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4.
Health Policy ; 124(12): 1287-1296, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33032846

RESUMO

Shortages of medicines have become a major public health challenge. The aim of this study was to survey national measures to manage and combat these shortages. A questionnaire survey was conducted with public authorities involved in the Pharmaceutical Pricing and Reimbursement Information (PPRI) network. Reponses relating to measures as of March / April 2020 were received from 24 countries (22 European countries, Canada and Israel). In 20 countries, manufacturers are requested to notify - usually on an obligatory basis - upcoming and existing shortages, which are recorded in a register. Further measures include a regular dialogue with relevant stakeholders (18 countries), financial sanctions for manufacturers in cases of non-supply and/or non-compliance with reporting or stocking requirements (15 countries) and simplified regulatory procedures (20 countries). For defined medicines, supply reserves have been established (14 countries), and legal provisions allow the issuing of export bans (10 countries). Some measures have been introduced since the end of 2019 and countries are planning and discussing further action. While governments reacted by taking national measures, the COVID-19 crisis might serve as an opportunity to join forces in cross-country collaboration and develop joint (e.g. European) solutions to address the shortage issue in a sustainable manner. A practical first step could be to work on a harmonisation of the national registers.


Assuntos
Indústria Farmacêutica/legislação & jurisprudência , Legislação de Medicamentos , Preparações Farmacêuticas/provisão & distribução , Canadá , Estudos Transversais , Europa (Continente) , Humanos , Israel , Inquéritos e Questionários
19.
Eur J Cancer ; 132: 100-103, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32335476

RESUMO

Direct-to-consumer (DTC) commercial companies offer genetic tests that are presented as allowing individuals the opportunity to increase their capacities to be in charge of their own healthcare managements. DTC companies deny performing medical tests, yet they provide data based on sequencing multigene panel or whole exome. This contradiction allows these companies to escape the requirements of a regulated medical practice that guarantees the quality of the tests, as well as the information and support for tested individuals. Herein, we illustrate the lack of such requirements by analysing the bad experience of a young man who dealt with DTC health genetic testing companies. There is an emergency for DTC testing to be either deprived of any medically relevant information, or carried out in a legally regulated medical framework.


Assuntos
Erros de Diagnóstico/prevenção & controle , Triagem e Testes Direto ao Consumidor/normas , Indústria Farmacêutica/normas , Testes Genéticos/normas , Disseminação de Informação/ética , Neoplasias/diagnóstico , Análise de Sequência de DNA/normas , Adulto , Triagem e Testes Direto ao Consumidor/legislação & jurisprudência , Indústria Farmacêutica/legislação & jurisprudência , Testes Genéticos/legislação & jurisprudência , Genoma Humano , Humanos , Achados Incidentais , Disseminação de Informação/legislação & jurisprudência , Masculino , Neoplasias/genética , Fatores de Risco
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