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Sophie Herold

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Sophie Herold is an associate in Covington’s Frankfurt office and a member of our Food, Drug and Device Practice. She advises clients on a broad range of regulatory and compliance matters.

Sophie counsels clients on all aspects of pharmaceutical and medical device regulation, clinical research, therapeutic product advertising, data protection and other regulatory issues over the entire product lifecycle. She also assists clients with legal, contractual and privacy issues that affect digital health products and services, including medical apps and AI-based devices.

Sophie's practice includes advisory work. She also represents clients before authorities and in court.

 

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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.

According to the explanatory memorandum of the GKV-FinStG, the cost increase is particularly due to the disproportionate increase of expenditures for medicinal products. Correspondingly, a number of new rules specifically target the pricing and reimbursement of pharmaceuticals. Key elements of the GKV-FinStG that apply to the pharmaceutical industry include the following measures:…

Continue Reading Germany significantly tightens Drug Pricing and Reimbursement Laws

In 2021, European lawmakers and agencies issued a number of proposals to regulate artificial intelligence (“AI”), the Internet of Things (“IoT”), connected and automated vehicles (“CAV”), and data privacy, as well as reports and funding programs to pursue the developments in these emerging areas.  From the adoption of more stringent cybersecurity standards for IoT devices to the deployment of standards-based autonomous vehicles, federal lawmakers and agencies have also promulgated new rules and guidance to promote consumer awareness and safety. While our team tracks developments across EMEA, this roundup focuses on a summary of the key developments in Europe in 2021 and what is likely to happen in 2022.

Part I: Internet of Things

With digital policy being a core priority for the current European Commission, the EU has pursued a range of initiatives in the area of IoT.  These developments tend to be interspersed throughout a range of policy and legislative decisions, which are highlighted below.

Connecting Europe Facility and IoT Funding

In July 2021, the European Parliament and Council of the EU adopted a regulation establishing the Connecting Europe Facility (€33.7 billion for 2021-2027) to accelerate investment in trans-European networks while respecting technological neutrality.  In particular, the regulation noted that the viability of “Internet of Things” services will require uninterrupted cross-border coverage with 5G systems, to enable users and objects to remain connected while on the move.  Given that 5G deployment in Europe is still sparse, road corridors and train connections are expected to be key areas for the first phase of new applications in the area of connected mobility and therefore constitute vital cross-border projects for funding under the Connecting Europe Facility.  The Parliament had also called earlier for “stable and adequate funding” for investments in AI and IoT, as well as for building transport and ICT infrastructure for intelligent transport systems (ITS), to ensure the success of the EU’s data economy.

In May 2021, the Council adopted a decision establishing a specific research funding programme (€83.4 billion for 2021-2027) under Horizon Europe.  In specifying the EU’s priorities, the decision identified the importance of IoT in health care, cybersecurity, key digital technologies including quantum technologies, next generation Internet, space, and satellite communications.
Continue Reading EMEA IoT & CAV Legislative and Regulatory Roundup 2021 and Forecast 2022