Access to essential medicines Research Papers (original) (raw)

2025

Os laboratórios públicos sempre tiveram um papel relevante no lançamento de novos medicamentos. Com base na experiência internacional, o artigo procura analisar as características peculiares dos laboratórios oficiais brasileiros e o papel que podem desempenhar na área de saúde, particularmente no caso de medicamentos para os quais não há incentivos claros de mercado, como aqueles destinados a doenças ditas negligenciadas. Nesse sentido, é sugerida a atuação dos laboratórios oficiais no desenvolvimento desses medicamentos, com base na experiência bem-sucedida do programa brasileiro da Aids, e proposta uma política pública específica, com flexibilização das atuais limitações de crédito ao setor público.

2025

sentam um mercado novo, cujo crescimento só teria sido iniciado na década de 1960 e cuja importância em termos quantitativos é ainda pequena. As vendas dos medicamentos fitoterápicos na Europa e nos Estados Unidos foram de,... more

2025

Отчет выполнен в рамках реализации проекта «Сеть развития лучших практик в медицине, науке и образовании» программы Приоритет 2030 Сеченовского университета. Целью отчета является предоставление профессиональному сообществу авторитетной и... more

2025, Revista Cubana de Plantas Medicinales

Introdução: com um número cada vez maior de estudos científicos e com os avanços na legislação brasileira e mundial, a fitoterapia se concretiza como uma opção de terapia complementar a medicina tradicional. A Relação Nacional de Medicamentos Essenciais (RENAME) no Sistema Único de Saúde (SUS), publicada em 2014, traz em seu elenco 12 fitoterápicos, os quais, por falta de informações claras e científicas, ainda não são conhecidos e prescritos pelos profissionais de saúde. Objetivo: realizar uma revisão sobre os medicamentos fitoterápicos da Relação Nacional de Medicamentos Essenciais com suas indicações e apresentações, com embasamento técnico-científico, criando assim um material de fácil entendimento para os profissionais da saúde. Métodos: trata-se de uma revisão de teor descritivo e natureza qualitativa sobre fitoterapia no SUS utilizando-se o site do Ministério da Saúde e artigos disponíveis nas bases eletrônicas Scielo, Lilacs e Medline. Resultados: verificou-se que existem inúmeros artigos científicos relacionado à temática e principalmente informações sobre as indicações dos fitoterápicos presentes na RENAME. Conclusão: e necessário que os profissionais da área saúde conheçam as indicações, a eficácia clínica e a segurança dos fitoterápicos da RENAME. No entanto, há muito por se fazer no que ser refere aos recursos humanos envolvidos na prescrição de fitoterápicos. Palavras chave: Fitoterapia; RENAME; SUS. Introducción: con un número creciente de estudios científicos y los avances en la legislación nacional e internacional, la fitoterapia se consolida como una opción de terapia complementaria a la medicina tradicional. La Relación Nacional de Medicamentos Esenciales (RENAME) en el Sistema Único de Salud (SUS), publicada en 2014, tiene en su reparto 12 hierbas medicinales, las cuales, por falta de información clara y científica, aún no son conocidas y prescritas por los profesionales de la salud. Objetivo: realizar una revisión sobre los medicamentos a base de hierbas de la RENAME, con sus declaraciones y presentaciones, con base técnica y científica, creando así un material fácil de entender por los profesionales de la salud. Métodos: se realizó un examen descriptivo y de naturaleza cualitativa de la fitoterapia en el SUS, utilizando la página web del Ministerio de Sanidad y artículos disponibles en bases de datos electrónicas Scielo, Lilacs y Medline. Resultados: se encontró que existen numerosos artículos científicos relacionados con el tema y sobre todo información sobre las indicaciones de las hierbas medicinales presentes en la RENAME. Conclusión: es necesario que los profesionales de la salud conozcan las señales, eficacia clínica y seguridad de los fitofármacos de la Relación Nacional de Medicamentos Esenciales. Sin embargo, queda mucho por hacer en términos de formación de recursos humanos involucrados en la prescripción de medicamentos a base de hierbas.

2025, World Health Organisation

Public domain report from expert review committee (R Sullivan committee member)

2025

A new study on medicine prices using the WHO/H A I methodology was conducted in Brazil following a pilot survey in 2001, undertaken as part of the methodology development process. Field collection of data for the pilot survey took place in only one State, Rio de Janeiro. Now, a broader study has produced a representative picture of medicine prices and availability throughout the country.

2025, Human Rights & the Global Economy eJournal

Many companies practice corporate social responsibility (CSR) as part of their branding and public relations efforts. For example, as part of their CSR strategies, some companies adopt voluntary codes of conduct in an effort to respect human rights. This Article contemplates the application of CSR principles to trade-related intellectual property (IP). In theory, patent and copyright laws promote progress and innovation, which is why IP rights are beneficial for both IP owners and for the public. Trademark rights encourage businesses to maintain certain standards and allow consumers to make more efficient choices. Though IP rights are often discussed in relation to the value they provide for business purposes, trade-related IP can also promote human progress, including as it relates to health, education and culture. A CSR model for international intellectual property offers an additional strategy to support ongoing efforts to make IP-related trade agreements more sensitive to human ...

