60 Amendments of Andrés PERELLÓ RODRÍGUEZ related to 2008/0238(COD)
Amendment 59 #
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 minimisze any risks associated with the transmission of diseases. Well-organized national transplant systems and use of the best available expertise, technology and innovative medical treatment can significantly reduce the associated risks of transplanted organs for patients.
Amendment 60 #
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 minimise any risks associated with the transmission of diseases. Well-organised national transplant systems and use of the best available expertise, technology and innovative medical treatment can significantly reduce the associated risks of transplanted organs for patients.
Amendment 67 #
Proposal for a directive
Recital 6 a (new)
Recital 6 a (new)
(6a) In accordance with Article 168(7) of the Treaty of the Functioning of the European Union, the measures adopted under paragraph 4(a) of that Article do not affect national provisions on the medical use of organs. Therefore the surgical act of transplantation itself does not fall within the scope of this Directive. However, in view of the objective of reducing the associated risks of the transplanted organs, it is necessary to include within the scope of this Directive certain provisions concerning the transplantation process and in particular provisions aimed at addressing those unintended and unexpected situations occurring during the transplantation that might affect the quality and safety of organs.
Amendment 72 #
Proposal for a directive
Recital 10
Recital 10
(10) Pre-transplant evaluation of potential donors is an essential part of organ transplantation. This evaluation must provide enough information for the transplant centre to undertake a proper risk-benefit analysis. The risks and characteristics of the organ must be identified and documented to allow allocation to a suitable recipient. Information from clinical history, physical examination and complementary tests should be collected for complete characterisation of the organ and the donor. To obtain an accurate, reliable and objective history, the medical team should interview the living donor or the relatives of the deceased donor. This is essential since the time constraints of the process of deceased donation reduce the ability to rule out potentially serious transmissible diseases. During the interviews, the team should properly inform the interviewees of the risks and consequences of donation and transplantation so as to make them aware of the importance of providing the medical team with all relevant information.
Amendment 74 #
Proposal for a directive
Recital 14
Recital 14
(14) Personnel directly involved in the donation, testing, characterisation, procurement, testing, preservation, transport and transplantation of human organs should be suitabley qualified and trainedcompetent.
Amendment 76 #
Proposal for a directive
Recital 16
Recital 16
(16) This Directive should respect the fundamo ensure the quality and safety of organs for transplantation, organ transplantation programmes should be founded on the principles of voluntary and unpaid donation. This is an essential rights and observeaspect, since the violation of these principles recognised in particular by the Charter of Fundamental Rights of the European Union11. In lmight be associated with unacceptable risks and poor outcomes for recipients and living donors. When donation is not voluntary and/or provides for financial gain, the quality of the process of donation cannot be fully guaranteed, since with that charter and to take account of, as appropriate the Convention on human rights and biomedicine12 , organ transplantation programmes should bimproving the quality of life or saving the life of a person is not the main and/or the sole objective to be achieved. Even if the process is developed in accordance with appropriate quality standards, the clinical history obtained either from the potential living donor or the relatives of the potential deceased donor might not be accurate enough in terms of those conditions and/or diseases which are potentially transmissible from donors to recipients when donors are seeking financial gain or are subjected to any kind of coercion. This would imply a safety problem for potential recipients since the team would have a limited capability for performing an appropriate risk analysis. This Directive should respect the founded on the principles of voluntary and unpaid donation, altruism of the donor and solidarity between donor and recipient while ensuring anonymity of the deceased donor and the recipient(s)amental rights and observe the principles recognised in particular by the Charter of Fundamental Rights of the European Union. In line with that Charter it should also take account of, as appropriate, the Convention on Human Rights and Biomedicine and the Revised World Health Organisation Guiding Principles on Human Cell, Tissue and Organ Transplantation.
Amendment 77 #
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 Union. In line with that charter and tit should also take account of, as appropriate, the Convention on hHuman rRights and bBiomedicine12 , org and transplantation programmes should be founded on the principles of voluntary and unpaid donation, altruism of the donor and solidarity between donor and recipient while ensuring anonymity of the deceased donor and the recipient(s)he Revised World Health Organization Guiding Principles on Human Cell, Tissue and Organ Transplantation.
Amendment 79 #
Proposal for a directive
Recital 16 a (new)
Recital 16 a (new)
(16a) The competent authority may consult the national Data Protection Authority in relation to developing a framework for the transfer of data concerning organs to and from third countries.
