Local view for "http://purl.org/linkedpolitics/eu/plenary/2005-11-30-Speech-3-176"
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".
Mr President, let me start by thanking Mr Van Hecke, the rapporteur, for the hard work he has put into this dossier. I would also like to thank the shadow rapporteurs and the members of all the committees involved. They have also made a major contribution to the work of Parliament on this file.
Let me now turn to the overall scope of the regulation. The WTO decision provides for export of medicines to WTO members who are least-developed countries or who are developing countries with insufficient manufacturing capacity of their own. There is no specific restriction on the pharmaceutical products covered, although there is acknowledgement that they are required to address public health problems, since that is in the context of the decision. The Commission originally took the view that we should reflect faithfully the scope of the decision as regards the countries eligible to receive exported medicines. That position was based on our assessment of the WTO decision, which specifically covers WTO members as beneficiary countries. I am pleased to say that since then we have accepted humanitarian arguments that all least-developed countries and certain low-income developing countries should be eligible, regardless of whether they are currently WTO members. At the same time, to help ensure that the right medicines get to the right patients, non-WTO members are also expected to make similar commitments to those required from WTO members. This means they should notify what medicines are required and commit to preventing trade diversion if they are to receive products under the EU mechanism.
Another important issue is the question of remuneration for patent holders. I do not think there is any disagreement that patent holders should receive some remuneration for the licences granted without their authorisation. This is a normal principle of law. In the interests of a certain transparency for industry investing in the production of medicines, and as part of the overall compromise package, we could support the proposed formula for remuneration which still leaves some leeway for determination on a case-by-case basis.
Let me conclude at this point by reiterating that the Commission remains very much in favour of the early adoption of this regulation, while respecting the overall objective of introducing a workable, transparent system which companies are able to use for the export of medicines to countries in need. I would call on Parliament to support the compromise package which is on the table.
The proposal from the Commission aims to implement at EU level the WTO General Council Decision of 30 August 2003, allowing copies of patented medicines to be produced for export to countries in need. This decision represents a waiver from the normal rules of patent law, particularly those set out in the WTO TRIPs Agreement. It has to be seen within the wider context of existing national and international frameworks for patent protection.
The discussions in the WTO leading up to the decision of 30 August were long and complex. The decision itself represents a delicate balance between the need to ensure access now to medicines for countries with public health problems, and the need to encourage development in the future of new medicines, through investment in research and innovation protected under the patent system. We have sought to reflect that balance in the Commission’s proposal.
As many of you will know, the decision itself is a temporary measure. It will remain in force until a permanent amendment is made to the TRIPs Agreement. The negotiations on such an amendment have not yet been successful, despite several deadlines having passed. The compulsory licensing issue thus remains on the agenda of the WTO. However, that is no reason for us to delay: bringing our regulation into force as early as possible will allow countries in need and EU producers of pharmaceuticals to use the mechanism we are putting in place. Indeed, all three institutions, Parliament, the Council and the Commission, have supported the principle of early agreement on the regulation, and intensive informal discussions have been taking place with that in mind. While these discussions have not always been easy, they took place in a spirit of good cooperation, and I must congratulate Mr Van Hecke again on the results which show how well the institutions can work together.
I am very pleased that these discussions have resulted in a compromise package. I should say now that the Commission could support such a package of amendments if it is voted through in its entirety and without any additions or subtractions.
What is the Commission’s proposal aiming to do? It sets out a mechanism in line with the WTO decision so that companies in the EU can apply for a licence to manufacture, without the authorisation of the patent holder, pharmaceutical products for export to countries in need of medicines and facing public health concerns. We have tried to produce an instrument that will allow the compulsory licensing procedure of the WTO decision to fit within the context of Member States’ existing national patent law and the compulsory licensing procedures they already have under that law.
An instrument at EU level implementing the WTO decision has great symbolic value as an external demonstration of the EU’s commitment to the decision. At the same time, we have to respect the principles of subsidiarity and proportionality, and so avoid regulating specific details which can better be dealt with under national law or by the competent authority which is processing the licensing application.
Parliament’s work has resulted in some helpful clarification, particularly as regards an explanation of the involvement of non-governmental and international organisations. We have always envisaged such organisations as being potentially involved in any purchasing procedures, and able to make requests on behalf of an importing country with that country’s approval. Of course it is unlikely that such organisations will themselves be manufacturing pharmaceuticals, but if they were they could simply apply for a licence under the regulation like any other manufacturer.
Another useful clarification has been improvement of the text relating to the possibility of using the EU’s scientific opinion procedure, or equivalent national procedures, to certify the safety and efficacy of medicines for export. This is not something regulated in the WTO decision, indeed it lies outside that framework. But in order to assist importing countries we felt it was a necessary complement to the licensing mechanism."@en4
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"Mr President, let me start by thanking Mr Van Hecke, the rapporteur, for the hard work he has put into this dossier. I would also like to thank the shadow rapporteurs and the members of all the committees involved. They have also made a major contribution to the work of Parliament on this file.
Let me now turn to the overall scope of the regulation. The WTO decision provides for export of medicines to WTO members who are least-developed countries or who are developing countries with insufficient manufacturing capacity of their own. There is no specific restriction on the pharmaceutical products covered, although there is acknowledgement that they are required to address public health problems, since that is in the context of the decision. The Commission originally took the view that we should reflect faithfully the scope of the decision as regards the countries eligible to receive exported medicines. That position was based on our assessment of the WTO decision, which specifically covers WTO members as beneficiary countries. I am pleased to say that since then we have accepted humanitarian arguments that all least-developed countries and certain low-income developing countries should be eligible, regardless of whether they are currently WTO members. At the same time, to help ensure that the right medicines get to the right patients, non-WTO members are also expected to make similar commitments to those required from WTO members. This means they should notify what medicines are required and commit to preventing trade diversion if they are to receive products under the EU mechanism.
Another important issue is the question of remuneration for patent holders. I do not think there is any disagreement that patent holders should receive some remuneration for the licences granted without their authorisation. This is a normal principle of law. In the interests of a certain transparency for industry investing in the production of medicines, and as part of the overall compromise package, we could support the proposed formula for remuneration which still leaves some leeway for determination on a case-by-case basis.
Let me conclude at this point by reiterating that the Commission remains very much in favour of the early adoption of this regulation, while respecting the overall objective of introducing a workable, transparent system which companies are able to use for the export of medicines to countries in need. I would call on Parliament to support the compromise package which is on the table.
The proposal from the Commission aims to implement at EU level the WTO General Council Decision of 30 August 2003, allowing copies of patented medicines to be produced for export to countries in need. This decision represents a waiver from the normal rules of patent law, particularly those set out in the WTO TRIPs Agreement. It has to be seen within the wider context of existing national and international frameworks for patent protection.
The discussions in the WTO leading up to the decision of 30 August were long and complex. The decision itself represents a delicate balance between the need to ensure access now to medicines for countries with public health problems, and the need to encourage development in the future of new medicines, through investment in research and innovation protected under the patent system. We have sought to reflect that balance in the Commission’s proposal.
As many of you will know, the decision itself is a temporary measure. It will remain in force until a permanent amendment is made to the TRIPs Agreement. The negotiations on such an amendment have not yet been successful, despite several deadlines having passed. The compulsory licensing issue thus remains on the agenda of the WTO. However, that is no reason for us to delay: bringing our regulation into force as early as possible will allow countries in need and EU producers of pharmaceuticals to use the mechanism we are putting in place. Indeed, all three institutions, Parliament, the Council and the Commission, have supported the principle of early agreement on the regulation, and intensive informal discussions have been taking place with that in mind. While these discussions have not always been easy, they took place in a spirit of good cooperation, and I must congratulate Mr Van Hecke again on the results which show how well the institutions can work together.
I am very pleased that these discussions have resulted in a compromise package. I should say now that the Commission could support such a package of amendments if it is voted through in its entirety and without any additions or subtractions.
What is the Commission’s proposal aiming to do? It sets out a mechanism in line with the WTO decision so that companies in the EU can apply for a licence to manufacture, without the authorisation of the patent holder, pharmaceutical products for export to countries in need of medicines and facing public health concerns. We have tried to produce an instrument that will allow the compulsory licensing procedure of the WTO decision to fit within the context of Member States’ existing national patent law and the compulsory licensing procedures they already have under that law.
An instrument at EU level implementing the WTO decision has great symbolic value as an external demonstration of the EU’s commitment to the decision. At the same time, we have to respect the principles of subsidiarity and proportionality, and so avoid regulating specific details which can better be dealt with under national law or by the competent authority which is processing the licensing application.
Parliament’s work has resulted in some helpful clarification, particularly as regards an explanation of the involvement of non-governmental and international organisations. We have always envisaged such organisations as being potentially involved in any purchasing procedures, and able to make requests on behalf of an importing country with that country’s approval. Of course it is unlikely that such organisations will themselves be manufacturing pharmaceuticals, but if they were they could simply apply for a licence under the regulation like any other manufacturer.
Another useful clarification has been improvement of the text relating to the possibility of using the EU’s scientific opinion procedure, or equivalent national procedures, to certify the safety and efficacy of medicines for export. This is not something regulated in the WTO decision, indeed it lies outside that framework. But in order to assist importing countries we felt it was a necessary complement to the licensing mechanism."@cs1
"Hr. formand, først vil jeg gerne takke ordføreren hr. Van Hecke for hans store arbejdsindsats med dette dokument. Jeg vil også takke skyggeordførerne og medlemmerne af de involverede udvalg. De har også ydet et stort bidrag til Parlamentets arbejde med betænkningen.
Nu vil jeg gå videre med forordningens overordnede anvendelsesområde. WTO-afgørelsen indeholder bestemmelser om eksport af lægemidler til de mindst udviklede WTO-medlemmer med utilstrækkelig intern produktionskapacitet. Der er ingen særlige begrænsninger for de omfattede lægemidler, selv om de skal tage sigte på folkesundhedsproblemer, da det ligger inden for afgørelsens rammer. Kommissionen havde oprindeligt den holdning, at vi trofast skulle afspejle afgørelsens anvendelsesområde med hensyn til de lande, der skal kunne modtage eksporterede lægemidler. Den holdning byggede på vores vurdering af WTO-afgørelsen, der specielt dækker WTO-medlemmer som berettigede lande. Jeg er glad for at kunne sige, at vi efterfølgende har accepteret humanitære argumenter om, at alle de mindst udviklede lande samt visse lavindkomstudviklingslande skal være berettigede, uanset om de er WTO-medlemmer eller ej. Samtidig forventes ikke-WTO-medlemmer at påtage sig lignende forpligtelser som WTO-medlemmerne for at sikre, at de rette lægemidler når frem til de rette patienter. Det betyder, at de skal meddele, hvilke lægemidler der er behov for, og forpligte sig til at hindre omdirigering af handel, hvis de modtager produkter under EU-mekanismen.
En anden vigtig sag er spørgsmålet om godtgørelse til patenthavere. Der er vist bred enighed om, at patenthaverne skal modtage en vis godtgørelse for de licenser, der udstedes uden deres tilladelse. Det er et normalt retsprincip. Af hensyn til en vis gennemsigtighed for den industri, der investerer i lægemiddelproduktion, og som en del af den overordnede kompromispakke, kan vi ikke støtte den foreslåede godtgørelsesformulering, der fortsat giver nogen plads til afgørelser fra sag til sag.
Jeg vil slutte her med at gentage, at Kommissionen i høj grad støtter en snarlig vedtagelse af denne forordning, samtidig med at den respekterer den overordnede målsætning om at indføre et bæredygtigt og gennemsigtigt system, som virksomhederne kan bruge til eksport af lægemidler til lande med behov herfor. Jeg vil opfordre Parlamentet til at støtte den aktuelle kompromispakke.
Forslaget fra Kommissionen har til formål på EU-plan at gennemføre den afgørelse, som WTO's Almindelige Råd traf den 30. august 2003, om, at det skal være lovligt at fremstille kopier af patenterede lægemidler til eksport til lande, der har behov derfor. Denne afgørelse er en undtagelse fra den normale patentlovgivning og i særdeleshed fra WTO's TRIPs-aftale. Den skal ses i en bredere sammenhæng mellem eksisterende nationale og internationale rammer for patentbeskyttelse.
Der var lange og komplekse diskussioner i WTO forud for afgørelsen den 30. august. Selve afgørelsen er en vanskelig balance mellem behovet for at sikre øjeblikkelig adgang til lægemidler for lande med folkesundhedsproblemer og behovet for at fremme den fremtidige udvikling af nye lægemidler gennem investeringer i forskning og innovation og under patentsystemets beskyttelse. Vi har forsøgt at afspejle denne balance i Kommissionens forslag.
Som mange af Dem vil vide, er selve afgørelsen en midlertidig foranstaltning, der er gældende, indtil der gennemføres en permanent ændring af TRIPs-aftalen. Forhandlingerne om en sådan ændring har endnu ikke været vellykkede, selv om flere tidsfrister er overskredet. Tvangslicensspørgsmålet er således stadig på WTO's dagsorden. Det er imidlertid ingen grund til, at vi udskyder en afgørelse. En snarlig ikrafttrædelse af forordningen vil give de lande, der har behov derfor, samt EU's lægemiddelproducenter mulighed for at udnytte de nye mekanismer. Både Parlamentet, Rådet og Kommissionen har støttet princippet om en hurtig aftale om forordningen, og der er gennemført omfattende uformelle diskussioner med dette formål for øje. Disse diskussioner har ikke altid været lette, men de fandt sted i en god samarbejdsånd, og jeg må atter lykønske hr. Van Hecke med resultaterne, der viser, hvor godt institutionerne kan samarbejde.
Jeg er meget tilfreds med, at diskussionerne har resulteret i en kompromispakke. Jeg vil sige, at Kommissionen kan støtte en sådan pakke af ændringsforslag, hvis der stemmes om den som helhed og uden tilføjelser eller fradrag.
Hvad er formålet med Kommissionens forslag? Det opstiller en mekanisme i overensstemmelse med WTO's afgørelse, så virksomheder i EU kan søge om en licens til uden patenthaverens tilladelse at fremstille lægemidler med henblik på eksport til lande, der har behov derfor, og som har folkesundhedsproblemer. Vi har forsøgt at udarbejde et instrument, der vil gøre det muligt at tilpasse tvangslicensproceduren fra WTO's afgørelse til medlemsstaternes eksisterende nationale patentlovgivning og de tvangslicensprocedurer, de allerede har i henhold til denne lov.
Et instrument på EU-plan, der gennemfører WTO-afgørelsen, har stor symbolværdi med hensyn til at vise omverdenen, at EU forpligter sig til afgørelsen. Samtidig skal vi respektere nærhedsprincippet og proportionalitetsprincippet og dermed undgå at lovgive om specifikke detaljer, der bedre reguleres af national lovgivning eller af den kompetente myndighed, der behandler licensansøgningen.
Parlamentets arbejde har resulteret i en nyttig afklaring, specielt i form af en forklaring på de ikke-statslige og internationale organisationers inddragelse. Vi har altid betragtet sådanne organisationer som værende potentielt involverede i købsprocedurer og i stand til at komme med forespørgsler på vegne af et importland med det pågældende lands godkendelse. Det er selvfølgelig usandsynligt, at sådanne organisationer selv fremstiller lægemidler, men skulle det være tilfældet, kunne de blot søge om en licens under forordningen på samme måde som enhver anden producent.
