Articles
Portugal Cuatrecasas October 2018
HTA Dossiers: Portugal
Join industry executives in staying informed on the market access and HTA process in Portugal. 1. Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link) Yes. Infarmed has published methodological guidelines for pharmacotherapeutic and economic assessment. The recommendations can be consulted here. 2. Have local Authorities published guidelines surrounding…
1. What are the basic requirements to obtain patent and trademark protection? Patents The three main criteria for obtaining patent protection are novelty, inventive step and industrial application (Article 2 Dutch Patent Act (Rijksoctrooiwet 1995), “DPA“). Trademarks The basic requirements for obtaining trademark protection are that of a distinctive character of the sign, a…
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials do not have to be conducted locally as a condition for marketing approval. This is not one of the prerequisite conditions for approval of the clinical trial protocol, which conditions are listed in Article…
Join industry executives in staying informed on the market access and HTA process in Portugal. 1. What are the pricing models, processes and principles for originator drugs? Prices of medicinal products are regulated by the System of Assessment of Health Technologies (SiNATS), approved by Decree-Law 97/2015, 1 June 2015, which established the provisions applicable to…
Canada Fasken October 2018
Bill 15: The Quebec Government Wants to Limit the Specific Medical Necessity Measure
On March 29 2023, the Quebec Health Minister (the “Minister”) introduced Bill 15, an Act to make the health and social services system more effective (the “Bill”). The Bill, which is still at the detailed study stage, proposes a major renewal of the framework for the health and social services system. Its purpose is to…
Join industry executives in staying informed on the market access and HTA process in Portugal. 1. Which are the main actors involved in public procurement and tendering? Within the health sector, public procurement and tendering involve mostly the participation of entities pertaining to the NHS, namely public companies who manage public healthcare facilities, clinics, hospitals,…
Portugal Cuatrecasas October 2018
HTA Decision Analysis Framework: Portugal
Join industry executives in staying informed on the market access and HTA process in Portugal. 1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The CATS and the DATS are responsible for SiNATS. 2. Do regulators require HTA studies in your country? Yes, regulators may require HTA…
1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport) The policy and regulation of drugs (‘medicinal products’), biologicals and medical devices falls under the jurisdiction of the Ministry of Health, Welfare and Sport. The Ministry…
1. Are there proposals for reform or significant change to the healthcare system? Reform of the Drug Reimbursement System The policy on medicinal products of the Ministry of Health Welfare and Sport is based on three core values: quality, accessibility and affordability. In order to improve the affordability of healthcare, the Minister proposed a reform…
Portugal Cuatrecasas October 2018
Healthcare System and Funding: Portugal
Join industry executives in staying informed on the market access and HTA process in Portugal. 1. Please make a general introduction to the public health sector in your country and its organization The Public sector is composed of the National Health Service (Serviço Nacional de Saúde), also referred as the NHS, and the central and…
