2002cm116






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    CM(2002)116 6 August 2002
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    807 Meeting, 11 September 2002
    10 Legal questions


    10.2 Steering Committee on Bioethics (CDBI) -

    Abridged report of the 22nd meeting (Strasbourg, 3-6 June 2002) 1

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    Introduction

    1. The Steering Committee on Bioethics (CDBI) met at the Palais de l’Europe (Strasbourg) from 3 to 6 June 2002.

    2. The meeting was chaired by Mrs Ruth REUSSER (Switzerland).

    3. The list of participants can be obtained from the Bioethics Division; the agenda is set out in the Appendix.

    4. The Chair welcomed the new delegation members and observers: Mr Samir MEKHTIYEV (Azerbaijan), Mrs Ana BOROVECKI (Croatia), Mrs Klaudie SOUCKOVA (Czech Republic), Ms Andrea SPELBERG (Germany), Dr George-Cristian CURCA (Romania), Ms Eva KARLSSON HELGHE (Sweden), Mrs Eva LINDEBLAD (Sweden), Mr Tsugumasa HORITA (Japan), Mr Frank GEORGE (WHO) and Dr Juhana E IDÄNPÄÄN-HEIKKILÄ (CIOMS).

    5. The Committee was delighted that Professor Jean-François MATTEI (France), who had very actively represented the Parliamentary Assembly at the CDBI for the past few years, had been appointed Minister of Health, Family and Handicapped Persons. The Committee asked the French delegation to convey its congratulations to Professor MATTEI.

    6. The Committee adopted the draft agenda and the order of business.

    Chart of signatures and ratifications of the Convention on Human Rights and Biomedicine, the Protocol on the Prohibition of Cloning Human Beings and the Protocol concerning Transplantation of Organs and Tissues of Human Origin

    7. The Committee took note of the latest changes. The Secretariat drew the attention of delegations whose countries had not yet signed or ratified the Convention and its Protocols to the importance of these texts and invited them to consider the advisability of proceeding to their signature or ratification.

    Developments in the field of bioethics in member States, other States and international organisations

    8. The Secretariat said that a document (CDBI/INF (2002) 4) was available to delegates. This was a public document and was published on line on the bioethics website.

    9. The German delegation informed the Committee that the parliamentary Study Commission on “Law and ethics in modern medicine” had presented its final report to the German parliament. This report can be found on the internet at:
    http://dip.bundestag.de/btd/14/090/1409020.pdf

    The section of the report on stem cells had been submitted to the parliament at an earlier date. It is also available on internet in English: http://www.bundestag.de/gremien/medi/2zwischen_engl.pdf

    The delegation then indicated that the German parliament had decided to prohibit the import of embryonic stem cells except in some specific circumstances. It also mentioned that an international bioethical conference had been organised in Berlin by the German and French Foreign Ministries in cooperation with the German and French National Ethics Committees to which many international experts from around the world had been invited. Finally, it was reported that the German Medical Association had decided that its members no longer had to abide by the Declaration of Helsinki.

    10. The Bulgarian delegate stated that a new law on transplantation of organs and tissues had already passed the first reading in the Parliament and that a new law on public health was under preparation.

    11. The Swiss delegate indicated that a referendum had just been held in her country in which 72 % of the population approved a reform in the law giving women a legal right to a voluntary interruption of a pregnancy. Furthermore, the government launched a consultation of the concerned institutions with respect to the draft law relating to research on supernumerary embryos and embryonic stem cells.

    12. The delegation from the Netherlands specified that the Dutch law on euthanasia had now entered into force on the 1st of April 2002.

    13. The Latvian delegate announced that her parliament had adopted a law on sexual and reproductive health and was now considering a draft law relating to research on the human genome.

