1.3.4 Medications
 
The workgroup discussed the MCT/MS/FINEP invitation letter that defines criteria for public selection of proposals for supporting technological cooperation between the productive sector and scientific and/or technological institutions within the scope of the technological and industrial chain in the pharmaceuticals area.
 

Context

Initially, the subject Medications was not inserted into the workshop’s program, but given the relevance and volume of the appeals brought, it was considered opportune to discuss the institutional agreement between the Ministry of Health and the Ministry of Science and Technology, with the participation of the Sectorial Fund for Health (Fundo Setorial de Saúde – CT-SAÚDE) and the National Fund for Health (Fundo Nacional de Saúde). The call for bid resulted from a demand from Forums, the Industrial Policy and companies, which allows a greater success in the application of resources.

Therefore, the dynamics and objectives of this workgroup are different from the others, once the subject of discussion will be the MCT/MS/FINEP invitation letter, which defines criteria for the public selection of proposals for supporting technological cooperation between the productive sector and scientific and/or technological institutions within the scope of the technological and industrial chain in the pharmaceuticals area. The relevant points of discussion that resulted in the priority setting for the area are presented as follows.

Need to strengthen the HR (Human Resources) development, mostly in the clinical and preclinical research areas.

Inclusion of medications originated from natural products – the phytomedications –, since it is a priority area of the MS, with policy approval for SUS. Main demands come from researches at the end of the chain, for development of products, and also researches with plant species enlisted in the National Lists of Medicinal and Phytotherapeutical Plants, which is to be concluded by the Ministry of Health.

Importance of participating in the Competitiveness Forum of the Pharmaceutical Productive Chain.

The proposal of the call for bid conforms with the purpose of the law of innovation.

The theme is discussed in the Sectorial Fund for Health and, from 2004 on, the public-private partnership was praised in the calls for bid. There is a rule that reserves 50 percent of resources for projects resulting from public-private partnerships. In 2006, the actions are aimed to the area of medications, thus representing an efficient moment for partnership of the Ministry of Science and Technology with the Ministry of Health..

Importance of clearly putting in the call for bid the priorities of the Ministry of Health. in the area of neglected and high-cost diseases. It was suggested to use the text of the Bioproducts call for bid as reference.

Interest in supporting thematic projects with transpositions of scales, thus being necessary to define patent situations – not only product patents, but process patents as well.

Eleven percent of health budget is destined to medications and the situation may reach a point intolerable in 2010 if it remains in such proportion.

The average time of development for medication surrounds 10 to 20 years. Therefore, projects that should be prioritized are the ones at the end of the chain such as development of innovations, namely pre-clinical and technological trials and essays.

The importance of linking research scholarships for HR capacity-building is highlighted as a point of the call for bid with the objective of strengthening HR in the technological development step with incentive from institutions.

Another point of consensus for inclusion in the document was in relation to the participations of the Pharmaceutical Assistance Department (Departamento de Assistência Farmacêutica – DAF) and the Science and Technology Department in the merit and follow-up assessment of supported projects.

The call for bid shall aim to public-private partnership projects with the objective of developing researches that reduce the country’s dependence on medications and fostering innovations.

The importance of valuing priority diseases is underscored not only in the economic aspect, but in the social aspect as well.

 

Methodology

Considering this group’s specificities, the proposed methodology was not used. The discussion dynamics used the policy agreement and the consensus among strategic players on the approval of proposal of the MCT/MS/FINEP invitation letter. This document defines criteria for public selection of proposals for supporting technological cooperation between the productive sector and scientific and/or technological institutions within the scope of the technological and industrial chain in the pharmaceuticals area.

Results

By consensus, the following changes were made to the document:

Subjects/Segments/Priority Lines

With this Invitation Letter, projects aiming to innovations in the technological and industrial chain of the pharmaceutical area will be supported, and proposals that approach activities included in the final phase of the innovation development chain will be prioritized, which are namely pharmaceutical formulation, scale transposition, preclinical trials, toxicological trials and essays.

Exceptionally, proposals that purport to develop innovations in the technological and industrial chain in the pharmaceutical area at all phases will be considered in order to obtain innovative products when they are aimed to these priority diseases: Cerebrovascular disease; Sexually transmitted diseases/AIDS; Hepatitis; High blood pressure; Hansen’s disease; American tegumentary leishmaniasis; Visceral leishmaniasis; Schistosomiasis; Malaria; Tuberculosis; Cancer; Chagas disease; Dengue fever.

 

Workgroup

Adriana Diaféria
ABDI – Brazilian Agency for Industrial Development (Agência Brasileira de Desenvolvimento Industrial)
Allan Kardec de Lima CNPq/MCT - National Council for Scientific and Technological Development
Ângelo Rodrigues DAF/SCTIE - Pharmaceutical Assistance Department of the Secretariat of Science, Technology and Strategic Inputs - Ministry of Health
Belmiro Salles CNPq - National Council for Scientific and Technological Development - Ministry of Science and technology
Carcílio Franco Decit/SCTIE - Science and Technology Department of the Secretariat of Science, Technology and Strategic Inputs - Ministry of Health
Cláudia Cunha DAF/SCTIE - Pharmaceutical Assistance Department of the Secretariat of Science, Technology and Strategic Inputs - Ministry of Health
Eliane Cortês SAS - Secretariat of Health Care Attention (Secretaria de Atenção à Saúde do Ministério da Saúde) - Ministry of Health
J. Lourenço Seixas Decit/SCTIE - Science and Technology Department of the Secretariat of Science, Technology and Strategic Inputs - Ministry of Health
José Luís SAS - Secretariat of Health Care Attention (Secretaria de Atenção à Saúde do Ministério da Saúde) - Ministry of Health
Laura Campos CNPq - National Council for Scientific and Technological Development - Ministry of Science and Technology
Luís A Barretos de Castro MCT – Ministry of Science and Technology
Manoel Roberto da Cruz Santos DAF/SCTIE/MS - Pharmaceutical Assistance Department of the Secretariat of Science, Technology and Strategic Inputs of the Ministry of Health
Maura Pacheco
Finep - Research and Projects Financing
Moisés Goldbaum SCTIE - Secretariat of Science, Technology and Strategic Inputs - Ministry of Health
Simone Paiva Finep - Research and Projects Financing
Sofia Daher CNPq - National Council for Scientific and Technological Development - Ministry of Science and Technology