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Acesso ao mercado dos dispositivos médicos na Europa
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Orientador(es)
Resumo(s)
A Europa apresenta uma das maiores quotas do mundo no que se refere ao mercado dos
dispositivos médicos, sendo o mesmo pautado pela inovação e pela heterogeneidade.
São continuamente desenvolvidos novos produtos procurando abranger diferentes áreas
terapêuticas. Existe uma ampla variedade de dispositivos médicos com diversas funções
e aplicações que permitem impactar positivamente e de forma continua, os profissionais
de saúde, os doentes, e os seus cuidadores, reduzindo de forma drástica o impacto que
as diferentes patologias acarretam para as suas vidas.
A importância dos dispositivos médicos na Europa é notória e está amplamente ligada
ao seu acesso ao mercado. A monografia desenvolvida pretende explorar alguns dos
fatores que envolvem o processo de acesso ao mercado, nomeadamente a estratégia,
algumas definições, a gestão de “stakeholders”, oportunidades e desafios e, ainda, as
diferenças entre o processo envolvendo o medicamento e os dispositivos médicos.
O acesso ao mercado envolve um conjunto de atividades necessárias para que os
dispositivos médicos sejam disponibilizados e para que os doentes consigam aceder aos
mesmos de forma rápida e contínua, sendo um processo que afeta a saúde pública, a
economia e a inovação tecnológica na saúde. Deste modo, o desenvolvimento de uma
estratégia de acesso ao mercado é de extrema importância para que se dê a sua
implementação de forma eficaz. É um processo desafiante, tendo em consideração
diversos fatores, como a análise de custo-efetividade conduzida pelas agências de
Avaliação de Tecnologias da Saúde, a definição de preço e estratégias de reembolso dos
dispositivos médicos que visam equilibrar o retorno do investimento efetuado pelas
empresas e a acessibilidade dos doentes, conhecer o mercado competitivo em que o
dispositivo médico se insere e a gestão de “stakeholders” envolvidos no processo.
A estratégia de acesso ao mercado deve acompanhar as várias fases do ciclo de vida do
dispositivo médico, desde a idealização à fase pós-comercialização, de modo a garantir
a continua recolha de dados que suportem a evidência clínica no que se refere à
segurança e desempenho dos dispositivos médicos, como auxiliar na sua avaliação
económica. Existem inúmeras diferenças no que se refere à via de acesso ao mercado
dos dispositivos médicos e dos medicamentos resultantes das diferenças envolvendo o
âmbito regulamentar, a avaliação das tecnologias de saúde, o ciclo de vida, a fixação de
preços e reembolso de ambos.
São múltiplos os desafios e oportunidades no acesso ao mercado dos dispositivos
médicos na Europa e o facto de existirem sistemas de saúde nos vários países
organizados de formas distintas, impossibilita a definição de uma estratégia global,
existindo a necessidade de uma continua adaptação local. Paralelamente a isto, de modo
a ultrapassar algumas das barreiras existentes na Europa, é importante a continua aposta
em colaborações internacionais de modo a promover a troca de informação, apostar no
reforço dos sistemas novos ou em desenvolvimento e uma maior transparência nas
decisões de cobertura, havendo ainda espaço para melhoria nestes aspetos.
Europe has one of the world's largest shares of the medical devices market, which is characterized by innovation and heterogeneity. New products are continually being developed to cover different therapeutic areas. There is a wide variety of medical devices with different functions and applications that make it possible to have a positive and continuous impact on healthcare professionals, patients and their carers, drastically reducing the impact that different pathologies have on their lives. The importance of medical devices in Europe is notorious and is largely linked to their access to the market. This monography aims to explore some of the factors involved in the market access process namely strategy, some definitions, stakeholder management, opportunities and challenges, and the differences between the process involving medicines and medical devices. Market access involves a set of activities necessary for medical devices to be available and for patients to be able to access them quickly and continuously, and this process affects public health, the economy and technological innovation in health. Therefore, the development of a market access strategy is extremely important if it is to be implemented effectively. It is a challenging process, taking into account several factors, such as the cost-effectiveness analysis conducted by Health Technology Assessment agencies, the definition of pricing and reimbursement strategies for medical devices that aim to balance the return on investment made by companies and accessibility for patients, knowing the competitive market in which the medical device is inserted and the management of stakeholders involved in the process. The market access strategy must accompany the various phases of the medical device's life cycle, from conception to the post-marketing phase, in order to guarantee the continuous collection of data that supports clinical evidence regarding the safety and performance of medical devices, as an aid to their economic evaluation. There are numerous differences in the market access pathway for medical devices and medicines resulting from differences involving the regulatory scope, health technology assessment, life cycle, pricing and reimbursement of both. There are many challenges and opportunities when it comes to accessing the medical devices market in Europe, and the fact that the health systems in the various countries are organized in different ways makes it difficult to define a global strategy, and there is a need for continuous local adaptation. At the same time, in order to overcome some of the existing barriers in Europe, it is important to continue to invest in international collaborations in order to promote the exchange of information, strengthen new or developing systems and increase transparency in coverage decisions, although there is still room for improvement in these aspects.
Europe has one of the world's largest shares of the medical devices market, which is characterized by innovation and heterogeneity. New products are continually being developed to cover different therapeutic areas. There is a wide variety of medical devices with different functions and applications that make it possible to have a positive and continuous impact on healthcare professionals, patients and their carers, drastically reducing the impact that different pathologies have on their lives. The importance of medical devices in Europe is notorious and is largely linked to their access to the market. This monography aims to explore some of the factors involved in the market access process namely strategy, some definitions, stakeholder management, opportunities and challenges, and the differences between the process involving medicines and medical devices. Market access involves a set of activities necessary for medical devices to be available and for patients to be able to access them quickly and continuously, and this process affects public health, the economy and technological innovation in health. Therefore, the development of a market access strategy is extremely important if it is to be implemented effectively. It is a challenging process, taking into account several factors, such as the cost-effectiveness analysis conducted by Health Technology Assessment agencies, the definition of pricing and reimbursement strategies for medical devices that aim to balance the return on investment made by companies and accessibility for patients, knowing the competitive market in which the medical device is inserted and the management of stakeholders involved in the process. The market access strategy must accompany the various phases of the medical device's life cycle, from conception to the post-marketing phase, in order to guarantee the continuous collection of data that supports clinical evidence regarding the safety and performance of medical devices, as an aid to their economic evaluation. There are numerous differences in the market access pathway for medical devices and medicines resulting from differences involving the regulatory scope, health technology assessment, life cycle, pricing and reimbursement of both. There are many challenges and opportunities when it comes to accessing the medical devices market in Europe, and the fact that the health systems in the various countries are organized in different ways makes it difficult to define a global strategy, and there is a need for continuous local adaptation. At the same time, in order to overcome some of the existing barriers in Europe, it is important to continue to invest in international collaborations in order to promote the exchange of information, strengthen new or developing systems and increase transparency in coverage decisions, although there is still room for improvement in these aspects.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, 2024, Universidade de Lisboa, Faculdade de Farmácia.
Palavras-chave
Acesso ao mercado; “Stakeholders”; Dispositivos Médicos; “Pricing”; Reembolso. “Stakeholders” Dispositivos médicos “Pricing” Mestrado Integrado - 2024