With nearly 1,000 attorneys, Arnold & Porter provides sophisticated litigation to the life sciences and financial services industries across the globe. Their lawyers cover more than 30 practice areas including corporate finance, intellectual property, litigation, real estate, tax, and bankruptcy. With over 100 years of history, the firm offers clients forward-looking and client driven services to resolve their legal needs.
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…
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…
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…
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…
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…
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…
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…
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…
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…
We recently published this Advisory for our US clients, but thought it may be a useful reminder for UK and EU teams given the number of updates in this area.
We are sure that you are aware that the European…
