On April 18, 2023, the European Commission published its proposal for an EU Cyber Solidarity Act (“CSA”). It aims to strengthen incident detection, situational awareness, and response capabilities, and to ensure that entities providing services critical for day-to-day life can access expert support to manage their cyber risk and respond to incidents. Specifically, the CSA
March 2023 Developments Under President Biden’s Cybersecurity Executive Order
This is the twenty-third in a series of Covington blogs on implementation of Executive Order 14028, “Improving the Nation’s Cybersecurity,” issued by President Biden on May 12, 2021 (the “Cyber EO”). The first blog summarized the Cyber EO’s key provisions and timelines, and the subsequent blogs described the actions taken by various government agencies to
EU Pharma Legislation Review Series: Access to Documents and Transparency of R&D Funding
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.
1. Draft Regulation – Further Clarity Regarding Public Access to Documents
Disclosure of documents in response to an access request under the EU
UK ICO Updates Guidance on Artificial Intelligence and Data Protection
On 29 March 2023, the UK Information Commissioner’s Office (“ICO”) published updated Guidance on AI and data protection (the “Guidance”) following “requests from UK industry to clarify requirements for fairness in AI”. AI has been a strategic priority for the ICO for several years. In 2020, the ICO published its first set of guidance on
Congressional Investigations and the Rules of the 118th Congress
At the start of a new Congress, the House and Senate, and their committees, adopt internal rules that govern their operations, including rules that affect congressional investigations. These rules are often revised from Congress to Congress. To assist our clients responding to congressional investigations, this alert summarizes the rules for the 118th Congress of the
EU Pharma Legislation Review Series: GMO Medicines
“Delays in clinical trials result in delays of potentially life-saving treatments”
The European Commission is streamlining the rules for clinical trials of medicines consisting of, or containing genetically modified organisms (“GMOs”). Under the current EU GMO framework, getting authorization for clinical trials of GMO medicines is a long and costly process. Industry groups have vocally
EU General Court Clarifies When Pseudonymized Data is Considered Personal Data
On April 26, 2023, the General Court of the European Union issued its judgment in Case T-557/20, SRB v EDPS.
The Court held that pseudonymized data transmitted to a data recipient will not be considered personal data if the data recipient does not have the means to re-identify the data subjects. The Court also clarified
EU Pharma Legislation Review Series: Addressing Environmental Risks
Pharmaceutical companies take note: the EU plans to refuse marketing authorizations for environmentally-unfriendly medicines.
The EU has published a package of revisions to the bloc’s common pharmaceutical regime. Many revisions aim to reduce the environmental impact of human medicinal products. The key environmental measures include:
- Pre-authorization — Environment-related refusals: The European authorities will be
EU Pharma Legislation Review Series: Pharmacy and Hospital Exemptions
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 that a key policy goal
EU Pharma Legislation Review Series: AMR and Transferable Exclusivity Vouchers
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 priority antimicrobials through the use