Local view for "http://purl.org/linkedpolitics/eu/plenary/2007-04-23-Speech-1-099"
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".
Mr President, I should like to address you today as the rapporteur on the proposal for a regulation on advanced therapy medicinal products. Furthermore, as a medical doctor, I should like to address the progress in medicine of highly specific medicinal products emerging onto the European market to treat patients with the diseases enumerated by the Commissioner.
I should like to seize this opportunity to thank the Commission for its proposal. The time has come to treat patients with products which are safe, efficient and based on non-controversial grounds.
Since the beginning of 2006, the European Parliament has been working hard on this proposal with the Committee on the Environment, Public Health and Food Safety, the Committee on Industry, Research and Energy and the Committee on Legal Affairs. The final report was adopted by a large majority. There is a broad consensus within Parliament that the report by the Committee on the Environment, as presented for the vote in this House, is excellent. All stakeholders, representatives of both the bioindustry and of patient groups welcomed it after its adoption last January.
Last week three Members of Parliament, on behalf of their political groups – Socialists, Liberals and GUE – tabled a number of amendments presented as a so-called compromise with the Council and the Commission. This individual action was undertaken without the knowledge of the rapporteur.
I would like to underline that no agreement was reached with the other two institutions at the end of the informal trialogue that took place last month. Ninety per cent of these amendments are a copy-and-paste of the committee report with cosmetic changes. The most relevant are the 10%. These amendments concerning the more sensitive political issues are the result of an individual initiative of three of our colleagues. As they mentioned in their letter last week, the interinstitutional agreement has not been finalised. Furthermore, many of the amendments presented in the package do not have the support of the committee responsible, the other two committees nor of the rapporteur. Therefore, I should like to urge all my colleagues to support the responsible report by the Committee on the Environment in the vote on Wednesday.
In order to speed up the legislative procedure, the informal trialogue with the Council and the Commission took place last month. The three meetings showed discrepancies. From a substantial point of view, several politically sensitive questions have not been solved. From the point of view of procedure, the question was raised of the two amendments tabled by the Committee on Legal Affairs which were directly incorporated into the report under the enhanced cooperation procedure. As the main rapporteur, I have tried to underline that the remit of that committee should be respected. In spite of the clear provisions in the Rules of Procedure on enhanced cooperation between parliamentary committees, colleagues from the two other institutions and some shadow rapporteurs refused to consider these amendments in the light of the first reading agreement. Apparently, enhanced cooperation is respected only when it suits certain colleagues. It is welcomed in files such as REACH, but as far as advanced therapies are concerned. Some go even further and misuse the voice of patients’ groups, declaring that the enhanced cooperation procedure is undemocratic.
I would like to raise one aspect of the proposal which still worries me: the principle of subsidiarity. In its fully harmonising proposal, the Commission introduces an op-out for Member States to apply their restrictive national legislation concerning certain contentious products. In practice, this would mean that certain products would not have access to the market of all Member States. Following the opinion of our Legal Service, this provision presents serious problems of incompatibility with the legal bases and could therefore be annulled by the European Court of Justice. If this is the case, this regulation would become a fully-harmonising measure for all products including those prohibited in some Member States. Here, the two amendments from the Committee on Legal Affairs bring legal certainty by excluding from the scope products containing or derived from embryonic stem cells.
As rapporteur, I have to respect the diversity of 27 sets of legislation relating to embryonic stem cell research, from the complete freedom of research to the prohibition of killing embryos for research purposes. If we do not support the amendments from the Committee on Legal Affairs, this regulation would de facto promote the development of products derived from embryonic stem cells, although this might be considered as ethically unacceptable by citizens and Member States.
As an elected representative of this House, I have the responsibility to listen to all opinions, to marry positions and to propose to our citizens a text which can be considered as modern, progressive and respecting universal principles and values such as human dignity. I welcome the tone of the recent Berlin Declaration regarding European values, as well as the programme of the President of the European Parliament, who stated that the question of human dignity is at the core of his and of our approach when voting on European legislation."@en4
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"Mr President, I should like to address you today as the rapporteur on the proposal for a regulation on advanced therapy medicinal products. Furthermore, as a medical doctor, I should like to address the progress in medicine of highly specific medicinal products emerging onto the European market to treat patients with the diseases enumerated by the Commissioner.
I should like to seize this opportunity to thank the Commission for its proposal. The time has come to treat patients with products which are safe, efficient and based on non-controversial grounds.
Since the beginning of 2006, the European Parliament has been working hard on this proposal with the Committee on the Environment, Public Health and Food Safety, the Committee on Industry, Research and Energy and the Committee on Legal Affairs. The final report was adopted by a large majority. There is a broad consensus within Parliament that the report by the Committee on the Environment, as presented for the vote in this House, is excellent. All stakeholders, representatives of both the bioindustry and of patient groups welcomed it after its adoption last January.
Last week three Members of Parliament, on behalf of their political groups – Socialists, Liberals and GUE – tabled a number of amendments presented as a so-called compromise with the Council and the Commission. This individual action was undertaken without the knowledge of the rapporteur.
I would like to underline that no agreement was reached with the other two institutions at the end of the informal trialogue that took place last month. Ninety per cent of these amendments are a copy-and-paste of the committee report with cosmetic changes. The most relevant are the 10%. These amendments concerning the more sensitive political issues are the result of an individual initiative of three of our colleagues. As they mentioned in their letter last week, the interinstitutional agreement has not been finalised. Furthermore, many of the amendments presented in the package do not have the support of the committee responsible, the other two committees nor of the rapporteur. Therefore, I should like to urge all my colleagues to support the responsible report by the Committee on the Environment in the vote on Wednesday.
In order to speed up the legislative procedure, the informal trialogue with the Council and the Commission took place last month. The three meetings showed discrepancies. From a substantial point of view, several politically sensitive questions have not been solved. From the point of view of procedure, the question was raised of the two amendments tabled by the Committee on Legal Affairs which were directly incorporated into the report under the enhanced cooperation procedure. As the main rapporteur, I have tried to underline that the remit of that committee should be respected. In spite of the clear provisions in the Rules of Procedure on enhanced cooperation between parliamentary committees, colleagues from the two other institutions and some shadow rapporteurs refused to consider these amendments in the light of the first reading agreement. Apparently, enhanced cooperation is respected only when it suits certain colleagues. It is welcomed in files such as REACH, but as far as advanced therapies are concerned. Some go even further and misuse the voice of patients’ groups, declaring that the enhanced cooperation procedure is undemocratic.
I would like to raise one aspect of the proposal which still worries me: the principle of subsidiarity. In its fully harmonising proposal, the Commission introduces an op-out for Member States to apply their restrictive national legislation concerning certain contentious products. In practice, this would mean that certain products would not have access to the market of all Member States. Following the opinion of our Legal Service, this provision presents serious problems of incompatibility with the legal bases and could therefore be annulled by the European Court of Justice. If this is the case, this regulation would become a fully-harmonising measure for all products including those prohibited in some Member States. Here, the two amendments from the Committee on Legal Affairs bring legal certainty by excluding from the scope products containing or derived from embryonic stem cells.
As rapporteur, I have to respect the diversity of 27 sets of legislation relating to embryonic stem cell research, from the complete freedom of research to the prohibition of killing embryos for research purposes. If we do not support the amendments from the Committee on Legal Affairs, this regulation would de facto promote the development of products derived from embryonic stem cells, although this might be considered as ethically unacceptable by citizens and Member States.
As an elected representative of this House, I have the responsibility to listen to all opinions, to marry positions and to propose to our citizens a text which can be considered as modern, progressive and respecting universal principles and values such as human dignity. I welcome the tone of the recent Berlin Declaration regarding European values, as well as the programme of the President of the European Parliament, who stated that the question of human dignity is at the core of his and of our approach when voting on European legislation."@cs1
"Hr. formand! Jeg taler til Dem i dag i egenskab af ordfører for betænkningen om forslaget til forordning om lægemidler til avanceret terapi. I min egenskab af læge vil jeg desuden gerne komme ind på udviklingen på medicinalområdet af yderst specifikke nye lægemidler på det europæiske marked til behandling af patienter med de sygdomme, som kommissæren nævnte.
Jeg vil gerne benytte denne lejlighed til at takke Kommissionen for dens forslag. Tiden er inde til at behandle patienter med sikre, effektive og ukontroversielle produkter.
Siden starten af 2006 har Parlamentet arbejdet hårdt med dette forslag sammen med Udvalget om Miljø, Folkesundhed og Fødevaresikkerhed, Udvalget om Industri, Forskning og Energi og Retsudvalget. Den endelige betænkning vedtoges med et stort flertal. Der er bred enighed i Parlamentet om, at nærværende betænkning til afstemning fra Udvalget om Miljø er fremragende. Alle aktører, repræsentanter fra både bioindustrien og patientgrupper, hilste den velkommen efter vedtagelsen i januar.
I sidste uge stillede tre medlemmer på vegne af deres politiske grupper - Socialdemokraterne, De Liberale og GUE - en række ændringsforslag, der blev præsenteret som et såkaldt kompromis med Rådet og Kommissionen. Ordføreren havde ikke kendskab til dette selvstændige initiativ.
Jeg vil gerne understrege, at der ikke blev indgået en aftale med de to andre institutioner i forbindelse med det uformelle trepartsmøde, der fandt sted i sidste måned. 90 % af disse ændringsforslag er taget direkte fra udvalgets betænkning, hvorefter der er blevet foretaget kosmetiske ændringer. De mest relevante er de 10 %. Disse ændringsforslag om de mere følsomme politiske spørgsmål er foranlediget af tre af vores kolleger, der har handlet på eget initiativ. Som de påpegede i deres brev i sidste uge, er den interinstitutionelle aftale endnu ikke endeligt udarbejdet. Mange af ændringsforslagene i pakken støttes desuden ikke af det korresponderende udvalg, de to andre udvalg eller af ordføreren. Jeg vil derfor opfordre mine kolleger til at støtte betænkningen fra det korresponderende udvalg, Udvalget om Miljø, under afstemningen på onsdag.
Der blev afholdt uformelle trepartsmøder med Rådet og Kommissionen i sidste måned med henblik på at fremskynde lovgivningsproceduren. Der blev givet udtryk for holdningsforskelle under de tre møder. Ud fra en indholdsmæssig betragtning er en række politisk følsomme spørgsmål ikke blevet løst. Ud fra en proceduremæssig betragtning blev der sat spørgsmålstegn ved de to ændringsforslag fra Retsudvalget, som blev direkte indarbejdet i betænkningen under den udvidede samarbejdsprocedure. Som hovedordfører har jeg forsøgt at understrege, at dette udvalgs kompetenceområde skal respekteres. På trods af de klare bestemmelser i forretningsordenen om udvidet samarbejde mellem Parlamentets udvalg nægtede visse kolleger fra de to andre institutioner og nogle skyggeordførere at overveje disse ændringsforslag i forbindelse med førstebehandlingen. Udvidet samarbejde respekteres tilsyneladende kun, når det passer visse kolleger. Det bifaldes i forbindelse med behandling af f.eks. Reach-forslaget, men ikke i forbindelse med avanceret terapi. Nogle går videre endnu og misbruger patientgruppernes udtalelser, idet de erklærer, at den udvidede samarbejdsprocedure er udemokratisk.
Jeg vil gerne gøre opmærksom på et aspekt i forslaget, der stadig bekymrer mig, nemlig subsidiaritetsprincippet. Kommissionen giver i sit fuldt ud harmoniserede forslag medlemsstaterne mulighed for at anvende deres restriktive nationale lovgivning i forbindelse med visse kontroversielle produkter. Det indebærer i praksis, at visse produkter ikke vil få adgang til markedet i alle medlemsstaterne. Ifølge Parlamentets Juridiske Tjeneste er denne bestemmelse yderst problematisk, idet den er i strid med retsgrundlaget, hvorfor den vil kunne blive annulleret af EF-Domstolen. Hvis dette sker, vil der være tale om en egentlig harmoniseringsforanstaltning for alle produkter, herunder produkter, der er forbudt i nogle medlemsstater. De to ændringsforslag fra Retsudvalget skaber retssikkerhed på dette område ved at undtage produkter, der indeholder eller er fremstillet af embryonale stamceller, fra forordningens anvendelsesområde.
Som ordfører er jeg nødt til at respektere de 27 forskellige regelsæt vedrørende forskning i embryonale stamceller, fra fuldstændig fri forskning til forbud mod destruktion af embryoner til forskningsformål. Hvis vi ikke støtter ændringsforslagene fra Retsudvalget, vil denne forordning i praksis fremme udviklingen af produkter fremstillet af embryonale stamceller, selv om borgerne og medlemsstaterne måske mener, at det er etisk uacceptabelt.
