Amendments on EP Report A5-0369/2003 (Report on the proposed Council decision amending decision 2002/834/EC on the specific programme for research, technological development and demonstration: "Integr

November 19, 2003

Brussels, 18 Nov 2003

Full text of Amendments 001 - 019 PIN archive of Amendments 001 - 019

13 November 2003 A5-0369/ 1-19

AMENDMENTS 1-19
tabled by the Committee on Industry, External Trade, Research and Energy

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Text proposed by the Commission

Amendments by Parliament

Amendment 1
RECITAL 4

(4) There is a great diversity among Member States concerning the ethical acceptability of various research fields and this is reflected in the national laws in accordance with the principle of subsidiarity. In particular, regulation and legislation of research using human embryos and human embryonic stem cells is handled very differently among Member States. The specific programme already provides that national provisions apply and no research forbidden in any given Member State will be supported by Community funding to a legal entity established in that State.
(4) There is a great diversity among Member States concerning the ethical acceptability of various research fields and this is reflected in the national laws in accordance with the principle of subsidiarity. In particular, regulation and legislation regarding research using human embryos created for the purpose of in vitro fertilisation and not used for this purpose any more (i.e. supernumerary embryos) and human embryonic stem cells is handled very differently among the Member States. Therefore this decision in no way affects national laws concerning embryonic stem cells. Nevertheless, Member States which allow research on human embryos and human embryonic stem cells with support from EU funding will be expected to have effective regulation in place.

Justification

1. It needs to be made clear that we are talking about human embryos created for the purpose of in vitro fertilisation which are no longer likely to be used for this purpose.
2. The reference to the effect that no research forbidden in a Member State will be supported by European research policy should be deleted, because it creates more confusion than clarity. Anything prohibited by law in a Member State cannot be supported in any case, whatever the EU says.
3. It needs to be made clear that this proposal does not seek to harmonise rules on research with embryos and embryonic stem cells in the Member States, nor are any other efforts being made towards such harmonisation. Nevertheless, a general reference should be included to the effect that there is a need for rules to be adopted in this area by the Member States and that effective regulation is a pre-requisite for EU funding of research involving human embryos.

Amendment 2
RECITAL 5

(5) In light of the current state of knowledge on human embryonic stem cells, new human embryonic stem cell lines, derived from human supernumerary embryos, are required.
(5) Articles 163 et seq of the Treaty establish Community competences with regard to research; these provisions state that the Community may complement the activities of the Member States with a view to achieving the objective of strengthening the scientific and technological bases of European industry, encouraging international competitiveness and promoting research activities. The use of human embryonic stem cells for research purposes should be strictly limited.

Amendment 3
RECITAL 5a (new)

(5a) The destruction of embryos in order to produce human embryonic stem cell lines should be subject to the prior agreement of the parents.

Justification

This conforms to standard practice. There is already the requirement that agreement must be obtained for organ-removal and blood and tissue donations.

Amendment 4
RECITAL 5b (new)

(5b) The aims of stem cell research, especially the alleviation and cure of diseases which are currently not or not sufficiently treatable, are to be supported.

Justification

It is important to remember why the EU will be providing funding for this area of research.

Amendment 5
RECITAL 6

(6) This decision is intended to apply specifically to Community funding of research activities involving the procurement of stem cells from human embryos created before June 2002 as a result of medically-assisted in vitro fertilisation designed to induce pregnancy and were no longer to be used for that purpose (supernumerary embryos). This decision amends the specific programme by introducing several conditions for deciding on the Community funding of such research.
(6) This decision is intended to apply specifically to Community funding of research activities using stem cells procured from embryos that have been produced as a result of medically-assisted in vitro fertilisation designed to induce pregnancy and were no longer to be used for that purpose (supernumerary embryos). This decision amends the specific programme by introducing several conditions for deciding on the Community funding of such research.

Justification

This will improve the quality of stem cell lines.

Amendment 6
RECITAL 6a (new)

(6a) According to an overwhelming majority of scientists, transplantation of human embryonic stem cells to patients will not be possible, for purely scientific reasons, during the time frame of the sixth research framework programme (until the end of 2006), because this approach is mainly at the stage of basic research and transplantation at the current moment would lead to non-calculable risks for the recipients.

Justification

Leaving aside the ethical debate, it will not be possible in the short term to transfer embryonic stem cells to patients, since no solution has been found to the risk of malignant mutation and rejection.

Amendment 7
RECITAL 6b (new)

(6b) This decision concerns the use of human embryos for research only and not for therapeutic purposes. Research on human embryonic stem cells is desirable for the development of innovative treatments and, in particular, of treatments using adult stem cells.

Justification

Many scientists argue that basic research on human embryonic stem cells is necessary, even if the aim is to develop treatments using adult stem cells.

Amendment 8
RECITAL 7

(7) The present conditions are based on the principles established by the European Group on Ethics, especially the fundamental ethical principles underlined in the opinion No. 15: the principle of respect for human dignity (which requires provisions of guarantees against risks of arbitrary experimentation); the principle of human autonomy which entails the giving of informed consent and the protection of personal data; the principle of justice and of beneficence (namely with regard the improvement and protection of health); the principle of freedom of research (which should be balanced against other principles) and; the principle of proportionality (non-availability of adequate alternative methods in view of the scientific objectives to be reached).
(7) The present conditions are based on the principles established by the European Group on Ethics, especially the fundamental ethical principles underlined in opinion No. 15: the principle of respect for human dignity (which requires provisions of guarantees against risks of arbitrary experimentation); the principle of human autonomy which entails the giving of informed consent and the protection of personal data; the principle of justice and of beneficence (in particular as regards the improvement and protection of health); the principle of freedom of research (which should be balanced against other principles); and the principle of proportionality (non-availability of adequate alternative methods in view of the scientific objectives to be reached). The experience from other scientific communities should also be used.

Justification

Since worldwide exchange takes place in the field of stem cell research, experience in other scientific communities must be taken into account. In your rapporteur's view the most sensible alignment in this connection is one with the USA.

Amendment 9
RECITAL 10a (new)

(10a) The existence of so-called supernumerary embryos after artificial fertilisation constitutes an ethical dilemma, as the transplantation of such embryos to others than the genetic parents (embryo adoption) as well as the simple "letting die off" of those embryos and making them available for research purposes is connected with ethical problems. As a consequence, efforts should be made to reduce the number of supernumerary embryos in the future, and the responsibility for this lies with the Member States.

Justification

This amendment refers to Amendment 85 to the Caudron report adopted unanimously by Parliament at first reading. The problem of so-called `supernumerary' embryos must be tackled at its root. However, the regulation of in vitro fertilisation is a national responsibility.

Amendment 10
ANNEX
Annex I, point 1.1, paragraph 18, point (b) (Decision 2002/834/EC )

(b) the human embryos used for the procurement of stem cells must have been created before June 2002 as a result of medically-assisted in vitro fertilisation designed to induce pregnancy, and were no longer to be used for that purpose;
(b) the human embryos used for the procurement of stem cells must be 'supernumerary' early-stage (i.e. up to 14  days) human embryos (embryos genuinely created for the treatment of infertility so as to increase the success rate of in vitro fertilisation but no longer needed for that purpose and when destined for destruction); such research may be funded provided that it is legally permitted in the Member State(s) where it will be conducted under the rules and strict supervision of the competent authority/ies;

Justification

Imposing cut-off dates on research means arbitrarily preventing future research developments. The text of this amendment has already been adopted in plenary by the European Parliament by 317 votes to 190, with 28 abstentions at first reading of the Caudron report on the sixth research framework programme.

Amendment 11
ANNEX
Annex I, point 1.1, paragraph 18, (point d) (Decision 2002/834/EC )

(d) all other alternative methods (including existing or adult stem cell lines) must have been examined and demonstrated not to be sufficient for the purposes of the research in question;
Deleted

Justification

Research using human embryonic stem cells lines as foreseen in the sixth framework programme decision has the potential to provide radically new forms of treatment for serious disease and disability. The availability and quality of human embryonic stem cell lines may be crucial to the success of this research and subsequent medical advances.

Amendment 12
ANNEX
Annex I, point 1.1, paragraph 18, point (e) (Decision 2002/834/EC )

(e) the free, express, written and informed consent of the donor(s) should be provided in accordance with national legislation prior to the start of the research activities;
(e) the free, express, written and informed consent of the donor(s) should have been provided in accordance with national legislation prior to the procurement of the cells; where embryos are to be destroyed in order to produce human embryonic stem cell lines, the prior agreement of the parents must be secured;

Justification

Necessary clarification of Commission text. See also amendment to recital  5.

Amendment 13
ANNEX
Annex I, point 1.1, paragraph 18, point (f) (Decision 2002/834/EC )

(f) no monetary compensation or other benefit in kind must be granted or promised for the donation;
(f) no monetary compensation, benefit in kind or other consideration may be granted or promised for the donation of embryos used for the procurement of stem cells;

Justification

It is necessary here to specify very clearly both the concept of donation and the consequent personal advantage to the donor.

Amendment 14
ANNEX
Annex I, point 1.1, paragraph 18, point (g) (Decision 2002/834/EC )

(g) the protection of personal data, including the genetic data, of the donor(s) must be ensured;
(g) the protection of personal data, including the genetic data, of the donor(s) must have been ensured during the procurement;

Justification

Necessary clarification of Commission text.

