natgillin/translations-raw huggingface dataset:
This Directive and all Regulations referred to therein shall not affect the application of national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these cells , on ethical grounds .
This Directive and all Regulations referred to therein shall not affect the application of national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these cells , on ethical grounds .
The Member States shall communicate the national legislation concerned to the Commission .
The Member States shall communicate the national legislation concerned to the Commission .
The Commission shall publish the results in a public register.”
The Commission shall publish the results in a public register. ”
Member States should retain the rights to prohibit or allow products on ethical grounds reflecting the views held by that Member State.
Member States should retain the rights to prohibit or allow products on ethical grounds reflecting the views held by that Member State.
The Commission should be informed in a transparent manner by the Member States of which products will be allowed to be placed on the market with a view to allowing manufacturers to consult an authoritative list.
The Commission should be informed in a transparent manner by the Member States of which products will be allowed to be placed on the market with a view to allowing manufacturers to consult an authoritative list.
ARTICLE 29
ARTICLE 29
Advanced therapy medicinal products which were legally on the Community market in accordance with national or Community legislation at the time of entry into force of this Regulation shall comply with this Regulation no later than 2 years after its entry into force.
Advanced therapy medicinal products which were legally on the Community market in accordance with national or Community legislation at the time of entry into force of this Regulation shall comply with this Regulation no later than 2 years after its entry into force.
For advanced therapy medicinal products , other than tissue engineered products, which were legally on the Community market in accordance with national or Community legislation at the time of entry into force of this Regulation , an application for a marketing authorisation shall be filed no later than five years after the entry into force of this Regulation .
For advanced therapy medicinal products , other than tissue engineered products, which were legally on the Community market in accordance with national or Community legislation at the time of entry into force of this Regulation , an application for a marketing authorisation shall be filed no later than five years after the entry into force of this Regulation .
For tissue engineered products which are legally on the Community market in accordance with national or Community legislation at the time of entry into force of the technical requirements referred to in Article 8, an application for a marketing authorisation shall be filed no later than five years after the entry into force of the technical requirements referred to in Article 8.
For tissue engineered products which are legally on the Community market in accordance with national or Community legislation at the time of entry into force of the technical requirements referred to in Article 8, an application for a marketing authorisation shall be filed no later than five years after the entry into force of the technical requirements referred to in Article 8.
By way of derogation from Article 3(1) of Regulation (EC) No 297/95, no fee shall be payable to the Agency in respect of applications submitted for the authorisation of the advanced therapy medicinal products mentioned in paragraph 1.
By way of derogation from Article 3(1) of Regulation (EC) No 297/95, no fee shall be payable to the Agency in respect of applications submitted for the authorisation of the advanced therapy medicinal products mentioned in paragraph 1.
The envisaged Transitional period of two years is too short, since the duration of the clinical trials alone will in many cases exceed the proposed time period.
The envisaged Transitional period of two years is too short, since the duration of the clinical trials alone will in many cases exceed the proposed time period.
Furthermore the applicant should only be responsible for the date of filing the application and not for delays due to the Agency/national competent authorities or problems during the assessment phase.
Furthermore the applicant should only be responsible for the date of filing the application and not for delays due to the Agency/national competent authorities or problems during the assessment phase.
Otherwhise, it could deprive patients from these important new medicinal products.
Otherwhise, it could deprive patients from these important new medicinal products.
ARTICLE 30
ARTICLE 30
This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
It shall apply from [3 months after entry into force]
It shall apply from [3 months after entry into force]
It shall apply from * , except in relation to tissue engineered products.
It shall apply from * , except in relation to tissue engineered products.
In relation to tissue engineered products, this Regulation shall apply from the date on which all the requirements referred to in Articles 4, 5 and 8 have entered into force.
In relation to tissue engineered products, this Regulation shall apply from the date on which all the requirements referred to in Articles 4, 5 and 8 have entered into force.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
* 3 months after the date of entry into force of this Directive.
* 3 months after the date of entry into force of this Directive.
This is necessary to take into account the different timeframes necessary for the application of Regulations and Directives.
This is necessary to take into account the different timeframes necessary for the application of Regulations and Directives.
The proposal recognizes that the pharmaceutical regime cannot be applied to TEP as it currently stands.
The proposal recognizes that the pharmaceutical regime cannot be applied to TEP as it currently stands.
It is therefore important that the regulation is applicable only when all the directives modified by it are also of application.
It is therefore important that the regulation is applicable only when all the directives modified by it are also of application.
Proposal for a regulation of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004
Proposal for a regulation of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004
ITRE 30.11.2005
ITRE 30.11.2005
Giles Chichester 20.6.2006
Giles Chichester 20.6.2006
Šarūnas Birutis, Jan Březina, Renato Brunetta, Jerzy Buzek, Joan Calabuig Rull, Pilar del Castillo Vera, Jorgo Chatzimarkakis, Giles Chichester, Den Dover, Lena Ek, Nicole Fontaine, Adam Gierek, Norbert Glante, Umberto Guidoni, András Gyürk, Rebecca Harms, Erna Hennicot-Schoepges, Ján Hudacký, Romana Jordan Cizelj, Anne Laperrouze, Vincenzo Lavarra, Pia Elda Locatelli, Eugenijus Maldeikis, Eluned Morgan, Angelika Niebler, Umberto Pirilli, Miloslav Ransdorf, Herbert Reul, Teresa Riera Madurell, Mechtild Rothe, Andres Tarand, Britta Thomsen, Patrizia Toia, Catherine Trautmann, Claude Turmes, Nikolaos Vakalis, Alejo Vidal-Quadras Roca, Dominique Vlasto
Šarūnas Birutis, Jan Březina, Renato Brunetta, Jerzy Buzek, Joan Calabuig Rull, Pilar del Castillo Vera, Jorgo Chatzimarkakis, Giles Chichester, Den Dover, Lena Ek, Nicole Fontaine, Adam Gierek, Norbert Glante, Umberto Guidoni, András Gyürk, Rebecca Harms, Erna Hennicot-Schoepges, Ján Hudacký, Romana Jordan Cizelj, Anne Laperrouze, Vincenzo Lavarra, Pia Elda Locatelli, Eugenijus Maldeikis, Eluned Morgan, Angelika Niebler, Umberto Pirilli, Miloslav Ransdorf, Herbert Reul, Teresa Riera Madurell, Mechtild Rothe, Andres Tarand, Britta Thomsen, Patrizia Toia, Catherine Trautmann, Claude Turmes, Nikolaos Vakalis, Alejo Vidal-Quadras Roca, Dominique Vlasto
María del Pilar Ayuso González, Dorette Corbey, Peter Liese, Vittorio Prodi, John Purvis, Esko Seppänen
María del Pilar Ayuso González, Dorette Corbey, Peter Liese, Vittorio Prodi, John Purvis, Esko Seppänen
Prior to taking the final vote, Pia Elda Locatelli stated that given the fact that the amendments adopted had changed her initial position on the subject, she therefore could not continue as draftswoman.
Prior to taking the final vote, Pia Elda Locatelli stated that given the fact that the amendments adopted had changed her initial position on the subject, she therefore could not continue as draftswoman.
The Committee then appointed its chairman, Giles Chichester, draftsman.
The Committee then appointed its chairman, Giles Chichester, draftsman.
OPINION of the Committee on Legal Affairs (*)
OPINION of the Committee on Legal Affairs (*)
The Commission’s proposal seeks to regulate placing on the European market of products based on gene therapy, cell therapy and tissue engineering.
The Commission’s proposal seeks to regulate placing on the European market of products based on gene therapy, cell therapy and tissue engineering.
These products are of growing importance for modern medicine and can potentially help a lot of patients, but some serious health risks might occur in case of improper regulation.
These products are of growing importance for modern medicine and can potentially help a lot of patients, but some serious health risks might occur in case of improper regulation.
Especially in the area of tissue engineering no harmonised European approach exists.
Especially in the area of tissue engineering no harmonised European approach exists.
In general, the Commission’s proposal is welcome by all stakeholders but the public debate and discussion in Parliament committees has shown that there are some points that urgently need clarification to make the proposal legally consistent, to exclude controversial interpretations, to make the proposal coherent with the current legislation and to safeguard Parliament's rights.
In general, the Commission’s proposal is welcome by all stakeholders but the public debate and discussion in Parliament committees has shown that there are some points that urgently need clarification to make the proposal legally consistent, to exclude controversial interpretations, to make the proposal coherent with the current legislation and to safeguard Parliament's rights.
This is why the Committee on Legal Affairs proposes a number of amendments.
This is why the Committee on Legal Affairs proposes a number of amendments.
The rights of the Parliament in the comitology procedure.
The rights of the Parliament in the comitology procedure.
The Commission’s proposal foresees to delegate almost all important questions to the comitology procedure.
The Commission’s proposal foresees to delegate almost all important questions to the comitology procedure.
In such a highly political issue it is important to safeguard Parliament's rights.
In such a highly political issue it is important to safeguard Parliament's rights.
The Parliament should have the right to examine and to block such decisions.
The Parliament should have the right to examine and to block such decisions.
