Innovation and Industrial Innovation and Industrial Development in Health:Development in Health:

Prospection for ActionProspection for Action

Coordination: Presidency of FIOCRUZAn Agreenment between FIOCRUZ and FIOTEC – Ministry of Health

The Country’s Situation The Country’s Situation

TheThe Health SystemHealth System

National Health System/ SUS (1988/ 1990)

– Universalization, decentralization e hierarchization

– Federal Level: coordination, regulation and financing

Highly influential over the entire health system

– Ex: Medicine program (generics), immunizations, blood control, blood derived products, investments (REFORSUS), services, etc.

A Strong Demand for Health Services and Products

Health Industrial Complex

Pharmaceutical IndustryDrugs / Medications

Medical equipment and medical products industry

Non-electric/electronic devicesEletric/electronic devicesProsthetics and orthotics

Consumer goodsVaccine Industry

Blood-derivedproducts

Diagnostic Reagents Industry

Public Private Philanthtopy

Service Sector

Product Manufacturing Industries

Source: ECIB-COMPLEXO DA SAÚDE, 2002

GOVERNMENT-

PROMOTION AND REGULATION

Competition in the IndustryCompetition in the Industry

Downfall in Competitiveness in the 90’s

Growing gap between supply capacity and social needs

Outburst of the Trade Deficit – from US$ 750 million to US$ 3,5 billion

– Medications: US$ 860 million

– Drugs: US$ 1,250 million

– Vaccines: US$ 121 million

– Diagnostic reagents: US$ 126 million

– Material and Equipment: US$ 870 million

Major Determinant: domestic (in)capacity to produce innovation in terms of health

Risks and ProspectsRisks and Prospects

Risks Risks

Product re-specialization caused by globalization (products with low aggregate value)

Broadening of the technological gap and loss of competitiveness

Vulnerability of the Brazilian economy and social policy

Health policy highly and incresingly dependent on imports

– Present estimate: R$ 12 billion/year

ProspectsProspects Favorable political environment to implement socially

oriented development policies

Ex: BNDES Seminar on the Health Industrial Complex; The launching seminar of the Innovation Project ; The Forum on Competitiveness in the Pharmaceutic Production Chain and in Biotechnology

The new Lews: “Innovaton” and “PPP”

Evidence of significant space to move foward:

– The size of national health needs

– The structuring process of the Health System (SUS): the inducing role of the State

– The relevant deficit with developing countries

Major Instruments:

– Industrial and innovation-oriented policies

– Health policies: the use of the State’s purchase capacity, coordination and induction

ProspectsProspects

The establishment of a thorough tie between industrial, innovation and social policies

– Niche identification, innovation networks and anchors in the different segments of the complex

– Evaluation of health needs on short, mid and long terms

– Strengthening of the partnerships between the public and the private spheres

Strengthening of local innovation bases on a policy destined to reduce national inequalities

– Induction of local productive arrangements in health

– Use of local habilities and the formation of innovation networks in health

Objectives of the StudyObjectives of the Study

To propose a mid and long term plan for innovation and development in health

To serve as subsidy for the formulation and the establishment of innovation and industrial policies for manufacturing activities in health

To identify and promote competitive niches and windows of opportunities for Brazil

To develop a discussion over the matter and to define priorities as to the State, the production sector and the University (“Triple Helix”)(Brazilian brand-new “Triple Helix plus”).

General ObjectivesGeneral Objectives

Objectives of the StudyObjectives of the Study

To evaluate the world technological frontier in terms of health

To evaluate the Brazil’s capacity in innovation in health as compared to the rest of the world

To evaluate long term needs of development and innovation in health

To serve as subsidy for policies concerning the competitiveness of domestic manufacturers in terms of technology and management

To develop terms of commitment between the State and the manufacturers with the aim of expanding competitiveness and innovation

Specific ObjectivesSpecific Objectives

Selected Sectors and AreasSelected Sectors and Areas

Vertical Studies

– Drugs and Medications– Vaccines– Diagnostic Reagents

Priorities Defined by Health Needs

Horizontal Studies

– Disease Burden

– Intelectual Property

Methodology: Methodology: stressing the establishment of policies stressing the establishment of policies

Projects developed for different priority sectors and areas by specialized consultants

Discussion with specialist technical groups about the projects’ contributions (Workshops)

Discussion with public administrators aiming at defining policies and priorities for development and innovation in health

Dissemination of the results to the State and to society

Signing of the Terms of Commitment for development and innovation in health

Institutional PartnershipsInstitutional Partnerships

Ministry of Health

– Minister Cabinet, Executive Secretariat, Health Surveillance Secretariat, Science, Technology and Health Products Secretariat, SAS, ANVISA, ANS, FUNASA

Ministry of Science and Technology and Ministry of Education

– FINEP, CNPq, CAPES

Ministry of Development, Industry and Commerce

– BNDES

Brazil’s Private Industry

Public Manufacturers of Goods and Services in Health

Science and Technology in Health Community

International Institutions

Vaccine StudiesVaccine Studies

Ministry of Health / Financing Agencies / Manufacturers

Coordenation

FGV (Dr. José Castanhar)

UFRJ – Chem Department

(Dr. José Vítor)

International Consultant(Dra. Julie Milstien)

Institution

November 2003

October 2003

October 2003

July 2003

Report

11/05

09/29

09/12

Held in June 2003

Workshop

October

2003

09/15

08/15

Concluded

May 2003

Study

Beginning December 2003

Terms of Commitment

Includes negotiation with Ministries and Financing Agencies

Development of Propositions

Report with majorconclusions.

