Patents, access, and local production of medicines: reflections from experiences in the SUS

Fernandes, Daniela Rangel Affonso; Gadelha, Carlos Augusto Grabois; Maldonado, Jose Manuel Santos de Varge

doi:10.1590/S0104-12902024220791en

Acessibilidade / Reportar erro

Brasil

Español English

sumário « anterior atual seguinte »

Sumário

Essay • Saude soc. 33 (1) • 2024 • https://doi.org/10.1590/S0104-12902024220791en copy

Patents, access, and local production of medicines: reflections from experiences in the SUS¹ 1 This article received financial support from the Fiocruz/Fiotec project “Challenges for the Unified Health System (SUS) in the national and global context of social, economic and technological changes - CEIS 4.0” and the CNPq project “Science, Technology and Innovation in Health for the sustainability of the SUS.”

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

This article aims to contribute to the literature and to the national and global debate on overcoming the polarization related to the legal and administrative aspect of the innovation process, seeking to focus on patents as a conditioning factor of the technological trajectories that enable learning in the productive scope. It was based on a theoretical and political framework related to innovation and access to medicines, especially regarding Intellectual Property rights, and on a critical-reflexive analysis of Intellectual Property instruments used in Productive Development Partnerships (PDP), developed by a public national institute for synthetic drug technology. The results demonstrate the importance of making patent rights compatible with the construction of technological and innovation capacities in the country, which are linked to universal access, especially when they involve products that are intended to treat serious, technologically complex and high-cost diseases. In conclusion, to overcome technological dependence and expand access to medicines in Brazil, the State must seek a balance between public and private interests in the healthcare area, articulate the existing legal instruments and align its health, industry, ST&I and intellectual property policies.

Keywords:
National Science, Technology and Innovation Policy; CEIS; Intellectual Property, Public Health Policy, Universal Access

Flexibility	Article TRIPS	Related article in the IPL	Description
Transition periods	nº^o 65 and 66	n^oº 243	one year (until 1996) for developed countries, five years (until 2000) for developing countries, 11 years (until 2006) for less developed countries. Developing countries were also granted an additional five years to protect intellectual property in technological fields not previously protected.
Compulsory Licensing	n^oº 31	nº^o 68	Government authorization, which allows third parties to exploit a patented product or process without the consent of the patent holder. TRIPS foresees the following hypotheses for the concession: (1) public interest; (2) abuse of the right to exploit the patent; and (3) abuse of economic power.
Exhaustion of rights / parallel imports	n^oº 6	n^oº 43 inc. IV and n^oº 68 paragraph 4	Countries can implement national or international exhaustion of rights. In the national case, the exclusive right is exhausted only in the country where the product was placed on the domestic market by the owner or with their consent. In the international case, a country can import a patented product once it has already been placed on the market by the patent holder or by a third party with their consent.
Exceptions to the Rights Conferred (Experimental Use and Bolar Exception)	n^oº 30	nº^o 43, inc. VII	Experimental use refers to the possibility of exploiting a patented object for scientific research purposes. The Bolar exception allows tests to be carried out in order to obtain marketing registration with regulatory agencies before the patent expires, with the aim of obtaining approval to market the generic.

Medication	Partner(s)	Legal instrument
Efavirenz	Globequímica (SP), Cristália (SP), and Nortec (RJ)	Compulsory Licensing
Atazanavir	Bristol-Myers Squibb (BMS)	Voluntary Licensing
Sofosbuvir	Blanver Farmoquímica e Farmacêutica S.A. and Microbiológica Química e Farmacêutica LTDA	Patent opposition

Faculdade de Saúde Pública, Universidade de São Paulo. Associação Paulista de Saúde Pública. Av. dr. Arnaldo, 715, Prédio da Biblioteca, 2º andar sala 2, 01246-904 São Paulo - SP - Brasil, Tel./Fax: +55 11 3061-7880 - São Paulo - SP - Brazil
E-mail: saudesoc@usp.br

Acompanhe os números deste periódico no seu leitor de RSS

[1] Correspondence Daniela Fernandes Rua Ituverava, 532. Rio de Janeiro, RJ, Brasil. CEP 22775-903.