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2019 | OriginalPaper | Buchkapitel

10. Regulating the Copy Drug Market in Brazil: Testing Generics and Similar Medicines (1999–2015)

verfasst von : Marilena Correa, Maurice Cassier, Maria Andrea Loyola

Erschienen in: Health Innovation and Social Justice in Brazil

Verlag: Springer International Publishing

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Abstract

The chapter, written by Marilena Correa, Maurice Cassier and Maria Andrea Loyola, shows the formation, expansion and regulation of the similar and generic medicines’ markets since the 1990s. In particular, it explores the diffusion of bio-equivalence tests for the copy of both similar and generic medicines. The bio-equivalence tests carried out in centres authorized by ANVISA measure the quality of copies to guarantee their interchangeability with first medicines. The growth of the bio-equivalence test market and the extension of the network of bio-equivalence centres approved by the Health Surveillance Agency is a keystone in the construction of the pharmaceutical innovation system. In 2000, the national bio-equivalence centres performed only 27 percent of all bio-equivalence tests, whereas in 2010 they performed 87 percent of them. The process of standardizing Brazilian copies has until now been oriented primarily towards the needs of the domestic and regional markets. Obtaining the WHO prequalification standard could represent a new frontier of this standardization, aimed at international donor markets such as those of the Global Fund. To date, no Brazilian firm has acquired WHO prequalification, in contrast to Indian firms which make substantial use of them to conquer global generics markets.

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Vorheriges Kapitel Treatment Activism and Intellectual Property of Drugs in Brazil
Fußnoten
1
ANVISA is overseen by a collegiate directorate comprising five members with non-coincident three-year mandates. The members are reviewed by the Federal Senate before appointment and have tenure during their mandate. The chairman is appointed from among the five by decree by the President of the Republic. Decisions are taken in collegiate form, by simple majority.
 
2
As an independent regulatory agency, it is also entitled to charge duties and levy fines, as well as other functions, such as customs activities at ports and airports, which render it revenue to supplement the budget funds allocated by the national treasury.
 
4
These were: “Local Knowledge, Market Construction and Globalization: two modes of Pharmaceutical Innovation in the Global South: Brazil and India” supported by the Agence Nationale de la Recherche (ANR), France, coordinated by Maurice Cassier and Laurent Pordié; and “The new implications of the production of second-line ARVs in Brazil: Using the flexibilities of patent law to produce certified generic drugs” supported by the Agence Nationale de Recherches sur le Sida (ANRS), France, and coordinated by Maurice Cassier and Marilena C D V Corrêa.
 
5
In 1945, President Getúlio Vargas decreed pharmaceutical products excluded from patentability in Brazil. Once declared ‘commons’, it became legal to copy and produce drugs locally. That policy was designed to leverage two objectives at once: to encourage local production of essential drugs needed by Brazil’s population and to foster the creation of a local industry, with a view to substituting imports of foreign products.
 
6
The CODETEC had its origins within the university as an incubated firm. This type of incentive to set up a new technology firm allows a five-year grace period for it to become independent or incorporated into the university. Note that the CODETEC was first engaged in energy development and innovation processes, particularly in oil and fuel ethanol. Cf. CODETEC – Companhia de Desenvolvimento Tecnológico (re-edited by Rogério Cerqueira Leite) In: Revista Brasileira de Inovação Rio de Janeiro (RJ), 7(2), pp. 483–489, July/December 2008. CODETEC.
 
7
Active pharmaceutical ingredient (API) or active ingredient or active principle (as it is known in Brazil) is a substance introduced into the formulation of a pharmaceutical form which, when administered to a patient, acts as an active ingredient. These substances can produce pharmacological activity or effects in diagnostic tests, cure, treatment or prevention of a disease, and can affect the structure and functioning of the organism. Meanwhile, the term “raw materials” describes intermediate products of synthesis and active or inactive substances employed in the manufacture of medicinal products.
 
8
With regard to this “war”, see Loyola, M-A.; Guimarães, E. R. de B.; Villela, P. “Medicamentos e patentes na ordem do dia: mídia e ‘a guerra de patentes”. In Corrêa and Cassier (eds.) Aids e Saúde Pública: contribuições à reflexão sobre uma nova economia política do medicamento no Brasil. Rio de Janeiro: EdUERJ, 2010, pp. 71–104.
 
9
From then on, the DCB denomination was to be used to designate the generic medicine. If no appropriate name existed in Brazil’s official pharmacopeia, the Mercosur Common Nomenclature (Nomenclatura Común del Mercosur, NCM) could be used, or even the International Common Denomination (ICD).
 