2025, African Journal of …

The World Trade Organisation (WTO) agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has reawakened old arguments over the impact of the intellectual property (IP) system on public access to essential medicines. As used here, essential medicines are those needed in symptom management, palliative care, and in the treatment of infections, such as human immunodeficiency virus (HIV), malaria, tuberculosis, and sleeping sickness in places like sub-Saharan Africa. Some argue that patents will further inhibit access to these medicines in sub-Saharan Africa. Others, however, argue the opposite. The latter maintain that patent protection under TRIPS can promote the growth of the pharmaceutical industry in places like sub-Saharan Africa. Moreover, they assert that pharmaceutical patents are not responsible for the limited access to essential medicines in sub-Saharan Africa. Instead, they trace the problem of access to non-patent factors, such as poverty, the lack of supportive infrastructure, and poor governance. This paper set out to assess these contrasting arguments, with a view to determining the actual impact that pharmaceutical patents may be having on access to essential medicines in sub-Saharan Africa. Keyword search of electronic databases was conducted, in addition to a review of relevant literature from print sources. A manual analysis then followed. It was found that, rather than a single set of factors, both patent and nonpatent factors combine to inhibit access to essential medicines in sub-Saharan Africa. It is imperative for sub-Saharan African countries to review current tariff and taxation policies, take steps to improve the supply of vital infrastructure, and strengthen their overall healthcare systems. They should also ensure that their IP systems are supportive of public healthcare needs. Equally important, is that TRIPS and the IP system should be more supportive of sub-Saharan Africa's struggle to bear its disease burden, rather than focusing narrowly on profit maximisation for pharmaceutical companies. Sub-Saharan Africa also needs increased international financing, private-public collaboration in research, and the sharing of benefits in order to cater effectively for the health needs of its citizens.

2025

Para analizar por qué se instalan los derechos de propiedad intelectual, en el ámbito de discusión del GATT y, posteriormente, en el ámbito de la OMC, debemos hacer una breve reseña de las normativas preexistentes. La protección de los... more

2025, JCO Global Oncology

PURPOSE Access to essential cancer medicines is a major determinant of childhood cancer outcomes globally. The degree to which pediatric oncologists deem medicines listed on WHO's Model List of Essential Medicines for Children (EMLc) essential is unknown, as is the extent to which such medicines are accessible on the front lines of clinical care. METHODS An electronic survey developed was distributed through the International Society of Pediatric Oncology mailing list to members from 87 countries. Respondents were asked to select 10 cancer medicines that would provide the greatest benefit to patients in their context; subsequent questions explored medicine availability and cost. Descriptive and bivariate statistics compared access to medicines between low- and lower-middle–income countries (LMICs), upper-middle–income countries (UMICs), and high-income countries (HICs). RESULTS Among 159 respondents from 44 countries, 43 (27%) were from LMICs, 79 (50%) from UMICs, and 37 (23%) f...

2025, WHO South-East Asia journal of public health

India has outlined its commitment to achieving universal health coverage and several states in India are rolling out strategies to support this aim. In 2011, Rajasthan implemented an ambitious universal access to medicines programme based on a centralized procurement and decentralized distribution model. In terms of the three dimensions of universal health coverage, the scheme has made significant positive strides within a short period of implementation. The key objectives of this paper are to assess the likely implications of providing universal access to essential medicines in Rajasthan, which has a population of 70 million. Primary field-level data were obtained from 112 public health-care facilities using multistage random sampling. National Sample Survey Organization data and health system data were also analysed. The per capita health expenditure during the pre-reform period was estimated to be ₹5.7 and is now close to ₹50. Availability of essential medicines was encouraging a...

2025, Http Edoc Vifapol De Opus Volltexte 2011 2412 Pdf Op4 Pdf

Intellectual Property Rights are often considered as serious obstacles to trade and the transfer of technologies related to the conservation of biological diversity. 1 African countries are rich in biodiversity and indigenous knowledge which has flowed freely to the developed countries. However global market trends are such that Africa must urgently address issues pertaining property rights if they have to fit into the global economy and also stimulate inventions and innovations. 2 The challenge facing Africa is how to produce high quality goods and services while at the same time tackling aspects of poverty and unemployment. Africa is seen to participate in IPR as second comers already faced with other priority issues and lacking capacity to enforce IPR regimes. Stephen Devereux and Simon Maxwell in their book "Food Security in Sub-Saharan Africa" state clearly that nearly half the population of Sub Saharan Africa is living below the international poverty line of US $1 per day. African countries grapple with the challenge of a poorly performing agricultural sector giving rise to food & poverty crises. 70% of the African talent is locked up in peasant farming and rely on "climate fed" agriculture. In Africa, promise and opportunity sit side by side with disease, war and desperate poverty. 70% of Africa's population live in rural areas and depend on subsistence agriculture and 80% of African's expenditure is on food. Africa has invested heavily in seeking donor support and little in ensuring her people become productive. Third World countries especially in Africa have been on the frontline in arguing that intellectual property rights is a tool used by the West to make them poorer. The HIV-AIDS scourge has brought to the fore debates on whether intel-1 Illecas M. (1994) 2 www.mcc.org/us/globalization/hough/intellect.html Copyright consists of a bundle of rights given to creators in their literary and artistic works. These creators, their heirs, hold the exclusive right to use or license others to use the work on agreed terms. The creator of the work can prohibit or authorize, for example: Its reproduction in various forms, such as printed publication or a phonorecord; Its public performance, as in play or musical work; Its broadcasting, including by radio, television or satellite; Its translation into other languages, or its adaptation, such as the adaptation of a novel into a screenplay. Copyright applies to many types of artistic works, including paintings, music, poems, plays, books, architecture and choreography, as well as to works that are generally not considered artistic such as computer software, maps and technical drawings.

