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Regional Perspective of the Global Strategy and Plan Of Action on Public Health, Innovation and Intellectual Property (GSPA) in the Americas:An implementation overview (download document )
After the approval at the 61ST World Health Assembly of resolution WHA61.21, Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, GSPA, and as a result of an extensive consultation process; in October 2008 in its 48th Session PAHO Directing Council endorsed the organization as the leading international agency in the implementation of the Global Strategy through Resolution CD. 48R15, Global Strategy on Public Health, Innovation and Intellectual Property: a Regional Perspective which urged member States to promote research and technological innovation in the pharmaceutical, scientific, and manufacturing sectors while strengthening relations and collaboration among key stakeholders.
Special attention was paid to the improvement of “cooperation among countries and, where applicable, within sub regional integration organizations, in order to promote technology transfer and foster research and technological innovation among countries”. Subsequently, it asked PAHO secretariat to disseminate to society’s relevant stakeholders the global strategy and the plan of action and to collaborate constructively with other international organizations working in the Region with responsibility for regional, sub regional, and national implementation of the strategy.
Three intertwined and complementary vectors of action were identified for the regional implementation of the Global Strategy in the Americas: Access, Intellectual Property Rights management and Innovation. Such an approach sought to streamline the implementation of the GSPA within the ongoing technical cooperation activities of the organization expressed and endorsed by member States in the PAHO Strategic Plan 2008-2012 and Health Agenda for the Americas 2008-2017.
In November 2008, in cooperation with Brazilian Authorities, PAHO organized the 1st International Seminar on Access to High Cost and limited sourced medicines in Brasilia, Brazil gathering a wide representation of national delegations (1). The conclusions of the meeting highlighted among other priorities the need for integrated policies on access and Innovation and a management of intellectual property rights that took into account public health needs. A summary of the presentations delivered together with the ensuing dialogue and a deeper look into several issues were the basis for a publication, Access to High Cost Medicines in the Americas: Context, challenges and perspectives, to be distributed region-wide, after its presentation at the Global Health Research Forum in Havana, Cuba.
In March 2009 the first Pan American seminar on the Economic Regulation of Pharmaceutical products and medicines was convened by PAHO in collaboration with Brazil’s Sanitary Surveillance Agency (ANVISA) in Brasilia, Brazil with the participation of delegations from most member States of the Americas and the presence of several delegations from other regions, as well as representatives from other international agencies (2) .Among the conclusions of the seminar, it was highlighted the need to develop a regional platform for the presentation of cost-effectiveness studies and other pharmacoeconomic materials and the pertinence of assessing existing sub-regional prices databases. A bilingual list-server,
, on issues related to pharmaceutical regulation, pricing policies and intellectual property measures was launched and is currently in its consolidation phase (3).
Simultaneously a Regional Strategy for the Use of generic medicines is being developed after a pilot activity in Peru. A Regional Strategy for the Rational Use of medicines is also in the last phase of revision before its launching (4).
PAHO has integrated the promotion of intellectual property rights management from a public health perspective within its technical cooperation activities regarding the coherent implementation of flexibilities through the amendment of legal and administrative procedures. As part of the assessment of the impact of new standards of intellectual property rights on access to medicines under the light of the GSPA, PAHO, as the regional representative of an international consortium (5), co-hosted and contributed to different activities in the region. In June 2009, a workshop was organized in San Jose, Costa Rica to present the report on the evaluation of the impact of the US-Central America and Dominican Republic Free Trade Agreement (CAFTA-DOR) with the participation of representatives from Health Ministries and Patent Offices from Nicaragua, Honduras, El Salvador and Guatemala. In august a workshop on the impact of CAFTA-DOR on access to medicines in Dominican Republic was held in Santo Domingo, Dominican Republic with the participation of delegates from the health ministries and Intellectual Property Offices of El Salvador, Guatemala, Costa Rica, Nicaragua and the participation of the PAHO/WHO Caribbean sub-regional focal point (6).In both events, the regional perspective of the GSPA was presented and discussed with specific technical cooperation demands from national authorities on the use of flexibilities are currently being responded at the national level. Additionally, PAHO has been supporting the government of Ecuador in assessing the eventual impact of ongoing international trade negotiations.
On August 2009, the Presidents of the Union of South American Nations (UNASUR) met in Quito, Ecuador, to directly address a key issue that all Latin American and Caribbean countries are facing in the advent of pandemic Influenza A (H1N1), namely equitable access to antiviral medicines and vaccines. In article 23 of the declaration, the Presidents ratified ‘the principle that public health supersedes economic and commercial interests; noting that medicines, vaccines and health supplies required to address diseases of public health importance, amongst them pandemic influenza, should be considered as global public goods; declaring that intellectual property rights do not, nor should not impede Member States from adopting the means to protect Public Health; reaffirming that noted in the Doha Ministerial Declaration in relation to the Trips Agreement and Public Health; including the right to use flexibilities provided for and when necessary in health.” (7)
In late November (November 30th-December4th) , PAHO will be supporting and hosting the 4th edition of the International course on Public Health and Intellectual property, to be held in Buenos Aires, Argentina, in collaboration with the University of Buenos Aires and the Ministry of Health of Argentina. This latest edition will be focusing on the IP implications of the regional perspective within the GSPA and addressed at MERCOSUR health and Intellectual property government officials.
