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Identificação de oportunidades e propostas de melhoria para o aumento da competitividade de Portugal na investigação clínica
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Orientador(es)
Resumo(s)
O investimento em investigação clínica, para além de beneficiar os doentes, traz valor económico e conhecimento científico associado à realização de ensaios clínicos. Por outro lado, contribui para a redução da despesa pública, para a sustentabilidade do Serviço Nacional de Saúde e para a criação de emprego.
Portugal tem potencial para se tornar um país atrativo para a investigação clínica, graças à excelência dos seus centros de investigação, à elevada capacidade de trabalho e competência dos seus investigadores.
No entanto, e de acordo com a última atualização do estudo sobre “Ensaios Clínicos em Portugal”, realizado pela PwC por solicitação da APIFARMA, os seguintes fatores tornam o País pouco atrativo para a investigação clínica: a inexistência de sistemas informativos integrados; a burocracia associada aos processos dos ensaios; a limitada cooperação e articulação entre as várias unidades e profissionais de saúde, reduzindo a referenciação de doentes; a limitação da carreira de investigador e de tempo disponível para que os profissionais de saúde se possam dedicar à investigação clínica, o que se traduz num número reduzido de equipas especializadas.
Por outro lado, com a implementação do regulamento europeu para a investigação clínica e a rigidez dos prazos de aprovação que impõe, o cenário que se vislumbra no futuro próximo não é animador para Portugal se se mantiverem os atuais constrangimentos, sendo por isso necessário agir e tomar medidas concretas de adaptação que tornem o País competitivo para a realização de investigação clínica, sob pena desta vir a ser fortemente reduzida.
Deste modo, o presente projeto de dissertação tem como principal objetivo propor medidas concretas que melhorem a competitividade do País para a investigação clínica, tendo por base a análise das medidas que contribuíram para aumentar a competitividade em países com dimensão populacional semelhante à de Portugal e elevado número de ensaios clínicos (por exemplo, Países Baixos, Bélgica, Dinamarca e região da Catalunha) e, também, pela análise das propostas e medidas já implementadas por diversas empresas e instituições nacionais do setor.
The investment in clinical research, in addition to benefiting patients, brings economic value and scientific knowledge associated with conducting clinical trials. On the other hand, it contributes to the reduction of public expenditure, to the sustainability of the National Health Service and to job creation. Portugal has the potential to become an attractive country for clinical research, thanks to the excellence of its research centers, the high work capacity and competence of the investigators. However, according to the latest update of the study about “Clinical Trials in Portugal”, carried out by PwC at the request of APIFARMA, the following factors make the country unattractive to clinical research: the lack of integrated information systems; the bureaucracy associated with clinical trial processes; the limited cooperation and articulation between the various units and health professionals, reducing the referral of patients; the limitation of the investigator’s career and the time available for health professionals to dedicate to clinical research, which translates into a reduced number of specialized teams. On the other hand, with the implementation of the European Regulation for Clinical Trials and the strict approval deadlines that it imposes, the scenario is not encouraging for Portugal, if the current constraints are maintained, which is why is necessary to act and take measures that make the country competitive for clinical research, otherwise it will be strongly reduced. Thus, the main objective of this dissertation project is to propose concrete measures that would improve the country's competitiveness for clinical research, based on the analysis of measures that increased competitiveness in countries with a similar population size to Portugal and with a high number of clinical trials (for example, Netherlands, Belgium, Denmark and the region of Catalonia) and, also by the analysis of suggestions and measures implemented by national companies and institutions from the sector.
The investment in clinical research, in addition to benefiting patients, brings economic value and scientific knowledge associated with conducting clinical trials. On the other hand, it contributes to the reduction of public expenditure, to the sustainability of the National Health Service and to job creation. Portugal has the potential to become an attractive country for clinical research, thanks to the excellence of its research centers, the high work capacity and competence of the investigators. However, according to the latest update of the study about “Clinical Trials in Portugal”, carried out by PwC at the request of APIFARMA, the following factors make the country unattractive to clinical research: the lack of integrated information systems; the bureaucracy associated with clinical trial processes; the limited cooperation and articulation between the various units and health professionals, reducing the referral of patients; the limitation of the investigator’s career and the time available for health professionals to dedicate to clinical research, which translates into a reduced number of specialized teams. On the other hand, with the implementation of the European Regulation for Clinical Trials and the strict approval deadlines that it imposes, the scenario is not encouraging for Portugal, if the current constraints are maintained, which is why is necessary to act and take measures that make the country competitive for clinical research, otherwise it will be strongly reduced. Thus, the main objective of this dissertation project is to propose concrete measures that would improve the country's competitiveness for clinical research, based on the analysis of measures that increased competitiveness in countries with a similar population size to Portugal and with a high number of clinical trials (for example, Netherlands, Belgium, Denmark and the region of Catalonia) and, also by the analysis of suggestions and measures implemented by national companies and institutions from the sector.
Descrição
Tese de mestrado, Regulação e Avaliação do Medicamento e Produtos de Saúde, 2023, Universidade de Lisboa, Faculdade de Farmácia.
Palavras-chave
Ensaios clínicos Regulamento europeu de ensaios clínicos Competitividade Teses de mestrado - 2023