natgillin/translations-raw huggingface dataset:
In addition, the rapporteur would like to stress the important role of the Committee for Advanced Therapies within EMEA.
In addition, the rapporteur would like to stress the important role of the Committee for Advanced Therapies within EMEA.
This highly qualified body should play a vital role in the process of scientific evaluation of advanced therapy medicinal products and its internal decision procedure should be clearly defined.
This highly qualified body should play a vital role in the process of scientific evaluation of advanced therapy medicinal products and its internal decision procedure should be clearly defined.
Moreover, advanced therapy medicinal products could raise serious ethical concerns, as they are likely to contain human cells or tissues.
Moreover, advanced therapy medicinal products could raise serious ethical concerns, as they are likely to contain human cells or tissues.
The Commission's proposal should not have an impact on the national legislation prohibiting or restricting the use of certain type of human or animal cells (such as embryonic stem cells) or the sale, supply or use of medicinal products derived from these cells.
The Commission's proposal should not have an impact on the national legislation prohibiting or restricting the use of certain type of human or animal cells (such as embryonic stem cells) or the sale, supply or use of medicinal products derived from these cells.
According to Parliament's legal service, the original drafting of this provision raises serious concerns in the light of the legal basis of the proposal.
According to Parliament's legal service, the original drafting of this provision raises serious concerns in the light of the legal basis of the proposal.
The development in biotechnology and biomedicine should be carried out while fully respecting fundamental rights.
The development in biotechnology and biomedicine should be carried out while fully respecting fundamental rights.
Rights such as the right to human dignity or to the integrity of the person laid down in the Oviedo Convention as well as in the Charter of fundamental rights should be entirely respected.
Rights such as the right to human dignity or to the integrity of the person laid down in the Oviedo Convention as well as in the Charter of fundamental rights should be entirely respected.
Therefore, in his first draft report the rapporteur underlined that authorisation procedure should be carried out in accordance with the principle of non commercialisation of the human body or its parts as such.
Therefore, in his first draft report the rapporteur underlined that authorisation procedure should be carried out in accordance with the principle of non commercialisation of the human body or its parts as such.
These amendments were adopted by the Committee on Legal Affairs.
These amendments were adopted by the Committee on Legal Affairs.
Even though these amendments were adopted by the majority in ENVI committee, the first draft report as amended was rejected in the final vote.
Even though these amendments were adopted by the majority in ENVI committee, the first draft report as amended was rejected in the final vote.
The rapporteur is still convinced that the approach chosen by the JURI Committee is the most appropriate.
The rapporteur is still convinced that the approach chosen by the JURI Committee is the most appropriate.
Nevertheless, his intention is to find the broadest possible consensus in this area.
Nevertheless, his intention is to find the broadest possible consensus in this area.
Therefore, he does not propose any of these amendments in his new report.
Therefore, he does not propose any of these amendments in his new report.
Two amendments, 3 and 17, were incorporated in the report without vote in the Environment Committee, following enhanced cooperation (Rule 47) with the Legal Affairs Committee.
Two amendments, 3 and 17, were incorporated in the report without vote in the Environment Committee, following enhanced cooperation (Rule 47) with the Legal Affairs Committee.
on the 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
on the 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
Advanced therapies are highly innovative medical products based on genes (gene therapy), cells (cell therapy) or tissues (tissue engineering).
Advanced therapies are highly innovative medical products based on genes (gene therapy), cells (cell therapy) or tissues (tissue engineering).
These advanced therapies enable revolutionary treatment of diseases and injuries, such as cancer, Parkinson's disease, skin in burn victims or serious cartilage damage, and are expected to change medical practice significantly.
These advanced therapies enable revolutionary treatment of diseases and injuries, such as cancer, Parkinson's disease, skin in burn victims or serious cartilage damage, and are expected to change medical practice significantly.
Currently, the development of the field of advanced therapies is hampered by the lack of harmonised EU legislation.
Currently, the development of the field of advanced therapies is hampered by the lack of harmonised EU legislation.
Especially tissue-engineered products are at the moment not regulated on Community level, which leads to divergent national legislation and authorisation.
Especially tissue-engineered products are at the moment not regulated on Community level, which leads to divergent national legislation and authorisation.
This hampers the internal market and negatively affects EU's innovative capacity and competitiveness.
This hampers the internal market and negatively affects EU's innovative capacity and competitiveness.