10
Agência Nacional de Vigilância Sanitária. Resolução da Diretoria Colegiada n° 391 de 9 de agosto de 1999. Regulamento Técnico para registro de Medicamento genérico. Diário Oficial da União de 10 agosto de 1999. http://​www.​anvisa.​gov.​br/​hotsite/​genericos/​legis/​resolucoes/​391_​99.​htm (accessed in February 2016).
Agência Nacional de Vigilância Sanitária. Resolução da Diretoria Colegiada n°16 de 02 de novembro de 2007. Diario Oficial da Uniao de 5 de set 2007. Aprova o Regulamento Técnico para registro de medicamento genérico. 12 pp.
Agência Nacional de Vigilância Sanitária. Resolução da Diretoria Colegiada n°17 de 03 de novembro de 2007. Aprova o Regulamento Técnico para registro de medicamento similar. 14 pp.
 
11
As will be shown in more detail later, the discussion of the certification and supply of raw materials for generics has gathered strength globally in recent years with an increasing number of publications showing that the vast majority of medicinal product manufacturers in the central countries (particularly the USA) source their supplies from India and China.
 
12
Bio-equivalence testing in human subjects should, for ethical reasons, always be preceded by tests of pharmaceutical equivalence, because pharmaceutical equivalence testing assesses, in vitro, the dissolution profiles of the substances being compared (the reference drug and the candidate generic drug).
 
13
The bio-equivalence tests required for generic drugs are conducted on healthy volunteers and comprise three phases: clinical – volunteers are selected, generic and reference medicinal products administered at different times, then blood or urine samples collected at set times; analytical – the pharmaceutical ingredient in the samples is quantified by a specific method; and statistical – the values of the pharmacokinetic parameters found are calculated and subjected to statistical analysis comparing the reference and test medicinal products.
 
14
Brasil. Agência Nacional de Vigilância Sanitária. Resolução RDC n° 133 de 29 de maio de 2003a. Dispõe sobre o registro do medicamento similar e dá outras providências. Diário Oficial da União 19 set 2003.
Brasil. Agência Nacional de Vigilância Sanitária. Resolução RDC n° 134 de 29 de maio de 2003b. Dispõe sobre a adequação do medicamento similar e dá outras providências. Diário Oficial da União 25 set 2003.
 
15
Bio-waiver is a concept of the bio-pharmaceutical classification system meaning exemption from bio-equivalence testing for the purpose of certifying a copy as a generic drug, in view of characteristics (properties such as solubility, permeability) proper to the active ingredient, pharmacokinetic parameters, such as dissolution profile, or final formulation (solid, liquid, injectable, etc.). What this classification system contemplates is the product’s solubility in organic liquids and membrane permeability. For some generic drugs – a large number, actually – bioequivalence is inferred by simpler in vitro tests.
 
16
Cassier M.; Corrêa M. Propriedade Intelectual e Saúde Pública: a cópia de medicamentos contra HIV/Aids realizadas por laboratórios farmacêuticos públicos e privados. RECIIS. Rio de Janeiro, Jan.–Jul., 2007, 88–91.
 
18
Brazil. Portaria n. 3916. Dispõe sobre a aprovação da Política Nacional de Medicamentos. Diário Oficial da União 1988; 10 Nov.
 
19
Medicinal products from public procurement are stored in municipal health department stockrooms, hospital pharmacies, or in the network of public health posts and clinics, where outpatient care is given, and in emergency departments.
 
20
They also note that different copy versions (similar and generic, for instance, or generic and reference) should not compete to deliver the same active ingredient; or, put differently, there is discussion over whether or not it is acceptable for public procurement to entertain tenders for different versions of the same active ingredient.
 
21
In the private sector too, where individual users pay the full purchase cost, pharmacists are to be encouraged to substitute brand G.
 
22
As already mentioned at several points in our work, Miranda et al. (2009) and other authors cited in the course of this chapter revisit the issue of the copy drug market’s present-day slavish valorisation of bioequivalence taken in isolation, and emphasise GMP, quality and bioavailability, which can be inferred by simpler tests.
 
23
Pinto et al. (2010) write: “the measure of availability proposed by the WHO/AIS is flimsy in that it considers a medicinal product to be ‘available’ when there is one dosage unit in stock, regardless of treatment needs, seasonality, demand and so on. It would be useful to have information on stocks of units sufficient to provide for a therapeutic regime”, so as not to compromise rational access and use (by improper substitutions).
 
24
Guia 2014 – Interfarma Brasil p. 2/1.
 
25
http://​www.​anvisa.​gov.​br; accessed on 10 January 2016.
 
