On 9 July 2024, Regulation (EU) 2024/1860 amending the Medical Devices Regulation (MDR) and the In-Vitro Diagnostic Medical Devices Regulation (IVDR) was published in the Official Journal of the European Union. In particular, the new Regulation amended the provisions regarding the mandatory use of the European Medical Device Database (EUDAMED) for devices compliant with the MDR and IVDR and for legacy devices, providing for a phased implementation of the modules as they are verified and declared functional.
In a statement published on 18 June 2024, the European Medicines Agency (EMA) called on marketing authorization holders (MAHs) to adopt a Medicines Shortage Prevention Plan to reduce and prevent possible shortages and critical issues. The purpose of such a Plan is to collect information on the product, European and international marketing, supply chain vulnerabilities, measures to prevent shortages and, where appropriate, to reduce their impact on public health, and must contain appropriate measures to address shortages and mitigate their impact on patients.
Following the public hearing held on 22 May 2024, on 22 July 2024, the Italian Constitutional Court issued two judgments (judgment No. 139/2024 and judgment No. 140/2024) to decide the various appeals concerning the legitimacy of medical device payback regulation, i.e., the system under which medical device companies are required to contribute to the coverage of the NHS deficit in the years 2015-2018.
On 10 June 2024, the Member State Coordination Group on Health Technology Assessment adopted new HTA guidance on outcomes of joint clinical assessments and reporting requirements. In particular, the guidance on outcomes for clinical assessments aims at supporting both Member States’ authorities in defining the scope of such assessments and those responsible for such assessments in reporting all the elements needed by Member States to properly conduct clinical value-added analysis of health technologies at the national level.
The Italian Competition Authority (AGCM) has opened two investigations (PS12793 and PS12805) against two major luxury groups for alleged conduct in violation of Consumer Code rules in the promotion and sale of clothing items and accessories. According to the AGCM, in both cases, the companies may have made, in promoting their products, untrue ethical and social responsibility statements, particularly regarding working conditions and compliance with legal requirements at their suppliers.
The Spanish Agency for Medicines and Medical Devices (AEMPS) has implemented a new system for the payment of clinical trial fees in Spain. The Application, which is available on the AEMPS website, facilitates the payment process and eliminates payment errors that existed in the previous system.
Does your group have a German subsidiary or a German branch that pays royalties to a related party abroad under an intra-group license agreement? If so, a recent development in the German tax landscape could significantly affect you: The German Royalty Barrier Rule (RBR, Section 4j of the German Income Tax Act, (ITA)) is increasingly becoming relevant in German tax audits. Importantly, the German Tax Authorities (GTA) recently began expanding their scrutiny beyond traditional Patent/IP Box regimes.
In an article published in Compliance & Risk Journal, John Bracken and Lorren Martin explore the issue of non-financial misconduct in UK financial services firms, and how best to manage the potential risks.
In recent years, competition law enforcement has intensified in key emerging markets with significant developments in other developing countries. It is vital for companies to remain compliant with applicable antitrust laws and continue their commercially independent behavior. In this webinar, we provided the latest key antitrust and competition developments for the past year in emerging markets in Europe, Middle East and Africa and strategized for what is on the horizon.
On 20 June 2024, a new ordinance of the Austrian minister of health regarding the stockpiling of medicinal products for human use was published in the Austrian Federal Law Gazette (BGBl II 161/2024). The purpose of this ordinance is to take preventive measures avoiding supply bottlenecks for medicinal products in Austria, ensuring sufficient supply of medicinal products at all times for the Austrian population.