Rechtsanwalt*

Dr. iur. Claus Gawel

LLM (Uppsala), MCIArb

Life sciences and technology law

Dr. iur. Gawel advises on Swiss and EU law in life sciences and technology, including contracts, regulation, data protection and cross-border issues.

Discuss a matter contact@gawel.ch

Communication in English, German and French

* Registered in the Basel-Stadt public list of EU/EFTA lawyers under Art. 28 BGFA

In-house experience

Experience includes in-house legal roles at Johnson & Johnson, AbbVie, IFPMA, and the Swiss Digital Society.

Dr. iur. Gawel also studied microbiology and genetics (University of Vienna) as well as drug discovery and pharma management (University College London).

Illustration of a micropipette releasing a droplet into an assay plate — Laboratory liquid handling: AI-generated illustration of a pipette and assay plate

Conceptual transparent diagnostic cartridge with blue channels beside an off-white reader — Diagnostic cartridge and reader: AI-generated illustration

Concept illustration of a flexible wearable sensor patch with fine conductive tracks — Wearable sensor: AI-generated illustration

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Professional background

Admissions and registrations

Dr. iur. Gawel is admitted to the Berlin Bar under the professional title Rechtsanwalt (attorney-at-law): Rechtsanwaltskammer Berlin (opens in new tab).

In Switzerland, he is registered in the Basel-Stadt public list of EU/EFTA lawyers under Art. 28 BGFA. The list is kept by the supervisory commission for lawyers, the Aufsichtskommission über die Anwältinnen und Anwälte (opens in new tab).

The practice is governed by the German rules of professional conduct (BRAO and BORA) and, in Switzerland, by the BGFA.

Education

First and Second German State Examinations in law; Dr. iur.; LLM (Uppsala)

Further studies

Drug Discovery & Pharma ManagementUniversity College London
Microbiology & GeneticsUniversity of Vienna

Memberships and roles

Bar Association of the Canton of Basel-Stadt and Swiss Bar Association
Member of the Healthcare Practice Group and the Digital Practice Group of the Cantonal Bar Association
International Bar Association; IBA YLC National Representative for Switzerland
Member of the Chartered Institute of Arbitrators (MCIArb)

Recent writing

All articles

1 October 2026
Cyber Resilience Act Reporting: The 24-Hour Early Warning Duty for US and Swiss Manufacturers
29 September 2026
Arbitration or Litigation for Pharma Deal Disputes: 2026 ICC Rules, UPC Mediation and English-Language Courts
24 September 2026
EU Critical Medicines Act Proposal: Swiss and US Manufacturing in Public Tenders

