Photo of 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, and Device Practice Group. 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, 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.” (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 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.” (Legal 500 2022)
Provides advice at “an outstanding level.” (Legal 500 2015)
"Very strong negotiation skills.” (JUVE 2011)
Peer lawyers describe him as „top, experienced, specialized” (JUVE 2026) and as “the off-label-guru” (JUVE 2022)

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

Presentation  “GCP-Violations and their legal consequences,” Annual Conference Clinical Research, Cologne (October 12, 2026)
Presentation “Update on legal developments for Pharmacovigilance,“ Fachseminar: Arzneimittelsicherheit - Status Quo 2026, Online (October 13, 2026
Presentation “Data Protection Issues in Clinical Trials and Other Studies” at AKG-Seminar, Up-Date zum Datenschutz im Gesundheitswesen, Online (November 17, 2026)
Presentation “US MFN Drug Pricing & European Market Access: Strategic Briefing for 2027,” Online-Seminar (FORUM) (November 19, 2026)

Contact:Read more about Dr. Dr. Adem KoyuncuEmail

Hot off the press, yesterday evening, 29 September 2026, the German Government’s expert committee presented the eagerly awaited proposal for a new “location clause” (Standortklausel) to incentivize pharmaceutical R&D and manufacturing in Germany. Under this proposal, pharmaceutical companies can apply for a reduction or complete waiver of the just recently enacted 8.5% additional “manufacturer markdown” (Herstellerabschlag). So, what does this newly proposed German location clause mean for pharmaceutical companies?

This blog outlines the proposed location clause and summarizes initial stakeholder reactions. We also discuss whether the proposal would really be an improvement for pharmaceutical companies or rather a bureaucratic worsening compared to the currently applicable exemption.

Continue Reading Germany Reviews a New Pharma “Location Clause” (Standortklausel) for Pricing & Reimbursement Incentives – Improvement or Worsening for the Pharmaceutical Industry?

Tomorrow, on 30 July 2026, the “GKV-Beitragssatzstabilisierungsgesetz” (GKV-BStabG) will enter into force, marking the culmination of a fast-paced and politically contentious legislative process. The reform, which has attracted significant attention, introduces a broad package of cost-containment measures across the statutory health insurance (GKV) system. Several of these specifically target pharmaceutical spending and reimbursement and are highly relevant for pharmaceutical companies.

This blog discusses the new measures with direct relevance for manufacturers and highlights the key changes made between the draft and the final law. In our earlier blog from 28 April 2026, we have discussed the key elements of the draft GKV-BStabG and its potential implications. The final law retains the overall direction of the reform but introduces several important adjustments that will impact pharmaceutical companies.

Continue Reading What does the GKV-BStabG Reform Change for Pharma Pricing & Reimbursement in Germany? And the Reforms Are Not Over: What to Expect From the New German Minister of Health and the Pharma Dialogue?

I. Background – From Pharma-Dialogue to Compulsory Price Cuts

Tomorrow, on 29 April 2026, the German Government is expected to adopt a new law to stabilize the finances of the statutory health insurances. This draft law titled “GKV-Beitragssatzstabilisierungsgesetz” (GKV-BStabG) proposes manifold cost-containment measures that would also significantly impact pharmaceutical companies. As such, the new law inter alia proposes new (tightened) pricing rules and compulsory markdown payment obligations for drug companies.

The GKV-BStabG proposes a mix of spending cuts and revenue-increasing measures projected to save the German healthcare system almost €20 billion in 2027 and more than €42 billion by 2030. The cuts in pharmaceutical spending are expected to contribute around €1.9 billion savings in 2027.

The scope of the proposed cost containment measures appears to have hit the German pharmaceutical industry a bit off-guard. Over the last months, the German Government had initiated a Pharma & MedTech Dialogue (see our earlier blog on this dialogue) that gave hope that the Government was open to listen to the industry needs. While the GKV-BStabG is not final and will likely evolve during the legislation process, it clearly shows the Government’s primary interest in short-term cost-cuttings.

This article outlines the key proposals in the GKV-BStabG affecting the pharmaceutical industry and provides an overview of the roadmap of the legislation process. The proposed reform in Germany may also interfere with other international trends like the Most-Favored-Nation (MFN) pricing developments in the US.

Continue Reading Germany plans significant cuts in drug pricing and reimbursement – How would the GKV-Beitragssatzstabilisierungsgesetz impact pharmaceutical companies?

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 Strategy.

Continue Reading German Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospects

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, the court treats promotional social media reels/videos like TV ads which leads to subsequent disclosure obligations. Third, influencers can regularly qualify as “known persons” so that the restrictions under German law for drug advertising with known/famous persons can apply. Continue reading for more details on the case and its implications for pharmaceutical companies.

Continue Reading Influencer Marketing – German court sets new Guardrails for Pharmaceutical Advertising on Social Media

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 Area for scientific research purposes under the GDPR. These guidelines may be of particular relevance for pharmaceutical, medical device, and other life sciences companies that conduct clinical research.

