Unveiling patenting strategies of therapeutics and vaccines: evergreening in the context of COVID-19 pandemic.

In the pharmaceutical sector, evergreening is considered a range of practices applied to extend monopoly protection on existing products. Filing several patent applications related to the same active pharmaceutical ingredient (API) is one of the most common manifestations of evergreening. During the COVID-19 pandemic, several health technologies were developed.

Pharmaceutical Services and comprehensiveness 30 years after the advent of Brazil's Unified Health System.

This article examines pharmaceutical services and access to essential medicines in Brazil during the 30 years since the advent of Brazil's Unified Health System from a comprehensiveness perspective. The following topics are addressed: the "realignment" of pharmaceutical services; human resources in pharmaceutical services; the essential medicines concept; the rational use of medicines; technological advances and drug manufacturing; and ethical regulation. With a strong regulatory focus and a structural framework centered on the National Medicines Policy, the past three decades represent a mixture of progress and setbacks, considering the national complexities of the healthcare system and the political, economic and social changes that have influenced policy and access to medicines, which is a key concern even in the world's richest countries, as the forums of discussion on global health have demonstrated.

National Medicines Policy in retrospective: a review of (almost) 20 years of implementation.

Pharmaceutical services and the formulation of a medicines policy are SUS areas ensured by the organic health care law 8,080/90. Thus, after a widely participative process, involving stakeholders, the National Medicines Policy (NMP) was approved in 1998 by Ordinance 3,916.The NMP presents directives and priorities, aligned with organic health care law, which should guide the federal, states and municipals entities actions to achieve the policy goals.

Public procurement of hepatitis C medicines in Brazil from 2005 to 2015.

This paper analyzes the Minister of Health's (MoH) procurement of medicines for hepatitis C from 2005 to 2015. Data sources were the Integrated General Services Administration (SIASG), to estimate annual expenditure for selected medicines of the MoH Clinical Protocols and Therapeutic Guidelines (PCDT) for Hepatitis C. All presentations and strengths recorded on SIASG were included.

Farmácia Popular Program: pharmaceutical market analysis of antihypertensive acting on the renin-angiotensin system medicines.

This paper aims to analyse changes in the retail pharmaceutical market following policy changes in the Farmácia Popular Program (FP), a medicines subsidy program in Brazil. The retrospective longitudinal analyses focus on therapeutic class of agents acting on the renin-angiotensin system. Data obtained from QuintilesIMS (formerly IMS Health) included private retail pharmacy sales volume (pharmaceutical units) and sales values from 2002 to 2013.

Challenges in a product development partnership: a malaria treatment case study.

This paper examines the development of a treatment - a fixed-dose combination of artesunate and mefloquine - in Brazil, from three points of view: in terms of access to medication; to record and report successes; and to look at the lessons learned. This product development took place in the ambit of a public-private partnership. Semi-structured interviews were held with key actors involved in the different phases of the development, and documents were analyzed.

[Estimating demand for anti-Chagas drugs: a contribution for access in Latin America].

Objective: Describe a tool to estimate demand for benznidazole and nifurtimox to treat Chagas disease, and report on its implementation in a group of Latin American countries.

Methods: The project was carried out in the following stages: 1) development of a tool to estimate demand, and definition of the evaluation and decision variables to estimate demand 2) data collection via a questionnaire completed by representatives of control programs, complemented with data from the literature; 3) presentation of the tool, followed by validation, and adaptation by representatives of the control programs in order to plan drug procurement for 2012 and 2013; and 4) further analysis of the obtained data, especially regarding benznidazole, and comparison of country estimates.

Results: Fourteen endemic countries of Latin America took part in the third stage, and a consolidated estimate was made.

Initiatives to challenge patent barriers and their relationship with the price of medicines procured by the Brazilian Unified National Health System.

Since 1996, when antiretroviral (ARV) treatments started being guaranteed to people living with HIV in Brazil, the government has faced the challenge of ensuring sustainability of this policy within a context of incorporating patented medicines. This article sought to analyze the historical series of the price of lopinavir/ritonavir (LPV/r) in Brazil and in the international market also considering the initiatives to challenge patent barriers between 2001 and 2012. The methods used were mapping initiatives to challenge LPV/r patent barriers and the analysis of historical series of its price in Brazil and in the international market.

Strategies for price reduction of HIV medicines under a monopoly situation in Brazil.

Objective: To analyze Government strategies for reducing prices of antiretroviral medicines for HIV in Brazil.

Methods: Analysis of Ministry of Health purchases of antiretroviral medicines, from 2005 to 2013. Expenditures and costs of the treatment per year were analyzed and compared to international prices of atazanavir.

[Induction of hospital indebtedness due to medicine purchases under monopoly conditions: the case of imatinib mesylate].

Medicine expenditures consume a large share of the health budget, so knowledge on the use of these funds is essential for decision-making in public health and improvement of pharmaceutical care. This study analyzed the indebtedness of a high-complexity university hospital due to increased spending on imatinib mesylate. The descriptive study was based on analysis of documents and records in the Hospital Information System (SIH) from 2002 to 2010.

A proposal for an evaluation model of pharmaceutical services for malaria.

Malaria is a serious public health problem in over 90 countries worldwide. In Brazil the disease is prevalent in the Amazon and the control rationale is based on early diagnosis and treatment. Quality pharmaceutical services are considered a key element for control.

[Uncomplicated Plasmodium vivax and P. falciparum malaria in Brazil: evidence on single and combined drug treatments recommended by official guidelines].

Malaria is the most important endemic parasitic disease in the world. Conditions are favorable for transmission of the disease in 60% of Brazil's territory. Over 500,000 cases per year are recorded in the country.

Sustaining access to antiretroviral therapy in the less-developed world: lessons from Brazil and Thailand.

Unlabelled: ANTIRETROVIRAL ROLLOUT IN BRAZIL AND THAILAND: Brazil and Thailand are among few developing countries to achieve universal access to antiretroviral therapy. Three factors were critical to this success: legislation for free access to treatment; public sector capacity to manufacture medicines; and strong civil society action to support government initiatives to improve access. LOCAL PRODUCTION OF AFFORDABLE, NON-PATENTED DRUGS: Many older antiretroviral drugs are not patented in either country and affordable generic versions are manufactured by local pharmaceutical institutes.

A proposal for measuring the degree of public health-sensitivity of patent legislation in the context of the WTO TRIPS Agreement.

Objective: This study aims to propose a framework for measuring the degree of public health-sensitivity of patent legislation reformed after the World Trade Organization's TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement entered into force.

Methods: The methodology for establishing and testing the proposed framework involved three main steps:(1) a literature review on TRIPS flexibilities related to the protection of public health and provisions considered "TRIPS-plus"; (2) content validation through consensus techniques (an adaptation of Delphi method); and (3) an analysis of patent legislation from nineteen Latin American and Caribbean countries.

Findings: The results show that the framework detected relevant differences in countries' patent legislation, allowing for country comparisons.

[Evolution of the international intellectual property rights system: patent protection for the pharmaceutical industry and access to medicines].

This article discusses the evolution of the international intellectual property rights system in three phases and the implications for public health, especially for the implementation of policies for access to medicines. During the first phase, characterized by the Paris and Berne Convention, signatory countries defined which technological fields should be protected (or not). Under the second phase, with the enforcement of the WTO TRIPS Agreement, countries are obliged to grant patent protection for all technological fields, including for the pharmaceutical industry.

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.