This proposed Regulation intends to bridge the existing regulatory gap by addressing all advanced therapy products within a single, integrated legal framework.
This proposed Regulation intends to bridge the existing regulatory gap by addressing all advanced therapy products within a single, integrated legal framework.
The Regulation builds on already-existing legislation (in particular Directive 2001/83/EC on medical products and Regulation (EC) No 726/2004 on the European Medicines Agency), and should therefore be seen in their totality.
The Regulation builds on already-existing legislation (in particular Directive 2001/83/EC on medical products and Regulation (EC) No 726/2004 on the European Medicines Agency), and should therefore be seen in their totality.
The main elements of the Commission's proposal are:
The main elements of the Commission's proposal are:
· A centralised marketing authorisation procedure, to benefit from the pooling of expertise at European level and direct access to the EU market;
· A centralised marketing authorisation procedure, to benefit from the pooling of expertise at European level and direct access to the EU market;
· A new and multidisciplinary expert Committee (Committee for Advanced Therapies), within the European Medicines Agency (EMEA), to assess advanced therapy products and follow scientific developments in the field;
· A new and multidisciplinary expert Committee (Committee for Advanced Therapies), within the European Medicines Agency (EMEA), to assess advanced therapy products and follow scientific developments in the field;
· Tailor-made technical requirements, which are adapted to the particular characteristics of these products;
· Tailor-made technical requirements, which are adapted to the particular characteristics of these products;
· Strengthened requirements for risk management and traceability;
· Strengthened requirements for risk management and traceability;
· A system of low-cost, top-quality scientific advice provided by EMEA;
· A system of low-cost, top-quality scientific advice provided by EMEA;
· Special incentives for small and medium-sized enterprises (SMEs).
· Special incentives for small and medium-sized enterprises (SMEs).
The draftswoman welcomes the Commission's proposal.
The draftswoman welcomes the Commission's proposal.
Tissue engineering is an emerging biotechnology sector at the interface between medicine, cellular and molecular biology, materials science and engineering.
Tissue engineering is an emerging biotechnology sector at the interface between medicine, cellular and molecular biology, materials science and engineering.
By developing products designed to replace, repair or regenerate human tissues, it could mean the end of organ shortage, saving every year thousands of people in Europe.
By developing products designed to replace, repair or regenerate human tissues, it could mean the end of organ shortage, saving every year thousands of people in Europe.
The draftswoman therefore welcomes the creation of a robust and comprehensive regulatory framework, that will give the sector harmonised market access, while at the same time foster the competitiveness and guarantee a high level of health protection.
The draftswoman therefore welcomes the creation of a robust and comprehensive regulatory framework, that will give the sector harmonised market access, while at the same time foster the competitiveness and guarantee a high level of health protection.
The draftswoman would like to emphasise the fact that the definitions should be precise enough to provide the necessary legal certainty, but at the same time sufficient flexible in order to keep the pace with the evolution of science and technology.
The draftswoman would like to emphasise the fact that the definitions should be precise enough to provide the necessary legal certainty, but at the same time sufficient flexible in order to keep the pace with the evolution of science and technology.
Such a balance should also be sought for the marketing authorisation procedure.
Such a balance should also be sought for the marketing authorisation procedure.
The draftswoman supports the creation of a fully centralised authorisation procedure to benefit from the pooling of expertise, but at the same time stresses the need to alleviate the regulatory burden that such a procedure might entail, especially on SMEs.
The draftswoman supports the creation of a fully centralised authorisation procedure to benefit from the pooling of expertise, but at the same time stresses the need to alleviate the regulatory burden that such a procedure might entail, especially on SMEs.
As certain advanced therapy products may be based on human cells, they can raise important ethical issues.
As certain advanced therapy products may be based on human cells, they can raise important ethical issues.
Currently, decisions on the use or prohibition of any type of cells, including embryonic stem cells, are a national responsibility.
Currently, decisions on the use or prohibition of any type of cells, including embryonic stem cells, are a national responsibility.
In this proposal, this principle is kept, meaning that decisions on the development, use and/or sale of products based on any specific type of human or animal cells will remain a national responsibility.
In this proposal, this principle is kept, meaning that decisions on the development, use and/or sale of products based on any specific type of human or animal cells will remain a national responsibility.
This is fully in line with the Directive on the quality and safety of human tissues and cells (Directive 2004/23/EC).
