PORTUGAL Law and Practice Contributed by: Eduardo Nogueira Pinto, Hugo Monteiro de Queirós, Eliana Bernardo and Rúben do Carmo Pereira, PLMJ
in the population, etc (see 8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices ). 8.4 Cost-Benefit Analyses Medicines As a rule, State funding of medicines is cumulatively subject to prior scientific demonstration of therapeutic innovation or equivalence for the therapeutic indica- tions claimed, as well as demonstration of the eco- nomic advantage of the medicine. These factors are not decisive in setting the prices of medicines, given that prices tend to be fixed, taking into account those in the reference countries (see 8.1 Price Control for Pharmaceuticals and Medical Devices and 8.2 Price Levels of Pharmaceuticals or Medical Devices ). In the case of the acquisition of medicines for use in the NHS, additional negotiation/commercial conditions A cost-benefit analysis is also carried out in the State’s funding of medical devices, considering the therapeu- tic innovation demonstrated for the clinical purpos- es claimed and the demonstration of an economic advantage (see 8.1 Price Control for Pharmaceuti- cals and Medical Devices ). may also apply. Medical Devices In the case of the acquisition of medical devices for use in the NHS, additional negotiation/commercial conditions may also apply. 8.5 Regulation of Prescriptions and Dispensing by Pharmacies To support the financial sustainability of the NHS, reimbursed medicines must be prescribed using the international non-proprietary name. The commercial name may only be used in the exceptional circum- stances expressly provided for by law. Pharmacies must inform the patient about the medicine that, in compliance with the prescription, has the lowest price. These rules apply to reimbursed medical devices with the necessary adaptations.
Requests for price authorisation and price revision communications follow their own procedures and are submitted to INFARMED by the MA holder. Price Control for Medical Devices As a rule, State-financed medical devices have fixed maximum prices. Medical devices not financed by the State have free pricing. The pricing rules for medical devices are set out in Decree-Law 97/2015 of 1 June 2015, and there are Ministerial Orders that define the maximum prices applicable to certain devices or groups of medical devices, which usually include the marketing margins and VAT. In these cases, the RP proposed is indicat- ed by the manufacturer at the time of the request for reimbursement to INFARMED, which follows its own procedure. 8.2 Price Levels of Pharmaceuticals or Medical Devices Medicines The prices of medicines are generally set and reviewed based on the prices in reference countries with com- parable GDP per capita or the lowest price level, as defined annually among EU countries. Ministerial Order 394/2025/1 of 14 November has designated Spain, France, Italy and Belgium as refer- ence countries for 2026. Medical Devices Medical device prices do not depend on the prices applied in other countries. 8.3 Reimbursement From Public Funds Public funding of medicines and medical devices depends on an application to INFARMED by the MA holder or the manufacturer, respectively (Health Tech- nology Assessment). This public financing may be full or partial and differs according to various factors, such as pathologies or special groups of patients, thera- peutic indications, the prevalence of certain diseases
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