Strasbourg, 11 October 2022 CDBIO(2022)2REV
STEERING COMMITTEE FOR HUMAN RIGHTS IN THE FIELDS OF BIOMEDICINE AND HEALTH (CDBIO), Strategic Action Plan on Human Rights and Technologies in Biomedicine (2020-2025), Methodology and timeframe for the priority actions planned revised in the light of the priorities agreed taking into account the COVID-19 Pandemic
Blue texts correspond to modifications to the last version as presented to CDBIO in June 2022
and grey parts correspond to what has already been achieved.
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GOVERNANCE OF TECHNOLOGIES |
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Strategic Objective: Embedding human rights in technologies which have an application in the field of biomedicine |
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Action |
Activity |
Milestone |
Owner |
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1. Developing a report on the application of AI in healthcare, in particular regarding its impact on doctor-patient relationship |
· Designation of consultant expert – Secretariat proposal for Brent Mittelstadt, Senior Research Fellow at the OII and a Turing Fellow at the Alan Turing Institute, UK. He is a leading data ethicist and philosopher specializing in the ethical aspects of AI, algorithms, machine learning, predictive analytics, Big Data, and medical expert systems. His Bio/cv can be found here: OII | Dr Brent Mittelstadt (ox.ac.uk) |
Expert study - December 2021 Expert study launched, 7 June 2022 |
Secretariat |
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· Establishment of drafting group |
2022 |
CDBIO |
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· Meeting of drafting group |
Identify gaps/needs and corresponding policy questions – 2022 |
Drafting group |
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· Consultation period and/or meeting between drafting group and selected experts |
Orientates/validates approach, gaps/needs/policy questions of drafting group – 2023 |
Secretariat/drafting group |
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· Meetings of drafting group |
Draft report (includes elements of feasibility for further work) – 2023 |
Drafting group |
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Report agreed - 2024 |
CDBIO |
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2. Examining Article 13 of the Oviedo Convention in the light of developments in gene editing technologies |
· Study 2 (presentation in writing of the elements presented orally at the June 2019 plenary meeting) to be prepared by Prof. Heidi Howard |
Bureau update from Secretariat / Rapporteur |
Bureau/Rapporteur |
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· Consultation with member states. · Conclusion as to the need for possible clarification /revision of Article 13 |
November 2020 |
DH-BIO |
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· Setting up of a drafting group to prepared clarifications on the scope of the provision with regard to research and on the notions of “therapeutic, diagnostic and preventive purposes” |
Fall 2021 |
Drafting group |
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· Presentation of proposal for clarifications at the plenary meeting with a view to their finalisation · Clarifications finalised and presented to the Committee of Ministers · Publication of the final conclusions including clarification |
June 2022 September 2022 11 October 2022 |
CDBIO |
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Action |
Activity |
Milestone |
Owner |
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3. Assessing the relevance and sufficiency of the existing human rights framework to address the issues raised by the applications of neurotechnologies |
· Designation of a consultant expert to prepare a report on common Human Rights challenges raised by different application of neuro-technologies in the biomedical field |
End of 2020 |
Consultant, proposal: Dr Marcello Ienca (CH) Secretariat |
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· Expert report presented to the DH-BIO |
Spring 2021 |
DH-BIO |
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· Preparation of a workshop/round table on how to address the issues identified, taking into account relevant work (e.g. OECD Rec. on Responsible Innovation in Neurotechnology) · Designation of expert(s) to act as rapporteurs for the round table, including from DH-BIO, T-PD, OECD and UNESCO |
June – October 2021 |
Bureau, Secretariat DH-BIO, OECD |
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· Round table |
9 November 2021 |
Bureau, Secretariat CDDH DH-BIO, OECD |
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· Publication of the draft report from rapporteurs on conclusions from the round table |
November 2022 |
Rapporteurs, Secretariat |
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· Delegation exchange on the future work in the field of neurotechnologies on the basis of the draft conclusions |
November 2022 |
Rapporteurs, Secretariat |
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Strategic objective: Fostering public dialogue to promote democratic governance and transparency in the field of biomedicine |
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Action |
Activity |
Milestone |
Owner |
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4. Translating the Guide to public debate on human rights and biomedicine in non-official languages and disseminating it in CoE member states[1] |
· Launch of Guide · Call for voluntary contribution, including contribution in kind |
28 September 2020 |
Chair DH-BIO/ Secretariat |
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· Portuguese, German, Georgian, Armenian, Russian, Italian, Spanish translations of the Guide |
Spring-Autumn-Winter 2020 |
DH-BIO/Secretariat |
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· Presentation at 13th Global Summit NECs |
