PORTUGAL Trends and Developments Contributed by: Patrícia Paias, Francisco Marques Azevedo and Clara Nolasco Lamas, MFA Legal & Tech
chain resilience, maintain economic sustainability and support patient access to essential therapies. Key trends have been outlined below. • Enhanced supply chain transparency and digitali- sation: Following the implementation of Order no 233/2025, distributors and pharmacies are required to provide real time stock visibility and standard- ised availability classification. These measures are improving traceability, enabling faster responses to potential shortages and supporting more informed supply planning. • Economic sustainability in distribution: Stakehold- ers continue to advocate for mechanisms to main- tain distribution margins within a tightly regulated market. This includes consideration of automatic annual updates of medicine prices indexed to inflation, as well as operational efficiency improve- ments across the supply chain. • Expanded dispensing of hospital medicines via community pharmacies: Pilot initiatives and policy discussions are ongoing to allow selected hospital medicines to be dispensed in community pharma- cies, improving patient access and relieving pres- sures on hospital pharmacies. • Public health logistics: Vaccine distribution and other critical public health interventions remain a key focus. • Recognition of full service distributors: While no separate 2026 law formally codifies full service distributor status, industry stakeholders, notably ADIFA (the Portuguese Association of Pharmaceu- tical Distributors), are advocating for clearer legal recognition. This reflects a broader trend towards formalising operational standards, quality require- ments and record-keeping expectations within the distribution sector. • Cross-sector coordination: There is increasing emphasis on closer collaboration between manu- facturers, distributors, pharmacies and healthcare providers. Such coordination aims to enhance rap- id response to supply disruptions and to optimise inventory management across the national system. Overall, these developments illustrate a shift towards a more transparent, digitally enabled and resilient phar- maceutical distribution network in Portugal. Stakehold-
ers are aligning operational practices, digital reporting and strategic coordination to ensure continuity of sup- ply while supporting public health priorities in 2026. IP Strategy and Patent Positioning Intellectual property strategy in the life sciences sector is increasingly influenced by developments in the EU pharmaceutical reform agenda and structural chang- es to the European patent enforcement framework. These developments are encouraging companies operating in Portugal to align IP planning more closely with market access strategies, lifecycle management and regulatory timelines. A key policy discussion concerns the proposed clarifi- cation and expansion of the “Bolar” exemption within the EU pharmaceutical reform package, which may allow earlier preparation for generic and biosimilar entry, including activities related to regulatory submis- sions and participation in procurement. The establishment of the Unified Patent Court (UPC) has introduced the possibility of centralised enforce- ment and validity challenges across participating EU jurisdictions, influencing strategic planning for European patent portfolios and freedom to operate assessments. AI assisted innovation and data driven research are raising new questions about the ownership and pro- tection of intellectual assets, prompting collaboration agreements to: • address data rights;
• reuse restrictions; and • publication controls.
Trade secret protection is becoming more prominent where patentability is uncertain or disclosure through patent publication could undermine competitive advantage, placing greater emphasis on confidential-
ity frameworks and governance. Litigation and Corporate Risk
As Portugal’s life sciences sector expands, the dispute and risk landscape is becoming increasingly complex. Traditional exposure areas such as product liability and regulatory enforcement remain central, but they
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