    14. The Ukrainian delegate stated that Ukraine had signed the Convention on Human Rights and Biomedicine in March 2002.

    15. The delegate from Sweden indicated that a law regulating the use of human biological material from tissue banks within the medical care sector had recently been adopted. This act regulates how human biological material, with respect for the personal integrity of the individual, is to be stored and used for diagnosis or research. The act will come into force on 1 January 2003. Another development was that the Swedish government had recently decided to give supplementary terms of reference to the Committee on genetic integrity (at present reviewing a number of issues regarding genetic testing etc). According to the new terms of reference the Committee would consider certain issues relating to stem cell research. Proposals would be presented by December 2002. The Committee should submit proposals for amendments of the Swedish Embryo Research Act that the Committee deems necessary to elaborate a legal structure that would allow research on stem cells from fertilised eggs left over after from vitro fertilisation. The Committee would evaluate whether ethically acceptable conditions for somatic cell nuclear transfer exist and suggest necessary legislative changes. The Committee should also propose a clear ban on reproductive cloning.

    16. The delegates were informed that, in Croatia, the first National Ethics Committee was formed in 2001 and that a draft protocol and law on artificial reproduction was being prepared.

    17. The delegate from the Czech Republic indicated that a new law on transplantation had been enforced in which the “opting-out” system was chosen which enables persons refusing organ donation to register their opposition to such a course of action. Moreover, new laws on health care and biomedical research were being considered.

    18. The committee was informed that the Russian parliament had adopted a moratorium on human cloning and that the law on the moratorium was signed by President Putin on 7 May 2002.

    19. The Secretariat finally announced that the Secretary General had sent a letter and questionnaire concerning organ trafficking to the Foreign Affairs ministers of member States. The questionnaire was in two parts, the first relating to organisational aspects and the second to the legal situation in the countries.

    20. National delegations were also invited to send to the Secretariat any news concerning bioethics in their countries (with internet links) so that it could be included in the Council of Europe website.

    Working Party on Biomedical Research (CDBI-CO-GT2)

    21. The Chair of the Working Party on Biomedical Research, Dr. Rosemary BOOTHMAN (Ireland) gave an account of the 25-27 March meeting of the Working Party. She told that the Working Party had reviewed the comments sent in by CDBI delegations and European NGOs, took them into account and produced a final draft of the Protocol. This draft Protocol was now being submitted to the CDBI in view of adoption.

    22. The CDBI proceeded to review the Articles of the draft Protocol with a view to their final adoption.

    Article 1 – Object and purpose

    23. This Article was put to a vote. It was adopted without opposition with 1 abstention.

    Article 2 - Scope

    24. The CDBI started a discussion on the scope of the Protocol.

    25. The Chair of the CDBI called a vote on whether the Committee wished to give a mandate to the Secretariat and an editorial committee to prepare and propose for the December Plenary a definition of “biomedical research” that could be included in the Protocol itself. This proposal was supported by 17 delegations, with 12 against, and 5 abstaining.

    26. The Chair of the CDBI called a vote on whether the Committee wished to give a mandate to the Secretariat and an editorial committee to prepare and propose for the December Plenary a definition of “intervention” that could be included in the Protocol itself. This proposal was supported by 19 delegations, with 10 being opposed, and 4 abstaining.

    Article 3 – Primacy of the human being

    27. The Chair of the CDBI called a vote on the initial wording of the Article. It was adopted without opposition with 1 abstention.

    Article 4 – General rule

    28. The Chair of the CDBI called a vote on the Article. It was adopted without opposition with 1 abstention.

    Article 5 – Absence of alternatives

    29. The Chair of the CDBI proposed that the December Plenary reconsider this Article in the context of the reconsideration of Article 2 and the scope. It was requested that delegations send written comments to the Secretariat so that a new formulation of this Article could be prepared.

    Article 6 – Risks and benefits

    30. The Chair of the CDBI called a vote on the Article. It was adopted without opposition with 1 abstention.

    Article 7 – Research on persons without potential direct benefit

    31. It was agreed that this Article would be reconsidered.

    Article 8 - Approval

    32. The CDBI agreed to edit paragraph 1 so that it would reproduce the wording of the Convention.

    33. The Chair of the CDBI called a vote on the edited paragraph 1 of this Article. It was adopted without opposition with 2 abstentions.

