; 44(esp4):13-39., despite such a challenging situation. The WHO cannot be just a symbolic figure for the elaboration of fragile technical documents and resolutions. At the same time, a new global health architecture5454 World Health Organization. Global Leaders unite in urgent call for international pandemic treaty. 2021. [acesso em 2022 abr 25]. Disponível em: https://www.who.int/news/item/30-03-2021-global-leaders-unite-in-urgent-call-for-international-pandemic-treaty.
https://www.who.int/news/item/30-03-2021...
or binding arrangements5555 Friedman EA. “Towards a Framework Convention on Global Health: A Transformative Agenda for Health Justice”. Yale J. Health Pol. Law, Ethics. 2013. [acesso em 2022 abr 25]; 3(1). Disponível em: https://digitalcommons.law.yale.edu/yjhple/vol13/iss1/1/.
https://digitalcommons.law.yale.edu/yjhp...
alone are not enough to change the power structure, which is still favorable to corporate interests and restricted to the biomedical model5656 Schrecker T. Globalization and Health: Political Grand Challenges. Rev. Inter. Pol. Economy. 2019; 26-47. Disponível em: https://www.tandfonline.com/doi/abs/10.1080/09692290.2019.1607768.
https://www.tandfonline.com/doi/abs/10.1...
.

The Civil Society Declaration in 2017, presented during the election of the new WHO Director-General, among other issues, called for a WHO with

Leading voice for Health for All among international and multilateral actors, taking a courageous stand in favor of public health in relation to potentially harmful actions carried out by other entities, such as in the field of Access to Essential Medicines and IP Rights5757 Geneva Global Health Hub. The WHO we want and the leadership WHO needs. A message from civil society. 2017. [acesso em 2022 abr 25]. Disponível em: http://g2h2.org/posts/nextdg/.
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(1).

This declaration remains current, because, in the midst of the financial vulnerability of donor dependence with their own interests, as well as the possible failure in the coordination of some collaborative research initiatives to face COVID-19, it is urgent to progressively recover the character multilateral and normative of the WHO, ahead of the mission to promote, preserve and regulate global public health, despite fragile legal and binding obligations5858 Velásquez G. World Health Organization Reforms in the Time of Covid-19. Geneva: South Centre; 2020. [acesso em 2022 abr 25]. Disponível em: https://www.southcentre.int/wp-content/uploads/2020/11/RP-121.pdf.
https://www.southcentre.int/wp-content/u...
, 5959 Gostin LO, Moon S, Meier BM. Reimagining Global Health Governance in the Age of COVID-19. Ame. J. Pub. Health. 2020 [acesso em 2022 abr 25]; 110(11):1615-1619. Disponível em: https://doi.org/10.2105/AJPH.2020.305933.
https://doi.org/10.2105/AJPH.2020.305933...
.

Nay et al.6060 Nay O, Kieny MP, Mármora L, et al. The WHO we want. Lancet. 2020 [acesso em 2022 abr 25]; 395(10240):1818-1820. Disponível em: https://doi.org/10.1016/S0140-6736(20)31298-8.
https://doi.org/10.1016/S0140-6736(20)31...
(1819) point out that

WHO will not regain its full authority if Member States do not relinquish some of their national prerogatives for the benefit of global public health.

If in a pandemic everyone is affected, even if unequally, governance spaces should address access to health technologies as a common and solidarity right. Donations from high-income countries and other actors should not override the isonomy of bargaining power or make the implementation of resolutions and plans unfeasible. The Civil Society Declaration supporting the WHO states that:

The time has come for all WHO Member States to recognize and support the organization’s immense value in comprehensively addressing the health challenges that lie ahead due to climate change and other threats, rather than using their own mistakes as an excuse to further weaken the organization’s leadership and role in protecting global health6161 Geneva Global Health Hub. Time to rally behind the World Health Organization. A civil soc. Stat. 2020. [acesso em 2022 abr 25]. Disponível em: http://g2h2.org/posts/time-to-rally/.
http://g2h2.org/posts/time-to-rally/...
(1).

Engagement with private sector entities in implementing WHO actions highlights conflicts of interest, especially given the lack of independent WHO funding. Consequently, the organization is insufficiently protected from undue influence from industry lobbies. In multistakeholderism, despite the anticipated participation of multiple actors – including international organizations, the private sector, philanthropic foundations, global public-private partnerships and civil society – there is no standardized definition of stakeholders, nor accountability, governance or representative mandates. Thus, multistakeholderism allows transnational corporations to expand their interests and image, through the involvement of actors that address ethical and social issues, but with deep private interests.

