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Dr. Dr. Adem Koyuncu

Partner

Brussels +32 2 549 5240

Frankfurt +49 69 768063 366

English
  • About
  • Representative Matters
  • Credentials
  • About

    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. Adem is recognized as a "leading lawyer for pharma and medical devices law" (JUVE).

    Adem is a life sciences industry advisor with a broad practice that cuts across regulatory, compliance, IP, privacy and liability matters. He also provides strategic advice. He knows the life sciences sector also from his earlier work in the pharmaceutical industry and as a medical doctor. He represents clients before courts and authorities and assists them in contract negotiations, investigations and transactions. For years, Adem is listed in various lawyer rankings.

    See some Accolades from Clients and Surveys:

    • "Adem Koyuncu is one of the most intelligent lawyers I know." (Legal 500 2023)
    • "He is one of the most detail-oriented and client-focused partners I have ever encountered." (Client, Chambers 2021)
    • "Great professional and human competence, good team player." (Client/Adverse Party, JUVE 2022)
    • "I find him to be one of the most pragmatic regulatory lawyers. He was a doctor before a lawyer, has been in-house, worked on lots of stuff that I have to handle in-house, which helps when getting advice. He is really good at saying it's a complex situation and your best option is to do this." (Chambers 2022)
    • "He always comes through with extremely helpful advice. He brings a unique understanding and experience to his practice as both a lawyer and medical doctor." (Chambers 2021)
    • "He is an excellent dispute resolution lawyer and advises at the highest level, including, in particular, strategic advice." (Legal 500 2023)
    • "He is very sharp and quick, while at the same time having a good sense of humor and nerves of steel. Very pleasant to work with." (Legal 500 2022)
    • He is described as "versatile competent, reliable and high quality" (JUVE 2021) and "incredibly fast." (JUVE 2018)
    • Provides advice at "an outstanding level." (Legal 500 2015)
    • "Very strong negotiation skills." (JUVE 2011)
    • Clients appreciate his "very broad knowledge and long-standing expertise" (JUVE 2021/22) and that "he is approachable, knowledgeable and really easy to talk to over the various issues. He is calm and has seen most problems before." (Chambers 2020)
    • Peer lawyers described him as "highly competent" and a "very good and pleasant lawyer” (JUVE 2014) and as "the off-label-guru, substantively very good, creative." (JUVE 2022)

    Adem is the author of numerous publications (e.g., in leading books on pharma law, product liability and clinical trials) and frequent speaker at different events. As such, he will soon speak at following events:

    • "Medical Device Liability and Risk Transfer 2.0 | A liability issue for the Management?!" at BVMed Seminar (March 12, 2024)

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • Advised Mirati Therapeutics in the successful re-examination (appeal) proceeding before the EMA for the conditional marketing authorization of cancer-medicine Krazati (adagrasib).
    • Advice on new EU IVD Regulation (IVDR) and regulatory implementation and transition issues.
    • Advice on companion diagnostics (CDx), including combined studies with CDx and pharmaceuticals and parallel marketing authorization and CE-marking procedures.
    • Representation of several drug and device companies in product liability litigation.
    • Advice on implications of the draft EU "Data Act" and "European Health Data Space" regulation for life sciences companies.
    • 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.

    Areas of Expertise

  • Credentials
    Education
    • University of Cologne, 2001
        • Finalization of Law School
    • University of Cologne, 1998
        • Finalization of Medical School
    Bar Admissions
    • Germany
    • Brussels
    Languages
    • German
    • English
    • Turkish
    Accolades
    • Handelsblatt in cooperation with Best Lawyers in Germany, "Lawyer of the Year" for health law and pharma law (2023); recognized lawyer for Life Sciences, Pharmaceutical law and Biotech law (2022-2023)
    • Legal 500 Germany, "Leading lawyer" for Life Sciences & Healthcare (2023-2024)
    • Legal 500 EMEA (2013-2023)
    • JUVE, Leading Lawyer for Pharma and Medical Devices Law (2019-2024)
    • JUVE Pharma and Medical Devices Law (2006-2024)
    • Who’s Who Legal, Global Leader Life Sciences Regulatory (2016-2022)
    • Chambers Europe (2007-2023)
    • "Top Lawyer for Medical Law" WirtschaftsWoche (2019)
    • "Life Sciences Star" in LMG Life Sciences Europe (2014-2016)
    • Deutscher Arzt Recht Preis 2008 (German Medical Law Award)
    • Wissenschaftspreis im Gesundheitswesen 2005 (Science Award in Health Care)
    Memberships and Affiliations
    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).

    Areas of Expertise

News and Insights

Presentations and Speeches

Events