    34. The discussion turned to paragraph 2 of the Article concerning consideration being given to the relevance of the research to the local community.

    35. The Chair of the CDBI called a vote on deleting paragraph 2. Deletion was accepted without opposition with 4 abstentions.

    Article 9 –Scientific quality

    36. The Chair of the CDBI called a vote on adopting the Article. Adoption was accepted without opposition with 2 abstentions.

    Article 10 – Independent examination

    37. The Chair of the CDBI called a vote on the full Article. It was adopted without opposition with 1 abstention.

    Article 11 – Independence of the ethics committee

    38. The title of the Article was changed to “Independence of the ethics committee” to better reflect its content.

    39. The Chair of the CDBI called a vote on the Article with a modified title. It was adopted without opposition with 2 abstentions.

    Article 12 – Information for the ethics committee

    40. Several delegations thought that the list of items in this Article was too extensive. Other delegations were satisfied with the list.

    41. The Secretariat proposed a principle of requiring that sufficient information be submitted to the ethics committee followed by a list of items that could be relevant. It put forward a modified first paragraph reading, “ All information which is necessary to the ethical assessment of the project, shall be given in written form to the ethics committee. In particular, all the relevant information on the following items shall be included.”

    42. The Chair of the CDBI called a vote on the paragraph proposed by the Secretariat and the principle that the relevant items from the list would be supplied by researchers to the ethics committee. A full text would be proposed to the Plenary in December. Written comments would be accepted by the Secretariat until the end of August. The principle was supported without opposition with 4 abstentions.

    Article 13 - Undue influence

    43. It was proposed that Articles 13 and 14 be combined with the second paragraph reading, “ Particular attention shall be paid that dependent persons and vulnerable persons not be subjected to undue influence.”

    44. This modification of Article 13 and deletion of a separate Article 14 was supported in principle. The CDBI would return to the discussion in December.

    Article 15 – Information for research participants

    45. It was proposed that the words “where relevant” could be added to the end of paragraph 1 and that a list could follow. The CDBI did not object to the principle of this proposal and to the suggestion that the Plenary would return to this Article in December in the context of a decision on the scope.

    Article 16 - Consent

    46. The Chair of the CDBI concluded that more time was required to ponder this Article.

    Conclusion

    47. The Chair of the CDBI concluded that the aim would be to examine all the remaining articles and adopt the whole of the Protocol in December. Comments on the Protocol and its Explanatory report would be accepted until the end of August. A meeting of the Working Party or representatives of the Working Party would be held in the fall if budgetary conditions permit.

    Review of the draft instrument on the use of archived human biological materials and related personal data in biomedical research

    48. The rapporteurs, Dr. Imogen EVANS (United Kingdom) and Prof. Henriette ROSCAM ABBING (Netherlands), presented their work on the draft instrument on the use of archived human biological materials and related personal data in biomedical research.

    49. The text of the instrument and its Explanatory report were submitted to the CDBI with a view to their declassification for consultation in September in a manner to be determined by each Member State. It was explained that this text would be published in the name of the two rapporteurs with a view to collecting comments in order to elaborate an appropriate instrument.

    50. A vote was held. The result was unanimous for declassification with 4 abstentions.

    51. It was requested that comments on the instrument or its Explanatory report be sent to the Secretariat by the end of June 2002. These would be taken account of by the rapporteurs and the Secretariat in the updating of the instrument and Explanatory report, which would be published in September 2002. Comments issuing from the consultation on these texts would be accepted until the end of January 2003.

    Working Party on Xenotransplantation (CDBI/CDSP-XENO)

    General Comments

    52. The Chair of the Working Party, Mr. Bart WIJNBERG (Netherlands), gave a brief presentation of developments in xenotransplantation. He indicated that he had participated in two ad hoc meetings in December 2001 and April 2002 with representatives from the CDBI and the CDSP. At these meetings it had been decided to reinforce the Public Health aspects of the draft Recommendation on Xenotransplantation.

