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Strasbourg, 30 September 2022                                                CDBIO/T&EQ/CONS_RAP1

CONSULTATION MEETING ON THE DRAFT RECOMMENDATION ON EQUITABLE ACCESS TO MEDICINAL PRODUCTS AND MEDICAL EQUIPMENT

IN SITUATION OF SHORTAGE

Paris, 20 September 2022

Meeting report


I.          Welcome, introductory remarks and adoption of the agenda

1.      The Chair of the CDBIO Ms Ritva Halila (Finland), welcomed the participants to the meeting. The list of participants appears in Appendix I to this report. The agenda is attached as Appendix II to this report. The agenda was adopted without modifications.

II.        Examination of the Draft Recommendation revised in the light of delegations’ comments

Introduction

2.      The Chair reminded participants the objective of the Consultation meeting: To make proposals for the revision of the draft of the Recommendation on Equity of access to medicinal products and medical equipment in a situation of shortage, with a view to its finalisation, and to its approval at the 2nd CDBIO plenary meeting.

3.      The Chair also reminded participants that, at the 1st CDBIO plenary meeting (31 May – 3 June 2022), it was agreed “to organise a consultation meeting with delegations concerned to discuss in particular the wording of the scope and the section on criteria for priorisation.” In accordance with the methodology and timeframe for the Strategic Action Plan on Human rights and Technologies in biomedicine (2020 – 2025) agreed by the CDBIO, the finalisation, and approval of the draft Recommendation are foreseen at the 2nd plenary meeting (2–4 November 2022).

4.      The Chair clarified that the text under discussion was the revised version of the Draft Recommendation CDBIO (2022) 9 presented at the 1st CDBIO plenary meeting. This revised version considered the discussion held at the 1st CDBIO plenary meeting, including comments on the additional proposal presented by the Secretariat CDBIO (2022) Misc 1 BIL and the following written comments. This revised text was further submitted for comments to delegations.

5.      The exchange would focus first on chapter II of the draft Recommendation because this chapter received most of the comments (as compiled in documents CDBIO (2022) 19 and CDBIO (2022) 23). The discussion on the remaining parts will follow. Participants were also invited to propose modifications/clarifications to the draft Explanatory Memorandum (EM) prepared by the Secretariat in cooperation with Prof. Kristof Van Assche, consultant to the Secretariat.

6.      Upon request of one delegation, it was clarified, that the scope of the Recommendation does not cover vaccines despite some of its principles and provisions being applicable also to vaccines. It was agreed to clarify this issue in the Explanatory Memorandum.

Examination of the revised text and where relevant corresponding elements of the draft the Explanatory Memorandum

Chapter II, Article 4 – Non-discrimination

7.      Following a suggestion made by one delegation, it was clarified that the term discrimination should be read in the light of the jurisprudence of the European Court of Human Rights.


Chapter II, Article 5 – Prioritisation based on medical criteria

8.      Regarding paragraph 1, one delegation proposed to include in its list, the “will and preferences” of the individual involved. In reply, attention was drawn to the fact that the list focuses on medical criteria and medical assessment.

9.      In paragraph 2 the use of the term “urgent” was preferred on “immediate” because it is more relevant in the clinical practice and with the commonly used medical terminology.

10.   Most delegations agreed that the objectives of the priority-setting in paragraphs 2 (urgency) and 3 (non-urgency) have in common: first, reduction of mortality and "subsequently" morbidity. At the same time, it is recognized that the criteria and procedures for making decisions could be different. The term "worst off" in paragraph 3 did not appear clear in the context of this article.

11.   However, a delegation underlined that establishing as the sole objective the reduction of the risk of mortality and morbidity in any situation (urgency and non-urgency) was not acceptable considering that in a situation of non-urgency other objectives come into play, such as the improvement of the patient's quality of life or the gained years of life.  Other delegations agreed with this argument.

12.   In the light of the discussion, delegations agreed to delete paragraph 3 (situations where there is no urgent situation). The delegations agreed to leave it to each country to define the priority setting objectives when there was no urgent need for healthcare. 

