Programme of the French Presidency of the Council of the European Union on rare diseases
France has published its programme for the Presidency of the Council of the European Union from 1 January to 30 June 2022. The programme details the priorities and guidelines of the next six months, including in the field of health. On rare diseases, the programme indicates that the French Presidency will be holding a high-level conference entitled “Ministerial Conference on Research and Care Pathways: For a European policy on rare diseases” on 28 February 2022. The aim of this high-level conference, in accord with the Presidency Trio (including France, Czech Republic and Sweden) will be to put forward recommendations to further develop European regulations concerning rare diseases. The conference will provide the occasion to define the EU roadmap for this matter and to collectively prepare to implement a European plan for rare diseases by 2030.
A conference regarding health and data was held on 2 February 2022, in Paris. Entitled "Citizenship, ethics and health data", it aimed to promote the creation of a European ethical framework for data and digital health. This framework would ensure coherence with the European foundations of citizens' rights and ethics highlighted during the COVID-19 pandemic. This conference was part of a legislative agenda:
- notably via the draft Directive/Regulation on the future European Health Data Space, which is the responsibility of the EU Commission
- the EU wants to promote its "digital model" (notably shaped by the Covid European digital certificate), aligned with its sovereignty and its values.
Entry into application of the Clinical Trials Regulation and launch of CTIS and ACT EU
On 31 January 2022, the Regulation on Clinical Trial has entered into application. This Regulation aims at improving and strengthening the conduct of clinical trials in the EU. The regulation also launches a Clinical Trials Information System (CTIS) run by the European Medicines Agency. The CTIS will help harmonise the assessment and supervision of clinical trials in EU and ensure better outcomes and safety for patients. The CTIS website is also live and contains the submitted and authorised clinical trial applications. Using the momentum created by the implementation of the Clinical Trials Regulation and the launch of the CTIS, the European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) are coming together to optimise the environment for clinical research in Europe by launching the Accelerating Clinical Trials in the EU (ACT EU) initiative. ACT EU aims to straighten the European environment for Clinical Trials by promoting the development of high quality, safe and effective medicines and maintaining the protection of the participants, data quality and transparency. The designed strategy for 2022-2023 includes a priority action for the establishment of a multi-stakeholder platform, where the rare disease community, including the ERNs, can collaborate.
Commission's draft declaration on digital rights and principles
The EU Commission has proposed to the European Parliament and Council to sign up to a declaration of rights and principles that will guide the digital transformation in the EU. The declaration includes a guide for policy makers and companies when dealing with new technologies. The draft declaration covers key rights and principles for the digital transformation, such as placing people and their rights at its centre, including controlling how their personal data are used and with whom they are shared. The European Parliament and the Council are now invited to discuss the draft declaration, and to endorse it at the highest level by this summer. Once the declaration is endorsed, a recurring series of Eurobarometer surveys will be planned on an annual basis (from 2023 onwards) to collect qualitative data, based on citizens' perception of how the digital principles enshrined in the Declaration are implemented in the EU.