2025, JCO Oncology Practice

Purpose: Many oncologists have relationships with industry. Previous work has shown that these payments are usually modest; however, there exist a subset of medical oncologists who receive more than $100,000 US dollars (USD) annually. Here, we describe the characteristics of these physicians.
Methods: This retrospective cohort study used the Open Payments data set to identify all US-based medical oncologists/hematologists who received $100,0001 USD in general payments linked to cancer medications in 2018. Open Payments and a web-based search were used to identify physician characteristics, demographics, research profile, and leadership positions.
Results: One hundred thirty-nine medical oncologists received . 100,000USDingeneralpayments.Themedianpaymentwas100,000 USD in general payments. The median payment was 100,000USDingeneralpayments.Themedianpaymentwas154,613 USD, and the total payment was $24.2 million USD. These high-payment
physicians represent 1% of all US medical oncologists (N 5 10,620) yet account for 37% of all industry payments in 2018. Sixty percent (84 of 139) and 21% (29 of 139) of these high-payment physicians hold
hospital and specialty association leadership roles, respectively. One quarter (24%, 33 of 139) serve on journal editorial boards, and 10% (14 of 139) have authored clinical practice guidelines; 72% (100 of 139) hold faculty appointments.
Conclusion: A small number of medical oncologists receive very high payments from the pharmaceutical industry. These physicians hold major leadership roles within oncology. Further work is needed to understand
the extent to which these conflicts of interest may shape clinical practice and policy.

2025, Journal of the American Medical Informatics Association

Transgender patients have particular needs with respect to demographic information and health records; specifically, transgender patients may have a chosen name and gender identity that differs from their current legally designated name and sex. Additionally, sexspecific health information, for example, a man with a cervix or a woman with a prostate, requires special attention in electronic health record (EHR) systems. The World Professional Association for Transgender Health (WPATH) is an international multidisciplinary professional association that publishes recognized standards for the care of transgender and gender variant persons. In September 2011, the WPATH Executive Committee convened an Electronic Medical Records Working Group comprised of both expert clinicians and medical information technology specialists, to make recommendations for developers, vendors, and users of EHR systems with respect to transgender patients. These recommendations and supporting rationale are presented here.

2025

Resumo: O presente artigo apresenta como objetivo geral a elaboração de uma análise por meio de proxies para averiguar se o segmento industrial de produtos farmacêuticos e farmoquímicos apresenta sinais de desadensamento e perda de competitividade no período de 2003 a 2018. Além disso, o objetivo específico é organizar o debate acerca do desadensamento e da perda de competitividade da indústria de transformação nacional nos últimos anos. Conclui-se que os setores supracitados apresentam sinais de desadensamento e perda de competividade. A partir disso, é enfatizado que a combinação de baixo nível de adensamento e pouca competitividade nesses setores comprometeu a capacidade da nação brasileira no enfrentamento da pandemia causada pela covid-19. Palavras-chave: Desadensamento. Competitividade. Indústria de transformação. Setores farmacêutico e farmoquímico.

2025, ERN: Other Public Choice: Analysis of Collective Decision-Making (Topic)

Public health budgets and individual patients around the world struggle with high prices for pharmaceutical products. Difficulties are not limited to low income countries. Prices for newly introduced therapies to treat hepatitis C, cancer, joint disease and other medical conditions have entered the stratosphere. In the United States, state pharmaceutical acquisition budgets are at the breaking point -- or have passed it -- and treatment is effectively rationed.Competition/antitrust law has rarely been used to address “excessive pricing” of pharmaceutical products. This is a worldwide phenomenon. In the United States, the federal courts have refused to apply excessive pricing as an antitrust doctrine, either with respect to pharmaceutical products or more generally. Courts in some other countries have been more receptive to considering the doctrine, but application in specific cases has been sporadic, including with respect to pharmaceuticals.This remains a paradox of sorts. Competit...

2025, Međunarodna politika 75(1190):39-55

The focus of the research is the topic of compulsory licensing, the right under the Agreement on Trade-Related Aspects of Intellectual Property Rights, for countries to use patented medicines without the patent holder’s consent as a form of relief (flexibilities) for developing countries. The research aims to assess whether the application of compulsory licencing has fulfilled its primary goals and purpose. The research problem is the in consistency between the compulsory licencing application in practice and the original purpose. It is reflected in the mass use of this right by countries with higher incomes and, secondly, in the symbolic presence of contagious diseases. That was investigated using the Generalized Linear Model. The results confirmed that the actual situation of public health and the income level of beneficiaries had been marginalised as grounds for exercising compulsory licencing. The arbitrary application of compulsory licencing has led to the situation that the poorest countries, with the most significant health crises, remain in the background of this World Trade Organisation mechanism.