Amendment 15
ANNEX
Annex I, point 1.1, paragraph 18, point (ga) (new) (Decision 2002/834/EC )

(ga) in order to monitor these conditions, the Commission sets up a European register of embryonic stem cells; in doing this, the Commission uses the experience of the NIH (National Institutes of Health);

Justification

The Commission has already announced, in its second call for expressions of interest on the 6th Framework Research Programme, that it will fund a European register of embryonic stem cells. Incorporating this plan in the text of this proposal has the advantage that the action of the Commission will have the political support of the European Parliament and the Council, and of ensuring greater legal certainty.

Amendment 16
ANNEX
Annex I, point 1.1, paragraph 19 (Decision 2002/834/EC )

The scientific evaluation and the ethical review organised by the Commission of the research proposals shall include verification of these conditions. The conditions set out in point (c) and (d) shall be assessed during the scientific evaluation.
The scientific evaluation and the ethical review organised by the Commission of the research proposals shall include verification of these conditions. The conditions set out in point (c) shall be assessed by an independent scientific body created for this purpose including members involved in other kinds of cell research.

Justification

Since the issues addressed in point (c) are very complex technical matters, a special body should be set up for this purpose. Scientists who do not themselves work with stem cells might be unable to answer the questions raised.

Amendment 17
ANNEX
Annex I, point 1.1, paragraph 19a (new) (Decision 2002/834/EC )

Projects with adult somatic stem cells and umbilical cord blood cells should be encouraged for research involving other types of stem cells without excluding comparative studies.

Justification

It relates to the `Nistico amendment' adopted by Parliament at the first reading of the Caudron report. Many projects with adult stem cells have hitherto not been funded by the Commission. Parliament should express its support once again for this area of research.

Amendment 18
ANNEX
Annex I, point 1.1, paragraph 20a (new) (Decision 2002/834/EC )

Research on the use of human stem cells may be financed depending on both the contents of the scientific proposal and the legal framework of the Member State(s) involved; research using adult stem cells and reprogrammed adult cells should receive priority for financing; there is no restriction on financing research on stem cell lines already existing in scientific laboratories. In addition, research on embryonic or foetal stem cells deriving from spontaneous or therapeutic abortion may be funded.

Justification

While privileging research on adult stem cells the intention is not to prohibit research on embryonic cells. The text of this amendment has already been adopted in plenary by the European Parliament by 422 votes to 99, with 8 abstentions, at first reading of the Caudron report on the sixth research framework programme.

Amendment 19
ANNEX
Annex I, point 1.1, paragraph 22 (Decision 2002/834/EC )

A list of research projects involving the use of all types of human embryonic stem cells funded under the sixth framework programme will be published yearly by the Commission.
A list of research projects involving the use of all types of human adult or embryonic stem cells funded under the sixth framework programme will be published yearly by the Commission. In the case of research projects with embryonic stem cells, such publication must include a justification stating why other procedures were not usable.

Justification

This addition is required, the better to assess developments in efforts to promote research under the sixth framework programme.

PE 337.944/ 8
EN

PE 337.944/ 1
EN Full text of Amendments 024 - 026 PIN archive of Amendments 024 - 026

13 November 2003 A5-0369/ 24

AMENDMENT 24
tabled by Giuseppe Nisticò, John Bowis and José María Gil-Robles Gil-Delgado, on behalf of the PPE-DE Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 24
ANNEX
Annex I, point 1.1, paragraph 18, introduction (Decision 2002/834/EC )

In order to be funded by the Community, research projects involving the procurement of stem cells from human embryos must also meet the following conditions:
In the 6th Framework Programme, research on human embryos (including embryos created for reproduction purposes and no longer needed for this purpose and embryos created through cell nuclear transfer) will not be funded.

However, research on human embryonic stem cells and stem cell lines can be funded if the respective projects meet the following criteria:

Justification

The Commission's wording must be extended in order to reflect the Council mandate of 30
September 2002. The proposed wording is a compromise between those who oppose embryonic stem cell research in principle and those who favour it.

Or. en AMENDMENT 25
tabled by Giuseppe Nisticò, John Bowis and José María Gil-Robles Gil-Delgado, on behalf of the PPE-DE Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 25
ANNEX
Annex I, point 1.1, paragraph 18, point (b) (Decision 2002/834/EC )

(b) the human embryos used for the procurement of stem cells must have been created before June 2002 as a result of medically-assisted in vitro fertilisation designed to induce pregnancy, and were no longer to be used for that purpose;
(b) the stem cells or stem cell lines must have been procured before June 2002 from human embryos created as a result of medically assisted in-vitro fertilisation designed to induce pregnancy, and that were no longer to be used for that purpose.

Justification

The sense and purpose of fixing a cut-off date is to prevent the production of embryonic stem cells from being extended. To be able to guarantee this in practice, a considerably clearer wording is necessary at this point. Specifically, if an institution wishes to join a project under the sixth research framework programme it may not use to that end human stem cells procured from embryos created after June 2002.

Or. en AMENDMENT 26
tabled by Giuseppe Gargani, José María Gil-Robles Gil-Delgado and Francesco Fiori, on behalf of the PPE-DE Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 26
ANNEX
Annex I, point 1.1, paragraphs 18 to 22 (Decision 2002/834/EC )

In order to be funded by the Community, research projects involving the procurement of stem cells from human embryos must also meet the following conditions:
Research projects involving the use of procurement of stem cells from human embryos shall not be funded by the Community.
(a) prior to the start of research activities, participants must obtain ethical advice at local or national level in the countries where the research will be carried out;

(b) the human embryos used for the procurement of stem cells must have been created before June 2002 as a result of medically-assisted in vitro fertilisation designed to induce pregnancy, and were no longer to be used for that purpose;

(c) the project must serve particularly important research aims to advance scientific knowledge in basic research or to increase medical knowledge for the development of diagnostic, preventive or therapeutic methods to be applied to humans;

.../...

(d) all other alternative methods (including existing or adult stem cell lines) must have been examined and demonstrated not to be sufficient for the purposes of the research in question;

(e) the free, express, written and informed consent of the donor(s) should be provided in accordance with national legislation prior to the start of the research activities;

(f) no monetary compensation or other benefit in kind must be granted or promised for the donation;

(g) the protection of personal data, including the genetic data, of the donor(s) must be ensured;

(h) where appropriate, the participants in research projects must follow quality and safety standards on donation, procurement and storage in accordance to the state of the art, in order to ensure in particular the traceability of these stem cells.

The scientific evaluation and the ethical review organised by the Commission of the research proposals shall include verification of these conditions. The conditions set out in point (c) and (d) shall be assessed during the scientific evaluation.

.../...

The opinions of the European Group on Ethics in Science and New Technologies, and in particular those relating to research involving the use of human embryonic stem cells will be taken into account.

The participants in research projects should use their best efforts to make the newly derived human embryonic stem cell lines available to the scientific community on a non-profit making basis for research purposes.

A list of research projects involving the use of all types of human embryonic stem cells funded under the sixth framework programme will be published yearly by the Commission.

Or. en Full text of Amendments 0 - 036 PIN archive of Amendments 0 - 036

13 November 2003 A5-0369/

AMENDMENT
tabled by Seán Ó Neachtain, Brian Crowley, José Ribeiro e Castro and Isabelle Caullery, on behalf of the UEN Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment
RECITAL 4

(4)There is a great diversity among Member States concerning the ethical acceptability of various research fields and this is reflected in the national laws in accordance with the principle of subsidiarity. In particular, regulation and legislation of research using human embryos and human embryonic stem cells is handled very differently among Member States. The specific programme already provides that national provisions apply and no research forbidden in any given Member State will be supported by Community funding to a legal entity established in that State.
(4)There is a great diversity among Member States concerning the ethical acceptability of various research fields and this is reflected in the national laws in accordance with the principle of subsidiarity. In particular, regulation and legislation on research using human embryos and human embryonic stem cells is handled very differently among Member States. The specific programme already provides that national provisions apply. Consequently no research forbidden in any given Member State will be supported by Community funding.

Justification

In view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en AMENDMENT 28
tabled by Seán Ó Neachtain, Brian Crowley, José Ribeiro e Castro and Isabelle Caullery, on behalf of the UEN Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 28
RECITAL 5

(5) In light of the current state of knowledge on human embryonic stem cells, new human embryonic stem cell lines, derived from human supernumerary embryos, are required.
Deleted

Justification

In view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en AMENDMENT 29
tabled by Seán Ó Neachtain, Brian Crowley, José Ribeiro e Castro and Isabelle Caullery, on behalf of the UEN Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 29
RECITAL 6

(6) This decision is intended to apply specifically to Community funding of research activities involving the procurement of stem cells from human embryos created before June 2002 as a result of medically-assisted in vitro fertilisation designed to induce pregnancy and were no longer to be used for that purpose (supernumerary embryos). This decision amends the specific programme by introducing several conditions for deciding on the Community funding of such research.
(6) This decision is intended to apply specifically to research activities involving the procurement of stem cells from human embryos. This decision amends the specific programme by excluding Community funding of such research.