En anden nyttig afklaring har været forbedringen af teksten vedrørende muligheden for at bruge EU's procedure for videnskabelig udtalelse eller tilsvarende nationale procedurer til at dokumentere sikkerheden og effekten af lægemidler til eksport. Det er ikke noget, der reguleres i WTO's afgørelse, og det ligger uden for dens rammer. Men vi følte, at det var et nødvendigt supplement til licensmekanismen for at hjælpe importlandene."@da2
"Herr Präsident! Eingangs möchte ich dem Berichterstatter, Herrn Van Hecke, für die hervorragende Arbeit danken, die er zu dieser Thematik geleistet hat. Mein Dank gilt ferner den Schattenberichterstattern sowie den Mitgliedern aller beteiligten Ausschüsse. Auch sie haben einen wesentlichen Beitrag zur Arbeit des Parlaments für eine solche Verordnung geleistet.
Ich möchte mich nun dem Geltungsbereich der Verordnung insgesamt zuwenden. Der WTO-Beschluss sieht die Ausfuhr von Arzneimitteln in WTO-Mitgliedsländer vor, die zu den am wenigsten entwickelten Ländern gehören bzw. bei denen es sich um Entwicklungsländer handelt, die nicht über ausreichende eigene Produktionskapazitäten verfügen. Er enthält zwar keine speziellen Beschränkungen hinsichtlich der Arzneimittel, doch ist im Beschluss festgelegt, dass sie zur Bewältigung von Problemen der öffentlichen Gesundheit benötigt werden müssen. Ursprünglich war die Kommission der Meinung, dass wir uns hinsichtlich der Länder, die auf ausgeführte Arzneimittel Anspruch haben, genauestens an den Beschluss halten sollten. Dieser Standpunkt beruhte darauf, dass sich der WTO-Beschluss ausdrücklich auf WTO-Mitglieder als begünstigte Länder bezieht. Ich freue mich, Ihnen mitteilen zu können, dass wir humanitäre Argumente dahingehend akzeptiert haben, dass alle am wenigsten entwickelten Länder und bestimmte Entwicklungsländer mit niedrigem Einkommen unabhängig davon begünstigt sein sollten, ob sie gegenwärtig WTO-Mitglieder sind oder nicht. Um sicherzustellen, dass die richtigen Arzneimittel auch zu den richtigen Patienten gelangen, wird gleichzeitig von Nicht-WTO-Mitgliedern erwartet, dass sie ähnliche Verpflichtungen eingehen wie die WTO-Mitglieder. Das bedeutet, sie müssen mitteilen, welche Arzneimittel benötigt werden, und sich verpflichten, Handelsumlenkungen zu vermeiden, wenn sie Arzneimittel im Rahmen des EU-Systems erhalten möchten.
Eine weitere wichtige Frage betrifft die Entschädigung von Patentinhabern. Ich glaube, es besteht Übereinstimmung, dass Rechteinhaber eine angemessene Entschädigung für Lizenzen erhalten sollten, die ohne ihre Genehmigung erteilt wurden. Das ist ein normaler Rechtsgrundsatz. Im Interesse einer gewissen Transparenz für die Branche, die in die Herstellung von Arzneimitteln investiert, sowie im Kontext des Kompromisspakets können wir die vorgeschlagene Lösung für eine Entschädigung unterstützen, die immer noch einen gewissen Spielraum für die fallweise Berechnung bietet.
Lassen Sie mich abschließend erklären, dass sich die Kommission auch weiterhin für die baldige Annahme dieser Verordnung ausspricht, dabei jedoch auch im Auge hat, dass ein machbares, transparentes System eingeführt wird, das Unternehmen für die Ausfuhr von Arzneimitteln in bedürftige Länder nutzen können. Ich möchte das Parlament auffordern, das auf dem Tisch liegende Kompromisspaket zu unterstützen.
Ziel des Vorschlags der Kommission ist es, auf EU-Ebene den Beschluss des WTO-Generalrats vom 30. August 2003 umzusetzen, der die Herstellung von Generika patentgeschützter Arzneimittel und deren Ausfuhr in bedürftige Länder gestattet. Mit diesem Beschluss werden die üblichen Bestimmungen des Patentrechts, vornehmlich die des TRIPS-Übereinkommens, ausgesetzt. Er ist im größeren Zusammenhang bestehender nationaler und internationaler Rechtsvorschriften zum Patentschutz zu sehen.
Dem Beschluss vom 30. August gingen langwierige und schwierige Gespräche in der WTO voraus. Der Beschluss selbst stellt ein sorgfältig ausgehandeltes Gleichgewicht zwischen der Notwendigkeit, Ländern, die Probleme mit der öffentlichen Gesundheit haben, jetzt den Zugang zu Arzneimitteln zu ermöglichen, und der Notwendigkeit her, die Entwicklung neuer Arzneimittel in Zukunft zu ermöglichen, indem in Forschung und durch das Patentsystem geschützte Innovationen investiert wird. Wir haben versucht, dieser Ausgewogenheit im Vorschlag der Kommission Geltung zu verschaffen.
Wie vielen von Ihnen bekannt sein dürfte, ist der Beschluss selbst eine zeitlich befristete Maßnahme. Er behält bis zu endgültigen Abänderung des TRIPS-Übereinkommens seine Gültigkeit. Die Verhandlungen über eine solche Änderung konnten noch nicht erfolgreich abgeschlossen werden, obwohl bereits mehrere Fristen verstrichen sind. Daher bleibt auch die Frage der Zwangslizenzen weiterhin auf der Tagesordnung der WTO. Für uns ist das jedoch kein Grund, die Dinge weiter hinauszuschieben: Das baldmöglichste Inkrafttreten unserer Verordnung versetzt die bedürftigen Länder und die EU-Hersteller von Arzneimitteln in die Lage, den von uns eingerichteten Mechanismus anzuwenden. Unsere drei Organe – Parlament, Rat und Kommission – unterstützen prinzipiell eine frühzeitige Einigung über die Verordnung, und dazu finden intensive informelle Gespräche statt. Obgleich diese Diskussionen nicht immer einfach waren, wurden sie im Geist guter Zusammenarbeit geführt, und ich muss Herrn Van Hecke nochmals zu den erreichten Ergebnissen gratulieren, die zeigen, wie gut die Institutionen zusammenarbeiten können.
Ich freue mich, dass diese Gespräche zu einem Kompromisspaket geführt haben. Dazu möchte ich anmerken, dass die Kommission ein solches Paket von Änderungsvorschlägen unterstützen könnte, wenn darüber in seiner Gesamtheit abgestimmt wird, ohne dass etwas hinzukommt oder wegfällt.
Worauf zielt der Kommissionsvorschlag ab? Es soll ein Mechanismus in Übereinstimmung mit dem WTO-Beschluss eingerichtet werden, der es Unternehmen in der EU ermöglicht, ohne Genehmigung des Patentinhabers eine Lizenz für die Herstellung von Arzneimitteln zu beantragen, die für die Ausfuhr in Länder bestimmt sind, die Arzneimittel benötigen und Probleme im Bereich der öffentlichen Gesundheit haben. Wir haben versucht, ein Instrument zu entwickeln, durch das es möglich wird, das im WTO-Beschluss genannte Zwangslizenzverfahren mit dem in den Mitgliedstaaten bestehenden Patentrecht sowie den im Rahmen dieses Rechts bereits existierenden Zwangslizenzverfahren in Einklang zu bringen.
Ein Instrument auf EU-Ebene, mit dem der WTO-Beschluss umgesetzt wird, hat einen großen symbolischen Wert, da es nach außen hin das Engagement der EU für diesen Beschluss unter Beweis stellt. Gleichzeitig gilt es, die Grundsätze der Subsidiarität und der Verhältnismäßigkeit zu achten und damit zu vermeiden, dass bestimmte Details reguliert werden, die besser durch das einzelstaatliche Recht oder durch die zuständige Behörde, die sich mit dem Lizenzantrag befasst, geregelt werden können.
Die Arbeit des Parlaments hat zur Klarstellung des Sachverhalts beigetragen, insbesondere in Bezug auf die Mitwirkung von Nichtregierungs- und internationalen Organisationen. Wir sind immer davon ausgegangen, dass solche Organisationen möglicherweise in den Kauf einbezogen werden und im Auftrag und mit Zustimmung des einführenden Landes Anträge stellen können. Natürlich ist es unwahrscheinlich, dass solche Organisationen selbst Arzneimittel herstellen, doch wenn dies der Fall wäre, müssten sie entsprechend der Verordnung wie jeder andere Hersteller auch einfach nur eine Lizenz beantragen.
Eine weitere nützliche Klarstellung war die Verbesserung des Textes zur Möglichkeit der Anwendung des wissenschaftlichen Begutachtungsverfahrens der EU bzw. entsprechender nationaler Verfahren, um die Sicherheit und Wirksamkeit der für die Ausfuhr bestimmten Arzneimittel zu bescheinigen. Eine solche Regelung ist im WTO-Beschluss nicht vorgesehen, ja liegt sogar außerhalb seiner Bestimmungen. Um jedoch die einführenden Länder zu unterstützen, haben wir das als notwendige Ergänzung der Lizenzierung angesehen."@de9
"Κύριε Πρόεδρε, επιτρέψτε μου να αρχίσω ευχαριστώντας τον κ. Van Hecke, τον εισηγητή, για τη σκληρή δουλειά που κατέβαλε για αυτόν τον φάκελο. Θα ήθελα επίσης να ευχαριστήσω τους σκιώδεις εισηγητές και τους βουλευτές όλων των αρμοδίων επιτροπών που συνέβαλαν και αυτοί σημαντικά στο έργο του Κοινοβουλίου για αυτόν τον φάκελο.
Επιτρέψτε μου τώρα να επανέλθω στο συνολικό πεδίο εφαρμογής του κανονισμού. Η απόφαση του ΠΟΕ προβλέπει την εξαγωγή φαρμάκων στα μέλη του ΠΟΕ που είναι λιγότερο ανεπτυγμένες χώρες ή αναπτυσσόμενες χώρες με ανεπαρκή ίδια παρασκευαστική ικανότητα. Δεν υπάρχει ειδικός περιορισμός για τα φαρμακευτικά προϊόντα που καλύπτονται, αν και αναγνωρίζεται ότι πρέπει να χρησιμεύουν για την αντιμετώπιση προβλημάτων δημόσιας υγείας, εφόσον αυτό εμπίπτει στο πλαίσιο της απόφασης. Η Επιτροπή αρχικά ήταν της γνώμης ότι θα έπρεπε να αντικατοπτρίζεται επακριβώς το πεδίο εφαρμογής της απόφασης όσον αφορά τις χώρες που είναι επιλέξιμες να λάβουν εξαγόμενα φάρμακα. Αυτή η θέση στηρίχθηκε στην αξιολόγησή μας για την απόφαση του ΠΟΕ, η οποία καλύπτει ειδικά τα μέλη του ΠΟΕ ως δικαιούχους χώρες. Με χαρά αναφέρω ότι έκτοτε, δεχτήκαμε τα ανθρωπιστικά επιχειρήματα ότι όλες οι λιγότερο ανεπτυγμένες χώρες και ορισμένες αναπτυσσόμενες χώρες χαμηλού εισοδήματος πρέπει να είναι επιλέξιμες, ανεξαρτήτως του κατά πόσον είναι σήμερα μέλη του ΠΟΕ. Συγχρόνως, προκειμένου να βοηθήσουμε να διασφαλιστεί ότι τα σωστά φάρμακα πηγαίνουν στους σωστούς ασθενείς, οι χώρες μη μέλη του ΠΟΕ θα πρέπει επίσης να αναλάβουν δεσμεύσεις ανάλογες με αυτές που απαιτούνται από τα μέλη του ΠΟΕ. Αυτό σημαίνει ότι πρέπει να γνωστοποιούν ποια φάρμακα απαιτούνται και να δεσμεύονται για την πρόληψη εκτροπής του εμπορίου, εάν πρόκειται να λάβουν προϊόντα στο πλαίσιο του μηχανισμού της ΕΕ.
Άλλο ένα σημαντικό θέμα είναι το ζήτημα της αποζημίωσης των κατόχων διπλωμάτων ευρεσιτεχνίας. Πιστεύω ότι υπάρχει απόλυτη συμφωνία ότι οι κάτοχοι διπλωμάτων ευρεσιτεχνίας πρέπει να λαμβάνουν αποζημίωση για τις άδειες που χορηγούνται χωρίς την έγκρισή τους. Αυτή είναι συνήθης αρχής του δικαίου. Προκειμένου να επιτευχθεί ένας ορισμένος βαθμός διαφάνειας για τη βιομηχανία που επενδύει στην παραγωγή φαρμάκων, και στο πλαίσιο του συνολικού συμβιβαστικού πακέτου, θα μπορούσαμε να υποστηρίξουμε τον προταθέντα τύπο αποζημίωσης που αφήνει ακόμη κάποιο περιθώριο για καθορισμό ανά περίπτωση.
Επιτρέψτε μου να κλείσω σε αυτό το σημείο επαναλαμβάνοντας ότι η Επιτροπή εξακολουθεί να υποστηρίζει την έγκαιρη έγκριση αυτού του κανονισμού, σεβόμενη ταυτόχρονα τον συνολικό στόχο εισαγωγής ενός υλοποιήσιμου, διαφανούς συστήματος το οποίο οι εταιρείες δύνανται να χρησιμοποιούν για την εξαγωγή φαρμάκων σε χώρες που τα χρειάζονται. Παρακαλώ το Κοινοβούλιο να υποστηρίξει το συμβιβαστικό πακέτο που βρίσκεται ενώπιόν μας.
Η πρόταση της Επιτροπής στοχεύει στην εφαρμογή σε επίπεδο ΕΕ της απόφασης του Γενικού Συμβουλίου του ΠΟΕ της 30ής Αυγούστου 2003, η οποία επιτρέπει την παραγωγή αντιγράφων φαρμάκων κατοχυρωμένων με διπλώματα ευρεσιτεχνίας προκειμένου να εξαχθούν στις χώρες που τα χρειάζονται. Αυτή η απόφαση αποτελεί παρέκκλιση από τους συνήθεις κανόνες της νομοθεσίας για τα διπλώματα ευρεσιτεχνίας, ειδικά αυτούς που προβλέπονται στη συμφωνία TRIPs του ΠΟΕ. Πρέπει να εξεταστεί στο ευρύτερο πλαίσιο των υφιστάμενων εθνικών και διεθνών πλαισίων για την προστασία των διπλωμάτων ευρεσιτεχνίας.
Οι συζητήσεις στον ΠΟΕ που οδήγησαν στην απόφαση της 30ής Αυγούστου ήταν μακρές και περίπλοκες. Η απόφαση αυτή καθεαυτή δείχνει μία ευαίσθητη ισορροπία μεταξύ της ανάγκης να διασφαλιστεί τώρα η πρόσβαση στα φάρμακα για τις χώρες με προβλήματα δημόσιας υγείας, και την ανάγκη να ενθαρρυνθεί η ανάπτυξη στο μέλλον νέων φαρμάκων, μέσω της επένδυσης στην έρευνα και την καινοτομία υπό την προστασία του συστήματος διπλωμάτων ευρεσιτεχνίας. Επιδιώξαμε να εκφράσουμε αυτήν την ισορροπία στην πρόταση της Επιτροπής.