2025, In book: International Organizations and States’ Response to COVID-19

This paper deals with compulsory licensing for pharmaceuticals based on the TRIPS Agreement during the COVID-19 pandemic. Considering that the vaccines are under patent protection, and a pandemic is in effect, questions are arising about the timely delivery of the new vaccines on a global level at the time of a global health crisis. In this research, we provide an additional view on the question of the approach of the selected countries to compulsory licensing in the time of the COVID-19 pandemic. We examined multiple cases of countries and their approach to compulsory licensing during the pandemic, and we assessed examples of compulsory licensing in the past regarding antiretroviral therapy. We are also interested in understanding countries’ profiles considering the pandemic through factors that have potentially triggered decisions in preparation for compulsory licensing or in initiating such a request. To address this question, we use inductive and deductive methods in the analysis and synthesis of the observed literature, including a statistical showcase of the data. The results put additional light on the selected factors impacting countries’ decisions for compulsory licensing and the approaches of the observed countries/cases to the compulsory licensing considering national legislation and pandemic effects on the observed country.

2024, Bangladesh Journal of Pain

Background: Worldwide, opioid analgesics prescribed for the management of moderate to severe pain in both malignant and non-malignant patients. Use of opioids for pain management is very limited in healthcare facilities of Bangladesh. For ensuring proper management this study aims to explore opioid consumption, accessibility and availability especially in cancer pain in Bangladesh.
Methods: This observational study used preconstructed questionnaire to estimate annual production and use of opioids at different settings. Information was obtained from annual drug report of 2020-2021 Bangladesh’s Department of Narcotics Control (DNC), Director General of
Health Services of Bangladesh and three pharmaceutical companies. Availability and accessibility of morphine was explored among the tertiary care centre of Bangladesh using patient’s records
Results: Morphine and other 5 types of opioids are available in different formulations in Bangladesh. Locally only two pharmaceutical companies producing morphine though there are 3 are licensed. In last 5 years on an average 15.34 kg (range 10.9 kg – 20.1 kg) morphine produced. There are only a few hospitals where oral morphine is readily available. But almost all of them are metropolitan Dhaka based.
Conclusion: The low consumption of morphine indicates the poor pain management scenario of the country. Pain and palliative care professionals in Bangladesh continue to advocate for improvements which will ensure that opioids are available, accessible and affordable for all patients in Bangladesh.

2024, Texila International Journal of Public Health

Zimbabwe's regulation of medical devices and in vitro diagnostics (IVDs) lags behind that of medicines and vaccines despite the country's goal of achieving Universal Health Coverage (UHC) by 2030. This study, conducted from June to December 2022, rigorously evaluated Zimbabwe's regulatory framework for medical devices and IVDs using a comprehensive policy analysis framework. The study's methodology, which included document review and comparative analysis, was designed to align the regulatory framework with the UHC goal. The READ (Ready, Extract, Analyze, and Distill) approach systematically assessed the relationship between medical device regulations and national health strategic goals. Fourteen documents were analysed, revealing that current regulations under the Medicines and Allied Substances Control Act are insufficient for ensuring quality-assured medical devices and IVDs due to a lack of explicit definitions and standards, leading to inconsistent regulatory practices. The study found fragmented regulatory approaches, overlapping institutional responsibilities, and a lack of effective incorporation of medical device and IVD regulations in national health strategy and related policies, hindering UHC achievement. The study recommends comprehensive policy changes to harmonise regulations, clarify institutional roles, and integrate medical device and IVD regulations into the national health strategy. This ensures access to safe, effective, quality medical devices and IVDs, promoting Zimbabwe's UHC goals by 2030.

2024, Globalization and Health

Access to quality-assured medical products improves health and save lives. However, one third of the world's population lacks timely access to quality-assured medicines while estimates indicate that at least 10% of medicine in low-and middle-income countries (LMICs) are substandard or falsified (SF), costing approximately US$ 31 billion annually. National regulatory authorities are the key government institutions that promote access to quality-assured medicines and combat SF medical products but despite progress, regulatory capacity in LMICs is still insufficient. Continued and increased investment in regulatory system strengthening (RSS) is needed. We have therefore reviewed existing global normative documents and resources and engaged with our networks of global partners and stakeholders to identify three critical challenges being faced by NRAs in LMICs that are limiting access to medical products and impeding detection of and response to SF medicines. The challenges are; implementing value-added regulatory practices that best utilize available resources, a lack of timely access to new, quality medical products, and limited evidence-based data to support post-marketing regulatory actions. To address these challenges, we have identified seven focused strategies; advancing and leveraging convergence and reliance initiatives, institutionalizing sustainability, utilizing risk-based approaches for resource allocation, strengthening registration efficiency and timeliness, strengthening inspection capacity and effectiveness, developing and implementing risk-based post-marketing quality surveillance systems, and strengthening regulatory management of manufacturing variations. These proposed solutions are underpinned by 13 focused recommendations, which we believe, if financed, technically supported and implemented, will lead to stronger health system and as a consequence, positive health outcomes.