Article archive 87 articles

Swissmedic Authorization After FDA Approval: The Scope and Limits of Art. 13 HMG22 September 2026
The EU Biotech Act’s Proposed SPC Extension: Trial and Manufacturing Conditions for US and Swiss Sponsors17 September 2026
EU Data Act for US Medical Device Makers: The Access-by-Design Duty After 12 September 202615 September 2026
EU Drug Approval Revoked Over Trial Data Integrity: Lessons From Tavneos for Licensors and Licensees10 September 2026
Pseudonymized Health Data After the IQVIA Fine: Real-World Data Licensing and the EDPB's Draft Anonymization Test8 September 2026
Swiss Drug Pricing Under US Most-Favored-Nation Pressure: Confidential Rebates and a Pending Ordinance3 September 2026
Germany's 2026 Drug Pricing Law: 15.5 Percent Rebates, AMNOG Changes and Patented Drug Tenders1 September 2026
EU Product Liability for Software and SaMD: Germany's Pending Bill and the December 2026 Deadline27 August 2026
Swiss Anti-Kickback Rules for Medical Devices: What the Integrity Ordinance Extension Would Change for US MedTech25 August 2026
The Swiss Data-Protection Representative Under Art. 14 DSG: Which US Companies Must Appoint One20 August 2026
AI Literacy After the Digital Omnibus: What Art. 4 AI Act Still Requires of Life-Sciences Companies18 August 2026
EU AI Act Chatbot and AI Content Labels: Art. 50 AI Act Meets Pharma and MedTech Promotion13 August 2026
Cross-Border Pharmacovigilance Agreements: Contractual Allocation and Statutory Responsibility11 August 2026
Biosimilar Entry After the EU Pharma Package: Exclusivity and Evidence Requirements6 August 2026
Nordic Health Data for Real-World Evidence: What Findata Grants a US Biotech, and What the EHDS Changes4 August 2026
Denmark's 14-Day Procedure for Phase I and I–II Trials: Nordic Timelines and Their Limits30 July 2026
Swiss Health Data for US SaaS and Digital Therapeutics: How the DSG Differs From HIPAA and the GDPR28 July 2026
The EU MDR and IVDR Simplification Proposal: What Would Change for US Device Makers23 July 2026
The EU Pharma Package's Revised Hospital Exemption for ATMPs: Approval and Oversight21 July 2026
Three Regimes, One Supply Chain: Life Sciences Due Diligence Under the CSDDD, the LkSG and the Draft Swiss NUFG16 July 2026
AI-Enabled Medical Devices: Cybersecurity Under the EU AI Act, the MDR and Swiss Law14 July 2026
GDPR, Cookies and the Digital Omnibus: Planning Implications for US SaaS Businesses9 July 2026
The Unified Patent Court at Year Three: Opt-Out Strategy for US Portfolios7 July 2026
Transatlantic Data Transfers in 2026: The DPF After the Supreme Court's FTC Removal Ruling2 July 2026
The EU Digital Omnibus: Adopted AI Act Deferrals and Pending GDPR Changes30 June 2026
Swiss Merger Control Adopts the SIEC Test: The Revised Kartellgesetz and US MedTech and Pharma Deals25 June 2026
Switzerland's AI Regulation Versus the EU AI Act: Why the Federal Council Chose a Sector-Specific Path23 June 2026
The SoHO Regulation Reaches Cell and Gene Therapy: New EU Rules on Substances of Human Origin for US Biotech18 June 2026
Germany's Medizinforschungsgesetz (MFG): Pricing Relief and Confidential Reimbursement for Research in Germany16 June 2026
Switzerland's 24-Hour Cyberattack-Reporting Duty: The ISG Obligation for US Operators of Swiss Critical Infrastructure11 June 2026
EUDAMED Goes Live: What Mandatory Registration Means for US Device and IVD Makers9 June 2026
The EU Foreign Subsidies Regulation: An Additional Clearance for US Biotech M&A4 June 2026
Technology Transfer Block Exemptions in 2026: Divergent EU, UK, and Swiss Rules for US Biotech2 June 2026
The European Health Data Space: Access Conditions and Timelines for US Biotech28 May 2026
Bilaterals III and the Swiss MRA: Planning for the Possible Restoration of Device Recognition26 May 2026
EU AI Act GPAI Compliance for US Foundation-Model Providers: Enforcement From August 202621 May 2026
The EU AI Act and the MDR: Compliance Timelines for US Medical AI19 May 2026
Germany's DiGA Reform: Outcome-Based Pricing and Class IIb for US Digital Therapeutics14 May 2026
Swiss Clinical Trial Consent Under the HFG and DSG: One Form, Two Regimes12 May 2026
The EU Product Liability Directive and US Pharma: Strict Liability, Presumed Defects, and Long-Term Exposure7 May 2026
EU HTA Joint Clinical Assessment at One Year: Lessons for US Oncology and ATMP Sponsors5 May 2026
Swiss and EU Pharma Advertising Rules: Adapting US Promotional Practices30 April 2026