Όπως θα γνωρίζετε πολλοί από εσάς, η ίδια η απόφαση είναι προσωρινό μέτρο. Θα παραμείνει σε ισχύ μέχρι να γίνει μία μόνιμη τροποποίηση της συμφωνίας TRIPs. Οι διαπραγματεύσεις για μία τέτοια τροποποίηση δεν ήταν έως τώρα επιτυχείς, παρότι έχουν περάσει αρκετές προθεσμίες. Το θέμα της χορήγησης υποχρεωτικών αδειών παραμένει συνεπώς στην ημερήσια διάταξη του ΠΟΕ. Ωστόσο, αυτό δεν αποτελεί λόγο να καθυστερήσουμε: θέτοντας τον κανονισμό μας σε ισχύ όσο το δυνατόν νωρίτερα θα επιτρέψουμε στις χώρες που τα χρειάζονται και στους παραγωγούς φαρμακευτικών προϊόντων της ΕΕ να χρησιμοποιήσουν τον μηχανισμό που θέτουμε σε εφαρμογή. Πράγματι, και τα τρία θεσμικά όργανα, το Κοινοβούλιο, το Συμβούλιο, και η Επιτροπή, έχουν υποστηρίξει την αρχή της έγκαιρης συμφωνίας για τον κανονισμό, και εντατικές άτυπες συζητήσεις έχουν διεξαχθεί έχοντας αυτό κατά νου. Ενώ αυτές οι συζητήσεις δεν ήταν ανέκαθεν εύκολες, διεξήχθησαν σε πνεύμα καλής συνεργασίας, και πρέπει να συγχαρώ πάλι τον κ. Van Hecke για τα αποτελέσματα τα οποία δείχνουν πόσο καλά μπορούν να συνεργαστούν τα θεσμικά όργανα.
Χαίρομαι πολύ που αυτές οι συζητήσεις είχαν ως αποτέλεσμα ένα συμβιβαστικό πακέτο. Πρέπει να πω τώρα ότι η Επιτροπή θα μπορούσε να υποστηρίξει ένα τέτοιο πακέτο τροπολογιών εάν ψηφιστεί στο σύνολό του και χωρίς προσθέσεις ή αφαιρέσεις.
Ποιος είναι ο στόχος της πρότασης της Επιτροπής; Προβλέπει έναν μηχανισμό ευθυγραμμισμένο με την απόφαση του ΠΟΕ ούτως ώστε οι εταιρείες στην ΕΕ να μπορούν να υποβάλλουν αίτηση να παρασκευάσουν, χωρίς την έγκριση του κατόχου του διπλώματος ευρεσιτεχνίας, φαρμακευτικά προϊόντα για εξαγωγή σε χώρες που χρειάζονται φάρμακα και αντιμετωπίζουν προβλήματα δημόσιας υγείας. Προσπαθήσαμε να εκπονήσουμε ένα μέσο που θα επιτρέπει την προσαρμογή της διαδικασίας χορήγησης υποχρεωτικών αδειών της απόφασης του ΠΟΕ στο πλαίσιο της ισχύουσας εθνικής νομοθεσίας των κρατών μελών για τα διπλώματα ευρεσιτεχνίας και τις διαδικασίες χορήγησης υποχρεωτικών αδειών που προβλέπει ήδη η εν λόγω νομοθεσία.
Ένα μέσο σε επίπεδο ΕΕ για την εφαρμογή της απόφασης του ΠΟΕ έχει μεγάλη συμβολική αξία ως εξωτερική απόδειξη της δέσμευσης της ΕΕ σε αυτήν την απόφαση. Συγχρόνως, πρέπει να σεβαστούμε τις αρχές της επικουρικότητας και της αναλογικότητας, και να αποφύγουμε κατ’ αυτόν τον τρόπο τις ειδικές ρυθμιστικές λεπτομέρειες που μπορούν να αντιμετωπιστούν καλύτερα στο πλαίσιο της εθνικής νομοθεσίας ή από την αρμόδια αρχή η οποία επεξεργάζεται τις αιτήσεις χορήγησης άδειας.
Οι εργασίες του Κοινοβουλίου είχαν ως αποτέλεσμα ορισμένες χρήσιμες διευκρινίσεις, ειδικά όσον αφορά την εξήγηση της συμμετοχής μη κυβερνητικών και διεθνών οργανισμών. Ανέκαθεν, εξετάζαμε το ενδεχόμενο συμμετοχής των εν λόγω οργανισμών σε οιεσδήποτε αγοραστικές διαδικασίες, και της δυνατότητας υποβολής αιτημάτων εξ ονόματος μίας χώρας εισαγωγέα με την έγκριση αυτής της χώρας. Φυσικά είναι απίθανο ότι οι εν λόγω οργανώσεις θα παρασκευάσουν φαρμακευτικά προϊόντα οι ίδιες, αλλά εάν το κάνουν, θα μπορούν απλώς να υποβάλουν αίτηση χορήγησης άδειας σύμφωνα με τον κανονισμό όπως όλοι οι άλλοι παρασκευαστές.
Μία ακόμη χρήσιμη διευκρίνιση ήταν η βελτίωση του κειμένου που συνδέεται με τη δυνατότητα χρησιμοποίησης της διαδικασίας επιστημονικής γνωμοδότησης της ΕΕ, ή ισοδύναμων εθνικών διαδικασιών, για την πιστοποίηση της ασφάλειας και της αποτελεσματικότητας των προς εξαγωγή φαρμάκων. Αυτό είναι κάτι το οποίο δεν ρυθμίζεται στην απόφαση του ΠΟΕ, στην πραγματικότητα δεν εμπίπτει σε αυτό το πλαίσιο. Όμως, προκειμένου να ενισχυθούν οι χώρες εισαγωγείς, θεωρήσαμε ότι ήταν ένα απαραίτητο συμπλήρωμα του μηχανισμού χορήγησης αδειών."@el10
"Señor Presidente, permítame comenzar dando las gracias al ponente, el señor Van Hecke, por el gran esfuerzo que ha dedicado a este informe. También quiero dar las gracias a los ponentes alternativos y a los miembros de todas las comisiones implicadas, porque han hecho una importante contribución al trabajo del Parlamento sobre este informe.
Permítanme abordar ahora el ámbito de aplicación del Reglamento. La decisión de la OMC contempla la exportación de medicamentos a países menos adelantados o en desarrollo que sean miembros de la OMC y no tengan suficiente capacidad de producción propia. No hay restricción específica con respecto a los productos farmacéuticos, si bien se reconoce que tienen que tratar problemas de salud pública, porque ese es el contexto de la decisión. En un principio, la Comisión pensó que deberíamos reflejar fielmente el ámbito de aplicación de la decisión respecto de los países que pueden optar a la obtención de medicamentos exportados. Esa opinión estaba basada en nuestra evaluación de la decisión de la OMC, que incluye específicamente a los miembros de la OMC como países beneficiarios. Me complace decir que desde entonces hemos aceptado las razones humanitarias de que todos los países menos desarrollados y ciertos países en desarrollo de renta baja deberían poder acogerse a este mecanismo, independientemente de si son miembros o no de la OMC. Al mismo tiempo, para garantizar que los medicamentos adecuados lleguen a los pacientes que los necesitan, los países que no sean miembros de la OMC también deberán contraer compromisos similares a los que se exigen a los miembros de la OMC. Esto significa que tienen que notificar los medicamentos que necesitan y comprometerse a prevenir el comercio ilegal si quieren recibir productos al amparo del mecanismo de la UE.
Otra cuestión importante es la remuneración de los titulares de las patentes. Creo que todos estamos de acuerdo en que los titulares de las patentes tienen que recibir algún tipo de remuneración por las licencias que se otorgan sin su autorización. Es un principio jurídico normal. En interés de cierta transparencia para la industria que invierte en la producción de medicamentos, y en el marco del paquete de compromiso general, podríamos apoyar la fórmula propuesta de una remuneración que deje cierto margen para evaluar caso por caso.
Permítanme concluir reiterando que la Comisión está totalmente a favor de una pronta aprobación de este Reglamento, que respete el objetivo general de introducción de un sistema viable y transparente que las empresas puedan usar para la exportación de medicamentos a los países necesitados. Pido al Parlamento que apoye el paquete de compromiso que está sobre la mesa.
La propuesta de la Comisión está encaminada a aplicar en el ámbito de la UE la Decisión del Consejo General de la OMC de 30 de agosto de 2003, que permite producir copias de medicamentos patentados para exportarlos a los países necesitados. Esta decisión representa una derogación de las cláusulas normales de la legislación de patentes, en particular las establecidas en el Acuerdo sobre los ADPIC de la OMC. Tiene que verse en el contexto más amplio de los marcos nacionales e internacionales vigentes de protección de la propiedad industrial.
Los debates en la OMC que condujeron a la decisión del 30 de agosto fueron largos y complejos. La decisión representa un delicado equilibrio entre la necesidad de garantizar el acceso a los medicamentos para los países con problemas de salud pública, y la necesidad de fomentar el desarrollo de nuevos medicamentos en el futuro, a través de la inversión en investigación e innovación protegida por el sistema de patentes. La propuesta de la Comisión intenta reflejar ese equilibrio.
Como muchos de ustedes ya sabrán, la decisión es una medida temporal. Seguirá vigente hasta que se introduzca una enmienda permanente en el Acuerdo sobre los ADPIC. Las negociaciones sobre dicha enmienda aún no han tenido éxito, a pesar de que han transcurrido varios plazos límite. Así pues, la cuestión de las licencias obligatorias sigue figurando en el orden del día de la OMC. Pero no hay razón para retrasarnos: la entrada en vigor de nuestro Reglamento lo antes posible permitirá a los países necesitados y a las empresas farmacéuticas de la UE usar el mecanismo que estamos poniendo en marcha. En efecto, las tres instituciones, el Parlamento, el Consejo y la Comisión, han apoyado el principio de acuerdo temprano sobre el Reglamento, y se han celebrado intensos debates informales con este propósito. Si bien esos debates no siempre han sido fáciles, se han celebrado en un espíritu de buena cooperación, y tengo que volver a felicitar al señor Van Hecke por los resultados, que demuestran que las instituciones pueden trabajar muy bien juntas.
Me complace que los debates hayan dado lugar a un paquete de compromiso. Quiero decir que la Comisión apoyará dicho paquete de enmiendas si se vota en su totalidad y sin quitar ni poner nada.
¿Cuál es el objetivo de la propuesta de la Comisión? Establece un mecanismo acorde con la decisión de la OMC para que las empresas de la UE puedan solicitar una licencia de fabricación, sin la autorización del titular de los derechos, de productos farmacéuticos para la exportación a países necesitados y que se enfrentan a problemas de salud pública. Hemos intentado crear un instrumento que permita que el procedimiento de licencias obligatorias de la decisión de la OMC se ajuste al contexto de la legislación nacional sobre patentes vigente en los Estados miembros y a los procedimientos de licencias obligatorias ya contemplados en esa legislación.
Un instrumento a escala de la UE que aplique la decisión de la OMC tiene un gran valor simbólico como demostración hacia fuera del compromiso de la UE con la decisión. Al mismo tiempo, tenemos que respetar los principios de subsidiariedad y proporcionalidad, y evitar regular detalles específicos que la legislación nacional o la autoridad competente que tramite la solicitud de licencia puedan tratar mejor.
La labor del Parlamento ha clarificado algunas cosas, en particular una explicación de la participación de las organizaciones no gubernamentales e internacionales. Siempre nos hemos planteado que dichas organizaciones participen potencialmente en procedimientos de compra y que puedan presentar solicitudes en nombre de un país importador con la aprobación de dicho país. Por supuesto, es improbable que dichas organizaciones fabriquen productos farmacéuticos, pero si así fuera sencillamente tendrían que pedir una licencia como cualquier otro fabricante.
Otra clarificación útil ha sido la mejora del texto relativa a la posibilidad de usar el procedimiento de dictamen científico de la UE para certificar la seguridad y eficacia de los medicamentos que se pretende exportar. Esto no se ha regulado en la decisión de la OMC, pues se sitúa fuera de este marco. Pero pensamos que era un complemento necesario al mecanismo de licencias para ayudar a los países importadores."@es20
"Mr President, let me start by thanking Mr Van Hecke, the rapporteur, for the hard work he has put into this dossier. I would also like to thank the shadow rapporteurs and the members of all the committees involved. They have also made a major contribution to the work of Parliament on this file.
Let me now turn to the overall scope of the regulation. The WTO decision provides for export of medicines to WTO members who are least-developed countries or who are developing countries with insufficient manufacturing capacity of their own. There is no specific restriction on the pharmaceutical products covered, although there is acknowledgement that they are required to address public health problems, since that is in the context of the decision. The Commission originally took the view that we should reflect faithfully the scope of the decision as regards the countries eligible to receive exported medicines. That position was based on our assessment of the WTO decision, which specifically covers WTO members as beneficiary countries. I am pleased to say that since then we have accepted humanitarian arguments that all least-developed countries and certain low-income developing countries should be eligible, regardless of whether they are currently WTO members. At the same time, to help ensure that the right medicines get to the right patients, non-WTO members are also expected to make similar commitments to those required from WTO members. This means they should notify what medicines are required and commit to preventing trade diversion if they are to receive products under the EU mechanism.
Another important issue is the question of remuneration for patent holders. I do not think there is any disagreement that patent holders should receive some remuneration for the licences granted without their authorisation. This is a normal principle of law. In the interests of a certain transparency for industry investing in the production of medicines, and as part of the overall compromise package, we could support the proposed formula for remuneration which still leaves some leeway for determination on a case-by-case basis.
Let me conclude at this point by reiterating that the Commission remains very much in favour of the early adoption of this regulation, while respecting the overall objective of introducing a workable, transparent system which companies are able to use for the export of medicines to countries in need. I would call on Parliament to support the compromise package which is on the table.
The proposal from the Commission aims to implement at EU level the WTO General Council Decision of 30 August 2003, allowing copies of patented medicines to be produced for export to countries in need. This decision represents a waiver from the normal rules of patent law, particularly those set out in the WTO TRIPs Agreement. It has to be seen within the wider context of existing national and international frameworks for patent protection.
The discussions in the WTO leading up to the decision of 30 August were long and complex. The decision itself represents a delicate balance between the need to ensure access now to medicines for countries with public health problems, and the need to encourage development in the future of new medicines, through investment in research and innovation protected under the patent system. We have sought to reflect that balance in the Commission’s proposal.
As many of you will know, the decision itself is a temporary measure. It will remain in force until a permanent amendment is made to the TRIPs Agreement. The negotiations on such an amendment have not yet been successful, despite several deadlines having passed. The compulsory licensing issue thus remains on the agenda of the WTO. However, that is no reason for us to delay: bringing our regulation into force as early as possible will allow countries in need and EU producers of pharmaceuticals to use the mechanism we are putting in place. Indeed, all three institutions, Parliament, the Council and the Commission, have supported the principle of early agreement on the regulation, and intensive informal discussions have been taking place with that in mind. While these discussions have not always been easy, they took place in a spirit of good cooperation, and I must congratulate Mr Van Hecke again on the results which show how well the institutions can work together.
I am very pleased that these discussions have resulted in a compromise package. I should say now that the Commission could support such a package of amendments if it is voted through in its entirety and without any additions or subtractions.
