Council common position

Amendments by Parliament

It is necessary to promote information and awareness campaigns at national and European level on the donation of tissues, cells and organs based on the theme 'we are all potential donors'. The aim of these campaigns should be to help European citizens decide to become donors during their lifetime and let their families or legal representatives know their wishes.

It is necessary to promote information and awareness campaigns at national and European level on the donation of tissues, cells and organs based on the theme 'we are all potential donors'. The aim of these campaigns should be to help European citizens decide to become donors during their lifetime and let their families or legal representatives know their wishes. As there is a need to ensure the availability of tissues and cells for medical treatments, Member States should promote the donation of tissues and cells, including haematopoietic progenitors, of high quality and safety, thereby also increasing self-sufficiency in the Community.

As tissue and cell therapy is a field in which an intensive worldwide exchange is taking place, it is desirable to have worldwide standards.

As tissue and cell therapy is a field in which an intensive worldwide exchange is taking place, it is desirable to have worldwide standards. The Community should therefore endeavour to promote the highest possible level of protection to safeguard public health regarding quality and safety of tissues and cells. The Commission should include in its report to the European Parliament and the Council information on the progress made in this respect.

(6a) This Directive should apply to tissues and cells including haematopoietic peripheral blood, umbilical cord (blood) and bone marrow stem cells; reproductive cells (eggs, sperm); foetal tissues and cells, adult and embryonic stem cells.

This Directive should not interfere with decisions made by Member States concerning the use or non-use of any specific type of human cells, including germ cells and embryonic stem cells. If, however, any particular use of such cells is authorised in a Member State, this Directive will require the application of all provisions necessary to protect public health and guarantee respect for fundamental rights. Moreover, this Directive should not interfere with provisions of Member States defining the legal term 'person' or 'individual'.

This Directive should not interfere with decisions made by Member States concerning the use or non-use of any specific type of human cells, including germ cells and embryonic stem cells. If, however, any particular use of such cells is authorised in a Member State, this Directive will require the application of all provisions necessary to protect public health, given the specific risks of these cells based on the scientific knowledge and their particular nature, and guarantee respect for fundamental rights. Moreover, this Directive should not interfere with provisions of Member States defining the legal term 'person' or 'individual'.

(13a) The clinical use of tissues and cells of human origin for human application may be constrained by limited availability. Therefore it would be desirable that the criteria for access to such tissues and cells are defined in a transparent manner, on the basis of an objective evaluation of medical needs.

Tissues and cells used for allogeneic therapeutic purposes can be procured from both living and deceased donors. In order to ensure that the health status of a living donor is not affected by the donation, a prior medical examination should be required. The dignity of the deceased donor should be respected.

Tissues and cells used for allogeneic therapeutic purposes can be procured from both living and deceased donors. In order to ensure that the health status of a living donor is not affected by the donation, a prior medical examination should be required. The dignity of the deceased donor should be respected, notably through the reconstruction of the donor's body, so that it is as similar as possible to its original anatomical shape.

(16a) Voluntary and unpaid tissue and cell donations are a factor which may contribute to high safety standards for tissues and cells and therefore to the protection of human health.

(16b) Any establishment may also be accredited as a tissue and cell establishment provided it complies with the standards.

(16c) With due regard to the principle of transparency, all tissue establishments accredited, designated, authorised or licensed under the provisions of this Directive, including those manufacturing products from human tissues and cells, whether subject or not to other Community legislation, should have access to relevant tissues and cells procured in accordance with the provisions of this Directive, without prejudice to the provisions in force in Member States on the use of tissues and cells.

The procurement of human tissues and cells must take into account the general principles of the Charter of Fundamental Rights of the European Union and of the Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on human rights and biomedicine, in particular in relation to donor consent.

This Directive respects the fundamental rights and observes the principles reflected in the Charter of Fundamental Rights of the European Union and takes into account as appropriate the Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on human rights and biomedicine. Neither the Charter nor the Convention make express provision for harmonisation or prevent Member States from introducing more stringent requirements in their legislation.

As a general principle, the identity of the recipient(s) should not be disclosed to the donor or his family and vice versa, without prejudice to legislation in force in Member States on the conditions of disclosure, which could authorise in particular cases the lifting of donor anonymity.

As a general principle, the identity of the recipient(s) should not be disclosed to the donor or his family and vice versa, without prejudice to legislation in force in Member States on the conditions of disclosure, which could authorise in exceptional cases, notably in the case of gametes donation, the lifting of donor anonymity.

It is necessary that the best possible scientific advice is available to the Community in relation to the safety of tissues and cells; in particular in order to assist the Commission in adapting the provisions of this Directive to scientific and technical progress.

It is necessary that the best possible scientific advice is available to the Community in relation to the safety of tissues and cells, in particular in order to assist the Commission in adapting the provisions of this Directive to scientific and technical progress in particular in the light of the rapid advance in biotechnology knowledge and practice in the field of human tissues and cells.

4a. Guidelines concerning the conditions of the inspections and control measures, and on the training and qualification of the officials involved, in order to reach a consistent level of competence and performance shall be established in accordance with the procedure referred to in Article 29(2).

