Last week, Germany’s Federal Ministry of Health has adjusted the rules governing Digital Health Applications (DiGA) once more. Key changes include new reporting obligations that require manufacturers to measure and document the success of their digital health apps. This reform adds notable operational pressure, while the reported outcomes will directly
Continue Reading Germany changes rules for Digital Health Applications (DiGA) – More Reporting, More Transparency, More Work
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. Adem is recognized as a "leading lawyer for pharma and medical devices law" (JUVE).
Adem is a life sciences industry advisor with more than 25 years of professional experience. He has a broad practice that cuts across regulatory, compliance, IP, privacy and liability matters. Adem 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:
Webinar “Germany Life Sciences Update – Spotlight: Pharmaceutical Advertising“ (February 26, 2026)
Webinar “Most Favored Nation (MFN) Principle - Focus Pharma” (June 17/ 2026)
German Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospects
Germany has kicked off a new Pharma and MedTech Dialogue that aims to develop new policies and regulatory reform proposals to re‑establish Germany as a competitive, innovation‑friendly location for life sciences R&D and manufacturing. The outcome of this dialogue shall be the basis for a new German Pharma and MedTech…
Continue Reading German Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospects
European Commission Announces (Long Awaited) Proposal to Simplify EU Medical Device Regulations
The European Commission announced today (16 December) its plans to simplify the existing EU regulatory framework for medical devices and in vitro diagnostic medical devices (“IVDs”). Many industry stakeholders have criticized the current EU device rules as being slow, costly, unpredictable, and unnecessarily complex. Under the proposed revisions, the Commission…
Continue Reading European Commission Announces (Long Awaited) Proposal to Simplify EU Medical Device RegulationsInfluencer Marketing – German court sets new Guardrails for Pharmaceutical Advertising on Social Media
In a landmark judgement, the Higher Regional Court of Cologne has set new standards for pharmaceutical advertising with influencers. First, a key point from the decision is that the court qualifies paid influencers as agents of the drug company with respective consequences for the company (discussed below). Second…
Continue Reading Influencer Marketing – German court sets new Guardrails for Pharmaceutical Advertising on Social MediaNew German Guidelines on GDPR Requirements for International Transfers of Health Data in Medical Research
On September 17, 2025, the German Supervisory Authorities (Konferenz der unabhängigen Datenschutzaufsichtsbehörden des Bundes und der Länder, DSK) published new guidelines and recommendations addressing the complex requirements for transferring personal data, particularly health data (including health data contained in biomaterials), to countries outside of the European Economic…
Continue Reading New German Guidelines on GDPR Requirements for International Transfers of Health Data in Medical ResearchGermany enacts Standard Contractual Clauses for pharmaceutical clinical trial agreements – Changes for medical device studies also on the horizon
Germany has taken another step to improve the conditions for pharmaceutical research & development in Germany. Now, the Federal Government has adopted the “Standard Contractual Clauses” for pharmaceutical clinical trial agreements. In this blog, we discuss what the new standard clauses cover and how they will affect clinical trials in…
Continue Reading Germany enacts Standard Contractual Clauses for pharmaceutical clinical trial agreements – Changes for medical device studies also on the horizon
The Covington European Life Sciences Symposium 2025
On 23 January 2025, we hosted the 2025 edition of the Covington European Life Sciences Symposium. The Symposium brought together colleagues from London, Brussels, Frankfurt and Dublin with our industry connections to explore the evolving challenges and opportunities facing the European life sciences sector.
Continue Reading The Covington European Life Sciences Symposium 2025European Court of Justice requested to clarify the scope of the market exclusivity right for orphan drugs – German courts remain divided
In an earlier blog, we had reported on an interesting litigation case concerning the legal scope of the market exclusivity right for orphan drugs in the EU. Meanwhile, there have been further developments in this court case and its key questions have now been referred to the European Court…
Continue Reading European Court of Justice requested to clarify the scope of the market exclusivity right for orphan drugs – German courts remain dividedGermany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical Devices
On 1 July 2024, Germany has enacted stricter requirements for the processing of health data when using cloud-computing services. The new Section 393 SGB V aims to establish a uniform standard for the use of cloud-computing services in the statutory healthcare system which covers around 90% of the German population. In this blog…
Continue Reading Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical DevicesGermany amends drug pricing and reimbursement laws with “Medical Research Act” – Drug pricing becomes intertwined with local clinical research expectations
Last week, on 4 July 2024, the German Parliament (Bundestag) has passed significant changes to the country’s drug pricing and reimbursement laws. Just six months after the German Federal Health Ministry (BMG) presented a first draft bill for a “Medical Research Act” (Medizinforschungsgesetz or MFG), the German…
Continue Reading Germany amends drug pricing and reimbursement laws with “Medical Research Act” – Drug pricing becomes intertwined with local clinical research expectations