Commission Decision
of 26 March 2004
granting Australia and New Zealand temporary access to the Community reserves of foot-and-mouth disease virus antigens
(notified under document number C(2004) 967)
(Text with EEA relevance)
(2004/288/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES
,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 2003/85/EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and Decision 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC(1), and in particular Article 83(3) thereof,
Whereas:
(1) In accordance with Council Decision 91/666/EEC of 11 December 1991 establishing Community reserves of foot-and-mouth disease vaccines(2), stocks of antigens for the express formulation into vaccines against foot-and-mouth disease have been established.
(2) Pending the completion of their own arrangements for reserves of foot-and-mouth disease virus antigens, Australia and New Zealand have requested temporary assistance from the Community in case emergency vaccination would be introduced to control a possible foot-and-mouth disease outbreak.
(3) The competent authorities of Australia and New Zealand have provided information on their risk assessment and estimates of the quantities and subtypes of antigens required within the framework of their contingency plans.
(4) Following the assessment of the request made by the authorities of Australia and New Zealand and taking into account the capacity and availability of the quantities and subtypes of antigens stored in the Community antigen reserves, it appears that the requested assistance could be provided without unnecessarily compromising the Community contingency arrangements.
(5) Australia and New Zealand should be granted temporary access to the Community antigen reserves subject to certain conditions.
(6) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
Australia and New Zealand are granted temporary access to the Community reserves of antigens for the formulation of vaccines against foot-and-mouth disease under the following conditions:
1. access shall be granted until 31 December 2004, in the form of drawing rights for each of the two countries concerned for a maximum of 500000 vaccine equivalent cattle doses and in any case for both countries together not more than 50 % of the existing stocks of each of the antigens in the Community reserves;
2. depending on the specification in the written request by the competent authorities of Australia or New Zealand, the Commission shall immediately arrange for the urgent or immediate formulation of the appropriate antigens and the production, bottling, labelling and delivery of the vaccines under the terms of existing contracts concluded between itself and the manufacturer;
3. the Commission shall make arrangements so as to ensure that in the event referred to in paragraph 2 the costs for the following actions are born in appropriate proportions by the competent authorities of Australia or New Zealand, whoever has requested the formulation into vaccines of antigens stored in the Community reserves:
(a) the transfer of antigens from the place of storage to the establishment of the manufacturer;
(b) the formulation and production of vaccines, including any additional testing that might prove necessary;
(c) the bottling and labelling of the vaccines and their transport to the indicated place of delivery;
(d) the replacement without delay of any used quantity of antigen by antigens of at least the same quality and origin.
This Decision is addressed to the Member States.