Multistakeholder governance disregards standards for preventing conflicts of interest, transparency of members’ finances or financial transactions, and fundamental democratic safeguards. On the other hand, there is corporate self-interest, often with profit-oriented decision-making contrary to the public interest. A report by the Transnational Institute6262 Transnational Institute. Multistakeholderism: a critical look. Workshop report. 2019 mar. [acesso em 2022 abr 25]. Disponível em: https://www.tni.org/en/publication/multistakeholderism-a-critical-look.
https://www.tni.org/en/publication/multi...
exemplifies some side effects of multistake-holderism, as in the case of the GAVI Alliance, which does not address the strengthening of public and universal health systems as a strategic axis for immunization.

As for ‘multistakeholderism’, it is necessary to combat all forms of for-profit stakeholders that weaken the decision-making of Member States, that present conflicts of interest, that are harmful to the balance of power, that are undemocratic and that leave countries and populations at the mercy of private interests. For Dowbor6363 Dowbor L. Contra o ultracapitalismo, as velhas armas não servem. Outras Palavras. 2020. [acesso em 2022 abr 25]. Disponível em: https://outraspalavras.net/mercadovsdemocracia/dowbor-contra-o-ultra-capitalismo-as-velhas-armas-nao-servem/.
https://outraspalavras.net/mercadovsdemo...
(1):

In this era in which the planetary concentration of social wealth in a few hands is becoming unsustainable, understanding the mechanism of generation and appropriation of this wealth is fundamental.

The aforementioned ‘Great Reset’, organized by the World Economic Forum, which includes environmental aspects and access to vaccines, is a sample of how ‘multistakeholderism’ is trying to make multilateralism obsolete in addressing complex global issues. Organized civil society organizations have called the ‘Great Reset’ the ‘Great Take Over’, that is, the great capture of global governance6464 Transnational Institute. Time for a Democratic Reset – Global Crises Need Global Governance in the Public Interest Open Letter to the Global International Community. 2021. [acesso em 2022 abr 25]. Disponível em: https://www.cognitoforms.com/Multistakehol-derismActionGroup/TimeForADemocraticResetGlobalCrisesNeedGlobalGovernanceInThePublicInterest.
https://www.cognitoforms.com/Multistakeh...
. In addition, the World Economic Forum’s partnership with the UN has led to multistakeholder governance that drains public money and leverages UN legitimacy for initiatives by transnational corporations6565 Birn AE, Nervi L. “(Re-)Making a People’s WHO”, Ame. J. Pub Health. 2020 [acesso em 2022 abr 25]; 110(9):1352-1353. Disponível em: https://doi.org/10.2105/AJPH.2020.305806.
https://doi.org/10.2105/AJPH.2020.305806...
. In this sense, the Covax Facility initiative can be mentioned as an example, which brought several decisions outside the WHO. Other alternative multilateral articulations, such as the Paris Peace Forum6666 Paris Peace Forum. The 2020 Program. 2020. [acesso em 2022 abr 25]. Disponível em: https://parispe-aceforum.org/program-2020/.
https://parispe-aceforum.org/program-202...
, where funds were raised and strategies aligned, and the European Health Union6767 European Health Union. Protecting the health of Europeans and collectively responding to cross-border health crises. 2020. [acesso em 2022 abr 25]. Disponível em: https://ec.europa.eu/info/strategy/priorities-2019-2024/promoting-our-european-way-life/european-health-union_en.
https://ec.europa.eu/info/strategy/prior...
, took place outside the multilateral governance framework, included dominant corporate voices, and are likely to have lasting ramifications for the future of global health governance.

The UN has made several multistakeholder partnerships, such as the Global Action Plan for Healthy Lives and Well-being for All6868 World Health Organization. Stronger Collaboration, Better Health: Global Action Plan for Healthy Lives and Well-being for All. Geneva: WHO; 2019.. In addition, a Strategic Partnership Agreement was signed for the implementation of the 2030 Agenda for Sustainable Development, which institutionalized the corporate capture of the UN, providing preferential access to the formulation of initiatives to transnational companies6969 World Economic Forum. World Economic Forum and UN Sign Strategic Partnership Framework. 2019. [acesso em 2022 abr 25]. Disponível em: https://www.weforum.org/press/2019/06/world-economic-forum--and-un-sign-strategic-partnership-framework/.
https://www.weforum.org/press/2019/06/wo...
. Among these transnationals is the ‘big pharma’, which operates in the privatization of public investments and in the maintenance of the market monopoly, and not for equitable and universal access. A situation that did not differ from the receipt of large sums of public money for R&D of health supplies related to COVID-19.

