1.2 Methodology

The priorities of R&D&I identified in the analytical process can be related to the combat of three types of “flaws” - of science, market or of public health - for the development of different types of innovations in health.


Beginning of the Process

The first step to effectively develop the initiative was defining the technical cooperation scope, among the Center of Technological Development in Health (CDTS / FIOCRUZ) and Decit, followed by the organization of the process which led to a collective meeting, with the participation of the process coordinating institutions. Expert were invited to represent each disorder along with the technical areas of the Ministry of Health.

In the meeting, attendees came up with and agreed on strategies for holding a workshop at national level with the aim to learn the state of art and set research priorities for each disease.

Definition of Neglected Diseases Record

An important decision that required a lot of discussion refers to the selection of neglected diseases to be addressed in the public Call for Bid. To elucidate the subject, the historic evolution of the concept of neglected diseases was rescued, when it was reminded that the discussion had begun in 1977, with the Rockefeller Foundation instituting the Program Great Neglected Diseases of Mankind, which lasted until the year 2000. In this context, the World Health Organization (WHO) and Doctors Without Borders (DWB) intended to classify the disease into Global, Neglected and More Neglected.

Initially, 10 diseases were considered, defined now by the Special Program of Research and Training in Tropical Diseases of WHO (TDR / WHO) as neglected, and from those, six priority diseases in Research and Development (R&D) in Health were selected.

Criteria for the Composition of the Workgroups

The criterion for selecting researchers to participate in the preparatory phase of the workshop was based on the analysis of their publications productivity in the period 2000-2006, according to the Institute Web Knowledge for the Scientific Information related to each of the neglected diseases selected.

The same criterion was adopted to compose the workshops groups. The managers' selection to compose the workgroups was defined together with the areas of control of diseases and management of the Ministry of Health programs.

Methodological Path

The discussion went on to be subsidized by the study of the priorities in Research and Development (R&D) in neglected diseases, a study developed by international institutions, which began in the 90’s. The study proposes the categorization in two modes: Mode 1 and 2 to understand knowledge generation, according to the details and permanent adaptation of the chart below:

1994: Different modes of knowledge production:

Modo 1. The problems are identified and solved in an academic context that obeys specific communities' interests.

Former: CNPq, HHMI

Mode 2. The search for knowledge seeks a practical application:

Former: TDR, FINEP/MCT, Decit/MS e indústria.

This initiative, in partnership with the Science and Technology Department / Ministry of Health (Decit), along with the technical cooperation of the Center of Technological Development in Health (CDTS / FIOCRUZ) for Neglected Diseases, is inserted in Mode 2. The expectation is that this effort results in practical applications of research products, incentive to transdisciplinarity, assembling heterogeneous teams and exercising quality control with social, political and economical criteria.

1997: The Pasteur’s Quadrant and the “inspired research in use”

  • Failure of the linear model that separates basic from applied research
  • Basic Science
  • Necessary? YES
  • Necessary and sufficient? NO
  • A new model:
  • The bi-dimensional conceptual plan, (Stokes, 1997)

For the TDR method, the 10 neglected diseases can be grouped into 3 categories according to the description below:

Category 1 - Sleeping Sickness - Dengue – Leishmaniasis
  • Emerging or out of control diseases.
  • The focus should be on the generation of new knowledge and in the development of new interventions and systems.
Category 2 – Malaria - Schistosomiasis – Tuberculosis
  • In spite of a control strategy, the disease burden persists.
  • R&D activities cover a wide spectrum, but they are focused on the development and tests of new interventions and strategies.
Category 3 - Chagas’ Disease. Hansen’s Disease - Filariasis and Onchocerciasis
The control strategies are effective, the disease burden decreases and its elimination is planned as a public health issue.
The research aims to improve the current control activities and to eliminate risks.
For Morel, the three categories need strategies other than intervention as disclosed in the matrix below:



A fundamental contribution to the epidemic analysis of each disorder was the use of the conceptual base of the Study on Global Disease burdens, employing the DALY (Disability Adjusted Life Years) indicator. The study was fundamental for understanding the morbid-mortality of chronic-degenerative and transmissible diseases. The team of ENSP / FIOCRUZ that coordinated this work in 1998 presented the methodology's potential at the workshop, pointing out significant results about health in Brazil, obtained using that method.

Criteria of Prioritization in the WHO Special Research and Training Program on Tropical Diseases (TDR/WHO)

The prioritization criteria developed by WHO Special Research and Training Program in Tropical Diseases (TDR/ WHO) in R&D, guided the setting of research priorities in neglected diseases. With the objective of composing a referential mark for each selected disease and of addressing the categorization of the disease, strategic matrix and specific products, “the process was adopted in 7 Stages”, inserted in the TDR document on R&D priority setting. The tool consists of a script of questions to elucidate the problem and contextualize the situation of each disease, as described below:

Categorization of the disease

  • What is the size and nature of the disease burden, and what’s its epidemic trend?
  • What is the control strategy of the disease?
  • Why does the disease burden persist?
  • What are the R&D needs and priorities?
  • What is already being made in R&D?

Strategic matrix

  • What are the comparative advantages of TDR?
  • Setting of the strategic priorities for the disease in question.

After that stage, established the conceptual bases and defined the most appropriate methodology for setting priorities in research on neglected diseases, the script was elaborated to guide the workgroups’ discussion, as follows:

Guidelines for the groups discussion

Analytical Process

1. What is the nature and size of the disease burden and which are the epidemic trends?
2. What are the interventions and control strategies of the disease currently available?
3. Which are the major problems and challenges in controlling the disease?
4. Which activities of R&D&I would be necessary to face these problems and challenges?
5. Which activities of R&D&I are already in process? Do new opportunities exist?
6. Which are the activities in R&D&I where the Neglected Disease program would have a comparative advantage in performance, in comparison to existing programs?
7. Which should the specific priorities of R&D&I in the next call for bid of Decit?
8. Which recommendations would be submitted to Decit for financing strategies:
9. Projects of a great, medium or small size?
10. Individual support or networks?
11. Multi-centric studies?
12. Support to emerging group

How should primarily be invested 30% of the Calls for Bid resources that must obligatorily be allocated to the North, Northeast and Central-West regions?

Nature of the intended innovations

The priorities of R&D&I identified in the aforementioned analytical process can be related to the need of fighting three types of “flaws” - science, market or public health - for the development of different types of innovations in health, according to the schedule below:

Type of “flaw”




Models of innovation



Insufficient knowledge hinders the development of effective sanitary interventions

We do not know yet how to develop vaccines against parasite-transmitted illnesses; “hiatus 90/10”

More basic or strategic research; larger involvement of the productive sector

New products, new strategies of R&D&I

Bio-informatics, genomic in the identification of new objectives and drugs as fosmidomicina; PDPs; Law of Innovation 2004


High costs of existing interventions restrict use or access for marginalized populations

High cost of anti-retroviral drugs and anti-malaria drugs combination

DT of cheaper production processes; new financing strategies

New methods and processes; new financing strategies, new budgetary policies

Partnerships to develop products; global facilities; taxes; philanthropy; medicine donation

Public Health

Incompetence, disregard, crises, wars, corruption, factors cultural or religious hinder access to cheap or even free interventions

Difficulties in eradicating polio; opposition by the food and tobacco industries to the strategies to fight obesity and smoking habits

Social control; education; participation of the civil society; policies of human rights; good practices

Processes; political strategies

National vaccination days; campaigns to promote physical exercise; WHO Convention against tobacco