10 November 2022, 9:15 - 16:15 CET
 

Dialogue on genomic medicine is important because it helps to address issues which relate to individuals and societies. For example, access to genomic testing and the consent to the storage of (individual) genomic data can have implications for healthcare, such as access to health services. Dialogue helps to foster understanding and appreciation of the concepts of altruism and solidarity as well as the principle of reciprocity. In agreeing to share genetic information, there are corresponding obligations on the part of researchers, healthcare professionals and the state to provide inter alia information to data donors, robust governance mechanisms and equitable access to the treatments developed.

  • SESSION I: What is public dialogue on genomic medicine, why is it important, and when is it most important to carry out?
  • SESSION II: Examples of public dialogues – results, consequences, lessons learned
  • SESSION III: Open exchanges with young people - personal perspectives
  • SESSION IV: Two-way dialogue with all stakeholders - are we listening and learning enough?
  • SESSION V: What level of public involvement and/or oversight are needed for development, governance and regulation of genomic medicine?

Teaser video by Mark Bale,
Rapporteur for the Workshop on public dialogue on genome medicine:

Read more

To guarantee that the directions of innovation and the ethical challenges raised by technological developments are robustly deliberated, governance should go hand in hand with broad and informed public dialogue. This can assist policy makers in public consultations and, therefore, in ascertaining the most appropriate governance models needed for biomedical technologies and their applications. This can also allow to anticipate new regulatory needs linked to innovations in genomic medicine. This is in line with Article 28 of the Oviedo Convention, which provides that “the fundamental questions raised by the developments of biology and medicine are the subject of appropriate public discussion in the light, in particular, of relevant medical, social, economic, ethical and legal implications, and that their possible application is made the subject of appropriate consultation”.

Objectives

The workshop will explore why public dialogue on genomic medicine is so important and will consider its added value for policy makers, most notably to help authorities and other responsible bodies to:

  • Promote a common understanding of genomic medicine, to distinguish it from other fields of medicine, to grasp the various issues that it raises.
  • Explore how public dialogue facilitates information, open exchanges, and better understanding of issues in genomic medicine, having regard to their implications for human rights, and for bioethical principles, such as solidarity, altruism and reciprocity.
  • Consider the extent to which patient and public interest plays a role in its development and regulation and, to this end, what level of public involvement and/or oversight is needed.
  • Understand the prevalence of public dialogue on genomics both in member states and at the international level, reflecting on who the key stakeholders are, why do they matter and how to make their engagement count.
  • Discuss how public dialogue can be employed to anticipate innovations and the need for regulation in genomic medicine.

Programme

09:15-09:30 CET  -  Opening remarks
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  • Laurence Lwoff, Head of Human Rights and Biomedicine Division, Council of Europe
  • Siobhan O'Sullivan, Chair of the Steering Committee for Human Rights in the fields of Biomedicine and Health (CDBIO)

 

09:30-09:50 CET  -  SESSION I: What is public dialogue on genomic medicine, why is it important, and when is it most important to carry out?
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 What is our common understanding of genomic medicine, distinguish from other fields of medicine, explore various issues that it raises?

 What are the hopes and concerns for public dialogue on genomic medicine?

Introductory remarks

  • Anne CAMBON-THOMSEN, University of Toulouse (France)

 

09:50-10:50 CET  -  SESSION II: Examples of public dialogues – results, consequences, lessons learned
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 Explore how public dialogue facilitates information, open exchanges, and better understanding of issues in genomic medicine, having regard to their implications for human rights, and for bioethical principles, such as solidarity, altruism and reciprocity

 What has happened because of public dialogues on issues related to genomic medicine – what changed and what lessons were learned?

