[Alternatives to the drug research and development model]. / Alternativas al modelo de investigación y desarrollo de medicamentos.

One-third of the global population lacks access to medications; the situation is worse in poor countries, where up to 50% of the population lacks access. The failure of current incentive systems based in intellectual property to offer the necessary pharmaceutical products, especially in the global south, is a call to action. Problems related to drug access cannot be solved solely through improvements or modifications in the existing incentive models. The intellectual property system model does not offer sufficient innovation for developing countries; new mechanisms that effectively promote innovation and drug access simultaneously are needed. A binding international agreement on research and development, negotiated under the auspices of the World Health Organization, could provide an adequate framework for guaranteeing priority-setting, coordination, and sustainable financing of drugs at reasonable prices for developing countries.

The right to health and medicines: the case of recent multilateral negotiations on public health, innovation and intellectual property.

The negotiations of the intergovernmental group known as the 'IGWG', undertaken by the Member States of the WHO, were the result of a deadlock in the World Health Assembly held in 2006 where the Member States of the WHO were unable to reach an agreement on what to do with the 60 recommendations in the report on 'Public Health, Innovation and Intellectual Property Rights submitted to the Assembly in the same year by a group of experts designated by the Director General of the WHO. The result of these negotiations was the 'Global strategy and plan of action on public health, innovation and intellectual property' which was approved by the World Health Assembly in 2008. The intention of the Global Strategy and Plan of Action (GSPOA) which was produced by the IGWG was to substantially reform the pharmaceuticals' research and development system in view of the findings that this system, whose purpose is to produce medicines for diseases which affect the greater part of the world population which lives in developing countries, had failed. The intellectual property rights imposed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the recent trade agreements could become one of the main obstacles to access to medicines. The GSPOA makes a critical analysis of this reality, and opens the door to searching for new solutions to this problem.

Has the implementation of the TRIPS Agreement in Latin America and the Caribbean produced intellectual property legislation that favours public health?

OBJECTIVE: The World Trade Organization's Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement establishes minimum standards for intellectual property rights, including patent protection for pharmaceuticals; therefore, it may make it difficult for developing countries to gain access to medicines, especially those countries that are the least developed. This study aims to determine whether implementation of the TRIPS Agreement in Latin American and Caribbean countries has generated patent legislation that is sensitive to public health needs. METHODS: Legislation in 11 Latin American and Caribbean countries was analysed. The variables considered in the analysis were: the term of patents issued, patentable subject matter, transition periods (that is, time until legislation was enacted), reversal of the burden of proof of patent infringement, exhaustion of rights, compulsory licensing and the early working exception (which allows a country to complete all procedures necessary to register a generic product before the original patent expires). FINDINGS: By 2000, all of the countries studied had reformed their legislation to conform to the agreement. Brazil and Argentina used the transition period until 2005 to grant patents in the pharmaceutical industry. All countries, except Panama, made use of the safeguards and flexibilities available through the agreement by including mechanisms for compulsory licensing in their legislation. Argentina; Bolivia, Colombia, Ecuador, Peru and Venezuela (countries that represented the Andean community); the Dominican Republic; and Panama included mechanisms to allow parallel importation. Mexico did not. Brazil only permits parallel importation after a compulsory licence has been issued. The early working exception is included in legislation in Brazil and the Dominican Republic. CONCLUSION: The countries in this study did not incorporate all of the mechanisms allowed for by the Agreement and are not adequately using the provisions that enable World Trade Organization (WTO) members to obtain better health for the public, particularly in regard to gaining access to medicines. This situation may deteriorate in future if other agreements establish more restrictive rules for intellectual property rights.

Farmacoeconomía: evaluación científica o estrategia comercial? / Pharmacoeconomics: scientific assessment or commercial strategy?

The new global context, the dramatic rise in the cost of many health technologies, and the mounting pressures that constrain health sector budgets in most countries have created the need to evaluate health interventions, including pharmaceuticals, from an economic perspective. Pharmacoeconomics is "the application of economic theory to pharmacotherapeutics" and is often linked to commercial marketing. We propose standardizing the various methods of economic analysis so as to allow for comparisons and assessment of correct relationships. The author concludes pharmacoeconomics is simply an analytical fool that can be applied for scientific assessment or commercial promotion, depending on the objectives and purpose for which the use of this new discipline is intended

Farmacoeconomia: evaluación cientifica o estrategia comercial? / Pharmacoeconomics: Scientific assessment or commercial strategy?

The new global context, the dramatic rise in the cost of many health technologies, and the mounting pressures that constrain health sector budgets in most countries have created the need to evaluate health interventions, including pharmaceuticals, from an economic perspective. Pharmacoeconomics is "the application of economic theory to pharmacotherapeutics" and is often linked to commercial marketing. We propose standardizing the various methods of economic analysis so as to allow for comparisons and assessment of correct relationships. The author concludes pharmacoeconomics is simply an analytical fool that can be applied for scientific assessment or commercial promotion, depending on the objectives and purpose for which the use of this new discipline is intended