The European life sciences and health care sector is currently experiencing an intense wave of legislative and regulatory changes. Political initiatives such as the "Strategy for European Life Sciences," EU Pharmaceutical Law Package, and revised EU Product Liability Directive require companies to engage more actively with political decision makers at both the EU and national levels. Such engagement is essential to ensure that regulatory frameworks align with scientific innovation and commercial realities. At the same time, advocacy and lobbying activities are subject to various regulations, including criminal laws, on both the EU and Member State levels.

Complex legal framework for political engagement

The legal environment governing political advocacy has become increasingly complex. At the EU level, relevant obligations include the Transparency Register, the Regulation on European Political Parties and Foundations, and the Rules of Procedure and Code of Conduct of the European Parliament.

These rules intersect with national laws that vary significantly across Member States. Many countries have their own lobbying registers and transparency rules, complemented by criminal law provisions. For example, Germany recently introduced Section 108f of the Criminal Code, which criminalizes offering, promising, or granting benefits to members of federal, state, European and internal parliaments in exchange for them representing the benefactor's interests in breach of duty, such as through influence on ministries or authorities. Divergent national definitions of "lobbying" and "public official" further increase legal complexity for companies operating across borders.

Intensified enforcement and investigations

EU institutions have enhanced scrutiny of Transparency Register entries and increasingly impose sanctions for non-compliance.

In addition, enforcement of the criminal law framework has intensified. There are ongoing investigations by the European Public Prosecutor's office as well as by prosecutor offices of the Member States. One prominent example is the Munich Public Prosecutor's investigation in connection with consultancy agreements closed with members of the German Bundestag related to "mask deals." These investigations did not lead to convictions, but led to the introduction of additional criminal offenses relating to interactions with elected officials.

In all cases, such investigations are subject to high political and public scrutiny. In the life sciences sector, public scrutiny often even focuses on interactions that do not violate applicable laws.

Best practices for compliant advocacy

These developments underscore the need for the ability to demonstrate compliance in political engagement. This entails timely and accurate fulfilment of registration and disclosure duties, clear internal policies, regular employee training, and, most important, thorough documentation of interactions with policymakers. Continuous monitoring of legal developments across jurisdictions is equally essential.