Moderators:

  • Anne FORUS,  Senior Adviser at the Norwegian Directorate of Health (Norway),
  • Pierre MALLIA, Professor Family Medicine & Patients' Rights, Bioethics Coordinator, Bioethics Research Platform Chairman, Faculty Research Ethics Committee (Malta)

Panellists: 

  • Derick MITCHELL, Chief Executive Officer, IPPOSI – the Irish Platform for Patient Organisations, Science & Industry (Ireland)
  • Vivienne PARRY, Science Broadcaster & Head of Public Engagement Genomics England (UK)
  • Petra VERHOEF, Theme coordinator research & dialogue on health technologies at Rathenau Instituut (The Netherlands)
  • Eva WINKLER, Board of Managing Directors National Center for Tumor Diseases, Heidelberg Headof the Section for Translational Medical Ethics, Heidelberg University Hospital (UKHD) (Germany)
  • Borut PETERLIN, European Society of Human Genetics (ESHG) (Slovenia)

 

10:50-11:45 CET  -  SESSION III: Open exchanges with young people - personal perspectives
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 Why is genomic medicine important for young people?

 What benefits and disbenefits do you want to see addressed by public dialogues on genomic medicine?

 What qualities should public dialogue have to enable you to participate and voice your views?

 What forms of public dialogue suit young people best? Please explain

 Public dialogue has the potential to help shape the governance of genomic medicine – how do you understand this governance, what governance do you want?

Moderators: Murdo MACDONALD (CEC/UK), Ingo HARTEL (Germany)

Panellists:

  • Radosveta BOZHILOVA, PhD Student (Bulgaria)
  • Darina KACHAKOVA, PhD, Geneticist at Molecular Medicine Center in Medical University-Sofia (Bulgaria)
  • Zoha Panezai, Bioscience student at the University of Limerick (Ireland)
  • Justine MACE, Student in digital law and apprentice lawyer at the Ministerial Delegation of Digital Health (France)
  • Jimena PINTÓ, Student at the Swiss School of Barcelona (Spain)

 

11:45-14:00 CET  -  Lunch break

 

14:00-15:00 CET  -  SESSION IV: Two-way dialogue with all stakeholders - are we listening and learning enough?
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 Who are the key stakeholders, why do they matter, how to make engagement count?

 Examples of how individual stakeholders can initiate/contribute to public dialogue/debate

 Consent and information - how to give good information; how to manage/meet expectations?

Moderators:

  • Mark BALE, Genomics policy advisor and UK Delegate to CDBIO (UK)
  • Jozef GLASA (Slovakia)

Panellists:

  • Regina BECKER, Research Scientist, European "1+ Million Genomes" Initiative (Luxembourg)
  • Stefano BENVENUTI, Head of Public Affairs at Fondazione Telethon (Italy)
  • Nicolas GARNIER, Head of Patient Advocacy, Pfizer Global Product Development, Oncology & Rare Disease (Industry)
  • Andres METSPALU, Director of Genome Centre (Estonia)

 

15:00-16:00 CET  -  SESSION V: What level of public involvement and/or oversight are needed for development, governance and regulation of genomic medicine?
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 To what extent should patients and the public be involved in the development and regulation of genomic medicine, and how is it funded?

 How can public dialogue be employed to anticipate innovations and the need for regulation in genomic medicine?

 What role for biobanks in governance of genomic medicine?

 How should the public be involved in decisions concerning the collection and governance of genomic data?

Moderators:

  • Mélodie BERNAUX (France),
  • Aime KEIS, Vicechair, National Committee on Bioethics and Human Research Lecturer in medical reasearch University of Tartu (Estonia)

Panellists:

  • Philippe BERTA, Professor of Molecular Genetics, Deputy for Gard and President of the Rare Disease Study Group (France)
  • Sandra LIEDE, Senior Legal Specialist Healthtech Finland, part of TIF (Technology Industries Finland) (Finland)
  • Katherine LITTLER, Science Division, WHO
  • Alessandra PIERUCCI, Chair, Committee of Convention 108 (Italy)
  • Stefan SCHENNACH, Committee on Culture, Science, Education and Media, Parliamentary Assembly of the Council of Europe

 

16:00-16:15 CET  -  Concluding remarks and next steps
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  • Mark BALE, Genomics policy advisor and UK Delegate to CDBIO (UK)