Co-decision procedure

The PEG has been transformed into Paediatric Working Party in relation to implementation of Regulation (EC) No 726/2004. On 29 September 2004, the EC released the first proposal for a Regulation on Medicinal Products for Paediatric Use together with an explanatory memorandum, the Extended Impact Assessment and questions and answers document. The proposal has now been presented to the Council of Ministers and the European Parliament and it will go through the co-decision procedure. The earliest that the proposal is likely to become law is late 2006. 

Finally, a legislative strategy could be devised to deal with the issues raised by State aid law in this field. As with the current EU ETS Directive, the relevant legal basis under the EC Treaty for such legislation would be Article 175(1) EC, which would require a proposal from the Commission and the involvement and ultimate joint agreement of the Council and the European Parliament under the so-called co-decision procedure of Article 251 EC. If this is the only way in which to achieve the desired changes, it is vital that moves begin as soon as possible this process can be... 

Originally the Treaty of Rome required unanimous assent for a matter to be adopted, but the subsequent Treaties of Maastricht and Amsterdam have considerably modified the procedure. These Treaties introduced a co-decision procedure, shown diagrammatically in Figure 1.3, whereby the Council of the European Union (Council) and the European Parhament (EP) work on an equal footing and have to agree the text of proposed new EU legislation before it can be adopted. Where EP and the Council cannot agree, a Conciliation Committee has to be established to resolve any differences. 

Figure 1.3 Diagram of the co-decision procedure for adoption of a directive...

Since the first edition was published, there have been a surprising number of developments in, and rationalization of, legislative requirements. There have also been changes in the way in which EU directives are adopted as a result of the co-decision procedure introduced by the Maastricht and Amsterdam Treaties. This has given the European Parliament a much greater say in the content of directives. 

Originally known as the European Economic Community (EEC) and then as the European Commrmity (EC) it is now usual to refer to the Community as the European Union (EU). The primary legislation is the Treaty of Rome 1957 which established the Community and was incorporated into UK law by the European Corranunities Act 1972 the Single Emopean Act 1985 was incorporated into UK law in 1986 and the Treaty of European Union 1991 (TEU) (the Maastricht Treaty), incorporated into UK law by the European Commrmities Act 1992. The TEU and the Treaty of Amsterdam 1997 , strengthen the role of the European Parliament (EP) by extending the scope of the co-decision procedure (outlined below). The Treaty of Nice 2001 is directed to enlargement of the Emopean Union. 

The co-decision procedure involves up to three readings in EP and in the Council and, should there be disagreement between the two institutions, requires a Conciliation Committee (of Council members and a like number of Parliamentary representatives) to resolve it. The Commission takes the necessary initiatives to administer the procedure. 

If, within six weeks of its being convened, the Conciliation Committee approves a joint text, EP acting by absolute majority and Council acting by qualified majority each have six weeks in which to adopt the joint text when the proposal as amended is deemed to be adopted. If either of the two bodies fails to approve the joint text, the proposal fails. Figure 1.1.10 illustrates the co-decision procedure. 

The co-decision process appEes whenever the Treaty refers to Article 251 EC (formerly 189b) for implementation procedure an example is Article 137 of the Treaty... 

For applications to be processed via the centralised procedure, the CHMP appoints one of its members to act as rapporteur for the coordination of the evaluation of an application for a marketing authorisation. The CHMP may, and usually does, also appoint a second member to act as co-rapporteur. For line extensions, the CHMP will decide on the need for appointment of a corapporteur on a case-by-case basis. All members have an equal opportunity to act as the rapporteur or co-rapporteur, and therefore the CHMP members are invited to express their preference regarding rapporteurships in writing in advance of the meeting at which rapporteurs are appointed. Rapporteurs are usually appointed at every other meeting to facilitate the decision making process as regards (co)-rapporteurships. 

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