Covington & Burling LLP (LexBlog Germany)
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German Government Proposes to Amend Federal Data Protection Act
On February 7, 2024, the German Federal Cabinet approved a draft law (“the Draft Law”) amending the Federal Data Protection Act (“BDSG”). The Draft Law will now go to the Bundesrat (the legislative body that represents the sixteen Länder (federated states) of Germany at the federal level ) for its opinion and then to the...
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Germany 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 January 2024, the German government plans to add some additional...
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Germany 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 clinical trials, GMP issues for ATMPs up to pharmaceutical...
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German Data Protection Authorities Publish Paper on Cloud-Based Digital Health Applications
Digital health apps are increasingly used in practice. They raise various questions under regulatory and data protection and data security laws. On November 6, 2023, the German Conference of the Independent Data Protection Supervisory Authorities (Datenschutzkonferenz, DSK), a national body which brings together Germany’s federal and regional data protection authorities, issued a paper about the..
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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...
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Germany plans significant hospital reform with broad impact on life sciences companies
Germany’s hospital system is reported to be of high quality but is also very expensive by international standards. Hospitals and healthcare payers such as health insurances are exposed to increasing economic constraints. One particular point of criticism is, for example, the current system of Diagnosis Related Group (DRG)-based fees. Patient treatments are compensated based on...
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Germany plans significant hospital reform with broad impact on life sciences companies
Germany’s hospital system is reported to be of high quality but is also very expensive by international standards. Hospitals and healthcare payers such as health insurances are exposed to increasing economic constraints. One particular point of criticism is, for example, the current system of Diagnosis Related Group (DRG)-based fees. Patient treatments are compensated based on...
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Germany to enact new law with significant changes to drug pricing and reimbursement rules
In an earlier blog, we noted that the German drug pricing and reimbursement laws are among the most complicated legal areas in the entire field of life sciences law. Now, these laws and the respective German market access rules are becoming more complicated. A new law will come into effect in the next few weeks....
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Germany plans Health Data Use Act and stricter pricing & reimbursement rules for Digital Health Apps
At the end of June 2023, a draft Health Data Use Act (“GDNG”) and a draft Digital Act (“DigiG”) of the German Federal Ministry of Health have become public. These drafts are part of the German government’s digitalization strategy for the health sector. The Health Data Use Act plans to grant industry companies an access...
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COSCO FDI Review: Germany partially prohibits Chinese investment in a Hamburg container terminal – Spotlight on minority investments
On October 26, 2022, the German government permitted (with conditions) an investment by Chinese state-owned COSCO Shipping Group (“COSCO”) in one of Hamburg’s four shipping container terminals. Pursuant to foreign direct investment (“FDI”) laws, the German Ministry for Economic Affairs and Climate Action (Bundesministerium für Wirtschaft und Klimaschutz, “BMWK”) had been notified of the proposed..
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COSCO FDI Review: Germany partially prohibits Chinese investment in a Hamburg container terminal – Spotlight on minority investments
On October 26, 2022, the German government permitted (with conditions) an investment by Chinese state-owned COSCO Shipping Group (“COSCO”) in one of Hamburg’s four shipping container terminals. Pursuant to foreign direct investment (“FDI”) laws, the German Ministry for Economic Affairs and Climate Action (Bundesministerium für Wirtschaft und Klimaschutz, “BMWK”) had been notified of the proposed...
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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...
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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...
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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...
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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...
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German Supervisory Authorities Probe Data Transfers
On June 1, 2021, several German supervisory authorities (“SAs”) announced the launch of a “nationwide investigation” into German companies transferring personal data outside of the European Economic Area. Currently, there is no official list of all the SAs participating in the investigation, but at least 8 of Germany’s 16 regional SAs have announced their intention...
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Technology Sector under Closer Scrutiny – German Government Significantly Extends the Scope of Foreign Direct Investment Review in Germany
On 27 April 2021 the German government adopted the 17th amendment (“Amendment”) to the Foreign Trade and Payments Ordinance (“AWV”) aligning the German Foreign Direct Investments (“FDI”) regime with the EU Screening Regulation. The Amendment significantly extends the number of sectors and target activities that require mandatory notification in Germany and brings significant procedural changes...
