PORTUGAL Law and Practice Contributed by: Eduardo Nogueira Pinto, Hugo Monteiro de Queirós, Eliana Bernardo and Ricardo Rocha, PLMJ
Medical Devices A cost-benefit analysis is also carried out in the financing of medical devices by the State, considering the therapeutic innovation demon- strated for the clinical purposes claimed and the demonstration of an economic advantage – see 8.1 Price Control for Pharmaceuticals and Medical Devices . 8.5 Regulation of Prescriptions and Dispensing by Pharmacies In order to ensure the sustainability of the NHS, the prescribing of reimbursed medicines is made using the international non-proprietary name and may only include the commercial name of the medicines in the exceptional cases listed in the 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.
Ministerial Order 293/2024/1 of 15 November has defined Spain, France, Italy and Belgium as reference countries in 2025. Medical Devices Medical device prices do not depend on the prices applied in other countries. 8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds Public financing of medicines and medical devic- es depends on an application to INFARMED by the MA holder or the manufacturer, respectively. This public financing may be full or partial and differs according to various factors, such as pathologies or special groups of patients, ther- apeutic indications, the prevalence of certain diseases in the population, etc (see 8.4 Cost- Benefit Analyses for Pharmaceuticals and Medical Devices ). 8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices Medicines As a rule, State funding of medicines is cumula- tively subject to prior technical-scientific demon- stration of therapeutic innovation or equivalence for the therapeutic indications claimed, as well as demonstration of the economic advantage of the medicine. These factors are not decisive in fixing the price of medicines, given that these prices tend to be fixed, taking into account the prices in the reference countries – see 8.1 Price Control for Pharmaceuticals and Medical Devices and 8.2 Price Levels of Pharmaceuti- cals or Medical Devices .
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