Security of Supply Under the EU Pharma Package: Critical Medicines and Joint Procurement for US Sponsors28 April 2026
The 2026 EU Pharma Package: Sponsor Decisions Before Entry into Force23 April 2026
NIS2 in Austria: NISG 2026 Duties and Deadlines for US Pharma R&D21 April 2026
The EU Cyber Resilience Act: A 2026–2027 Compliance Map for US Software and Hardware Vendors16 April 2026
IVDR and Swiss IvDV Transition Rules: Matching Dates, Separate Obligations14 April 2026
The EU Data Act: New Limits on US Cloud and IoT Contracts9 April 2026
Where the Liability Cap Fails: Risk Allocation in US-Swiss Life-Sciences R&D Collaborations7 April 2026
Employee Inventions in Swiss Pharma R&D: Ownership and the Limits of US Assignment Clauses2 April 2026
Regulatory Sandboxes for Novel Therapies: A New EU Pathway for US Cell, Gene, and AI-Enabled Therapeutics31 March 2026
EU Environmental Risk Assessment: Asian API Supply Chains and US Antimicrobial Sponsors26 March 2026
Transferable Exclusivity Vouchers: Can the EU Incentive Support US Antimicrobial Developers?24 March 2026
The Expanded EU Bolar Exemption: Earlier Generic and Biosimilar Market Entry19 March 2026
EU Pharma Package: Launch Requests and the Risks of Selective Market Entry17 March 2026
EU Orphan-Drug Exclusivity: Product-Based Protection and Its Implications for US Biotech12 March 2026
The 90-Day Rule: How the EU Pharma Package Rewrites Global Filing Strategy for US Sponsors10 March 2026
Clinical Trials with Pregnant Participants in Switzerland, the EU and the US: One Evidence Gap5 March 2026
FDA-Regulated Trials with Pregnant Participants: Subpart B and the Distance Between Policy and Rules3 March 2026
Clinical Trials with Pregnant Participants Under the EU CTR: The Gap Between Permission and Practice19 February 2026
Clinical Trials with Pregnant Participants in Switzerland: When Protection Becomes Exclusion17 February 2026
Nordic NIS2 Enforcement: Five Countries, Two Regimes, and Separate Supervisors for Pharma R&D12 February 2026
Austria's Accelerated Clinical Trial Pathway: What the 35-Day Timeline Does Not Tell US Biotech10 February 2026
EU AI Act and German Pharma R&D: The 2026–2027 Compliance Deadlines5 February 2026
Swiss Pharma Pricing Under Pressure: What the Three-Year Review Means for R&D Investment3 February 2026
Biotech M&A Earnouts: Anatomy of Milestone Disputes27 January 2026
Swiss MedTech Export Without the MRA: What Third-Country Status Requires8 January 2026
Cross-Border Clinical Trial Agreements: Coordinating Switzerland, the EU and the UK6 January 2026
NIS2 for Connected Medical Devices: Cybersecurity Requirements and Implications30 December 2025
Cybersecurity for SaMD: MDR Requirements and Related Obligations23 December 2025
Cloud Service Contracts: Jurisdictional Complexity9 December 2025
AI in Drug Discovery: Intellectual Property and Data Ownership Challenges4 December 2025
EU MDR Compliance for Swiss MedTech: The Dual-Track Reality2 December 2025
AI-Enabled Medical Devices: The Regulatory Convergence Problem27 November 2025
Biotech Licensing: Hidden Contractual Pitfalls25 November 2025
Post-Market Surveillance for SaMD: When Software Keeps Changing28 October 2025
Clinical Evidence for SaMD: What Swiss and EU Regulators Actually Expect21 October 2025
Does Switzerland Offer a Regulatory Sandbox for Digital Health?16 October 2025
Swiss Professional Secrecy and International E-Discovery: Where the Duties Conflict14 October 2025
Parallel Imports in Switzerland: Protection Under Pharma Distribution Agreements9 October 2025
Software as a Medical Device (SaMD): Classification Pitfalls in Switzerland and the EU7 October 2025
ATMP Hospital Exemption: Regulatory Limits and Licensing Risks2 October 2025
EU Authorized Representatives for Swiss Manufacturers Under the MDR and IVDR30 September 2025
Pharma Supply Chain Liability: The Limits of Contractual Protection25 September 2025
Data Privacy in Clinical Trials: GDPR Meets DSG23 September 2025
GMP Manufacturing of ATMPs: Regulatory Differences Between the EU and Switzerland18 September 2025
Pharma R&D Partnerships: Contractual Risk Allocation16 September 2025

Discuss your matter

Tell me about your situation and what you would like to achieve.

Make an enquiry contact@gawel.ch

An abstract study of curved glass fibers catching blue and white light — Glass fibers and light: AI-generated abstract illustration

Dr. iur. Claus Gawel

Life sciences and technology law

In-house experience

Biotech and pharma

MedTech and diagnostics

Technology and digital health