    53. The Chair of the Working Party also emphasised that the draft Recommendation defined xenotransplantation as covering the transplantation of human tissues and cells which had been in contact with live animal cells. In this respect he indicated that procedures such as the use of skin cells grown on animal feeder cells in the treatment of burns victims were not considered as research procedures in a number of States and that the draft Recommendation had to include provisions taking into account both clinical research and standard clinical practice.

    Draft Recommendation on Xenotransplantation [these comments are developed in the full version of the CDBI meeting report (CDBI/RAP22)]

    Preamble

    54. It was agreed by the delegates to add the term “cultural” to the different possible issues to be taken into account when considering xenotransplantation, it being understood that religion was included in cultural issues.

    55. The delegates accepted (by 27 delegations in favour, 2 against and 6 abstentions) to replace the original expression in indent A by “adapt their legislation and practice in the field of xenotransplantation to the following principles and guidelines…”, it being understood that the word “adapt” in this sentence included the meaning of “adoption” and could be used with respect to States already having or not yet having texts on xenotransplantation.

    56. The Committee accepted (by 20 delegations in favour, 5 against and 7 abstentions) to include in indent A a sentence on public debate reading “take steps to make the provisions of this Recommendation subject to public debate”.

    Article 1 - Object of the Recommendation

    57. Article 1 was adopted without opposition or further comment.

    Article 2 – Scope of the Recommendation

    58. After a short discussion on the scope of the Recommendation, Article 2 was adopted without opposition.

    Article 3 - Definition

    59. The Committee agreed to give a description and examples of close personal contacts under the comments relating to Article 14 of the Explanatory Report.

    60. Article 3 was then adopted without opposition.

    Article 4 – Xenotransplantation - the setting

    61. Article 4 was adopted without opposition or further comment.

    Article 5 – Xenotransplantation authorisation

    62. The Committee agreed that the Explanatory Report should make it clear that the wording in paragraph 1.a.i and 2.i is meant to imply that, in accordance to the state of the art, there is no foreseeable risk.

    63. The Committee agreed that Article 5 should not only cover risks of infection but all risks which could be of relevance to the general population and to make the necessary changes in this and all subsequent Articles.

    64. The delegates decided to mention in the Explanatory Report that authorisation to clinical research needed to address the benefit (in a broader sense) for the recipient and that a reference should be made to Article 12.

    65. The delegates also decided to emphasise in paragraph 2 indent i that the evidence stating that no risks existed for the general population should be demonstrated in an appropriate manner and therefore that it should be in accordance with internationally accepted scientific standards.

    66. The Article was then adopted without opposition.

    Article 6 – Xenotransplantation teams and centres

    67. The Article was adopted without opposition.

    Article 7 – Public Health Protection Plan

    68. The Committee agreed that the plan should not just address infectious events but should have a wider scope to cover any events possibly related to a xenotransplantation which could compromise public health, the Committee also decided to make a particular reference to the need for public authorities to take appropriate measures to respond to events of transmissible or previously unknown illness related to xenotransplantation including, in exceptional circumstances, the possibility of isolation.

    69. Since it was important that other States be informed of any adverse events, the Committee accepted to make a reference in the Explanatory Report to Article 32 which covers international co-operation in Public Health.

    70. The Article was then adopted without opposition.

    Article 8 - Follow-up

    Paragraph 1.

    71. The Committee agreed that to take into account only infectious events possibly related to a xenotransplantation appeared to be too restrictive and decided to make the necessary modifications in this respect.

    72. The delegates also decided, in order to emphasise the importance of enabling the traceability of the xenotransplants, to place Article 11 before Article 8.

    73. The Committee decided to give additional information concerning what was an “event” in the Explanatory Report. It also agreed that events possibly related to clinical xenotransplantation research which could be of relevance to public health should be addressed in the plan ensuring the traceability and monitoring of the recipients, their close personal contacts and the professional staff involved in xenotransplantation.