Justification

In view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en AMENDMENT 30
tabled by Seán Ó Neachtain, Brian Crowley, José Ribeiro e Castro and Isabelle Caullery, on behalf of the UEN Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 30
RECITAL 7

(7) The present conditions are based on the principles established by the European Group on Ethics, especially the fundamental ethical principles underlined in the opinion No. 15: the principle of respect for human dignity (which requires provisions of guarantees against risks of arbitrary experimentation); the principle of human autonomy which entails the giving of informed consent and the protection of personal data; the principle of justice and of beneficence (namely with regard the improvement and protection of health); the principle of freedom of research (which should be balanced against other principles) and; the principle of proportionality (non-availability of adequate alternative methods in view of the scientific objectives to be reached).
Deleted

Justification

In view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en AMENDMENT 31
tabled by Seán Ó Neachtain, Brian Crowley, José Ribeiro e Castro and Isabelle Caullery, on behalf of the UEN Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 31
RECITAL 8

(8) These conditions should be assessed during the course of a scientific evaluation and an ethical review.
Deleted

Justification

In view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en AMENDMENT 32
tabled by Seán Ó Neachtain, Brian Crowley, José Ribeiro e Castro, Cristiana Muscardini and Isabelle Caullery, on behalf of the UEN Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 32
RECITAL 9

(9) In order for this research to benefit the scientific community at large, the participants in research projects should use their best efforts to make the newly derived human embryonic stem cell lines available to the scientific community for research purposes.
Deleted

Justification

In view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en AMENDMENT 33
tabled by Seán Ó Neachtain, Brian Crowley, José Ribeiro e Castro, Cristiana Muscardini and Isabelle Caullery, on behalf of the UEN Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 33
RECITAL 10

(10) In order to ensure transparency a list of research projects involving the use of human embryonic stem cells funded under the sixth framework programme should be published annually by the Commission.
Deleted

Justification

In view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en AMENDMENT 34
tabled by Seán Ó Neachtain, Brian Crowley, José Ribeiro e Castro, Cristiana Muscardini and Isabelle Caullery, on behalf of the UEN Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 34
ANNEX
Annex I, point 1.1, paragraphs 18 to 22 (Decision 2002/834/EC )

In order to be funded by the Community, research projects involving the procurement of stem cells from human embryos must also meet the following conditions:
In conformity with the principle of subsidiarity, research projects involving the procurement or use of stem cells from human embryos shall not be funded by the Community.
(a) prior to the start of research activities, participants must obtain ethical advice at local or national level in the countries where the research will be carried out;

(b) the human embryos used for the procurement of stem cells must have been created before June 2002 as a result of medically-assisted in vitro fertilisation designed to induce pregnancy, and were no longer to be used for that purpose;

(c) the project must serve particularly important research aims to advance scientific knowledge in basic research or to increase medical knowledge for the development of diagnostic, preventive or therapeutic methods to be applied to humans;

.../...

(d) all other alternative methods (including existing or adult stem cell lines) must have been examined and demonstrated not to be sufficient for the purposes of the research in question;

(e) the free, express, written and informed consent of the donor(s) should be provided in accordance with national legislation prior to the start of the research activities;

(f) no monetary compensation or other benefit in kind must be granted or promised for the donation;

(g) the protection of personal data, including the genetic data, of the donor(s) must be ensured;

(h) where appropriate, the participants in research projects must follow quality and safety standards on donation, procurement and storage in accordance to the state of the art, in order to ensure in particular the traceability of these stem cells.

The scientific evaluation and the ethical review organised by the Commission of the research proposals shall include verification of these conditions. The conditions set out in point (c) and (d) shall be assessed during the scientific evaluation.

.../...

The opinions of the European Group on Ethics in Science and New Technologies, and in particular those relating to research involving the use of human embryonic stem cells will be taken into account.

The participants in research projects should use their best efforts to make the newly derived human embryonic stem cell lines available to the scientific community on a non-profit making basis for research purposes.

A list of research projects involving the use of all types of human embryonic stem cells funded under the sixth framework programme will be published yearly by the Commission.

Justification

In view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en 13 November 2003 A5-0369/ 35 AMENDMENT 35
tabled by Seán Ó Neachtain, Brian Crowley, Cristiana Muscardini, José Ribeiro e Castro and Isabelle Caullery, on behalf of the UEN Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Rejects the Commission proposal.

Justification

The Commission proposal does not comply with the request made by Council as outlined in the minutes of 30 September 2003. The Commission was asked to propose "guidelines on principles for deciding on the Community funding of research projects involving the use of human embryos." In fact the Commission has started from the assumption that such projects will be financed and merely proposes for the financing. Furthermore, the Commission's proposal is not based on an accurate reflection of the majority view expressed at the Interinstutional Seminar.

Finally, in view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, where such research is legally prohibited in some Member States, a criminal offence and against the Constitution of others, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en AMENDMENT 36
tabled by Seán Ó Neachtain, Brian Crowley, Cristiana Muscardini, José Ribeiro e Castro and Isabelle Caullery, on behalf of the UEN Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Draft legislative resolution

Paragraph 2

2. Calls on the Council to extend indefinitely the de-facto moratorium, as stipulated in the Council minutes of 30 September 2002, on Community funding of research involving the use of human embryos or human embryonic stem cells;

Justification

The Commission proposal does not comply with the request made by Council as outlined in the minutes of 30 September 2003. The Commission was asked to propose "guidelines on principles for deciding on the Community funding of research projects involving the use of human embryos." In fact the Commission has started from the assumption that such projects will be financed and merely proposes for the financing. Furthermore, the Commission's proposal is not based on an accurate reflection of the majority view expressed at the Interinstutional Seminar.

Finally, in view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, where such research is legally prohibited in some Member States, a criminal offence and against the Constitution of others, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en Full text of Amendments 037 - 044 PIN archive of Amendments 037 - 044

13 November 2003 A5-0369/ 37

AMENDMENT 37
tabled by Giuseppe Gargani, Gerard Onesta, Brian Crowley, Johannes Blokland, Hans Modrow, Generoso Andria, Paolo Bartolozzi, Christopher Beazley, Bastiaan Belder, Rolf Berend, Reimer Böge, Christian Ulrik von Boetticher, Hiltrud Breyer, Isabelle Caullery, Marcello Dell'Utri, Nirj Deva, Jan Dhaene, Den Dover, Conceptio Ferrer, Francesco Fiori, Marialiese Flemming, Karl-Heinz Florenz, Jas Gawronski, José Maria Gil-Robles Gil-Delgado, Per Gahrton, Vitaliano Gemelli, Anne-Karin Glase, Lutz Goepel, Christopher Heaton-Harris, Marie Anne Isler Béguin, Georg Jarzembowski, Sylvia-Yvonne Kaufmann, Patricia Mc Kenna, Hedwig Keppelhoff-Wiechert, Eva Klamt, Eija-Riitta Anneli Korhola, Jean Lambert, Paul Lannoye, Klaus-Heiner Lehne, Alan Lipietz, Giorgio Lisi, Caroline Lucas, Jean-Charles Marchiani, Helmut Markov, Xavier Mayer, Mario Mauro, Winfried Menrad, Peter Michael Mombaur, Francesco Musotto, Hatmut Nassauer, Sean O' Neachtain, Doris Pack, Adriana Poli Bortone, Bernd Posselt, Luis Queíro, Jose Ribeiro e Castro, Didier Claude Rod, Lennard Sacredeus, Jacques Santer, Giacomo Santini, Amalia Sartori, Dana Rosemary Scallon, Ursula Schleicher, Ingo Schmit, Horst Schnellhardt, Ilka Schröder, Elisabeth Schroedter, Renate Sommer, Bart Staes, Gabriele Stauner, Antonio Tajani, Dietmut Theato, Nicole Thomas Mauro, Matti Wuori, Stefano Zappalænbsp;, Sabine Zissener

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 37
RECITAL 4

(4)There is a great diversity among Member States concerning the ethical acceptability of various research fields and this is reflected in the national laws in accordance with the principle of subsidiarity. In particular, regulation and legislation of research using human embryos and human embryonic stem cells is handled very differently among Member States. The specific programme already provides that national provisions apply and no research forbidden in any given Member State will be supported by Community funding to a legal entity established in that State.
(4)There is a great diversity among Member States concerning the ethical acceptability of various research fields and this is reflected in the national laws in accordance with the principle of subsidiarity. In particular, regulation and legislation on research using human embryos and human embryonic stem cells is handled very differently among Member States. The specific programme already provides that national provisions apply. Consequently no research forbidden in any given Member State will be supported by Community funding.
.../...

Justification

In view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en 13 November 2003 A5-0369/ 38 AMENDMENT 38
tabled by Giuseppe Gargani, Gerard Onesta, Brian Crowley, Johannes Blokland, Hans Modrow, Generoso Andria, Paolo Bartolozzi, Christopher Beazley, Bastiaan Belder, Rolf Berend, Reimer Böge, Christian Ulrik von Boetticher, Hiltrud Breyer, Isabelle Caullery, Marcello Dell'Utri, Nirj Deva, Jan Dhaene, Den Dover, Conceptio Ferrer, Francesco Fiori, Marialiese Flemming, Karl-Heinz Florenz, Jas Gawronski, José Maria Gil-Robles Gil-Delgado, Per Gahrton, Vitaliano Gemelli, Anne-Karin Glase, Lutz Goepel, Christopher Heaton-Harris, Marie Anne Isler Béguin, Georg Jarzembowski, Sylvia-Yvonne Kaufmann, Patricia Mc Kenna, Hedwig Keppelhoff-Wiechert, Eva Klamt, Eija-Riitta Anneli Korhola, Jean Lambert, Paul Lannoye, Klaus-Heiner Lehne, Alan Lipietz, Giorgio Lisi, Caroline Lucas, Jean-Charles Marchiani, Helmut Markov, Xavier Mayer, Mario Mauro, Winfried Menrad, Peter Michael Mombaur, Francesco Musotto, Hatmut Nassauer, Sean O' Neachtain, Doris Pack, Adriana Poli Bortone, Bernd Posselt, Luis Queíro, Jose Ribeiro e Castro, Didier Claude Rod, Lennard Sacredeus, Jacques Santer, Giacomo Santini, Amalia Sartori, Dana Rosemary Scallon, Ursula Schleicher, Ingo Schmit, Horst Schnellhardt, Ilka Schröder, Elisabeth Schroedter, Renate Sommer, Bart Staes, Gabriele Stauner, Antonio Tajani, Dietmut Theato, Nicole Thomas Mauro, Matti Wuori, Stefano Zappalænbsp;, Sabine Zissener

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 38
RECITAL 5

(5) In light of the current state of knowledge on human embryonic stem cells, new human embryonic stem cell lines, derived from human supernumerary embryos, are required.
(5) Articles 163 and following of the Treaty establish Community competences with regard to research; these provisions state that the Community may complement the activities of the Member States with a view to achieving the objective of strengthening the scientific and technological bases of European industry, encouraging international competitiveness and promoting research activities.

Or. en AMENDMENT 39
tabled by Giuseppe Gargani, Gerard Onesta, Brian Crowley, Johannes Blokland, Hans Modrow, Generoso Andria, Paolo Bartolozzi, Christopher Beazley, Bastiaan Belder, Rolf Berend, Reimer Böge, Christian Ulrik von Boetticher, Hiltrud Breyer, Isabelle Caullery, Marcello Dell'Utri, Nirj Deva, Jan Dhaene, Den Dover, Conceptio Ferrer, Francesco Fiori, Marialiese Flemming, Karl-Heinz Florenz, Jas Gawronski, José Maria Gil-Robles Gil-Delgado, Per Gahrton, Vitaliano Gemelli, Anne-Karin Glase, Lutz Goepel, Christopher Heaton-Harris, Marie Anne Isler Béguin, Georg Jarzembowski, Sylvia-Yvonne Kaufmann, Patricia Mc Kenna, Hedwig Keppelhoff-Wiechert, Eva Klamt, Eija-Riitta Anneli Korhola, Paul Lannoye, Klaus-Heiner Lehne, Alan Lipietz, Giorgio Lisi, Jean-Charles Marchiani, Helmut Markov, Xavier Mayer, Mario Mauro, Winfried Menrad, Peter Michael Mombaur, Francesco Musotto, Hatmut Nassauer, Sean O' Neachtain, Doris Pack, Adriana Poli Bortone, Bernd Posselt, Luis Queíro, Jose Ribeiro e Castro, Didier Claude Rod, Lennard Sacredeus, Jacques Santer, Giacomo Santini, Amalia Sartori, Dana Rosemary Scallon, Ursula Schleicher, Ingo Schmit, Horst Schnellhardt, Ilka Schröder, Elisabeth Schroedter, Renate Sommer, Bart Staes, Gabriele Stauner, Antonio Tajani, Dietmut Theato, Nicole Thomas Mauro, Matti Wuori, Stefano Zappalænbsp;, Sabine Zissener

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 39
RECITAL 6

(6) This decision is intended to apply specifically to Community funding of research activities involving the procurement of stem cells from human embryos created before June 2002 as a result of medically-assisted in vitro fertilisation designed to induce pregnancy and were no longer to be used for that purpose (supernumerary embryos). This decision amends the specific programme by introducing several conditions for deciding on the Community funding of such research.
(6) The Community's competences with regard to research complement those of the Member States and the Community should make use of these complementary competences essentially through initiatives to provide financial support and/or non-binding coordination or to support and complement national policies. This may never, even indirectly, equate to harmonisation of national provisions.

Or. en
AMENDMENT 40
tabled by Giuseppe Gargani, Gerard Onesta, Brian Crowley, Johannes Blokland, Hans Modrow, Generoso Andria, Paolo Bartolozzi, Christopher Beazley, Bastiaan Belder, Rolf Berend, Reimer Böge, Christian Ulrik von Boetticher, Hiltrud Breyer, Isabelle Caullery, Marcello Dell'Utri, Nirj Deva, Jan Dhaene, Den Dover, Conceptio Ferrer, Francesco Fiori, Marialiese Flemming, Karl-Heinz Florenz, Jas Gawronski, José Maria Gil-Robles Gil-Delgado, Per Gahrton, Vitaliano Gemelli, Anne-Karin Glase, Lutz Goepel, Christopher Heaton-Harris, Marie Anne Isler Béguin, Georg Jarzembowski, Sylvia-Yvonne Kaufmann, Patricia Mc Kenna, Hedwig Keppelhoff-Wiechert, Eva Klamt, Eija-Riitta Anneli Korhola, Paul Lannoye, Klaus-Heiner Lehne, Alan Lipietz, Giorgio Lisi, Jean-Charles Marchiani, Helmut Markov, Xavier Mayer, Mario Mauro, Winfried Menrad, Peter Michael Mombaur, Francesco Musotto, Hatmut Nassauer, Sean O' Neachtain, Doris Pack, Adriana Poli Bortone, Bernd Posselt, Luis Queíro, Jose Ribeiro e Castro, Didier Claude Rod, Lennard Sacredeus, Jacques Santer, Giacomo Santini, Amalia Sartori, Dana Rosemary Scallon, Ursula Schleicher, Ingo Schmit, Horst Schnellhardt, Ilka Schröder, Elisabeth Schroedter, Renate Sommer, Bart Staes, Gabriele Stauner, Antonio Tajani, Dietmut Theato, Nicole Thomas Mauro, Matti Wuori, Stefano Zappalænbsp;, Sabine Zissener

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 40
RECITAL 7

(7) The present conditions are based on the principles established by the European Group on Ethics, especially the fundamental ethical principles underlined in the opinion No. 15: the principle of respect for human dignity (which requires provisions of guarantees against risks of arbitrary experimentation); the principle of human autonomy which entails the giving of informed consent and the protection of personal data; the principle of justice and of beneficence (namely with regard the improvement and protection of
(7) Intervention by the Community on the basis of its complementary competences should be limited to supplementing, supporting or coordinating the action of the Member States. In such areas negative delimitation of competence (e.g. the exclusion of harmonisation in certain areas) is common. The Community may only act to encourage cooperation between the Member States and, if necessary, to support and supplement their actions. The power to adopt legislative rules in these areas remains in

.../...

health); the principle of freedom of research (which should be balanced against other principles) and; the principle of proportionality (non-availability of adequate alternative methods in view of the scientific objectives to be reached).
the hands of the Member States, and intervention by the Community cannot have the effect of excluding intervention by the Member States.

Or. en 13 November 2003 A5-0369/ 41 AMENDMENT 41
tabled by Giuseppe Gargani, Gerard Onesta, Brian Crowley, Johannes Blokland, Hans Modrow, Generoso Andria, Paolo Bartolozzi, Christopher Beazley, Bastiaan Belder, Rolf Berend, Reimer Böge, Christian Ulrik von Boetticher, Hiltrud Breyer, Isabelle Caullery, Marcello Dell'Utri, Nirj Deva, Jan Dhaene, Den Dover, Conceptio Ferrer, Francesco Fiori, Marialiese Flemming, Karl-Heinz Florenz, Jas Gawronski, José Maria Gil-Robles Gil-Delgado, Per Gahrton, Vitaliano Gemelli, Anne-Karin Glase, Lutz Goepel, Christopher Heaton-Harris, Marie Anne Isler Béguin, Georg Jarzembowski, Sylvia-Yvonne Kaufmann, Patricia Mc Kenna, Hedwig Keppelhoff-Wiechert, Eva Klamt, Eija-Riitta Anneli Korhola, Paul Lannoye, Klaus-Heiner Lehne, Alan Lipietz, Giorgio Lisi, Jean-Charles Marchiani, Helmut Markov, Xavier Mayer, Mario Mauro, Winfried Menrad, Peter Michael Mombaur, Francesco Musotto, Hatmut Nassauer, Sean O' Neachtain, Doris Pack, Adriana Poli Bortone, Bernd Posselt, Luis Queíro, Jose Ribeiro e Castro, Didier Claude Rod, Lennard Sacredeus, Jacques Santer, Giacomo Santini, Amalia Sartori, Dana Rosemary Scallon, Ursula Schleicher, Ingo Schmit, Horst Schnellhardt, Ilka Schröder, Elisabeth Schroedter, Renate Sommer, Bart Staes, Gabriele Stauner, Antonio Tajani, Dietmut Theato, Nicole Thomas Mauro, Matti Wuori, Stefano Zappalænbsp;, Sabine Zissener

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament
Amendment 41
RECITAL 8

(8) These conditions should be assessed during the course of a scientific evaluation and an ethical review.
(8) Article 168 of the Treaty stipulates that in implementing the multiannual framework programme, supplementary programmes may be decided on involving the participation of only those Member States which shall finance them, subject to possible Community participation, and therefore Community initiatives must be restricted to covering activities for which none of the Member States oppose the fact that they are funded from the Community budget. Therefore, Community initiatives must be restricted to covering activities for which all the Member States agree with (or at least for which none oppose) the fact that they are funded from the Community budget.

Or. en
AMENDMENT 42
tabled by Giuseppe Gargani, Gerard Onesta, Brian Crowley, Johannes Blokland, Hans Modrow, Generoso Andria, Paolo Bartolozzi, Christopher Beazley, Bastiaan Belder, Rolf Berend, Reimer Böge, Christian Ulrik von Boetticher, Hiltrud Breyer, Isabelle Caullery, Marcello Dell'Utri, Nirj Deva, Jan Dhaene, Den Dover, Conceptio Ferrer, Francesco Fiori, Marialiese Flemming, Karl-Heinz Florenz, Jas Gawronski, José Maria Gil-Robles Gil-Delgado, Per Gahrton, Vitaliano Gemelli, Anne-Karin Glase, Lutz Goepel, Christopher Heaton-Harris, Marie Anne Isler Béguin, Georg Jarzembowski, Sylvia-Yvonne Kaufmann, Patricia Mc Kenna, Hedwig Keppelhoff-Wiechert, Eva Klamt, Eija-Riitta Anneli Korhola, Paul Lannoye, Klaus-Heiner Lehne, Alan Lipietz, Giorgio Lisi, Jean-Charles Marchiani, Helmut Markov, Xavier Mayer, Mario Mauro, Winfried Menrad, Peter Michael Mombaur, Francesco Musotto, Hatmut Nassauer, Sean O' Neachtain, Doris Pack, Adriana Poli Bortone, Bernd Posselt, Luis Queíro, Jose Ribeiro e Castro, Didier Claude Rod, Lennard Sacredeus, Jacques Santer, Giacomo Santini, Amalia Sartori, Dana Rosemary Scallon, Ursula Schleicher, Ingo Schmit, Horst Schnellhardt, Ilka Schröder, Elisabeth Schroedter, Renate Sommer, Bart Staes, Gabriele Stauner, Antonio Tajani, Dietmut Theato, Nicole Thomas Mauro, Matti Wuori, Stefano Zappalænbsp;, Sabine Zissener

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 42
RECITAL 9

(9) In order for this research to benefit the scientific community at large, the participants in research projects should use their best efforts to make the newly derived human embryonic stem cell lines available to the scientific community for research purposes.
Deleted

Justification

In view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en AMENDMENT 43
tabled by Giuseppe Gargani, Gerard Onesta, Brian Crowley, Johannes Blokland, Hans Modrow, Generoso Andria, Paolo Bartolozzi, Christopher Beazley, Bastiaan Belder, Rolf Berend, Reimer Böge, Christian Ulrik von Boetticher, Hiltrud Breyer, Isabelle Caullery, Marcello Dell'Utri, Nirj Deva, Jan Dhaene, Den Dover, Conceptio Ferrer, Francesco Fiori, Marialiese Flemming, Karl-Heinz Florenz, Jas Gawronski, José Maria Gil-Robles Gil-Delgado, Per Gahrton, Vitaliano Gemelli, Anne-Karin Glase, Lutz Goepel, Christopher Heaton-Harris, Marie Anne Isler Béguin, Georg Jarzembowski, Sylvia-Yvonne Kaufmann, Patricia Mc Kenna, Hedwig Keppelhoff-Wiechert, Eva Klamt, Eija-Riitta Anneli Korhola, Paul Lannoye, Klaus-Heiner Lehne, Alan Lipietz, Giorgio Lisi, Jean-Charles Marchiani, Helmut Markov, Xavier Mayer, Mario Mauro, Winfried Menrad, Peter Michael Mombaur, Francesco Musotto, Hatmut Nassauer, Sean O' Neachtain, Doris Pack, Adriana Poli Bortone, Bernd Posselt, Luis Queíro, Jose Ribeiro e Castro, Didier Claude Rod, Lennard Sacredeus, Jacques Santer, Giacomo Santini, Amalia Sartori, Dana Rosemary Scallon, Ursula Schleicher, Ingo Schmit, Horst Schnellhardt, Ilka Schröder, Elisabeth Schroedter, Renate Sommer, Bart Staes, Gabriele Stauner, Antonio Tajani, Dietmut Theato, Nicole Thomas Mauro, Matti Wuori, Stefano Zappalænbsp;, Sabine Zissener

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 43
RECITAL 10

(10) In order to ensure transparency a list of research projects involving the use of human embryonic stem cells funded under the sixth framework programme should be published annually by the Commission.
Deleted

Justification

In view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en AMENDMENT 44
tabled by Giuseppe Gargani, Gerard Onesta, Brian Crowley, Johannes Blokland, Hans Modrow, Generoso Andria, Paolo Bartolozzi, Christopher Beazley, Bastiaan Belder, Rolf Berend, Reimer Böge, Christian Ulrik von Boetticher, Hiltrud Breyer, Isabelle Caullery, Marcello Dell'Utri, Nirj Deva, Jan Dhaene, Den Dover, Conceptio Ferrer, Francesco Fiori, Marialiese Flemming, Karl-Heinz Florenz, Jas Gawronski, José Maria Gil-Robles Gil-Delgado, Per Gahrton, Vitaliano Gemelli, Anne-Karin Glase, Lutz Goepel, Christopher Heaton-Harris, Marie Anne Isler Béguin, Georg Jarzembowski, Sylvia-Yvonne Kaufmann, Patricia Mc Kenna, Hedwig Keppelhoff-Wiechert, Eva Klamt, Eija-Riitta Anneli Korhola, Paul Lannoye, Klaus-Heiner Lehne, Alan Lipietz, Giorgio Lisi, Jean-Charles Marchiani, Helmut Markov, Xavier Mayer, Mario Mauro, Winfried Menrad, Peter Michael Mombaur, Francesco Musotto, Hatmut Nassauer, Sean O' Neachtain, Doris Pack, Adriana Poli Bortone, Bernd Posselt, Luis Queíro, Jose Ribeiro e Castro, Didier Claude Rod, Lennard Sacredeus, Jacques Santer, Giacomo Santini, Amalia Sartori, Dana Rosemary Scallon, Ursula Schleicher, Ingo Schmit, Horst Schnellhardt, Ilka Schröder, Elisabeth Schroedter, Renate Sommer, Bart Staes, Gabriele Stauner, Antonio Tajani, Dietmut Theato, Nicole Thomas Mauro, Matti Wuori, Stefano Zappalænbsp;, Sabine Zissener

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 44
ANNEX
Annex I, point 1.1, paragraphs 18 to 22 (Decision 2002/834/EC )

In order to be funded by the Community, research projects involving the procurement of stem cells from human embryos must also meet the following conditions:
Research projects involving the use or procurement of stem cells from human embryos shall not be funded by the Community.
(a) prior to the start of research activities, participants must obtain ethical advice at local or national level in the countries where the research will be carried out;

.../...

(b) the human embryos used for the procurement of stem cells must have been created before June 2002 as a result of medically-assisted in vitro fertilisation designed to induce pregnancy, and were no longer to be used for that purpose;

(c) the project must serve particularly important research aims to advance scientific knowledge in basic research or to increase medical knowledge for the development of diagnostic, preventive or therapeutic methods to be applied to humans;

(d) all other alternative methods (including existing or adult stem cell lines) must have been examined and demonstrated not to be sufficient for the purposes of the research in question;

(e) the free, express, written and informed consent of the donor(s) should be provided in accordance with national legislation prior to the start of the research activities;

(f) no monetary compensation or other benefit in kind must be granted or promised for the donation;

(g) the protection of personal data, including the genetic data, of the donor(s) must be ensured;

(h) where appropriate, the participants in research projects must follow quality and safety standards on donation, procurement and storage in accordance to the state of the art, in order to ensure in particular the traceability of these stem cells.

.../...

The scientific evaluation and the ethical review organised by the Commission of the research proposals shall include verification of these conditions. The conditions set out in point (c) and (d) shall be assessed during the scientific evaluation.

The opinions of the European Group on Ethics in Science and New Technologies, and in particular those relating to research involving the use of human embryonic stem cells will be taken into account.

The participants in research projects should use their best efforts to make the newly derived human embryonic stem cell lines available to the scientific community on a non-profit making basis for research purposes.

A list of research projects involving the use of all types of human embryonic stem cells funded under the sixth framework programme will be published yearly by the Commission.