Lisbon, 9 September 2020 |
Conselho Nacional de Ética para as Ciências da Vida |
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· Webinar on public debate and COVID-19 |
February 2021 |
Secretariat |
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· Other translation |
2025 |
Secretariat |
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5. Promoting dialogue amongst the public, practitioners and policy makers to ensure that patient and public interests is a key priority in the developments and regulation of genomic medicine |
· Consideration by DH BIO of the setting-up of a small preparatory group to facilitate the organisation of the workshop and paper. |
June 2021 |
Secretariat/ Consultant |
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· Preparatory work for workshop (in particular to define the needs, scope and questions needed to practically engage stakeholders in dialogue on genomic medicine) |
First meeting of the preparatory group, 22 October 2021 Second meeting, 20 January 2022 Third meeting, 5 April 2022 |
Rapporteur on genetics and genomics / Secretariat/ Preparatory group/ Bureau |
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· Exchange with CDBIO delegations on the approach and orientation of the workshop. |
June 2022 |
CDBIO |
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· Workshop with stakeholders (i.e. Healthcare professionals, researchers, policy makers, public) |
10 November 2022 |
Secretariat |
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· Paper, based on the conclusions of the workshop, prepared by the workshop rapporteur (including good practices regarding methodologies, questions for dialogue on genomic medicine) |
Early 2023 |
Workshop rapporteur/ Secretariat |
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· Paper based on conclusions of the workshop is examined and endorsed with a view to contributing to developments at the international level and identifying future possible actions |
June 2023 |
CDBIO |
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EQUITY IN HEALTHCARE |
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Strategic Objective: Promote equitable and timely access to appropriate innovative treatments and technologies in healthcare |
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Action |
Activity |
Owner |
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1. Equitable and timely access to vaccines, treatments and equipment taking into account the COVID19 pandemic and the ethical issues it raises. |
Vaccine |
· Overview and analysis of vaccine development framework and ongoing initiative on equitable access. |
November 2020 - Background documents. - Outlines for draft instrument/statement. |
Secretariat/ Consultant/ DH-BIO-Drafting group/ DH-BIO |
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· Setting up of a drafting group |
November 2020 |
Secretariat/ DH-BIO-Drafting group |
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· Finalisation of a Statement |
January 2021 |
Secretariat/ Consultant/ DH-BIO-Drafting group/ DH BIO |
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Treatment and Equipment |
· Drafting a working methodology · Outlines for draft instrument. |
June 2021 |
Secretariat/ Consultant/ DH-BIO |
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· Setting up of a drafting group. |
July 2021 |
Secretariat/ Consultant/ DH-BIO-Drafting group |
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· Presentation of a draft instrument to the DH-BIO. |
End 2021 |
DH-BIO |
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· Targeted consultation on the draft recommendation prepared by the drafting group. |
March 2022 |
Drafting group/ Secretariat/ Consultant/ |
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· Presentation of the draft Recommendation to the CDBIO |
June 2022 |
CDBIO |
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· Finalisation of the Draft Recommendation |
September 2022 |
Consultation meeting |
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· Presentation to the CDBIO for approval |
November 2022 |
CDBIO |
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· Subject to approval by CDBIO, presentation to the Committee of Ministers for adoption |
January 2023 |
Secretariat |
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2. Elaborating a draft recommendation on equitable and timely access to innovative treatments and technologies in health care systems. NB: provisional timeline which may need to be adapted. |
· [Designation of a coordinator within the CDBIO] |
[2022] |
[Secretariat/ Consultant] |
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· [Overview and analysis of existing guidance/ codes/ regulation/ practices on the way decisions are taken with regard to access to innovative treatments: - at European/international level (e.g. orphan diseases/drugs…) - at national level] |
[2022 Questionnaire to MS and stakeholders] |
[Secretariat/ Consultant] |
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· Call for expression of interest for a drafting group |
2022 |
CDBIO |
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· Drafting a working methodology · Drafting a background Report · Identification of a consultant to prepare an expert Report |
2022 |
Secretariat |
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· Establishment of a drafting group |
2022 |
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· Preparation of an outline for draft guidelines |
2022-2023 |
Drafting group |
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· Presentation of outlines for draft guidelines to the CDBIO |
June 2023 |
CDBIO |
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· Preparation of |
2023 |
Drafting group |
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· Presentation of draft guidelines to the CDBIO |
November 2023 |
