19 Amendments of Peter LIESE related to 2008/0238(COD)
Amendment 87 #
Proposal for a directive
Article 2 – paragraph 1 a (new)
Article 2 – paragraph 1 a (new)
1a. It shall apply also to parts of organs if it is their function to be used for the same purpose as the entire organ in the human body and to complex tissues.
Amendment 98 #
Proposal for a directive
Article 3 – point g
Article 3 – point g
(g) ‘organ’ means both a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with an important level of autonomy and parts of organs if it is their function to be used for the same purpose as the entire organ in the human body and complex tissues ;
Amendment 99 #
Proposal for a directive
Article 3 – point g
Article 3 – point g
(g) "organ" means both a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with an important level of autonomy; and parts of organs, if it is their function to be used for the same purpose as the entire organ in the human body, maintaining the requirements of structure and vascularisation;
Amendment 107 #
Proposal for a directive
Article 3 – point m
Article 3 – point m
(m) ‘serious adverse event’ means any undesired and unexpected occurrence associated with any stage of the chain from donation to transplantationthe procurement, preservation and making available of organs that might lead to the transmission of a communicablen infectious disease, to death or a life- threatening, disabling, or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity condition or to the disabling of donors or recipients, necessitate hospitalisation or cause another illness, providing it is not a matter of the side- effects of immune suppression;
Amendment 108 #
Proposal for a directive
Article 3 – point n
Article 3 – point n
(n) ) ‘serious adverse reaction’ means an unintended or unexpected serious response, including a communicable disease, in the donor or in the recipient associated with any stage of the chain from donation tothe donation, procurement, preservation, making available or transplantation of an organ, that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidityunexpected morbidity; side-effects of immune suppression are excluded;
Amendment 110 #
Proposal for a directive
Article 3 – point p
Article 3 – point p
(p) ‘transplantation’ means the process of restoring certain functions of the human body by transferring equivalenthuman organs to a recipient;
Amendment 134 #
Proposal for a directive
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
2. Member States shall ensure that procurementdonation takes place in dedicappropriated facilities, which are designed, constructed, maintained and operated so as to comply with the requirements laid down in this Directive and which allow minimising bacterial or other contamination of procured human organs in accordance with best medical practices. These facilities shall meet operating theatre standards.
Amendment 136 #
Proposal for a directive
Article 8 – paragraph 1 – point a
Article 8 – paragraph 1 – point a
(a) the organisations, bodies or companies involved in the transportation of organs have appropriate standard operating procedures in place to ensure the integrity ofensure that the organ duringis transport and that transport time is minimised.ed with due care;
Amendment 149 #
Proposal for a directive
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Member States shall ensure that there is a reporting system in place to report, investigate, register and transmit relevant and necessary information concerning serious unexpected adverse events and reactions that may influence the quality and safety of human organs and which may be attributed to the procurement, testing, and transport of organs, as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities.
Amendment 161 #
Proposal for a directive
Article 15 – paragraph 1 a (new)
Article 15 – paragraph 1 a (new)
1 a. Living donations shall be seen as complementary to post-mortem donations and only serve as a last resort where no suitable alternative, such as an organ from a deceased donor, is available. Living donations shall in principle be restricted to donations among close relatives and spouses due to the implicit danger of exploitation.
Amendment 162 #
Proposal for a directive
Article 15 – paragraph 2
Article 15 – paragraph 2
2. Member States shall ensure that living donors are selected on the basis of their health and medical history, including a psychological evaluation if deemed necessary, by qualified and trained professionals. Such assessments may provide for the exclusion of persons whose donation could present a health risk to others, such as the possibility of transmitting diseases, or a serious risk to themselves. Member States shall also ensure that living donors are legally insured.
Amendment 164 #
Proposal for a directive
Article 15 – paragraph 2 a (new)
Article 15 – paragraph 2 a (new)
2a. In order to comply with the principle of non-commercialisation of the human body, Member States shall ensure that possible compensation for living donors is strictly limited to ensuring healthcare insurance for donation-related long-term medical conditions and to making good the expenses relating to the donation, such as travel expenses, child minding costs, loss of earnings or costs of recovery, and prohibiting any financial incentives for a potential donor.
Amendment 173 #
Proposal for a directive
Article 17
Article 17
Member States shall take all necessary measures to ensure that all personal data of donors and recipients gathered and processed within the scopeframework of this Directive are rendered anonymous so that neitherto which third parties have access are rendered anonymous or pseudonymous so that donors norand recipients aremain identifiable protected.
Amendment 187 #
Proposal for a directive
Article 19 – paragraph 1 – point c
Article 19 – paragraph 1 – point c
(c) establishes and maintains a register of procurementhealth care establishments, teams or departments of a hospital org anisatioother establishment authorised to procure human organs and transplantation centres.
Amendment 188 #
Proposal for a directive
Article 19 – paragraph 2
Article 19 – paragraph 2
2. Member States shall, upon the request of the Commission or another Member State, provide information on the register of procurementhealth care establishments, teams or departments of a hospital org anisatioother establishment authorised to procure human organs and transplantation centres.
Amendment 191 #
Proposal for a directive
Article 21 – paragraph 1
Article 21 – paragraph 1
1. Member States shall ensure that all exchanges of organs from or to third countries, are authorised by the competent authority.
Amendment 192 #
Proposal for a directive
Article 21 – paragraph 1 a (new)
Article 21 – paragraph 1 a (new)
1 a. Responsibility for authorising organ exchanges with third countries may be transferred by the Member States to European organ exchange organisations.
Amendment 196 #
Proposal for a directive
Article 25 – paragraph 1 – point a
Article 25 – paragraph 1 – point a
(a) rules for the updating and transmission of information on human organs and donor characterisation as detailed in the Annex;
Amendment 203 #
Proposal for a directive
Annex – Introduction
Annex – Introduction
For the purpose of Article 7 the following information shall be gathered by the procurement organisation or procurement team on the characteristics of the organ and of the donor, following testing where necessarybearing in mind the individual circumstances, and processed in line with the legal requirements on the protection of personal data and confidentiality. In the absence of data, a decision shall be taken about the transplant after individual risk assessment of the donor and the recipient: