Council of Europe

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Strasbourg, 28 October 2022 CDBIO(2022)OT+OJ2 PROV

IN THE FIELDS OF BIOMEDICINE AND HEALTH (CDBIO), 2nd meeting, 2-4 November 2022, Room 11 (Palais de l’Europe), Draft Agenda/draft Order of Business

LIST OF ITEMS

1. Adoption of the agenda

2. Equitable access to medicinal products and medical equipment in shortage situation

3. Draft recommendation for the promotion of voluntary measures

4. Guide to health literacy: contributing to trust building and equitable access to healthcare

5. Guide on children participation in decision making process on matters relevant to their health

6. Neurotechnologies and human rights

7. Preparation of the mid-term review of the SAP

8. Youth Forum

9. Artificial intelligence and biomedicine

10. Overview of legislation and practices on patients’ rights

11. Bureau elections

12. Adoption of decisions taken at the 2^nd plenary meeting

13. Dates of the next meetings

14. Other business

Points for information to be dealt only in writing

15. Developments in the field of bioethics

16. Chart of signatures and ratifications of the Convention on Human Rights and Biomedicine, the Protocol on the Prohibition of Cloning Human Beings, the Protocol concerning Transplantation of Organs and Tissues of Human Origin, the Protocol concerning Biomedical Research and the Protocol concerning Genetic Testing for Health Purposes

17. Cooperation with other committees

Wednesday 2 November 2022 (09.30- 13.00 / 14.30 - 18.00)
	1. Adoption of the draft agenda o New CDBIO members invited to introduce themselves o Reminder about the main decisions to be taken during the meeting
	Essential documents
	CDBIO(2022)OT+OJ2PROV	Draft Order of Business and Draft Agenda
	CDBIO/BU RAP(2022)2	Meeting Report of the Bureau (Paris, 20-21 September 2022)
	CDBIO/RAP1	Meeting Report of the 1^st CDBIO meeting (31 May-3 June 2022)

	2. Equitable access to medicinal products and medical equipment in shortage situation Objectives: o Approval of the draft Recommendation on equitable access to medicinal products and medical equipment in shortage situation, with a view to its presentation to the Committee of Ministers for adoption o Finalisation of the Explanatory Memorandum
	Essential documents
	CDBIO(2022)9 REV2	Draft Recommendation revised in the light of the comments at the consultation meeting on 20 September 2022
	CDBIO(2022)22	Draft Explanatory Memorandum
	Useful documents
	CDBIO(2022)23	Comments from CDBIO delegations on the draft Recommendation (doc. CDBIO(2022)9REV)
	CDBIO(2022)19	Comments from CDBIO delegations on the draft Recommendation (doc. CDBIO (2022) Misc 1 BIL)
	CDBIO (2022) Misc 1 BIL	Draft Recommendation on equitable access to scarce medicinal products and medical equipment
	CDBIO(2022)2 REV	SAP Update methodology and timeframe for the priority actions planned revised in the light of the priorities agreed
	CDBIO/TEQ/CONS RAP1	Meeting report of the Consultation meeting (Paris, 20 September 2022)
		Statement on COVID-19 and vaccines: Ensuring equitable access to vaccination during the current and future pandemics

	3. Draft Recommendation for the promotion of voluntary measures Objective: o Examination of the preliminary draft Recommendation prepared by the Bureau
	Essential documents
	CDBIO(2022)27	Draft Recommendation promoting the use of voluntary measures in mental health care services – key principles, Bureau proposal, document prepared by Dr Elaine Gadd, Consultant
	CDBIO(2022)28	Preliminary outline of draft Recommendation promoting the use of voluntary measures in mental healthcare services, proposed by the Bureau, based on a document prepared by Dr Elaine Gadd, Consultant
	Useful documents
	CDBIO(2022)32	Comments on Draft Recommendation promoting the use of voluntary measures in mental health care services
	CDBIO/BU RAP(2022)2	Report of the Bureau meeting (20-21 September 2022)
	CM/Del/Dec(2022)1434/4.2	Decision of the Committee of Ministers
Thursday 3 November 2022 (9.00-13.00 / 14.30-18.00)
	4. Guide to health literacy: contributing to trust building and equitable access to healthcare Objective: o Adoption of the Guide
	Essential document
	CDBIO(2022)6 REV	Draft “Guide to health literacy: contributing to trust building and equitable access to healthcare” revised in the light of the delegations’ comments received
	Useful documents
	CDBIO(2022)25	Comments from the CDBIO delegations on the draft Guide (doc. CDBIO(2022)6 REV)
	CDBIO(2022)20	Comments from the CDBIO delegations on the draft Guide (doc. CDBIO(2022)6)
	CDBIO(2022)6	Draft “Guide to health literacy: contributing to trust building and equitable access to healthcare”
	CDBIO(2022)6 Addendum	Addendum to the Draft Guide to health literacy: contributing to trust building and equitable access to healthcare
	CDBIO(2022)2 REV	SAP Update methodology and timeframe for the priority actions planned revised in the light of the priorities agreed