    74. Because the term “traçabilité” was considered by delegations as unacceptable in the French version when used in the context of a person, the Committee agreed to use the expression “pouvoir être retrouvés” instead.

    Paragraph 2.

    75. The Committee concurred to separate the two issues of traceability and monitoring and agreed that a plan should be set-up to address xenotransplantation other than in clinical research. This plan should enable traceability of the recipient in every circumstance. The delegates agreed to mention in the Article that the plan should include communication to national public health authorities of any events, in particular of infection, possibly related to xenotransplantation other than in clinical research and which could be of relevance to public health.

    76. The Article was then adopted without opposition.

    Article 9 – Precautions relating to the transmission of disease

    77. The committee agreed that the Quality Assurance should reflect its “appropriateness” and decided to make the relevant modification.

    78. Article 9 was then adopted without opposition.

    Article 10 - Prohibition relating to the use of certain animals

    Paragraph 2.

    79. The Committee decided to enable the xenotransplantation of cell lines obtained from non-human primates. It also agreed to continue to emphasise the protection of public health, making it a condition that the provisions of Article 5 were fulfilled. The delegates, at the same time, concurred to address the protection of non-human primates while implying that Great Apes should not be used as source animals.

    80. The Article was then adopted without opposition.

    Article 11 - Storage of data and biological samples

    81. The Committee agreed to place Article 11 before Article 8 in order to make it clear that samples of source animals were also being traced.

    82. The Article was then adopted without opposition.

    Article 12 – Conditions for patient participation

    Indent i.

    83. The Committee agreed that the Explanatory Report should make it clear that the possibility of allotransplantation for the patient should always be considered before xenotransplantation. The delegates decided, furthermore, to mention in the Explanatory Report that some routine procedures in clinical xenotransplantation may evolve with time and that indent i. should take this into account.

    84. The Article was then adopted without opposition.

    Article 13 – Information to be given to patients

    Paragraphs 1 and 2:

    85. The Committee agreed that the information should be given to the recipient in a comprehensible manner and decided to amend the text in this respect.

    Paragraph 2: Indents ii and iii.

    86. The Committee concurred that medical secrecy could only be lifted by the patient who should agree that information be passed-on and decide to modify Articles 14 and 16 in this respect.

    87. Moreover, the delegates accepted that only a xenotransplantation team was suitably qualified to provide the information to the recipient and to close personal contacts concerning the risks of infection and the constraints associated with xenotransplantation. The Committee decided to reflect this in the wording of the Article.

    88. The Article was then adopted without opposition.

    Article 14 – Information to be given to close personal contacts of the patient

    89. The delegates agreed that close personal contacts should only be informed by the medical team with the consent of the patient.

    90. The Article was then adopted without opposition.

    Article 15 – Information to be given to the professional staff involved in xenotransplantation

    91. This article was adopted without opposition or further comment.

    Article 16 – Consent to xenotransplantation

    92. The delegates accepted modifying the provisions to address the issue of consent by the patient that the necessary information concerning his or her current close contacts be provided to the medical team. Furthermore, the Committee agreed that the patient should accept that his or her current and future close personal contacts be given information concerning the xenotransplantation.

    93. A vote was then taken concerning the question: “Is Article 16 acceptable?”
    30 delegations were in favour, 0 were against, and 3 abstained.

    Article 17 - Counselling and support

    94. Article 17 was adopted without opposition or further comment.

    Article 18 – Right to medical care

    95. Article 18 was adopted without opposition or further comment.

    Article 19 – Patients not able to consent

    96. The Committee decided to make reference to Article 12 in the Explanatory Report to address the requirement that xenotransplantation should only be undertaken in the absence of a therapeutic alternative.