What is the Commission’s proposal aiming to do? It sets out a mechanism in line with the WTO decision so that companies in the EU can apply for a licence to manufacture, without the authorisation of the patent holder, pharmaceutical products for export to countries in need of medicines and facing public health concerns. We have tried to produce an instrument that will allow the compulsory licensing procedure of the WTO decision to fit within the context of Member States’ existing national patent law and the compulsory licensing procedures they already have under that law.
An instrument at EU level implementing the WTO decision has great symbolic value as an external demonstration of the EU’s commitment to the decision. At the same time, we have to respect the principles of subsidiarity and proportionality, and so avoid regulating specific details which can better be dealt with under national law or by the competent authority which is processing the licensing application.
Parliament’s work has resulted in some helpful clarification, particularly as regards an explanation of the involvement of non-governmental and international organisations. We have always envisaged such organisations as being potentially involved in any purchasing procedures, and able to make requests on behalf of an importing country with that country’s approval. Of course it is unlikely that such organisations will themselves be manufacturing pharmaceuticals, but if they were they could simply apply for a licence under the regulation like any other manufacturer.
Another useful clarification has been improvement of the text relating to the possibility of using the EU’s scientific opinion procedure, or equivalent national procedures, to certify the safety and efficacy of medicines for export. This is not something regulated in the WTO decision, indeed it lies outside that framework. But in order to assist importing countries we felt it was a necessary complement to the licensing mechanism."@et5
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Arvoisa puhemies, haluan aloittaa kiittämällä esittelijä Van Heckeä hänen panostuksestaan tähän asiakirjaan. Haluan kiittää myös työhön osallistuneita varjoesittelijöitä ja valiokunnan jäseniä, jotka myös ovat antaneet suuren panoksen työhön, jota parlamentti on tehnyt tämän asiakirjan hyväksi.
Palaan nyt asetuksen yleiseen soveltamisalaan. WTO:n päätöksessä säädetään lääkkeiden viennistä WTO:n jäsenmaihin, jotka ovat vähiten kehittyneitä maita tai kehitysmaita, joiden oma tuotantokapasiteetti ei ole riittävä. Lääkkeitä, joita päätös koskee, ei ole erityisesti määritelty, mutta niiden edellytetään olevan tarkoitettu kansanterveysongelmien hoitoon, koska se on päätöksen ala. Aluksi komissio oli sitä mieltä, että vientilääkkeitä vastaanottamaan oikeutettuja maita mietittäessä olisi noudatettava täsmällisesti päätöksen soveltamisalaa. Tämä kanta perustui tekemäämme arvioon WTO:n päätöksestä, jossa edunsaajavaltioiksi käsitetään erityisesti WTO:n jäsenmaat. Olen tyytyväinen voidessani todeta, että tämän jälkeen olemme hyväksyneet muutamia humanitaarisia näkökantoja, joiden mukaan kaikki vähiten kehittyneet ja jotkin matalatuloiset kehitysmaat olisi hyväksyttävä edunsaajavaltioiksi huolimatta siitä, ovatko ne sillä hetkellä WTO:n jäseniä. Samalla kuitenkin muiden kuin WTO:n jäsenten odotetaan tekevän samat sitoumukset, joita edellytetään WTO:n jäseniltä. Näin autetaan varmistamaan, että oikeat lääkkeet tavoittavat oikeat potilaat. Tämä tarkoittaa sitä, että valtion on ilmoitettava, mitä lääkkeitä tarvitaan ja sitouduttava ennaltaehkäisemään kaupan vinoutumista, mikäli ne haluavat vastaanottaa tuotteita EU:n järjestelmän kautta.
Toinen tärkeä kysymys koskee patentinhaltijoille maksettavaa korvausta. Luulen, että kaikki ovat samaa mieltä siitä, että patentinhaltijoiden on saatava jonkinlainen korvaus ilman heidän lupaa myönnetyistä lisensseistä. Tämä on normaali oikeusperiaate. Jotta teollisuuden lääketuotantoon tekemät investoinnit saataisiin avoimemmiksi, voimme tukea ehdotetun korvausmenettelyn sisällyttämistä kompromissipakettiin, sillä menettely jättää varaa tapauskohtaisille ratkaisuille.
Haluan lopettaa tähän toteamalla vielä kerran, että komissio kannattaa erityisesti asetuksen nopeaa hyväksymistä. Samalla komissio kunnioittaa kuitenkin yleistavoitetta luoda toimiva ja avoin järjestelmä, jota yritykset voivat käyttää lääkkeiden viemiseksi kehitysmaihin. Kehotan parlamenttia tukemaan tätä käsiteltävänä olevaa kompromissipakettia.
Komission ehdotuksella pyritään panemaan EU:n osalta täytäntöön WTO:n yleisneuvoston 30. elokuuta 2003 tekemä päätös, jolla sallitaan patentoitujen lääkkeiden kopioiden valmistaminen kehitysmaihin suuntautuvaan vientiin. Tällä päätöksellä luovutaan patenttilainsäädännön normaaleista määräyksistä, erityisesti WTO:n TRIPS-sopimuksen määräyksistä. Päätöstä on tarkasteltava laajemmassa kontekstissa, johon liittyvät olemassa olevat kansalliset ja kansainväliset patenttisuojat.
WTO:ssa käytiin pitkät ja monitahoiset keskustelut ennen kuin saatiin aikaan 30. elokuuta tehty päätös. Päätös itsessään edustaa kahden tarpeen välistä herkkää tasapainoa. Toisaalta on taattava lääkkeiden saanti kansanterveysongelmista kärsiviin maihin nyt, ja toisaalta on edistettävä uusien lääkkeiden kehittämistä tulevaisuudessa investoimalla tutkimukseen ja innovaatioon, joita suojataan patenttijärjestelmällä. Olemme pyrkineet sisällyttämään tämän tasapainon komission ehdotukseen.
Monet teistä huomaavat, että päätös on vain väliaikainen toimenpide. Se on voimassa kunnes TRIPS-sopimukseen tehdään pysyvä muutos. Neuvottelut muutoksesta eivät ole vielä tuottaneet tulosta, vaikka monia määräaikoja on jo ohitettu. Pakkolisensointi pysyy kuitenkin edelleen WTO:n asialistalla. Tämä ei ole kuitenkaan syy viivyttelyyn, sillä panemalla asetus täytäntöön mahdollisimman nopeasti sallitaan kehitysmaiden ja EU:n lääkevalmistajien hyödyntää käyttöön otettavaa järjestelmää. Kaikki kolme toimielintä, parlamentti, neuvosto ja komissio, itse asiassa tukevat asetuksesta sopimista mahdollisimman nopeasti. Tämän aikaansaamiseksi on käyty intensiivisiä epävirallisia neuvotteluja, jotka eivät ole aina olleet helppoja, mutta niiden aikana on kuitenkin vallinnut hyvän yhteistyön ilmapiiri. Haluankin vielä kiittää jäsen Van Heckeä tuloksista, jotka osoittavat kuinka hyvin toimielimet kykenevät työskentelemään yhdessä.
Olen erittäin tyytyväinen, että keskustelut ovat johtaneet kompromissipakettiin. Totean tässä, että komissio voisi tukea tätä tarkistuspakettia, jos se äänestetään läpi sellaisenaan lisäämättä tai poistamatta mitään.
Mihin komission ehdotuksella pyritään? Sillä pannaan alulle WTO:n päätöksen kanssa yhdenmukainen järjestelmä. Järjestelmä antaa yrityksille EU:ssa mahdollisuuden hakea ilman patentinhaltijan lupaa valmistuslisenssiä lääkkeille, jotka viedään kansanterveysongelmista kärsiviin, lääkkeitä tarvitseviin kehitysmaihin. Olemme pyrkineet luomaan välineen, jonka avulla WTO:n päätöksen mukainen pakkolisensointimenettely sopii yhteen jäsenvaltioiden voimassa olevien kansallisten patenttilakien kanssa sekä näiden lakien alaisten pakkolisensointimenettelyjen kanssa.
EU:ssa käytettävällä välineellä, jolla pannaan täytäntöön WTO:n päätös, on valtava symbolinen merkitys, sillä se osoittaa ulkomaailmalle, että EU on sitoutunut päätökseen. Meidän on samaan aikaan kunnioitettava toissijaisuus- ja suhteellisuusperiaatteita, ja siten vältettävä pienistä yksityiskohdista sääntelyä. Niitä on parempi käsitellä kansallisessa lainsäädännössä tai lisensointihakemusta käsittelevän toimivaltaisen viranomaisen toimesta.
Parlamentin työn ansiosta on saatu muutamia hyödyllisiä selvennyksiä ja erityisesti selvennys kansainvälisten ja kansalaisjärjestöjen osallistumisesta. On aina ajateltu, että tällaiset järjestöt voisivat osallistua ostomenettelyihin ja tehdä pyyntöjä tuojamaan puolesta kyseisen maan valtuuttamana. On tietysti epätodennäköistä, että tällaiset järjestöt itse valmistaisivat lääkkeitä tulevaisuudessa. Jos näin kuitenkin olisi, ne voisivat yksinkertaisesti hakea lisenssiä asetuksen mukaisesti aivan kuten muutkin valmistajat.
Toinen hyödyllinen selvennys oli parannus tekstiin, jossa käsitellään mahdollisuutta käyttää EU:n tieteellisen lausunnon menettelyä, tai vastaavia kansallisia menettelyjä, vientiin tarkoitettujen lääkkeiden turvallisuuden ja tehokkuuden varmistamiseksi. Tästä ei säädetä WTO:n päätöksessä, ja se on itse asiassa päätöksen viitekehyksen ulkopuolella. Tämä on mielestämme kuitenkin tarpeellinen lisäys lisenssijärjestelmään, jotta voimme avustaa tuojamaita."@fi7
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Monsieur le Président, permettez-moi tout d’abord de remercier M. Van Hecke, le rapporteur, pour les gros efforts qu’il a déployés dans le cadre de ce dossier. Je tiens également à remercier les rapporteurs fictifs et les membres de toutes les commissions concernées. Ils ont, eux aussi, grandement contribué aux travaux du Parlement dans ce dossier.
Permettez-moi à présent d’évoquer le champ d’application général du règlement. La décision de l’OMC prévoit l’exportation de médicaments vers les membres de l’OMC les moins avancés ou les pays en développement membres souffrant d’un manque de capacité de production de médicaments. Les produits pharmaceutiques couverts ne font l’objet d’aucune restriction, bien que l’on reconnaisse qu’ils doivent répondre à des problèmes de santé publique, conformément au contexte de la décision. La Commission estimait au départ que nous devions respecter fidèlement le champ d’application de la décision concernant les pays ayant droit aux exportations de médicaments. Nous fondions notre avis sur notre évaluation de la décision de l’OMC, qui limite les pays bénéficiaires aux pays membres de l’Organisation. Je suis ravi de pouvoir dire qu’à présent, nous avons accepté comme argument humanitaire d’élargir cette disposition à tous les pays les moins avancés et à certains pays en développement à bas revenus, qu’ils soient membres de l’OMC ou non. Parallèlement, les pays non membres de l’OMC devraient également prendre des engagements semblables à ceux des pays qui en sont membres afin de veiller à ce que les patients obtiennent les médicaments adéquats. En d’autres termes, ils devraient notifier les médicaments requis et s’engager à prévenir le détournement des médicaments s’ils désirent obtenir des produits dans le cadre du mécanisme communautaire.
Un autre aspect important concerne la rémunération des titulaires de brevets. Je ne pense pas que quiconque désapprouve le versement d’une certaine rémunération aux titulaires de brevets en échange des licences octroyées sans leur autorisation. Il s’agit d’un principe de droit normal. Par souci d’une certaine transparence de l’industrie qui investit dans la production de médicaments et dans le cadre du paquet global de compromis, nous pourrions soutenir la formule proposée de rémunération, qui laisse une certaine marge de manœuvre pour la détermination du montant au cas par cas.
Permettez-moi de conclure à ce stade en vous rappelant que la Commission reste bel et bien favorable à l’adoption de ce règlement dans les plus brefs délais, tout en respectant l’objectif général, qui est d’introduire un système fonctionnel et transparent auquel les entreprises puissent recourir pour exporter des médicaments vers les pays dans le besoin. J’invite le Parlement à soutenir le paquet de compromis à l’examen.
La proposition de la Commission vise à mettre en œuvre la décision du Conseil général de l’OMC du 30 août 2003 au niveau communautaire, à savoir autoriser l’exportation de copies de médicaments brevetés vers les pays dans le besoin. Cette décision déroge au droit des brevets, notamment aux règles fixées dans l’accord TRIPS/ADPIC de l’OMC. Elle s’inscrit dans le contexte général des cadres nationaux et internationaux de protection des brevets.
Les débats au sein de l’OMC qui ont abouti à la décision du 30 août ont été longs et complexes. La décision en elle-même représente un équilibre fragile entre, d’une part, la nécessité de garantir l’accès aux médicaments des pays victimes de problèmes de santé publique et, d’autre part, la nécessité d’encourager la conception de nouveaux médicaments, grâce aux investissements dans la recherche et l’innovation sous la protection du système de brevets. Nous avons tenté de refléter cet équilibre dans la proposition de la Commission.
Comme nombre d’entre vous le savent, la décision en elle-même est une mesure temporaire. Elle restera en vigueur jusqu’à l’inclusion d’un amendement permanent dans l’accord sur les ADPIC. Les négociations sur cet amendement n’ont pas encore produit de résultat, malgré le dépassement de plusieurs délais. La question de licence obligatoire reste donc à l’ordre du jour de l’OMC. Quoi qu’il en soit, nous n’avons de notre côté aucune raison de reporter l’affaire: l’adoption de notre règlement dans les plus brefs délais permettra aux pays dans le besoin et aux producteurs communautaires de médicaments de recourir au mécanisme que nous mettons en place. En effet, les trois institutions, à savoir le Parlement, le Conseil et la Commission, se sont prononcées en faveur du principe d’accord précoce sur ce règlement et des débats informels intensifs ont eu lieu dans cet esprit. Si les discussions n’ont pas toujours été faciles, elles se sont tenues dans un bon esprit de coopération et je me dois de féliciter M. Van Hecke encore une fois pour le résultat, qui démontre la grande qualité de la collaboration dont sont capables les institutions.
Je suis extrêmement ravi que ces discussions aient permis d’aboutir à un paquet de compromis. Je puis vous dire à présent que la Commission soutiendra cet ensemble d’amendements s’ils sont adoptés dans leur intégralité et sans ajout ni soustraction.
Quel est l’objectif de la proposition de la Commission? Elle met en place un mécanisme conforme à la décision de l’OMC, afin que les entreprises communautaires puissent faire une demande de licence pour fabriquer des produits pharmaceutiques sans l’autorisation du titulaire du brevet en vue de les exporter vers des pays qui ont besoin de médicaments et sont confrontés à des problèmes en matière de santé publique. Nous avons tenté de créer un instrument qui permettra la correspondance entre la procédure de licence obligatoire prévue par la décision de l’OMC et le droit des brevets des États membres, notamment les procédures de licence obligatoire déjà prévues dans le droit national en la matière.