Som valgt repræsentant i Parlamentet er jeg forpligtet til at lytte til alle synspunkter, at forene holdninger og at præsentere vores borgere for en moderne og progressiv tekst, der er i overensstemmelse med universelle principper og værdier såsom menneskelig værdighed. Jeg bifalder tonen i den nylige Berlin-erklæring om europæiske værdier samt programmet fra formanden for Europa-Parlamentet, der har understreget, at hensynet til den menneskelige værdighed er af afgørende betydning for hans og for Europa-Parlamentets holdning til vedtagelsen af europæisk lovgivning."@da2
"Herr Präsident! Ich spreche heute zu Ihnen als Berichterstatter über den Vorschlag für eine Verordnung über Arzneimittel für neuartige Therapien. Außerdem möchte ich mich als Arzt zu den Fortschritten bei äußerst speziellen Medizinprodukten äußern, die auf dem europäischen Markt für die Behandlung von Krankheiten auftauchen, wie sie der Herr Kommissar soeben genannt hat.
Ich möchte mich bei dieser Gelegenheit bei der Kommission für diesen Vorschlag bedanken. Es ist höchste Zeit, dass Patienten mit Medizinprodukten behandelt werden, die unbedenklich, wirksam und unumstritten sind.
Seit Anfang 2006 hat sich das Europäische Parlament im Ausschuss für Umweltfragen, Volksgesundheit und Lebensmittelsicherheit, im Ausschuss für Industrie, Forschung und Energie sowie im Rechtsausschuss intensiv mit diesem Vorschlag befasst. Der Bericht wurde mit großer Mehrheit angenommen. Im Parlament herrscht weitgehend Einigkeit, dass dieser Bericht des Ausschusses für Umweltfragen, Volksgesundheit und Lebensmittelsicherheit, wie er diesem Hohen Haus zur Abstimmung vorliegt, hervorragend ist. Er wurde von allen Interessierten, Vertretern sowohl der Biotechnologiebranche als auch von Patientengruppen nach seiner Annahme im Januar begrüßt.
Vergangene Woche haben drei Abgeordnete im Namen ihrer Fraktionen – Sozialdemokraten, Liberale und GUE – eine Reihe von Änderungsanträgen als so genannten Kompromiss mit dem Rat und der Kommission vorgelegt. Dieses individuelle Vorgehen erfolgte ohne Wissen des Berichterstatters.
Ich möchte betonen, dass am Ende des informellen Trilogs im vergangenen Monat mit den beiden anderen Organen keine Einigung erzielt wurde. Neunzig Prozent dieser Änderungsanträge sind ein Plagiat des Berichts des Ausschusses mit einigen kosmetischen Änderungen. Maßgeblich sind die restlichen 10 %. Diese Änderungsanträge zu den kritischeren politischen Fragen sind das Ergebnis einer Einzelinitiative von drei unserer Kollegen. Wie sie in ihrem Schreiben vergangene Woche erwähnten, ist die interinstitutionelle Vereinbarung noch nicht unter Dach und Fach. Außerdem werden viele der in diesem Paket vorgelegten Änderungsanträge weder von dem zuständigen Ausschuss, den anderen beiden Ausschüssen noch vom Berichterstatter befürwortet. Daher ersuche ich alle meine Kollegen nachdrücklich, bei der Abstimmung am Mittwoch den vom federführenden Umweltausschuss vorgelegten Bericht zu unterstützen.
Um das Gesetzgebungsverfahren zu beschleunigen, fand der informelle Trilog mit dem Rat und der Kommission im vergangenen Monat statt. Die drei Sitzungen brachten Differenzen zum Vorschein. Inhaltlich konnten mehrere politisch heikle Fragen nicht geklärt werden. Verfahrenstechnisch stellte sich die Frage der beiden Änderungsanträge, die vom Rechtsausschuss vorgelegt und im Rahmen der verstärkten Zusammenarbeit zwischen den Ausschüssen direkt in den Bericht aufgenommen wurden. Als Hauptberichterstatter habe ich versucht zu unterstreichen, dass der Auftrag dieses Ausschusses respektiert werden sollte. Ungeachtet der eindeutigen Bestimmungen in der Geschäftsordnung zur verstärkten Zusammenarbeit zwischen parlamentarischen Ausschüssen haben sich die Kollegen von den beiden anderen Institutionen und einige Schattenberichterstatter geweigert, diese Änderungsanträge für eine Einigung in erster Lesung zu berücksichtigen. Offensichtlich gilt eine verstärkte Zusammenarbeit nur dann, wenn es bestimmten Kollegen passt. Bei Themen wie REACH wird sie begrüßt, doch bei neuartigen Therapien gehen einige sogar so weit, dass sie Äußerungen von Patientengruppen missbrauchen und erklären, die verstärkte Zusammenarbeit sei undemokratisch.
Ich möchte einen Aspekt des Vorschlags ansprechen, der mir nach wie vor Sorgen bereitet: das Subsidiaritätsprinzip. In ihrem Vorschlag zur vollständigen Harmonisierung bietet die Kommission Mitgliedstaaten eine Ausnahmeregelung an, indem sie bei bestimmten umstrittenen Produkten ihre nationale restriktive Gesetzgebung anwenden dürfen. In der Praxis würde dies bedeuten, dass bestimmten Produkten der Zugang zum Markt aller Mitgliedstaaten verwehrt würde. Nach Meinung unseres Juristischen Dienstes ist diese Bestimmung sehr problematisch im Hinblick auf eine Unvereinbarkeit mit den Rechtsgrundlagen und könnte daher vom Europäischen Gerichtshof für nichtig erklärt werden. In diesem Fall würde diese Verordnung zu einem für alle gleichermaßen geltenden Rechtsakt für alle Produkte werden, auch derjenigen, die in einigen Mitgliedstaaten verboten sind. Hier bringen die beiden Änderungsanträge des Rechtsausschusses Rechtssicherheit, indem Produkte vom Geltungsbereich ausgeschlossen werden, die embryonale Stammzellen enthalten oder von ihnen stammen.
Als Berichterstatter muss ich der Unterschiedlichkeit von 27 einzelnen Rechtsvorschriften in Bezug auf embryonale Stammzellenforschung – von der vollkommenen Freiheit der Forschungstätigkeit bis zum Verbot des Tötens von Embryos zu Forschungszwecken – Rechnung tragen. Wenn wir die Änderungsanträge des Rechtsausschusses nicht unterstützen, wird diese Verordnung de facto die Entwicklung von Produkten fördern, die von embryonalen Stammzellen stammen, obwohl dies von Bürgern und Mitgliedstaaten als ethisch inakzeptabel betrachtet könnte.
Als gewählter Abgeordneter dieses Hohen Hauses habe ich die Pflicht, mir alle Meinungen anzuhören, Standpunkte miteinander zu verbinden und unseren Bürgerinnen und Bürgern einen Text vorzulegen, der als modern und fortschrittlich angesehen wird und allgemeingültige Grundsätze und Werte wie die Menschenwürde respektiert. Ich begrüße den Tenor der jüngsten Berliner Erklärung zu den europäischen Werten sowie das Programm des Präsidenten des Europäischen Parlaments, in dem er erklärt, dass die Frage der Menschenwürde im Mittelpunkt seines und unseres Herangehens steht, wenn wir über europäische Gesetzgebung abstimmen."@de9
"Κύριε Πρόεδρε, θέλω να απευθυνθώ σήμερα στο Σώμα ως εισηγητής της πρότασης κανονισμού για τα φάρμακα προηγμένων θεραπειών. Επίσης, ως ιατρός, θα ασχοληθώ με την πρόοδο της ιατρικής όσον αφορά τα άκρως εξειδικευμένα φάρμακα που εμφανίζονται στην ευρωπαϊκή αγορά για τη θεραπεία ασθενών που πάσχουν από τις νόσους που απαρίθμησε ο Επίτροπος.
Επιτρέψτε μου δε να επωφεληθώ της ευκαιρίας για να ευχαριστήσω την Επιτροπή για την πρότασή της. Είναι πλέον καιρός η θεραπεία των ασθενών να πραγματοποιείται με προϊόντα τα οποία είναι ασφαλή, αποτελεσματικά και δεν είναι αμφιλεγόμενα.
Από την αρχή του 2006, το Ευρωπαϊκό Κοινοβούλιο εργάστηκε σκληρά γι’ αυτήν την πρόταση με την Επιτροπή Περιβάλλοντος, Δημόσιας Υγείας και Ασφάλειας των Τροφίμων, την Επιτροπή Βιομηχανίας, Έρευνας και Ενέργειας και την Επιτροπή Νομικών Θεμάτων. Η τελική έκθεση εγκρίθηκε με μεγάλη πλειοψηφία. Υπάρχει ευρεία συναίνεση εντός του Κοινοβουλίου ως προς το ότι η έκθεση της Επιτροπής Περιβάλλοντος, όπως υποβλήθηκε προς ψηφοφορία στο Κοινοβούλιο, είναι εξαιρετική. Όλοι οι ενδιαφερόμενοι, οι εκπρόσωποι τόσο της βιομηχανίας όσο και των οργανώσεων ασθενών, την χαιρέτισαν μετά την έγκρισή της τον περασμένο Ιανουάριο.
Την περασμένη εβδομάδα τρεις βουλευτές του Κοινοβουλίου, εξ ονόματος των πολιτικών τους ομάδων –των Σοσιαλιστών, των Φιλελευθέρων και της Συνομοσπονδιακής Ομάδας της Ευρωπαϊκής Ενωτικής Αριστεράς– κατέθεσαν αρκετές τροπολογίες οι οποίες παρουσιάστηκαν ως δήθεν συμβιβαστική λύση με το Συμβούλιο και την Επιτροπή. Αυτή η ατομική δράση αναλήφθηκε εν αγνοία του εισηγητή.
Θέλω να υπογραμμίσω ότι δεν επιτεύχθηκε συμφωνία με τα άλλα δύο θεσμικά όργανα στο τέλος του άτυπου τριμερούς διαλόγου που διεξήχθη τον περασμένο μήνα. Το ενενήντα τοις εκατό αυτών των τροπολογιών αποτελούν αντιγραφή και επικόλληση της έκθεσης της επιτροπής με επιφανειακές αλλαγές. Οι πιο ουσιαστικές αντιστοιχούν στο 10%. Αυτές οι τροπολογίες σχετικά με τα πιο ευαίσθητα πολιτικά θέματα είναι αποτέλεσμα μιας ατομικής πρωτοβουλίας τριών συναδέλφων μας. Όπως ανέφεραν στην επιστολή τους την προηγούμενη εβδομάδα, η διοργανική συμφωνία δεν έχει οριστικοποιηθεί. Επιπλέον, πολλές από τις τροπολογίες που κατατέθηκαν στο πλαίσιο της δέσμης δεν έχουν τη στήριξη της αρμόδιας επιτροπής, των άλλων δύο επιτροπών ή του εισηγητή. Ως εκ τούτου, καλώ όλες και όλους τους συναδέλφους να στηρίξουν τη σχετική έκθεση της Επιτροπής Περιβάλλοντος στην ψηφοφορία της Τετάρτης.
Προκειμένου να επισπευσθεί η νομοθετική διαδικασία, ο άτυπος τριμερής διάλογος με το Συμβούλιο και την Επιτροπή διεξήχθη τον προηγούμενο μήνα. Οι τρεις συνεδριάσεις έδειξαν αντιφάσεις. Επί της ουσίας, αρκετά πολιτικά ευαίσθητα θέματα δεν επιλύθηκαν. Επί της διαδικασίας, τέθηκε το θέμα των δύο τροπολογιών που κατατέθηκαν από την Επιτροπή Νομικών Θεμάτων, οι οποίες ενσωματώθηκαν αμέσως στην έκθεση βάσει της διαδικασίας ενισχυμένης συνεργασίας. Ως ο βασικός εισηγητής, επιχείρησα να υπογραμμίσω ότι η αρμοδιότητα της εν λόγω κοινοβουλευτικής επιτροπής πρέπει να γίνεται σεβαστή. Παρά τις σαφείς διατάξεις του Κανονισμού σχετικά με τη διαδικασία ενισχυμένης συνεργασίας μεταξύ των κοινοβουλευτικών επιτροπών, συνάδελφοι από τα άλλα δύο θεσμικά όργανα και ορισμένοι σκιώδεις εισηγητές αρνήθηκαν να εξετάσουν αυτές τις τροπολογίες υπό το πρίσμα της συμφωνίας σε πρώτη ανάγνωση. Προφανώς, η ενισχυμένη συνεργασία τηρείται μόνον όταν εξυπηρετεί ορισμένους συναδέλφους. Είναι ευπρόσδεκτη σε φακέλους όπως ο REACH, όχι όμως όσον αφορά τις προηγμένες θεραπείες. Ορισμένοι προχωρούν ακόμη μακρύτερα και εκμεταλλεύονται τη φωνή των οργανώσεων ασθενών, δηλώνοντας ότι η διαδικασία ενισχυμένης συνεργασίας είναι αντιδημοκρατική.