Amendment 80 #
Proposal for a directive
Recital 16 b (new)
Recital 16 b (new)
(16b) As a general principle, the identity of the recipient(s) should not be disclosed to the donor or his/her family or vice versa, without prejudice to legislation in force in Member States which under specific conditions might allow such information to be made available to donor or donors' families and organ recipients, with the consent of both parties.
Amendment 81 #
Proposal for a directive
Recital 17
Recital 17
(17) Article 8 of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data13 prohibits in principle the processing of data concerning health. Limited exemptions to this prohibition principle are laid down. Directive 95/46/EC also requires the controller to implement appropriate technical and organiszational measures to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access and against all other unlawful forms of processing. In line with that Directive, strict confidentiality rules and security measures should be in place for the protection of the donors’ and the recipients’ personal data. Moreover, the competent authority may also consult the national Data Protection Authority in relation to developing a framework for the transfer of data concerning organs to and from third countries.
Amendment 82 #
Proposal for a directive
Recital 17
Recital 17
(17) Article 8 of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data13 prohibits in principle the processing of data concerning health. Limited exemptions to this prohibition principle are laid down. Directive 95/46/EC also requires the controller to implement appropriate technical and organisational measures to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access and against all other unlawful forms of processing. In line with that Directive, strict confidentiality rules and security measures should be in place for the protection of the donors’ and the recipients’ personal data. Moreover, the competent authority may also consult the national Data Protection Authority in relation to developing a framework for the transfer of data concerning organs to and from third countries.
Amendment 86 #
Proposal for a directive
Article 1
Article 1
This Directive lays down rules to ensure high standards of 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 88 #
Proposal for a directive
Article 3 – point a
Article 3 – point a
(a) "authoriszation"‘ means authoriszation, accreditation, designation or licensing or registration, depending of the concepts used in each Member State;
Amendment 90 #
Proposal for a directive
Article 3 – point a a (new)
Article 3 – point a a (new)
aa) "competent authority means one (or more than one) non-profit authority, body, organisation and/or institution responsible for implementing the requirements of this Directive.
Amendment 91 #
Proposal for a directive
Article 3 – point a a (new)
Article 3 – point a a (new)
(aa) 'competent authority' means one or more than one non-profit authority, body, organisation and/or institution responsible for implementing the requirements of this Directive.
Amendment 93 #
Proposal for a directive
Article 3 – point c
Article 3 – point c
(c) "donor"' means every human source of organs, whether living or deceasedperson who donates one or several organs, whether the donation occurred during that person's lifetime or after death;
Amendment 94 #
Proposal for a directive
Article 3 – point c
Article 3 – point c
(c) "donor" means every human source of organs, whether living or deceased person who donates one or several organs, whether the donation occurred during that person's lifetime or after death;
Amendment 96 #
Proposal for a directive
Article 3 – point e
Article 3 – point e
(e) "‘donor characteriszation"’ means the collection of the relevant information on the characteristics of the donor needed to evaluate his/her suitability, to undertake a proper risk assessment in order toand minimisze the risks for the recipient, and to optimisensure an effective organ allocation;
Amendment 97 #
Proposal for a directive
Article 3 – point f
Article 3 – point f
(f) "'European organ exchange organisation"' means a non-profit organisation, whether public or private, dedicated especially toto national and/or cross-border organ exchange; the countries members of such an organisation are in their majority Member States of the Community;
Amendment 100 #
Proposal for a directive
Article 3 – point g
Article 3 – point g
(g) "'organ"' means 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; a part of an organ is also considered to fall within the scope of this definition if its function is to be used for the same purpose as the entire organ in the human body, maintaining the requirements of structure and vascularisation;
Amendment 101 #
Proposal for a directive
Article 3 – point h
Article 3 – point h
(h) "'organ characterisation"' means the collection of the relevant information on the characteristics of the organ needed to evaluate its suitability, to undertake a proper risk assessment in order toand minimise the risks for the recipient, and to optimisensure an effective organ allocation;
Amendment 109 #
Proposal for a directive
Article 3 – point n
Article 3 – point n
(n) "'serious adverse reaction"' means an unintended response, including a communicable disease, in the living donor or in the recipient that might be associated with any stage of the chain from donation to transplantation that is fatal, life- threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity;
Amendment 112 #
Proposal for a directive
Chapter II – title
Chapter II – title
Amendment 113 #
Proposal for a directive
Article 4 – title
Article 4 – title
Amendment 115 #
Proposal for a directive
Article 4 – paragraph 2 – introductory part
Article 4 – paragraph 2 – introductory part
2. The national quality programmesframework for quality and safety shall provide for the adoption and implementation of:
Amendment 116 #
Proposal for a directive
Article 4 – paragraph 2 – point a
Article 4 – paragraph 2 – point a
(a) standard operating procedures for the verification of donor identity;
Amendment 117 #
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 authorisation in accordance with national rules applying where donation and procurement take place;
Amendment 119 #
Proposal for a directive
Article 4 – paragraph 2 – point c
Article 4 – paragraph 2 – point c
(c) standard operating procedures for the verification of the completion of the organ and donor characterisation in accordance with Article 7 and with the model set out in the Annex;
Amendment 120 #
Proposal for a directive
Article 4 – paragraph 2 – point e
Article 4 – paragraph 2 – point e
(e) rulprocedures for the transportation of human organs in accordance with Article 8.