    97. Delegates agreed that though it may be possible for a xenotransplantation procedure to indicate that it might be lifesaving, this was still not seen a sufficient reason when considering a xenotransplantation research procedure for a patient unable to consent. Indeed, in this case the medical doctors should consider that no alternative means of saving the life of the specific patient which was unable to consent existed. The Committee decided, therefore, to add the appropriate text in this respect.

    98. A vote was taken concerning the question: “Should an improved formulation of paragraph 2 remain, allowing clinical xenotransplantation research on patients unable to consent?” 23 delegations were in favour, 6 were against and 5 abstained.

    99. Committee also accepted that a new paragraph should be included addressing the use of xenotransplantation for patients unable to consent in situations other than in clinical research.

    100. After considering the new paragraph 2 a vote was taken concerning the following questions:
    “Is the new paragraph 2 acceptable?” 26 delegations were in favour, 0 were against and 9 abstained.
    “Is the whole new Article 19 acceptable?” 26 delegations were in favour, 0 were against and 9 abstained.

    Article 20 - Confidentiality

    101. With some changes in the wording, Article 20 was adopted without opposition.

    Article 21 – Compulsory constraints relating to Public Health

    102. The Committee agreed that compulsory constraints should only apply, if the patient refused to comply with those constraints, once the xenotransplantation had taken place and decide to make the relevant changes to the first paragraph.

    103. Article 21 was then adopted without opposition.

    Article 22 – Compliance with animal protection regulations

    104. The Committee accepted that since it may not be possible to fully comply with the requirements of Appendix A because of the requirements of biosecurity necessary for xenotransplantation, the text should be amended to: “including the principles of Appendix A”.

    105. Article 22 was then adopted without opposition.

    Article 23 – Minimisation of the number of animals involved

    106. The Committee agreed to delete Article 23 and integrate the provision concerning the minimization of the number of animals involved into Article 24. The delegates also concurred to amend Article 32 to state that the use and suffering of the animals should be minimised.

    Article 24 – Husbandry, care and requirements of animals

    107. The delegates agreed that the minimisation of pain should be included in the text to bring it into conformity with other international instruments and decided to modify the text in this respect.

    108. Article 24 was then adopted without opposition.

    Article 25 – Responsibility for husbandry and care of animals

    109. Article 25 was adopted without opposition or further comment.

    Article 26 – Surgical derivation and early weaning techniques

    110. Article 26 was adopted without opposition or further comment.

    Article 27– Transport of animals

    111. Article 27 was adopted without opposition or further comment.

    Article 28 – Organ and tissue procurement from animals

    112. The delegates agreed that the explicit prohibition on sequential harvest of solid organs from individual animals was an important protective prohibition and decided to re-insert it in the text.

    113. After modifications in the wording, Article 28 was adopted without opposition.

    Article 29 – Collection of animal records

    114. Article 29 was adopted without opposition or further comment.

    Article 30 – Pre-clinical research

    115. Article 30 was adopted without opposition or further comment.

    Article 31 – Public debate

    116. The delegates agreed that the Article on public debate should also cover religious aspects and decided to add the term “cultural” into the list of implications to be discussed by the general public in accordance with the changes in the Preamble.

    117. Article 31 was then adopted without opposition.

    Article 32 – International co-operation in medical safety

    118. The Committee accepted to split Article 32 into two new ones, whereby the first Article would cover international co-operation in medical research and the second Article would address international co-operation in public health.

    119. The two new Articles were adopted without opposition.

    Article 34 – Implementation of the Recommendation

    120. Article 34 was adopted without opposition or further comment.

    Additional new Article on compensation

    121. After a discussion on the appropriateness of inserting a new Article on compensation, a vote was taken on the following questions:

    “Should the text relating to compensation found in the Convention on Human Rights and Biomedicine (and not any other text) be chosen without modifications?”
    19 delegation were in favour, 3 were against and 9 abstained.

    “Should the text relating to compensation found in the Convention on Human Rights and Biomedicine be added to the draft Recommendation on Xenotransplantation?”
    17 delegations were in favour, 2 were against and 7 abstained.

