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- Home
- Professionals
- Dr. Dr. Adem Koyuncu
Dr. Dr. Adem Koyuncu
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).
Dr. Koyuncu is the author of numerous publications and frequent speaker at different events. As such, he will speak at following upcoming events:
- "The Information Officer - Responsible Person under § 74a AMG," Seminar, Munich (11/23/2020)
- "The Person Responsible for Regulatory Compliance - The MDR and New Responsibilities," Seminar, Amsterdam (1/27/2021)
- COVID-19 matters: clinical trial advice; special authorizations for medical devices; liability issues, advice on indemnity agreements with EU member states.
- 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).
2000-present
These books include: "Heidelberger Kommentar Arztrecht Krankenhausrecht Medizinrecht“ (HK-AKM), Mitbearbeiter, Loseblatt (2017) "Haftung aus dem Arzneimittelgesetz," Kommentierung in Kullmann/Pfister/Stöhr/Spindler, Produzentenhaftung Kommentar, Loseblatt (2015) "WiKo-Kommentar - Medizinprodukterecht," Mitbearbeiter, Loseblatt (2015) ...
Practical Law Life Sciences
2015-present
Dr. Koyuncu covers the Germany section of this monthly multi-jurisdictional newsletter.
December 2020, Practical Law Life Science
Data Protection and Data Security after GDPR in Clinical Trials
October 6, 2020, Speech (in German) at "Annual Conference Clinical Trials (Chem-Academy)" Conference
Real World Evidence and Pharma Regulation
October 1, 2020, Speech (in German) at conference 23. Marburger Gespräche zum Pharmarecht, Marburg
September 28, 2020, Inside EU Life Sciences
On 10 September 2020, the German Federal Social Court (Bundessozialgericht – “BSG”) has issued an important decision with significant impact on the drug pricing and reimbursement system. It ruled that a pharmaceutical company can file a direct legal action against the early benefit assessment in the so-called AMNOG process. This was not possible so far....… ...
August 10, 2020, Inside EU Life Sciences
On 3 July 2020, the German parliament passed a draft bill (German language) for patient data protection and for more digitalisation in the German healthcare system (Patientendaten-Schutz-Gesetz). The draft bill is currently in the legislative procedure and is expected to enter into force in autumn 2020. One of the main objectives of the bill is...… Continue ...
July 2020, Practical Law Life Sciences
July 2020, Practical Law Life Sciences
June 27, 2020
WASHINGTON—Covington represented Piramal Enterprises Limited (PEL) in the sale of a 20% stake in Piramal Pharma Limited (Piramal Pharma), a wholly owned subsidiary of PEL that will contain its pharmaceutical businesses, to CA Clover Intermediate II Investments, an affiliated entity of CAP V Mauritius Limited, an investment fund managed and advised by affiliated ...
May 2020, Case note (in German) on Judgment of OVG Münster from 19 November 2019, 13 A 1326/17, juris-Praxisreport Medizinrecht
April 6, 2020, Covington Alert
On April 3, 2020, the European Commission published its proposal for a new Regulation to amend the application date of the Medical Devices Regulation 2017/745 (“MDR”) by one year. The proposed new legislation also amends the MDR rules on exceptional special authorizations of non-CE-marked medical devices with immediate effect.
January 30, 2020, Covington Alert
It has been another strong year in anti-corruption enforcement, with 2019 meeting or beating the high-water mark for enforcement across a number of measurements.
January 1, 2020, Case note (in German) on BGH-Judgment from 15 October 2019, VI ZR 105/18, juris-Praxisreport Medizinrecht
November 2019, Case note (in German) on BGH-Judgment from 16 April 2019, VI ZR 157/18, juris-Praxisreport Medizinrecht
Speech on legal aspects of Pharmacovigilance on "7. Jahrestagung Pharmakovigilanz"
October 15, 2019, Conference, Köln
Vendor Oversight in a regulatory environment - Regulatory affairs, vigilance and other GxP areas
October 8, 2019, Seminar, Berlin
The new EU Medical Device Regulation Legal Responsibilities and Consequences
September 28, 2019, Speech (in German) at conference "5. Ärzte- und Juristentag," Düsseldorf
Liability for Medical Devices - before and after EU MDR
September 19, 2019, Presentation (in German) at Conference "Forum für Medizinprodukterecht," Augsburg
August 27, 2019
FRANKFURT—WirtschaftsWoche, Germany’s leading business weekly news magazine, has named Covington as the top law firm for IT law and Dr. Lars Lensdorf, a partner in Covington’s Frankfurt office, to its list of top IT lawyers in Germany. Dr. Lensdorf focuses his practice on IT law, outsourcing, digitalization and industry 4.0, IT related bank regulatory matters, ...
