The latest draft pharmaceutical legislation published by the European Commission (“Commission”) is set to shake up the regulatory exclusivity protections available to innovator pharmaceutical companies operating in the EU (as discussed in further in our previous blog). As part of these developments, the Commission has clarified the
Continue Reading EU Pharma Legislation Review Series: Bolar Exemption under Patent Rights
The EU’s latest draft pharmaceutical legislation contains some interesting developments on transparency matters, both in relation to access to documents and transparency around the funding of research and development of medicinal products.
Disclosure of documents in response to an
Continue Reading EU Pharma Legislation Review Series: Access to Documents and Transparency of R&D Funding
The European Commission has proposed specific measures to increase the supervision and monitoring of the use of antimicrobial medicinal products (or “antimicrobials”), with the aim to counter the spread of antimicrobial resistance (“AMR”). At the same time, the measures are also aimed at promoting and incentivizing the development of new
Continue Reading EU Pharma Legislation Review Series: AMR and Transferable Exclusivity Vouchers
The existing EU pharmaceutical legislation provides for a number of specific exemptions from the marketing authorisation requirement, including products supplied on a named patient or compassionate use bases; products compounded and dispensed in pharmacies (magistral and officinal formulations) and also for products necessary to respond to public health emergencies. Given
Continue Reading EU Pharma Legislation Review Series: Pharmacy and Hospital Exemptions
As part of its policy goal of promoting innovation, the Commission’s proposed Regulation creates the concept of a “regulatory sandbox.” If the concept survives the legislative process, the sandbox will be a structured, regulated and time-limited environment in which innovative technologies, products, services or approaches might be tested in a
Continue Reading EU Pharma Legislation Review Series: The Regulatory Sandbox – A Safe Space for Innovators to Grow
On 26 April 2023, the European Commission published its long awaited proposal to revise the EU’s general pharmaceutical legislation. As expected, the Commission’s proposal represents a significant overhaul of the EU medicine rules. Not least the incorporation of the EU’s amended paediatric and orphan
Continue Reading EU Pharma Legislation Review Series: Paediatric Medicines
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
The European Commission (“Commission”) intends to change the rules on regulatory data protection (“RDP”) of medicinal products. The Commission stated in its Impact Assessment for the revised pharmaceutical legislation that it wants to strike a balance between “providing attractive incentives for innovation and supporting timely patient access to medicinal
Continue Reading EU Pharma Legislation Review Series: Regulatory Data Protection
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 third episode of Covington’s Life Sciences Audiocast, where Grant Castle, Stefanie Doebler, and Raj Gathani discuss social media challenges for pharma companies in Europe and the U.S.