Context
The Science and Technology Department (Decit) organized a meeting with participation of specialists, researchers and managers for promoting a broad discussion on the current scenario of research and development of diagnostic products in Brazil. The objective of this meeting was the identification of research priorities and the development and innovation of diagnostic products for health so as to subsidize the investment focus definition for the development of diagnostic kits, thus complying with the sub-agenda of the Health Productive Complex within the National Agenda of Priority Research in Health. The Agenda set as priority for fomentation the support to research, development and innovation of diagnostic products in health.
Methodology
As support data for discussions concerning identification of fomentation priorities in the diagnostic kits area, the work “National technological prospecting on reagents for diagnosis within Public Health domain” was presented. It was carried out for the Innovation in Health Project and was aimed to detect opportunities for development of laboratorial diagnostic reagents for transmitted diseases – blood control: AIDS, cytomegalovirus, dengue fever, Chagas disease, filariasis, viral hepatitis, herpes, HTLV I and II, Leishmaniasis disease, leptospirosis, malaria, rubella, measles, syphilis, toxoplasmosis. This study was conducted under three approaches: market vision, development vision and innovative vision.
The market vision identified the main imported products and their main importers for the 16 diseases selected for the study. It was possible to see who imports, what are the imported products, and the amount of resources destined to each disease. Concerning governmental expenditure with procedures, it identified the frequency magnitude and the value of diagnostic tests the SUS run. Such data, analyzed for the most representative diseases (hepatitis B, toxoplasmosis, AIDS and hepatitis C) calculated as expenditure of US$73.9 million from July, 2003 to June, 2004, disregarding the under-registration and quality of data – problems that are inherent to health public databanks.
The development vision sought to identify present initiatives in governmental programs, in the Academia and in the productive sector. In the public sector, the study failed to identify an initiative that organizes governmental programs and facilitates access to information. R&D in the Academia, in turn, revealed that only 12 diseases are researched by 60 research groups, among which 41 work on only one disease and 19 work on more than one. In the productive sector, few groups in Brazil work on developing kits; therefore, only nine companies were identified as having productive capacity, counterposing the 89 different companies that have product registration in Ministry of Health - National Agency for Sanitary Surveillance (Agência Nacional de Vigilância Sanitária - Anvisa), which includes name and/or antibodies of diseases.
Under the focus of innovation, the study concluded that there are competencies within the country, but market information in Brazil are disorganized. In addition, researchers observed a lack of interest from the part of big companies in producing reagents for the identification of the transmitted diseases encompassed in the study.
According to the study results and experience of invited researchers, it was possible to identify the main weaknesses and strengths that permeate technological development in this field and which can be supported by fomentation initiatives in the mold of universal calls for bid. Aspects such as viability, feasibility and opportunity for defining the call for bid outline were considered purporting to raise the potential of available fomentation resources.
For the call for bid concerning diagnostic kits, the identified main objective was the selection of proposals that stimulate the national production – within public-private sectors partnerships – of inputs and reactants for diagnosis of economically-impacting or neglected diseases for supplying the public health system with. As a specific objective, in addition to stimulating partnerships, the intention is to select projects for the development of inputs, equipment and reactants for diagnosing neglected diseases or diseases which have great impact on public expenditure.
The choice of diseases to be included in this call for bid was ruled by a series of pertinent considerations that refined the first selection of neglected diseases and disease which have a great economic impact on public health. In addition to the assessment and identification of most relevant aspects at the present moment for each one of the diseases, the listing of diseases was tailored regarding the capacity of possible proponents in developing competitive products within the national market. As most of the research and development institutions lacks capability of competing with big companies, it is a fact that neglected diseases represent a more accessible market niche to be occupied by the national industry, which turns back to the need for obtaining technology by establishing partnerships with small companies so that the public-sector market be supplied with. Within this strategy, the need for developing competencies aimed to business management in the public sector was also identified. For that purpose, it is necessary to train people for making them capable to negotiate and to use public purchasing power for building and strengthening national capacity, thus seeking autonomy in production.
Results
Concerning the desired characteristics
for this call for bid, a period inferior to one year was
considered inadequate to the aimed type of technological
development, so a period of two years was established as
the ideal for execution of projects ranging between US$
185,000 and US$ 750,000.