Managerial Capacity of Public Manufacturers

Report with major conclusions.

Prospection of Domestic Capacity of R&D in Vaccines

International Prospection Studies of the World Market

ObservationsStudies/Stages

Present StagePresent Stage

Dr. Manuel Limonta (Cuba)

September 2003

08/1107/31Technological Capacity of Vaccine Production

Report with major conclusions.

Report with major conclusions.

Estudos HorizontaisEstudos Horizontais

ENSP/ FIOCRUZ(Dr.Jorge Bermudez)

ENSP/ FIOCRUZ(Dra.Joyce Schramm)

Institution

July 2004

June 2004

Report

September 2004

August 2004

Workshop

March 2004

March 2004

Study

- The TRIPS Agreement and its impact on public health and innovation

Intelectual Property

- 2003-2015 Projections

Disease Burden – Epidemiology / Demographics

ObservationsStudies/Stages

Disease Burden – aims at contributing to identify the priorities of scientific and technological development of health products and research from 2003 to 2015, considering the morbidity/mortality rates

Intelectual Property – Considering international agreements at the World Commerce Organization (TRIPS), it intends to serve as a subsidy for the definition of politics for the development, management and manufacturing of public health products in the country.

Estágio AtualEstágio Atual

PROGRAMA INOVACINA

Formulação e Estado Atual

Setembro de 2006

José R. Carvalheiro

Projeto Inovação em Saúde/ FIOCRUZ

jrcarval@fiocruz.br

MARCOS ESSENCIAIS NO DESENVOLVIMENTO

2002: Projeto Inovação em Saúde: vacinas, medicamentos e reagentes

2003: Estudo de vacinas: metodologia, a hélice tripla, “Inovacina”, livro

2004: Fóruns Competitividade (MDIC), Cadeia Farmacêutica, Biotecnologia (GT de Saúde Humana), aceita “Inovacina” como base

2005: documento que define “Política Brasileira de Desenvolvimento Industrial” (ABDI, CGEE); atualizar o “Inovacina”, apreciação por especialistas, Seminário para definir proposta. [DOCUMENTO]

PROGRAMA NACIONAL DE COMPETITIVIDADE EM VACINAS (INOVACINA)

4 COMPONENTES:

A) Definição de políticas e organização da produção.

B) Modernização do parque produtivo.

C) Avaliação e regulação (Anvisa) (Ensaio Clínico/não clínico).

D) Desenvolvimento e inovação (Translational).

Legislação encaminhada (2006)Legislação encaminhada (2006)

Maio (2006) Portarias GM / MS 972 e 973: cria “Inovacina” e a “Câmara Técnica de Imunobiológicos”

Julho (2006) no Fórum de Competitividade de Biotecnologia: “Estratégia Nacional de Biotecnologia” e “Política de Desenvolvimento da Bioindústria”, acolhendo a essência do “Inovacina”; os 4 Ministros (MDIC, Saúde, Agricultura e C&T) assinam Exposição de Motivos ao Presidente da República com Minuta de Decreto; cria um “Comitê Nacional de Biotecnologia” coordenado pelo MDIC com 14 representantes de ministérios.

Novas Prioridades (Maio/Julho 2006)

Até 3 anos

Pentavalente (DTP/HB+Hib) Raiva em cultura celular Meningite Meningococica, C conjugada. Leishamaniose canina Vacina DNA para uso terapêutico da tuberculose (câncer de

pescoço e cabeça) Raiva para uso canino em cultura de tecidos Gripe Pandêmica – aviária

Até 5 anos Meningite Meningococica, B + C conjugada Febre Amarela Inativada Streptococcus pneumoniae HPV Poliomielite inativada DTPa (pertussis acelular) MMR/Varicela Hepatite A Meningite Meningococica B

Até 10 anos Rotavírus

Meningite A conjugada

DTPa/HB + Hib

MMR/ Varicela

Meningite C conj + Hib + pneumococos

HBV/HAV

Até 15 anos

Leishmaniose

Prazo Indefinido

Malária Dengue HIV/AIDS Leptospirose Hepatite C Xistosoma Varíola Tuberculose

Outros

Necator

Adjuvantes

Soros hiperimunes