CDBIO |
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· Revision of the draft guidelines in the light of the comments received |
2023-2024 |
Drafting group |
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· Public consultation on the draft · [Seminar to discuss findings/outcome of public consultation with WHO, EU, patients organisations, industry, competent authorities] TBC |
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Drafting group/ CDBIO |
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· Revision of the draft guidelines in the light of the comments received |
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Drafting group |
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· Presentation of a revised draft |
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CDBIO |
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· Revision of the draft guidelines in the light of the comments received |
2024-2025 |
Drafting group |
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· Presentation |
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CBDIO |
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Strategic Objective: Combat health disparities created by social and demographic changes in Council of Europe Member States |
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Action |
Activity |
Milestone |
Owner |
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2. Developing a guide to health literacy for equitable access to health care. |
· Consultants supporting the Secretariat are identified as Dr Leena Paakkari (FI) and Dr Kristine Sørensen (DK). |
Spring 2021 |
Secretariat |
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· Development of a project outline building on previous work namely by the Council of Europe and WHO https://gateway.euro.who.int/en/themes/health-literacy/
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Outline prepared by consultants and examined by Bureau on 4 May 2021. |
Secretariat (and consultant), DH-BIO |
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· · Consultants Report presented and examined by DH BIO · Setting up of a small drafting group |
June 2021
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· Collection of examples of good practices (from Delegations, stakeholders…) |
July 2021 – April 2022 |
Secretariat (and consultant) |
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· Installation of a drafting group, including members of other Committees, where relevant, supported by a consultant(s) |
First meeting of the drafting group, 14 September 2021 |
Drafting group |
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Second meeting of the drafting group, 20 December 2021 |
Drafting group |
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Third meeting of the drafting group, 27-28 April 2022 |
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· Targeted consultation on the draft guide, prepared by the drafting group |
16 February to 18 March 2022 |
Drafting group, consultant, Secretariat |
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· Draft guide presented to CDBIO |
June 2022 |
CDBIO |
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· Finalisation of draft guide based on comments from Delegations |
Autumn 2022 |
Drafting group, consultant |
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· Presentation of the draft guide with a view to its approval of the guide by the CDBIO |
November 2022 |
CDBIO |
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PHYSICAL AND MENTAL INTEGRITY |
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Strategic Objective: Strengthening children participation in the decision-making process on matters regarding their health |
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Action |
Activity |
Milestone |
Owner |
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1. Developing a guide to good practice concerning the participation of children in the decision-making process on matters regarding their health · Mapping existing legislation and good practices relevant to decision making process in health-related matters (in different situations) · To draft a guide on decision making process for health professionals |
· Elaboration of a concept note/outline of a guide · Draft outline presented to DH-BIO and to the Steering Committee for the Rights of the Child (CDENF) |
Autumn 2020 |
Rapporteur: Ritva Halila (FI) Consultant: Dr Annagrazia Altavilla (FR), member of ethics groups of the European Network of Pediatric research (TEDDY), lawyer |
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· Collection of existing legislation and good practices relevant to decision making process in health-related matters (Delegations, stakeholders…) |
April 2021 |
Rapporteur, Secretariats (and consultant) |
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· Presentation of the first overview of the result of the survey at the Plenary meetings of the DH-BIO of the CDENF in the form of synthesis of analyses · Call for nomination of Delegations and experts among the two Committees |
May – June 2021 |
Rapporteur, Secretariats (and consultant) |
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· Establishment of a joint drafting group (DH-BIO, CDENF…) - meetings of drafting group |
Autumn 2021-Spring 2022 |
Drafting group, Secretariats (and consultant) |
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· Preparation of the first outline of the Guide by the Consultant for submission to the drafting group written comments with a view to the preparation of a revised outline by the Consultant for the first drafting group meeting. |
September 2021 – November 2021 |
Drafting group, Secretariats (and consultant) |
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· First drafting group meeting (*dates and format of follow-up meetings to be decided by the drafting group during the first meeting) |
