On 3 February, the European Medicines Agency, the Heads of Medicines Agencies and the European Commission launched a public consultation on the establishment of a multi-stakeholder platform to improve clinical trials in the European Union.
On 19 January 2023, the Court of Justice of the European Union specified that Art. 2(2) of Directive 2001/83/EC, pursuant to which, in case of doubt on the classification of a product as a medicine or a medical device, the provisions on medicinal products shall apply, covers both “medicinal products by function” (i.e., substances exerting pharmacological, immunological or metabolic action) and “medicinal products by presentation” (i.e., substances presented as having properties for treating or preventing disease).
2023 is gearing up to be an interesting year for those in the life sciences sector, with upcoming reforms to the established regulatory and IP landscapes that will impact innovator strategies in R&D, commercialization, and patent enforcement. While reforms are currently under draft by the European Commission, the key areas of anticipated change are highlighted in a newly published article in The Life Sciences Lawyer.
On 19 December 2022, the Recommendation Paper on Decentralized Elements in Clinical Trials was published on the website of the European Medicines Agency (EMA), with the aim to facilitate the conduct of decentralized clinical trials in the EU, while safeguarding the rights and well-being of participants and the robustness and reliability of the data collected.
Starting from 31 January 2023, the Clinical Trial Information System, provided for in Art. 80 of Regulation EU 536/2014, will become the single point of access for the submission, authorization and supervision of clinical trial applications in the EU and the European Economic Area countries. The single portal was launched on 31 January 2022, initiating the one-year transition period during which sponsors could choose whether to submit a clinical trial application according to the Clinical Trials Directive or through the single portal. As of 31 January 2023, submission of clinical trial applications through the single portal will become mandatory.
Following concerns expressed about the capacity of Notified Bodies to certify medical devices in accordance with the EU Medical Device Regulation within the transitional periods provided therein, on 6 January 2023 the European Commission adopted a proposal to extend the transitional periods under Article 120(3) of the MDR.
On 22 December 2022, the Court of Justice of the European Union ruled on Case C-530/20 concerning the interpretation of Articles 86, 87, and 90 of Directive 2001/83/EC on the advertising of medicinal products for human use.
Requests for preliminary rulings made by courts of EU Member States have always been dealt with by the European Court of Justice. Over the years the CJEU handled numerous customs cases on tariff classification, customs valuation, origin and procedural customs law. Due to capacity restraints at the CJEU, an alternative distribution of jurisdiction between the CJEU and the lower EU General Court is proposed by the CJEU. More specifically, the CJEU requests that the EU Commission propose a change to the Treaty of the Functioning of the EU, such that preliminary ruling requests for, amongst others, VAT and customs matters, are to be submitted to the General Court.
On 8 December 2022, the Court of Justice of the EU rendered its first judgment with respect to the EU directive n° 2018/822 of 25 May 2018, i.e., DAC 6. The CJEU ruled that the legal obligation for a lawyer-intermediary, subject to legal professional privilege, to inform other intermediaries is invalid in light of the right to privacy, as protected by Article 7 of the Charter of Fundamental Rights of the European Union.
On 28 November 2022, the EU institutions formally adopted a Regulation on foreign subsidies distorting the internal market. The new rules will have a major impact on M&A transactions and will significantly increase the administrative burden facing many EU and non-EU companies doing business in Europe. The Regulation is part of a broader effort to protect the EU’s geopolitical “open strategic autonomy”. It aims to level the playing field by allowing the European Commission to intervene where foreign subsidies granted directly or indirectly by third countries threaten to distort the EU internal market.