2024

Patente e um documento publico de concessao que garante ao seu titular a exclusividade de explorar comercialmente a sua criacao. E por meio dela que se garante que terceiros nao poderao fabricar, usar, vender, oferecer ou importar a dita invencao. O setor quimico-farmaceutico sao os que mais necessitam de protecao patentaria uma vez que a maioria das moleculas estudadas podeser encontradas na literatura da quimica orgânica. Alem disso, um medicamento novo precisar passar por testes pre-clinico e clinico, tornando-se partes dos segredos, publico. O objetivo do presente trabalho foi analisar o desenvolvimento patentario brasileiro de medicamentos frente ao âmbito mundial assim como a colaboracao patentaria da industria farmaceutica da regiao de Itapira-Cristalia. Para isso, foi realizada uma revisao na literatura e pesquisa a industria Cristalia, no qual foram apontadas: a posicao e a evolucao do Brasil no mercado farmaceutico; a estimativa de custo para desenvolvimento de um novo far...

2024

Africa’s continued dependency on foreign medicines and intellectual property (IP) is increasingly becoming a serious concern. This is compounded by an upsurge in drug resisting diseases like N1H1 and Tuberculosis that have been witnessed in the past years. A threat posed by the safety-concerned is that some of these diseases are potential agents of weapons of mass destruction. Of notable significance is that even though the World Trade Organisation’s (WTO) TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement has provided opportunities for African countries to review and adjust their intellectual property systems so as to migrate towards producing their own medicines. African countries have failed to capitalise on these opportunities. This is due to various reasons. First being a possibility that most African countries are still dependent on donor funds for their health systems, thus reviewing IP policies might upset funding arrangements. Second, being that some Af...

2024, Healthcare

This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY.
Pharmaceutical care was proposed to address morbidity and mortality associated with medicine-related problems. It utilises the pharmacist’s expertise in medicines, their relationship with the patient and cooperation with other healthcare professionals to optimise the use of medicines.
The European Directorate for the Quality of Medicines & HealthCare (EDQM), part of the Council of Europe, found significant variation in the acceptance of pharmaceutical care and in the implementation of pharmaceutical care in Europe. A multidisciplinary group was established to draft a statement of principles and recommendations concerning pharmaceutical care. Through face-to-face meetings, circulation of draft texts and informal consultation with stakeholders, the group produced
a resolution. On 11 March 2020, the resolution was adopted by the Committee of Ministers of the Council of Europe. It explains pharmaceutical care and illustrates pharmacists’ contribution to medicine optimisation in different care settings. Pharmaceutical care’s value to health services and its place in health policy were emphasised by addressing the risks and harms from suboptimal use
of medicines. Pharmaceutical care can improve medicine use, promote rational use of healthcare resources and reduce inequalities in healthcare by realigning the roles and responsibilities of pharmacists and healthcare professionals. EDQM will promote and advocate for the implementation of pharmaceutical care by enacting practice Resolution CM/Res(2020)3.

2024

The most notorious example of poor decision-making in this regard is the failed effort of USAID to stimulate the development of a malaria vaccine. During the 1980s, the agency spent over $60 million on a project that, in its judgment, would likely lead to an effective vaccine. In the end, the initiative produced nothing of value. See Robert S. Desowitz, The Malaria Capers: Tales of Parasites and People(New York: W.W. Norton, 1991). In truth, the probative value of this example is limited. The principal investigator, it turned out, was lining his own pockets, and the agency's project director was receiving kickbacks. Thus, this particular episode may reveal more about the potential for a few corrupt actors to waste a great deal of money than it does about the merits of "push" programs in general.

2024, Guia Sindusfarma de Acesso ao Mercado Brasileiro de Saúde - da regulação às estratégias de acesso aos medicamentos (Atena Editora)

A ampliação do acesso a medicamentos modernos como forma de melhorar a saúde pública no Brasil é um tema permanente da agenda do Sindusfarma.
Ao longo dos anos, a entidade vem marcando posição a respeito dos principais aspectos que esta questão envolve, entre eles o modelo de regulação econômica do mercado farmacêutico, a carga tributária, o financiamento e a incorporação de novas tecnologias no SUS – Sistema Único de Saúde.
Por exemplo, o Sindusfarma defende uma regra de preços que remunere adequadamente o esforço de desenvolvimento e lançamento de produtos com inovação radical ou incremental e crítica a elevada e irracional tributação que limita o acesso da população aos medicamentos.
Também reivindica fontes de financiamento amplas e duradouras que favoreçam a inovação e chama a atenção para a importância da inclusão periódica de produtos de última geração nos tratamentos oferecidos pelo SUS. Uma medida que, além dos benefícios terapêuticos para os pacientes, incentiva os laboratórios farmacêuticos a investir cada vez mais na descoberta e desenvolvimento de novos princípios ativos e, sem dúvida, reduz as despesas com internações.

