Local view for "http://purl.org/linkedpolitics/eu/plenary/2003-12-16-Speech-2-258"
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"en.20031216.6.2-258"2
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".
First of all, I would like to thank and warmly congratulate the two rapporteurs, Mrs Müller and Mrs Grossetête, for their work and efforts, particularly in the search for a global compromise with the Council.
Regarding the scope of the centralised procedure and the need to reinforce the role of the European Medicines Agency, despite your support during the first reading, the Council has taken a more limited approach on the scope. The common position did not follow the Commission and Parliament approach, but extended the current scope of the centralised procedure to some extent.
The current compromise further extends that scope, and more importantly, allows for future development. It takes account of some of the most important therapeutic needs of today and probably of the near future. The Commission welcomes the compromise solution.
More generally, the new legislation will consolidate the Agency’s international role and will increase its role in key sectors such as market surveillance, pharmacovigilance and public awareness of medicinal products. This development is also to be welcomed.
To perform these tasks, the Agency had to undergo some adjustment, and the compromise amendments related to its administrative structure, and in particular the composition of the management board and of the scientific committees, meet this objective on the whole.
Third, the environmental aspects. The possible effects of the use of medicinal products on the environment is important. The question needed to be addressed carefully as, at the end of the day, the availability of certain medicines was at stake. The compromise amendments, which require an environmental impact assessment and possible mitigating measures but leave the criteria for granting the marketing authorisation untouched, are to be seen as a well-balanced solution.
Fourth, the implementation of the Doha Decision concerning the granting of compulsory licences for the export of patented medicines to countries with insufficient manufacturing capacity. First of all, I would like to stress and reiterate the Commission’s political commitment to ensuring that the implementation of this decision is facilitated and that the right conditions are in place for its operation and efficient application.
However, Amendments Nos 6 and 19 pose a problem of form because a clause regulating the exports cannot be part of a directive dealing with the placing of medicines on the Community market. This proposal concerns only market authorisation in Europe. It in no way impacts on exports of medicines from Europe.
Nevertheless, the Commission fully agrees with the principle of the implementation of the WTO General Council Decision of 30 August 2003, both at Community and at Member State level, in the context of the patent legislation.
The Commission undertakes to address the implementation of this decision in the EU as a matter of the highest priority in early 2004 with a view to bringing forward an appropriate legislative proposal.
Finally, information to patients. The Commission’s attempt to modernise this part of the legislation has not been as fruitful as I would have wished. However, I am pleased to note that the issue is now part of the compromise. I would like to ensure that we make steady progress towards a future Community information strategy to deal with this question.
The review package, as originally proposed by the Commission, had three important objectives: first, to guarantee European citizens a high level of health protection; second, to increase the availability of innovative medicinal products while at the same time encouraging competition with generic products; and third, to prepare for enlargement. I am glad to note that the final compromise proposed by the two rapporteurs and by the Council would indeed meet these objectives.
Concerning recommendations for second reading from Mrs Müller and Mrs Grossetête, the Commission can accept entirely the global compromise package as proposed by the Council and accepted by the two rapporteurs. As to Mrs Müller's request, once the legislation is adopted my services will organise a hearing with a view to adequately implement Article 2(2), where all stakeholders will be given the possibility to have input.
This compromise allows the settlement of a number of important questions and a dynamic approach to the tasks of the agency and the scope of this centralised procedure. The proposed harmonisation of the data protection scheme, irrespective of the procedure used, is a major improvement. I would also like to reiterate the importance of the new environmental features introduced in the legislation.
As regards the veterinary legislation, we also note that if the provisions have been brought into line globally with those of the human medicinal products directive, some specificity has been adequately kept, in particular concerning environmental impact.
In the veterinary sector, environmental impact may determine the final authorisation of the given product and therefore constitutes a criterion for its evaluation.
In conclusion, I would like to urge Members of Parliament to support the two rapporteurs on the approval of the compromise so as to conclude, at this stage, the legislative process of the pharmaceutical review for the benefit of all European citizens.
Where the compromise amendments are concerned, I would like to concentrate on the most important issues. First, the data protection scheme and generic competition.
The Commission wanted to strike the right balance between innovation and generic competition by adjusting criteria for achieving it.
The measures in favour of generic competition we proposed were agreed upon and even improved on thanks to Parliament’s amendments during the first reading.
Regarding innovative industry, the Commission proposed harmonising the data protection period at 10 years across the board as an essential element for a smoother operation of the single market. This period also represented one of the major tools available in the context of pharmaceutical legislation for rewarding innovation. We also proposed a one-year extension when an innovative indication is granted after initial market authorisation. The current compromise, known as 8+2+1, meets our objectives and expectations. I am fully aware that the impact of this harmonisation in the new Member States was much discussed during the debate.
First, I would like to welcome the provision regarding the non-retroactivity of this harmonisation. This was a preoccupation of the acceding countries and is now a part of the compromise today. This provision will limit the effect of the new protection period to medicinal products authorised after the implementation of the directives.
Second, I would like to state that the Commission will give full consideration to any request for a transitional period presented by the new Member States on adoption of the legislative package.
The rest of the compromise on the data protection scheme and generic competition, including a one-year period in the case of switches and a one-year period for well-established substances in the case of innovative indication and clarification of generic and bio-similar definitions, is also welcome and acceptable to the Commission."@en1
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