Local view for "http://purl.org/linkedpolitics/eu/plenary/2005-11-30-Speech-3-176"
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"en.20051130.16.3-176"2
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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."@en1
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