Un instrument communautaire pour appliquer la décision de l’OMC a une grande valeur symbolique, car il démontre l’engagement de l’Union européenne à se conformer à la décision. Parallèlement, nous devons respecter les principes de subsidiarité et de proportionnalité et éviter par conséquent de légiférer sur des aspects spécifiques qu’il est préférable de laisser à la discrétion du droit national ou de l’autorité compétente en charge des demandes de licence.
Les travaux du Parlement ont permis de clarifier quelque peu les choses, notamment l’explication de la participation d’organisations non gouvernementales et internationales. Nous avons toujours envisagé la participation potentielle de ces organisations dans les procédures d’achat et la possibilité pour celles-ci d’introduire des demandes au nom d’un pays importateur, avec son autorisation. Il est bien entendu peu probable qu’elles produisent elles-mêmes des produits pharmaceutiques, mais si c’était le cas, elles pourraient tout bonnement demander une licence dans le cadre du règlement au même titre que n’importe quel fabricant.
En matière de clarification toujours, les travaux du Parlement ont permis d’améliorer le texte prévoyant la possibilité de recourir à la procédure communautaire d’avis scientifique ou aux procédures nationales équivalentes pour certifier la sécurité et l’efficacité des médicaments destinés à l’exportation. Cet aspect n’est pas abordé par la décision de l’OMC et ne relève donc pas de son champ d’application. Toutefois, pour aider les pays importateurs, nous estimions qu’il s’agissait d’un complément nécessaire au mécanisme d’octroi de licences."@fr8
"Mr President, let me start by thanking Mr Van Hecke, the rapporteur, for the hard work he has put into this dossier. I would also like to thank the shadow rapporteurs and the members of all the committees involved. They have also made a major contribution to the work of Parliament on this file.
Let me now turn to the overall scope of the regulation. The WTO decision provides for export of medicines to WTO members who are least-developed countries or who are developing countries with insufficient manufacturing capacity of their own. There is no specific restriction on the pharmaceutical products covered, although there is acknowledgement that they are required to address public health problems, since that is in the context of the decision. The Commission originally took the view that we should reflect faithfully the scope of the decision as regards the countries eligible to receive exported medicines. That position was based on our assessment of the WTO decision, which specifically covers WTO members as beneficiary countries. I am pleased to say that since then we have accepted humanitarian arguments that all least-developed countries and certain low-income developing countries should be eligible, regardless of whether they are currently WTO members. At the same time, to help ensure that the right medicines get to the right patients, non-WTO members are also expected to make similar commitments to those required from WTO members. This means they should notify what medicines are required and commit to preventing trade diversion if they are to receive products under the EU mechanism.
Another important issue is the question of remuneration for patent holders. I do not think there is any disagreement that patent holders should receive some remuneration for the licences granted without their authorisation. This is a normal principle of law. In the interests of a certain transparency for industry investing in the production of medicines, and as part of the overall compromise package, we could support the proposed formula for remuneration which still leaves some leeway for determination on a case-by-case basis.
Let me conclude at this point by reiterating that the Commission remains very much in favour of the early adoption of this regulation, while respecting the overall objective of introducing a workable, transparent system which companies are able to use for the export of medicines to countries in need. I would call on Parliament to support the compromise package which is on the table.
The proposal from the Commission aims to implement at EU level the WTO General Council Decision of 30 August 2003, allowing copies of patented medicines to be produced for export to countries in need. This decision represents a waiver from the normal rules of patent law, particularly those set out in the WTO TRIPs Agreement. It has to be seen within the wider context of existing national and international frameworks for patent protection.
The discussions in the WTO leading up to the decision of 30 August were long and complex. The decision itself represents a delicate balance between the need to ensure access now to medicines for countries with public health problems, and the need to encourage development in the future of new medicines, through investment in research and innovation protected under the patent system. We have sought to reflect that balance in the Commission’s proposal.
As many of you will know, the decision itself is a temporary measure. It will remain in force until a permanent amendment is made to the TRIPs Agreement. The negotiations on such an amendment have not yet been successful, despite several deadlines having passed. The compulsory licensing issue thus remains on the agenda of the WTO. However, that is no reason for us to delay: bringing our regulation into force as early as possible will allow countries in need and EU producers of pharmaceuticals to use the mechanism we are putting in place. Indeed, all three institutions, Parliament, the Council and the Commission, have supported the principle of early agreement on the regulation, and intensive informal discussions have been taking place with that in mind. While these discussions have not always been easy, they took place in a spirit of good cooperation, and I must congratulate Mr Van Hecke again on the results which show how well the institutions can work together.
I am very pleased that these discussions have resulted in a compromise package. I should say now that the Commission could support such a package of amendments if it is voted through in its entirety and without any additions or subtractions.
What is the Commission’s proposal aiming to do? It sets out a mechanism in line with the WTO decision so that companies in the EU can apply for a licence to manufacture, without the authorisation of the patent holder, pharmaceutical products for export to countries in need of medicines and facing public health concerns. We have tried to produce an instrument that will allow the compulsory licensing procedure of the WTO decision to fit within the context of Member States’ existing national patent law and the compulsory licensing procedures they already have under that law.
An instrument at EU level implementing the WTO decision has great symbolic value as an external demonstration of the EU’s commitment to the decision. At the same time, we have to respect the principles of subsidiarity and proportionality, and so avoid regulating specific details which can better be dealt with under national law or by the competent authority which is processing the licensing application.
Parliament’s work has resulted in some helpful clarification, particularly as regards an explanation of the involvement of non-governmental and international organisations. We have always envisaged such organisations as being potentially involved in any purchasing procedures, and able to make requests on behalf of an importing country with that country’s approval. Of course it is unlikely that such organisations will themselves be manufacturing pharmaceuticals, but if they were they could simply apply for a licence under the regulation like any other manufacturer.
Another useful clarification has been improvement of the text relating to the possibility of using the EU’s scientific opinion procedure, or equivalent national procedures, to certify the safety and efficacy of medicines for export. This is not something regulated in the WTO decision, indeed it lies outside that framework. But in order to assist importing countries we felt it was a necessary complement to the licensing mechanism."@hu11
"Signor Presidente, permettetemi di iniziare ringraziando il relatore, onorevole Van Hecke, per il duro lavoro svolto nella stesura del presente documento. Tengo inoltre a ringraziare i relatori ombra e i membri di tutte le commissioni interessate: anch’essi hanno fornito un importante contributo a quanto fatto dal Parlamento per questo
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Permettetemi ora di passare al campo d’applicazione del regolamento. La decisione dell’OMC prevede l’esportazione di farmaci a membri dell’OMC, ad esempio paesi meno avanzati o paesi in via di sviluppo le cui capacità di produzione nel settore sono insufficienti. Non esistono limitazioni specifiche ai prodotti farmaceutici, pur riconoscendo che devono essere esclusivamente richiesti per problemi di salute pubblica, poiché questo è il contesto in cui si inserisce la decisione. All’inizio la Commissione era del parere che, nella scelta dei paesi ammessi a ricevere medicinali esportati, avremmo dovuto rispecchiare fedelmente il campo d’applicazione della decisione. Questa posizione si basava sulla nostra valutazione della decisione dell’OMC, che considera come paesi beneficiari solo quelli che aderiscono all’OMC. Sono felice di poter dire che, da allora, abbiamo accolto considerazioni di natura umanitaria secondo cui occorre concedere l’ammissibilità a tutti i paesi meno avanzati e ad alcuni paesi in via di sviluppo a basso reddito, a prescindere dalla loro appartenenza all’OMC. Contemporaneamente, per garantire che i medicinali giusti finiscano nelle mani dei pazienti giusti, i paesi che non aderiscono all’OMC devono assumersi impegni analoghi a quelli che devono rispettare i membri dell’OMC. Ciò significa che, nel caso in cui debbano ricevere prodotti nell’ambito del meccanismo comunitario, sono tenuti a notificare i medicinali richiesti e si impegnano a prevenire la deviazione degli scambi.
Un’altra questione importante riguarda la retribuzione dei titolari del brevetto. Credo che nessuno sia contrario al fatto che i titolari del brevetto debbano ricevere un compenso per le licenze concesse senza la loro autorizzazione. Si tratta di un normale principio di legge. Nell’interesse di una certa trasparenza per un settore che investe nella produzione di farmaci, e nel quadro del pacchetto di compromesso, potremmo accettare l’idea proposta sulla retribuzione che lascia, comunque, un certo margine di manovra nel determinare l’entità del compenso in base ai singoli casi.
A questo punto vorrei concludere ricordando che la Commissione vede con estremo favore la tempestiva adozione del presente regolamento e rispetta, al tempo stesso, l’obiettivo generale di introdurre un sistema fattibile e trasparente di cui le imprese possano avvalersi per l’esportazione di farmaci verso paesi bisognosi. Invito quindi il Parlamento ad approvare il pacchetto di compromesso proposto.
La proposta della Commissione è volta ad attuare a livello comunitario la decisione del Consiglio generale dell’OMC del 30 agosto 2003, che consente di fabbricare farmaci coperti da brevetto per destinarli all’esportazione verso paesi in situazioni di bisogno. Questa decisione costituisce una deroga alle normali regole che disciplinano il diritto brevettuale, in particolare quelle previste dall’accordo TRIPs dell’OMC, e deve essere vista alla luce del più ampio contesto dei quadri legislativi nazionali e internazionali esistenti sulla tutela dei brevetti.
I dibattiti dell’OMC che hanno portato alla decisione del 30 agosto sono stati lunghi e complessi. La decisione, di per sé, rappresenta un delicato punto di equilibrio tra il bisogno di garantire l’accesso immediato ai farmaci a paesi con problemi di sanità pubblica e l’esigenza di incoraggiare lo sviluppo di nuovi farmaci, grazie a investimenti nella ricerca e nell’innovazione protetti dal sistema dei brevetti. Abbiamo cercato di tenere conto di questo equilibrio nella proposta della Commissione.
Come molti di voi sapranno, la decisione è una misura temporanea e rimarrà in vigore sino a quando non verrà definitivamente emendato l’accordo TRIPs. I negoziati su tale modifica non hanno ancora dato risultati, pur essendo già andati oltre i termini previsti. La concessione di licenze obbligatorie, quindi, rimane un tema all’ordine del giorno dell’OMC. Tuttavia, non c’è alcun motivo per indugiare: con la rapida entrata in vigore del nostro regolamento, permetteremo ai paesi bisognosi e ai produttori di farmaci dell’UE di avvalersi del meccanismo che stiamo mettendo a punto. In effetti le tre Istituzioni, Parlamento, Consiglio e Commissione, concordano sull’idea di pervenire rapidamente a un accordo sul regolamento e, in questo spirito, hanno tenuto intensi colloqui informali. Pur non essendo sempre stati facili, i dibattiti sono stati caratterizzati da una buona collaborazione e, ancora una volta, devo congratularmi con l’onorevole Van Hecke per i risultati che dimostrano che, effettivamente, le Istituzioni possono lavorare bene insieme.
Sono molto lieto che i nostri dibattiti siano sfociati in un compromesso. La Commissione potrà appoggiare questo pacchetto di emendamenti se verrà votato nella sua interezza e senza aggiunte o cancellature.
Qual è l’obiettivo della proposta della Commissione? Essa mette a punto un meccanismo conforme alla decisione dell’OMC in maniera tale che le imprese dell’UE possano richiedere una licenza per produrre, senza l’autorizzazione del titolare del brevetto, prodotti farmaceutici destinati all’esportazione verso paesi bisognosi di medicinali e con problemi di sanità pubblica. Abbiamo cercato di creare uno strumento che permettesse di integrare la procedura di concessione di licenze obbligatorie, stabilita dalla decisione dell’OMC, nelle leggi nazionali sui brevetti esistenti negli Stati membri e nelle procedure di concessione di licenze obbligatorie da esse previste.
Uno strumento a livello comunitario che attua la decisione dell’OMC ha grande valore simbolico poiché, esternamente, dimostra l’impegno assunto dall’UE in questo settore. Al tempo stesso, dobbiamo rispettare i principi di sussidiarietà e di proporzionalità e, di conseguenza, evitare di regolamentare i dettagli specifici, che possono essere meglio trattati dalle leggi nazionali o dalle autorità competenti che vagliano la richiesta di concessione della licenza.
Il lavoro del Parlamento ha contribuito a dare chiarimenti utili, soprattutto in merito al coinvolgimento delle organizzazioni internazionali e non governative. Abbiamo sempre pensato che queste organizzazioni potessero essere implicate nelle procedure di acquisto e avanzare richieste a nome di un paese importatore con l’autorizzazione di quest’ultimo. E’ ovviamente improbabile che queste organizzazioni fabbrichino prodotti farmaceutici ma, nel caso in cui lo facessero, dovrebbero semplicemente, in base al regolamento, richiedere una licenza come qualsiasi altro produttore.
Un altro chiarimento utile riguarda le migliorie apportate al testo sulla possibilità di ricorrere alla procedura di parere scientifico dell’UE, o a procedure analoghe esistenti a livello nazionale, per certificare la sicurezza e l’efficacia dei medicinali destinati all’esportazione. Questo punto non è regolamentato dalla decisione dell’OMC, bensì al di fuori di tale contesto, ma per assistere i paesi importatori abbiamo creduto fosse necessaria un’integrazione al meccanismo di concessione delle licenze."@it12
"Mr President, let me start by thanking Mr Van Hecke, the rapporteur, for the hard work he has put into this dossier. I would also like to thank the shadow rapporteurs and the members of all the committees involved. They have also made a major contribution to the work of Parliament on this file.
Let me now turn to the overall scope of the regulation. The WTO decision provides for export of medicines to WTO members who are least-developed countries or who are developing countries with insufficient manufacturing capacity of their own. There is no specific restriction on the pharmaceutical products covered, although there is acknowledgement that they are required to address public health problems, since that is in the context of the decision. The Commission originally took the view that we should reflect faithfully the scope of the decision as regards the countries eligible to receive exported medicines. That position was based on our assessment of the WTO decision, which specifically covers WTO members as beneficiary countries. I am pleased to say that since then we have accepted humanitarian arguments that all least-developed countries and certain low-income developing countries should be eligible, regardless of whether they are currently WTO members. At the same time, to help ensure that the right medicines get to the right patients, non-WTO members are also expected to make similar commitments to those required from WTO members. This means they should notify what medicines are required and commit to preventing trade diversion if they are to receive products under the EU mechanism.
Another important issue is the question of remuneration for patent holders. I do not think there is any disagreement that patent holders should receive some remuneration for the licences granted without their authorisation. This is a normal principle of law. In the interests of a certain transparency for industry investing in the production of medicines, and as part of the overall compromise package, we could support the proposed formula for remuneration which still leaves some leeway for determination on a case-by-case basis.
Let me conclude at this point by reiterating that the Commission remains very much in favour of the early adoption of this regulation, while respecting the overall objective of introducing a workable, transparent system which companies are able to use for the export of medicines to countries in need. I would call on Parliament to support the compromise package which is on the table.
The proposal from the Commission aims to implement at EU level the WTO General Council Decision of 30 August 2003, allowing copies of patented medicines to be produced for export to countries in need. This decision represents a waiver from the normal rules of patent law, particularly those set out in the WTO TRIPs Agreement. It has to be seen within the wider context of existing national and international frameworks for patent protection.
The discussions in the WTO leading up to the decision of 30 August were long and complex. The decision itself represents a delicate balance between the need to ensure access now to medicines for countries with public health problems, and the need to encourage development in the future of new medicines, through investment in research and innovation protected under the patent system. We have sought to reflect that balance in the Commission’s proposal.
