22 Amendments of Frédérique RIES related to 2008/0238(COD)
Amendment 57 #
Proposal for a directive
Recital 1
Recital 1
(1) Over the past 50 years organ transplantation has become an established worldwide practice, bringing immense benefits to hundreds of thousands of patients. The use of human organs for transplantation has steadily increased during the last two decades. Organ transplantation is now the most cost- effective treatmenttreatment with the best risk/benefit ratio for end-stage renal and pancreatic failure, while for end- stage failure of organs such as the liver, lung, intestines and heart it is the only available treatment.
Amendment 58 #
Proposal for a directive
Recital 2
Recital 2
(2) Risks however are associated with the use of organs in transplantation. The extensive therapeutic use of human organs for transplantation demands that their quality and safety should be such as to improve the risk/benefit ratio while minimiseing any risks associated with the transmission of diseases. inherent in the logistics by which organs are obtained.
Amendment 63 #
Proposal for a directive
Recital 3 a (new)
Recital 3 a (new)
(3a) The principal challenge faced by the European Union and Member States with regard to organ transplantation is that of reducing the shortage of organs and donors. It is therefore crucial to expand the pool of available organs by acquiring the means, at Union level, of optimising the number of donations after brain death or cardiac failure, increase the number of living donors and broaden the pool of potential donors to cover persons who meet 'expanded' donor criteria.
Amendment 64 #
Proposal for a directive
Recital 4
Recital 4
(4) Every year organs are exchanged between Member States. The exchange of organs is an important way of expanding the pool of organs available and ensuring a better match between donor and recipient and therefore improving the quality of the transplant. This is particularly important for the optimum treatment of specific patients such as patients requiring urgent treatments, hypersensitised patients or paediatric patients. Available organs should be able to cross borders without unnecessary problems and delays.
Amendment 70 #
Proposal for a directive
Recital 7
Recital 7
(7) In order to reduce the risks and maximise the benefits of the transplantation process. Member States need to operate an effective national quality programme, ensuring that they have a precise description of the donor and the organs. This programme should be implemented and maintained throughout the entire chain from donation to transplantation or disposal, and should cover the personnel and organisation, premises, equipment, materials, documentation and record-keeping involved. The national quality programme should include auditing where necessary. Member States should be able to delegate, through written agreements, the responsibility for parts of this programme to European organ exchange organisations.
Amendment 71 #
Proposal for a directive
Recital 8
Recital 8
(8) The conditions of procurement should be supervised by the Competent Authorities, through the authorisation of identified procurementaking into account the specific national situation as regards the selection of transplantation organisations. The authorisation should assume that proper organisation, qualified staff and adequate facilities and material are in place.
Amendment 78 #
Proposal for a directive
Recital 16
Recital 16
(16) This Directive should respect the fundamental rights and observe the principles recognised in particular by the Charter of Fundamental Rights of the European Union11. In line with that charter and to take account of, as appropriate the Convention on human rights and biomedicine12, organ transplantation programmes should be founded on the principles of voluntary and unpaid donation, altruism of the living donor and solidarity between donor and recipient while ensuring anonymity of the deceased donor and the recipient(s).
Amendment 84 #
Proposal for a directive
Recital 22
Recital 22
(22) In particular, power should be conferred on the Commission to lay down, where the organs concerned are to be exchanged between Member States, the procedures for the transmission to transplantation centres of the information on the characteristics of the donor and the organs, the procedures needed to ensure the traceability of the organs, including labelling requirements, and the procedures for the reporting of serious adverse events or reactions. Since these measures are of general scope and are designed to amend non-essential elements of this Directive, or to supplement this Directive with new non- essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Amendment 85 #
Proposal for a directive
Article 1
Article 1
This Directive lays down rules to ensure high standards ofthe framework for quality and safety for organs of human origin intended for transplantation to the human body, in order to ensure a high level of human health protection.
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 118 #
Proposal for a directive
Article 4 – paragraph 2 – point b
Article 4 – paragraph 2 – point b
(b) standard operating procedures for the verification of the details of donor or donor family consent or authorisationthe absence of any objection by the donor or donor family in accordance with national rules;
Amendment 126 #
Proposal for a directive
Article 4 – paragraph 3 – point b a (new)
Article 4 – paragraph 3 – point b a (new)
(ba) authorise, in life-threatening emergencies, transplant operations using an organ which is not optimal, after consultation between the medical staff and the patient or his close family if the patient is unable to state his choice.
Amendment 129 #
Proposal for a directive
Article 4 – paragraph 3 – point c a (new)
Article 4 – paragraph 3 – point c a (new)
(ca) determine the status of transplant coordinators from the organ donation stage to monitoring of the recipient.
Amendment 131 #
Proposal for a directive
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
Amendment 133 #
Proposal for a directive
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
2. Member States shall ensure that procurement takes place in dedicated 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 practiccomply with normal standards for operating theatres.
Amendment 135 #
Proposal for a directive
Article 6 – paragraph 2 – subparagraph 2 – introductory part
Article 6 – paragraph 2 – subparagraph 2 – introductory part
Amendment 139 #
Proposal for a directive
Article 8 – paragraph 1 – point b – indent 3
Article 8 – paragraph 1 – point b – indent 3
– a statement that the package contains a human organ and marked HANDLE WITH CARE'HUMAN ORGAN';
Amendment 140 #
Proposal for a directive
Article 8 – paragraph 1 – point b – indent 4
Article 8 – paragraph 1 – point b – indent 4
Amendment 142 #
Proposal for a directive
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The Competent authority shall indicate in the accreditation, designation, authorisation or licence which activitiprogrammes the transplantation centre concerned may undertake.
Amendment 144 #
Proposal for a directive
Article 9 – paragraph 4
Article 9 – paragraph 4
4. Member States shall, upon the request of the Commission or another Member State, provide information on the national requirements for the authorisation of transplantation centres. Member States shall seek to render authorisation criteria uniform throughout the Union.
Amendment 153 #
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
1. Member States shall ensure that donations of human organs from deceased and living donors are voluntary and unpaid. The principle of non-payment must not prevent a living donor from receiving compensation for expenses incurred or for loss of income, provided that this does not constitute a financial benefit.
Amendment 156 #
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
Procurement shall only be carried out only after compliance with all mandatory conrequirements relating to the absentce orf authorisation requirementsny objection to organ donation in force in the Member State concerned.