	5. Guide on children participation in decision-making process on matters relevant to their health o Information on the progress of the Consultation process being carried out
	Useful documents
	BIO/ENF-CP (2022)1 REV2	Revised Draft Guide to good practice concerning the participation of children in the decision-making processes on matters regarding their health, sent for stakeholders and children consultation
	BIO-ENF/CP (2022) 4	Comments children participation
	BIO-ENF/CP (2022)3 REV3	Compilation of examples of practices aimed at promoting children’s participation in the decision-making process in matters regarding their health
	CDBIO(2022)8 CDENF(2022)09	Draft Guide to good practice concerning the participation of children in the decision-making processes on matters regarding their health
	BIO-ENF/CP (2021) 2 REV5	Timeline of the BIO/ENF-CP Drafting Group
	BIO/ENF-CP RAP (2022)3	Report of the 3rd meeting of the Joint Drafting Group BIO/ENF-CP (22-23 September 2022)
	CDBIO(2022)2 REV	SAP Update methodology and timeframe for the priority actions planned revised in the light of the priorities agreed

	6. Neurotechnologies and human rights Objectives: o Presentation of the report of the Round table o Information on the communication strategy for the report
	Essential document
			Report of the Round table on human rights and neurotechnologies
	Useful document
			Neurotechnologies and human rights framework: do we need new human rights?

	7. Preparation of the mid-term review of the SAP Objectives: o Agreement on the methodology for the preparation of the mid-term report planned in the SAP o Early discussions on possible future priorities with a view to the mid-term review requested in spring 2023 by the Committee of Ministers for the quadrennium 2022-2025
	Essential document
	CDBIO(2022)30	Proposal from the Bureau on the methodology for the preparation of the mid-term report planned in the SAP
	Useful documents
	CDBIO/BU RAP(2022)2	Report of the Bureau meeting (20-21 September 2022)
	CDBIO(2022)2 REV	SAP Update methodology and timeframe for the priority actions planned revised in the light of the priorities agreed

	8. Youth Forum Objective: o Examination of the proposal prepared by the preparatory group for the (pilot) Youth Forum to be held in Spring 2023
	Essential document
	CDBIO(2022)21	Concept note for the (pilot) Youth Forum
	Useful document
	CDBIO(2022)2 REV	SAP Update methodology and timeframe for the priority actions planned revised in the light of the priorities agreed
Friday 4 November 2022 (9.00- 13.00)
	9. Artificial intelligence and biomedicine Objective: o Presentation of the conclusions of the first meeting of the drafting group and guidance from the CDBIO on the way forward
	Essential document
	CDBIO/AI(2022)RAP1		Report of the 1^st meeting of the Drafting Group (3 October 2022)
	Useful documents
	CDBIO/INF(2022)5		Report on the impact of artificial intelligence on the doctor-patient relationship by Brent Mittelstadt
	CDBIO(2022)2 REV		SAP Update methodology and timeframe for the priority actions planned revised in the light of the priorities agreed

	10. Overview of legislation and practices on patients’ rights Objective: o Examination of the proposal from the Bureau

	Essential document
	CDBIO/BU RAP(2022)2	Report of the Bureau meeting (20-21 September 2022), Paragraphs 16-25