Amendment 121 #
Proposal for a directive
Article 4 – paragraph 2 – points a – ec (new)
Article 4 – paragraph 2 – points a – ec (new)
Amendment 122 #
Proposal for a directive
Article 4 – paragraph 3 – introductory part
Article 4 – paragraph 3 – introductory part
3. The national quality programmes shalIn addition, the framework for quality and safety shall ensure that the healthcare personnel involved at all stages of the chain from donation to transplantation or disposal is suitably qualified and competent, and shall develop specific training programmes for such personnel
Amendment 123 #
Proposal for a directive
Article 4 – paragraph 3 – point a – introductory part
Article 4 – paragraph 3 – point a – introductory part
Amendment 124 #
Proposal for a directive
Article 4 – paragraph 3 – point b – introductory part
Article 4 – paragraph 3 – point b – introductory part
Amendment 127 #
Proposal for a directive
Article 4 – paragraph 3 – point c
Article 4 – paragraph 3 – point c
Amendment 128 #
Proposal for a directive
Article 4 – paragraph 3 – point c
Article 4 – paragraph 3 – point c
(c) establish the qualifications required by thor competencies required for the healthcare personnel involved at all stages of the chain from donation to transplantation or disposal, and develop specific training programmes for such personnel in accordance with recognised international standards.
Amendment 137 #
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 of the organ during transport and that transport time is optimised and where possible minimised.
Amendment 141 #
Proposal for a directive
Article 8 – paragraph 1 – point b – indent 4
Article 8 – paragraph 1 – point b – indent 4
Amendment 145 #
Proposal for a directive
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Member States shall ensure the implementation of a donor identification system that can identify each donation and each of the organs associated with it. Member States shall ensure that this donor identification system are designed and selected in accordance with the aim of collecting, processing or using no personal data or as little personal data as possible. In particular, use is to be made of the possibilities for pseudonymisation or rendering individuals anonymoue confidentiality of patient data is respected in accordance with national rules.
Amendment 146 #
Proposal for a directive
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Member States shall ensure the implementation of a donor identification system that can identify each donation and each of the organs associated with it. Member States shall ensure that this donor identification system are designed and selected in accordance with the aim of collecting, processing or using no personal data or as little personal data as possible. In particular, use is to be made of the possibilities for pseudonymisation or rendering individuals anonymoue confidentiality of patient data is respected in accordance with national rules.
Amendment 147 #
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 adverse events and reactions that may influence the quality and safety of human organs and which may be attributed to the testing, characterisation, procurement, testing,preservation and transport of organs, as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities.
Amendment 148 #
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 adverse events and reactions that may influence the quality and safety of human organs and which may be attributed to the testing, characterisation, procurement, testing,preservation and transport of organs, as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities.
Amendment 151 #
Proposal for a directive
Chapter III – title
Chapter III – title
DONOR AND RECIPIENT PROTECSELECTION AND EVALUATION
Amendment 152 #
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. This should not prevent living donors from receiving compensation, which shall be strictly limited to making good the expense and inconvenience involved in the donation. In that case, Member States shall define the conditions under which compensation may be granted.
Amendment 157 #
Proposal for a directive
Article 14 – paragraph 1 a (new)
Article 14 – paragraph 1 a (new)
1a In order to meet the quality and safety requirements laid down in this Directive, Member States shall endeavour to obtain all necessary information from living donors and to provide them with the information which they need to understand the consequences of donation. In the case of deceased donation, Member States shall endeavour to obtain such information from relatives or other persons authorizing donation. Member States shall also make all parties from whom information is requested aware of the importance of the swift transmission of such information.