Or. en Full text of Amendments 041 - 041 PIN archive of Amendments 041 - 041

13 November 2003 A5-0369/ 41/rev.

AMENDMENT 41/rev.
tabled by Giuseppe Gargani, Gerard Onesta, Brian Crowley, Johannes Blokland, Hans Modrow, Generoso Andria, Paolo Bartolozzi, Christopher Beazley, Bastiaan Belder, Rolf Berend, Reimer Böge, Christian Ulrik von Boetticher, Hiltrud Breyer, Isabelle Caullery, Marcello Dell'Utri, Nirj Deva, Jan Dhaene, Den Dover, Conceptio Ferrer, Francesco Fiori, Marialiese Flemming, Karl-Heinz Florenz, Jas Gawronski, José Maria Gil-Robles Gil-Delgado, Per Gahrton, Vitaliano Gemelli, Anne-Karin Glase, Lutz Goepel, Christopher Heaton-Harris, Marie Anne Isler Béguin, Georg Jarzembowski, Sylvia-Yvonne Kaufmann, Patricia Mc Kenna, Hedwig Keppelhoff-Wiechert, Eva Klamt, Eija-Riitta Anneli Korhola, Paul Lannoye, Klaus-Heiner Lehne, Alan Lipietz, Giorgio Lisi, Jean-Charles Marchiani, Helmut Markov, Xavier Mayer, Mario Mauro, Winfried Menrad, Peter Michael Mombaur, Francesco Musotto, Hatmut Nassauer, Sean O' Neachtain, Doris Pack, Adriana Poli Bortone, Bernd Posselt, Luis Queíro, Jose Ribeiro e Castro, Didier Claude Rod, Lennard Sacredeus, Jacques Santer, Giacomo Santini, Amalia Sartori, Dana Rosemary Scallon, Ursula Schleicher, Ingo Schmit, Horst Schnellhardt, Ilka Schröder, Elisabeth Schroedter, Renate Sommer, Bart Staes, Gabriele Stauner, Antonio Tajani, Dietmut Theato, Nicole Thomas Mauro, Matti Wuori, Stefano Zappalænbsp;, Sabine Zissener

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament
Amendment 41/rev.
RECITAL 8

(8) These conditions should be assessed during the course of a scientific evaluation and an ethical review.
(8) Article 168 of the Treaty stipulates that in implementing the multiannual framework programme, supplementary programmes may be decided on involving the participation of only those Member States which shall finance them, subject to possible Community participation, and therefore Community initiatives must be restricted to covering activities for which all the Member States agree with (or at least for which none oppose) the fact that they are funded from the Community budget.

Or. en Full text of Amendments 045 - 059 PIN archive of Amendments 045 - 059

13 November 2003 A5-0369/ 45

AMENDMENT 45
tabled by Bastiaan Belder and Johannes Blokland, on behalf of the EDD Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 45
RECITAL 4

(4)There is a great diversity among Member States concerning the ethical acceptability of various research fields and this is reflected in the national laws in accordance with the principle of subsidiarity. In particular, regulation and legislation of research using human embryos and human embryonic stem cells is handled very differently among Member States. The specific programme already provides that national provisions apply and no research forbidden in any given Member State will be supported by Community funding to a legal entity established in that State.
(4)There is a great diversity among Member States concerning the ethical acceptability of various research fields and this is reflected in the national laws in accordance with the principle of subsidiarity. In particular, regulation and legislation on research using human embryos and human embryonic stem cells is handled very differently among Member States. The specific programme already provides that national provisions apply. Consequently no research forbidden in any given Member State will be supported by Community funding.

Justification

In view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en AMENDMENT 46
tabled by Bastiaan Belder and Johannes Blokland, on behalf of the EDD Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 46
RECITAL 5

(5) In light of the current state of knowledge on human embryonic stem cells, new human embryonic stem cell lines, derived from human supernumerary embryos, are required.
Deleted

Justification

In view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en AMENDMENT 47
tabled by Bastiaan Belder and Johannes Blokland, on behalf of the EDD Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 47
RECITAL 6

(6) This decision is intended to apply specifically to Community funding of research activities involving the procurement of stem cells from human embryos created before June 2002 as a result of medically-assisted in vitro fertilisation designed to induce pregnancy and were no longer to be used for that purpose (supernumerary embryos). This decision amends the specific programme by introducing several conditions for deciding on the Community funding of such research.
(6) This decision is intended to apply specifically to research activities involving the procurement of stem cells from human embryos. This decision amends the specific programme by excluding Community funding of such research.

Justification

In view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en AMENDMENT 48
tabled by Bastiaan Belder and Johannes Blokland, on behalf of the EDD Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 48
RECITAL 7

(7) The present conditions are based on the principles established by the European Group on Ethics, especially the fundamental ethical principles underlined in the opinion No. 15: the principle of respect for human dignity (which requires provisions of guarantees against risks of arbitrary experimentation); the principle of human autonomy which entails the giving of informed consent and the protection of personal data; the principle of justice and of beneficence (namely with regard the improvement and protection of health); the principle of freedom of research (which should be balanced against other principles) and; the principle of proportionality (non-availability of adequate alternative methods in view of the scientific objectives to be reached).
Deleted

Justification

In view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en AMENDMENT 49
tabled by Bastiaan Belder and Johannes Blokland, on behalf of the EDD Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 49
RECITAL 8

(8) These conditions should be assessed during the course of a scientific evaluation and an ethical review.
Deleted

Justification

In view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en AMENDMENT 50
tabled by Bastiaan Belder and Johannes Blokland, on behalf of the EDD Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 50
RECITAL 9

(9) In order for this research to benefit the scientific community at large, the participants in research projects should use their best efforts to make the newly derived human embryonic stem cell lines available to the scientific community for research purposes.
Deleted

Justification

In view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en AMENDMENT 51
tabled by Bastiaan Belder and Johannes Blokland, on behalf of the EDD Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 51
RECITAL 10

(10) In order to ensure transparency a list of research projects involving the use of human embryonic stem cells funded under the sixth framework programme should be published annually by the Commission.
Deleted

Or. en AMENDMENT 52
tabled by Bastiaan Belder and Johannes Blokland, on behalf of the EDD Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 52
ANNEX
Annex I, point 1.1, paragraphs 18 to 22 (Decision 2002/834/EC )

In order to be funded by the Community, research projects involving the procurement of stem cells from human embryos must also meet the following conditions:
In conformity with the principle of subsidiarity, research projects involving the procurement or use of stem cells from human embryos shall not be funded by the Community.
(a) prior to the start of research activities, participants must obtain ethical advice at local or national level in the countries where the research will be carried out;

(b) the human embryos used for the procurement of stem cells must have been created before June 2002 as a result of medically-assisted in vitro fertilisation designed to induce pregnancy, and were no longer to be used for that purpose;

(c) the project must serve particularly important research aims to advance scientific knowledge in basic research or to increase medical knowledge for the development of diagnostic, preventive or therapeutic methods to be applied to humans;

.../...

(d) all other alternative methods (including existing or adult stem cell lines) must have been examined and demonstrated not to be sufficient for the purposes of the research in question;

(e) the free, express, written and informed consent of the donor(s) should be provided in accordance with national legislation prior to the start of the research activities;

(f) no monetary compensation or other benefit in kind must be granted or promised for the donation;

(g) the protection of personal data, including the genetic data, of the donor(s) must be ensured;

(h) where appropriate, the participants in research projects must follow quality and safety standards on donation, procurement and storage in accordance to the state of the art, in order to ensure in particular the traceability of these stem cells.

The scientific evaluation and the ethical review organised by the Commission of the research proposals shall include verification of these conditions. The conditions set out in point (c) and (d) shall be assessed during the scientific evaluation.

.../...

The opinions of the European Group on Ethics in Science and New Technologies, and in particular those relating to research involving the use of human embryonic stem cells will be taken into account.

The participants in research projects should use their best efforts to make the newly derived human embryonic stem cell lines available to the scientific community on a non-profit making basis for research purposes.

A list of research projects involving the use of all types of human embryonic stem cells funded under the sixth framework programme will be published yearly by the Commission.

Justification

In view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en 13 November 2003 A5-0369/ 53 AMENDMENT 53
tabled by Bastiaan Belder and Johannes Blokland, on behalf of the EDD Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Rejects the Commission proposal.

Justification

The Commission proposal does not comply with the request made by Council as outlined in the minutes of 30 September 2003. The Commission was asked to propose "guidelines on principles for deciding on the Community funding of research projects involving the use of human embryos." In fact the Commission has started from the assumption that such projects will be financed and merely proposes for the financing. Furthermore, the Commission's proposal is not based on an accurate reflection of the majority view expressed at the Interinstutional Seminar.

Finally, in view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, where such research is legally prohibited in some Member States, a criminal offence and against the Constitution of others, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds

Or. en
AMENDMENT 54
tabled by Bastiaan Belder and Johannes Blokland, on behalf of the EDD Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Draft legislative resolution

Paragraph 2

2. Calls on the Council to extend indefinitely the de-facto moratorium, as stipulated in the Council minutes of 30 September 2002, on Community funding of research involving the use of human embryos or human embryonic stem cells;

Justification

The Commission proposal does not comply with the request made by Council as outlined in the minutes of 30 September 2003. The Commission was asked to propose "guidelines on principles for deciding on the Community funding of research projects involving the use of human embryos." In fact the Commission has started from the assumption that such projects will be financed and merely proposes for the financing. Furthermore, the Commission's proposal is not based on an accurate reflection of the majority view expressed at the Interinstutional Seminar.

Finally, in view of the greatly different legal frameworks between Member States pertaining to research involving human embryos, where such research is legally prohibited in some Member States, a criminal offence and against the Constitution of others, it should be a matter for each individual Member State, in conformity with the principle of subsidiarity, to decide whether they wish to fund this type of research out of their own national funds.

