WHO expert advisory committee on developing global standards for governance and oversight of human genome editing: report of the fifth meeting, 23–24 November 2020

WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing Report of the fifth meeting 23–24 November 2020 WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing: report of the fifth meeting, 23–24 November 2020 ISBN 978-92-4-003477-8 (electronic version) ISBN 978-92-4-003476-1 (print version) © World Health Organization 2021 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial- ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. 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This publication contains the collective views of the WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing and does not necessarily represent the decisions or the policies of WHO. ii Contents 1. Background ...................................................................................................................... 1 2. Past work .......................................................................................................................... 1 3. Work of the meeting ........................................................................................................ 4 4. Outcomes ......................................................................................................................... 4 5. Future work of the Committee ......................................................................................... 5 1 1. Background In December 2018, the World Health Organization (WHO) established a global, multidisciplinary expert advisory committee to examine the scientific, ethical, social and legal challenges associated with human genome editing (both somatic and germline). The Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing includes members from Africa, the Americas, South-East Asia, Europe, the Eastern Mediterranean and the Western Pacific.1 The Committee has been tasked with advising and making recommendations on appropriate institutional, national, regional and global governance mechanisms for human genome editing. During the course of its work, the Committee will review literature on current human genome editing research and its applications, consider existing proposals for governance and relevant ongoing initiatives, and solicit information about societal attitudes towards the different uses of this technology. The Committee will explore how best to promote transparent and trustworthy practices and how to ensure appropriate assessments are performed prior to any relevant work being undertaken. The recent application of tools, such as CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats; Cas9 nuclease), to edit the human genome with the intention of treating or avoiding disease has highlighted the need for robust oversight in this area. The Committee will work in a consultative manner and build on existing initiatives to develop a responsible and responsive governance framework for the application of genome editing technologies going forward. It will liaise with relevant United Nations and other international agencies and will communicate with academies of science and medicine and other national or professional bodies, patient groups and civil society organizations that have worked, or are working, in this area. 2. Past work The Committee held its first meeting from 18 to 19 March 2019. The first meeting included a review of the current state of relevant science and technology and briefings on existing initiatives and reports relevant to its work. Participants also began to identify and discuss specific issues, mechanisms and stakeholders that could comprise, or contribute to the development of, a governance framework. The Committee also considered how these elements may differ at international, regional, national or local level. The group made three recommendations to the Director-General: (a) to develop a registry to provide a more structured mechanism for collecting and curating details of planned and ongoing relevant research and development; (b) that “it would be irresponsible at this time for anyone to 1 https://www.who.int/groups/expert-advisory-committee-on-developing-global-standards-for-governance-and- oversight-of-human-genome-editing/about. 2 proceed with clinical applications of human germline genome editing”, and that the Director- General should communicate this view to relevant regulatory bodies around the world; and (c) to enhance WHO’s capacity to share information with, and collect information from, both technical and lay audiences. Each of these recommendations was aligned with one of the guiding principles adopted by the Committee: (a) transparency; (b) the responsible stewardship of science; and (c) inclusivity. A report of the meeting is available online.2 In a statement issued on 26 July 2019, the Director-General formally and publicly endorsed the Committee’s recommendation that it would be irresponsible for anyone to proceed with clinical applications of human germline genome editing.3 He stated that regulatory authorities in all countries should not allow any further work in this area until its implications had been properly considered. WHO has begun communicating this opinion to its regional and country offices. The Committee held its second meeting from 26 to 28 August 2019. The second meeting focused on hearing additional views and insights relevant to the Committee’s work. The meeting included updates on relevant activities in different countries and from national, regional, and international organizations, as well as briefings by external experts on aspects of its mandate. The Committee’s working groups reviewed progress on establishing a registry of relevant research and development and responsible scientific stewardship. During closed sessions on the final day of the meeting, the Committee discussed a range of scenarios that could be used to help develop and test the governance framework, as well as opportunities for education, engagement and empowerment. The meeting outcomes included confirming the scope of the Committee’s work; providing clearer rationale for including somatic human genome editing in the committee’s mandate and in the online registry; revising and updating the guiding principles; establishing a phased approach to the development of the Registry; the creation of a working group on education, engagement and empowerment; plans for two rounds of online consultation to further expand opportunities for input into the Committee’s work; and initial reflections on content for a governance framework. A report of the meeting is available online.4 The first online consultation ran from 15 January 2020 to 7 February 2020. The spread of COVID-19 increased significantly during this time, making the dissemination of the survey challenging. The Committee anticipated wider circulation than proved possible at the time. The survey included 12 questions divided into four parts: (a) questions on who was providing a response; (b) questions on the general approach taken by the Committee; (c) questions on the draft governance framework being developed by the Committee; and (d) final comments – an open question for respondents to provide additional input for the Committee. Major 2 https://apps.who.int/iris/bitstream/handle/10665/341017/WHO-SCI-RFH-2019.01-eng.pdf. 3 https://www.who.int/news-room/detail/26-07-2019-statement-on-governance-and-oversight-of-human- genome-editing. 