	11. Bureau elections Objectives: o Election of the Chair and Vice Chair for a one-year term renewable once o Subject to the result of the election of the Chair and Vice Chair, election of three Bureau members: - The terms of three Bureau members are coming to an end. Two are not re-eligible (Pierre Mallia and Rodica Gramma) and one is re-eligible for another term of two years (Assunta Morresi) Submission for nominations should be sent in writing to the Secretariat by Thursday 3 November 2022 at 2.00 pm.
	Essential document
	CDBIO(2022)29	Bureau elections

	12. Adoption of decisions taken by the CDBIO at its 2^nd meeting o Approval of the abridged meeting report which includes the decisions

	13. Dates of the next meetings 3^rd meeting of the CDBIO: 6-9 June 2023 4^th meeting of the CDBIO: 14-17 November 2023

	14. Other business o Equitable and timely access to innovative treatments and technologies in the healthcare system: setting up of a Drafting group

POINTS TO BE DEALT WITH IN WRITING


	15. Developments in the field of bioethics Delegations, including observers, are invited to send information in writing. Developments in member states and other states Developments in the field of bioethics in international organisations Developments in other Council of Europe bodies Developments at the European Court of Human Rights
	Essential documents
	a. CDBIO/INF(2022)15	Developments in the field of bioethics in member states and other states
	b. CDBIO/INF(2022)16	Developments in the field of bioethics in international organisations
	c. CDBIO(2022)31	Developments in the field of bioethics in other Council of Europe bodies
	d. CDBIO/INF(2022)14	Developments in the field of bioethics in the European Court of Human Rights

	16. Chart of signatures and ratifications of the Convention on Human Rights and Biomedicine, the Protocol on the Prohibition of Cloning Human Beings, the Protocol concerning Transplantation of Organs and Tissues of Human Origin, the Protocol concerning Biomedical Research and the Protocol concerning Genetic Testing for Health Purpose
	Useful document
	CDBIO/INF(2022)4	Chart of signatures and ratifications

	17. Cooperation with other committees a. European Committee on Organ Transplantation (CD-P-TO) b. European Committee on Blood Transfusion (CD-P-TS) c. Consultative Committee of the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (T-PD) d. Steering Committee for the Rights of the Child (CDENF) e. Steering Committee for Legal Cooperation (CDCJ)
	Useful documents
	CDBIO(2022)31	Developments in the field of bioethics in other Council of Europe bodies
	CD-P-TO	Terms of reference
	CD-P-TS	Terms of reference
	T-PD	Rules of procedure
	CDENF	Terms of reference
	CDCJ	Terms of reference

DOCUMENTS FOR POSSIBLE UPDATE BY DELEGATIONS
	Delegations are invited to provide where appropriate updated information of the following documents
	CDBIO/INF(2022)9	Updated Questionnaire on Medically Assisted Procreation (MAP). Replies of delegations
	CDBIO/INF(2022)9 Addendum	Replies to the questionnaire on surrogacy
	CDBIO/INF(2022)10	Background document on preimplantation and prenatal genetic testing -legislation
	CDBIO(2022)14	Legislative developments on nuclear transfer and their relationship with Article 18.2 of the Convention
USEFUL DOCUMENTS FOR SEVERAL ITEMS
	CDBIO/RAP1	Report of the 1^st meeting of the CDBIO (31 May-3 June 2022)
	CDBIO/BU RAP(2022)2	Meeting Report of the Bureau (Paris, 20-21 September 2022)
GENERAL INFORMATION DOCUMENTS FOR REFERENCE
		Strategy for the Rights of the Child (2022-2027)
	CM/Res(2021)3	Resolution on intergovernmental committees and subordinate bodies, their terms of reference and working methods
	CDBIO/INF(2022)2	Information document on the CDBIO
	CDBIO/INF(2022)3	Texts of the Council of Europe on bioethical matters, Volume I
	CDBIO/INF(2022)3	Texts of the Council of Europe on bioethical matters, Volume II
	Please click on the respective link to open the Convention and its Protocols	Convention on Human Rights and Biomedicine (ETS 164)
		Explanatory Report to the Convention on Human Rights and Biomedicine
		Additional Protocol to the Convention on Human Rights and Biomedicine on the Prohibition of Cloning Human Beings (ETS 168)
		Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin (ETS 186)
		Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research (CETS 195)
		Additional Protocol concerning Genetic Testing for Health Purposes (CETS 203)