Or. en AMENDMENT 55
tabled by Bastiaan Belder and Johannes Blokland, on behalf of the EDD Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 55
ANNEX
Annex I, point 1.1, paragraphs 18 to 22 (Decision 2002/834/EC )

In order to be funded by the Community, research projects involving the procurement of stem cells from human embryos must also meet the following conditions:
In accordance with the statements to the Council minutes of 30 September 2002 and following the interinstitutional seminar of 24 April 2003, the following guidelines on principles for deciding on the Community funding of research projects involving the use of human embryos and human embryonic stem cells are established:
(a) prior to the start of research activities, participants must obtain ethical advice at local or national level in the countries where the research will be carried out;
- research involving the destruction of human embryos cannot be given financial support from the European Union;
(b) the human embryos used for the procurement of stem cells must have been created before June 2002 as a result of medically-assisted in vitro fertilisation designed to induce pregnancy, and were no longer to be used for that purpose;
- according to the subsidiarity principle European research funding is exclusively used for purposes agreed upon by all the Member States, i.e. research which is not forbidden under the law of any Member State;

.../...

(c) the project must serve particularly important research aims to advance scientific knowledge in basic research or to increase medical knowledge for the development of diagnostic, preventive or therapeutic methods to be applied to humans;
(d) all other alternative methods (including existing or adult stem cell lines) must have been examined and demonstrated not to be sufficient for the purposes of the research in question;
(e) the free, express, written and informed consent of the donor(s) should be provided in accordance with national legislation prior to the start of the research activities;
- the precautionary principle should apply;
- the principle of proportionality should apply to research involving the destruction of human embryos. However, there are alternative methods aimed at the treatment of degenerative diseases which can be as adequate an application for treatment in human beings as the destructive research might turn out to be. The proportionality principle has therefore not been met. Research involving the destruction of the embryo would therefore form an impediment to the proportionality principle.
(f) no monetary compensation or other benefit in kind must be granted or promised for the donation;

(g) the protection of personal data, including the genetic data, of the donor(s) must be ensured;

(h) where appropriate, the participants in research projects must follow quality and safety standards on donation, procurement and storage in accordance to the state of the art, in order to ensure in particular the traceability of these stem cells.

The scientific evaluation and the ethical review organised by the Commission of the research proposals shall include verification of these conditions. The conditions set out in point (c) and (d) shall be assessed during the scientific evaluation.

.../...

The opinions of the European Group on Ethics in Science and New Technologies, and in particular those relating to research involving the use of human embryonic stem cells will be taken into account.

The participants in research projects should use their best efforts to make the newly derived human embryonic stem cell lines available to the scientific community on a non-profit making basis for research purposes.

A list of research projects involving the use of all types of human embryonic stem cells funded under the sixth framework programme will be published yearly by the Commission.

Justification

The Commission proposal does not comply with the agreements made, since it does not consist of guidelines for principles, but of conditions for financial support. Firstly, the European Parliament is not in favour of research involving the destruction of human embryos as stated in its resolution of the 30th March 2000 (resolution 0301/2000). Secondly, it is harming the subsidiarity principle. Thirdly, the precautionary principle is not respected, since the considerable medical risks and uncertainties related to the research require an extensive risk-analysis. Fourthly, the proportionality principle should apply as well. It is not possible to state that adequate alternative methods to destructive research in view of the scientific objectives to be reached are not available. For example somatic or adult stem cells. Both embryonic and adult stem cell research have their specific advantages and disadvantages with regard to their possible application as treatment in human beings and it is unclear which of them offers the best perspective.

Or. en 13 November 2003 A5-0369/ 56 AMENDMENT 56
tabled by Hiltrud Breyer, on behalf of the Verts/ALE Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 56
ANNEX
Annex I, point 1.1, paragraph 18, point (e) (Decision 2002/834/EC )

(e) the free, express, written and informed consent of the donor(s) should be provided in accordance with national legislation prior to the start of the research activities;
(e) prior to the creation of the human embryo both donors must have given their free, express, written and fully informed consent to the use of the stem cells for research purposes;

Justification

Self-explanatory.

Or. en AMENDMENT 57
tabled by Hiltrud Breyer, on behalf of the Verts/ALE Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 57
ANNEX
Annex I, point 1.1, paragraph 18, point (g) (Decision 2002/834/EC )

(g) the protection of personal data, including the genetic data, of the donor(s) must be ensured;
(g) the protection of personal data, including the genetic data, of both donors must be ensured;

Justification

Self-explanatory.

Or. en AMENDMENT 58
tabled by Hiltrud Breyer, on behalf of the Verts/ALE Group

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 58
ANNEX
Annex I, point 1.1, paragraph 21 (Decision 2002/834/EC )

The participants in research projects should use their best efforts to make the newly derived human embryonic stem cell lines available to the scientific community on a non-profit making basis for research purposes.
The human embryonic stem cell lines must be made available to the scientific community on a non-profit making basis.

Justification

Self-explanatory.

Or. en AMENDMENT 59
tabled by David Robert Bowe and others

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 59
RECITAL 6

(6) This decision is intended to apply specifically to Community funding of research activities involving the procurement of stem cells from human embryos created before June 2002 as a result of medically-assisted in vitro fertilisation designed to induce pregnancy and were no longer to be used for that purpose (supernumerary embryos). This decision amends the specific programme by introducing several conditions for deciding on the Community funding of such research.
(6) This decision is intended to apply specifically to Community funding of research activities involving the procurement of stem cells from human embryos created as a result of medically-assisted in vitro fertilisation designed to induce pregnancy and which were no longer to be used for that purpose (supernumerary embryos). This decision amends the specific programme by introducing several conditions for deciding on the Community funding of such research.

Justification

A "cut off" date contained in the Commission proposal could actually increase the number of embryos needed for research. It is imperative that the embryos donated for research are those most likely to provide quality stem cell lines. Continuing advances in the techniques used to freeze embryos for IVF have the potential to improve the success rate of IVF and therefore limit the number of embryos created. These same advances also point to the use of more recent embryos, if donated, for the derivation of stem cell lines. For this reason the proposed cut off date may be counter-productive, both in terms of the outcome of the research and in terms of the number of embryos required.

Or. en Full text of Amendments 060 - 067 PIN archive of Amendments 060 - 067

13 November 2003 A5-0369/ 60

AMENDMENT 60
tabled by Johannes Blokland, on behalf of the EDD Group
Evelyne Gebhardt, Erika Mann, Garrelt Duin, Wilhelm Ernst Piecyk, Rosemarie Müller, Helmut Kuhne, Bernd Lange, Lissy Gröner, Jutta D. Haug, Wolfgang Kreissl-Dörfler, Barbara Weiler, Willi Görlach, Hiltrud Breyer, Ozan Ceyhun, Gerhard Schmid, Christian Ulrik von Boetticher, Alima Boumediene-Thiery, Per Gahrton, Ilka Schröder, Marie Anne Isler Béguin, Patricia McKenna, Paul A.A.J.G. Lannoye, Hans-Peter Martin

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 60
RECITAL 5

(5) In light of the current state of knowledge on human embryonic stem cells, new human embryonic stem cell lines, derived from human supernumerary embryos, are required.
Deleted

Justification

This wording is very ambiguous, and could be interpreted as meaning that embryos are
allowed to be created for research purposes, which the European Group of Advisers on
Ethics firmly rejects.

Or. en AMENDMENT 61
tabled by Johannes Blokland, on behalf of the EDD Group
Evelyne Gebhardt, Erika Mann, Garrelt Duin, Wilhelm Ernst Piecyk, Rosemarie Müller, Helmut Kuhne, Bernd Lange, Lissy Gröner, Jutta D. Haug, Wolfgang Kreissl-Dörfler, Barbara Weiler, Willi Görlach, Hiltrud Breyer, Ozan Ceyhun, Gerhard Schmid, Christian Ulrik von Boetticher, Alima Boumediene-Thiery, Per Gahrton, Ilka Schröder, Marie Anne Isler Béguin, Patricia McKenna, Paul A.A.J.G. Lannoye, Hans-Peter Martin, Peter Liese

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 61
RECITAL 6

(6) This decision is intended to applyspecifically to Community funding of research activities involving the procurement of stem cells from human embryos created before June 2002 as a result of medically-assisted in vitro fertilisation designed to induce pregnancy and were no longer to be used for that purpose (supernumerary embryos). This decision amends the specific programme by introducing several conditions for deciding on the Community funding of such research.
(6) This decision is intended to applyspecifically to Community funding of research activities involving the use of stem cells procured before 7 August 2001 from human embryos created as a result of medically-assisted in vitro fertilisation designed to induce pregnancy and which were no longer to be used for that purpose (supernumerary embryos). This decision amends the specific programme by introducing several conditions for deciding on the Community funding of such research.

Justification

This rule has been introduced in this form in the USA for promotion of research in this area by the NIH.