Θέλω να επισημάνω μια πτυχή της πρότασης η οποία εξακολουθεί να με ανησυχεί: την αρχή της επικουρικότητας. Στην πρότασή της, η οποία αποσκοπεί σε πλήρη εναρμόνιση, η Επιτροπή εισάγει μια εξαίρεση, προκειμένου τα κράτη μέλη να εφαρμόζουν την περιοριστική εθνική νομοθεσία τους σε ορισμένα επίμαχα προϊόντα. Στην πράξη, αυτό θα σήμαινε ότι ορισμένα προϊόντα δεν θα είχαν πρόσβαση στην αγορά όλων των κρατών μελών. Κατά την άποψη της Νομικής Υπηρεσίας μας, αυτή η διάταξη θέτει σοβαρά προβλήματα ασυμβατότητας με τις νομικές βάσεις και θα μπορούσε συνεπώς να ακυρωθεί από το Ευρωπαϊκό Δικαστήριο. Εάν ισχύει κάτι τέτοιο, αυτός ο κανονισμός θα καταστεί ένα πλήρως εναρμονισμένο μέτρο για όλα τα προϊόντα, περιλαμβανομένων αυτών που απαγορεύονται σε ορισμένα κράτη μέλη. Επ’ αυτού, οι δύο τροπολογίες της Επιτροπής Νομικών Θεμάτων προσφέρουν ασφάλεια δικαίου, αποκλείοντας από το πεδίο εφαρμογής προϊόντα που περιέχουν ή προέρχονται από εμβρυϊκά βλαστοκύτταρα.
Ως εισηγητής, πρέπει να σεβαστώ την ποικιλομορφία 27 νομοθεσιών σχετικά με την έρευνα στον τομέα των εμβρυϊκών βλαστοκυττάρων, από την απόλυτη ελευθερία της έρευνας έως την απαγόρευση της θανάτωσης εμβρύων για ερευνητικούς σκοπούς. Εάν δεν στηρίξουμε τις τροπολογίες της Επιτροπής Νομικών Θεμάτων, ο εν λόγω κανονισμός θα προωθήσει εκ των πραγμάτων την ανάπτυξη προϊόντων που προέρχονται από εμβρυϊκά βλαστοκύτταρα, παρότι αυτό ενδέχεται να θεωρείται ηθικά απαράδεκτο από πολίτες και κράτη μέλη.
Ως εκλεγμένος αντιπρόσωπος του παρόντος Κοινοβουλίου, έχω το καθήκον να εισακούω όλες τις απόψεις, να συνδυάζω θέσεις και να προτείνω στους πολίτες μας ένα κείμενο το οποίο μπορεί να θεωρηθεί ότι είναι σύγχρονο, προοδευτικό και σέβεται καθολικές αρχές και αξίες όπως η ανθρώπινη αξιοπρέπεια. Χαιρετίζω το πνεύμα της πρόσφατης διακήρυξης του Βερολίνου σχετικά με τις ευρωπαϊκές αξίες, καθώς και το πρόγραμμα του Προέδρου του Ευρωπαϊκού Κοινοβουλίου, ο οποίος δήλωσε ότι το ζήτημα της ανθρώπινης αξιοπρέπειας βρίσκεται στο επίκεντρο της δικής του και της δικής μας προσέγγισης κατά την ψήφιση της ευρωπαϊκής νομοθεσίας."@el10
"Señor Presidente, hoy me dirijo a ustedes en calidad de ponente sobre la propuesta de Reglamento sobre medicamentos de terapia avanzada. Además, como médico quiero abordar el tema del progreso en medicina de los medicamentos altamente específicos que aparecen en el mercado europeo para tratar a los pacientes que sufren las enfermedades enumeradas por el Comisario.
Quiero aprovechar esta oportunidad para dar las gracias a la Comisión por su propuesta. Ha llegado el momento de tratar a los pacientes con productos que sean seguros, eficientes y basados en principios no controvertidos.
Desde comienzos de 2006, el Parlamento Europeo ha trabajado con ahínco en torno a esta propuesta con la Comisión de Medio Ambiente, Salud Pública y Seguridad Alimentaria, la Comisión de Industria, Investigación y Energía y la Comisión de Asuntos Jurídicos. El informe final fue aprobado por amplia mayoría. Existe un amplio consenso en el Parlamento de que el informe de la Comisión de Medio Ambiente, tal como se somete a votación en esta Cámara, es excelente. Todas las partes interesadas, representantes de la industria biotecnológica y de grupos de pacientes, lo han acogido con satisfacción después de su aprobación el pasado mes de enero.
La semana pasada, tres diputados, en nombre de sus Grupos políticos –socialistas, liberales y GUE– presentaron varias enmiendas basadas en un supuesto compromiso con el Consejo y la Comisión. Esta acción individual tuvo lugar sin que el ponente tuviera conocimiento de ello.
Quiero subrayar que no se había llegado a ningún acuerdo con las otras dos instituciones al término del diálogo a tres bandas informal que tuvo lugar el mes pasado. El noventa por ciento de esas enmiendas consisten en simples recortes sacados del informe de la comisión, con cambios puramente superficiales. Lo más importante es el 10 % restante. Esas enmiendas, relativas a las cuestiones políticas más delicadas, son el resultado de una iniciativa individual de tres de nuestros colegas. Como señalan en su carta de la semana pasada, el acuerdo interinstitucional no está ultimado. Además, muchas de las enmiendas presentadas en el paquete no cuentan con el apoyo del responsable de la comisión, ni de las otras dos comisiones ni del ponente. Por lo tanto, quiero instar a todos mis colegas a que en la votación del miércoles apoyen el informe responsable presentado por la Comisión de Medio Ambiente.
Con el fin de acelerar el procedimiento legislativo, el diálogo a tres bandas informal con el Consejo y la Comisión se celebró el mes pasado. En las tres reuniones hubo discrepancias. Desde un punto de vista del contenido, hay varias cuestiones políticamente delicadas que no se han resuelto. Desde el punto de vista del procedimiento, se planteó la cuestión de las dos enmiendas presentadas por la Comisión de Asuntos Jurídicos, que se incorporaron directamente al informe de conformidad con el procedimiento de cooperación reforzada. Como ponente principal, he intentado destacar que hay que respetar las atribuciones de dicha comisión. A pesar de las claras disposiciones del Reglamento sobre cooperación reforzada entre comisiones parlamentarias, los colegas de las otras dos instituciones y algunos ponentes alternativos se negaron a considerar esas enmiendas a la luz del acuerdo en primera lectura. Parece que la cooperación reforzada solo se respeta cuando conviene a determinados colegas. Se acoge con satisfacción en expedientes como REACH, pero no cuando se trata de terapias avanzadas. Algunos van incluso más lejos y, abusando de la opinión de grupos de pacientes, declaran que el procedimiento de la cooperación reforzada no es democrático.
Quiero comentar un aspecto de la propuesta que aún me preocupa: el principio de subsidiariedad. En su propuesta plenamente armonizadora, la Comisión introduce una cláusula de exclusión voluntaria para que los Estados miembros puedan aplicar su legislación nacional restrictiva en relación con determinados productos contenciosos. En la práctica, esto significaría que algunos productos no tendrían acceso al mercado de todos los Estados miembros. De acuerdo con la opinión de nuestro Servicio Jurídico, esta disposición presenta graves problemas de incompatibilidad con los fundamentos jurídicos y. por lo tanto, podría ser anulada por el Tribunal de Justicia Europeo. Si así fuera, este Reglamento se convertiría en una medida totalmente armonizadora para todos los productos, incluidos los que están prohibidos en algunos Estados miembros. Aquí, las dos enmiendas de la Comisión de Asuntos Jurídicos aportan seguridad jurídica al excluir de su ámbito de aplicación los productos que contienen células madre embrionarias o se derivan de ellas.
Como ponente, debo respetar la diversidad de los 27 sistemas legislativos relativos a la investigación con células madre embrionarias, desde la completa libertad de investigación hasta la prohibición de matar embriones en aras de la investigación. Si no apoyamos las enmiendas de la Comisión de Asuntos Jurídicos, este Reglamento promoverá de facto el desarrollo de productos derivados de células madre embrionarias, aunque los ciudadanos y los Estados miembros pudieran considerarlo éticamente inaceptable.
Como representante elegido a esta Cámara, tengo la responsabilidad de escuchar todas las opiniones, de hacer encajar posturas y proponer a nuestros ciudadanos un texto que pueda considerarse moderno, progresivo y que respete principios y valores universales como la dignidad humana. Agradezco el tono de la reciente Declaración de Berlín respecto a los valores europeos, así como el programa del Presidente del Parlamento Europeo, que dijo que la cuestión de la dignidad humana es el centro de su enfoque y del nuestro cuando votamos sobre legislación europea."@es21
"Mr President, I should like to address you today as the rapporteur on the proposal for a regulation on advanced therapy medicinal products. Furthermore, as a medical doctor, I should like to address the progress in medicine of highly specific medicinal products emerging onto the European market to treat patients with the diseases enumerated by the Commissioner.
I should like to seize this opportunity to thank the Commission for its proposal. The time has come to treat patients with products which are safe, efficient and based on non-controversial grounds.
Since the beginning of 2006, the European Parliament has been working hard on this proposal with the Committee on the Environment, Public Health and Food Safety, the Committee on Industry, Research and Energy and the Committee on Legal Affairs. The final report was adopted by a large majority. There is a broad consensus within Parliament that the report by the Committee on the Environment, as presented for the vote in this House, is excellent. All stakeholders, representatives of both the bioindustry and of patient groups welcomed it after its adoption last January.
Last week three Members of Parliament, on behalf of their political groups – Socialists, Liberals and GUE – tabled a number of amendments presented as a so-called compromise with the Council and the Commission. This individual action was undertaken without the knowledge of the rapporteur.
I would like to underline that no agreement was reached with the other two institutions at the end of the informal trialogue that took place last month. Ninety per cent of these amendments are a copy-and-paste of the committee report with cosmetic changes. The most relevant are the 10%. These amendments concerning the more sensitive political issues are the result of an individual initiative of three of our colleagues. As they mentioned in their letter last week, the interinstitutional agreement has not been finalised. Furthermore, many of the amendments presented in the package do not have the support of the committee responsible, the other two committees nor of the rapporteur. Therefore, I should like to urge all my colleagues to support the responsible report by the Committee on the Environment in the vote on Wednesday.
In order to speed up the legislative procedure, the informal trialogue with the Council and the Commission took place last month. The three meetings showed discrepancies. From a substantial point of view, several politically sensitive questions have not been solved. From the point of view of procedure, the question was raised of the two amendments tabled by the Committee on Legal Affairs which were directly incorporated into the report under the enhanced cooperation procedure. As the main rapporteur, I have tried to underline that the remit of that committee should be respected. In spite of the clear provisions in the Rules of Procedure on enhanced cooperation between parliamentary committees, colleagues from the two other institutions and some shadow rapporteurs refused to consider these amendments in the light of the first reading agreement. Apparently, enhanced cooperation is respected only when it suits certain colleagues. It is welcomed in files such as REACH, but as far as advanced therapies are concerned. Some go even further and misuse the voice of patients’ groups, declaring that the enhanced cooperation procedure is undemocratic.
I would like to raise one aspect of the proposal which still worries me: the principle of subsidiarity. In its fully harmonising proposal, the Commission introduces an op-out for Member States to apply their restrictive national legislation concerning certain contentious products. In practice, this would mean that certain products would not have access to the market of all Member States. Following the opinion of our Legal Service, this provision presents serious problems of incompatibility with the legal bases and could therefore be annulled by the European Court of Justice. If this is the case, this regulation would become a fully-harmonising measure for all products including those prohibited in some Member States. Here, the two amendments from the Committee on Legal Affairs bring legal certainty by excluding from the scope products containing or derived from embryonic stem cells.
As rapporteur, I have to respect the diversity of 27 sets of legislation relating to embryonic stem cell research, from the complete freedom of research to the prohibition of killing embryos for research purposes. If we do not support the amendments from the Committee on Legal Affairs, this regulation would de facto promote the development of products derived from embryonic stem cells, although this might be considered as ethically unacceptable by citizens and Member States.
As an elected representative of this House, I have the responsibility to listen to all opinions, to marry positions and to propose to our citizens a text which can be considered as modern, progressive and respecting universal principles and values such as human dignity. I welcome the tone of the recent Berlin Declaration regarding European values, as well as the programme of the President of the European Parliament, who stated that the question of human dignity is at the core of his and of our approach when voting on European legislation."@et5
".
Arvoisa puhemies, haluan tänään pitää teille puheen pitkälle kehitetyssä terapiassa käytettäviä lääkkeitä koskevaa asetusehdotusta käsittelevänä esittelijänä. Lisäksi haluan lääkärinä käsitellä lääketieteen kehitystä niiden pitkälle erikoistuneiden lääkkeiden osalta, joita on tulossa EU:n markkinoille ja joilla voidaan hoitaa potilaita, jotka kärsivät komission varapuheenjohtajan luettelmista sairauksista.
Haluan tässä yhteydessä kiittää komissiota sen tekemästä ehdotuksesta. Potilaita on aika hoitaa tuotteilla, jotka ovat turvallisia, tehokkaita ja perusteiltaan kiistattomia.
