Pharma & Life Science Industry
Compliance in a Transforming Pharmaceutical Sector
The pharmaceutical industry is undergoing profound change, driven by technological innovation, increasing regulatory complexity, and heightened societal expectations. From artificial intelligence and blockchain to data governance and patient safety, companies must navigate a landscape where compliance, innovation, and market access are closely intertwined.
EU Artificial Intelligence Regulation
Artificial intelligence is increasingly used in drug discovery, clinical trials, and patient monitoring.
The EU AI Act introduces obligations concerning risk classification, transparency, and oversight. We advise pharma and life science companies on how to comply with these requirements and integrate them into their operations in a practical way.
Pharmacovigilance and Regulatory Compliance
Safeguarding patient safety remains a paramount obligation. We support clients in establishing and maintaining pharmacovigilance systems that comply with EU standards.
Our advice extends to:
- the integration of AI and
- data analytics
into electronic signal detection, ensuring overlapping compliance while enhancing the effectiveness of risk detection and reporting.
A particular concern at present is that, in the absence of certain binding legal interpretations from the Court of Justice of the European Union, there is a risk of overlapping compliance obligations arising from:
- Regulation (EC) No 726/2004 (Authorization and Supervision of Medicinal Products)
- Implementing Regulation (EU) No 520/2012 (Performance of Pharmacovigilance Activities)
- Commission Implementing Regulation (EU) 2025/1466 (Amending Implementing Regulation (EU) No 520/2012)
- Directive 2001/83/EC (Community Code Relating to Medicinal Products)
- Regulation (EU) 2017/745 (Medical Device Regulation)
- Regulation (EU) 2024/1689 (Artificial Intelligence Act)
Competition Law
In an industry characterized by high barriers to entry and intensive R&D collaboration, competition law plays a decisive role.
We advise on:
- Art. 101 TFEU Risks
- Art. 102 TFEU Risks
- Pre-Merger considerations
- Structuring partnerships,
- Joint ventures, and
- Distribution models
to mitigate exposure to antitrust scrutiny while preserving commercial flexibility.
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Data Protection and Digital Compliance
Pharmaceutical companies increasingly rely on compliance software to manage sensitive information, particularly the personal data contained in Individual Case Safety Reports (ICSRs).
Under the GDPR, strict obligations apply to the collection, processing, storage, and transfer of such data, including special categories of health information. This is especially important when safety data is managed through automated platforms or transferred across jurisdictions.
We advise on the design and operation of GDPR-compliant pharmacovigilance and compliance systems, covering issues such as lawful basis for processing, data minimisation, retention, security safeguards, and vendor agreements.
Where artificial intelligence is used to support pharmacovigilance or risk detection, we address both GDPR and the EU AI Act, ensuring transparency, accountability, and human oversight.
Blockchain and Digital Assets
Blockchain technology is increasingly applied to strengthen supply chain integrity, ensure clinical trial transparency, and enhance data traceability. We advise on the legal implications of blockchain-based solutions, including smart contracts and tokenization, ensuring that innovation in this space is implemented within robust regulatory frameworks.