On 14 February 2023, the German Federal Ministry of Health (BMG) has presented the new draft “Act to Combat Supply Shortages of Off-Patent Medicines and to Improve the Supply of Paediatric Medicines” (Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz or “ALBVVG”). Some commentators also refer to the new law as the “Generics Act” but
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 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)
CJEU Rules on the Advertising of “Unspecified Medicinal Products” in the EU
On 22 December 2022, the Court of Justice of the European Union (CJEU) — sitting in Grand Chamber — published its judgement in case C-530, Euroaptieka. The judgement adds further commentary to the meaning of “advertising medicinal products” in the EU and the competencies of EU Member States to restrict drug advertising activities. The judgement has particular implications for advertising “unspecified medicinal products”. No doubt, this judgement will be of interest to pharmaceutical companies and pharmacies looking at the communications activities they carry out in the EU and the risks entailed.…
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European Commission proposes significant changes to transition timelines of the Medical Device Regulation and IVD Regulation
Further to our discussion on the European Commission’s proposal to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the Commission has adopted a formal proposal for a legislative amendment of the MDR and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and published a press release, Q&A and factsheet on the proposal. The proposal does not introduce any substantive changes to the broader MDR but focuses on amending the transitional provisions in the MDR.
The proposed changes to the MDR transition provisions aim to address concerns regarding Notified Body capacity and the significant number of medical devices yet to transition from the former Directives to the MDR. This situation is currently threatening the availability of such devices within the EU market.…
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Germany significantly tightens Drug Pricing and Reimbursement Laws
The German regulation of pricing and reimbursement of pharmaceuticals is probably one of the most complicated legal areas in the entire world of life sciences laws. Now, the German government is adding another layer of complexity to the existing rules.
On 20 October 2022, the German Parliament has accepted the draft Act for the Financial Stabilization of the German Statutory Health Insurance System („GKV-FinStG“). The new act was subject to month-long controversial discussions within and outside of the Parliament and affected stakeholders. This was due to the fact that the new rules will affect almost all players within the healthcare system, including the health insurers, doctors, hospitals, pharmacies and, especially, the pharmaceutical industry. The new law encompasses significant cost-containment measures as the German healthcare system faces increased costs while, at the same time, the system suffers from a reduced inflow of funds.…
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The New Italian Sunshine Act: What Companies Should Know And How To Get Ready
On 31 May 2022, the Italian Parliament approved Law 62/2022, also known as the Sunshine Act. The Sunshine Act entered into force on 26 June 2022. However, it will become fully enforceable once the Ministry of Health sets up the Public Register where companies will have to disclose their data and issues the necessary implementing acts. This means that realistically the new transparency system will not be operational before 2023. Nonetheless, it is critical that companies operating in Italy make sure that they are ready when the time comes. Here, we outline some of the key features of the new Sunshine Act and the steps that companies could take in preparation.…
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New German Government plans significant changes with Impact on the Healthcare, Life Sciences and Food Sector
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.…
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German court extends legal redress options for pharma companies in the drug pricing and reimbursement system
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.…
Germany Prepares New Law for Patient Data Protection and Increased Digitalisation in Healthcare and for “Data Donations” for Research Purposes
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…
German government has started enforcement of the Nagoya Protocol and reviews compliance of pharmaceutical companies
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.
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German court allows pharma company public promotional statements about Rx-drug to counter a “shitstorm” – a trend also for the rest of the EU?
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?…
Continue Reading German court allows pharma company public promotional statements about Rx-drug to counter a “shitstorm” – a trend also for the rest of the EU?