Amendment 158 #
Proposal for a directive
Article 14 – paragraph 1 a (new)
Article 14 – paragraph 1 a (new)
In order to meet the quality and safety requirements laid down in this Directive, Member States shall endeavour to obtain all necessary information from living donors and to provide them with the information which they need to understand the consequences of donation. In the case of deceased donation, Member States shall endeavour to obtain such information from relatives or other persons authorizing donation. Member States shall also make all parties from whom information is requested aware of the importance of the swift transmission of such information.
Amendment 159 #
Proposal for a directive
Article 15 – paragraph 1
Article 15 – paragraph 1
Amendment 165 #
Proposal for a directive
Article 15 – paragraph 2 a (new)
Article 15 – paragraph 2 a (new)
2a. Donors may receive compensation, which shall be strictly limited to making good the expense and inconvenience involved in the donation. In such cases, Member States shall define the conditions under which compensation may be granted.
Amendment 166 #
Proposal for a directive
Article 15 – paragraph 2 a (new)
Article 15 – paragraph 2 a (new)
2aThis should not prevent living donors from receiving compensation, which shall be strictly limited to making good the expense and inconvenience involved in the donation. In such cases, Member States shall define the conditions under which compensation may be granted.
Amendment 168 #
Proposal for a directive
Article 15 – paragraph 3
Article 15 – paragraph 3
3. Member States shall ensure that the competent authority keeps a register of the living donors after the donation, in line with provisions on the protection of the personal data and statistical confidentiality, and collects information on their follow up and, and specifically, on complications related to their donation that might appear in the short, mid and long term.
Amendment 169 #
Proposal for a directive
Article 15 – paragraph 3 a (new)
Article 15 – paragraph 3 a (new)
3 a. Member States shall ensure that living donors are followed up in accordance with national provisions, in order to identify, report, and manage any event potentially relating to the quality and safety of the donated organ, and hence of the recipient, as well as any serious adverse reaction in the living donor that may result from the donation.
Amendment 170 #
Proposal for a directive
Article 16 – paragraph 1
Article 16 – paragraph 1
Member States shall ensure that the fundamental right to protection of personal data is fully and effectively protected in all organ donation and transplantation activities, in conformity with Community provisions on the protection of personal data, such as Directive 95/46/EC, and in particular Articles 8 (3), 16, 17 and 28 (2) of that Directive.
Amendment 179 #
Proposal for a directive
Article 18 – paragraph 1
Article 18 – paragraph 1
Member States shall designate the competent authority, or authorities (hereafter competent authority), responsible for implementing the requirements of this Directive.
Amendment 181 #
Proposal for a directive
Article 18 – paragraph 2 – point a
Article 18 – paragraph 2 – point a
(a) put in place and keep updated a national quality programmeframework for quality and safety in accordance with Article 4;
Amendment 182 #
Proposal for a directive
Article 18 – paragraph 2 a (new)
Article 18 – paragraph 2 a (new)
(aa) Each Member State may delegate, or may allow a Competent Authority to delegate, part or all of the tasks assigned to it under this Directive to another body which is deemed appropriate under national provisions. Such a body may also assist a Competent Authority in carrying out its functions.
Amendment 183 #
Proposal for a directive
Article 18 – paragraph 2 a (new)
Article 18 – paragraph 2 a (new)
(aa) Each Member State may delegate, or may allow a Competent Authority to delegate, part or all of the tasks assigned to it under this Directive to another body which is deemed appropriate under national provisions. Such a body may also assist a Competent Authority in carrying out its functions.
Amendment 194 #
Proposal for a directive
Article 23 – paragraph 1
Article 23 – paragraph 1
1. Member States shall report to the Commission before …………*.and every three years thereafter on the activities undertaken in relation to the provisions of this Directive, and on the experience gained in implementing it. * 6 years after the entry into force of this Directive.
Amendment 195 #
Proposal for a directive
Article 23 – paragraph 2
Article 23 – paragraph 2
2. Before …….** and every three years thereafter, the Commission shall transmit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions ,a report on the implementation of this Directive **5 years after the entry into force of this Directive
Amendment 200 #
Proposal for a directive
Article 27 – paragraph 1 a (new)
Article 27 – paragraph 1 a (new)
1a This Directive shall not prevent a Member State from maintaining or introducing more stringent protective measures, provided that they comply with the provisions of the Treaty.
Amendment 201 #
Proposal for a directive
Article 27 – subparagraph 2 a (new)
Article 27 – subparagraph 2 a (new)
1a. This Directive shall not prevent a Member State from maintaining or introducing more stringent protective measures, provided that they comply with the provisions of the Treaty.
Amendment 202 #
Proposal for a directive
Article 27 – paragraph 2
Article 27 – paragraph 2
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.