13.   Regarding the proposal to include a paragraph 4 under Article 5 or a paragraph 2 under Article 6, recommending "specific attention for individuals and groups who are disadvantaged in relation to health" delegations agreed that this paragraph was neither relevant to the elements of Article 5, which focuses on medical criteria, nor to Article 6, focusing on barriers that prevent equitable access to health.

14.   Considering the importance of providing provisions for these individuals and groups, also in the light of the experience gained during the COVID19 pandemic, delegations agreed to create a new article. This article was placed immediately after the general provisions on non-discrimination (art. 4) and before the provisions on medical criteria. It was also agreed that the causes mentioned as the origin of possible situations of disadvantage (economic and social conditions, disability, chronic disease, and age) should be cited as examples.

Chapter II, Article 6 – Appropriate support and removal of barriers

15.   No modification was made in the provisions.

Chapter II, Article 7 – Respect for dignity

16.   The title was changed to read Respect for dignity of persons excluded from access. The word “opportune” was substituted with “appropriate.” 

Other provisions and preamble

17.   In the light of this change introduced in Chapter II, the definition of “health inequities” in Art. 3 was suppressed as well as Art. 20, to avoid redundancies.

18.   In Article 18, delegations agreed to delete the provisions referring to “adapting equipment for alternative purposes” and “re-using materials,” as well as to delete in the preamble the reference to “unpredictable events and developments, such as epidemiological outbreaks and armed conflicts, and by the negative health-related effects of climate change.”

19.   The Secretariat was entrusted with the task of verifying in each paragraph of the Recommendation whether it was appropriate to use “and/or” rather than "and" (medicinal products and/or medical equipment). In the English version, the delegations agreed to change in the title of article 1 the word “Purpose” with “Object”.

20.   One delegation requested to include in the Explanatory Memorandum a reference to “solidarity” that was eliminated from the preamble in the revision of the draft Recommendation. The importance of having in place policies and systems to prevent situations of shortage will be stressed in the Explanatory Memorandum.

III.   Conclusions

21.   The Chair thanked participants for their work and constructive discussions during this meeting.

22.   The version of the draft Recommendation as revised during the Consultation meeting, which be sent to Delegations in view of it approval at the 2nd CDBIO (2–4 November 2022).


APPENDIX I

List of participants

ANDORRA

KUDO

Mr David PÉREZ SURRIBAS

President of the National Committee of bioethics

ARMENIA

KUDO

Ms Anna MKRTUMYAN

Head of the Legal Department

Ministry of Health

AUSTRIA

COE

KUDO

Prof. Andreas VALENTIN

Member of the Bioethics Commission

Mr Stefan SCHWAB

Judge

Ministry of Justice

AZERBAIJAN

KUDO

Apologised

Dr Ismayil S ZULFUGAROV

Head of Proteomics Lab

Institute of Molecular Biology and Biotechnologies of the Azerbaijan National Academy of Sciences

BELGIUM

KUDO

Apologised

Prof. Paul COSYNS

Comité consultatif de Bioéthique de Belgique

BOSNIA AND HERZEGOVIA

KUDO

Apologised

Ms Dunja PEJOVIC

Coordinator of the Regional Health Development Center for Mental Health in SEE

Ministry of Civil Affairs

CZECH REPUBLIC

COE

(Bureau member)

Doc. JUDr. Tomáš DOLEŽAL

Head of the Department of Private Law and Head of the Research Unit for Medical Law and Bioethics

Czech Academy of Science, Institute of State and Law

ESTONIA

KUDO

Dr Aime KEIS

Vicechair of the National Committee on Bioethics and Human Research

University of Tartu

FINLAND

COE

(Bureau member)

Prof. Ritva HALILA

Docent, Senior Medical Officer

Ministry of Social Affairs and Health

FRANCE

COE

Mr Kamyar ASSARI

Consultant juridique

Sous-direction des droits de l’Homme

Direction des affaires juridiques

Ministère de l’Europe et des Affaires étrangères

IRELAND

KUDO

(Bureau member)

