Articles

1. Please describe the main cost containment policies in place in your country and their fundamental principles   a. Pricing and impact of generic/biosimilar approval Currently there are no policies in place in this regard.   b. Clawback/Payback/Discounts/Rebates In Portugal, the main mechanism for cost-containment is the prior evaluation, regulated by Decree-Law No. 97/2015 of…
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. 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…
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,…
Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In principle, the Dutch Opium Act (Opiumwet) (“DOA“) prohibits selling or warehousing, as well as manufacturing, preparing, processing, delivering, dispensing and transporting of products included in ‘List I‘ and ‘List II‘ of the DOA. This includes cannabis: the product ‘hemp’ is included in list II…
Join industry executives in staying informed on the market access and HTA process in Portugal.  1. Are there any Managed entry agreements in place in your country? (If so, please list them) Yes. Infarmed can choose to enter into managed entry agreements (MEA) with marketing authorization holders to regulate the risk of expenditure on innovative…
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. 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…
Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece is focused on the expenditure control and cost containment policies that currently exist in the Romanian pharma market. Buy The Pharma Legal Handbook: Market Access & HTA – Romania here for £359.   1. Please describe the main cost…
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…