On 21 May 2025, the European Commission published its Proposal for a Regulation (“Proposal”), amending several existing regulations, including the General Data Protection Regulation (EU) 2016/67 (“GDPR”), to simplify obligations for small and medium-sized enterprises (“SMEs”) and extend certain mitigating
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Arnold & Porter Kaye Scholer LLP Blogs
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An update from the European Court of Justice on discount campaigns run by mail order pharmacies
Do discount campaigns on prescription-only medicines (POMs) run by mail order pharmacies lure patients into consuming medicinal products? The European Court of Justice (CJEU) in the case of Apothekerkammer Nordrhein (C-517/23) has held that they do not.
Following on from…
EU Biotech Act– what we know so far
The current EU regulatory landscape for biotechnology is widely viewed as insufficient to be able to exploit the full potential of such technologies. Regulatory hurdles exist at EU and Member State level, and this is thought to have driven investment…
Virtual and Digital Health Digest – April 2025
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during March and early April 2025 from the United States, United Kingdom, and…
Recent updates on reform of UK clinical trial landscape
On 11 April 2025, the MHRA announced that the much anticipated changes to the clinical trial rules in the UK, the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 (the new Regulations), have been signed into law.
In January, we…
European Data Protection Board publishes study on secondary use of personal health data for scientific research
The European Data Protection Body (EDPB) has published a study on how personal health data is and/or can be reused for scientific research in the EU under the EU General Data Protection Regulation (GDPR). The study highlights the related practical…
LDTs Are Not Devices Under the FDCA: Eastern District of Texas Vacates FDA Final Rule on LDTs
In our blog in December 2024, we provided an update on the U.S. Food and Drug Administration (FDA) final rule, revising the regulatory definition of an in vitro diagnostic (IVD) to explicitly capture IVDs manufactured by laboratories (known as…
ABPI calls for changes to “unsustainable” medicines pricing scheme
The Association of the British Pharmaceutical Industry (ABPI) has published a report (the Report) setting out its members’ concerns regarding the operation of the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG).
VPAG is an agreement between…
UK Public Procurement Landscape Transformed: What Does It Mean for Medicines?
By Jackie Mulryne & Heba Jalil
On February 24, 2025, new rules came into force in the UK transforming the public procurement landscape. The new regime aims to provide a simplified and flexible framework for contracting authorities when conducting procurement processes, including the purchase of medicinal…
Virtual and Digital Health Digest – March 2025
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during February and early March 2025 from the United States, United Kingdom, and…