Prof. Siobhán O’SULLIVAN

Royal College of Surgeons


ITALY

COE

(Bureau member)

Prof. Assunta MORRESI

Prof. Associato di Chimica Fisica, Dipartimento di Chimica, Biologia e Biotecnologi

Università degli Studi di Perugia

GERMANY

COE

Dr Ingo HÄRTEL

Division 316

Federal Ministry of Health

MALTA

COE

(Bureau member)

Prof. Pierre MALLIA

Professor of Family Medicine, Bioethics & Patients’ Rights, Chairperson, National Health Ethics Committee, Dept. of Health, Chairperson, Bioethics Consultative Committee

Ministry of Health

NETHERLANDS

COE

Mr Harrie STORMS

Ministry of Health, Welfare and Sports

Ms Sanne VAN WEEZEL

Ministry of Health, Welfare and Sports

SAN MARINO

COE

Dr Luisa BORGIA

President of the National Bioethics Committee

SERBIA

KUDO

Prof. Dr Zvonko MAGIC

Head of the Institute for Medical Research in the MMA (Military Medical Academy), professor of the human genetics at the Medical Faculty and Cochairmen of the National Committee for bioethics of UNESCO Commission of Serbia

Serbian Academy of Sciences and Arts

SLOVENIA

KUDO

Prof. dr. Marjeta TERČELJ ZORMAN, MD

Vice President of the National Ethics Commission

SWEDEN

KUDO

Ms Tesi ASCHAN

Legal Adviser

The National Board of Health and Welfare, Socialstyrelsen

UKRAINE

KUDO

Ms Iuliia DAVYDOVA

Professor, Head of High-Risk Pregnancy Department

Institute of Pediatrics, Obstetrics and Gynecology, member of Local Bioethics Committee

UNITED KINGDOM

COE

(Bureau member)

Dr Mark BALE

Advisor to the Science Research and Evidence Directorate

Department of Health and Social Care

MEXICO

KUDO Apologised

KUDO

KUDO

Patricio SANTILLAN DOHERTY, MD

National Bioethics Commissioner

Gabriela PINEDA HERNANDEZ, PhD

Director on Institutional Development

Gustavo OLAIZ BARRAGAN, MA

Deputy Director on Public Policy and Bioethics

OCDE

COE

Apologised

Mr Hermann GARDEN

Policy Analyst

Directorate for Science, Technology and Innovation

CONSULTANT

COE

Prof. Kristof VAN ASSCHE

Universiteit Antwerpen

Belgium

SECRETARIAT OF HUMAN RIGHTS AND BIOMEDICINE DIVISION

COE

Ms Laurence LWOFF

Secretary of the CDBIO

[email protected]

Dr Lorenzo MONTRASIO

Scientific Administrator

[email protected]

THE INTERPRETING, TRAVEL, EVENTS AND MULTIMEDIA DEPARTMENT (ITEM)

COE

Ms Léa OUEDRAOGO

Ms Fabienne KISSIAN


APPENDIX II

Agenda

1.    Adoption of the agenda

2.    Examination of the Draft Recommendation revised in the light of delegations’ comments

a. Introduction

-       Short introduction of the changes made in the revised draft

-       Delegations invited to make general comments on the revised draft

             

b.  Examination of the revised text and where relevant corresponding elements of the draft the Explanatory Memorandum

                                 i.   Chapter II, Article 4 – Non-discrimination

                                ii.   Chapter II, Article 5 – Prioritisation based on medical criteria

                               iii.   Chapter II, Article 6 – Appropriate support and removal of barriers

                              iv.   Chapter II, Article 7 – Respecting for dignity

                               v.   Other provisions and preamble

3.    Conclusions

Useful documents

Draft Recommendation on equitable access to scarce medicinal products and medical equipment

Comments from CDBIO delegations on version CDBIO(2022)9

Comments from CDBIO delegations on version CDBIO(2022)9REV