PORTUGAL Trends and Developments Contributed by: Patrícia Paias, Francisco Marques Azevedo and Clara Nolasco Lamas, MFA Legal & Tech
In 2025 and early 2026, Portugal’s life sciences and pharmaceutical regulatory landscape has continued to evolve in the context of broader European reforms and domestic policy developments. At the EU level, the major revision of pharmaceutical legislation is advanc- ing, aimed at securing equitable access to medicines, strengthening supply resilience and boosting compet- itiveness across the European Union. These develop- ments are expected to influence national implementa- tion from 2026 to 2028. At the national level, 2025 saw significant regulatory activity reflecting a strategic emphasis on medicine availability, cost containment and regulatory alignment with EU frameworks. Medicines Availability and Pricing In 2025, Infarmed introduced new regulations on the management of medicine availability and transaction control aimed at reinforcing stock monitoring and improving supply chain resilience. Additionally, the authority has imposed temporary export bans on a range of medicines to ensure supply continuity amid shortages. These measures were introduced through: • Order No 233/2025, establishing the Regulation on the Management of the Availability of Medicinal Products; and • Order No 234/2025, which introduced the Regula- tion on the Control of Transactions of Medicinal Products Abroad. The new regulations on the management of medicine availability and transaction control reinforce report- ing obligations and stock-monitoring plans for critical medicines and establish related measures to integrate real time availability information into distributor and pharmacy systems to improve supply chain transpar- ency. Alongside these measures, the government adopted exceptional price review criteria for 2026, continu- ing efforts to prevent price erosion, particularly for essential and low cost medicines. The 2026 Annual Price Revision was established under Ordinance No 394/2025/1, which defines criteria for the 2026 review process.
The 2026 State Budget included increased overall health expenditure while maintaining a strong focus on efficiency and sustainability in pharmaceutical spend- ing. These measures include initiatives to reduce poly- pharmacy, limit clinical waste and intervene in high impact therapeutic groups of medicines. Distributors and pharmacy representatives have also actively engaged with public authorities to address issues related to economic sustainability and pricing updates. Industry stakeholders have called for mech- anisms that would allow automatic annual updates to medicine prices, for example, through inflation index- ing, to preserve distribution margins within a tightly regulated market. Alignment with European Regulation Portugal’s regulatory environment in 2025–2026 con- tinues to be shaped by several major EU develop- ments that are progressively influencing national pol- In March 2025, the European Commission proposed the Critical Medicines Act, a regulation intended to improve availability, supply and resilience of critical medicines across the EU; it supports collaborative procurement and strategic production projects for critical medicines. Health Technology Assessment Regulation (HTAR) The EU Health Technology Assessment Regulation (Regulation (EU) 2021/2282), which entered into force in January 2022 and became fully applicable on 12 January 2025, established an EU wide framework for joint clinical and scientific assessment of innovative health technologies, aiming to reduce duplication and support coordinated evidence based decision mak- ing. AI Regulation (AI Act) The EU Artificial Intelligence Act (Regulation (EU) 2024/1689) introduces a risk based regulatory frame- work for AI systems. Healthcare applications, such as diagnostic and clinical decision support systems categorised as high risk, will require robust data qual- ity, risk management and human oversight. (Imple- icy and the life sciences sector. Critical Medicines Act (CMA)
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