Digital Health and Medical Devices
June 12, 2019, Presentation (in German) on BVMed-Symposium zum Medizinprodukterecht, Conference, Cologne
Placement of Equipment - An Underestimated Compliance Risk
May 15, 2019, Talk on Global Medtech Compliance Conference 2019, Paris
The EU Medical Devices Regulation: Consequences for Device companies in and outside of the EU
May 10, 2019, Presentation at Covington-Seminar: "Medical Device Regulation in the U.S., China and the EU: Overview, Recent Developments, and Trends", Frankfurt
22. Marburger Gespräche zum Pharmarecht (Speech on Digital-Health-Regulation)
March 22, 2019, Conference, Marburg
January 31, 2019, juris-Praxisreport Medizinrecht
The Information Officer - Responsible Person under § 74a AMG
November 19, 2018, Seminar, Munich
ExpertFORUM Pharmacovigilance 2018
November 12-13, 2018, Conference, Frankfurt
Equipment Placement & Bundling
November 6, 2018, 10. BVMed Healthcare Compliance Conference, Berlin
November 2018, Practical Law Life Sciences
October 25, 2018, juris-Praxisreport Medizinrecht
Vendor Oversight in a Regulatory Environment
October 15, 2018, Seminar, Berlin
Speech on Legal and Liability Issues in Pharmacovigilance
October 8, 2018, 6. Jahrestagung Pharmakovigilanz,, Köln
Liability for Medical Devices – today and after EU MDR
June 14, 2018, Presentation (in German) on BVMed-Symposium zum Medizinprodukterecht, Conference, Cologne
May 25, 2018, Inside EU Life Sciences
The “Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity” is an international agreement which aims at sharing the benefits arising from the utilization of genetic resources in a fair and equitable way. It entered into force on 12...… Continue Reading
May 2018, Covington Alert
The Nagoya Protocol to the Convention on Biological Diversity entered into force on 12 October 2014. It imposes a complex set of multi-jurisdictional compliance obligations on businesses active in the cosmetics, food, pharmaceutical and other life science sectors. It now has more than 100 contracting parties, including the European Union.
Covington Opens Frankfurt Office
March 28, 2018
LONDON—Covington will open an office in Frankfurt, Germany on April 3 led by eight partners. Frankfurt will be the firm’s third European office and will work closely with the firm’s five offices in the United States, its three offices in Asia, and its offices in the Middle East and Africa. “Covington will offer German companies a unique capability to help them ...
January 29, 2018, Inside EU Life Sciences
By Dr. Dr. Adem Koyuncu, Covington & Burling LLP In the EU, drug companies are not allowed to publicly promote prescription-only medicines. As courts also apply a broad interpretation of the term “promotional”, nearly all public statements that mention a prescription drug are likely to be qualified as illegal advertising. In certain circumstances, this may...… ...
BREXIT - Your To-Dos in the healthcare business until 2019
December 4, 2017, Seminar, Berlin
The new EU-Medical Devices Regulation - Special issues
July 5, 2017, Speech at BVMed-Symposium on Medical Device Laws, Cologne
ExpertFORUM Labelling: nationally, within the EU & globally
May 31, 2017-June 1, 2017, Seminar, Frankfurt
February 23, 2017, juris-Praxisreport Medizinrecht (Case note on a German court decision on limitations to provide free drug samples to pharmacists under drug advertising rules)
German Pharma Law Day 2017
February 21, 2017, Speech at Conference, Frankfurt
What does BREXIT mean to your healthcare business?
January 31, 2017, Seminar, Düsseldorf
January 2017, Practical Law Life Sciences
2016, In: Deutsches Ärzteblatt 47, p. A 2170
EU Regulations for Medical Devices and In-vitro-Diagnostics
December 12, 2016, German Platform for NanoBioMedicine, Frankfurt
December 7, 2016, Covington Alert
In October 2014, the Nagoya Protocol entered into force. It created a new international regulatory system affecting all life science companies that conduct R&D on biological material such as animals, seeds, flowers, viruses, fragrances, flavonoids, essential oils, enzymes, yeasts, and so on. So far, compliance by companies is progressing slowly due to ...
