5 Amendments of Frédérique RIES related to 2011/0421(COD)
Amendment 38 #
Proposal for a decision
Recital 10
Recital 10
(10) The European Parliament in its resolution of 8 March 2011 and the Council in its Conclusions of 13 September 2010 stressed the need to introduce a common procedure for the joint procurement of medical countermeasures, and in particular of pandemic vaccines, to allow Member States, on a voluntary basis, to benefit from such group purchases. With regard to pandemic vaccines, in the context of limited production capacities at global level, such a procedure would increase the availis undertaken with the aim of enability of those products and ensure fairer access to them among Member States participating in the joint procurementng more equitable access to vaccines for the Member States involved, to help them better meet the vaccination needs of their citizens, in line with national vaccination policies.
Amendment 45 #
Proposal for a decision
Recital 17
Recital 17
(17) The applicability of some specific provisions of Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council and Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products, depends on the recognition at Union level in the framework of Decision 2119/98/EC, of an emergency situation or of a pandemic situation with respect to human influenza. Those provisions allow for the accelerated marketing of certain medicinal products in case of urgent needs, by means, respectively, of a conditional marketing authorisation and of the temporary possibility to grant a variation to the terms of a marketing authorisation for a human influenza vaccine even where certain non- clinical or clinical data are missing. However, in spite of the utility of such provisions in the event of a crisis, there is to date no specific procedure for issuing such recognitions at Union level. It is therefore appropriate to provide for such a procedure as part of the standards of quality and safety for medicinal products. The declaration of an emergency situation at Union level should be without prejudice to the effects of a decision taken by the World Health Organisation to trigger the production of vaccines from seasonal to pandemic
Amendment 70 #
Proposal for a decision
Article 4 – paragraph 2 – point iii a (new)
Article 4 – paragraph 2 – point iii a (new)
(iiia) specific mechanisms to monitor and report on vaccines coverage in respect of those listed in the Annex to Decision 2119/98/EC.
Amendment 80 #
Proposal for a decision
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
1a. The actors in the Early Warning and Response System shall perform their duties independently and in the public interest. Prior to taking up their duties, they shall make available a declaration of interests, setting out any activities or roles which may compromise their integrity. Those declarations should be updated when significant changes occur, or at least once a year
Amendment 91 #
Proposal for a decision
Article 10 – paragraph 2 – point c a (new)
Article 10 – paragraph 2 – point c a (new)
(ca) on the assessment of the World Health Organisation, when provided, in the case of an international public health emergency.