29 November 2021 |
Drafting group, Secretariats (and consultant) |
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· Revision in the light of the discussion at the 1st meeting of the BIO/ENF-CP |
December 2021 – February 2022 |
Drafting group, Secretariats (and consultant) |
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· Second meeting of the BIO/ENF-CP |
10-11 March 2022 |
Drafting group, Secretariats (and consultant) |
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· Revision in the light of the discussion at the 2nd meeting of the BIO/ENF CP |
April 2022 |
Drafting group, Secretariats (and consultant) |
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· Presentation of the draft Guide to the Plenary of the CDBIO and CDENF |
May - June 2022 |
Drafting group, Secretariats (and consultant) |
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· Written comments requested from CDBIO and CDENF and revision of the Guide by the Consultant |
June – August 2022 |
CDBIO, CDENF, Drafting group, Secretariats (and consultant) |
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· Third meeting of the BIO/ENF CP |
22-23 September 2022 |
Drafting group, Secretariats (and consultant) |
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· Stakeholders Consultation Process |
October – November 2022 |
Drafting group, Secretariats (and consultant) |
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· Children Consultation Process |
October – November 2022 |
Drafting group, Secretariats (and consultant) |
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· Revision in light of the comments received during the consultation with stakeholders |
December 2022 January 2023 |
Consultant/ Drafting group/ Secretariat |
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· Examination of the revised version of the draft Guide by CDBIO and CDENF plenaries |
Spring 2023 |
CDBIO CDENF |
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· Where necessary, revision of the Guide in the light of the comments made by CDBIO and CDENF delegations |
Summer 2023 |
Drafting Group Secretariat |
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· Adoption of the Guide by the CDBIO and CDENF |
Autumn 2023 |
CDBIO CDENF |
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Strategic Objective: safeguarding children-rights in relation to medical practices which have future or long-term implications for them |
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Action |
Activity |
Milestone |
Owner |
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2. Organising a seminar on relevant legislation and good practices with regard to early intervention on intersex children |
· Collection of information on relevant developments and examples of good practices |
End 2021 – Beginning of 2022 |
Delegations, Secretariat |
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Autumn 2021 |
DH-BIO Rapporteur on children’s rights in cooperation with CDENF and SOGI with the support of the Bureau and Secretariat |
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· Invitation of speakers and other participants |
January - February 2022 |
Conference Rapporteur, DH-BIO Children rights rapporteur, Secretariat |
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· Seminar |
31 May 2022 |
CDBIO |
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· Publication of conclusions of the Seminar |
Autumn 2022 |
Conference Rapporteur, CDBIO Children rights rapporteur and Secretariat |
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Strategic Objective: Safeguarding the rights of persons with mental health difficulties |
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Action |
Activity |
Milestone |
Owner |
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3. Elaborating a legal instrument to protect the human rights and dignity of person with mental disorders with regard to involuntary placement and involuntary treatment |
· Revision of the draft additional protocol based on drafting proposals made by Delegations |
Bureau meeting - Spring 2020 |
Bureau, Secretariat |
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· Written contributions from DH-BIO member States on the revised draft before 25 May, analysed by the Bureau |
June 2020 |
DH-BIO |
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· Revision of the Explanatory Report in line with the revision of the text |
August – September 2020 |
Secretariat |
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· Bureau finalises proposals on the basis of comments received |
September 2020 |
Delegations, Bureau-Rapporteur, Secretariat |
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· DH-BIO exchanges on changes proposed |
November 2020 |
DH-BIO |
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· Consultation meeting at Delegation level, if necessary |
Beginning of 2021 |
Delegations, Bureau-Rapporteur, Secretariat |
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· Draft text is finalised |
Bureau, Secretariat |
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· DH-BIO agreed to send the draft text to the Committee of Ministers for decision |
November 2021 |
DH-BIO |
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Action |
Activity |
Milestone |
Owner |
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4. Developing a compendium of good practices to promote voluntary measures in the field of mental healthcare[2] |
· Project outline finalised · Questionnaire prepared |
January - June 2020 |
DH-BIO Rapporteur, Secretariat |
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· Outline and questionnaire sent to Delegations and stakeholders · Data collection (Delegations, stakeholders, administrative entities at regional level) |
July – December 2020 |
Secretariat |
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· Information on the collection process given to the DH-BIO |