The European institutions have just reached a new agreement on the comitology procedure which is a step forward in balancing their powers.
The European institutions have just reached a new agreement on the comitology procedure which is a step forward in balancing their powers.
In the meantime, a proposed amendment introduces a procedure strengthening Parliament's role.
In the meantime, a proposed amendment introduces a procedure strengthening Parliament's role.
Legal safety on the issue of subsidiarity.
Legal safety on the issue of subsidiarity.
There is broad agreement that the European Union should not harmonise the legislation on the use of human embryos and human embryonic stem cells.
There is broad agreement that the European Union should not harmonise the legislation on the use of human embryos and human embryonic stem cells.
The Commission proposes to safeguard the legislative right of the Member States in Article 28(2).
The Commission proposes to safeguard the legislative right of the Member States in Article 28(2).
However, this provision is not adequate and may be challenged in the Court of Justice, as it causes serious problems with regard to the legal basis of the proposal.
However, this provision is not adequate and may be challenged in the Court of Justice, as it causes serious problems with regard to the legal basis of the proposal.
It can not be excluded that the proposed Regulation constitutes a complete harmonisation.
It can not be excluded that the proposed Regulation constitutes a complete harmonisation.
The Committee therefore proposes to exclude embryonic stem cells from the scope of the Regulation in Article 1.
The Committee therefore proposes to exclude embryonic stem cells from the scope of the Regulation in Article 1.
It would make clear that there will be no harmonization in these delicate areas.
It would make clear that there will be no harmonization in these delicate areas.
To make the proposal coherent with the current EU legislation, some technologies that are banned in other European legislation should also not get authorisation under the current Commission’s proposal.
To make the proposal coherent with the current EU legislation, some technologies that are banned in other European legislation should also not get authorisation under the current Commission’s proposal.
Regardless of the competence of the Member States there should not be any compromises regarding human rights and constitutional law, even if progress in some areas is rapid.
Regardless of the competence of the Member States there should not be any compromises regarding human rights and constitutional law, even if progress in some areas is rapid.
The principle of the non-commercialization of the human body has to be respected.
The principle of the non-commercialization of the human body has to be respected.
The integrity of the person is protected under the Oviedo Convention and the Charter of Fundamental Rights.
The integrity of the person is protected under the Oviedo Convention and the Charter of Fundamental Rights.
The production of human-animal hybrids or chimeras constitutes a breach of the principle of the integrity of the person and of the principle of inviolability of human dignity.
The production of human-animal hybrids or chimeras constitutes a breach of the principle of the integrity of the person and of the principle of inviolability of human dignity.
Interventions in the human germ line are explicitly named in the Oviedo Convention as endangering human dignity.
Interventions in the human germ line are explicitly named in the Oviedo Convention as endangering human dignity.
Products which intervene in the human germ line are excluded from clinical trials in Directive 2001/20/EC and are non patentable according to Directive 98/44/EC as are also human-animal hybrids being against ordre public.
Products which intervene in the human germ line are excluded from clinical trials in Directive 2001/20/EC and are non patentable according to Directive 98/44/EC as are also human-animal hybrids being against ordre public.
To insure the voluntary and unpaid donation of human tissues and cells the Directive 2004/23/EC must be amended.
To insure the voluntary and unpaid donation of human tissues and cells the Directive 2004/23/EC must be amended.
Straight in connection with advanced therapies which are subject to rapid development and for products of which the human tissue and cells are increasingly needed, the principle of the non-commercialization of the human body requires Member States to ensure the voluntary and unpaid donation and procurement of human cells and tissues.
Straight in connection with advanced therapies which are subject to rapid development and for products of which the human tissue and cells are increasingly needed, the principle of the non-commercialization of the human body requires Member States to ensure the voluntary and unpaid donation and procurement of human cells and tissues.
Therefore the Directive 2004/23/EC must be amended for the purposes of the suggested Regulation.
Therefore the Directive 2004/23/EC must be amended for the purposes of the suggested Regulation.
The Committee on Legal Affairs calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to incorporate the following amendments in its report:
The Committee on Legal Affairs calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to incorporate the following amendments in its report:
Proposal for a Regulation of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004
Proposal for a Regulation of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004
Proposal for a Regulation of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC , Regulation (EC) No 726/2004 and Directive 2004/23/EC
Proposal for a Regulation of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC , Regulation (EC) No 726/2004 and Directive 2004/23/EC
The title of the proposal need to be changed, as Directive 2004/23/EC is also amended (see amendment 45).
The title of the proposal need to be changed, as Directive 2004/23/EC is also amended (see amendment 45).
