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A cooperação global na regulação do medicamento e os desafios para o acesso à inovação
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Orientador(es)
Resumo(s)
O aumento exponencial da globalização da indústria farmacêutica, exige uma evolução
constante da regulação por parte das autoridades reguladoras. A cooperação internacional
entre estas, as indústrias e outras organizações de saúde é uma das formas de se atingir a
harmonização regulamentar, obter melhores resultados em saúde e enfrentar os desafios
atuais e futuros. Contudo, a questão que se coloca incide na forma como se consegue
cooperar alcançando objetivos comuns e apoiando a regulação de produtos médicos cada
vez mais complexos.
A World Health Organization é responsável por gerir e coordenar a saúde mundial,
divulgar e promover programas de prevenção e tratamento de doenças e apoiar os Estados-Membros a atingir os objetivos da Universal Health Coverage, ou seja, acesso equitativo de
cuidados de saúde para toda a população, independentemente do seu país, etnia, condição
financeira, entre outros. Tem também como função elaborar guidelines científicas e éticas
que garantam a qualidade, segurança e eficácia dos medicamentos. Apesar de os requisitos
regulamentares diversificarem entre regiões, a partilha de informação e colaboração entre
Estados-Membros, facilita o acesso aos medicamentos e à inovação. De forma a promover
a colaboração entre reguladores, indústrias e outras partes interessadas em saúde, existem
várias iniciativas, como é o caso da International Conference of Drug Regulatory
Authorities que proporcionam discussões onde há partilha de informação e que guiam e
orientam outras regiões para desafios regulamentares.
A pandemia COVID-19 veio realçar falhas dos sistemas de saúde e a necessidade de
transformação estrutural e tecnológica, o que leva à necessidade de sistemas regulamentares
mais evoluídos e eficientes. Neste sentido, para além da cooperação internacional é
importante perceber a relevância que as tecnologias emergentes (impressão 3D, a
inteligência artificial, entre outros) e a transformação digital vão ter na indústria e, portanto,
nos reguladores e na saúde dos doentes. Efetivamente, o futuro da saúde deverá estar focado
no bem-estar e na prevenção ao invés de no tratamento das doenças. Assim, através de
iniciativas como a Innovative Health Initiative e a Estratégia Farmacêutica para a Europa, a
União Europeia pretende tornar-se líder na investigação e desenvolvimento de
medicamentos e na inovação da saúde.
The exponential increase in the globalization of the pharmaceutical industry requires regulatory evolution from regulatory authorities. International cooperation between them, industries, and other health associations, is one way to achieve regulatory harmonization, better health outcomes and to face current and future challenges. However, the question that arises here, is how we can manage to cooperate in achieving common goals and supporting the regulation of medical products which are increasingly complex. The World Health Organization is responsible for managing and coordinating global health, publicizing, and promoting disease prevention and treatment programs and supporting Member States to achieve the goals of Universal Health Coverage, which means equitable access in health care for the entire population, regardless of their country, ethnicity, financial condition, among others. It is also responsible for developing scientific and ethical guidelines that guarantee the quality, safety, and efficacy of medicines. While regulatory requirements vary across regions, sharing information and collaboration across Member States facilitates access to medicines and innovation. In order to promote collaboration between regulators, industries and other stakeholders in health, there are several initiatives, such as the International Conference of Medicines Regulatory Authorities that provide information sharing and guidance to other regions for challenges regulatory requirements. The COVID-19 pandemic highlights the health systems failures and the need for structural and technological transformation, which leads to the need for more evolved and efficient regulatory systems. In this sense, in addition to international cooperation, it is important to understand the relevance that emerging technologies (3D printing, artificial intelligence, among others) and digital transformation will have in industry and, therefore, in regulators and in patients' health. Effectively, the future of health must be focused on the well-being and prevention and not so much in the treatment of diseases. Thus, through initiatives such as the Innovative Health Initiative and the Pharmaceutical Strategy for Europe, the European Union aims to become a leader in drug research and development and in health innovation.
The exponential increase in the globalization of the pharmaceutical industry requires regulatory evolution from regulatory authorities. International cooperation between them, industries, and other health associations, is one way to achieve regulatory harmonization, better health outcomes and to face current and future challenges. However, the question that arises here, is how we can manage to cooperate in achieving common goals and supporting the regulation of medical products which are increasingly complex. The World Health Organization is responsible for managing and coordinating global health, publicizing, and promoting disease prevention and treatment programs and supporting Member States to achieve the goals of Universal Health Coverage, which means equitable access in health care for the entire population, regardless of their country, ethnicity, financial condition, among others. It is also responsible for developing scientific and ethical guidelines that guarantee the quality, safety, and efficacy of medicines. While regulatory requirements vary across regions, sharing information and collaboration across Member States facilitates access to medicines and innovation. In order to promote collaboration between regulators, industries and other stakeholders in health, there are several initiatives, such as the International Conference of Medicines Regulatory Authorities that provide information sharing and guidance to other regions for challenges regulatory requirements. The COVID-19 pandemic highlights the health systems failures and the need for structural and technological transformation, which leads to the need for more evolved and efficient regulatory systems. In this sense, in addition to international cooperation, it is important to understand the relevance that emerging technologies (3D printing, artificial intelligence, among others) and digital transformation will have in industry and, therefore, in regulators and in patients' health. Effectively, the future of health must be focused on the well-being and prevention and not so much in the treatment of diseases. Thus, through initiatives such as the Innovative Health Initiative and the Pharmaceutical Strategy for Europe, the European Union aims to become a leader in drug research and development and in health innovation.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, 2021, Universidade de Lisboa, Faculdade de Farmácia.
Palavras-chave
Cooperação Harmonização Regulação Inovação Acesso Mestrado integrado - 2021