The axes identified for establishing the support logic were: diseases, technology, development stage, equipment, and business management. In what concerns the proposition of call for bid, these axes were considered conjointly so there would be no disharmony or discontinuity in the technological development, which might take place were only one of the axes supported. Furthering the call for bid outline, the specification of targets for investment was centered in the technological development and production of diagnostic inputs, equipment and reactants for enzymatic essays, molecular essays and quick tests, focusing on sanitary priorities concerning the following:
- Neglected diseases: dengue fever, tuberculosis, tegumentary leishmaniasis, visceral leishmaniasis, leptospirosis and malaria.
- Diseases of great impact on public expenditure: AIDS, cytomegalovirus, hepatitis B, hepatitis C, toxoplasmosis, rubella and syphilis.
The group opted for free demand of projects concerning inputs and equipment, as long as it is required that they be aimed to development stages stipulated for the call for bid, which praises only the ones in more advanced stages, according to the degree to be detailed in the project (levels ranging from I to V). The purpose is to concentrate the initiative in products, and equipment for supporting those products, which is an aspect that should be analyzed by specialists when judging proposals presented in the call for bid.
As to diagnostic reactants, they should conform to the investment priorities established in Table 1: |
After setting priorities, the group considered important to link points criteria (for selection and classification) to development stages, taking into account the objective of supporting projects in more advanced stages, thus being placed in levels II, III, and IV, pursuant to criteria below. It is observed that the other levels were included just for keeping the notion of the set.
Previous Criteria
1. Patentability assessment.
2. Demand (MS projection).
3. Epidemiological studies, understanding of disease and of etiologic agent.
4. Market studies.
5. Technical qualification.
6. Infrastructure (implementation of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)).
7. Viability study (technical, economic, social, environmental, political).
Level I – Prospect Research (Pre-Development)
1. Characterization of target (antigen, antibody, conjugates and inputs).
2. Selection of diagnostic method (technological platform).
3. Internal assessment in the research laboratory.
4. GLP conformity (technical report, product/project background, updated bibliography).
5. Analysis and/or application of patentability (publishing).
6. Work Value Scale (WVS).
Level II – Technological Development
1. Document analysis of the pre-development stage.
2. Establishment of the seed batch (it varies from case to case, according to the antigen, antibody or input utilized).
3. Definition of the technological platform.
4. Definition of test format and standard, and its inputs.
5. Assessment against samples and reference panels (primary validation of sensitiveness, specificity, reproducibility, and stability).
6. Patentability analysis.
7. Determination of technical and economic viability for production.
Level III – Obtaining Prototype
1. GMP conformity.
2. Obtaining pilot batches.
3. Preliminary definition of kit presentation.
Level IV – Validation
1. Validation (multicentric studies)
a. Sensitiveness analysis.
b. Specificity analysis.
c. Reproducibility analysis.
d. Stability analysis.
e. Analysis of product adaptation to the target-user network.
f. Dossier preparation.
2. Registration
a.
Technical report.
- Project background records.
- Standard formula.
- GLP and GMP documentation.
b. Previous analysis according to regulatory agency requirements.
c. GLP and GMP certification.
d. Request for registration.
3. Transfer to Production.
Level V – Product Accompaniment and Control in the Market
1. Post-Marketing studies.
a. Product observation and accompaniment in the market.
b. Product studies for market prospecting.
c. Development of studies aimed to product export.
d. Technology transfer.
Once the desired level of development had been defined, some criteria were established for observing both the selection and the classification of proposals. In selection criteria, there was a suggestion for highlighting business management as an item to be observed in the institutional infrastructure in order to complete the common model for universal calls for bid of Finep. As to classification items, a great emphasis was given to: (1) adherence and viability of implementation in SUS; (2) product development stage; (3) productive sector involvement; (4) existence of intellectual property rights claim (patents); and (5) financial participation of the intervenor. The latter two criteria may be observed in Tables 2 and 3 below.
Points criteria – selection
At this stage, which has competitive and classificatory nature, an Assessment Committee formed by ad hoc consultants shall analyze the merit of pre-classified proposals according to criteria below; such proposals are to be valued in terms of achievement degrees for the comparative analysis of competing proposals. |