(6) The regulation of advanced therapy medicinal products at Community level should not interfere with decisions made by Member States on whether to allow the use of any specific type of human cells, such as embryonic stem cells, or animal cells.
(6) The regulation of advanced therapy medicinal products at Community level should not interfere with decisions made by Member States on whether to allow the use of any specific type of human cells, such as embryonic stem cells, or animal cells.
It should also not affect the application of national legislation prohibiting or restricting the sale, supply or use of medicinal products containing, consisting of or derived from these cells.
It should also not affect the application of national legislation prohibiting or restricting the sale, supply or use of medicinal products containing, consisting of or derived from these cells.
(6) Legislation in force in Member States concerning the use of certain types of cells, such as embryonic stem cells, varies considerably.
(6) Legislation in force in Member States concerning the use of certain types of cells, such as embryonic stem cells, varies considerably.
The regulation of advanced therapy medicinal products at Community level should not interfere with decisions made by Member States on whether to allow the use of any specific type cells.
The regulation of advanced therapy medicinal products at Community level should not interfere with decisions made by Member States on whether to allow the use of any specific type cells.
Moreover, it is impossible to assess when, if ever, research on these cells will reach the stage at which commercial products made from these cells could be placed on the market.
Moreover, it is impossible to assess when, if ever, research on these cells will reach the stage at which commercial products made from these cells could be placed on the market.
In order to respect the basic principles and the proper functioning of the internal market and to ensure legal certainty, this Regulation should apply only to products made of cells, for which marketing is feasible in the near future and which do not raise major controversies.
In order to respect the basic principles and the proper functioning of the internal market and to ensure legal certainty, this Regulation should apply only to products made of cells, for which marketing is feasible in the near future and which do not raise major controversies.
(7a) This Regulation fully respects the prohibition on making the human body and its parts as such a source of financial gain, as set out as an inalienable minimum safeguard in the Charter of Fundamental Rights of the European Union and further underlined by the European Parliament in its resolutions of 10 March 2005 on the trade in human egg cells 1 and of 26 October 2005 on patents for biotechnological inventions 2 .
(7a) This Regulation fully respects the prohibition on making the human body and its parts as such a source of financial gain, as set out as an inalienable minimum safeguard in the Charter of Fundamental Rights of the European Union and further underlined by the European Parliament in its resolutions of 10 March 2005 on the trade in human egg cells 1 and of 26 October 2005 on patents for biotechnological inventions 2 .
To that end, it is necessary to ensure that the donation of tissues and cells is voluntary and unpaid and that their procurement is carried out on a non-profit basis.
To that end, it is necessary to ensure that the donation of tissues and cells is voluntary and unpaid and that their procurement is carried out on a non-profit basis.
Voluntary and unpaid tissue and cell donations also contribute to high safety standards for tissues and cells and therefore to the protection of human health.
Voluntary and unpaid tissue and cell donations also contribute to high safety standards for tissues and cells and therefore to the protection of human health.
1 OJ C 320 E, 15.12.2005, p.
1 OJ C 320 E, 15.12.2005, p.
2 Texts Adopted of that date, P6_TA(2005)0407 .
2 Texts Adopted of that date, P6_TA(2005)0407 .
Rapid developments in biotechnology and biomedicine must not be allowed to compromise the protection of fundamental rights.
Rapid developments in biotechnology and biomedicine must not be allowed to compromise the protection of fundamental rights.
These rights of which one of the most important one is the right to the integrity of the person are laid down in the Oviedo Convention as well as in the Charter of Fundamental Rights.
These rights of which one of the most important one is the right to the integrity of the person are laid down in the Oviedo Convention as well as in the Charter of Fundamental Rights.
These standards should be met especially for tissue- and cell-based advanced therapy medicinal products as highly innovative new products.
These standards should be met especially for tissue- and cell-based advanced therapy medicinal products as highly innovative new products.
In this context, voluntary and unpaid donation as well as procurement on a non-profit basis are the key principles that should be imperatively respected in the Community.
In this context, voluntary and unpaid donation as well as procurement on a non-profit basis are the key principles that should be imperatively respected in the Community.
(7b) Directive 2001/20/EC 1 prohibits gene therapy trials that result in modifications to a subject's germ line genetic identity.
(7b) Directive 2001/20/EC 1 prohibits gene therapy trials that result in modifications to a subject's germ line genetic identity.
Directive 98/44/EC 2 provides that processes for modifying the human germ line genetic identity are to be regarded as unpatentable.
Directive 98/44/EC 2 provides that processes for modifying the human germ line genetic identity are to be regarded as unpatentable.