Euroopan parlamentti on vuoden 2006 alusta lähtien valmistellut ahkerasti tätä ehdotusta ympäristön, kansanterveyden ja elintarvikkeiden turvallisuuden valiokunnassa, teollisuus-, tutkimus- ja energiavaliokunnassa sekä oikeudellisten asioiden valiokunnassa. Lopullinen mietintö hyväksyttiin suurella äänten enemmistöllä. Parlamentissa vallitsee laaja yhteisymmärrys siitä, että ympäristövaliokunnan mietintö on erinomainen siinä muodossa kuin se tuli parlamentin äänestettäväksi. Kaikki sidosryhmät sekä bioteollisuuden ja potilasryhmien edustajat olivat ehdotukseen tyytyväisiä sellaisena kuin se hyväksyttiin viime tammikuussa.
Viime viikolla kolme parlamentin jäsentä jätti kukin oman poliittisen ryhmänsä – sosialidemokraattisen ryhmän, liberaalidemokraattien liiton ryhmän ja yhtyneen vasemmiston konfederaatioryhmän – puolesta käsiteltäväksi joukon tarkistuksia, joiden sanottiin olevan niin sanottu neuvoston ja komission kanssa tehtävä kompromissi. Tähän yksittäiseen tekoon ryhdyttiin esittelijän tietämättä.
Haluan korostaa sitä, että kahden muun toimielimen kanssa ei päästy viime kuussa käytyjen epävirallisten kolmikantaneuvottelujen aikana yhteisymmärrykseen. Näistä tarkistuksista 90 prosenttia on laadittu valiokunnan mietinnön pohjalta leikkaamalla ja liimaamalla ja tekemällä kosmeettisia muutoksia. Kaikkein eniten merkitystä on kymmenellä prosentilla tarkistuksista. Nämä tarkistukset, jotka koskevat arkaluonteisempia poliittisia kysymyksiä, syntyivät kolmen kollegamme omasta aloitteesta. Kuten he viimeviikkoisessa kirjeessään mainitsivat, toimielintenvälistä yhteisymmärrystä ei ole syntynyt. Lisäksi monilla pakettiin sisältyvillä tarkistuksilla ei ole asiasta vastaavan valiokunnan, kahden muun valiokunnan eikä esittelijän tukea. Tämän vuoksi haluan kehottaa kaikkia kollegojani tukemaan ympäristövaliokunnan keskiviikkoisessa äänestyksessä hyväksymää vastuullista mietintöä.
Viime kuussa neuvoston ja komission kanssa käytiin epävirallisia kolmikantaneuvotteluja lainsäädäntömenettelyn nopeuttamiseksi. Kolmessa kokouksessa ilmeni ristiriitoja. Olennaisen sisällön näkökulmasta monet poliittisesti arat kysymykset ovat ratkaisematta. Menettelyn näkökulmasta esille nousi kysymys oikeudellisten asioiden valiokunnan esittämästä kahdesta tarkistuksesta, jotka sisällytettiin mietintöön suoraan tiiviimpää yhteistyötä koskevan menettelyn avulla. Pääesittelijänä olen yrittänyt korostaa sitä, että tämän valiokunnan toimivaltaa olisi kunnioitettava. Vaikka työjärjestykseen sisältyy selkeitä sääntöjä parlamentin valiokuntien välisestä tiiviimmästä yhteistyöstä, kahta muuta toimielintä edustavat kollegat ja eräät varjoesittelijät kieltäytyivät ottamasta huomioon näitä tarkistuksia yhteisymmärryksen saavuttamiseksi ensimmäisessä käsittelyssä. Nähtävästi tiiviimpää yhteistyötä noudatetaan ainoastaan, jos se sopii eräiden kollegojen pirtaan. Siihen suhtaudutaan myönteisesti Reach-asetuksen kaltaisissa asioissa, mutta siltä osin kuin kyse on pitkälle kehitetyistä terapioista jotkut menevät vieläkin pidemmälle ja käyttävät väärin potilasryhmien kantaa väittäessään tiiviimpää yhteistyötä koskevaa menettelyä epädemokraattiseksi.
Haluan ottaa esiin erään ehdotukseen liittyvän seikan, joka huolestuttaa minua edelleen, millä tarkoitan toissijaisuusperiaatetta. Täydelliseen yhdenmukaistamiseen tähtäävässä ehdotuksessaan komissio esittää poikkeusmahdollisuutta, jonka mukaan jäsenvaltiot voivat soveltaa tiettyjen kiistanalaisten tuotteiden osalta kunkin omaa rajoittavaa kansallista lainsäädäntöä. Käytännössä tämä tarkoittaisi sitä, että eräät tuotteet eivät pääsisi kaikkien jäsenvaltioiden markkinoille. Oikeudellisen yksikkömme antaman lausunnon mukaan tähän mahdollisuuteen liittyy vakavia yhteensopivuusongelmia oikeusperustojen osalta, ja näin ollen yhteisöjen tuomioistuin saattaa kumota sen. Jos näin käy, tästä asetuksesta tulisi täydellistä yhdenmukaistamista tarkoittava toimenpide, joka koskisi kaikkia tuotteita, mukaan luettuna niitä tuotteita, jotka ovat eräissä jäsenvaltioissa kiellettyjä. Tältä osin oikeudellisten asioiden valiokunnan esittämällä kahdella tarkistuksella luodaan oikeusvarmuutta sitä kautta, että soveltamisalan ulkopuolelle jätetään tuotteet, jotka sisältävät ihmisalkion kantasoluja tai ovat niistä johdettuja.
Minun on esittelijänä kunnioitettava sitä moninaisuutta, joka johtuu siitä, että ihmisalkion kantasolututkimuksesta säädetään 27:ssä eri lainsäädännössä, joissa esiintyy vaihtelua täydestä tutkimusvapaudesta siihen, että alkioiden tappaminen tutkimustarkoituksessa on kielletty. Jos emme tue oikeudellisten asioiden valiokunnan tarkistuksia, tällä asetuksella edistetään tosiasiassa alkion kantasoluista johdettujen lääkkeiden kehittämistä, vaikka kansalaiset ja jäsenvaltiot saattaisivat pitää tätä eettisesti mahdottomana hyväksyä.
Parlamenttiin valittuna edustajana minulla on velvollisuus kuunnella kaikkien näkemyksiä, sovitella kantoja ja esittää kansalaisillemme sellainen säädösteksti, jota voidaan pitää uudenaikaisena, edistyksellisenä ja yleismaailmallisia periaatteita ja arvoja, kuten ihmisarvoa, kunnioittavana. Olen tyytyväinen äskeisen eurooppalaisia arvoja koskevan Berliinin julistuksen sävyyn sekä Euroopan parlamentin puhemiehen ohjelmaan hänen todetessaan, että ihmisarvokysymys on keskeistä sekä hänen lähestymistavassaan että meidän lähestymistavassamme eurooppalaisesta lainsäädännöstä äänestäessämme."@fi7
".
Monsieur le Président, je voudrais m’adresser à vous aujourd’hui en tant que rapporteur pour la proposition de règlement concernant les médicaments de thérapie innovante. En outre, en ma qualité de docteur en médecine, je voudrais parler des progrès de la médecine en matière de produits de thérapie hautement spécifiques qui apparaissent sur le marché européen pour traiter les patients atteints des affections énumérées par le commissaire.
Je voudrais saisir cette occasion pour remercier la Commission pour sa proposition. Le temps est venu de traiter les patients avec des produits sûrs, efficaces et basés sur des principes qui ne donnent pas lieu à controverse.
Depuis le début de 2006, le Parlement européen a travaillé assidûment à cette proposition avec la commission de l’environnement, de la santé publique et de la sécurité alimentaire, la commission de l’industrie, de la recherche et de l’énergie et la commission des affaires juridiques. Le rapport final a été adopté à une large majorité. Il y a un large consensus au sein du Parlement selon lequel le rapport de la commission de l’environnement, tel qu’il est présenté pour le vote par cette Assemblée, est excellent. Toutes les parties intéressées, les représentants de l’industrie biotechnologique et des associations de patients l’ont salué après son adoption en janvier dernier.
La semaine dernière, trois députés du Parlement ont déposé au nom de leur groupe politique - socialistes, libéraux et GUE - plusieurs amendements présentés comme un soi-disant compromis avec le Conseil et la Commission. Cette action individuelle a été entreprise à l’insu du rapporteur.
Je voudrais souligner qu’aucun accord n’a été conclu avec les deux autres institutions à la fin du trilogue informel qui a eu lieu le mois dernier. Quatre-vingt-dix pour cent de ces amendements sont un simple copier-coller du rapport de la commission, assorti de retouches esthétiques. Les plus pertinents sont les 10 % restants. Ces amendements, qui concernent les questions politiques plus délicates, sont le résultat d’une initiative individuelle de trois de nos collègues. Comme ils l’ont indiqué dans leur lettre la semaine dernière, l’accord interinstitutionnel n’a pas été finalisé. De plus, nombre des amendements présentés dans ce paquet n’ont le soutien ni de la commission saisie au principal, ni des deux autres commissions, ni du rapporteur. Par conséquent, j’invite instamment tous mes collègues à soutenir le rapport final de la commission de l’environnement lors du vote de mercredi.
Le trilogue informel avec le Conseil et la Commission, qui avait pour but d’accélérer la procédure législative, a eu lieu le mois dernier. Les trois réunions ont fait apparaître des divergences. Au point de vue du fond, plusieurs questions politiquement sensibles n’ont pas été résolues. Au point de vue de la procédure, la question des deux amendements déposés par la commission des affaires juridiques et directement intégrés au rapport selon la procédure de coopération renforcée a été soulevée. En tant que principal rapporteur, j’ai tenté de faire remarquer que les attributions de cette commission devraient être respectées. En dépit des dispositions claires prévues par le règlement en matière de coopération entre commissions parlementaires, des collègues des deux autres institutions et certains rapporteurs fictifs ont refusé d’examiner ces amendements à la lumière de l’accord de première lecture. Apparemment, la coopération renforcée est respectée uniquement quand elle arrange certains collègues. Elle est la bienvenue pour des dossiers tels que REACH, mais pour autant que les thérapies innovantes soient concernées. Certains vont même plus loin et abusent de la voix des associations de patients, déclarant que la procédure de coopération renforcée est antidémocratique.
Je voudrais évoquer un aspect de la proposition qui me préoccupe encore: le principe de subsidiarité. Dans sa proposition pleinement harmonisée, la Commission introduit une option de dispense pour les États membres afin de leur permettre d’appliquer leur législation nationale restrictive concernant certains produits litigieux. Dans la pratique, cela signifierait que certains produits n’auraient pas accès au marché de tous les États membres. D’après l’avis de notre service juridique, cette disposition comporte de graves problèmes d’incompatibilité avec les bases juridiques et pourrait donc être annulée par la Cour de justice européenne. Si c’est le cas, ce règlement deviendrait une mesure pleinement harmonisée applicable à tous les produits, y compris ceux qui sont interdits dans certains États membres. À ce point de vue, les deux amendements de la commission des affaires juridiques apportent une sécurité juridique en excluant du champ d’application les produits contenant des cellules souches embryonnaires ou dérivés de celles-ci.
En tant que rapporteur, je dois respecter la diversité de 27 législations nationales relatives à la recherche sur les cellules souches embryonnaires, de la liberté totale de la recherche à l’interdiction de tuer des embryons à des fins de recherche. Si nous ne soutenons pas les amendements de la commission des affaires juridiques, ce règlement serait de facto un encouragement au développement de produits dérivés de cellules souches embryonnaires, bien que cette pratique puisse être considérée inacceptable du point de vue éthique par les citoyens et les États membres.
En tant que représentant élu de cette Assemblée, j’ai le devoir d’écouter toutes les opinions, de concilier les positions et de proposer aux citoyens un texte pouvant être considéré comme moderne, progressiste et respectant les principes et les valeurs universels, comme la dignité humaine. Je salue le ton de la récente déclaration de Berlin sur les valeurs européennes, ainsi que le programme du président du Parlement européen, qui a déclaré que la question de la dignité humaine est au cœur de son approche et de la nôtre lorsqu’il s’agit de voter sur la législation européenne."@fr8
"Mr President, I should like to address you today as the rapporteur on the proposal for a regulation on advanced therapy medicinal products. Furthermore, as a medical doctor, I should like to address the progress in medicine of highly specific medicinal products emerging onto the European market to treat patients with the diseases enumerated by the Commissioner.
I should like to seize this opportunity to thank the Commission for its proposal. The time has come to treat patients with products which are safe, efficient and based on non-controversial grounds.
Since the beginning of 2006, the European Parliament has been working hard on this proposal with the Committee on the Environment, Public Health and Food Safety, the Committee on Industry, Research and Energy and the Committee on Legal Affairs. The final report was adopted by a large majority. There is a broad consensus within Parliament that the report by the Committee on the Environment, as presented for the vote in this House, is excellent. All stakeholders, representatives of both the bioindustry and of patient groups welcomed it after its adoption last January.
