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Ministers'
Deputies Concerning transplantation of organs and tissues of human origin and Draft
explanatory report The Netherlands wishes the following comments to be taken into account.
We cannot agree to the new wording of article 3 and would be glad if article 7 were amended.
Preamble:
Please refer to 2001 recommendation on the management of organ transplant waiting lists and waiting times.
Article 3:
The passage “are allocated in conformity with transparent and duly justified rules taking particular account of medical criteria and individual health benefits for the patient in question” is unclear and could lead to confusion.
The phrase “taking particular account of” leaves room for non-medical criteria to be taken into account, which is legally incorrect and could give rise to problems of interpretation.
The additional phrase “and the individual health benefits for the patient in question” is also confusing. It is treated as a separate criterion but adds nothing since its exact meaning is unclear. Worse still, it could lead to unfair prioritisation. Individual health benefits are normally included in medical criteria and should not constitute a separate criterion.
The wording of the CDSP recommendation on the management of organ transplant waiting lists and waiting times, which was accepted at the beginning of this year, is clear and unambiguous. A convention should not be less clearly drafted than a recommendation. Moreover, it would seem odd for two different texts to be accepted in close succession if this is likely to create doubt about the correct application.
Proposal: “are allocated in conformity with transparent and duly justified rules according to medical criteria”.
Article 7 (Article 8 in the revised version):
Text following “in particular” should be dropped. The principle should apply in all cases without regard to individual circumstances.
Explanatory Memorandum:
The text of the Explanatory Memorandum should be checked since it does not exactly reflect the text of the protocol. The inclusion of medical details is both unnecessary and risky. In any case, CDSP is currently preparing a text on health and safety from the medical point of view. Para. 55 could make concrete reference to this (text has already been issued for public consultation and is to be finalised at the end of this year).
Paras. 21, 25 and 109:
The text should be revised to clarify whether stem cells from cord blood come within the scope of the Protocol.
Para. 48:
Third line from the end: should be scrapped. This is not a subject that should be propagated or endorsed at member-state level. Nor is it part of any generally accepted professional standard. If it happens at all, it is highly exceptional and a matter for the individual doctor and patient. The same point was already criticised by us and dropped from an earlier CDSP text. The subject recurs again in line 3 of para. 52. It is not appropriate in the context of this sort of Explanatory Memorandum.
Para. 51:
Last line: insert “informed” before “consent”.
Para. 56:
The part of the sentence preceding the comma bears no relation to the subject in hand. It relates to good medical care, not to equity. Should be scrapped.
Para. 60:
Final sentence: wording is too general. It can be medically useful to use dialysis for a while before a transplant takes place. Proposal: insert “always” before “considered”.
Para. 69: line 5:
“Consent should not be given” etc. is incorrect. This is not a question of consent. If there is a serious risk to the health of the donor, the proposal to remove the organ should not be made in the first place (professional standard).
Finally:
Would it be possible to include a general reference to Good Manufacturing Practices where applicable? |