One reason for initiating a public debate activity might be a principled commitment to involve those potentially affected by biomedical developments in the governance In this guide ‘governance’ means the accountable use of power or authority to set, monitor, and enforce standards and behaviours within systems or organisations. It can mean both steering people’s behaviour and ensuring that they are held to account. Governance can be given effect through compulsory and non-compulsory measures (legal provision, licensing systems, professional norms, codes of conduct, recommendations etc.,). Governance can be a function of both public and private actors. of those developments, recognising that all voices are entitled to be heard. In the case of developments in biomedicine, the scope of those potentially affected extends to the whole of society.

A development that concerns people’s human rights or challenges implicit social norms is likely to be one where public debate In this document and in Article 28 of the Oviedo Convention the overarching concept of ‘public debate’ is used to describe discursive interactions in the public sphere (that is, not in a professional context) through which individuals and groups may identify, explore and resolve their different interests in matters that affect (or potentially affect) them all. is not only desirable but morally and, in some domains, legally required.

 Consideration should be given to whether a development has implications for people’s human rights.

See Germany example

Good decision-making requires consideration of broad questions of vision and value that technical experts are not always well placed to answer. Professional advice is often limited in scope and questions about the application of new developments are not necessarily technical questions so much as moral and political questions.

Technical questions could be whether it is safe, useful or economical to implement a new technology, whereas the initiator The person who takes the initiative in a public debate activity (see ‘invited/ uninvited public debate’). The initiator will usually provide or co-ordinate the resources for the activity and may commission specialists to facilitate or deliver the activity on their behalf. may further want to explore whether any risk is considered socially or morally acceptable, and who should be empowered to decide this.

 It is useful to open up questions in ways that can challenge professional assumptions in a constructive way. The framing of questions to be addressed can reveal or embed underlying values.

 Consulting the public can help to ‘crowd source’ expert input or identify considerations that may not be present in the mainstream.

Another reason policy makers may wish to initiate public debate is to seek legitimacy for decisions about the implementation of a development that raises novel or unusual issues that have not been discussed previously. This might occur further ‘downstream’ where a technology has emerged rapidly or where there is pressure to transfer a new technology from other national settings.

In circumstances in which policy makers propose to introduce a controversial new development, initiating public debate activities can help to inform the public, assess its acceptability and, where appropriate, prepare the way for implementation.

 Consideration should be given to the need to inform the public about the proposed introduction of new biomedical developments and what level of public awareness and acceptance would provide assurance that implementation decisions enjoy broad societal support.

See France and Russian Federation examples