Last week three Members of Parliament, on behalf of their political groups – Socialists, Liberals and GUE – tabled a number of amendments presented as a so-called compromise with the Council and the Commission. This individual action was undertaken without the knowledge of the rapporteur.
I would like to underline that no agreement was reached with the other two institutions at the end of the informal trialogue that took place last month. Ninety per cent of these amendments are a copy-and-paste of the committee report with cosmetic changes. The most relevant are the 10%. These amendments concerning the more sensitive political issues are the result of an individual initiative of three of our colleagues. As they mentioned in their letter last week, the interinstitutional agreement has not been finalised. Furthermore, many of the amendments presented in the package do not have the support of the committee responsible, the other two committees nor of the rapporteur. Therefore, I should like to urge all my colleagues to support the responsible report by the Committee on the Environment in the vote on Wednesday.
In order to speed up the legislative procedure, the informal trialogue with the Council and the Commission took place last month. The three meetings showed discrepancies. From a substantial point of view, several politically sensitive questions have not been solved. From the point of view of procedure, the question was raised of the two amendments tabled by the Committee on Legal Affairs which were directly incorporated into the report under the enhanced cooperation procedure. As the main rapporteur, I have tried to underline that the remit of that committee should be respected. In spite of the clear provisions in the Rules of Procedure on enhanced cooperation between parliamentary committees, colleagues from the two other institutions and some shadow rapporteurs refused to consider these amendments in the light of the first reading agreement. Apparently, enhanced cooperation is respected only when it suits certain colleagues. It is welcomed in files such as REACH, but as far as advanced therapies are concerned. Some go even further and misuse the voice of patients’ groups, declaring that the enhanced cooperation procedure is undemocratic.
I would like to raise one aspect of the proposal which still worries me: the principle of subsidiarity. In its fully harmonising proposal, the Commission introduces an op-out for Member States to apply their restrictive national legislation concerning certain contentious products. In practice, this would mean that certain products would not have access to the market of all Member States. Following the opinion of our Legal Service, this provision presents serious problems of incompatibility with the legal bases and could therefore be annulled by the European Court of Justice. If this is the case, this regulation would become a fully-harmonising measure for all products including those prohibited in some Member States. Here, the two amendments from the Committee on Legal Affairs bring legal certainty by excluding from the scope products containing or derived from embryonic stem cells.
As rapporteur, I have to respect the diversity of 27 sets of legislation relating to embryonic stem cell research, from the complete freedom of research to the prohibition of killing embryos for research purposes. If we do not support the amendments from the Committee on Legal Affairs, this regulation would de facto promote the development of products derived from embryonic stem cells, although this might be considered as ethically unacceptable by citizens and Member States.
As an elected representative of this House, I have the responsibility to listen to all opinions, to marry positions and to propose to our citizens a text which can be considered as modern, progressive and respecting universal principles and values such as human dignity. I welcome the tone of the recent Berlin Declaration regarding European values, as well as the programme of the President of the European Parliament, who stated that the question of human dignity is at the core of his and of our approach when voting on European legislation."@hu11
"Signor Presidente, oggi ho il piacere di intervenire in qualità di relatore in merito alla proposta di regolamento sui medicinali per terapie avanzate. Inoltre, in veste di medico, desidero parlare dei progressi compiuti in medicina nel campo dei prodotti medici altamente specifici che vengono immessi nel mercato europeo per il trattamento di pazienti affetti dalle patologie indicate dal Commissario.
Desidero cogliere questa opportunità per ringraziare la Commissione della proposta. E’ ora di curare i pazienti con prodotti sicuri ed efficaci, che poggiano su presupposti non controversi.
Dall’inizio del 2006 il Parlamento europeo lavora strenuamente su questa proposta attraverso la commissione per l’ambiente, la sanità pubblica e la sicurezza alimentare, la commissione per l’industria, la ricerca e l’energia e la commissione giuridica. La relazione definitiva è stata approvata a larga maggioranza. L’Assemblea conviene ampiamente sul fatto che la relazione della commissione per l’ambiente, presentata in Aula per il voto, sia eccellente. Tutti gli interlocutori interessati, i rappresentanti sia dell’industria degli agenti biologici sia delle associazioni di pazienti l’hanno accolta con favore a seguito della sua adozione lo scorso gennaio.
La settimana scorsa tre deputati, a nome dei rispettivi gruppi – i socialisti, i liberali e il gruppo GUE/NGL – hanno presentato una serie di emendamenti sotto forma di un cosiddetto compromesso con il Consiglio e la Commissione. Questa azione individuale è stata avviata all’insaputa del relatore.
Tengo a sottolineare che non è stato raggiunto alcun accordo con le altre due Istituzioni alla fine del trilogo informale che ha avuto luogo il mese scorso. Il 90 per cento di questi emendamenti sono un “copia incolla” dei paragrafi della relazione con l’aggiunta di alcune modifiche cosmetiche. I più rilevanti sono il 10 per cento. Questi emendamenti relativi alle questioni politiche più delicate sono frutto di un’iniziativa personale di tre colleghi. Come essi stessi hanno indicato nella loro lettera della scorsa settimana, l’accordo interistituzionale non è stato finalizzato. Inoltre molti degli emendamenti presentati nel pacchetto non godono del sostegno della commissione competente, delle altre due commissioni e nemmeno del relatore. Pertanto esorto tutti i colleghi a sostenere la relazione responsabile della commissione per l’ambiente nel voto di mercoledì.
Per accelerare la procedura legislativa, il mese scorso si è svolto un trilogo informale con il Consiglio e con la Commissione. Le tre riunioni hanno messo in luce le discrepanze. Da un punto di vista sostanziale sono diverse le questioni politicamente sensibili che non hanno trovato soluzione. Dal punto di vista della procedura sono stati discussi i due emendamenti presentati dalla commissione giuridica che sono stati direttamente incorporati nella relazione ai sensi della procedura di cooperazione rafforzata. In veste di relatore principale ho cercato di enfatizzare la necessità di rispettare l’ambito della commissione. Seppur le disposizioni del Regolamento siano chiare in materia di cooperazione rafforzata, i colleghi delle altre due Istituzioni e alcuni relatori ombra si sono rifiutati di prendere in considerazione questi emendamenti alla luce dell’accordo in prima lettura. Pare proprio che la cooperazione rafforzata venga ottemperata solo quando fa comodo a determinati colleghi. E’ apprezzata solo per fascicoli come REACH, ma non altrettanto per le terapie avanzate. Alcuni si spingono persino oltre, manipolando la voce delle associazioni di pazienti e dichiarando che la procedura di cooperazione rafforzata è antidemocratica.
Desidero porre in luce un aspetto della proposta che continua a preoccuparmi: il principio di sussidiarietà. Nella sua proposta di piena armonizzazione la Commissione introduce una deroga per gli Stati membri sull’applicazione delle normative nazionali restrittive su determinati prodotti controversi. In pratica, ciò significa che certi prodotti non avranno accesso al mercato di tutti gli Stati membri. Seguendo il parere del Servizio giuridico, tale disposizione pone gravi problemi di incompatibilità rispetto alle basi giuridiche e potrebbe quindi essere annullata dalla Corte europea di giustizia. In tal caso il regolamento diventerebbe una misura di piena armonizzazione per tutti i prodotti, anche quelli vietati in alcuni Stati membri. In questo senso i due emendamenti della commissione giuridica apportano chiarezza giuridica, escludendo dal campo di applicazione i prodotti contenenti o derivanti da cellule staminali embrionali.
In veste di relatore ho rispettato la diversità delle 27 normative nazionali in materia di ricerca sulle cellule staminali embrionali: tali normative vanno infatti dalla libertà più assoluta per la ricerca al divieto di sopprimere gli embrioni per fini di ricerca. Se non sosteniamo gli emendamenti della commissione giuridica, questa normativa promuoverà di fatto lo sviluppo di prodotti derivanti da cellule staminali embrionali, anche laddove tale sviluppo può essere considerato eticamente incettabile dai cittadini e dagli Stati membri.
In qualità di rappresentate eletto di quest’Assemblea, ho il compito di ascoltare tutte le opinioni, di assumere determinate posizioni e di proporre ai cittadini un testo che possa essere considerato moderno, progressista e rispettoso dei principi e dei valori universali, come la dignità umana. Ho apprezzato il tono della recente dichiarazione di Berlino sui valori europei nonché il programma del Presidente del Parlamento europeo, il quale ha dichiarato che il tema della dignità umana è al centro del suo e del nostro approccio quando siamo chiamati a esprimere un voto sulla legislazione europea."@it12
"Mr President, I should like to address you today as the rapporteur on the proposal for a regulation on advanced therapy medicinal products. Furthermore, as a medical doctor, I should like to address the progress in medicine of highly specific medicinal products emerging onto the European market to treat patients with the diseases enumerated by the Commissioner.
I should like to seize this opportunity to thank the Commission for its proposal. The time has come to treat patients with products which are safe, efficient and based on non-controversial grounds.
Since the beginning of 2006, the European Parliament has been working hard on this proposal with the Committee on the Environment, Public Health and Food Safety, the Committee on Industry, Research and Energy and the Committee on Legal Affairs. The final report was adopted by a large majority. There is a broad consensus within Parliament that the report by the Committee on the Environment, as presented for the vote in this House, is excellent. All stakeholders, representatives of both the bioindustry and of patient groups welcomed it after its adoption last January.
Last week three Members of Parliament, on behalf of their political groups – Socialists, Liberals and GUE – tabled a number of amendments presented as a so-called compromise with the Council and the Commission. This individual action was undertaken without the knowledge of the rapporteur.
I would like to underline that no agreement was reached with the other two institutions at the end of the informal trialogue that took place last month. Ninety per cent of these amendments are a copy-and-paste of the committee report with cosmetic changes. The most relevant are the 10%. These amendments concerning the more sensitive political issues are the result of an individual initiative of three of our colleagues. As they mentioned in their letter last week, the interinstitutional agreement has not been finalised. Furthermore, many of the amendments presented in the package do not have the support of the committee responsible, the other two committees nor of the rapporteur. Therefore, I should like to urge all my colleagues to support the responsible report by the Committee on the Environment in the vote on Wednesday.
In order to speed up the legislative procedure, the informal trialogue with the Council and the Commission took place last month. The three meetings showed discrepancies. From a substantial point of view, several politically sensitive questions have not been solved. From the point of view of procedure, the question was raised of the two amendments tabled by the Committee on Legal Affairs which were directly incorporated into the report under the enhanced cooperation procedure. As the main rapporteur, I have tried to underline that the remit of that committee should be respected. In spite of the clear provisions in the Rules of Procedure on enhanced cooperation between parliamentary committees, colleagues from the two other institutions and some shadow rapporteurs refused to consider these amendments in the light of the first reading agreement. Apparently, enhanced cooperation is respected only when it suits certain colleagues. It is welcomed in files such as REACH, but as far as advanced therapies are concerned. Some go even further and misuse the voice of patients’ groups, declaring that the enhanced cooperation procedure is undemocratic.
I would like to raise one aspect of the proposal which still worries me: the principle of subsidiarity. In its fully harmonising proposal, the Commission introduces an op-out for Member States to apply their restrictive national legislation concerning certain contentious products. In practice, this would mean that certain products would not have access to the market of all Member States. Following the opinion of our Legal Service, this provision presents serious problems of incompatibility with the legal bases and could therefore be annulled by the European Court of Justice. If this is the case, this regulation would become a fully-harmonising measure for all products including those prohibited in some Member States. Here, the two amendments from the Committee on Legal Affairs bring legal certainty by excluding from the scope products containing or derived from embryonic stem cells.
As rapporteur, I have to respect the diversity of 27 sets of legislation relating to embryonic stem cell research, from the complete freedom of research to the prohibition of killing embryos for research purposes. If we do not support the amendments from the Committee on Legal Affairs, this regulation would de facto promote the development of products derived from embryonic stem cells, although this might be considered as ethically unacceptable by citizens and Member States.
As an elected representative of this House, I have the responsibility to listen to all opinions, to marry positions and to propose to our citizens a text which can be considered as modern, progressive and respecting universal principles and values such as human dignity. I welcome the tone of the recent Berlin Declaration regarding European values, as well as the programme of the President of the European Parliament, who stated that the question of human dignity is at the core of his and of our approach when voting on European legislation."@lt14
"Mr President, I should like to address you today as the rapporteur on the proposal for a regulation on advanced therapy medicinal products. Furthermore, as a medical doctor, I should like to address the progress in medicine of highly specific medicinal products emerging onto the European market to treat patients with the diseases enumerated by the Commissioner.
I should like to seize this opportunity to thank the Commission for its proposal. The time has come to treat patients with products which are safe, efficient and based on non-controversial grounds.
