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Adem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm's "Food, Drug & Device" practice group and also a member of our Compliance practice. Dr. Koyuncu is recognized as a "leading lawyer for pharma and medical devices Law" (JUVE 2019).

He has a broad European life sciences practice and knows the healthcare sector also from his earlier work in the pharmaceutical industry and as a medical doctor. Clients praise his “understanding of complex regulatory issues, business acumen and industry experience” (Legal 500 2015). He helps clients on a wide range of EU and German law issues and also provides strategic advice. His broader practice also includes compliance, privacy and liability matters. He represents clients before courts and authorities and assists them in contract negotiations, internal investigations and transactions. For many years, Dr. Koyuncu is listed in various rankings. He is described as "versatile and competent" (JUVE 2019), "incredibly fast" (JUVE 2018) and "very good and pleasant lawyer"(JUVE 2017) who provides advice at "an outstanding level" (Legal 500 2015).

  • COVID-19 matters: advice on clinical trials; special authorizations for medical devices and medicines, vaccine supply agreements with several countries; GMP, GCP and off-label use issues.
  • Advice on regulatory and contractual issues of CAR-T and gene therapies.
  • Virtual medical conferences (drug promotion and compliance issues).
  • Litigation and arbitration in pharma contract disputes.
  • Several matters on Implementation of the EU-Medical Device Regulation (MDR).
  • Advised on regulatory requirements for drug distribution, marketing authorisations, market/data exclusivity, pharmacovigilance, clinical trials, GCP, GVP, GDP and GMP.
  • Medical devices distribution and regulatory compliance, obtaining CE marks and vigilance issues.
  • Advice on off-label-use of medical devices and drugs as well as “named patient use” and compassionate use programs.
  • Litigation before German courts (e.g., unfair competition, IP, liability cases).
  • Advice on product recalls with representation in product liability litigation and settlement negotiations.
  • Research with human biomaterial and biobanks and related data protection and contractual issues.
  • Numerous matters on advertising for drugs and medical devices, including unfair competition litigation.
  • Advised on organizational compliance in pharmacovigilance.
  • Advised on legal requirements for mobile health apps and telemedicine systems.
  • Advised on various aspects of market access, pricing and reimbursement for drugs and medical devices (including AMNOG, NUB).
  • Advised several clients in the establishment of company-wide compliance programs.
  • Internal investigations in cases with (1) suspected anti-corruption issues and (2) suspected violations of regulatory and privacy requirements for clinical trials.
  • Representation of clients in proceedings against distribution of counterfeited products.
  • Advised a US medical devices manufacturer in the acquisition of a German devices distribution company.
  • Regulatory and compliance due diligences in several transactions and IPOs.

Memberships and Affiliations

  • Visiting Lecturer at the Bucerius Law School, Hamburg, University of Marburg and at the University of Düsseldorf 
  • Member of the Law360 Life Sciences Editorial Advisory Board (2015-2016)
  • Member of the Ethics Committee of the University of Dresden
  • Associated Member of the "Legal Working Group" (Arbeitskreis Recht) of BVMed, the German Medical Devices Industry Association   
  • Vice-Chair of Legal Working Group of EUCOPE (European Confederation of Pharmaceutical Entrepreneurs) 
  • Member of the “Life Science Committee” of the DVFA (Society of Investment Professionals in Germany)
  • Society for Law and Politics in Health Care (GRPG)
  • German Society for Medical Law (DGMR)   
  • Member of the Editorial Boards of the following Legal Journals:
    • Pharma Recht (Pharma Law)
    • Medizinprodukte-Recht (Medical Devices Law)

Previous Experience

  • Partner and co-head of the global Life Sciences-group at an international law firm.
  • Drug safety advisor in an international pharmaceutical company.
  • Member of the Ethics Committee of the University of Dresden.
  • Expert in several hearings before the German Parliament (health committee) on medical devices law (June 2012) and on pharmaceutical law (May 2016).
  • "Leading Lawyer for Pharma and Medical Devices Law" (JUVE Handbook 2019/2020) 
  • "Top Lawyer for Medical Law" WirtschaftsWoche (2019)
  • JUVE (2006-2019/2020)
  • Who’s Who Legal: Life Sciences 2016-2019
  • "Life Sciences Star" in LMG Life Sciences Europe 2014-2016
  • Chambers Europe (2007-2020): Leading Individual for Life Sciences
  • Legal 500
  • PLC Which Lawyer?
  • Deutscher Arzt Recht Preis 2008 (German Medical Law Award)
  • Wissenschaftspreis im Gesundheitswesen 2005 (Science Award in Health Care)