French Bioethics Law: an original participatory approach for the National Bioethics Consultation

"What sort of world do we want to create for the future?" That was the question asked by the French National Consultative Ethics Committee (CCNE) when the National Bioethics Consultation was launched in 2018. "The aim of the National Bioethics Consultation was to encourage discussions on a variety of different topics, some of which were directly linked to recent advances in science and technology," said Professor Jean-François Delfraissy, Chairman of the CCNE, in an interview that he granted us in April 2018. "These included artificial intelligence, genetics research, the relationship between health and the environment, and the question of health data."

The idea behind the National Bioethics Consultation was to identify avenues for the revision of the French Bioethics Law (which dates from 1994, with new versions in 2004 and 2011). "The statutory periodic revision of the Bioethics Law provides an opportunity to hold regular discussions on ethical issues related to progress in medicine and biology," reiterated the government following the Council of Ministers session on July 24. The revision takes place every seven years, and the bill tabled on July 24, 2019 is part of this process.

The Bioethics Law lays down regulations in areas such as organ donation, medically assisted reproduction (MAR), prenatal diagnosis and also biomedical research. The legislative framework prohibits research on human embryos, for example (apart from exceptional cases when special permission is granted).

During the National Bioethics Consultation, the CCNE raised nine important topics for reflection by citizens and experts.

Neuroscience was one of the nine topics submitted for reflection by citizens and experts during the French National Bioethics Consultation in 2018. Here, an image of the reconstruction of brain connectivity in white matter, obtained using data from diffusion-weighted imaging. Copyright: Institut Pasteur / Roberto José Toro Olmedo.

In 2018, the CCNE asked the public to share their thoughts on the topics identified for debate. "The consultation was designed to serve as a democratic public debate, an opportunity to consult both citizens and experts, encouraging them to express their views and engage in a dialog," explained Jean-François Delfraissy at the discussion session with Institut Pasteur scientists on the topic "science and society" on Tuesday June 25, 2019. To make sure this participatory exercise would produce effective results, the committee established various channels for consultation in mainland France and its overseas territories:

• a website (approximately 65,000 contributions and more than 800,000 votes);
• a citizens' committee (22 members took part in themed weekends);
• regional events (271 events were attended by 21,000 participants, a third of whom were students);
• hearings (with 154 organizations);
• meetings with institutional ethics committees.

The CCNE also guaranteed the transparency of the process by carefully moderating the website and setting up a citizens' committee to provide a critical perspective. "Our aim was for all the various means of communication to complement each other, and we tried to compensate the biases that are inherent in any form of consultation," continued Jean-François Delfraissy. The information provided to civil society was taken from the website and the debates held in all the regions and territories, for example, and an extensive series of hearings were held to enable experts, associations and organizations interested in bioethics issues (health insurance companies, think tanks, etc.) to air their views.

Following this broad national consultation, the CCNE expressed its satisfaction but also a number of reservations, acknowledging that any consultation method is imperfect and that it is only by considering all the communication channels together that an accurate picture of public opinion can be established. "Views on bioethics in France are strongly influenced by French culture and the country's solidarity-based healthcare system," explained Jean-François Delfraissy. "What emerged from the public consultation is that the many views expressed are not necessarily representative of public opinion. Various difficulties were encountered when it came to topics with societal relevance such as reproduction, and we did not always manage to include more vulnerable populations."

At the meeting of the French Council of Ministers on July 24, 2019 (page in French), a bill was tabled, laying down a series of legal regulations governing all medical and/or research practices. According to the French government website, the bill reflects a desire to "support free and responsible [biomedical] research that benefits human health, by removing various legal barriers and eliminating unjustified restrictions, especially when it comes to research on stem cells. At the same time, it reaffirms France's ethical values in the area of research, such as the ban on creating embryos for research purposes and changing the genetic heritage of embryos intended for pregnancy."

The bill also establishes a framework for a system of bioethics governance that will keep pace with advances in science and new techniques "by extending the missions of the National Consultative Ethics Committee (CCNE) for life sciences and health so that it considers the impact of any innovations on health."