This is fully in line with the Directive on the quality and safety of human tissues and cells (Directive 2004/23/EC).
(5) Advanced therapy medicinal products should be regulated in so far as they are intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process, within the meaning of Article 2(1) of Directive 2001/83/EC.
(5) Advanced therapy medicinal products should be regulated in so far as they are intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process, within the meaning of Article 2(1) of Directive 2001/83/EC.
Advanced therapy medicinal products which are both prepared in full and used in a hospital, in accordance with a medical prescription for an individual patient, should thus be excluded from the scope of the present Regulation.
Advanced therapy medicinal products which are both prepared in full and used in a hospital, in accordance with a medical prescription for an individual patient, should thus be excluded from the scope of the present Regulation.
Advanced therapy medicinal products which are prepared in full in a hospital on a one-off basis according to a specific, non-standardised and non-patented process , and used in a hospital, in order to comply with an individual medical prescription for an individual patient, should thus be excluded from the scope of this Regulation.
Advanced therapy medicinal products which are prepared in full in a hospital on a one-off basis according to a specific, non-standardised and non-patented process , and used in a hospital, in order to comply with an individual medical prescription for an individual patient, should thus be excluded from the scope of this Regulation.
Where hospitals or other institutions prepare products using an established process to create treatments for patients on a serial and routine basis, they should have to comply with the provisions of this Regulation.
Where hospitals or other institutions prepare products using an established process to create treatments for patients on a serial and routine basis, they should have to comply with the provisions of this Regulation.
However, when hospitals produce advanced therapy products for research purposes or on an exceptional, one-off basis, they should not have to comply with the centralised authorisation procedure.
However, when hospitals produce advanced therapy products for research purposes or on an exceptional, one-off basis, they should not have to comply with the centralised authorisation procedure.
(7b) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use 1 prohibits gene therapy trials that result in modifications to a subject's germ line genetic identity.
(7b) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use 1 prohibits gene therapy trials that result in modifications to a subject's germ line genetic identity.
Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions 2 considers processes for modifying the human germ line genetic identity non-patentable.
Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions 2 considers processes for modifying the human germ line genetic identity non-patentable.
To ensure legal coherence, this Regulation should prohibit any authorisation of products that modify the germ line genetic identity of human beings.
To ensure legal coherence, this Regulation should prohibit any authorisation of products that modify the germ line genetic identity of human beings.
1 L 121, 1.5.2001, p.
1 L 121, 1.5.2001, p.
2 L 213, 30.7.1998, p.
2 L 213, 30.7.1998, p.
As Articles 1 and 13 of the Oviedo Convention make it clear, human dignity is compromised when the inheritance of genetic identity is altered.
As Articles 1 and 13 of the Oviedo Convention make it clear, human dignity is compromised when the inheritance of genetic identity is altered.
Products which are neither properly subject to clinical trials under Directive 2001/20/EC nor legally patentable under Directive 98/44/EC should not be eligible for authorisation under this regulation.
Products which are neither properly subject to clinical trials under Directive 2001/20/EC nor legally patentable under Directive 98/44/EC should not be eligible for authorisation under this regulation.
RECITAL 7 C (new)
RECITAL 7 C (new)
(7c) This Regulation should prohibit any authorisation of products derived from human-animal hybrids or chimeras or containing tissues or cells originating or derived from human-animal hybrids or chimeras.
(7c) This Regulation should prohibit any authorisation of products derived from human-animal hybrids or chimeras or containing tissues or cells originating or derived from human-animal hybrids or chimeras.
This provision should not exclude the transplantation of somatic animal cells or tissues to the human body for therapeutic purposes, in so far as it does not interfere with the germ line.
This provision should not exclude the transplantation of somatic animal cells or tissues to the human body for therapeutic purposes, in so far as it does not interfere with the germ line.
The physical and mental integrity of the person and human dignity must be respected, as underlined in Articles 1 and 3 of the Charter of fundamental rights of the European Union.
The physical and mental integrity of the person and human dignity must be respected, as underlined in Articles 1 and 3 of the Charter of fundamental rights of the European Union.
The creation of human-animal hybrids or chimeras is a threat to the right to integrity of a person and a violation of human dignity.
The creation of human-animal hybrids or chimeras is a threat to the right to integrity of a person and a violation of human dignity.
Therefore, no authorisation for products containing or originating from human-animal hybrids or chimeras should be granted under this regulation.