2024

Patents pose a significant barrier to accessing innovative medicines, due to exclusivity granted to inventors by the Trade Related Agreement on Intellectual Property Rights (TRIPS), which sets the basis for protection of intellectual property at the international level. The founding of the World Trade Organization and adoption of TRIPS in 1994 brought harmonized intellectual property standards to member states. Compulsory licenses are exemptions to patent exclusivity, allowing a government or a third party to use patented subject matter for commercial, public or emergency use provided certain requirements are fulfilled. To evaluate outcomes and policy approaches used by different countries for compulsory licenses under the Article 31 framework of TRIPS, and identify shortfalls and best practices in order to inform policy changes on national, and multilateral levels. This retrospective study is comprised of a cross-case comparison of compulsory licensing in varying countries, including Low, Middle and High Income Countries to enable access to generic medications. Each case has been driven by varying contexts and scenarios. After a detailed search for all compulsory licenses threatened and issued after 1994, a database was developed and focus cases selected. Specifics of license and outcomes associated with use were then recorded and compared. Among aspects evaluated were national legislation and delivery instruments for procured generics. I began my masters' studies in Innsbruck, Austria in October 2014, shifting from clinical practice to adjuvant health disciplines. The EU-HEM program is structured to immerse candidates in disciplines of health economics and policy from a global perspective, by encouraging mobility between European universities. During an exchange semester at Erasmus University Rotterdam, The Netherlands, I was introduced to compulsory licensing and was intrigued by methods used by countries to promote market access to pharmaceuticals and health technology. Before moving to Oslo for the final stretch of the program, I was granted an internship with the European Union-Delegation to India, and moved to New Delhi, India where compulsory licenses were often discussed in relation to the ongoing negotiations over the EU-India BTIA. The controversial nature of compulsory licensing then led me to settle on a thesis topic, and begin work on a proposal. The process has been highly rewarding, enriching, and eye opening at times. Thanks are owed to many individuals in different countries who I have met along this journey; First, my supervisor, John-Arne Røttingen for accepting my proposal, and for introducing me to the Access to Medicine community. The effort he has put into guiding and advising me, along with the leads and comments during the process of researching and writing this document have been invaluable and highly encouraging. My parents, George and Molly for their unconditional support, and my siblings, Neha and Tanya for always encouraging me.

2024, Revista Cesco De Derecho De Consumo

2024

This paper presented the experience gained in the introduction of social studies of science and technology in the field of healthcare during the specialization phase of the medical education. The so-called Miracle Mission has generated great demands for the formation of specialists and, together with its social impact, it has also revolutionized the ophthalmology teaching in Cuba. The emergence of the Cuban Faculty of Ophthalmology is part of these efforts. The objective of this paper was to substantiate the relevance of science-technology-society education for the graduate formation of health professionals, and in assessing its impact on the Faculty of Ophthalmology, taking into account the need of promoting new behaviors in the formative process. The experience gained under the auspices of the Science, Technology and Society plus Research professorship at Havana University in the science-technology-society education in the graduate level has contributed to the development of the scientific, technological and humanistic culture. This is a contribution to the Cuban perspective of social studies of science and technology in the healthcare field and the corresponding reflect on the new ways of thinking and behaviors promoted by the Cuban School of Medical Education in the processes of internationalization and Latin American integration.

2024, Ciencia & Saude Coletiva

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. Two important points of reference orienting the design of the study and analysis were: a logical model for access to medication; and evaluation of programs. It is concluded that there were several successes over the course of the project, but insufficient attention was given in the project's architecture to planning of adoption of the product: irregularities in demand caused difficulties in planning and production, and adoption of the product was irregular in the Americas. It is concluded that the project can be considered to have been successful: the product was created, and the aims were met-strengthening of institutional and individual capacities and alliances, and advocacy. However, there were weaknesses in the process, which need to be mitigated in future projects of the same type.

2024, International Journal For Multidisciplinary Research

The DDD concept is a method for quantifying a drug. Drug use in terms of DDD aids in converting the number of pharmaceuticals readily available into medically significant units and in estimating the number of people who have been exposed to a specific drug or class of drugs. In a hospital setting, the unit DDD per 100 bed-days suggests the proportion of inpatients that may receive a DDD. DDD in antihypertensive medications helps to track down prescription drug usage and examine drug usage trends. A 6-month prospective and observational study was conducted to assess the drug utilisation of antihypertensives. In this study we found that Diuretics were commonly prescribed antihypertensives. Furosemide and Spironolactone were mostly prescribed antihypertensives as single therapy, while Telmisartan+Hydrochlorothiazide was commonly prescribed as combination therapy. Propranolol was over utilised antihypertensives with 187.82 DDD/100bed-days and 1.74 PDD:DDD ratio.

2024, Texto para Discussão

2024, PATENTES E SISTEMA NACIONAL DE INOVAÇÃO

A busca contínua pela inovação tecnológica, visando aprimorar a competitividade da indústria nacional, representa um desafio premente. Nesse cenário, a indústria farmacêutica se destaca como uma arena acirrada de desenvolvimento de produtos inovadores. "Patentes e Sistema Nacional de Inovação: Análise do Setor Farmacêutico" revela os desafios enfrentados para manter os investimentos em Pesquisa e Desenvolvimento no país. Este trabalho propõe uma análise crítica das políticas públicas, com foco nos impactos da atual política de patentes na indústria farmacêutica, identificando uma eficácia limitada na promoção da inovação tecnológica. Desde a década de 1970, mudanças institucionais, em boa parte por escolhas legislativas geraram uma notável dependência externa em relação a produtos farmacêuticos inovadores estrangeiros, refletida na importação de produtos protegidos por patentes, desequilibrando a balança comercial do país. Com uma abordagem fundamentada em teorias de inovação, a pesquisa visa avaliar a eficácia das atuais políticas e propor melhorias substanciais, buscando equilibrar a inovação tecnológica com as necessidades de saúde pública no Brasil.

