Articles
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,…
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In principle, the regulatory framework set out in the previous Chapters applies. However, differing requirements or procedures apply for specific types of medicinal products. The Medicines Act distinguishes several types of medicinal products, including homeopathic medicinal products and herbal medicinal…
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…
Join industry executives in staying informed on the market access and HTA process in Portugal. 1. Price 1.1. How does price control at ex-factory prices work in your country? Ex-factory prices (PVA) are relevant to determine the retail price (PVP) of medicinal products and their maximum legal margins, as below. 1.2. What are the…
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…
Portugal Cuatrecasas October 2018
Healthcare Actors and Payers: Portugal
Join industry executives in staying informed on the market access and HTA process in Portugal. 1.Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? The most relevant administrations, bodies and institutions in charge of public health in Portugal are: • Ministry of Health…
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…
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…
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 types of liability are recognized in your jurisdiction? Dutch liability law generally distinguishes between contractual liability on the one hand and non-contractual liability on the other. Non-contractual liability not only includes fault-based liability (‘onrechtmatige daad‘) but also includes a regime of strict liability for defective products (‘productaansprakelijkheid‘). The regime for strict liability constitutes…