Therefore, no authorisation for products containing or originating from human-animal hybrids or chimeras should be granted under this regulation.
However, the Xenotransplantation for therapeutic purposes should not be excluded, as far as it does not interfere with the germ line.
However, the Xenotransplantation for therapeutic purposes should not be excluded, as far as it does not interfere with the germ line.
RECITAL 9
RECITAL 9
(9) The evaluation of advanced therapy medicinal products often requires very specific expertise, which goes beyond the traditional pharmaceutical field and covers areas on the borderline to other sectors such as biotechnology and medical devices.
(9) The evaluation of advanced therapy medicinal products often requires very specific expertise, which goes beyond the traditional pharmaceutical field and covers areas on the borderline to other sectors such as biotechnology and medical devices.
For this reason, it is appropriate to create, within the Agency, a Committee for Advanced Therapies, which the Committee for Medicinal Products for Human Use of the Agency should consult on the assessment of data related to advanced therapy medicinal products, before issuing its final scientific opinion .
For this reason, it is appropriate to create, within the Agency, a Committee for Advanced Therapies, which the Committee for Medicinal Products for Human Use of the Agency should consult on the assessment of data related to advanced therapy medicinal products, before issuing its final scientific opinion .
In addition, the Committee for Advanced Therapies may be consulted for the evaluation of any other medicinal product which requires specific expertise falling within its area of competence.
In addition, the Committee for Advanced Therapies may be consulted for the evaluation of any other medicinal product which requires specific expertise falling within its area of competence.
For this reason, it is appropriate to create, within the Agency, a Committee for Advanced Therapies, which should be responsible for preparing a draft opinion on the quality, safety and efficacy of each advanced therapy medicinal product for final approval by the Committee for Medicinal Products for Human Use of the Agency.
For this reason, it is appropriate to create, within the Agency, a Committee for Advanced Therapies, which should be responsible for preparing a draft opinion on the quality, safety and efficacy of each advanced therapy medicinal product for final approval by the Committee for Medicinal Products for Human Use of the Agency.
In addition, the Committee for Advanced Therapies should be consulted for the evaluation of any other medicinal product which requires specific expertise falling within its area of competence.
In addition, the Committee for Advanced Therapies should be consulted for the evaluation of any other medicinal product which requires specific expertise falling within its area of competence.
RECITAL 9 A (new)
RECITAL 9 A (new)
(9a) The Committee for Advanced Therapies should provide advice to the Committee for Medicinal Products for Human Use on whether a product falls within the definition of an advanced therapy medicinal product.
(9a) The Committee for Advanced Therapies should provide advice to the Committee for Medicinal Products for Human Use on whether a product falls within the definition of an advanced therapy medicinal product.
Due to its specific expertise in advanced therapy medicinal products, the Committee for Advanced Therapies should assist the CHMP in its classification task of whether a product is or is not an advanced therapy medicinal product.
Due to its specific expertise in advanced therapy medicinal products, the Committee for Advanced Therapies should assist the CHMP in its classification task of whether a product is or is not an advanced therapy medicinal product.
RECITAL 14
RECITAL 14
(14) As a matter of principle, human cells or tissues contained in advanced therapy medicinal products should be procured from voluntary and unpaid donation.
(14) As a matter of principle, human cells or tissues contained in advanced therapy medicinal products should be procured from voluntary and unpaid donation.
Voluntary and unpaid tissue and cell donations are a factor which may contribute to high safety standards for tissues and cells and therefore to the protection of human health.
Voluntary and unpaid tissue and cell donations are a factor which may contribute to high safety standards for tissues and cells and therefore to the protection of human health.
This recital can be deleted as a consequence to the introduction of a new recital 7a and new articles 3a and 28a.
This recital can be deleted as a consequence to the introduction of a new recital 7a and new articles 3a and 28a.
RECITAL 16
RECITAL 16
(16) The manufacture of advanced therapy medicinal products should be in compliance with the principles of good manufacturing practice, as set out in Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.
(16) The manufacture of advanced therapy medicinal products should be in compliance with the principles of good manufacturing practice, as set out in Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.
Furthermore, guidelines specific to advanced therapy medicinal products should be drawn up, so as to properly reflect the particular nature of their manufacturing process.
Furthermore, guidelines specific to advanced therapy medicinal products should be drawn up, so as to properly reflect the particular nature of their manufacturing process.