Cécile van der Heijden

In sectors such as medical devices, cosmetics, food, feed, dietary supplements, and related products, the way you communicate about your products is subject to strict and ever-evolving regulations. Whether it concerns nutrition claims, health claims, environmental & sustainability claims, or beauty claims, what you say matters both commercially and legally. Getting it right builds consumer trust. Getting it wrong can lead to regulatory action and reputational damage.

Data is the backbone of the life sciences sector, driving innovation during the R&D phase, scientific research, patient care, and regulatory compliance. Data collection and processing however is subject to a wide array of legislation which directly impact the commercial viability and regulatory compliance of your product or service. But with the GDPR, the European Health Data Space Act (EHDS Act), the Data Act, the Network and Information Security Directive (NIS II Directive), and the AI Act, the regulatory landscape for (personal) data and AI is increasingly complex, particularly where these laws interact with product legislation such as the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). The interaction between these frameworks demands an integrated compliance approach.

Before entering into a transaction or a collaboration with another party, it is essential to understand what you are dealing with. In life sciences, that is rarely straightforward. The value or risk of a counterparty is often concentrated in assets and arrangements that require specialist knowledge to assess properly: a regulatory approval that may be narrower in scope than it appears on paper, an IP portfolio with unresolved ownership questions, or supply chain arrangements that carry hidden compliance risks. Identifying these issues before you commit determines whether a deal or partnership delivers what you expect.

EU environmental and sustainability legislation increasingly affects life sciences companies and the broader green innovation sector. Whether you manufacture medical devices, develop medicinal products, scale biotech processes, or bring biobased materials to the market in the EU, your products and operations are likely to trigger obligations under frameworks such as REACH, the Battery Regulation, the Waste Electrical and Electronic Equipment Directive (WEEE), the Restriction of Hazardous Substances Directive (RoHS), the Packaging & Packaging Waste Regulation (PPWR), and the Persistent Organic Pollutants Regulation (POPs). PFAS restrictions and reporting obligations add further complexity. Managing the intersection of environmental and product regulation is essential for any company placing products on the EU market.

Disputes in the life sciences sector arise in many forms: product liability claims, complaints, contractual breakdowns, regulatory enforcement actions, intellectual property conflicts, freedom of information procedures, or challenges to product authorisations. Whatever the nature of the dispute, effective litigation in this sector requires more than legal skill. It requires a thorough understanding of the technical and regulatory context in which the conflict arose, as that context often determines both the strength of the legal arguments and the practical outcome of a case.

Life sciences companies regularly find themselves on the receiving end of government action. Regulatory authorities such as the Dutch Health and Youth Care Inspectorate (IGJ), the Dutch Food Safety Authority (NVWA), the Dutch Data Protection Authority (AP), and the Netherlands Authority Consumers and Markets (ACM) have broad powers to investigate, sanction, and impose corrective measures. At the same time, companies may face freedom of information requests at governmental authorities or need to comply with other legal obligations that risk exposing confidential business data, or must navigate strict procurement rules when contracting with public institutions. In each of these situations, you are dealing with a government body that operates under its own legal framework, and you need a legal partner who knows both that framework and your sector inside out.

Spin-outs and life sciences starters sit at the crossroads of company formation, intellectual property, financing, and regulatory compliance. Whether you are a researcher spinning out a venture from a university or knowledge institute, or an entrepreneur launching a life sciences startup, the early decisions you make on corporate structure, IP-ownership, funding, and team incentives will shape the trajectory of your company for years to come. Getting these foundations right from day one is a necessity.