Following the federal election in September 2021, Germany will soon be led by a new three-party coalition, the so-called “traffic light coalition”, composed of the Social Democratic Party (SPD), the Liberal Democrats (FDP) and the Green Party (Die Grünen). This new federal government led by the new chancellor Olaf Scholz from the Social Democrats will replace the Merkel administration and will be in office for four years. On November 24, 2021, the new coalition has presented their coalition agreement with their plans for the next 4 years. The agreement needs to be approved by the respective party committees and it is expected that all three parties will approve it.
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 2021).
Adem helps clients on a wide range of EU and German law issues, including regulatory, compliance, 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:
- "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)
- "Adem Koyuncu is not only a lawyer but also a doctor and has worked in industry. He knows the perspectives that also move in-house lawyers.” (Legal 500 2022)
- “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?!," BVMed, Webinar (3/24/2023)
- "Data Protection Requirements and Open Issues in the Pharma Sector – Status quo," Speech at conference, 26. Marburger Gespräche zum Pharmarecht, Marburg (3/16/2023)
- "Vendor Oversight & Vendor (Quality) Management in the Pharma Industry," FORUM-Institut, Online Seminar (4/19/2023)
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.…
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…
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 October 2014.
The Nagoya Protocol imposes a complex set of multi-jurisdictional compliance obligations on businesses active in the pharmaceutical, food, cosmetics and other life science sectors. It now has more than 100 contracting parties, including the EU. The key legal source in the EU is Regulation (EU) No. 511/2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union.
Continue Reading German government has started enforcement of the Nagoya Protocol and reviews compliance of pharmaceutical companies
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 be the case even if no drug is mentioned.
But what should a drug company do if false statements about its product are distributed? What is allowed in case of a so-called shitstorm? What can the company do to counter negative public statements about its drugs by HTA bodies or other institutions of the healthcare system?…
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 of the Federal Council (Bundesrat) on 30 November 2016 and it has become clear that the Federal Council will not object to it in its final deliberations later this month. Therefore, the new law will likely become effective at the beginning of 2017.
The new law especially amends the existing clinical trial rules so that German law will comply with the new Clinical Trials Regulation (EU) No 536/2014. The amendments particularly affect the approval procedure for new studies and the competencies of the ethics committees and regulatory authorities. While currently, two full stand-alone approvals for a study are required (i.e., from the ethics committee and the competent authority), under the new law, certain parts of the ethics committee’s opinion may be overruled by the authority. In addition, a new federal ethics committee can be established by the regulatory authorities which would additionally lead to significant changes in the procedure.
Continue Reading Another round of upcoming amendments to the medicines laws in Germany – Clinical Trials, Advertising, Biologics and more…
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. 536/2014). For instance, several provisions of the German Drug Act related to clinical trials (e.g., definitions) will then refer to the Clinical Trials Regulation or are amended accordingly. The German Ordinance on Good Clinical Practice (GCP-Verordnung) will cease to be in force. Furthermore, some amendments, particularly those that refer to the informed consent of study subjects, will go beyond the scope of the Clinical Trials Regulation.
Continue Reading Comprehensive Amendments of German Drug Laws upcoming
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 the CJEU, it is now upon the CJEU to provide further clarity on the responsibilities and liability scheme for medical devices in the EU. The key questions relate to the responsibility of the Notified Bodies which are in charge of granting the CE mark which again is required to place medical devices on the EU market. The CJEU’s answer will have an impact on the work of Notified Bodies and will be relevant for the liability of medical device manufacturers in the EU.
In the current case, the plaintiff has sued the German Notified Body TÜV Rheinland for damages as she had been implanted a PIP breast implant. PIP stands for the company name Poly Implant Prothèse which, for years, was illegally selling breast implants containing industrial silicone instead of the medical silicone for which they had received the CE mark. The founder of PIP and several former executives and managers were convicted of fraud and sentenced to jail by a court in France.
Continue Reading European Court to Clarify Responsibilities and Liability for Medical Devices
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 sanctions active and passive bribery of a wide range of healthcare professionals – not only of medical doctors.
The envisioned new § 299a StGB would significantly sharpen the German anti-corruption laws as far as interactions between life sciences companies with medical doctors and other healthcare professionals are concerned. The criminal culpability would apply to both the healthcare professional that accepts a bribe and the company representative that pays a bribe.
Continue Reading Germany Headed to Stricter Criminal Laws Against “Corruption In The Healthcare Sector”