December 2, 2016, Inside EU Life Sciences
On 11 November 2016, the German Parliament passed another new law amending different parts of the German Medicines Act (Arzneimittelgesetz) and the Act on Advertising for Healthcare Products (Heilmittelwerbegesetz). The law is titled “Viertes Gesetz zur Änderung arzneimittelrechtlicher und anderer Vorschriften“. The draft was deliberated in the health committee ...
November 2016, Practical Law Life Sciences
October 21, 2016
WASHINGTON—Covington represented India-based Piramal Enterprises and its wholly owned Critical Care subsidiary in the UK in the acquisition of five anesthesia and pain management injectable products from Janssen Pharmaceutica NV, in an all cash deal for an upfront consideration of US$155 million, and up to an additional US$20 million. The products to be acquired ...
Key issues of the new EU Medical Devices Regulation – Classification, Conformity Assessment and Clinical Evaluation
October 6, 2016, 12. Augsburger Forum für Medizinprodukterecht, Augsburg
October 2016, Practical Law Life Sciences
Product Demarcation from the Medical Devices Industry’s Perspective
September 19, 2016, BfArM-im-Dialog: Abgrenzung von Arzneimitteln, Bonn
New German Anticorruption Law and Implications for the Healthcare Industry
September 15, 2016, EUCOPE Legal Working Group Meeting, Berlin
Compliance – new anti-corruption law in Germany
June 21, 2016, EUCOPE Members Meeting
Legal Update: Medicines Information and Advertising
June 9, 2016, Online Pharma Forum
2016, In: GesundheitsRecht (6/2016)
National Update on Germany and Coffee-Talk
May 25, 2016, Global MedTech Compliance Conference 2016
Off-label use - Between Support, Tolerating and Liability
April 14, 2016, Seminar, FORUM-Institut
Outsourcing in der Pharmakovigilanz
January 28, 2016, Seminar, FORUM-Institut
Wettbewerbsrechtliche Überprüfbarkeit der Fachinformation eines Arzneimittels und Reichweite der Legitimationswirkung der Arzneimittelzulassung
January 20, 2016, juris-Praxisreport Medizinrecht (Case note on legal options to challenge a competitor drug's SmPC and the scope of a marketing authorisation's legal protection), Author
December 22, 2015, Inside EU Life Sciences
Recently, the German Federal Ministry of Health published a new draft law (“Viertes AMG-Änderungsgesetz”) which aims to amend several provisions of the German Drug Act (Arzneimittelgesetz) and other drug-related laws. Most of the intended amendments result from an adjustment of German laws to the new European Clinical Trials Regulation (Regulation (EU) No. ...
EU's Highest Court strikes down “Safe Harbor” - Consequences for the pharmaceutical industry
October 2015, Vortrag, Ko-Referent, EUCOPE Regulatory/Pharmacovigilance Working Group Meeting
Covington Advises Allergy Therapeutics on £11.5 Million Placement and License Agreement
November 23, 2015
LONDON, November 23, 2015 — Covington represented Allergy Therapeutics, the AIM-listed specialty pharmaceutical company specializing in allergy vaccines, in the placement of ordinary shares raising approximately £11.5 million. The placement was conducted through an accelerated bookbuilding process with Panmure Gordon & Co acting as financial adviser, nominated ...
Lobbying Compliance in the Healthcare Sector
November 19, 2015, BVMed Healthcare Compliance Conference 2015
Off-Label-Use und Compassionate Use von Medizinprodukten
November 5, 2015, Vortrag, BVMed-Sonderveranstaltung - Das Medizinproduktegesetz in der praktischen Umsetzung
September 2015, (Case note on Medical Device Product Liability decision of German Supreme Civil Court)
June 2015, Intellectual Property & Technology Journal
June 11, 2015
BRUSSELS, June 11, 2015 — Covington has received 20 leading practice group rankings in the 2015 editions of Chambers Europe and Legal 500 EMEA. The legal guides have recognised the firm’s expertise in the following areas: CHAMBERS EUROPE Europe-wide - Regulatory - Agro/Food Europe-wide - Regulatory - Environment Europe-wide - Regulatory - ...