November 2020 |
Secretariat, DH-BIO |
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· Examination by a consultant of the examples collected, requests for further information, where appropriate |
October 2020 – May 2021 |
DH-BIO Rapporteur, Consultant: Dr Piers Gooding, Research Fellow at the Melbourne Social Equity Institute (Australia) |
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· Presentation of draft compendium to DH-BIO |
June 2021 |
DH-BIO |
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· Finalisation of compendium, consultation meeting with stakeholder representatives, where appropriate. |
September 2021 |
DH-BIO Rapporteur, Consultant [Bureau] |
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· Final draft presented to the DH-BIO for approval |
November 2021 |
DH-BIO |
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5. Developing a draft recommendation for the promotion the use of voluntary measures in mental health care services |
· Identification of the key principles on which a draft recommendation could be based, using the Compendium as a reference (see point 4. Above) · Preparation of an outline of a draft recommendation |
September 2022 |
Consultant, Bureau |
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· Presentation of the outline to the CDBIO |
November 2022 |
CDBIO |
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· Revision of the outline in the light of the comments made by CDBIO delegations, participants and observers |
Bureau, Secretariat |
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· Presentation of a draft recommendation to the CDBIO |
June 2023 |
CDBIO |
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· Revision of the draft in the light of the comments from CDBIO delegations, participants and observers |
Bureau, Secretariat |
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· Consultation on the draft recommendation |
Summer/Fall 2023 |
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· Presentation of the revised draft recommendation in the light of the comments received during the consultation |
November 2023 |
CDBIO |
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· Approval of the draft recommendation by the CBDIO · Presentation to the Committee of Ministers for adoption |
June/November 2024 |
CDBIO |
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CO-OPERATION AND COMMUNICATION |
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Strategic Objective: Developing long-term strategic cooperation with CoE committees and other inter-governmental bodies working in the field of bioethics |
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Action |
Activity |
Milestone |
Owner |
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1. Cooperation Strategy |
· Preliminary draft prepared |
Spring 2020 |
Secretariat. |
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· Examination of the draft Strategy |
Bureau meeting Autumn 2020 |
Secretariat, Bureau members. |
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November 2020. Presentation at the plenary meeting. |
DH-BIO |
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· Presentation of DH-BIO draft Cooperation Strategy with concrete examples/proposals |
Approval of the Strategy by DH-BIO plenary June 2021 |
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2. Co-Establishing link and co-operation with National Training Institutions to help disseminate the HELP course on bioethics in Council of Europe members states |
· Translation of the HELP course and adaption to national legal systems |
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· In co-operation with the HELP Unit, launch of tutored courses in member States organised in co-operation with national training institutions |
Armenia 27-29/07/2021 Italy 07/07/2021 Italy 17/05/2021 Italy 24/04/2021 Italy 27/01/2021 Greece 24/09/2020 Poland 25/09/2020 North Macedonia 05/10/2023 |
Secretariat and HELP Unit |
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Strategic Objective: Ensuring the communication and dissemination of the outputs of the DH-BIO to internal and external stakeholders to maximise their uptake and utility |
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Action |
Activity |
Milestone |
Owner |
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3. Hosting a Youth Forum for Bioethics to provide young people with an opportunity to share their views on bioethical topics and to inform the work of the DH-BIO |
· Contacts and informal exchange of views between Secretariat (including DGII colleagues), representatives of Advisory Council on Youth and the Bureau |
2020 |
Bureau, Secretariat, Advisory Council on Youth |
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· Call for voluntary contributions by member states |
Voluntary contribution of 10,000 Euros for pilot youth forum on bioethics |
Ireland |
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· Youth Forum for Bioethics – pilot with young people from Ireland |
5-6 June 2023 - Held over 2 days, back-to-back with a half day/one day overlapping with CDBIO |
CDBIO |
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4. Developing an annual online newsletter covering the work of the DH-BIO, bioethical developments in CoE member states and the ECHR case law |
· Strategic group to be set up within the Bureau to work on the content of the newsletter and its modalities with a view to make a proposal to the DH-BIO |
Strategic group and Secretariat |
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· Editorial board to be set up · To reach out larger audience · ECHR case law and major legal developments in member states · Relevant information provided by delegations and other possible national resources such as national ethics committees. |
Secretariat Editorial board |
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