26
Contract Research Organizations (CROs) have become established at the global level as a specialized industry directed to recruiting subjects for clinical research. Their goals include “rationalizing” clinical trials by lowering the cost of forming pools of volunteers, while meeting all ethical and scientific requirements. Petryna (2005) describes how attractive Eastern Europe and Latin America are to this process. Brazil has highly-qualified doctors, a well-developed system of university hospitals, treatment-naïve patients, miscegenation and policies to expand access. The country would thus seem to be coveted as a field for such trials, but comparison using the international platform at www.​clinicaltrials.​org shows that the density of such clinical trialling is still low.
The global trend is towards pharmaceutical bio-equivalence and bio-availability testing also to be conducted through CROs, which are now a widespread presence in operationalizing clinical trials. In the case of generic drug testing, CROs are in the process of internalization and ANVISA certification.
 
27
The Rede Brasileira de Laboratórios Analíticos em Saúde (REBLAS) comprises public or private, ANVISA-authorized, analytical laboratories able to offer quality, reliable, safe and traceable healthcare-related services. Accreditation relates the REBLAS Code to the laboratory’s address and analytical scope and its criteria are set out in RDC No. 12, of 16 February 2012. Authorised laboratories may display the REBLAS logo on printed or electronic trial or test reports, providing these are within its authorized scope. Use of the ANVISA logo is prohibited on pain of legal sanction, in addition to cancellation of accreditation.
 
28
Source: presentation by Rodrigo CRISTOFOLETI, head of the ANVISA bioequivalence department, at the 13th International Conference of Drug Regulatory Authorities (ICDRA).
 
29
See Pan-American Health Organization (PAHO): www.​paho.​org TC 37 – Reorganização do Sistema Nacional de Vigilância Sanitária 2006 (Reorganizing the National System of Health Surveillance, 2006), which includes among other initiatives financing public and universitary centres for bio-equivalence trials and pharmaceutical equivalence tests. See also ANVISA: “Workshop discute atividades dos Centros Públicos de Bioequivalência (2006)”, at www.​anvisa.​gov.​br/​divulga/​noticias/​2006/​220306_​3.​htm
 
31
On this issue, see the differing discussions in Greene (2010), Hayden (2008) and Sanabria (2014).
 
33
Cf., Araújo L. U., Albuquerque, K. T., Kato, K. C., Silveira, G. S., Maciel, N. R., Spósito, P. A., et al. Medicamentos genéricos no Brasil: panorama histórico e legislação. Rev. Panam Salud Publica. 2010; 28(6): 480–492; Bate, R., Aparna, M., Lever, H., Thakur, D. et al. Generics substitution, bioequivalence standards, and international oversight: complex issues facing the FDA. Trends in Pharmacological Sciences; in press Elsevier Ltda. 8 pp. (https://​doi.​org/​10.​1016/​j.​tips2015.​11.​005); Borg, John; Joseph et al. ‘Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective’. Scientia Pharmaceutica 82.4 (2014): 847–856. PMC. Web. 30 Jan. 2016; Brazil. Agência Nacional de Vigilância Sanitária. Resolução – RDC n. 60 de 10 de outubro de 2014. ‘Dispõe sobre a concessão do registro de medicamentos com princípios ativos sintéticos e semissintéticos, classificados como novos, genéricos e similares e dá outras providências’ http://​bvsms.​saude.​gov.​br/​bvs/​saudelegis/​anvisa/​2014/​rdc0060_​10_​10_​2014.​pdf; Carpenter D. and Tobbell D. A. Bioequivalence: the regulatory career of a pharmaceutical concept. Bulletin of the History of Medicine, v. 85, n. 1, Spring 2011, pp. 93–131; Storpirtis S. et al. ‘Aspectos técnicos relativos ao registro de medicamentos genéricos no Brasil’. http://​www.​anvisa.​gov.​br/​medicamentos; accessed in February 2012.
 
35
Already in 1999 – before the IPL was amended as such in 2001 – the government issued a decree (Provisional Order No. 2.014-1 of 1999), instituting the juridical provision of anuência prévia (pre-grant opposition) for pharmaceutical patents. On this point, see Guimarães, in this book.
 
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Metadaten
Titel
Regulating the Copy Drug Market in Brazil: Testing Generics and Similar Medicines (1999–2015)
verfasst von
Marilena Correa
Maurice Cassier
Maria Andrea Loyola
Copyright-Jahr
2019
Buch
Health Innovation and Social Justice in Brazil

Print ISBN: 978-3-319-76833-5

Electronic ISBN: 978-3-319-76834-2

Copyright-Jahr: 2019

DOI
https://doi.org/10.1007/978-3-319-76834-2_10