Moderator of Plenary Session: Exchange of best practices: Meeting the challenges of the transition towards an 'indirect-only-sponsorship' model and Coffee Talk: National Update on Germany
May 19-21, 2015, Global MedTech Compliance Conference 2015
April 14, 2015, Inside EU Life Sciences
A more detailed analysis of the impact of the work at the CJEU is featured in Clinica Medtech Intelligence. Liability Spotlight now on the Notified Bodies Background and Context The so-called PIP-Breast-implant scandal now reaches the Court of Justice of the European Union (CJEU). As last week a German court referred a liability case to...… Continue Reading
Pharmacovigilance Laws and Liability Implications
March 5, 2015, Marburger Gespräche zum Pharmarecht 2015
February 19, 2015, Inside EU Life Sciences
On 4 February 2015, the German Ministry of Justice published a new draft law specifically aimed to combat corruption in the healthcare sector. Key element of the draft legislation will be a newly defined criminal offence that will be inserted as a new Section 299a of the German Criminal Code (StGB). This new criminal offence...… Continue Reading
Off-label use - between support, tolerating and liability
February 19, 2015, FORUM Institut für Management GmbH
Healthcare Compliance - Where is the journey heading?
November 25, 2014, BVMed-Healthcare Compliance-Konferenz
Update on Pharma Law in Germany & Europe
November 17, 2014, FORUM Institut für Management GmbH
October 27, 2014, Covington E-Alert
The Importance of Creating a Coordinated Multi-Jurisdictional Compliance Program
October 16, 2014, Life Sciences Essentials Series Webinar
Liability issues in Clinical Trials with Drugs
September 23, 2014, FORUM Institut für Management GmbH
Aktuelle Rechtsfragen zu klinischen Prüfungen
June 26, 2014, BVMed-Symposium zum Medizinprodukterech
7th DVFA Life Science Conference: Innovative Treatment Strategies for Cancer
May 7, 2014, DVFA GmbH
Update on Pharma Law in Germany & Europe
May 6, 2014, FORUM Institut für Management GmbH
Verantwortungsbereich des Sponsors und Abgrenzung" and "Arzneimittelschäden bei klinischen Prüfungen: Haftung des Sponsors
April 22, 2014, Haftungsfragen bei klinischen Prüfungen mit Arzneimitteln (Liability issues in Clinical Trials with Drugs)
Clinical Trial Regulation” & “Outlook on the new EU-laws on Medical Devices
March 27, 2014, Medizinprodukterecht (Medical Devices Law)
Biosimilars Regulatory Frames & Harmonization - USA: biological & biosimilar pathway
March 5, 2014, International Beyond Quality Forum 2014
Named Patient Programmes, Compassionate Use, Off-Label Use – Reimbursement and Liability under German Law
February 20, 2014, EUCOPE Orphan Drug Working Group Meeting
Product Liability for Drugs
February 19, 2014, Deutscher Pharma Recht Tag 2014 (German Pharma Law Day 2014)
Off-Label-Use, Compassionate Use, Off-License-Use
February 4, 2014, Off-Label-Use
Covington Boosts European Life Sciences Group
December 19, 2013
Brussels, 19 December, 2013 — Covington & Burling is pleased to announce that Adem Koyuncu is joining its life sciences practice as a partner, along with associate Sabine Stute. Dr. Koyuncu and Ms. Stute will be resident in the firm’s Brussels office, and will focus on issues involving the law of the European Union and, in particular, of Germany. Dr. Koyuncu, ...
Sponsoring of Medical Education of Healthcare Professionals by Pharma and Medical Device Companies
June 2013, Arzneimittel & Recht
Compliance in Processing of Patient Data
January 2013, Compliance und Datenschutzrecht im Gesundheitsmarkt
January 2013, FORUM Institut für Management GmbH
Off-Label-Use of Medical Devices
April 2013, BVMed Conference on Medical Devices Law
2013, Buchbeitrag, in Voit (Hrsg.), Kommunikation und Transparenz im Gesundheitswesen
Legal issues resulting from Social Media with respect to information, advertisement and pharmacovigilance
2012, Drug Law Conference
2012, Die Neuordnung des Arzneimittelmarktes –Veränderungen und Perspektiven
2012, Buchbeitrag, in Voit (Hrsg.), Die Neuordnung des Arzneimittelmarktes
2011, PHi - Haftpflicht International
- "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)