2024, Boletin 1 Aprob Sistemas de salud y bienestar

POR EL DERECHO A LA SALUD MENTAL SIN
DISCRIMINACIÓN Y EN CONDICIONES DE EQUIDAD
CON LA SALUD FÍSICA. Diagnóstico de la Salud Mental en Chile y las respuestas del Estado. Las brechas actuales

2024, Cadernos de Saúde Pública

2024, Reciis

Resumo O artigo pretende demonstrar como o Instituto Nacional da Propriedade Industrial (INPI) está examinado os pedidos de patente relativos às formas polimórficas na área farmacêutica. Para tanto foi feito um levantamento do número de pedidos de patente nesta área já analisados pelo INPI no período de janeiro de 2008 a março de 2009. Os resultados revelam que a maioria dos pedidos de patente não preenche alguns dos requisitos de patenteabilidade, assim como da condição de suficiência descritiva, conforme as disposições legais da Lei 9.279/96 (LPI) e a proposta de diretrizes de exame elaborada pelo Instituto. Palavras-chave medicamentos; polimorfos; forma cristalina Artigos originais Polimorfos: definição, propriedades e proteção patentária O termo polimorfismo pode ser definido como a existência de alterações no arranjo cristalino de uma substância sem, porém, observar-se modificação na estrutura das moléculas (conformação molecular e espacial). As propriedades químicas das diferentes formas cristalinas de uma substância são idênticas, mas o mesmo não ocorre com suas propriedades físicas e físico-químicas como, por exemplo, ponto de fusão, condutividade, volume, densidade, viscosidade, cor, índice de refração, solubilidade, higroscopicidade, estabilidade e perfil de dissolução (GIRO et al., 2002). A presença de diferentes estruturas cristalinas de um princípio ativo pode comprometer a execução das diversas operações na produção de um medicamento como filtração, lavagem, secagem, moagem, liofilização, encapsulamento e compressão, além de afetar suas propriedades de solubilidade e biodisponibilidade (BOTTOM, 1999; BRITTAIN, 2006). Por exemplo, segundo Froehlic, amostras de matérias-primas e medicamentos de mebendazol disponíveis no mercado apresentam diferentes polimorfos em sua composição, o que pode afetar sua dissolução e, consequentemente, sua biodisponibilidade (FROEHLIC et al., 2005). A patente é considerada um grande incentivo ao desenvolvimento tecnológico, tanto por ser um documento oficial que concede proteção legal à invenção quanto por ser um documento considerado como a mais rica fonte de informação tecnológica no mundo, agregando, em seu conteúdo, dados inéditos que não estão disponíveis em nenhum tipo de publicação técnico-científica. Para proteger uma invenção por meio de uma patente, é necessário que sejam obedecidos os requisitos básicos de patenteabilidade previstos nas legislações de propriedade industrial: novidade, atividade inventiva e aplicação industrial (LONGA, 2007). Geralmente, as patentes já concedidas nos escritórios internacionais relativas às formas polimórficas na área farmacêutica reivindicam o produto e processos de obtenção de formas cristalinas de fármacos já conhecidos em uma "Fórmula Markush". Tais patentes tornaram-se polêmicas devido ao fato de os titulares utilizarem as formas cristalinas como uma estratégia para a extensão da proteção da molécula base. Ressalta-se que uma "Fórmula Markush" é

2024, Reciis

Este artigo visa a apresentar resultados de um estudo sobre o exame de pedidos de patentes farmacêuticas realizado pela Agência Nacional de Vigilância Sanitária (Anvisa), conhecido como anuência prévia. A implementação de um exame de patentes no seio da Anvisa-agência reguladora da área da saúde no país-é um exemplo de utilização dos dispositivos flexibilizadores dos Acordos TRIPS da Organização Mundial do Comércio (OMC) e instrumento de promoção do direito à saúde. Com a adesão ao Acordo TRIPS, o Brasil foi levado a reconhecer patentes para produtos e processos farmacêuticos, o que resultou na promulgação da Lei da Propriedade Industrial (Lei 9.279 de 1996). O monopólio temporário criado pela patenteabilidade interfere com o acesso a medicamentos e as políticas de saúde, em particular na área farmacêutica. Para limitar essa interferência, o Brasil implementou, a partir de 1999 (com a criação da anuência prévia), um trâmite específico para o exame das patentes farmacêuticas, realizado em duas etapas: no Instituto Nacional da Propriedade Industrial (INPI) e na Coordenação de Propriedade Intelectual da Anvisa (Coopi-Anvisa). A prática resultante desta medida é permeada até hoje por inúmeros conflitos e tensões envolvendo diferentes setores da sociedade brasileira. O estudo desta experiência baseou-se na literatura especializada, no levantamento em material de imprensa, pedidos de patente, leis e decretos relativos a medicamentos e propriedade intelectual e em entrevistas com os responsáveis pelo funcionamento da anuência prévia Palavras-chave: patentes; propriedade intelectual; acesso à saúde; Anvisa

2024, Reciis

2024, Revista de Direito Sanitário

El Tribunal de Apelaciones en lo Civil de 2º Turno, confirma la sentencia de primera instancia que, en aplicación de la normativa protectora de los consumidores en el ámbito del Derecho a la Salud, condenó al laboratorio farmacéutico fabricante de un medicamento con el que fue tratado un paciente para el acné, y que posteriormente desarrolló una aplasia medular. Aún sin quedar comprobada la causalidad entre la ingesta del medicamento y el daño sufrido por el paciente, la falta de advertencia en el prospecto de que se habían dado una serie de casos que se habrían asociado a la enfermedad aunque no comprobados, hace incurrir al fabricante en responsabilidad objetiva.

