Simplifying Health Research and Taking Innovation into Account: What Changes Should Be Made to Articles 22 and 23 of the Simplification of Economic Life Bill?
The bill to simplify economic life is currently being debated by the National Assembly. Among the many articles under debate, articles 22 and 23 deal with major issues: the simplification of health research procedures and changes to the role of the CNIL in relation to innovation. Here's a look at the changes and the debates surrounding them.
🔹 Article 22: Simplification of Health Research Procedures
Article 22 aims to adapt the legislative framework for medical research by facilitating certain administrative procedures and taking into account the new challenges of clinical research.
What are the main changes?
- Expansion of research sites: Research involving patients will be able to be carried out in new locations, in particular patients' homes or local sites that facilitate their participation.
- Facilitating the re-use of health data: It will be simpler to use data collected during previous studies, provided that patients are clearly informed and their right to object is respected.
- Simplification of procedures for importing and exporting biological materials: Research sponsors will find it easier to import and export samples of blood, organs or other human tissues for scientific purposes.
- Clarification of the rules on the use of human body parts in research: Procedures will be harmonised to ensure compliance with European standards and facilitate clinical research.
- Adaptation of regulations for overseas territories: Certain provisions will be specifically adapted to local needs and constraints.
⚖️ A Debate on Health Data Protection
Article 22 has been criticised, particularly by some MEPs who fear that it will reduce ethical guarantees and weaken the protection of patients' health data. However, the text's defenders insist on the need to reduce the red tape that is holding back French research in the face of international competition.
A number of amendments have been adopted to clarify the conditions of application of these measures, particularly with regard to the extension of research sites and the simplification of clinical trial procedures.
🔹 Article 23: A CNIL More Involved in Innovation
Article 23 amends the Data Protection Act to adapt the role of the Commission nationale de l'informatique et des libertés (CNIL) to the challenges posed by digital innovation and artificial intelligence.
What are the changes for the CNIL?
- Taking into account the challenges of innovation: The CNIL will have to explicitly consider the needs of innovation in its decisions and recommendations, particularly in the areas of algorithms and artificial intelligence.
- Strengthening its role in supporting businesses: The CNIL will be able to develop assistance programmes for data controllers, in order to better reconcile compliance with the RGPD and support for innovation.
- Opening up to consultation with economic players: Before issuing certain recommendations, the CNIL will have to consult the companies concerned to take better account of the realities on the ground.
- Changes to the composition of the CNIL's college: A much-debated amendment was adopted to include representatives of private companies on the CNIL's college, raising concerns about its independence.
- Greater transparency: CNIL consultative documents will be more accessible to the public.
⚠️ Controversy Over the CNIL's Independence
One of the main criticisms concerns the introduction of private sector representatives on the CNIL board. Some see this as a threat to the independence of the authority responsible for protecting personal data. Others consider that it is essential to take better account of the needs of businesses in order to encourage innovation while complying with data protection rules.
Another debate concerned the mention of artificial intelligence in the text. In the end, references to AI were removed, following criticism of the need to coordinate this issue at European level.
⚖️ A Balance Between Simplification and Guarantees?
These articles illustrate the ongoing tension between the need for administrative simplification and the guarantees to be provided in terms of ethics and data protection. While researchers and businesses are calling for the rules to be relaxed to make them more competitive, others fear that the fundamental protections afforded to citizens will be undermined.
The remainder of the legislative process, with the discussion in the public session and the examination by the Senate, will allow these balances to be fine-tuned and any corrections to be made to the texts adopted in committee.