Comparative study between global pharmaceutical company and public institution of production and innovation in health

Rocha, Kelly Cristina Rodrigues da; Gadelha, Carlos Augusto Grabois

doi:10.1590/0103-1104202313802I

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ORIGINAL ARTICLE • Saúde debate 47 (138) • Jul-Sep 2023 • https://doi.org/10.1590/0103-1104202313802I copy

Comparative study between global pharmaceutical company and public institution of production and innovation in health

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

The technological scenario in the field of health is an alarming fact, especially in the context caused by COVID-19. In this context, the Oswaldo Cruz Foundation, through the Bio-Manguinhos Unit, and the Butantan Institute were protagonists for universal access, dialoguing with international strategies. In the strategic discussion for Public Institutions of Production and Innovation in Health (IPPIS), the use of guidelines of the Technological Assessment in Health stands out as a way of paradigmatic change for the introduction of technologies in the Unified Health System (SUS) in line with the vision of future innovation in health in accordance with national demands. This article, methodologically developed through qualitative descriptive research, bibliographical, documentary and field work, sought to trace symmetries and asymmetries based on the experiences collected in a global pharmaceutical company and a public national reference institution in the field of technological incorporation in health. As a result, key points are explained for the technical and political strengthening of the Health Economic-Industrial Complex, through the organizational review of the IPPIS regarding innovation and management aspects, culminating in the promotion of improvements in the science, technology and innovation policy in response to the challenge of sustainability, effectiveness and access in the SUS.

KEYWORDS
Access to essential medicines and health technologies; Technology assessment, biomedical; Unified Health System; Health Economic-Industrial Complex

Ranking	Economic Group	Classification
1	Grupo Sanofi/Medley/Genzyeme	> = 3 billion
2	Grupo E.M.S	> = 3 billion
3	Grupo Sandoz/Novartis	> = 3 billion
4	Grupo Aché/Biosintética	> = 3 billion
5	Grupo Eurofarma/Momenta	> = 3 billion
6	Grupo Hypera	> = 3 billion
7	Grupo Johnson & Johnson	Between 2 billion and 3 billion
8	Grupo Pfizer/Wyeth	Between 2 billion and 3 billion
9	Grupo MSD/Schering Plough	Between 2 billion and 3 billion
10	Grupo Glaxo/Stiefel	Between 2 billion and 3 billion
11	Grupo Bayer/Schering do Brasil	Between 2 billion and 3 billion
12	Grupo takeda/Multilab	Between 2 billion and 3 billion
13	Grupo Cristália	Between 2 billion and 3 billion

			PHASES
General Framework		OUTPUTS	I	II	III	IV	Total
Current PDP	62	Biotechnological	1	6	7		14
Biotechnological	14	Blood products			1		1
Blood products	1	Synthetic	6	14	10	14	44
Synthetic	44	Vaccines			3		3
Vaccines	3	total	7	20	21	14	62
Bio-Manguinhos	9
Farmanguinhos	9
Butantan	8

Ranking	Benchmarking	Bio-Manguinhos
Dimension	• It has ofces in more than 115 countries, as well as major research centers; • Extensive production network in about 70 locations worldwide.	• It has CtV, one of the largest production centers in latin America, and the pilot plant installed on FIOCRuZ’s campus in Manguinhos. Forecast of new units in Santa Cruz and Eusébio; • Linked to the MH, since 1976, it meets the needs of the SuS, and has been a strategic agent of public health policies as one of the drivers of the National Immunization Program (PNI) and of export of products to more than 70 countries.
Management Model and Organizational Structure	• Smaller groups, more agile and with greater decision-making power.	• Large groups, verticalized decision fow, with traditional and divided structure;
R&D	• Investment of £4.6 billion in 2019; • There are 6 studies currently planned in Brazil, 3 in multiple myeloma, two in head and neck cancer, and one in lung cancer, involving 59 research centers and 144 participants.	• Investment of R$70 million (3.2% of total revenue), in 2019; • 14 ongoing technological development projects and 13 current PDP; • 16 initiatives in the InovaBio Notice and participation in the Inova labs FIOCRuZ and Inova FIOCRuZ programs
Partnerships	• Partnership with FIOCRuZ since 1985 and with Bio-Manguinhos since 1998; • Partnership with another public agency in the Onco-Hematology market in Brazil constituting a portfolio with more than 15 therapeutic options in clinical development on several fronts, including Immuno-Oncology, Epigenetics, Synthetic lethality and Gene therapy (prospective basis of the Brazilian scenario in 2040).	• Twelve technology transfer projects managed in 2019, four of which are viral vaccines (triple viral, quadrivalent viral, rotavirus, and inactivated polio); one of bacterial vaccine (pneumococcal 10-valent); six of biopharmaceuticals (epoetin alpha, interferon alpha, infiximab, interferon beta 1a, alfataliglycerase and etanercept); and one of diagnostic kit on DPPs® and DDPPs® platforms.
HTA	• Use of HtA methodologies in its processes and in the organizational structure; • It uses the studies produced by a Country’s HTA agency; • Consulted for contribution inserted in the set of actors of the Country’s fow of technological incorporation assessment in health.	• It has institutionalized the economic and fnancial analysis center, responsible for the EVE activity of products and has Evidence-Based Medicine activities in Clinical Advisory and Prospecting activity directly linked to the Board; • The unit makes incipient use of the studies advertised by CONItEC; • Occasional performance in a public call and in the submission to evaluate the expansion of the use of a medicine.

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E-mail: revista@saudeemdebate.org.br

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[1] Confict of interests: non-existent