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German Court Overturns GDPR Fine, Raises Legal Questions About Fines Against Companies
On February 18, 2021, the District Court of Berlin overturned a €14.5 million fine that had been imposed on German real estate company Deutsche Wohnen SE. The Court held that the fine – which was issued by the Berlin Supervisory Authority (“SA”) and had been the second highest fine in Germany so far under the...
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A New Day for GDPR Damages Claims in Germany?
Until now, damages claims awarded by German courts pursuant to Article 82 of the General Data Protection Regulation (“GDPR”) – in particular, claims for non-material damages – have been relatively low. This restrained approach thus far has been predicated primarily on the position that German law requires a serious violation of personality rights to justify...
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German Supervisory Authorities Plan to Circulate Questionnaires on Personal Data Transfers in Wake of Schrems II Decision
On February 3, 2021, the Conference of the Supervisory Authorities (“SAs”) of Germany (known as the Datenschutzkonferenz or “DSK”) published minutes from its meetings held in November 2020 (available here, in German). The minutes include discussions about how the German SAs plan to enforce the recent Schrems II ruling of the Court of Justice of...
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Google Knowledge Panels Challenged In Germany
On 17 December 2020, the media authority of the German federal state of Schleswig-Holstein initiated legal proceedings against Google Ireland Ltd. under Germany’s new Interstate Media Treaty (Medienstaatsvertrag – “MStV”, downloadable here, German only). The authority (Landesmedienanstalt) is investigating whether Google’s treatment of information from a “National Health Portal” offered by the...
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Germany Publishes New Draft Rules for Cookies and Similar Technologies
On January 12, 2021, the German Ministry for the Economy and Energy released a new draft Law on Data Protection and the Protection of Privacy in Telecommunications and Telemedia (“TTDSG” or “draft law”). If enacted, the draft law will replace the existing data protection and privacy provisions of Germany’s Telemedia Act and Telecommunications Act (“Telemedia...
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Germany: The wind of change – Substantial competition law amendments
On 19 January 2021, the 10th amendment of the German Act against Restraints of Competition (“ARC”), the so-called ARC Digitisation Act (the “ARC-DA”) entered into force. The ARC-DA brings far-reaching amendments to German competition law, containing inter alia the introduction of a new framework to intervene in the digital sector and a revision of the...
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German Federal Government Passes Draft Law Amending Germany’s Information Technology Laws
On December 16, 2020, the German Federal Government passed a draft law that substantially amends some of Germany’s information technology laws (“IT laws”). These amendments aim to adapt the current legal framework to the increasing digitalization of products and services, the proliferation of IoT products, and the appearance of new cybersecurity threats. The draft law...
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German Federal Government Passed a Draft Law Amending Germany’s Information Technology Laws
On December 16, 2020, the German Federal Government passed a draft law that substantially amends some of Germany’s information technology laws (“IT laws”). These amendments aim to adapt the current legal framework to the increasing digitalization of products and services, the proliferation of IoT products, and the appearance of new cybersecurity threats. The draft law...
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Draft Law for a New German Restructuring Framework
So far, restructurings in Germany have been implemented either by way of consensual pre-insolvency solutions or formal and comprehensive insolvency proceedings with court oversight. The EU Restructuring Directive (EU) 2019/1023 of 20 June 2019 paved the way for the implementation of pre-insolvency restructuring proceedings in all EU member states that allow debtors to restructure effectively at...
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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 bill is...
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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 bill is...
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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 bill is...
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German Federal Agencies Publish Privacy and IT Security Requirements for Digital Health Applications
On April 21, 2020, the Regulation on the Requirements and Reimbursement Process for Digital Health Applications (Digitale Gesundheitsanwendungen-Verordnung or „DiGAV“, available here) entered into force in Germany. Among other provisions, the DiGAV includes specific IT security and privacy requirements. Shortly after the law took effect, Germany’s Federal Medicines and Medical Devices Agency (“B