Regulatory reforms to watch out for in Portuguese pharma. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.
1. Are there proposals for reform or significant change to the healthcare system?
As far as publicly made available by the Portuguese Government and Parliament, there is no proposals for reform or significant changes to the healthcare system.
In any case, with respect to health law in general, it is worth noting that, following the entry into force of Regulation (EU) 2017/245 on 26 May 2021, a new legal framework for medical devices is currently under preparation, which intends to update the applicable national law according to the European regulations.
2. When are they likely to come into force?
Initially, the new legal regime for medical devices was expected to enter into force on 26 May 2021, together with the Medical Devices Regulation, but the respective legislation hasn’t yet been published.
Based on Infarmed’s announcement regarding this matter, we understand that the proposal is still undergoing the applicable legislative procedure and should come into force in the upcoming weeks (or months).