The Clinical Trials Regulation entered into application on 31 January 2022. It praises itself to ensure a favourable environment for clinical research on a large scale in the EU, with high standards of public transparency and safety for clinical trial participants.
On 31 January 2022, the Regulation repealed the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States, which regulated clinical trials in the EU.
Although the Regulation entered into force on 16 June 2014, the timing of its application depended on the development of a functional EU clinical trials portal and database, verified by the European Medicines Agency (EMA) Management Board.
Harmonisation and centralised procedure
The Regulation improves harmonisation of the rules for conducting clinical trials throughout the EU, accompanied by an authorisation procedure based on a single submission via a single EU portal CTIS, an assessment procedure leading to a single decision, hence, a more efficient clinical trial submission and assessment process. The Regulation also introduces a new category of studies: the low-intervention clinical studies with simplified risk-proportional monitoring and safety reporting as estimated by the trial sponsor. The centralised procedure will significantly make it easier for pharmaceutical companies to conduct multinational clinical trials.
Transparency and disclosure obligations
On the other hand, the Regulation sets forth disclosure requirements. For the industry, such transparency standards impose a risk of reduced IP protection, as outlined in our MIP article on the subject. Sponsors of all clinical trials will have to submit summaries of the clinical trial results within one year from the end of the clinical trial in all Member States concerned, which will then be made publicly available. To compare – under EMA Policy 0070, clinical data (clinical overview, clinical summaries and clinical study reports) and the anonymisation report were published. Under the Regulation, all clinical trial-related information generated during the life cycle of a clinical trial (e.g. protocol, assessment and decision on trial conduct, summary of trial results, study reports, inspections) are published.
The implications of the new requirements should be considered by companies in the pharmaceuticals and biotech sectors when looking for the ‘ideal’ times in the development process for filing patent applications. Whilst the relevance of any mandatory disclosures (and whether such disclosures might render an invention not patentable) will depend on the context, some technical background is always part of the disclosure. Access to the information can only be restricted to protect personal data; commercially confidential information (unless there is an overriding public interest in disclosure); confidential communication among member states regarding their assessment; or clinical trial supervision by member states.
Time schedule for applicability
- 31 January 2022 to 31 January 2023: sponsors may submit clinical trials under the legal framework of the Regulation but must not do so.
- As of 31 January 2023: all clinical trial applications are subject to the Regulation. However, trials approved under the repealed Directive before 31 January 2023 can continue to be regulated under the Directive until 31 January 2025.
- 31 January 2025 onwards: all clinical trials subject to the Regulation