Since the beginning of 2006, the European Parliament has been working hard on this proposal with the Committee on the Environment, Public Health and Food Safety, the Committee on Industry, Research and Energy and the Committee on Legal Affairs. The final report was adopted by a large majority. There is a broad consensus within Parliament that the report by the Committee on the Environment, as presented for the vote in this House, is excellent. All stakeholders, representatives of both the bioindustry and of patient groups welcomed it after its adoption last January.
Last week three Members of Parliament, on behalf of their political groups – Socialists, Liberals and GUE – tabled a number of amendments presented as a so-called compromise with the Council and the Commission. This individual action was undertaken without the knowledge of the rapporteur.
I would like to underline that no agreement was reached with the other two institutions at the end of the informal trialogue that took place last month. Ninety per cent of these amendments are a copy-and-paste of the committee report with cosmetic changes. The most relevant are the 10%. These amendments concerning the more sensitive political issues are the result of an individual initiative of three of our colleagues. As they mentioned in their letter last week, the interinstitutional agreement has not been finalised. Furthermore, many of the amendments presented in the package do not have the support of the committee responsible, the other two committees nor of the rapporteur. Therefore, I should like to urge all my colleagues to support the responsible report by the Committee on the Environment in the vote on Wednesday.
In order to speed up the legislative procedure, the informal trialogue with the Council and the Commission took place last month. The three meetings showed discrepancies. From a substantial point of view, several politically sensitive questions have not been solved. From the point of view of procedure, the question was raised of the two amendments tabled by the Committee on Legal Affairs which were directly incorporated into the report under the enhanced cooperation procedure. As the main rapporteur, I have tried to underline that the remit of that committee should be respected. In spite of the clear provisions in the Rules of Procedure on enhanced cooperation between parliamentary committees, colleagues from the two other institutions and some shadow rapporteurs refused to consider these amendments in the light of the first reading agreement. Apparently, enhanced cooperation is respected only when it suits certain colleagues. It is welcomed in files such as REACH, but as far as advanced therapies are concerned. Some go even further and misuse the voice of patients’ groups, declaring that the enhanced cooperation procedure is undemocratic.
I would like to raise one aspect of the proposal which still worries me: the principle of subsidiarity. In its fully harmonising proposal, the Commission introduces an op-out for Member States to apply their restrictive national legislation concerning certain contentious products. In practice, this would mean that certain products would not have access to the market of all Member States. Following the opinion of our Legal Service, this provision presents serious problems of incompatibility with the legal bases and could therefore be annulled by the European Court of Justice. If this is the case, this regulation would become a fully-harmonising measure for all products including those prohibited in some Member States. Here, the two amendments from the Committee on Legal Affairs bring legal certainty by excluding from the scope products containing or derived from embryonic stem cells.
As rapporteur, I have to respect the diversity of 27 sets of legislation relating to embryonic stem cell research, from the complete freedom of research to the prohibition of killing embryos for research purposes. If we do not support the amendments from the Committee on Legal Affairs, this regulation would de facto promote the development of products derived from embryonic stem cells, although this might be considered as ethically unacceptable by citizens and Member States.
As an elected representative of this House, I have the responsibility to listen to all opinions, to marry positions and to propose to our citizens a text which can be considered as modern, progressive and respecting universal principles and values such as human dignity. I welcome the tone of the recent Berlin Declaration regarding European values, as well as the programme of the President of the European Parliament, who stated that the question of human dignity is at the core of his and of our approach when voting on European legislation."@lv13
"Mr President, I should like to address you today as the rapporteur on the proposal for a regulation on advanced therapy medicinal products. Furthermore, as a medical doctor, I should like to address the progress in medicine of highly specific medicinal products emerging onto the European market to treat patients with the diseases enumerated by the Commissioner.
I should like to seize this opportunity to thank the Commission for its proposal. The time has come to treat patients with products which are safe, efficient and based on non-controversial grounds.
Since the beginning of 2006, the European Parliament has been working hard on this proposal with the Committee on the Environment, Public Health and Food Safety, the Committee on Industry, Research and Energy and the Committee on Legal Affairs. The final report was adopted by a large majority. There is a broad consensus within Parliament that the report by the Committee on the Environment, as presented for the vote in this House, is excellent. All stakeholders, representatives of both the bioindustry and of patient groups welcomed it after its adoption last January.
Last week three Members of Parliament, on behalf of their political groups – Socialists, Liberals and GUE – tabled a number of amendments presented as a so-called compromise with the Council and the Commission. This individual action was undertaken without the knowledge of the rapporteur.
I would like to underline that no agreement was reached with the other two institutions at the end of the informal trialogue that took place last month. Ninety per cent of these amendments are a copy-and-paste of the committee report with cosmetic changes. The most relevant are the 10%. These amendments concerning the more sensitive political issues are the result of an individual initiative of three of our colleagues. As they mentioned in their letter last week, the interinstitutional agreement has not been finalised. Furthermore, many of the amendments presented in the package do not have the support of the committee responsible, the other two committees nor of the rapporteur. Therefore, I should like to urge all my colleagues to support the responsible report by the Committee on the Environment in the vote on Wednesday.
In order to speed up the legislative procedure, the informal trialogue with the Council and the Commission took place last month. The three meetings showed discrepancies. From a substantial point of view, several politically sensitive questions have not been solved. From the point of view of procedure, the question was raised of the two amendments tabled by the Committee on Legal Affairs which were directly incorporated into the report under the enhanced cooperation procedure. As the main rapporteur, I have tried to underline that the remit of that committee should be respected. In spite of the clear provisions in the Rules of Procedure on enhanced cooperation between parliamentary committees, colleagues from the two other institutions and some shadow rapporteurs refused to consider these amendments in the light of the first reading agreement. Apparently, enhanced cooperation is respected only when it suits certain colleagues. It is welcomed in files such as REACH, but as far as advanced therapies are concerned. Some go even further and misuse the voice of patients’ groups, declaring that the enhanced cooperation procedure is undemocratic.
I would like to raise one aspect of the proposal which still worries me: the principle of subsidiarity. In its fully harmonising proposal, the Commission introduces an op-out for Member States to apply their restrictive national legislation concerning certain contentious products. In practice, this would mean that certain products would not have access to the market of all Member States. Following the opinion of our Legal Service, this provision presents serious problems of incompatibility with the legal bases and could therefore be annulled by the European Court of Justice. If this is the case, this regulation would become a fully-harmonising measure for all products including those prohibited in some Member States. Here, the two amendments from the Committee on Legal Affairs bring legal certainty by excluding from the scope products containing or derived from embryonic stem cells.
As rapporteur, I have to respect the diversity of 27 sets of legislation relating to embryonic stem cell research, from the complete freedom of research to the prohibition of killing embryos for research purposes. If we do not support the amendments from the Committee on Legal Affairs, this regulation would de facto promote the development of products derived from embryonic stem cells, although this might be considered as ethically unacceptable by citizens and Member States.
As an elected representative of this House, I have the responsibility to listen to all opinions, to marry positions and to propose to our citizens a text which can be considered as modern, progressive and respecting universal principles and values such as human dignity. I welcome the tone of the recent Berlin Declaration regarding European values, as well as the programme of the President of the European Parliament, who stated that the question of human dignity is at the core of his and of our approach when voting on European legislation."@mt15
"Mijnheer de Voorzitter, ik richt vandaag het woord tot u als de rapporteur over het voorstel voor een verordening betreffende geneesmiddelen voor geavanceerde therapie. Verder wil ik als arts stilstaan bij de medische vooruitgang op het gebied van zeer specifieke geneesmiddelen die in Europa in de handel worden gebracht om patiënten te behandelen die lijden aan de ziekten die de commissaris opsomde.
Ik wil van de gelegenheid gebruik maken om de Commissie te bedanken voor haar voorstel. Het wordt tijd dat patiënten worden behandeld met veilige, doeltreffende middelen op basis van oncontroversiële redenen.
Het Europees Parlement werkt al sinds begin 2006 samen met de Commissie milieubeheer, volksgezondheid en voedselveiligheid, de Commissie industrie, onderzoek en energie en de Commissie juridische zaken, hard aan dit voorstel. Het definitieve verslag is door een ruime meerderheid aangenomen. Er bestaat binnen het Parlement brede consensus dat het verslag van de Commissie milieubeheer, zoals dat voor de stemming in dit Parlement is gepresenteerd, van uitstekende kwaliteit is. Alle belanghebbenden, vertegenwoordigers van zowel de bio-industrie als patiëntengroepen, juichten het verslag toe toen het afgelopen januari werd aangenomen.
Vorige week hebben drie afgevaardigden namens hun fracties – de Sociaal-democratische Fractie in het Europees Parlement, de Alliantie van Liberalen en Democraten voor Europa fractie en de Confederale Fractie Europees Unitair Links/Noords Groen Links – een aantal amendementen ingediend die werden gepresenteerd als een zogenaamd compromis met de Raad en de Commissie. Deze individuele actie werd ondernomen buiten medeweten van de rapporteur.
Ik wijs er met klem op dat er tijdens de informele trialoog die vorige maand is gehouden, geen overeenstemming met de andere twee instellingen is bereikt. Negentig procent van deze amendementen was knip- en plakwerk uit het verslag van de commissie met een paar cosmetische aanpassingen. Het gaat om de resterende 10 procent. Deze amendementen met betrekking tot de gevoeliger politieke kwesties zijn het resultaat van een individueel initiatief van drie van onze collega’s. Zoals ze vorige week in hun brief aangaven, is de interinstitutionele overeenkomst niet afgerond. Verder worden veel van de gepresenteerde amendementen niet gesteund door de verantwoordelijke commissie, de andere twee commissies en de rapporteur. Daarom dring ik er bij mijn collega’s op aan om het verslag ten principale van de Commissie milieubeheer woensdag tijdens de stemming te steunen.
Om de wetgevingsprocedure te versnellen is vorige maand de informele trialoog met de Raad en de Commissie gehouden. Er was sprake van discrepanties tussen de drie vergaderingen. Inhoudelijk gezien kan worden gesteld dat verschillende politiek gevoelige kwesties niet zijn opgelost. In verband met de procedure werd het punt van de twee amendementen die de Commissie juridische zaken had ingediend en die door middel van de versterkte samenwerkingsprocedure rechtstreeks in het verslag werden opgenomen, aan de orde gesteld. Als hoofdrapporteur heb ik geprobeerd te benadrukken dat de opdracht van die commissie moet worden gerespecteerd. Ondanks de duidelijke bepalingen in het Reglement inzake de versterkte samenwerking tussen parlementaire commissies hebben collega’s van de andere twee instellingen en enkele schaduwrapporteurs in het licht van de overeenkomst in eerste lezing geweigerd om deze amendementen te overwegen. Kennelijk wordt de versterkte samenwerking door bepaalde collega’s alleen gerespecteerd als het hun uitkomt. Versterkte samenwerking wordt verwelkomd in dossiers zoals REACH, maar alleen als het gaat om geavanceerde therapie. Sommigen gaan zelfs nog verder en maken misbruik van de stem van patiëntengroepen door te verklaren dat de versterkte samenwerkingsprocedure ondemocratisch is.
Ik wil graag één aspect van het voorstel waar ik me nog steeds zorgen om maak, naar voren brengen, te weten het subsidiariteitsbeginsel. De Commissie introduceert in haar volledig harmoniserende voorstel een uitstapclausule zodat lidstaten in verband met bepaalde omstreden middelen hun beperkende nationale wetgeving kunnen toepassen. In de praktijk zou dit betekenen dat bepaalde middelen niet in alle lidstaten in de handel kunnen worden gebracht. Volgens het advies van onze juridische dienst vormt deze bepaling een ernstig probleem omdat ze onverenigbaar is met de rechtsgronden, wat betekent dat het Europese Hof van Justitie de bepaling ongeldig zou kunnen verklaren. Als dit het geval is, zou deze verordening een volledig harmoniserende maatregel worden voor alle producten, waaronder middelen die in sommige lidstaten verboden zijn. Op dit punt bieden de twee amendementen van de Commissie juridische zaken rechtszekerheid doordat middelen die embryonale stamcellen bevatten of daarvan afgeleid zijn, worden uitgesloten.
Als rapporteur moet ik rekening houden met de verschillen tussen 27 wetgevingen inzake onderzoek naar embryonale stamcellen, variërend van volledige onderzoeksvrijheid tot het verbod op het doden van embryo’s voor onderzoeksdoeleinden. Als we de amendementen van de Commissie juridische zaken niet steunen, zal deze verordening de ontwikkeling van middelen afgeleid van embryonale stamcellen in feite bevorderen, hoewel dit door burgers en lidstaten misschien als ethisch onaanvaardbaar wordt beschouwd.