Gleckman7070 Gleckman H. Multistakeholder Governance and Democracy. A Global Challenge. Londres: Routledge; 2018.(xv) questions if

The current unique responsibilities and obligations of nation-states will change when powerful non-state actors play a formal or semi-formal decision-making role in international relations.

Added to this is the concern about how these changes influence the participation of civil society and the general public and how this directly affects our daily lives. The political rise (and increase in wealth) of the transnational elite, including through supposed strategies of ‘benevolence’7171 Gleckman H. COVAX: A global multistakeholder group that poses political and health risks to developing countries and multilateralism. [acesso em 2022 abr 25]. Disponível em: https://longreads.tni.org/co-vax.
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, and a loss of trust in governments can contribute to the lack of perspective on health as a right and a common and accessible good to all.

Reports from 2017 to 2020 prepared by the UN Conference on Trade and Development recommend inducing inclusive growth in the age of digitization, ending austerity and fiscal gaps, and counterbalancing corporate power7272 United Nations. United Nations Conference on Trade and Development. Trade and Development Report. 2021. [acesso em 2022 abr 25]. Disponível em: https://unctad.org/topic/macroeconomics/trade--development-report.
https://unctad.org/topic/macroeconomics/...
. However, these recommendations can be rhetorical, without really breaking the circuit that feeds dependency and without having human dignity and nature as pillars in initiatives that recognize the contradictions of ‘inclusion’ and ‘developmentalism’, crossed by the new geography of domination subsidized by disruptive technological changes and growing inequity.

Multilateralism needs to be rebuilt through strategies that make power relations less unequal and initiatives less fragmented. Unequal relations of political power condition public policies – and how we live (or survive), get sick and die – and favor a neoliberal vision of health. For this, funding and allocation of resources need to be ensured, issues need to be addressed in an integrated manner and articulated with human, natural and intergenerational needs, enabling the participation of people and subordinate populations in the formulation of strategic global issues for the global agenda and in decision-making.

Final considerations

The economic discourse of pharmaceutical corporations has perpetuated the situation of scarcity and colonial exploitation, even if disguised as ‘pro life’ capitalist companies. To effectively promote PS for all peoples, it is necessary to recognize biopharmaceuticals as public goods and based on a comprehensive, participatory and inclusive public health approach that integrates rights, social dimensions, progressive taxation to reduce inequality and debt cancellation of the poorest countries. Furthermore, there is the importance of remodeling the R&D and IP ecosystem, with greater technical-scientific, financial and political independence, greater authority and transparency of the WHO; and that the different forms of knowledge and innovation have equity and universality as objectives.

Subsidizing PS that are integrated, efficient and oriented for the scaling up and rational use of medicines requires interventions and structural reforms at all stages of the value chain, including research, IP, production, pricing, regulation, health systems and services, procurement, analysis of the health situation and approach to the social determinants of health. It is necessary to consider that low and lowermiddle-income countries cannot participate in pre-purchase agreements; they lack financing, have tax and fiscal injustice, deficit in purchasing power (especially with low quantity demand) to negotiate prices of pharmaceutical products and implement services that promote their rational and appropriate use. In general, they have fragile regulatory systems and may not have the necessary technical infrastructure for the proper and safe use of pharmaceuticals.

The question is whether we will be able and willing to face the pharmaceutical industry, the private and health insurance systems and the professional categories that are traversed by subordination in its various layers and strata. More critical and transdisciplinary analyzes are suggested, focusing on the intersections between policies related to pharmaceuticals, public health, and economic constraints that determine the chances of health and good living everywhere.

  • Financial support: non-existent
  • *
    Orcid (Open Researcher and Contributor ID).

References

Publication Dates

  • Publication in this collection
    17 June 2022
  • Date of issue
    Apr-Jun 2022

History

  • Received
    13 Aug 2021
  • Accepted
    23 Dec 2021
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