PORTUGAL Trends and Developments Contributed by: Patrícia Paias, Francisco Marques Azevedo and Clara Nolasco Lamas, MFA Legal & Tech
increasingly intersect with risks relating to data pro- tection, digital health technologies and cybersecurity. Hybrid health products, where medicines, medical devices and digital tools operate together, present multi layered regulatory and litigation exposure. A single inci- dent – product malfunction, data breach or software failure – can trigger parallel scrutiny from health authori- ties, data protection regulators and cybersecurity over- sight bodies, as well as potential civil litigation. Procurement and market access disputes are also gaining prominence. Hospital procurement processes play a decisive role in determining access to therapies, particularly in specialised therapeutic areas. Challeng- es to tender specifications or award decisions can delay market entry and disrupt supply planning. Corporate transactions reflect these evolving risk dynamics as investors increasingly focus on opera- tional compliance during due diligence, including: • clinical trial governance; • quality management systems; Risk governance is increasingly viewed as a strate- gic differentiator, with robust compliance frameworks enhancing investment and partnership prospects. Environmental Regulation of Pharmaceutical Products Another emerging regulatory area concerns the envi- ronmental impact of pharmaceutical products. The EU pharmaceutical reform introduces additional regula- tory attention to the environmental footprint of medi- cines, including strengthened requirements relating to environmental risk assessments and monitoring of pharmaceutical residues. As part of the proposed revision of EU pharmaceutical legislation, the Directive 2001/83/EC on the Commu- nity code relating to medicinal products for human use and the Regulation (EC) No 726/2004 estab- lishing procedures for the authorisation and super- vision of medicinal products are being amended to strengthen requirements concerning environmental • regulatory compliance; • data governance; and • cybersecurity preparedness.
risk assessments (ERAs). Under the reform propos- als presented by the European Commission, pharma- ceutical companies will be required to submit more robust environmental data during marketing authori- sation procedures, including improved evaluation of the environmental impact of active substances, their metabolites and degradation products. The updated framework aims to ensure that environ- mental risks are systematically considered through- out the lifecycle of medicinal products, including dur- ing development and post-authorisation monitoring. In particular, the reform introduces mechanisms to improve transparency and monitoring of pharmaceu- tical residues in water systems, addressing concerns about environmental contamination and the contribu- tion of certain substances to antimicrobial resistance (AMR). These developments complement broader EU envi- ronmental legislation addressing pharmaceutical pollutants. In particular, the revised Directive (EU) 2024/3019 concerning urban wastewater treatment strengthens monitoring and treatment requirements for micropollutants, including pharmaceutical resi- dues released into wastewater systems. The direc- tive introduces an extended producer responsibility (EPR) scheme under which pharmaceutical and cos- metic manufacturers may contribute financially to the costs of advanced wastewater treatment technologies designed to remove micropollutants. Although several elements of these reforms will be implemented progressively during the transition period expected to run until approximately 2028, they are already influencing regulatory planning and compliance strategies across the pharmaceutical sector. Pharmaceutical companies operating in Por- tugal are therefore increasingly required to consider environmental impact during product development, regulatory submissions and manufacturing processes, including the generation of environmental data and the implementation of risk mitigation measures. Over time, these developments are expected to inte- grate environmental sustainability more directly into pharmaceutical regulation, aligning health policy objectives with broader EU environmental and public health strategies.
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