Innovation strategies in medicines and vaccines within the scope of CEIS – models, mechanisms, and expectations

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

doi:10.1590/0103-1104202313801I

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ORIGINAL ARTICLE • Saúde debate 47 (138) • Jul-Sep 2023 • https://doi.org/10.1590/0103-1104202313801I copy

Innovation strategies in medicines and vaccines within the scope of CEIS – models, mechanisms, and expectations

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

The article aimed to present relevant and original information about the innovation strategies used by Official Pharmaceutical Laboratories (LFO) to reduce the vulnerabilities of the Brazilian Unified Health System (SUS) and the productive and technological capacity of the Health Economic-Industrial Complex. The methods used included a literature review and the analysis of primary data from interviews conducted in two of the largest LFOs in the country. Their efforts and results in Research and Development (R&D) and incorporation of medicines and vaccine technologies were identified and analyzed, with emphasis on Productive Development Partnerships (PDP). Although R&D activities still need to advance, benefits were brought about by technology transfer agreements, especially by PDPs. However, the industrial and technological capacity of the Institutes is still limited and lacks investments, which hinders technological accumulation and diffusion. Thus, improvements are necessary so that the innovation strategies for the SUS present more effective results and can be reversed to the welfare of society.

KEYWORDS
National science, technology and innovation policy; Access to health technology; CEIS; Public-private partnerships

Block	Topic	Topics Covered
1	The characteristics of the interviewee	Position and years of experience in the role
2	Characteristics of the Institution in relation to innovation	Number and type of partnerships undertaken, patents, innovative products, strengths, and weaknesses for partnerships
3	Impacts of PDP for LFO and SUS	Technological training, billing, production, human resources, new technological niches, new products generated
4	Partnerships	Mechanisms for prospecting and selecting partners, technologies of interest, priority products for partnerships.
5	Challenges, suggestions, and perspectives	PDP Challenges, PDP Framework, ST&I Legal Framework

Strategic Instrument	Description	Technology	Partner Selection (via)	TTT	Regulatory policy
PDP	“Partnerships between public institutions and private entities aimed at accessing priority technologies, reducing the vulnerability of the Unified Health System (SUS) in the long term and rationalizing and reducing prices of strategic health products, with the commitment to internalize and develop new strategic technologies and high added value.”	Existing but not nationally dominated	Bidding Waiver	Yes	Ordinance No. 2531/2014
ETECS	“Hiring modalities, by the government, of a non-profit research institution, with exemption from bidding, for innovation activities involving technological risk, for solving a specific technical problem or obtaining an innovative product, service or process.”	Non-existing, presence of technological risk	Bidding Waiver	Yes or No	Decree 9283/2018
MECS	“Any compensatory practice established as a condition for the strengthening of the production of goods, technological development or the provision of services, with the intention of generating benefits of an industrial, technological or commercial nature achieved.”	Existing	Licitation	Yes or No	*

Type of agreement	BIO	FAR
Product Development Partnership	13	13
Non-Disclosure Agreements	31	34
Agreements for the transfer of biological material	1	1
Research and Development Agreements (including agreements for clinical trials)	4	2
Technology Transfer Agreements	2	5
Technical Cooperation Agreement	7	5
Agreements for the provision of technological services	1	6
Technological Order	1	0

Internal challenges

External challenges

– agility in responding to demands;

– collaboration and interaction between the sectors involved;

– alignment with the partner;

– bureaucracy of public administration;

– lack of team dedicated to the projects;

– lack of resources for reinvestment in the project;

– insufficient number of personnel;

– hardening of management processes;

– current management model;

– planning based on the lack of definition and clarity on the end of the MS regarding demand and prices;

– competition with the market and the need to expand knowledge about the possibilities of the Innovation Law.

– lack of investment to adapt the manufacturing infrastructure;

– often insufficient budget to cover expenses;

– time/transfer ratio and absorption of knowledge or technologies that are the object of the partnership;

– legal uncertainty (need for changes in the legal framework);

– political instability; change of actors in government;

– insecurity regarding the maintenance of the price and volume of acquisition by the MS;

– exchange rate fluctuation;

– international logistics;

– pressure from the control bodies;

– difficulty for foreign partners to adapt to Brazilian legislation;

– culture of external public agents in relation to the need for investments in Research, Development and Innovation (RD&I).

Suggestions for improving the Framework (Ordinance No. 2531/2014) through the review of the PDP regulations (Ordinance No. 05/2017 – Annex XCV)

Bio-Manguinhos

Farmanguinhos

– distinction of the concept and responsibilities of the private entity that owns the technology, the private entity that develops/absorbs the technology;

– characterization and distinction of API concepts of synthetic API products from organic products;

– alignment of concepts between the product object of PDP and the API;

– adaptation of the text to the reality of PDPs of organic products;

– greater clarity should be given at other parts in the text.

– better definition of RD&I and PDP;

– better clarification on Phase IV and its closure;

– clarification on the nationalization of the national API and its acquisition after the finalization of the PDP by the LFO;

– approval of the demand for 100% of a medicine for only one laboratory (to analyze the division of demand, as it impacts the viability of the project);

– definition of clear criteria to differentiate the values of medicine acquisition and technology transfer;

– minimum criteria for the composition of monitoring reports;

– criteria and indicators for assessing technology transfer.

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[1] Conflict of interests: non-existent