    Final vote concerning the whole draft Recommendation on Xenotransplantation:

    122. A vote was taken on the whole draft Recommendation on Xenotransplantation with the question: “Is the whole draft Recommendation on Xenotransplantation acceptable?”
    30 delegations were in favour, 0 were against and 3 abstained.

    Next steps

    123. The Committee noted that the draft Recommendation on Xenotransplantation would be sent to the CDSP for approval in the following weeks.

    124. If only small modifications were suggested by the CDSP, it was agreed by the Committee that these suggestions should be sent to the CDBI delegates and that both Secretariats of the Steering Committees would make any changes which were necessary. If, on the other hand, more important differences appeared between the CDBI and the CDSP, the Committee concurred that a small meeting with representatives and the chairpersons from both Steering Committees should take place with the Chairman of the Working Party on Xenotransplantation to resolve the differences, unless such differences were to be settled by the Committee of Ministers.

    125. Once both the Steering Committees had approved the draft Recommendation on Xenotransplantation, delegates were informed that it would then be submitted to the Committee of Ministers. At this point it was envisaged that the Committee of Ministers might decide to send the draft Recommendation to the Parliamentary Assembly for an opinion. The document would then be declassified and made public.

    Draft Explanatory Report to the draft Recommendation on Xenotransplantation

    126. Delegations were invited to submit any written comments they may have on the draft Explanatory Report on Xenotransplantation CDBI (2002) 14 to the CDBI Secretariat before 30 August 2002. This document would then be finalised by the Secretariat for 15 September 2002.

    State of the Art Report on Xenotransplantation

    127. Delegations were invited to check the State of the Art Report on Xenotransplantation that was presented to the Committee and send to the secretariat of the CDSP any necessary modifications or updates.

    Working Party on the Protection of the Human Embryo and Foetus (CDBI-CO-GT3)

    128. Professor Daniel SERRÃO (Portugal), Chair of the Working Party, presented to the CDBI the way forward considered for the work on the protection of embryo and foetus.

    129. He paid tribute to Ms Sandrine SABATIER and the members of the Working Party for the work achieved. However, he regretted the insufficient number of meetings and the lack of time at the plenary meetings for a thorough discussion on this issue.

    130. He recalled that the result of the indicative vote taken on the draft Protocol prepared by the Working Party has forced to reconsider for the moment the possibility of elaborating a binding Protocol to the Convention.

    131. It was now considered to elaborate a report which would present the issues and the different options possible.

    132. The Working Party should meet on 10-12 September 2002 to start the elaboration of this report which may require a second meeting before it is presented to the CDBI.

    Working Party on Human Genetics (CDBI-CO-GT4)

    133. In the absence of Dr Stefan WINTER (Germany), Chairman of the Working Party, Dr Elaine GADD (United Kingdom), Vice-Chair of the Working Party, presented the progress achieved in the elaboration of the draft Protocol.

    134. She recalled the requests made by the CDBI to exclude the applications of genetics to the embryo and the foetus from the scope of the Protocol and to finalise the provisions concerning the applications of human genetics for health purposes.

    135. The Working Party, while starting the drafting of the provisions concerning the applications of human genetics in the field of employment, was now working towards a finalisation of the medical chapter by the end of the year.

    136. To that end, the Working Party would welcome the views of the delegations of the CDBI on the question as to whether or not genetic counselling should always be necessary. Dr GADD pointed out that although information prior to consent was always necessary, the degree of genetic counselling might vary depending on the type of genetic application considered. She referred to the two alternative texts presented by the Working Party in Article 15 of the draft Protocol which could be considered by the CDBI.

    137. The CDBI had a brief exchange of views on this question. Several delegations stressed the need for a difference to be made between the tests depending on their implications when considering the need for genetic counselling.

    138. The cost of providing genetic counselling in all cases was also stressed.

    139. A delegation noted that the principle of proportionality should apply when considering genetic counselling. However, genetic counselling should always be provided even in a minimum form.