Als gekozen vertegenwoordiger van dit Parlement heb ik de verantwoordelijkheid om naar alle adviezen te luisteren, standpunten te combineren en onze burgers een tekst voor te stellen die modern en vooruitstrevend genoemd kan worden en waarin universele beginselen en waarden zoals menselijke waardigheid worden gerespecteerd. Ik verwelkom de toonzetting van de recente Verklaring van Berlijn ten aanzien van Europese waarden en het programma van de Voorzitter van het Europees Parlement, die verklaarde dat menselijke waardigheid de kern raakt van zijn en onze benadering als we over Europese wetgeving stemmen."@nl3
"Mr President, I should like to address you today as the rapporteur on the proposal for a regulation on advanced therapy medicinal products. Furthermore, as a medical doctor, I should like to address the progress in medicine of highly specific medicinal products emerging onto the European market to treat patients with the diseases enumerated by the Commissioner.
I should like to seize this opportunity to thank the Commission for its proposal. The time has come to treat patients with products which are safe, efficient and based on non-controversial grounds.
Since the beginning of 2006, the European Parliament has been working hard on this proposal with the Committee on the Environment, Public Health and Food Safety, the Committee on Industry, Research and Energy and the Committee on Legal Affairs. The final report was adopted by a large majority. There is a broad consensus within Parliament that the report by the Committee on the Environment, as presented for the vote in this House, is excellent. All stakeholders, representatives of both the bioindustry and of patient groups welcomed it after its adoption last January.
Last week three Members of Parliament, on behalf of their political groups – Socialists, Liberals and GUE – tabled a number of amendments presented as a so-called compromise with the Council and the Commission. This individual action was undertaken without the knowledge of the rapporteur.
I would like to underline that no agreement was reached with the other two institutions at the end of the informal trialogue that took place last month. Ninety per cent of these amendments are a copy-and-paste of the committee report with cosmetic changes. The most relevant are the 10%. These amendments concerning the more sensitive political issues are the result of an individual initiative of three of our colleagues. As they mentioned in their letter last week, the interinstitutional agreement has not been finalised. Furthermore, many of the amendments presented in the package do not have the support of the committee responsible, the other two committees nor of the rapporteur. Therefore, I should like to urge all my colleagues to support the responsible report by the Committee on the Environment in the vote on Wednesday.
In order to speed up the legislative procedure, the informal trialogue with the Council and the Commission took place last month. The three meetings showed discrepancies. From a substantial point of view, several politically sensitive questions have not been solved. From the point of view of procedure, the question was raised of the two amendments tabled by the Committee on Legal Affairs which were directly incorporated into the report under the enhanced cooperation procedure. As the main rapporteur, I have tried to underline that the remit of that committee should be respected. In spite of the clear provisions in the Rules of Procedure on enhanced cooperation between parliamentary committees, colleagues from the two other institutions and some shadow rapporteurs refused to consider these amendments in the light of the first reading agreement. Apparently, enhanced cooperation is respected only when it suits certain colleagues. It is welcomed in files such as REACH, but as far as advanced therapies are concerned. Some go even further and misuse the voice of patients’ groups, declaring that the enhanced cooperation procedure is undemocratic.
I would like to raise one aspect of the proposal which still worries me: the principle of subsidiarity. In its fully harmonising proposal, the Commission introduces an op-out for Member States to apply their restrictive national legislation concerning certain contentious products. In practice, this would mean that certain products would not have access to the market of all Member States. Following the opinion of our Legal Service, this provision presents serious problems of incompatibility with the legal bases and could therefore be annulled by the European Court of Justice. If this is the case, this regulation would become a fully-harmonising measure for all products including those prohibited in some Member States. Here, the two amendments from the Committee on Legal Affairs bring legal certainty by excluding from the scope products containing or derived from embryonic stem cells.
As rapporteur, I have to respect the diversity of 27 sets of legislation relating to embryonic stem cell research, from the complete freedom of research to the prohibition of killing embryos for research purposes. If we do not support the amendments from the Committee on Legal Affairs, this regulation would de facto promote the development of products derived from embryonic stem cells, although this might be considered as ethically unacceptable by citizens and Member States.
As an elected representative of this House, I have the responsibility to listen to all opinions, to marry positions and to propose to our citizens a text which can be considered as modern, progressive and respecting universal principles and values such as human dignity. I welcome the tone of the recent Berlin Declaration regarding European values, as well as the programme of the President of the European Parliament, who stated that the question of human dignity is at the core of his and of our approach when voting on European legislation."@pl16
"Senhor Presidente, dirijo-me à Assembleia na qualidade de relator para a proposta de regulamento relativo a medicamentos de terapias avançadas. Além disso, enquanto médico, gostaria de me debruçar sobre os progressos registados no domínio dos medicamentos altamente específicos, emergentes no mercado europeu, destinados ao tratamento de pacientes que sofrem das doenças enumeradas pelo Senhor Comissário.
Gostaria de aproveitar o ensejo para agradecer à Comissão a sua proposta. Chegou a hora de tratarmos os doentes com produtos que sejam seguros, eficientes e baseados em princípios incontroversos.
O Parlamento Europeu está a trabalhar arduamente nesta proposta, com a Comissão do Ambiente, da Saúde Pública e da Segurança Alimentar, a Comissão da Indústria, da Investigação e da Energia e a Comissão dos Assuntos Jurídicos desde o início de 2006. O relatório final foi adoptado por uma larga maioria. No Parlamento, existe um consenso alargado de que o relatório da Comissão do Ambiente, tal como foi apresentado para votação nesta Câmara, é excelente. Todas as partes interessadas, representantes tanto da indústria biotecnológica como de associações de pacientes, saudaram a sua adopção, no passado mês de Janeiro.
Na semana transacta, três deputados propuseram, em nome dos seus grupos políticos – Socialista, Liberais e GUE –, uma série de alterações, que foram apresentadas como sendo de compromisso com o Conselho e a Comissão. A iniciativa individual em causa foi tomada sem conhecimento do relator.
Queria sublinhar que no trílogo informal que teve lugar no mês passado não foi alcançado acordo algum com as outras duas instituições. Noventa por cento das alterações referidas são uma cópia retocada do relatório da comissão. As mais relevantes são os 10% restantes. Essas alterações referentes às questões políticas mais sensíveis são fruto de uma iniciativa individual de três colegas nossos. Conforme se observa na sua carta da semana passada, o acordo interinstitucional não se consumou. Além disso, muitas das alterações que integram o "pacote" não têm o apoio nem da comissão competente nem das outras duas nem do relator. Consequentemente, gostaria de exortar todos os colegas a apoiarem o competente relatório da Comissão do Ambiente na votação de quarta-feira.
Para acelerar o processo legislativo, teve lugar no mês passado o trílogo informal com o Conselho e a Comissão. Verificaram-se discrepâncias nas três reuniões. No plano substantivo, não foram solucionadas várias questões politicamente sensíveis. No plano processual, foi levantada a questão das duas alterações apresentadas pela Comissão dos Assuntos Jurídicos que foram directamente incorporadas no relatório ao abrigo do processo de cooperação reforçada. Como relator principal, tentei frisar que a área de competência da comissão devia ser respeitada. A despeito da clareza das disposições do Regimento referentes à cooperação reforçada entre comissões parlamentares, os colegas das outras duas instituições e alguns relatores-sombra recusaram-se a considerar estas alterações à luz do acordo em primeira leitura. Aparentemente, o regime de cooperação reforçada só é respeitado quando isso convém a certos colegas. É bem aceite em processos como o do REACH, mas no que toca a terapias avançadas. Alguns vão ainda mais longe e invocam de forma abusiva as posições das associações de doentes, declarando que o processo de cooperação reforçada é anti-democrático.
Queria fazer referência a um aspecto da proposta que continua a preocupar-me: o princípio da subsidiariedade. Na sua proposta de harmonização plena, a Comissão ressalva a possibilidade de os Estados-Membros aplicarem legislação nacional restritiva a certos produtos litigiosos controversos. Na prática, isto significa que certos produtos não terão acesso ao mercado de todos os Estados-Membros. De acordo com o parecer do nosso Serviço Jurídico, este preceito levanta sérios problemas de incompatibilidade com as bases jurídicas e pode, por conseguinte, vir a ser derrogado pelo Tribunal de Justiça Europeu. Nesse caso, a harmonização plena do regulamento tornar-se-á extensiva à totalidade dos produtos, incluindo os proibidos nalguns Estados-Membros. Nesta matéria, as duas alterações propostas pela Comissão dos Assuntos Jurídicos propiciam certeza jurídica, excluindo do âmbito de aplicação do diploma os produtos que contêm ou derivam de células estaminais de embriões.
Como relator, tenho de respeitar a diversidade dos 27 regimes legais em matéria de investigação no campo das células estaminais, que vão da liberdade absoluta de investigação à proibição de provocar a morte de embriões para fins de pesquisa. Se não apoiarmos as alterações da Comissão dos Assuntos Jurídicos, o presente regulamento acabará por promover, de facto, o desenvolvimento de produtos derivados de células estaminais embrionárias, não obstante o facto de ele poder ser reputado eticamente inaceitável por cidadãos e Estados-Membros.
Como representante eleito desta Assembleia, tenho o dever de ouvir todas as opiniões, tentar conciliar posições e propor aos nossos concidadãos um texto que possa ser considerado moderno, progressivo e respeitador de princípios e valores universais como a dignidade humana. Saúdo o tom da recente Declaração de Berlim sobre os valores europeus, bem como o programa do Presidente do Parlamento Europeu, em que se declara que a dignidade humana tem uma importância nuclear na sua e nossa abordagem em sede de adopção de legislação europeia."@pt17
"Mr President, I should like to address you today as the rapporteur on the proposal for a regulation on advanced therapy medicinal products. Furthermore, as a medical doctor, I should like to address the progress in medicine of highly specific medicinal products emerging onto the European market to treat patients with the diseases enumerated by the Commissioner.
I should like to seize this opportunity to thank the Commission for its proposal. The time has come to treat patients with products which are safe, efficient and based on non-controversial grounds.
Since the beginning of 2006, the European Parliament has been working hard on this proposal with the Committee on the Environment, Public Health and Food Safety, the Committee on Industry, Research and Energy and the Committee on Legal Affairs. The final report was adopted by a large majority. There is a broad consensus within Parliament that the report by the Committee on the Environment, as presented for the vote in this House, is excellent. All stakeholders, representatives of both the bioindustry and of patient groups welcomed it after its adoption last January.
Last week three Members of Parliament, on behalf of their political groups – Socialists, Liberals and GUE – tabled a number of amendments presented as a so-called compromise with the Council and the Commission. This individual action was undertaken without the knowledge of the rapporteur.
I would like to underline that no agreement was reached with the other two institutions at the end of the informal trialogue that took place last month. Ninety per cent of these amendments are a copy-and-paste of the committee report with cosmetic changes. The most relevant are the 10%. These amendments concerning the more sensitive political issues are the result of an individual initiative of three of our colleagues. As they mentioned in their letter last week, the interinstitutional agreement has not been finalised. Furthermore, many of the amendments presented in the package do not have the support of the committee responsible, the other two committees nor of the rapporteur. Therefore, I should like to urge all my colleagues to support the responsible report by the Committee on the Environment in the vote on Wednesday.
In order to speed up the legislative procedure, the informal trialogue with the Council and the Commission took place last month. The three meetings showed discrepancies. From a substantial point of view, several politically sensitive questions have not been solved. From the point of view of procedure, the question was raised of the two amendments tabled by the Committee on Legal Affairs which were directly incorporated into the report under the enhanced cooperation procedure. As the main rapporteur, I have tried to underline that the remit of that committee should be respected. In spite of the clear provisions in the Rules of Procedure on enhanced cooperation between parliamentary committees, colleagues from the two other institutions and some shadow rapporteurs refused to consider these amendments in the light of the first reading agreement. Apparently, enhanced cooperation is respected only when it suits certain colleagues. It is welcomed in files such as REACH, but as far as advanced therapies are concerned. Some go even further and misuse the voice of patients’ groups, declaring that the enhanced cooperation procedure is undemocratic.
I would like to raise one aspect of the proposal which still worries me: the principle of subsidiarity. In its fully harmonising proposal, the Commission introduces an op-out for Member States to apply their restrictive national legislation concerning certain contentious products. In practice, this would mean that certain products would not have access to the market of all Member States. Following the opinion of our Legal Service, this provision presents serious problems of incompatibility with the legal bases and could therefore be annulled by the European Court of Justice. If this is the case, this regulation would become a fully-harmonising measure for all products including those prohibited in some Member States. Here, the two amendments from the Committee on Legal Affairs bring legal certainty by excluding from the scope products containing or derived from embryonic stem cells.
As rapporteur, I have to respect the diversity of 27 sets of legislation relating to embryonic stem cell research, from the complete freedom of research to the prohibition of killing embryos for research purposes. If we do not support the amendments from the Committee on Legal Affairs, this regulation would de facto promote the development of products derived from embryonic stem cells, although this might be considered as ethically unacceptable by citizens and Member States.