Member States shall ensure that all tissues and cells procured, processed, stored or distributed on their territory can be traced from the donor to the recipient and vice versa.

Member States shall ensure that all tissues and cells procured, processed, stored or distributed on their territory can be traced from the donor to recipient and vice versa. This traceability shall also apply to all relevant data relating to products and materials coming into contact with these tissues and cells.

All tissues and cells must be identified with a label that contains the information referred to in Article 28(g) and (i).

All tissues and cells must be identified with a label that contains the information or references allowing a link to the information referred to in Article 28(g) and (i).

3a. Tissue establishments shall keep the data necessary to ensure traceability at all stages. Data required for full traceability shall be kept for a minimum of 30 years after clinical use. Data storage may also be in electronic form.

3b. The traceability requirements for tissues and cells, as well as for products and materials coming into contact with these tissues and cells and having an effect on their quality and safety, shall be established by the Commission in accordance with the procedure referred to in Article 29(2).

Member States shall take all necessary measures to ensure that all imports of tissues and cells from third countries are undertaken by tissue establishments accredited, designated, authorised or licensed for the purpose of those activities. Those Member States that receive such imports from third countries shall ensure that they meet standards of quality and safety equivalent to the ones laid down in this Directive.

Member States shall take all necessary measures to ensure that all imports of tissues and cells from third countries are undertaken by tissue establishments accredited, designated, authorised or licensed for the purpose of those activities, and that imported tissues and cells can be traced from the donor to the recipient and vice versa in accordance with the procedures referred to in Article 8. Member States and tissue establishments that receive such imports from third countries shall ensure that they meet standards of quality and safety equivalent to the ones laid down in this Directive.

Member States shall take the necessary measures to encourage voluntary and unpaid donations of human tissues and cells with a view to ensuring that, insofar as is possible, they are obtained from such donations.

Member States shall endeavour to ensure voluntary and unpaid donations of tissues and cells.

Donors may receive compensation, which is strictly limited to making good the expenses and inconveniences related to the donation.

In that case, Member States define the conditions under which compensation may be granted.

Member States shall encourage the procurement of tissues and cells to be carried out on a non-profit basis.

Member States shall endeavour to ensure that the procurement of tissues and cells as such is carried out on a non-profit basis.

Member States shall, in keeping with their national legislation, take all necessary measures to ensure that donors, their relatives or any persons granting authorisation on behalf of the donors are provided with all appropriate information as referred to in Article 28(d).

Member States shall, in keeping with their national legislation, take all necessary measures to ensure that donors, their relatives or any persons granting authorisation on behalf of the donors are provided with all appropriate information as referred to in the Annex.

Member States shall take all necessary measures to ensure that the identity of the recipient(s) is not disclosed to the donor or his family and vice versa, without prejudice to legislation in force in Member States on the conditions for disclosure.

Member States shall take all necessary measures to ensure that the identity of the recipient(s) is not disclosed to the donor or his family and vice versa, without prejudice to legislation in force in Member States on the conditions for disclosure, notably in the case of gametes donation.

In the case of cells used for reproduction purposes, the conditions for donor selection, evaluation and procurement shall be laid down in accordance with the requirements referred to in Article 28(j).

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Tissue establishments shall keep the data required for full traceability for a minimum of 30 years. Data storage may also be in electronic form.

Tissue establishments shall keep the data necessary to ensure traceability in accordance with Article 8.

4a. Member States shall ensure that tissue establishments have agreements and procedures in place to ensure that, in the event of termination of activities for whatever reason, stored tissues and cells shall be transferred to other tissue establishment or establishments accredited, designated, authorised or licensed in accordance with Article 6, without prejudice to Member States' legislation concerning the disposal of donated tissues or cells, according to the consent pertaining to them.

(b) where a third party provides goods and services that affect tissue or cell quality and safety assurance;

(b) where a third party provides goods and services that affect tissue or cell quality and safety assurance, including their distribution;

Information to be provided on the donation of cells and/or tissues;

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Determination of conditions for the selection, evaluation and procurement of cells used for reproduction purposes;

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ANNEX

INFORMATION TO BE PROVIDED ON THE DONATION OF CELLS AND/OR TISSUES

LIVING DONORS

The person in charge of the donation process shall ensure that the donor has been properly informed of at least those aspects relating to the donation and procurement process outlined in paragraph 3. Information must be given prior to the procurement.

The information must be given by a trained person able to transmit it in an appropriate and clear manner, using terms that are easily understood by the donor.

The information must cover: the purpose and nature of the procurement, its consequences and risks; analytical tests, if they are performed; recording and protection of donor data, medical confidentiality; therapeutic purpose and potential benefits, and information on the applicable safeguards intended to protect the donor.

The donor must be informed that he has the right to receive the confirmed results of the analytical tests clearly explained.

Information must be given on the necessity for requiring the applicable mandatory consent, certification, and authorisation in order that the tissue and/or cell procurement can be carried out.

DECEASED DONOR

All information must be given and all necessary consents and authorisations must be obtained in accordance with the legislation in force in Member States.

The confirmed results of the donor's evaluation must be communicated, and clearly explained to the relevant persons in accordance with the legislation in Member States.