    140. A flexible approach to genetic counselling was generally supported.

    141. Lack of time prevented the CDBI from continuing its discussion on this issue. Dr GADD insisted on the importance of written comments to be sent to enable the Working Party to finalise the medical chapter of the Protocol. In addition to genetic counselling, these comments should focus on the provisions concerning genetic screening and research.

    142. Delegations to the CDBI were invited to send written comments, by 25 September 2002, on the draft Protocol on the applications of human genetics, in particular :
    - on genetic counselling, in particular the alternative texts presented for Article 15, and
    - on the provisions of the medical chapter of the draft Protocol, in particular those concerning genetic screening and research.

    Working Party on Psychiatry and Human Rights (CDBI-PH)

    143. There having been no further meetings of the Working Party since last year, the Committee noted that the Working Party will meet again at the beginning of autumn to consider the comments from delegations concerning the draft Recommendation. Delegations having not sent their comments are invited to do so as soon as possible and, at the latest, before the end of July 2002.

    144. The Bureau also noted that, following the publication of the White Paper, the Committee on Legal Affairs and Human Rights of the Parliamentary Assembly had decided to closely monitor the subject.

    DEBRA Project

    145. The Secretariat presented the DEBRA meetings foreseen for 2003: 2-3 September (Russian Federation), 16-17 September (for Ukraine in Strasbourg), and 23-24 October (Slovakia).

    Information on the European Conference of National Ethics Committees (COMETH)

    146. The Committee took note of the proceedings of the 6th European Conference of National Ethics Committees (COMETH) in Paphos, Cyprus. It was also informed that the next conference was being prepared for 2003.

    Preliminary draft report on the issues raised by Parliamentary Assembly Recommendation 1418 (1999) on Protection of the human rights and dignity of the terminally ill and the dying

    147. The Committee was informed that the discussion on the protection of human rights and dignity of the terminally ill and dying would take place during the CDBI meeting in December 2002. Dr Michael ABRAMS would then give a presentation of his report.

    Election of the Chair and Vice-Chair

    148. The Committee unanimously re-elected Mrs Ruth REUSSER (Switzerland) as Chair.

    149. The CDBI unanimously decided to extend the mandate of Ms Dubravka SIMONOVIC (Croatia) as Vice-Chair of the Committee until its next meeting in December, and have the election with her present then.

    Activities and working methods of the CDBI

    150. The Committee agreed that its main priority at the December meeting would be to finalise the draft Protocol on biomedical research.

    Dates of future meetings

    151. The next two meetings of the CDBI will take place in Strasbourg from 3 to 6 December 2002 and from 10 to 13 June 2003.

    Other business

    152. There was no other business.

    Appendix

    Agenda

    1. Adoption of the Agenda

    2. Chart of signatures and ratifications of the Convention on Human Rights and Biomedicine, the Protocol on the Prohibition of Cloning Human Beings and the Protocol concerning Transplantation of Organs and Tissues of Human Origin

    3. Developments in the field of bioethics in member States, other States and international organisations

    4. Working Party on Biomedical Research (CDBI-CO-GT2)

    5. Review of the draft instrument on the use of archived human biological materials and related personal data in biomedical research

    6. Working Party on Xenotransplantation (CDBI/CDSP-XENO)

    7. Working Party on the Protection of the Human Embryo and Foetus (CDBI-CO-GT3)

    8. Working Party on Human Genetics (CDBI-CO-GT4)

    9. Working Party on Psychiatry and Human Rights (CDBI-PH)

    10. DEBRA Project

    11. Information on the European Conference of National Ethics Committees (COMETH)

    12. Preliminary draft report on the issues raised by Parliamentary Assembly Recommendation 1418 (1999) on Protection of the human rights and dignity of the terminally ill and the dying

    13. Election of the Chair and Vice-Chair

    14. Activities and working methods of the CDBI

    15. Dates of future meetings

    16. Other business

Note 1 A more detailed report - including in particular the list of participants - can be obtained from the Directorate General I.


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