As many of you will know, the decision itself is a temporary measure. It will remain in force until a permanent amendment is made to the TRIPs Agreement. The negotiations on such an amendment have not yet been successful, despite several deadlines having passed. The compulsory licensing issue thus remains on the agenda of the WTO. However, that is no reason for us to delay: bringing our regulation into force as early as possible will allow countries in need and EU producers of pharmaceuticals to use the mechanism we are putting in place. Indeed, all three institutions, Parliament, the Council and the Commission, have supported the principle of early agreement on the regulation, and intensive informal discussions have been taking place with that in mind. While these discussions have not always been easy, they took place in a spirit of good cooperation, and I must congratulate Mr Van Hecke again on the results which show how well the institutions can work together.
I am very pleased that these discussions have resulted in a compromise package. I should say now that the Commission could support such a package of amendments if it is voted through in its entirety and without any additions or subtractions.
What is the Commission’s proposal aiming to do? It sets out a mechanism in line with the WTO decision so that companies in the EU can apply for a licence to manufacture, without the authorisation of the patent holder, pharmaceutical products for export to countries in need of medicines and facing public health concerns. We have tried to produce an instrument that will allow the compulsory licensing procedure of the WTO decision to fit within the context of Member States’ existing national patent law and the compulsory licensing procedures they already have under that law.
An instrument at EU level implementing the WTO decision has great symbolic value as an external demonstration of the EU’s commitment to the decision. At the same time, we have to respect the principles of subsidiarity and proportionality, and so avoid regulating specific details which can better be dealt with under national law or by the competent authority which is processing the licensing application.
Parliament’s work has resulted in some helpful clarification, particularly as regards an explanation of the involvement of non-governmental and international organisations. We have always envisaged such organisations as being potentially involved in any purchasing procedures, and able to make requests on behalf of an importing country with that country’s approval. Of course it is unlikely that such organisations will themselves be manufacturing pharmaceuticals, but if they were they could simply apply for a licence under the regulation like any other manufacturer.
Another useful clarification has been improvement of the text relating to the possibility of using the EU’s scientific opinion procedure, or equivalent national procedures, to certify the safety and efficacy of medicines for export. This is not something regulated in the WTO decision, indeed it lies outside that framework. But in order to assist importing countries we felt it was a necessary complement to the licensing mechanism."@lt14
"Mr President, let me start by thanking Mr Van Hecke, the rapporteur, for the hard work he has put into this dossier. I would also like to thank the shadow rapporteurs and the members of all the committees involved. They have also made a major contribution to the work of Parliament on this file.
Let me now turn to the overall scope of the regulation. The WTO decision provides for export of medicines to WTO members who are least-developed countries or who are developing countries with insufficient manufacturing capacity of their own. There is no specific restriction on the pharmaceutical products covered, although there is acknowledgement that they are required to address public health problems, since that is in the context of the decision. The Commission originally took the view that we should reflect faithfully the scope of the decision as regards the countries eligible to receive exported medicines. That position was based on our assessment of the WTO decision, which specifically covers WTO members as beneficiary countries. I am pleased to say that since then we have accepted humanitarian arguments that all least-developed countries and certain low-income developing countries should be eligible, regardless of whether they are currently WTO members. At the same time, to help ensure that the right medicines get to the right patients, non-WTO members are also expected to make similar commitments to those required from WTO members. This means they should notify what medicines are required and commit to preventing trade diversion if they are to receive products under the EU mechanism.
Another important issue is the question of remuneration for patent holders. I do not think there is any disagreement that patent holders should receive some remuneration for the licences granted without their authorisation. This is a normal principle of law. In the interests of a certain transparency for industry investing in the production of medicines, and as part of the overall compromise package, we could support the proposed formula for remuneration which still leaves some leeway for determination on a case-by-case basis.
Let me conclude at this point by reiterating that the Commission remains very much in favour of the early adoption of this regulation, while respecting the overall objective of introducing a workable, transparent system which companies are able to use for the export of medicines to countries in need. I would call on Parliament to support the compromise package which is on the table.
The proposal from the Commission aims to implement at EU level the WTO General Council Decision of 30 August 2003, allowing copies of patented medicines to be produced for export to countries in need. This decision represents a waiver from the normal rules of patent law, particularly those set out in the WTO TRIPs Agreement. It has to be seen within the wider context of existing national and international frameworks for patent protection.
The discussions in the WTO leading up to the decision of 30 August were long and complex. The decision itself represents a delicate balance between the need to ensure access now to medicines for countries with public health problems, and the need to encourage development in the future of new medicines, through investment in research and innovation protected under the patent system. We have sought to reflect that balance in the Commission’s proposal.
As many of you will know, the decision itself is a temporary measure. It will remain in force until a permanent amendment is made to the TRIPs Agreement. The negotiations on such an amendment have not yet been successful, despite several deadlines having passed. The compulsory licensing issue thus remains on the agenda of the WTO. However, that is no reason for us to delay: bringing our regulation into force as early as possible will allow countries in need and EU producers of pharmaceuticals to use the mechanism we are putting in place. Indeed, all three institutions, Parliament, the Council and the Commission, have supported the principle of early agreement on the regulation, and intensive informal discussions have been taking place with that in mind. While these discussions have not always been easy, they took place in a spirit of good cooperation, and I must congratulate Mr Van Hecke again on the results which show how well the institutions can work together.
I am very pleased that these discussions have resulted in a compromise package. I should say now that the Commission could support such a package of amendments if it is voted through in its entirety and without any additions or subtractions.
What is the Commission’s proposal aiming to do? It sets out a mechanism in line with the WTO decision so that companies in the EU can apply for a licence to manufacture, without the authorisation of the patent holder, pharmaceutical products for export to countries in need of medicines and facing public health concerns. We have tried to produce an instrument that will allow the compulsory licensing procedure of the WTO decision to fit within the context of Member States’ existing national patent law and the compulsory licensing procedures they already have under that law.
An instrument at EU level implementing the WTO decision has great symbolic value as an external demonstration of the EU’s commitment to the decision. At the same time, we have to respect the principles of subsidiarity and proportionality, and so avoid regulating specific details which can better be dealt with under national law or by the competent authority which is processing the licensing application.
Parliament’s work has resulted in some helpful clarification, particularly as regards an explanation of the involvement of non-governmental and international organisations. We have always envisaged such organisations as being potentially involved in any purchasing procedures, and able to make requests on behalf of an importing country with that country’s approval. Of course it is unlikely that such organisations will themselves be manufacturing pharmaceuticals, but if they were they could simply apply for a licence under the regulation like any other manufacturer.
Another useful clarification has been improvement of the text relating to the possibility of using the EU’s scientific opinion procedure, or equivalent national procedures, to certify the safety and efficacy of medicines for export. This is not something regulated in the WTO decision, indeed it lies outside that framework. But in order to assist importing countries we felt it was a necessary complement to the licensing mechanism."@lv13
"Mr President, let me start by thanking Mr Van Hecke, the rapporteur, for the hard work he has put into this dossier. I would also like to thank the shadow rapporteurs and the members of all the committees involved. They have also made a major contribution to the work of Parliament on this file.
Let me now turn to the overall scope of the regulation. The WTO decision provides for export of medicines to WTO members who are least-developed countries or who are developing countries with insufficient manufacturing capacity of their own. There is no specific restriction on the pharmaceutical products covered, although there is acknowledgement that they are required to address public health problems, since that is in the context of the decision. The Commission originally took the view that we should reflect faithfully the scope of the decision as regards the countries eligible to receive exported medicines. That position was based on our assessment of the WTO decision, which specifically covers WTO members as beneficiary countries. I am pleased to say that since then we have accepted humanitarian arguments that all least-developed countries and certain low-income developing countries should be eligible, regardless of whether they are currently WTO members. At the same time, to help ensure that the right medicines get to the right patients, non-WTO members are also expected to make similar commitments to those required from WTO members. This means they should notify what medicines are required and commit to preventing trade diversion if they are to receive products under the EU mechanism.
Another important issue is the question of remuneration for patent holders. I do not think there is any disagreement that patent holders should receive some remuneration for the licences granted without their authorisation. This is a normal principle of law. In the interests of a certain transparency for industry investing in the production of medicines, and as part of the overall compromise package, we could support the proposed formula for remuneration which still leaves some leeway for determination on a case-by-case basis.
Let me conclude at this point by reiterating that the Commission remains very much in favour of the early adoption of this regulation, while respecting the overall objective of introducing a workable, transparent system which companies are able to use for the export of medicines to countries in need. I would call on Parliament to support the compromise package which is on the table.
The proposal from the Commission aims to implement at EU level the WTO General Council Decision of 30 August 2003, allowing copies of patented medicines to be produced for export to countries in need. This decision represents a waiver from the normal rules of patent law, particularly those set out in the WTO TRIPs Agreement. It has to be seen within the wider context of existing national and international frameworks for patent protection.
The discussions in the WTO leading up to the decision of 30 August were long and complex. The decision itself represents a delicate balance between the need to ensure access now to medicines for countries with public health problems, and the need to encourage development in the future of new medicines, through investment in research and innovation protected under the patent system. We have sought to reflect that balance in the Commission’s proposal.
As many of you will know, the decision itself is a temporary measure. It will remain in force until a permanent amendment is made to the TRIPs Agreement. The negotiations on such an amendment have not yet been successful, despite several deadlines having passed. The compulsory licensing issue thus remains on the agenda of the WTO. However, that is no reason for us to delay: bringing our regulation into force as early as possible will allow countries in need and EU producers of pharmaceuticals to use the mechanism we are putting in place. Indeed, all three institutions, Parliament, the Council and the Commission, have supported the principle of early agreement on the regulation, and intensive informal discussions have been taking place with that in mind. While these discussions have not always been easy, they took place in a spirit of good cooperation, and I must congratulate Mr Van Hecke again on the results which show how well the institutions can work together.
I am very pleased that these discussions have resulted in a compromise package. I should say now that the Commission could support such a package of amendments if it is voted through in its entirety and without any additions or subtractions.
What is the Commission’s proposal aiming to do? It sets out a mechanism in line with the WTO decision so that companies in the EU can apply for a licence to manufacture, without the authorisation of the patent holder, pharmaceutical products for export to countries in need of medicines and facing public health concerns. We have tried to produce an instrument that will allow the compulsory licensing procedure of the WTO decision to fit within the context of Member States’ existing national patent law and the compulsory licensing procedures they already have under that law.
An instrument at EU level implementing the WTO decision has great symbolic value as an external demonstration of the EU’s commitment to the decision. At the same time, we have to respect the principles of subsidiarity and proportionality, and so avoid regulating specific details which can better be dealt with under national law or by the competent authority which is processing the licensing application.
Parliament’s work has resulted in some helpful clarification, particularly as regards an explanation of the involvement of non-governmental and international organisations. We have always envisaged such organisations as being potentially involved in any purchasing procedures, and able to make requests on behalf of an importing country with that country’s approval. Of course it is unlikely that such organisations will themselves be manufacturing pharmaceuticals, but if they were they could simply apply for a licence under the regulation like any other manufacturer.
Another useful clarification has been improvement of the text relating to the possibility of using the EU’s scientific opinion procedure, or equivalent national procedures, to certify the safety and efficacy of medicines for export. This is not something regulated in the WTO decision, indeed it lies outside that framework. But in order to assist importing countries we felt it was a necessary complement to the licensing mechanism."@mt15
".
Mijnheer de Voorzitter, om te beginnen dank ik de heer Van Hecke, de rapporteur, voor het vele werk dat hij in dit dossier heeft gestopt. Ik dank ook de schaduwrapporteurs en de leden van alle betrokken commissies. Ook zij hebben een belangrijke bijdrage geleverd aan het werk van het Parlement inzake dit dossier.
Ik wil het nu hebben over de algemene reikwijdte van de verordening. Het WTO-besluit voorziet in de uitvoer van medicijnen naar minst ontwikkelde landen of ontwikkelingslanden met onvoldoende productiecapaciteit die WTO-lid zijn. Er geldt geen specifieke beperking voor de farmaceutische producten die onder het besluit vallen, hoewel wel wordt aangegeven dat ze bedoeld moeten zijn om volksgezondheidsproblemen op te lossen. Daar is het besluit immers op gericht. Oorspronkelijk was de Commissie van mening dat we de reikwijdte van het besluit wat betreft de landen die voor uitgevoerde medicijnen in aanmerking komen, trouw moesten volgen. Dat standpunt was gebaseerd op onze beoordeling van het WTO-besluit, dat WTO-leden specifiek als begunstigde landen beschouwt. Ik ben blij te kunnen zeggen dat we op grond van humanitaire argumenten inmiddels tot het inzicht zijn gekomen dat alle minst ontwikkelde landen en bepaalde ontwikkelingslanden met lage lonen voor de regelingen in aanmerking moeten kunnen komen, of ze nu WTO-lid zijn of niet. Om ervoor te zorgen dat de juiste medicijnen bij de juiste patiënten terechtkomen, dienen niet-WTO-leden evenwel aan dezelfde eisen te voldoen als WTO-leden. Dat betekent dat ze moeten melden welke medicijnen nodig zijn en moeten voorkomen dat handelsstromen worden omgeleid, als ze op grond van het EU-mechanisme producten willen ontvangen.
Een andere belangrijke kwestie is de vergoeding voor octrooihouders. Ik denk dat we het er allemaal over eens zijn dat octrooihouders een vergoeding dienen te krijgen voor de zonder hun toestemming verleende licenties. Dat is een normaal rechtsbeginsel. In het belang van een zekere transparantie voor de industrie die investeert in de vervaardiging van medicijnen en als onderdeel van een algeheel compromispakket, steunen we de voorgestelde formule voor het berekenen van de vergoeding, die enige speelruimte biedt om gevallen afzonderlijk te bekijken.
Tot slot herhaal ik dat de Commissie nog steeds groot voorstander is van tijdige aanneming van deze verordening, zonder de algemene doelstelling uit het oog te verliezen om een werkbaar, transparant stelsel in te voeren waarvan bedrijven gebruik kunnen maken voor de uitvoer van medicijnen naar in nood verkerende landen. Ik doe een beroep op het Parlement om het ingediende compromispakket te steunen.
Het voorstel van de Commissie is erop gericht het besluit van 30 augustus 2003 van de Algemene Raad van de WTO op Europees niveau ten uitvoer te leggen. Dit besluit maakt het mogelijk geoctrooieerde medicijnen te vervaardigen voor export naar in nood verkerende landen. Dit besluit behelst een opschorting van de normale octrooiregels, met name de regels in de TRIPs-overeenkomst van de WTO. Dit moet gezien worden in de bredere context van bestaande nationale en internationale kaders voor octrooibescherming.
De besprekingen in de WTO die tot het besluit van 30 augustus hebben geleid, waren lang en ingewikkeld. Het besluit zelf is de neerslag van een breekbaar evenwicht tussen de noodzaak om nu medicijnen beschikbaar te stellen aan landen met volksgezondheidsproblemen en de noodzaak om in de toekomst de ontwikkeling van nieuwe medicijnen te stimuleren door te investeren in onderzoek en innovatie onder bescherming van het octrooistelsel. We hebben getracht dit evenwicht in het voorstel van de Commissie weer te geven.
