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 Research
Germany 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 2025
European 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 expectationsGermany prepares new National Strategy for Gene and Cell Therapies
1. Background
Gene and cell therapies are on the rise. On June 12, 2024, the German Federal Government was handed the strategy paper for a National Strategy for Gene and Cell Therapies. The paper is intended to serve as a basis for policymaking to give Germany a leading
Continue Reading Germany prepares new National Strategy for Gene and Cell TherapiesGermany again to reform drug pricing and reimbursement laws – With “confidential reimbursements prices” that impede international reference pricing
In an earlier blog, we wrote that the German regulation of pharmaceutical pricing and reimbursement is one of the most complicated legal areas in the entire world of life sciences laws. With the new draft “Medical Research Act” (Medizinforschungsgesetz or MFG) that came out in
Continue Reading Germany again to reform drug pricing and reimbursement laws – With “confidential reimbursements prices” that impede international reference pricingGermany will revise laws for clinical trials with pharmaceuticals, medical devices and companion diagnostics – Overview of the “Medical Research Act”
Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented the draft for a “Medical Research Act” (Medizinforschungsgesetz or MFG). The draft bill proposes legislative amendments in several areas that span from
Continue Reading Germany will revise laws for clinical trials with pharmaceuticals, medical devices and companion diagnostics – Overview of the “Medical Research Act”German Government pursues new Pharma Strategy with significant Reform Ideas
The German government is discussing a new Pharma Strategy with a number of reforms to improve the conditions for the pharmaceutical industry in Germany. Recently, the “Strategy Paper 4.0 – Improving the General Conditions for the Pharmaceutical Sector in Germany” (original title: Strategiepapier 4.0: Verbesserung der Rahmenbedingungen für den Pharmabereich in Deutschland – Handlungskonzepte für den Forschungs- und Produktionsstandort) became public that reportedly has the backing of the German Chancellor and the Federal Health Minister.
This strategy paper presents a range of measures to strengthen, among other things, pharmaceutical research and production in Germany and to improve the market access and pricing environment. These measures would have a significant impact for a multitude of players in the life sciences field. As such, the German government anticipates faster approvals for clinical trials, faster access to innovative medicines, more digitalization, greater supply security, a more investment-friendly environment and reduction of bureaucracy. Currently, and this is widely acknowledged by the government and most stakeholders, there is significant room for improvement in all of these areas.Continue Reading German Government pursues new Pharma Strategy with significant Reform Ideas