4 https://apps.who.int/iris/bitstream/handle/10665/341018/WHO-SCI-RFH-2019.02-eng.pdf. 3 themes appearing in the responses included concern over appropriate outreach to a wide audience to ensure consideration of social implications beyond technical or medical considerations; suggestions about integrating views of industry, bioethicists and governments; recognition of cross-border challenges to harmonization or coordination of policies; and the importance of ongoing consultation and transparency. Feedback was provided on a draft of the governance framework being developed by the Committee. Very few respondents identified elements in the framework they found to be unacceptable. Many comments included suggestions for improving the framework, such as additions or alterations to the proposed framework. A report of the consultation is available online.5 The Committee held its third meeting from 25 to 26 February 2020. The meeting focused on hearing the views and insights of those often excluded from international science policy processes. The meeting included contributions by African research organizations, community groups from Africa, and African bioethicists, as well as first-hand testimony from those affected by conditions that have been connected to human genome editing. The meeting was also briefed on satellite meetings supported by Committee members in other parts of the world. During closed working sessions, the Committee heard an initial overview of responses to its first online consultation; considered updates and reports from its working groups; continued to develop its governance framework; and developed plans for a second online consultation, taking into account lessons learned from its earlier consultation. The meeting outcome focused on revising and restructuring the governance framework in light of feedback. The Committee also considered how it might capture, in its future work, systemic issues connected to public health and sustainable development agendas that are likely to have a notable impact on the future development of human genome editing. A report of the meeting is available online.6 The second online consultation ran from 14 July 2020 to 19 August 2020. The survey included 12 questions divided into four parts: (a) questions on who was providing a response; (b) questions on the general approach to developing a governance framework; (c) questions on specific parts of the draft governance framework; and (d) final comments – an open question for respondents to provide additional input for the Committee. Responses received were largely positive, with wide support for the approach taken by the Committee, its efforts to be inclusive, differentiation between somatic and germline human genome editing, and improvements in the draft since the first online consultation. Some negative responses were received, with concerns being raised over the length of the framework and possible repetitions, and calls to focus more heavily on specific aspects of human genome editing. A very limited number of comments raised concerns over the approach taken by the Committee. Feedback on the draft governance framework included a large number of specific proposals for additions, alterations, or other edits for the Committee to consider. 5 https://apps.who.int/iris/bitstream/handle/10665/344007/9789240032446-eng.pdf. 6 Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing (who.int). 4 The Committee held its fourth meeting remotely from 2 to 4 September 2020. Each day addressed a separate topic. The first day focused on the report Heritable human genome editing produced by the International Commission on the Clinical Use of Human Germline Genome Editing. The meeting was briefed by the co-chairs and members of the Commission. During the second day, the Committee considered the responses from the second online consultation. The Committee agreed a workplan to revise the draft governance framework in light of the responses received and its subsequent discussions. There were also briefings by WHO programmes on strategic foresight and regulatory harmonization. During the final day of the meeting, the Committee reviewed expected outputs from its work and began developing an outline for its final report. The Committee’s working groups provided updates. The Committee discussed and took decisions on the timeline for future work, as well as on appropriate ways of working. 3. Work of the meeting From 23 to 24 November 2020, members of the Committee met remotely. A separate topic was addressed each day. On 23 November, the Committee focused on the governance framework. The Committee reviewed the overall status of the governance framework and developed a workplan to fill the gaps. The Committee also agreed on a workplan to develop a series of scenarios to both test the utility of, and demonstrate how to use, the governance framework. It then considered efforts since its previous meeting to revise the values and principles underpinning the governance framework. The Committee identified a number of areas that required additional refinement following the meeting and agreed on a programme of work. On 24 November, the Committee focused on its final report and associated conclusions and recommendations. Members of the Committee considered the range of issues on which they would draw conclusions and make recommendations, and agreed on a template to help standardize the development of those conclusions and recommendations. The Committee then discussed potential findings on two issues: the reporting of unregistered, unethical or illegal research and development activities; and international arrangements to support governance and oversight of human genome editing. The Committee also discussed and agreed upon a roadmap for its future work, including more regular online meetings of the Committee and additional webinars to seek input into its work. 4. Outcomes On the governance framework, the Committee agreed that the scenarios would be further developed with input from individuals who had assisted its work by participating in its meetings and webinars. For each of the seven scenarios, the Committee would seek opinions on: 5 • which issues would be important to draw out; • which of the Committee's identified values and principles seemed particularly valuable; • which of the Committee's questions to be considered when developing governance measures seemed particularly valuable; • what governance actions would be important to take. The results from those consultations would be compiled by WHO and used to revise the scenarios. On possible conclusions and recommendations, the Committee considered: • creation of a common set of values and principles on public health for use by WHO; • how to prevent instances where researchers or companies located relevant activities in countries with weaker regulatory infrastructure for no reason other than to avoid regulation and ethics guidelines that existed in other countries; • the reporting of unregistered, unethical or illegal research and development activities; • international arrangements to support governance and oversight of human genome editing; • intellectual property; • a Registry for human genome editing; • education, engagement and empowerment; • release activities and initial implementation of its findings. The Committee agreed that when developing conclusions and recommendations, it would, when possible, identify: • the purpose and intended outcome, linked to relevant values and principles; • specific actions being recommended; • relevant practical considerations, such as the time frame for action, the role of WHO, other potential partners and resource requirements; • whether any additional information was required before a conclusion or recommendation could be made. 5. Future work of the Committee The Committee agreed that its next and final meeting would take place during the last week of February 2021. The next meeting of the Committee would finalize its outputs and provide an opportunity for comment by relevant parts of WHO. 6 In advance of its final meeting, the Committee would: • make use of small working groups that would work further on specific topics, both in terms of the governance framework and the Committee’s final report; • hold monthly online meetings to keep the full membership of the Committee appraised of progress made by the small working groups; • continue to consult with relevant groups, in particular through the use of remote meeting tools. _________