Continue Reading New German Guidelines on GDPR Requirements for International Transfers of Health Data in Medical Research

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 Germany.

Continue Reading Germany enacts Standard Contractual Clauses for pharmaceutical clinical trial agreements – Changes for medical device studies also on the horizon

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.

Throughout the day our speakers shared their perspectives on a range of legal, regulatory, and business trends, including the evolving regulatory frameworks in the EU and UK; information exchange in ongoing collaboration; investigations and whistleblowing; key ESG topics, and the complexity of options to acquire in pharma deals.

We have set out some of the discussion from the sessions below.

European Life Sciences – The Changing Landscape for Pharma and Biotech

Grant Castle, Head of Covington’s European Life Sciences Regulatory Practice, Peter Bogaert, Marie Doyle-Rossie and Anna Wawrzyniak kicked off with a discussion about the Changing Landscape for Pharma and Biotech.

The UK and EU both aim to deliver access to innovative and transformative medicines and foster international competitiveness in the life sciences industry. Despite the practical challenges faced by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in recent years, it has emerged as an ambitious regulator and is establishing innovative regulatory frameworks, including an international reliance scheme (see our update here), point of care manufacturing regulations, and the relaunch of the Innovative Licensing and Access Pathway (ILAP).

The EU is also pursuing a wave of legislative reform, including wide ranging revisions to the EU’s pharmaceutical legislation, the EU’s supplementary protection certificates (SPC) rules, and proposals for a compulsory licensing scheme.

There can sometimes be a tension between the UK’s and EU’s aims and the practical impacts of regulatory reform, especially in the early stages of implementation.

Continue Reading The Covington European Life Sciences Symposium 2025

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 post, we describe the specific new requirements for the processing of health and social data using cloud-computing. We will also discuss whether the new rules may impact medical research and other projects that utilize cloud-computing for processing health data.

1. Scope and Background of Sec. 393 SGB V

The new Section 393 SGB V (Social Security Code – Book V) has been enacted with the recent “Digital Act” (see our earlier blog on the Digital Act). The title of Section 393 SGB V is “Cloud-Use in the Healthcare System“. Hence, it aims to impose specific requirements for healthcare service providers, statutory health insurances and their contract data processors when they process health data and social data using cloud-computing services. According to the German legislator, the provision aims at enabling the secure use of cloud services as a “modern, generally widespread technology in the healthcare sector and to create minimum technical standards for the use of IT systems based on cloud-computing”.

The new requirements apply to data processing using cloud-computing irrespective of whether the cloud-computing is offered by an external vendor or utilizes a tool that the healthcare providers or health insurance has developed on their own.

The term “cloud-computing service” is defined in the law as “a digital service that enables on-demand management and comprehensive remote access to a scalable and elastic pool of shared computing resources, even if these resources are distributed across multiple locations” (Section 384 Sentence 1 No. 5 SGB V). This reflects the corresponding definition of cloud-computing in Article 6 (30) of the NIS2-Directive (EU) 2022/2555 on cybersecurity measures. Services that fall under this definition include, inter alia, Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS).

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 Devices

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 Parliament has now accepted a modified version of that bill. The Medical Research Act mainly amends (1) national laws for clinical trials with drugs and medical devices, (2) rules for ATMPs (3) drug pricing and reimbursement laws (AMNOG) and (4) initiates a re-organization of the regulatory agencies and ethics committees.

In this blog, we take a closer look at the much-discussed changes in the German drug pricing and reimbursement area. We will focus on two key elements:

  • The controversial new feature of “confidential reimbursement prices”; and
  • The new link between drug pricing and local clinical trials which offers pricing incentives for companies that can show that a “relevant part”  of the clinical trials for a new medicine were conducted in Germany.

We had noted in an earlier blog that the German rules for pharmaceutical pricing and reimbursement are among the most complicated legal areas in the entire world of life sciences laws. With the now coming new laws, Germany adds some additional complexity to its system.

1. Background

The discussed changes to the German drug pricing and reimbursement laws are part of the German Government’s new National Pharma Strategy that aims to enhance Germany’s attractiveness as a place for pharmaceutical research, development, and manufacturing. The Government presented an underlying strategy paper in December 2023 and the Medical Research Act is the first legislative implementation step of that strategy. For an overview of this new National Pharma Strategy, we invite you to read our previous blog on this topic.

The Medical Research Act was first presented to stakeholders in late January 2024. For a comprehensive overview of this first draft, please see our earlier earlier blog. After an initial consultation, the Government revised the draft and initiated the legislative process at the end of May 2024. Overall, the Government has deployed an unusually fast pace and was successful with its plan to get the bill through Parliament before the summer break.

Continue Reading Germany amends drug pricing and reimbursement laws with “Medical Research Act” – Drug pricing becomes intertwined with local clinical research expectations