Zoals velen van u weten, is het besluit zelf een tijdelijke maatregel. Het besluit blijft van kracht tot de TRIPs-overeenkomst definitief is geamendeerd. De onderhandelingen over een wijziging zijn nog niet afgerond, hoewel er reeds verschillende einddata zijn overschreden. De kwestie betreffende de verlening van dwanglicenties blijft dus op de agenda van de WTO staan. Dat is voor ons echter geen reden voor uitstel: door onze verordening zo snel mogelijk te laten ingaan, stellen we in nood verkerende landen en Europese producenten van farmaceutische producten in staat om gebruik te maken van de mechanismen die wij invoeren. Alledrie de instellingen, het Parlement, de Raad en de Commissie, hebben zich uitgesproken vóór een tijdige overeenkomst over de verordening en met dat doel zijn intensieve informele besprekingen gevoerd. Deze besprekingen waren niet altijd gemakkelijk, maar ze zijn in een geest van goede samenwerking gevoerd en ik moet de heer Van Hecke wederom feliciteren met de resultaten die aantonen hoe goed de samenwerking tussen de instellingen kan zijn.
Ik ben heel blij dat deze besprekingen een compromispakket hebben opgeleverd. Ik kan u wel vertellen dat de Commissie zo’n pakket amendementen kan steunen, mits het in zijn geheel en zonder toevoegingen of weglatingen door de stemming komt.
Waar is het voorstel van de Commissie op gericht? Het bevat een mechanisme dat is afgestemd op het WTO-besluit, zodat bedrijven in de EU een licentie kunnen aanvragen om zonder de toestemming van de octrooihouder farmaceutische producten te vervaardigen voor uitvoer naar in nood verkerende landen met volksgezondheidsproblemen. We hebben geprobeerd een instrument op te stellen dat het mogelijk maakt de dwanglicentieprocedure van het WTO-besluit in te passen in de bestaande octrooiwetgeving van de lidstaten en de dwanglicentieprocedures die krachtens die wetgeving gelden.
Een instrument op EU-niveau bedoeld om het WTO-besluit ten uitvoer te leggen, heeft een grote symbolische waarde, omdat de rest van de wereld dan kan zien dat de EU zich gebonden acht aan het besluit. Tegelijkertijd moeten we ons houden aan het subsidiariteits- en proportionaliteitsbeginsel om zo te voorkomen dat we bepaalde details regelen die beter kunnen worden geregeld in de nationale wetgeving of door de bevoegde autoriteit die de licentieaanvraag verwerkt.
Het werk van het Parlement heeft een nuttige verduidelijking opgeleverd, met name de uitleg omtrent de betrokkenheid van niet-gouvernementele en internationale organisaties. We hebben ons altijd voorgesteld dat dergelijke organisaties in potentie bij aanschafprocedures betrokken zijn en in staat zijn om namens een invoerend land met de toestemming van dat land verzoeken te doen. Het ligt natuurlijk niet voor de hand dat zulke organisaties zelf farmaceutische producten gaan vervaardigen, maar als ze dat wel zouden doen, zouden ze op grond van de verordening net als iedere andere producent gewoon een licentie kunnen aanvragen.
Een andere nuttige verduidelijking is de verbetering van de tekst waar het gaat om de mogelijkheid gebruik te maken van de wetenschappelijke adviesprocedure van de EU of vergelijkbare nationale procedures om de veiligheid en de werkzaamheid van medicijnen bestemd voor uitvoer vast te stellen. Dat is niet in het WTO-besluit geregeld. Dat ligt buiten het raamwerk van het besluit, maar om invoerende landen te helpen, vonden we het een noodzakelijke aanvulling op het licentiemechanisme."@nl3
"Mr President, let me start by thanking Mr Van Hecke, the rapporteur, for the hard work he has put into this dossier. I would also like to thank the shadow rapporteurs and the members of all the committees involved. They have also made a major contribution to the work of Parliament on this file.
Let me now turn to the overall scope of the regulation. The WTO decision provides for export of medicines to WTO members who are least-developed countries or who are developing countries with insufficient manufacturing capacity of their own. There is no specific restriction on the pharmaceutical products covered, although there is acknowledgement that they are required to address public health problems, since that is in the context of the decision. The Commission originally took the view that we should reflect faithfully the scope of the decision as regards the countries eligible to receive exported medicines. That position was based on our assessment of the WTO decision, which specifically covers WTO members as beneficiary countries. I am pleased to say that since then we have accepted humanitarian arguments that all least-developed countries and certain low-income developing countries should be eligible, regardless of whether they are currently WTO members. At the same time, to help ensure that the right medicines get to the right patients, non-WTO members are also expected to make similar commitments to those required from WTO members. This means they should notify what medicines are required and commit to preventing trade diversion if they are to receive products under the EU mechanism.
Another important issue is the question of remuneration for patent holders. I do not think there is any disagreement that patent holders should receive some remuneration for the licences granted without their authorisation. This is a normal principle of law. In the interests of a certain transparency for industry investing in the production of medicines, and as part of the overall compromise package, we could support the proposed formula for remuneration which still leaves some leeway for determination on a case-by-case basis.
Let me conclude at this point by reiterating that the Commission remains very much in favour of the early adoption of this regulation, while respecting the overall objective of introducing a workable, transparent system which companies are able to use for the export of medicines to countries in need. I would call on Parliament to support the compromise package which is on the table.
The proposal from the Commission aims to implement at EU level the WTO General Council Decision of 30 August 2003, allowing copies of patented medicines to be produced for export to countries in need. This decision represents a waiver from the normal rules of patent law, particularly those set out in the WTO TRIPs Agreement. It has to be seen within the wider context of existing national and international frameworks for patent protection.
The discussions in the WTO leading up to the decision of 30 August were long and complex. The decision itself represents a delicate balance between the need to ensure access now to medicines for countries with public health problems, and the need to encourage development in the future of new medicines, through investment in research and innovation protected under the patent system. We have sought to reflect that balance in the Commission’s proposal.
As many of you will know, the decision itself is a temporary measure. It will remain in force until a permanent amendment is made to the TRIPs Agreement. The negotiations on such an amendment have not yet been successful, despite several deadlines having passed. The compulsory licensing issue thus remains on the agenda of the WTO. However, that is no reason for us to delay: bringing our regulation into force as early as possible will allow countries in need and EU producers of pharmaceuticals to use the mechanism we are putting in place. Indeed, all three institutions, Parliament, the Council and the Commission, have supported the principle of early agreement on the regulation, and intensive informal discussions have been taking place with that in mind. While these discussions have not always been easy, they took place in a spirit of good cooperation, and I must congratulate Mr Van Hecke again on the results which show how well the institutions can work together.
I am very pleased that these discussions have resulted in a compromise package. I should say now that the Commission could support such a package of amendments if it is voted through in its entirety and without any additions or subtractions.
What is the Commission’s proposal aiming to do? It sets out a mechanism in line with the WTO decision so that companies in the EU can apply for a licence to manufacture, without the authorisation of the patent holder, pharmaceutical products for export to countries in need of medicines and facing public health concerns. We have tried to produce an instrument that will allow the compulsory licensing procedure of the WTO decision to fit within the context of Member States’ existing national patent law and the compulsory licensing procedures they already have under that law.
An instrument at EU level implementing the WTO decision has great symbolic value as an external demonstration of the EU’s commitment to the decision. At the same time, we have to respect the principles of subsidiarity and proportionality, and so avoid regulating specific details which can better be dealt with under national law or by the competent authority which is processing the licensing application.
Parliament’s work has resulted in some helpful clarification, particularly as regards an explanation of the involvement of non-governmental and international organisations. We have always envisaged such organisations as being potentially involved in any purchasing procedures, and able to make requests on behalf of an importing country with that country’s approval. Of course it is unlikely that such organisations will themselves be manufacturing pharmaceuticals, but if they were they could simply apply for a licence under the regulation like any other manufacturer.
Another useful clarification has been improvement of the text relating to the possibility of using the EU’s scientific opinion procedure, or equivalent national procedures, to certify the safety and efficacy of medicines for export. This is not something regulated in the WTO decision, indeed it lies outside that framework. But in order to assist importing countries we felt it was a necessary complement to the licensing mechanism."@pl16
"Senhor Presidente, Senhoras e Senhores Deputados, permitam-me começar por agradecer ao relator, o senhor deputado Van Hecke, pelo árduo trabalho que devotou a este dossiê. Gostaria igualmente de agradecer aos relatores-sombra e aos membros de todas as comissões especializadas envolvidos neste projecto. Deram igualmente um importante contributo para o trabalho do Parlamento relativamente a este dossiê.
Permitam-me abordar agora o âmbito geral do regulamento. A decisão da OMC estipula a exportação de medicamentos para membros da OMC que sejam países menos desenvolvidos ou países em desenvolvimento com insuficiente capacidade de produção própria. Não existe qualquer restrição específica quanto aos produtos farmacêuticos abrangidos, embora seja reconhecida a necessidade de estes se destinarem a problemas de saúde pública, uma vez que é esse o contexto da decisão. A Comissão pensou, no início, que deveríamos reproduzir fielmente o âmbito da decisão em relação aos países elegíveis para receber medicamentos exportados. Tal posição baseava-se na nossa avaliação da decisão da OMC que inclui especificamente membros da OMC como países beneficiários. É com satisfação que digo que, desde então, aceitámos argumentos de carácter humanitário no sentido de todos os países menos desenvolvidos e alguns países em desenvolvimento com baixos rendimentos poderem ser elegíveis, independentemente de serem presentemente membros da OMC. Ao mesmo tempo, para ajudar a assegurar que os medicamentos certos vão ter com as pessoas certas, os países não pertencentes à OMC terão de preencher os mesmos requisitos que os que pertencem. Quer isto dizer que devem comunicar os medicamentos de que necessitam e comprometer-se a impedir quaisquer desvios comerciais no caso de virem a receber produtos ao abrigo deste mecanismo da UE.
Outro importante aspecto é o da remuneração dos titulares das patentes. Penso não existir qualquer discordância em relação ao facto de os titulares das patentes deverem receber alguma compensação pelas licenças concedidas sem a sua autorização. Trata-se de um princípio normal do direito. A bem de uma certa transparência para a indústria que investe na produção de medicamentos e enquanto parte de um pacote de compromisso abrangente, poderíamos subscrever a fórmula proposta para a compensação, deixando esta ainda alguma margem para determinação caso a caso.
Permitam-me concluir, referindo que a Comissão é extremamente favorável a uma adopção atempada deste regulamento, respeitando em simultâneo o objectivo global de introdução de um sistema exequível e transparente que as empresas possam usar para exportar medicamentos para os países deles necessitados. Exorto o Parlamento a dar o seu apoio ao pacote de compromisso em apreço.
A proposta da Comissão tem como objectivo a implementação a nível da UE da decisão do Conselho Geral da OMC de 30 de Agosto de 2003, autorizando a produção de cópias de medicamentos patenteados para exportação com destino a países necessitados. Esta decisão representa uma derrogação às regras normais do direito de patentes, particularmente às que são impostas pelo Acordo TRIPS da OMC, sendo necessária a sua apreciação no âmbito mais alargado dos quadros existentes a nível nacional e internacional relativamente a protecção de patentes.
Os debates travados na OMC e que culminaram na decisão de 30 de Agosto foram morosos e complexos. A decisão em si constitui um delicado equilíbrio entre a necessidade de assegurar, neste momento, o acesso a medicamentos aos países com problemas de saúde pública e a necessidade de encorajar o desenvolvimento, no futuro, de novos medicamentos, através do investimento na investigação e na inovação sob a protecção do sistema de patentes. Procurámos dar conta deste equilíbrio na proposta da Comissão.
Como muito dos senhores saberão, a própria decisão constitui uma medida temporária. Manter-se-á em vigor até que uma alteração permanente seja feita ao Acordo TRIPS. As negociações sobre tal alteração ainda não foram concluídas com êxito, apesar dos vários prazos entretanto ultrapassados. Deste modo, a questão da licença obrigatória continua ainda na ordem do dia da OMC. No entanto, isso não constitui motivo para que protelemos: implementar o nosso regulamento tão rapidamente quanto possível permitirá aos países necessitados e aos fabricantes de produtos farmacêuticos da UE a utilização do mecanismo que estamos a criar. Na verdade, as três Instituições, Parlamento, Conselho e Comissão, apoiaram o princípio de um acordo a montante sobre o regulamento, tendo sido realizadas discussões informais intensas, tendo em conta este ponto. Se bem que estas discussões nem sempre tenham sido fáceis, tiveram lugar num espírito de grande cooperação, sendo forçoso felicitar mais uma vez o senhor deputado Van Hecke pelos resultados obtidos e que demonstram como as Instituições conseguem funcionar em conjunto.
Muito me apraz que estas discussões tenham resultado num pacote de compromisso. Devo referir neste momento que a Comissão poderia dar o seu apoio a um pacote de alterações deste tipo, se este for votado na sua totalidade e sem quaisquer adições ou subtracções.
O que pretende a proposta da Comissão? Estabelece um mecanismo em consonância com a decisão da OMC, de modo a permitir que as empresas da UE possam requerer uma licença, sem autorização do titular da patente, para fabrico de produtos farmacêuticos destinados a exportação para países necessitados de medicamentos e enfrentando graves problemas de saúde pública. Tentámos obter um instrumento que permita que o procedimento de concessão de licença obrigatória da decisão da OMC se enquadre no contexto da legislação sobre patentes, existente nos Estados-Membros, bem como nos procedimentos de concessão de licença obrigatória já existentes no âmbito dessa legislação.
Um instrumento ao nível da UE, implementando a decisão da OMC, possui grande valor simbólico enquanto demonstração externa do empenhamento da UE em relação a essa decisão. Ao mesmo tempo, temos de respeitar os princípios da subsidiariedade e da proporcionalidade, evitando assim regulamentar pormenores específicos que podem ser tratados de uma forma mais correcta ao abrigo da legislação nacional e pela autoridade competente que se encontra a processar o requerimento para concessão de licença.
O trabalho do Parlamento teve como resultado alguma clarificação útil, particularmente no que se refere a uma explicação quanto ao envolvimento de organizações não governamentais e de organizações internacionais. Sempre considerámos tais organizações como potencialmente envolvidas em quaisquer procedimentos de aquisição e capazes de efectuarem pedidos em nome de um país importador, com a aprovação desse mesmo país. Claro que não é provável serem tais organizações a fabricar produtos farmacêuticos, mas se fossem, poderiam simplesmente requerer uma licença no âmbito deste regulamento, tal como qualquer outro fabricante.
Outro esclarecimento útil foi a melhoria do texto no que respeita à possibilidade de utilizar o procedimento de emissão de parecer científico da UE, ou procedimentos nacionais equivalentes, para certificar a segurança e a eficácia dos medicamentos para a exportação. Este ponto não se encontra regulamentado na decisão da OMC, estando inclusive situado fora deste enquadramento, mas, numa perspectiva de ajuda aos países importadores, pensámos tratar-se de um complemento necessário ao mecanismo de licenciamento."@pt17
"Mr President, let me start by thanking Mr Van Hecke, the rapporteur, for the hard work he has put into this dossier. I would also like to thank the shadow rapporteurs and the members of all the committees involved. They have also made a major contribution to the work of Parliament on this file.