As an elected representative of this House, I have the responsibility to listen to all opinions, to marry positions and to propose to our citizens a text which can be considered as modern, progressive and respecting universal principles and values such as human dignity. I welcome the tone of the recent Berlin Declaration regarding European values, as well as the programme of the President of the European Parliament, who stated that the question of human dignity is at the core of his and of our approach when voting on European legislation."@ro18
"Mr President, I should like to address you today as the rapporteur on the proposal for a regulation on advanced therapy medicinal products. Furthermore, as a medical doctor, I should like to address the progress in medicine of highly specific medicinal products emerging onto the European market to treat patients with the diseases enumerated by the Commissioner.
I should like to seize this opportunity to thank the Commission for its proposal. The time has come to treat patients with products which are safe, efficient and based on non-controversial grounds.
Since the beginning of 2006, the European Parliament has been working hard on this proposal with the Committee on the Environment, Public Health and Food Safety, the Committee on Industry, Research and Energy and the Committee on Legal Affairs. The final report was adopted by a large majority. There is a broad consensus within Parliament that the report by the Committee on the Environment, as presented for the vote in this House, is excellent. All stakeholders, representatives of both the bioindustry and of patient groups welcomed it after its adoption last January.
Last week three Members of Parliament, on behalf of their political groups – Socialists, Liberals and GUE – tabled a number of amendments presented as a so-called compromise with the Council and the Commission. This individual action was undertaken without the knowledge of the rapporteur.
I would like to underline that no agreement was reached with the other two institutions at the end of the informal trialogue that took place last month. Ninety per cent of these amendments are a copy-and-paste of the committee report with cosmetic changes. The most relevant are the 10%. These amendments concerning the more sensitive political issues are the result of an individual initiative of three of our colleagues. As they mentioned in their letter last week, the interinstitutional agreement has not been finalised. Furthermore, many of the amendments presented in the package do not have the support of the committee responsible, the other two committees nor of the rapporteur. Therefore, I should like to urge all my colleagues to support the responsible report by the Committee on the Environment in the vote on Wednesday.
In order to speed up the legislative procedure, the informal trialogue with the Council and the Commission took place last month. The three meetings showed discrepancies. From a substantial point of view, several politically sensitive questions have not been solved. From the point of view of procedure, the question was raised of the two amendments tabled by the Committee on Legal Affairs which were directly incorporated into the report under the enhanced cooperation procedure. As the main rapporteur, I have tried to underline that the remit of that committee should be respected. In spite of the clear provisions in the Rules of Procedure on enhanced cooperation between parliamentary committees, colleagues from the two other institutions and some shadow rapporteurs refused to consider these amendments in the light of the first reading agreement. Apparently, enhanced cooperation is respected only when it suits certain colleagues. It is welcomed in files such as REACH, but as far as advanced therapies are concerned. Some go even further and misuse the voice of patients’ groups, declaring that the enhanced cooperation procedure is undemocratic.
I would like to raise one aspect of the proposal which still worries me: the principle of subsidiarity. In its fully harmonising proposal, the Commission introduces an op-out for Member States to apply their restrictive national legislation concerning certain contentious products. In practice, this would mean that certain products would not have access to the market of all Member States. Following the opinion of our Legal Service, this provision presents serious problems of incompatibility with the legal bases and could therefore be annulled by the European Court of Justice. If this is the case, this regulation would become a fully-harmonising measure for all products including those prohibited in some Member States. Here, the two amendments from the Committee on Legal Affairs bring legal certainty by excluding from the scope products containing or derived from embryonic stem cells.
As rapporteur, I have to respect the diversity of 27 sets of legislation relating to embryonic stem cell research, from the complete freedom of research to the prohibition of killing embryos for research purposes. If we do not support the amendments from the Committee on Legal Affairs, this regulation would de facto promote the development of products derived from embryonic stem cells, although this might be considered as ethically unacceptable by citizens and Member States.
As an elected representative of this House, I have the responsibility to listen to all opinions, to marry positions and to propose to our citizens a text which can be considered as modern, progressive and respecting universal principles and values such as human dignity. I welcome the tone of the recent Berlin Declaration regarding European values, as well as the programme of the President of the European Parliament, who stated that the question of human dignity is at the core of his and of our approach when voting on European legislation."@sk19
"Mr President, I should like to address you today as the rapporteur on the proposal for a regulation on advanced therapy medicinal products. Furthermore, as a medical doctor, I should like to address the progress in medicine of highly specific medicinal products emerging onto the European market to treat patients with the diseases enumerated by the Commissioner.
I should like to seize this opportunity to thank the Commission for its proposal. The time has come to treat patients with products which are safe, efficient and based on non-controversial grounds.
Since the beginning of 2006, the European Parliament has been working hard on this proposal with the Committee on the Environment, Public Health and Food Safety, the Committee on Industry, Research and Energy and the Committee on Legal Affairs. The final report was adopted by a large majority. There is a broad consensus within Parliament that the report by the Committee on the Environment, as presented for the vote in this House, is excellent. All stakeholders, representatives of both the bioindustry and of patient groups welcomed it after its adoption last January.
Last week three Members of Parliament, on behalf of their political groups – Socialists, Liberals and GUE – tabled a number of amendments presented as a so-called compromise with the Council and the Commission. This individual action was undertaken without the knowledge of the rapporteur.
I would like to underline that no agreement was reached with the other two institutions at the end of the informal trialogue that took place last month. Ninety per cent of these amendments are a copy-and-paste of the committee report with cosmetic changes. The most relevant are the 10%. These amendments concerning the more sensitive political issues are the result of an individual initiative of three of our colleagues. As they mentioned in their letter last week, the interinstitutional agreement has not been finalised. Furthermore, many of the amendments presented in the package do not have the support of the committee responsible, the other two committees nor of the rapporteur. Therefore, I should like to urge all my colleagues to support the responsible report by the Committee on the Environment in the vote on Wednesday.
In order to speed up the legislative procedure, the informal trialogue with the Council and the Commission took place last month. The three meetings showed discrepancies. From a substantial point of view, several politically sensitive questions have not been solved. From the point of view of procedure, the question was raised of the two amendments tabled by the Committee on Legal Affairs which were directly incorporated into the report under the enhanced cooperation procedure. As the main rapporteur, I have tried to underline that the remit of that committee should be respected. In spite of the clear provisions in the Rules of Procedure on enhanced cooperation between parliamentary committees, colleagues from the two other institutions and some shadow rapporteurs refused to consider these amendments in the light of the first reading agreement. Apparently, enhanced cooperation is respected only when it suits certain colleagues. It is welcomed in files such as REACH, but as far as advanced therapies are concerned. Some go even further and misuse the voice of patients’ groups, declaring that the enhanced cooperation procedure is undemocratic.
I would like to raise one aspect of the proposal which still worries me: the principle of subsidiarity. In its fully harmonising proposal, the Commission introduces an op-out for Member States to apply their restrictive national legislation concerning certain contentious products. In practice, this would mean that certain products would not have access to the market of all Member States. Following the opinion of our Legal Service, this provision presents serious problems of incompatibility with the legal bases and could therefore be annulled by the European Court of Justice. If this is the case, this regulation would become a fully-harmonising measure for all products including those prohibited in some Member States. Here, the two amendments from the Committee on Legal Affairs bring legal certainty by excluding from the scope products containing or derived from embryonic stem cells.
As rapporteur, I have to respect the diversity of 27 sets of legislation relating to embryonic stem cell research, from the complete freedom of research to the prohibition of killing embryos for research purposes. If we do not support the amendments from the Committee on Legal Affairs, this regulation would de facto promote the development of products derived from embryonic stem cells, although this might be considered as ethically unacceptable by citizens and Member States.
As an elected representative of this House, I have the responsibility to listen to all opinions, to marry positions and to propose to our citizens a text which can be considered as modern, progressive and respecting universal principles and values such as human dignity. I welcome the tone of the recent Berlin Declaration regarding European values, as well as the programme of the President of the European Parliament, who stated that the question of human dignity is at the core of his and of our approach when voting on European legislation."@sl20
"Herr talman! Jag talar i dag som föredragande för förslaget till förordning om läkemedel för avancerad terapi. I egenskap av läkare vill jag också ta upp framstegen inom det medicinska området i och med att mycket specifika läkemedel släpps ut på marknaden i EU så att patienter med de sjukdomar som kommissionsledamoten räknade upp får behandling.
Jag vill passa på att tacka kommissionen för förslaget. Det är hög tid att patienter behandlas med läkemedel som är säkra, effektiva och inte bygger på kontroversiella grunder.
Sedan början av 2006 har Europaparlamentet arbetat hårt med detta förslag tillsammans med utskottet för miljö, folkhälsa och livsmedelssäkerhet, utskottet för industrifrågor, forskning och energi samt utskottet för rättsliga frågor. Det slutliga betänkandet antogs med stor majoritet. Den rådande uppfattningen inom parlamentet är att miljöutskottets betänkande, i den form som det lades fram för omröstning i kammaren, är utmärkt. Samtliga intressenter, företrädare för både bioteknikindustrin och patientgrupperna, välkomnade förslaget efter antagandet i januari förra året.
Förra veckan lade tre parlamentsledamöter, som talesmän för de politiska grupperna socialdemokraterna, liberalerna och GUE, fram ett antal ändringsförslag som presenterades som en så kallad kompromiss med rådet och kommissionen. Denna enskilda handling företogs utan föredragandens vetskap.
Låt mig betona att ingen överenskommelse nåddes med de andra två institutionerna när den informella trepartsdialogen avslutades förra månaden. Av dessa ändringsförslag har 90 procent tagit direkt från utskottets betänkande, och man har bara gjort några smärre ändringar. De viktigaste är de andra 10 procenten. Dessa ändringsförslag, som rör de mer känsliga politiska frågorna, är ett resultat av ett eget initiativ från tre av våra kolleger. Som de nämnde i sin skrivelse förra veckan har man ännu inte nått en interinstitutionell överenskommelse. Många av de ändringsförslag som lades fram i paketet stöds inte heller av det ansvariga utskottet, de andra två utskotten eller av föredraganden. Jag uppmanar därför mina kolleger att stödja miljöutskottets ansvarsfulla betänkande i onsdagens omröstning.
För att skynda på lagstiftningsförfarandet ägde den informella trepartsdialogen med rådet och kommissionen rum förra månaden. Vid de tre mötena framkom avvikelser. Innehållsmässigt har flera politiskt känsliga frågor inte lösts. Ur förfarandemässig synvinkel tog man upp frågan om de två ändringsförslag som lades fram av utskottet för rättsliga frågor. Dessa införlivades direkt i betänkandet vid förfarandet för förstärkt samarbete. Som huvudföredragande har jag försökt att betona att utskottets ansvarsområde ska respekteras. Trots arbetsordningens tydliga bestämmelser om förstärkt samarbete mellan parlamentsutskotten vägrade kollegerna från de två andra institutionerna och vissa skuggföredragande att behandla dessa ändringsförslag på grund av överenskommelsen vid första behandlingen. Det förstärkta samarbetet respekteras tydligen bara när det passar somliga kolleger. Det välkomnas för vissa förslag, exempelvis Reach, men inte när det gäller läkemedel för avancerad terapi. En del går ännu längre och missbrukar patientgruppernas röst genom att påstå att förfarandet för förstärkt samarbete är odemokratiskt.
Jag vill ta upp en punkt i förslaget som fortfarande oroar mig, nämligen subsidiaritetsprincipen. Kommissionens enhetliga förslag innehåller en möjlighet för medlemsstaterna att tillämpa striktare nationell lagstiftning när det gäller vissa omstridda läkemedel. I praktiken skulle detta betyda att vissa läkemedel inte skulle kunna släppas ut på marknaden i en del medlemsstater. Enligt rättstjänsten skulle denna bestämmelse leda till stora problem eftersom den är oförenlig med de rättsliga grunderna och skulle därför kunna upphävas av EG-domstolen. Om så är fallet skulle bestämmelsen bli en helt enhetlig åtgärd för samtliga läkemedel, även de som är förbjudna i vissa medlemsstater. I detta avseende skapar de två ändringsförslagen från utskottet för rättsliga frågor rättssäkerhet genom att läkemedel som innehåller eller härrör från embryonala stamceller inte tas med i förordningens tillämpningsområde.
Som föredragande måste jag respektera 27 helt olika lagstiftningar när det gäller forskning om embryonala stamceller, allt från total forskningsfrihet till förbud mot att döda embryon i forskningssyfte. Om vi inte stöder ändringsförslagen från utskottet för rättsliga frågor skulle förordningen i själva verket främja utvecklingen av läkemedel som härrör från embryonala stamceller, trots att somliga medborgare och medlemsstater anser att detta är etiskt oacceptabelt.
I egenskap av vald företrädare för parlamentet är jag skyldig att lyssna till alla åsikter, att sammanföra dem och att erbjuda medborgarna ett förslag som är modernt, progressivt och som respekterar universella principer och värderingar, till exempel den mänskliga värdigheten. Jag välkomnar tonfallet i Berlinförklaringen när det gäller europeiska värderingar, och även den programförklaring som har formulerats av Europaparlamentets talman, där han slår fast att den mänskliga värdigheten ska vara vägledande både för honom och för oss när vi röstar om EU-lagstiftningsförslag."@sv22
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