Or. en
AMENDMENT 62
tabled by Johannes Blokland, on behalf of the EDD Group
Evelyne Gebhardt, Ulrich Stockmann, Garrelt Duin, Wilhelm Ernst Piecyk, Rosemarie Müller, Bernd Lange, Erika Mann, Helmut Kuhne, Lissy Gröner, Jutta D. Haug, Rolf Linkohr, Wolfgang Kreissl-Dörfler, Barbara Weiler, Hiltrud Breyer, Ozan Ceyhun, Gerhard Schmid, Christian Ulrik von Boetticher, Hans-Peter Martin, Alima Boumediene-Thiery, Per Gahrton, Ilka Schröder, Marie Anne Isler Béguin, Patricia McKenna, Paul A.A.J.G. Lannoye, Raina A. Mercedes Echerer

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 62
RECITAL 7

(7) The present conditions are based on the principles established by the European Group on Ethics, especially the fundamental ethical principles underlined in the opinion No. 15: the principle of respect for human dignity (which requires provisions of guarantees against risks of arbitrary experimentation); the principle of human autonomy which entails the giving of informed consent and the protection of personal data; the principle of justice and of beneficence (namely with regard the improvement and protection of health); the principle of freedom of research (which should be balanced against other principles) and; the principle of proportionality (non-availability of adequate alternative methods in view of the scientific objectives to be reached).
(7) The present conditions are based on the principles established by the European Group of Advisers on Ethics, especially the fundamental ethical principles underlined in the opinion No. 15: the principle of respect for human dignity (which requires provisions of guarantees against risks of arbitrary experimentation and consideration of the dignity of human beings, particularly of women, who must not be treated as storage units and providers of raw materials); the principle of human autonomy which entails the giving of informed consent and the protection of personal data; the principle of justice and of beneficence (in particular as regards the improvement and protection of health); the principle of freedom of research (which should be balanced against other principles); and the principle of proportionality (non-availability of adequate alternative methods in view of the scientific objectives to be reached).

.../...

Justification

It is repeatedly forgotten in the debate that before the creation of an embryo, following a
physically and mentally harrowing hormone treatment, an invasive intervention in a woman's body is needed in order to have the possibility of creating embryos. Everything must be done to prevent women being objectified as suppliers of raw materials.

Or. en 13 November 2003 A5-0369/ 63 AMENDMENT 63
tabled by Johannes Blokland, on behalf of the EDD Group
Evelyne Gebhardt, Ulrich Stockmann, Garrelt Duin, Wilhelm Ernst Piecyk, Rosemarie Müller, Helmut Kuhne, Bernd Lange, Lissy Gröner, Jutta D. Haug, Erika Mann, Rolf Linkohr, Wolfgang Kreissl-Dörfler, Barbara Weiler, Willi Görlach, Hiltrud Breyer, Ozan Ceyhun, Gerhard Schmid, Christian Ulrik von Boetticher, Alima Boumediene-Thiery, Per Gahrton, Ilka Schröder, Marie Anne Isler Béguin, Patricia McKenna, Paul A.A.J.G. Lannoye, Hans-Peter Martin

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 63
RECITAL 10

(10) In order to ensure transparency a list of research projects involving the sue of human embryonic stem cells funded under the sixth framework programme should be published annually by the Commission.
(10) In order to ensure transparency a list of research projects involving the sue of human adult or embryonic stem cells funded under the sixth framework programme should be published annually by the Commission.

Justification

This addition is important to make it easier to assess developments in the promotion of research in the framework of the 6th Research Framework Programme.

Or. en AMENDMENT 64
tabled by Johannes Blokland, on behalf of the EDD Group
Evelyne Gebhardt, Garrelt Duin, Wilhelm Ernst Piecyk, Rosemarie Müller, Helmut Kuhne, Bernd Lange, Lissy Gröner, Jutta D. Haug, Erika Mann, Wolfgang Kreissl-Dörfler, Barbara Weiler, Willi Görlach, Hiltrud Breyer, Ozan Ceyhun, Gerhard Schmid, Christian Ulrik von Boetticher, Alima Boumediene-Thiery, Per Gahrton, Ilka Schröder, Marie Anne Isler Béguin, Patricia McKenna, Paul A.A.J.G. Lannoye, Hans-Peter Martin, Peter Liese

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 64
ANNEX
Annex I, point 1.1, paragraph 18, point (b) (Decision 2002/834/EC )

(b) the human embryos used for the procurement of stem cells must have been created before June 2002 as a result of medically-assisted in vitro fertilisation designed to induce pregnancy, and were no longer to be used for that purpose;
(b) the stem cell lines must have been procured before 7 August 2001 from embryos created as a result of medically-assisted in vitro fertilisation designed to induce pregnancy, and which were no longer to be used for that purpose;

Justification

This rule has been introduced in this form in the USA for promotion of research in this area by the NIH.

Or. en AMENDMENT 65
tabled by Johannes Blokland, on behalf of the EDD Group
Evelyne Gebhardt, Ulrich Stockmann, Garrelt Duin, Wilhelm Ernst Piecyk, Rosemarie Müller, Helmut Kuhne, Bernd Lange, Lissy Gröner, Jutta D. Haug, Erika Mann, Wolfgang Kreissl-Dörfler, Willi Görlach, Hiltrud Breyer, Ozan Ceyhun, Christian Ulrik von Boetticher, Alima Boumediene-Thiery, Per Gahrton, Ilka Schröder, Marie Anne Isler Béguin, Patricia McKenna, Paul A.A.J.G. Lannoye, Hans-Peter Martin

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 65
ANNEX
Annex I, point 1.1, paragraph 18, point (d) (Directive 2002/834/EC )

(d) all other alternative methods (including existing or adult stem cell lines) must have been examined and demonstrated not to be sufficient for the purposes of the research in question;
(d) all other alternative methods (including existing or adult stem cell lines) must have been examined and proved not to be sufficient for the purposes of the research in question;

Justification

Self-explanatory.

Or. en
AMENDMENT 66
tabled by Johannes Blokland, on behalf of the EDD Group
Evelyne Gebhardt, Ulrich Stockmann, Garrelt Duin, Wilhelm Ernst Piecyk, Rosemarie Müller, Helmut Kuhne, Bernd Lange, Lissy Gröner, Jutta D. Haug, Rolf Linkohr, Wolfgang Kreissl-Dörfler, Barbara Weiler, Willi Görlach, Hiltrud Breyer, Ozan Ceyhun, Gerhard Schmid, Christian Ulrik von Boetticher, Alima Boumediene-Thiery, Per Gahrton, Ilka Schröder, Marie Anne Isler Béguin, Patricia McKenna, Paul A.A.J.G. Lannoye, Hans-Peter Martin

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 66
ANNEX
Annex I, point 1.1, paragraph 18, point (f) (Directive 2002/834/EC )

(f) no monetary compensation or other benefit in kind must be granted or promised for the donation;
(f) no monetary compensation or other benefit in kind must be granted or promised for the donation, not even in the form of a reduced price for in vitro fertilisation;

Justification

Self-explanatory.

Or. en AMENDMENT 67
tabled by Johannes Blokland, on behalf of the EDD Group
Evelyne Gebhardt, Ulrich Stockmann, Garrelt Duin, Wilhelm Ernst Piecyk, Rosemarie Müller, Helmut Kuhne, Bernd Lange, Lissy Gröner, Jutta D. Haug, Wolfgang Kreissl-Dörfler, Barbara Weiler, Ozan Ceyhun, Gerhard Schmid, Christian Ulrik von Boetticher, Alima Boumediene-Thiery, Per Gahrton, Ilka Schröder, Marie Anne Isler Béguin, Patricia McKenna, Paul A.A.J.G. Lannoye, Hans-Peter Martin

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 67
ANNEX
Annex I, point 1.1, paragraph 22 (Directive 2002/834/EC )

A list of research projects involving the use of all types of human embryonic stem cells funded under the sixth framework programme will be published yearly by the Commission.
A list of research projects involving the use of all types of human adult or embryonic stem cells funded under the sixth framework programme will be published yearly by the Commission. In the case of research projects with embryonic stem cells, this publication must be accompanied by a statement of the reasons for which it was not possible to use other procedures.

Justification

This addition is important to make it easier to assess developments in the promotiion of research in the framework of the 6th Research Framework Programme.

Or. en Full text of Amendments 068 - 068 PIN archive of Amendments 068 - 068

14 November 2003 A5-0369/ 68

AMENDMENT 68
tabled by David Robert Bowe and others

REPORT by Peter Liese A5-0369/2003
Integrating and strengthening the European research area

Proposal for a decision
( COM(2003) 390 - C5-0349/2003 - 2003/0151(CNS))

Commission proposal

Amendments by Parliament

Amendment 68
ANNEX
Annex I, point 1.1, paragraph 18, point (b) (Directive 2002/834/EC )

(b) the human embryos used for the procurement of stem cells must have been created before June 2002 as a result of medically-assisted in vitro fertilisation designed to induce pregnancy, and were no longer to be used for that purpose;
(b) the human embryos used for the procurement of stem cells must have been created as a result of medically-assisted in vitro fertilisation designed to induce pregnancy, and were no longer to be used for that purpose;

Justification

A "cut off" date contained in the Commission proposal could actually increase the number of embryos needed for research. It is imperative that the embryos donated for research are those most likely to provide quality stem cell lines. Continuing advances in the techniques used to freeze embryos for IVF have the potential to improve the success rate of IVF and therefore limit the number of embryos created. These same advances also point to the use of more recent embryos, if donated, for the derivation of stem cell lines. For this reason the proposed cut off date may be counter-productive, both in terms of the outcome of the research and in terms of the number of embryos required.

Or. en

Report A5-0369/2003

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