Let me now turn to the overall scope of the regulation. The WTO decision provides for export of medicines to WTO members who are least-developed countries or who are developing countries with insufficient manufacturing capacity of their own. There is no specific restriction on the pharmaceutical products covered, although there is acknowledgement that they are required to address public health problems, since that is in the context of the decision. The Commission originally took the view that we should reflect faithfully the scope of the decision as regards the countries eligible to receive exported medicines. That position was based on our assessment of the WTO decision, which specifically covers WTO members as beneficiary countries. I am pleased to say that since then we have accepted humanitarian arguments that all least-developed countries and certain low-income developing countries should be eligible, regardless of whether they are currently WTO members. At the same time, to help ensure that the right medicines get to the right patients, non-WTO members are also expected to make similar commitments to those required from WTO members. This means they should notify what medicines are required and commit to preventing trade diversion if they are to receive products under the EU mechanism.
Another important issue is the question of remuneration for patent holders. I do not think there is any disagreement that patent holders should receive some remuneration for the licences granted without their authorisation. This is a normal principle of law. In the interests of a certain transparency for industry investing in the production of medicines, and as part of the overall compromise package, we could support the proposed formula for remuneration which still leaves some leeway for determination on a case-by-case basis.
Let me conclude at this point by reiterating that the Commission remains very much in favour of the early adoption of this regulation, while respecting the overall objective of introducing a workable, transparent system which companies are able to use for the export of medicines to countries in need. I would call on Parliament to support the compromise package which is on the table.
The proposal from the Commission aims to implement at EU level the WTO General Council Decision of 30 August 2003, allowing copies of patented medicines to be produced for export to countries in need. This decision represents a waiver from the normal rules of patent law, particularly those set out in the WTO TRIPs Agreement. It has to be seen within the wider context of existing national and international frameworks for patent protection.
The discussions in the WTO leading up to the decision of 30 August were long and complex. The decision itself represents a delicate balance between the need to ensure access now to medicines for countries with public health problems, and the need to encourage development in the future of new medicines, through investment in research and innovation protected under the patent system. We have sought to reflect that balance in the Commission’s proposal.
As many of you will know, the decision itself is a temporary measure. It will remain in force until a permanent amendment is made to the TRIPs Agreement. The negotiations on such an amendment have not yet been successful, despite several deadlines having passed. The compulsory licensing issue thus remains on the agenda of the WTO. However, that is no reason for us to delay: bringing our regulation into force as early as possible will allow countries in need and EU producers of pharmaceuticals to use the mechanism we are putting in place. Indeed, all three institutions, Parliament, the Council and the Commission, have supported the principle of early agreement on the regulation, and intensive informal discussions have been taking place with that in mind. While these discussions have not always been easy, they took place in a spirit of good cooperation, and I must congratulate Mr Van Hecke again on the results which show how well the institutions can work together.
I am very pleased that these discussions have resulted in a compromise package. I should say now that the Commission could support such a package of amendments if it is voted through in its entirety and without any additions or subtractions.
What is the Commission’s proposal aiming to do? It sets out a mechanism in line with the WTO decision so that companies in the EU can apply for a licence to manufacture, without the authorisation of the patent holder, pharmaceutical products for export to countries in need of medicines and facing public health concerns. We have tried to produce an instrument that will allow the compulsory licensing procedure of the WTO decision to fit within the context of Member States’ existing national patent law and the compulsory licensing procedures they already have under that law.
An instrument at EU level implementing the WTO decision has great symbolic value as an external demonstration of the EU’s commitment to the decision. At the same time, we have to respect the principles of subsidiarity and proportionality, and so avoid regulating specific details which can better be dealt with under national law or by the competent authority which is processing the licensing application.
Parliament’s work has resulted in some helpful clarification, particularly as regards an explanation of the involvement of non-governmental and international organisations. We have always envisaged such organisations as being potentially involved in any purchasing procedures, and able to make requests on behalf of an importing country with that country’s approval. Of course it is unlikely that such organisations will themselves be manufacturing pharmaceuticals, but if they were they could simply apply for a licence under the regulation like any other manufacturer.
Another useful clarification has been improvement of the text relating to the possibility of using the EU’s scientific opinion procedure, or equivalent national procedures, to certify the safety and efficacy of medicines for export. This is not something regulated in the WTO decision, indeed it lies outside that framework. But in order to assist importing countries we felt it was a necessary complement to the licensing mechanism."@sk18
"Mr President, let me start by thanking Mr Van Hecke, the rapporteur, for the hard work he has put into this dossier. I would also like to thank the shadow rapporteurs and the members of all the committees involved. They have also made a major contribution to the work of Parliament on this file.
Let me now turn to the overall scope of the regulation. The WTO decision provides for export of medicines to WTO members who are least-developed countries or who are developing countries with insufficient manufacturing capacity of their own. There is no specific restriction on the pharmaceutical products covered, although there is acknowledgement that they are required to address public health problems, since that is in the context of the decision. The Commission originally took the view that we should reflect faithfully the scope of the decision as regards the countries eligible to receive exported medicines. That position was based on our assessment of the WTO decision, which specifically covers WTO members as beneficiary countries. I am pleased to say that since then we have accepted humanitarian arguments that all least-developed countries and certain low-income developing countries should be eligible, regardless of whether they are currently WTO members. At the same time, to help ensure that the right medicines get to the right patients, non-WTO members are also expected to make similar commitments to those required from WTO members. This means they should notify what medicines are required and commit to preventing trade diversion if they are to receive products under the EU mechanism.
Another important issue is the question of remuneration for patent holders. I do not think there is any disagreement that patent holders should receive some remuneration for the licences granted without their authorisation. This is a normal principle of law. In the interests of a certain transparency for industry investing in the production of medicines, and as part of the overall compromise package, we could support the proposed formula for remuneration which still leaves some leeway for determination on a case-by-case basis.
Let me conclude at this point by reiterating that the Commission remains very much in favour of the early adoption of this regulation, while respecting the overall objective of introducing a workable, transparent system which companies are able to use for the export of medicines to countries in need. I would call on Parliament to support the compromise package which is on the table.
The proposal from the Commission aims to implement at EU level the WTO General Council Decision of 30 August 2003, allowing copies of patented medicines to be produced for export to countries in need. This decision represents a waiver from the normal rules of patent law, particularly those set out in the WTO TRIPs Agreement. It has to be seen within the wider context of existing national and international frameworks for patent protection.
The discussions in the WTO leading up to the decision of 30 August were long and complex. The decision itself represents a delicate balance between the need to ensure access now to medicines for countries with public health problems, and the need to encourage development in the future of new medicines, through investment in research and innovation protected under the patent system. We have sought to reflect that balance in the Commission’s proposal.
As many of you will know, the decision itself is a temporary measure. It will remain in force until a permanent amendment is made to the TRIPs Agreement. The negotiations on such an amendment have not yet been successful, despite several deadlines having passed. The compulsory licensing issue thus remains on the agenda of the WTO. However, that is no reason for us to delay: bringing our regulation into force as early as possible will allow countries in need and EU producers of pharmaceuticals to use the mechanism we are putting in place. Indeed, all three institutions, Parliament, the Council and the Commission, have supported the principle of early agreement on the regulation, and intensive informal discussions have been taking place with that in mind. While these discussions have not always been easy, they took place in a spirit of good cooperation, and I must congratulate Mr Van Hecke again on the results which show how well the institutions can work together.
I am very pleased that these discussions have resulted in a compromise package. I should say now that the Commission could support such a package of amendments if it is voted through in its entirety and without any additions or subtractions.
What is the Commission’s proposal aiming to do? It sets out a mechanism in line with the WTO decision so that companies in the EU can apply for a licence to manufacture, without the authorisation of the patent holder, pharmaceutical products for export to countries in need of medicines and facing public health concerns. We have tried to produce an instrument that will allow the compulsory licensing procedure of the WTO decision to fit within the context of Member States’ existing national patent law and the compulsory licensing procedures they already have under that law.
An instrument at EU level implementing the WTO decision has great symbolic value as an external demonstration of the EU’s commitment to the decision. At the same time, we have to respect the principles of subsidiarity and proportionality, and so avoid regulating specific details which can better be dealt with under national law or by the competent authority which is processing the licensing application.
Parliament’s work has resulted in some helpful clarification, particularly as regards an explanation of the involvement of non-governmental and international organisations. We have always envisaged such organisations as being potentially involved in any purchasing procedures, and able to make requests on behalf of an importing country with that country’s approval. Of course it is unlikely that such organisations will themselves be manufacturing pharmaceuticals, but if they were they could simply apply for a licence under the regulation like any other manufacturer.
Another useful clarification has been improvement of the text relating to the possibility of using the EU’s scientific opinion procedure, or equivalent national procedures, to certify the safety and efficacy of medicines for export. This is not something regulated in the WTO decision, indeed it lies outside that framework. But in order to assist importing countries we felt it was a necessary complement to the licensing mechanism."@sl19
".
Herr talman! Låt mig börja med att tacka föredraganden Johan Van Hecke för hans hårda arbete med detta ärende. Jag vill också tacka skuggföredragandena och ledamöterna i alla delaktiga utskott. De har också bidragit stort till parlamentets arbete med denna fråga.
Låt mig nu övergå till förordningens allmänna räckvidd. I WTO:s beslut föreskrivs export av läkemedel till WTO-medlemmar som är minst utvecklade länder eller utvecklingsländer och vars egen tillverkningskapacitet inte är tillräcklig. Det finns inga särskilda restriktioner för de läkemedelsprodukter som omfattas, även om det medges att de måste vara inriktade på folkhälsoproblem, eftersom det är vad beslutet rör. Kommissionen ansåg till en början att vi troget borde återspegla beslutets räckvidd vad gäller de länder som är berättigade att ta emot exporterade läkemedel. Denna ståndpunkt byggde på vår bedömning av WTO-beslutet, som särskilt omfattar WTO-medlemmar som mottagarländer. Det gläder mig att säga att vi sedan dess har godkänt humanitära argument om att alla minst utvecklade länder och vissa fattiga utvecklingsländer borde vara berättigade, oavsett om de för närvarande är WTO-medlemmar eller inte. Samtidigt förväntas icke-WTO-medlemmar också göra liknande åtaganden som de som krävs av WTO-medlemmar, för att hjälpa till att garantera att rätt läkemedel kommer till rätt patient. Detta innebär att de måste tillkännage vilka läkemedel som behövs och förbinda sig att förhindra att handeln avleds om de ska ta emot produkter i enlighet med EU-mekanismen.
En annan viktig fråga är frågan om ersättning för patenthavare. Jag tror inte att det finns några meningsskiljaktigheter när det gäller att patenthavare borde få viss ersättning för de licenser som beviljas utan deras tillstånd. Detta är en normal lagstiftningsprincip. För att gynna en viss insyn för den industri som investerar i läkemedelsproduktion, och som en del av det allmänna kompromisspaketet, skulle vi kunna stödja den föreslagna ersättningsmodellen som fortfarande lämnar ett visst utrymme för avgöranden från fall till fall.
Låt mig nu avsluta med att upprepa att kommissionen fortfarande starkt stöder ett tidigt antagande av förordningen, samtidigt som den respekterar det allmänna målet med att införa ett fungerande och öppet system som företagen kan använda för export av läkemedel till länder som har behov av dem. Jag vill uppmana parlamentet att stödja det kompromisspaket som lagts fram.
Kommissionens förslag syftar till att på EU-nivå genomföra beslutet av den 30 augusti 2003 från WTO:s allmänna råd, genom vilket kopior av patenterade läkemedel får tillverkas för export till länder som har behov av dem. Detta beslut utgör ett undantag från de normala bestämmelserna i patentlagstiftningen, särskilt de som fastställs i WTO:s TRIPs-avtal. Beslutet måste betraktas i det vidare sammanhanget med de befintliga nationella och internationella ramarna för patentskydd.
De diskussioner inom WTO som ledde fram till beslutet den 30 augusti var långdragna och komplexa. Själva beslutet utgör en vansklig balans mellan behovet av att garantera omedelbar tillgång till läkemedel för länder med folkhälsoproblem, och behovet av att uppmuntra den framtida utvecklingen av nya läkemedel genom investeringar i forskning och innovation som skyddas enligt patentsystemet. Vi har försökt att återspegla denna balans i kommissionens förslag.
Liksom många av er känner till är själva beslutet en tillfällig åtgärd. Det kommer att fortsätta att gälla till dess att TRIPs-avtalet ändras permanent. Förhandlingarna om en sådan ändring har ännu inte varit framgångsrika, trots att flera tidsfrister har passerat. Frågan om obligatoriska licenser kvarstår alltså på WTO:s agenda. Det är dock inget skäl att fördröja frågan: att förordningen träder i kraft så snart som möjligt gör att de länder som behöver läkemedlen och EU:s läkemedelsproducenter kan använda den mekanism som vi inför. Samtliga tre institutioner, parlamentet, rådet och kommissionen, har faktiskt stött principen med att snabbt enas om förordningen, och intensiva formella diskussioner har ägt rum med detta i åtanke. Samtidigt som dessa diskussioner inte alltid har varit enkla har de ägt rum i en god samarbetsanda, och jag måste återigen gratulera Johan Van Hecke till de resultat som visar hur väl institutionerna kan samarbeta.
Det gläder mig mycket att dessa diskussioner har resulterat i ett kompromisspaket. Jag vill nu säga att kommissionen kan stödja ett paket med ändringsförslag om det röstas igenom i sin helhet och utan att något läggs till eller tas bort.
Vad syftar kommissionens förslag till? I förslaget inrättas en mekanism i enlighet med WTO:s beslut så att EU-företag kan ansöka om en licens för tillverkning av läkemedelsprodukter, utan patentinnehavarens tillstånd, för export till länder som behöver läkemedel och som har folkhälsoproblem. Vi har försökt att ta fram ett instrument som gör att förfarandet med obligatoriska licenser från WTO-beslutet kan passas in i medlemsstaternas befintliga nationella patentlagstiftning och de förfaranden för obligatoriska licenser som redan finns i denna lagstiftning.
Ett EU-instrument för tillämpning av WTO:s beslut har stort symbolvärde som en extern demonstration av EU:s åtagande i fråga om beslutet. Samtidigt måste vi respektera subsidiaritets- och proportionalitetsprinciperna, för att därigenom undvika att reglera specifika detaljer som bättre kan hanteras i den nationella lagstiftningen eller av den behöriga myndighet som hanterar licensansökan.
Parlamentets arbete har resulterat i vissa nyttiga klargöranden, särskilt vad gäller en förklaring av icke-statliga och internationella organisationers delaktighet. Vi har alltid förutsett att sådana organisationer skulle kunna delta i eventuella upphandlingsförfaranden, och göra förfrågningar till förmån för ett importerande land med detta lands godkännande. Det är naturligtvis osannolikt att sådana organisationer själva kommer att tillverka läkemedel, men om de gjorde det skulle de helt enkelt kunna ansöka om en licens i enlighet med förordningen som vilken tillverkare som helst.
Ett annat nyttigt klargörande har varit förbättringen av texten om möjligheten att använda EU:s förfarande med vetenskapliga yttranden, eller motsvarande nationella förfaranden, för att intyga säkerheten och effektiviteten hos de läkemedel som ska exporteras. Detta regleras inte i WTO:s beslut, utan ligger faktiskt utanför den ramen. Men för att hjälpa de importerande länderna ansåg vi att det var ett nödvändigt komplement till licensmekanismen."@sv21
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