2024, Indicadores Econômicos FEE

Resumo A década de 90 foi permeada por estudos que vinculam os investimentos em pesquisa e desenvolvimento (P&D) à competitividade dos países desenvolvidos. Esses indicam que havia uma relação direta entre o domínio tecnológico e a geração de vantagens competitivas no mercado internacional. No Brasil, estudos realizados na década de 90 indicam como desafio competitivo da indústria nacional a superação da dependência tecnológica, pressupondo incrementos nos investimentos públicos e privados em P&D. Assim, o objetivo deste trabalho é verificar como está o panorama nacional acerca dessa questão e verificar se esse novo cenário guarda relação com a inserção competitiva dos produtos nacionais no mercado internacional, evidenciada pela expansão das exportações no período 2000-04.

2024, Frontiers in Drug Discovery

Among the lessons learned from the COVID-19 pandemic is the need to develop antiviral drugs poised to treat the next pandemic. Unfortunately, traditional drug development economic models, centered principally on patents, are ineffective to induce private sector investment due to unpredictable timing and cause of the next pandemic. As a result, illustrated by the COVID-19 pandemic, it is the public and philanthropic sectors sectors that overwhelmingly fund the development of innovative vaccines and therapies. To meet the need for proactive antiviral medicines in advance of the next pandemic, new models of drug development are needed. Open science partnerships (OSPs) show promise in this regard. Rather than rely principally on patents and private investment, OSPs combine a variety of academic, philanthropic, governmental, and private sector incentives to share knowledge and develop and test antiviral drugs. Private sector investments are, within an OSP, not only leveraged against inve...

2024, JGO Global

PURPOSE There is an urgent need to improve access to cancer therapy globally. Several independent initiatives have been undertaken to improve access to cancer medicines, and additional new initiatives are in development. Improved sharing of experiences and increased collaboration are needed to achieve substantial improvements in global access to essential oncology medicines.

2024

Nesta tese objetiva-se desenvolver uma metodologia de prospecção tecnológica útil na identificação de pedidos de patentes, contendo tecnologias de interesse do Ministério da Saúde, visando subsidiar a operacionalização da priorização de sua respectiva análise técnica pelo INPI e Anvisa, baseada no instrumental teórico-prático de prospecção tecnológica. A priorização do exame de patentes é uma das linhas de gestão do backlog de patentes normatizada pelo INPI, com potencial para otimizar a morosidade da concessão de patentes farmacêuticas no Brasil e seus efeitos deletérios na dinâmica de inovação do setor farmacêutico nacional. Foi utilizada a abordagem hipotético-dedutiva combinando às técnicas de levantamento bibliográfico documental, mineração de dados em ciência e tecnologia com o procedimento monográfico. Adicionalmente foi realizado um estudo de caso aplicando a metodologia de prospecção tecnológica no campo tecnológico dos medicamentos imunossupressores pós-transplante de órgãos. Foram identificados 48 pedidos de patentes aptos ao exame prioritário no país e 23 produtos futuros no campo tecnológico supracitado. Constatou-se que a ausência de uma política explicita que delineie o papel ocupado pelo subsistema de concessão de patentes farmacêuticas, compromete as iniciativas de políticas vigentes. Por fim foram tecidas recomendações aos operadores das políticas públicas no país a partir das conclusões do estudo de caso e da tese. Palavras-chaves: Patentes farmacêuticas. Prospecção tecnológica. Propriedade industrial. Anvisa. INPI.

2024, Globalization and Health

Background It is widely accepted that intellectual property legal requirements such as patents and data exclusivity can affect access to medicines, but to date there has not been a comprehensive review of the empirical evidence on this topic. The World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires Member States to implement minimum standards of intellectual property protection including patents for pharmaceutical products, but also contains ‘flexibilities’ designed to address barriers to access to medicines. National intellectual property laws can also include TRIPS-plus rules that go beyond what is required by TRIPS. We aimed to systematically review literature that measures the impact of intellectual property rules on access to medicines, whether implemented as a result of TRIPS, TRIPS-plus provisions in other trade agreements, or unilateral policy decisions. Methods We searched Proquest, SCOPUS, Web of Science, PubMed, JS...

2024

INTRODUCTION: The delay in oncological treatment start may affect treatment efficacy. The objective of this study was to describe the delays in the provision of non-surgical cancer treatments and patient satisfaction with the administrative procedure as well as the relationship with patient educational level and treatment costs in two public hospitals in Buenos Aires and Tucumán. METHODS: The study was based on a survey. Patients with an indication of medical or radiation treatment, or relatives in charge of the administrative procedure, were eligible for the study. The primary outcomes were the proportion of subjects with a self-reported time longer than one month from the indication of the treatment until its start and the level of satisfaction with the administrative procedure. RESULTS: Of the 73 survey participants, 74.3% reported waiting times longer than one month; 47.2% showed some degree of difficulty in understanding the process and 45.2% in its execution; 57.5% had some le...