Royal Irish Academy Briefing

1. Royal Irish Academy Briefing Bert Rima

2. H5N1 Gain of Function (GoF) research: continuing scientific debate • GoF research explores possibilities to modify influenza virus to help understand pandemic potential • Benefit-risk considerations examined by EASAC member academies in Netherlands, UK, Germany (2012 - ) • Letters to President of European Commission in 2013 from European Society Virology and Foundation for Vaccine Research, setting out differing views on benefits-risks • Continuing scientific interest worldwide e.g. meetings in Hannover and Washington DC (2014)

3. Gain of Function (GoF) • In specific context here: recent research on influenza virus, particularly H5N1 variant, to affect its transmission potential

4. Biorisk management • Biosafety – safeguarding researchers, the general public and the environment • Biosecurity – safeguarding against intentional misuse • Bioethics – the moral principles and duties that govern experimentation

5. Experiments of interest as defined in the 2004 Fink report Biotechnology in an age of terrorism

6. Scope of the EASAC project • Self-governance and scientific responsibility • Benefit-risk assessment • Research review and management systems • Research moratoria and alternatives • Bioethics – issues and place in research review • Biosecurity advisory issues – mechanisms and advisory bodies • Publication of sensitive information and options for management • Public engagement – and the responsibilities of academies • Global context – and how to inform discussion and action worldwide

7. EASAC recommendations • Emphasising a layered approach with integration of responsibilities and action at researcher, research institution, research funder, national and international levels • Focus on biosafety but biosecurity also recognised as important

8. EASAC key messages: Self-regulation • Good practice requires – conforming with regulations/safety conditions/codes of conduct, justifying proposed research • Self-regulation means – checks and balances on research within the scientific community, requires raising awareness of researchers and their institutions, with need for education • Academies of science have a continuing role – in promoting biosafety and biosecurity norms and supporting audit of research practices

9. EASAC key messages: Benefit-risk assessment • Not a “once and for all” calculation but continuing, collective commitment to understand and communicate the issues • Benefit can be quantified as potential public health impact or described in terms of generation of scientific knowledge • Academies and learned societies need to continue to promote discussion across scientific community and with other stakeholders

10. EASAC key messages: EU/national activities and organisations in biosafety/biosecurity • Importance of guidance for research funded by Horizon 2020 as well as at national level • Importance for all researchers and their institutions conforming with EU regulations as implemented nationally • No new EU-level body is recommended • Member States should have clear national regulations

11. EASAC key messages: Publication of sensitive information • Researchers and their institutions all have responsibility to make decisions about publishing sensitive information • Journals should obtain appropriate advice, including from security experts • European Commission’s Export Control Regulation is an inappropriate and ineffective vehicle to block publication

12. EASAC key messages: Public engagement • Trust and openness are crucial for researchers and their institutions • Academies and others in the scientific community should actively participate in public dialogue – articulating objectives for research, potential for benefit and risk, and biorisk management practices adopted • EASAC is committed to continuing working with academies to promote engagement

13. EASAC key messages: Global context • Countries worldwide vary in their standards, national guidelines, legal frameworks and in their attitudes to benefit-risk balance • Collectively, there is much more to do to understand, share and implement good practice • Academies should consider what they can do to help convene and inform global discussions

14. EASAC goals for the project • Bringing together scientists, nominated by academies, with a broad range of expertise and views • To explore where there is consensus • To clarify which issues are still unresolved • To advise on what additional analysis is needed to assess future options for the research area • Emphasising which current EU regulations govern research and what good practice already exists at national level • Identifying what is national or EU-level responsibility

15. Background to considering issues raised by these GoF studies • Such studies are already subject to stringent EU and national regulations • Characterisation of concerns for creation of novel pathogens discussed in detail in US National Academies Fink Report

16. EASAC project: collective academy work at the EU level • Drawing on analysis, commitment and prior work by EASAC member academies • Research and regulation issues, and societal implications, are relevant for all EU Member States and for collaborative EU research, e.g. Horizon 2020 • Need for consistent EU-wide understanding and practices, and to support global discussion