On 26 April 2023, the European Commission published its long awaited proposal to revise the EU pharmaceutical legislation. The proposal includes a new draft Regulation, which will repeal Regulation (EC) No 726/2004, the Orphan Medicines Regulation 141/2000 and the Paediatric Regulation 1901/2006.
As expected, the draft Regulation significantly shakes
Continue Reading EU Pharma Legislation Review Series: Orphan Medicines
This is the first in a series of Covington blogs about the EU’s proposals to amend the current pharmaceutical regulatory framework, which were released today (see here). It introduces some of the key aims and themes and invites readers to read more in-depth summaries as we release them.
Continue Reading EU Pharma Legislation Review Series: The EU’s proposals to amend its pharmaceutical laws released todayTune into the first episode of Covington’s Talking Life Sciences Audiocast, where Grant Castle, Peter Bogaert and Marie Doyle-Rossi discuss key developments and trends in the pharma sector. Our speakers review the major issues of 2022, including the Clinical Trials Regulation, the Health Technology Assessment Regulation, European Health
Continue Reading EU Talking Life Sciences Audiocast: Episode 1 – Key Developments in the Pharma Sector: A Review of 2022 and Insights for 2023On 1 July 2021, the new French rules on early access to unauthorized medicinal products and off-label use of authorized medicinal products entered into force. The rules were introduced by the Social Security Financing Law for 2021 (LOI n° 2020-1576 du 14 décembre 2020 de financement de la sécurité sociale pour 2021 or “LFSS 2021”, available here). The reform seeks to simplify existing rules, make early access and off-label use more predictable for all users, and ensure the sustainability of these programs for the public health insurance system. In this blog, we present an overview of the new rules.
Continue Reading New Early Access and Off-Label Use Rules in France
The EU pharmaceutical industry landscape is in significant flux. There are many pressures to provide new therapies and to make them available more early and for as many qualifying patients as possible. In that context, the industry model and the role of exclusivity rights as a tool to stimulate innovation are being discussed. At the same time, discovering and developing new products is more complex and requires a collaborative effort. This happens against the background of new rules on medical devices and the protection of personal data, which are, for instance, relevant in assessing clinical effectiveness and relying on real world evidence.
Three members of the Covington European Life Sciences team will be speaking on these topics at the EU Pharmaceutical Law Forum being held in Brussels on 16-18th May.
Continue Reading Exploring the EU Horizon for Pharma
A new food labeling regulation, which revamps the entire EU regulatory framework on food information, including labeling, starts to apply from this Saturday, 13 December 2014. Regulation 1169/2011 on the provision of food information to consumers (FIC Regulation) consolidates a number of EU food laws and establishes some new principles to provide better consumer protection in relation to food information whilst ensuring smooth functioning of the EU market.
The FIC Regulation governs all food information provided to the consumer through any commercial communication, including in particular labeling and websites. The Regulation affects all food business operators along the whole supply chain as it changes the existing provisions and introduces new ones:
Continue Reading Comprehensive New EU Food Labeling Regulation Goes Into Effect December 13
Article originally published in the FDLI Update (January/February 2013)
“Being able to use innovative products at the earliest possible time – and in Europe we deliver innovation about three years before our American counterparts with their own system – is a benefit to patients that we cannot put aside.” This
Continue Reading Innovation vs. Safety: The New Proposed Rules for Medical Devices in the European Union
Originally published as Covington E-Alert on December 10, 2012
On 6 December 2012, the EU Court of Justice dismissed AstraZeneca’s appeal of the General Court’s judgment in AstraZeneca v Commission. The Court of Justice affirmed the reasoning and holdings of the General Court and rejected all of AstraZeneca’s arguments, including
Continue Reading Judgment of the Court of Justice in AstraZeneca v Commission
Article originally published in Covington E-Alert, 10 December 2012
On 6 December 2012, the EU Court of Justice dismissed AstraZeneca’s appeal of the General Court’s judgment in AstraZeneca v Commission. The Court of Justice affirmed the reasoning and holdings of the General Court and rejected all of AstraZeneca’s arguments, including
Continue Reading Judgment of the Court of Justice in AstraZeneca v. Commission
Originally published as Covington E-Alert on October 3, 2012
French Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products has been inserted into the Public Health Code (‘Code de la santé publique’ or CSP). It includes new advertising rules
Continue Reading France – Prior Approval for Advertising for Medical Devices and IVDs