In September PAHO, with the support of TDR, organized an informal consultation with representatives from scientific and research institutions of Argentina, Brazil, Bolivia, Chile, Cuba, Panama and Uruguay; the goal being to seek their input on how to prioritize research in the Americas while identifying main obstacles for health innovation in the region. Such activity had a follow-up in November in the Global Forum on Health Research in Havana, Cuba, where PAHO organized on satellite session on Innovation and the regional perspective of the GSPA and a parallel event on innovation for neglected diseases with the participation of a wide range of stakeholders.
The 49th Session of PAHO Directing Council examined several issues of relevance for the implementation of the Regional Perspective of the GSPA. The possibility of adopting a Regional Policy on Research for Health was taken into consideration after being examined and discussed at the 144th Session of the Executive Committee. A resolution (CD.49.R10) was finally adopted. Member States were also asked to consider taking action on the eradication of neglected and tropical diseases in the Americasthrough the adoption of the Resolution CD49.R19.
Taking into account the need of reliable data and information on the current situation (main features, shortcomings and opportunities) PAHO has undertaken an ambitious mapping out a two-fold exercise on Innovation and Intellectual Property. In connection with Innovation the collaboration of Red de Indicadores de Ciencia y Tecnología -Iberoamericana e Interamericana a survey was conducted identifying the main characteristics of the Research and Development national models in the region, including their legal basis, funding mechanisms and eventual links (or lack of) with national public health systems. As it refers to Intellectual Property law, the region was divided in three sub-regions (Central America + Mexico, Andean Region and Southern cone + Brazil ) upon which sub-regional integration bodies already exist, a basic and identical questionnaire for the whole region was used to enquire not only about the legal and domestic framework shaping intellectual property rights application but also about the institutional mechanisms through which different State institutions coordinate and interact with each other. Regional specificities were incorporated for each one of the identified sub-areas. Both exercises had Brasil, Colombia and Argentina as pilot countries. Conclusions of both exercises will be available in early 2010 and will be critical for a better understanding of the necessary need for improvement and reform for a successful national, sub-regional and regional implementation of the GSPA (8).
Additionally PAHO has been examining in collaboration with national authorities of selected countries (notably Mexico, Brazil and Argentina) the regional production capabilities in connection with priority products. Technical support has been provided to the Andean countries in cooperation with the Andean Sanitary Organization, (ORAS) in the enhancement and promotion of public production. Such scheme is going to be replicated throughout the region once its first phase of implementation is completed in the first semester of 2010. Finally PAHO secretariat has been working closely with national authorities on identifying available instruments and strategies to improve the Innovation and Production capabilities of the region regarding Neglected and Tropical Diseases: most specially Chagas and Leishmaniasis.
The need for integrating pharmaceutical policies and innovation together with economic regulation and intellectual property issues is as clear in the Americas as evident was in the interrelation of research, access and financing in the GSPA. A detailed concept of a regional platform that brings together these different elements and facilitates the sharing and exchange of information is being currently developed. With the input and feed-back of member States, scientific institutions and other concerned parties a provisory platform is expected to be launched in 2010.
(1) Including representatives from Argentina, Bolivia, Brazil, Colombia, Costa Rica, Cuba, Chile, Jamaica, Barbados, Dominican Republic, Panama and Uruguay, Suriname, Ecuador.
(2) Participants in the First Seminar on Economic Regulation of Pharmaceutical Products and Medicines included Argentina, Barbados, Brazil, Colombia, Costa Rica, Cuba, Honduras, Mexico, Peru, Venezuela, Suriname, Ecuador, Canada and Uruguay. Delegations from Australia, Mozambique and South Africa were also present.
(3) The list-server, with around 90 participants from Governments and State institutions was identified as low-cost mechanism to ensure information sharing and continuous exchange beyond physical meetings. It has issued two bulletins with information, papers and announcements of activities within the region.
(4) Both documents will become part of the PAHO Technical and Reference document series and made available to Member States, collaborating centers and interested institutions.
(5) Which includes the World Health Organization (WHO), United Nations Development Program (UNDP), United Nations Agency on Trade and Development (UNCTAD), World Bank Institute (WBI) and the International Centre for Trade and Sustainable Development (ICSTD).
(6) In the case of Costa Rica, the report “Nuevos estándares de propiedad intelectual y acceso a medicamentos en Costa Rica”, was elaborated by the Centro Internacional para la Politica Economica (CINPE) at the National University in Costa Rica, and co-edited with PAHO and ICSTD was launched in December 2009. As for the Dominican Republic the study “CAFTA-DOR y acceso a medicameentos esenciales en R. Dominicana” was elaborated by Fundación Plenitud and the Secretariat of State for Public Health and Social Welfare (SESPAS), was presented in November 2009 with the endorsement of PAHO. Both reports are being distributed throughout the region.
(7) III Reunión Ordinaria del Consejo de Jefas y Jefes de Estado y de Gobierno de la Unión de Naciones Suramericanas (UNASUR) .Declaración Presidencial de Quito August 10. Para 23
(8) A detailed analysis of the legal and institutional IP framework and its impact on access to drugs in the Caribbean (+Dominican Republic) sub-region was completed during 2009. PAHO assisted CARICOM in the commissioning and thecnical revision of the document which will be launched in early 2010.