Abstract
In November 1990, the European Commission (the commission) proposed a new European Community (EC) marketing approval system for human and veterinary medicinal products, wherein decisions would be binding on all Member States. As proposed, the new system was to be firmly grounded in science and medicine, independent as far as possible from national or local influence. The intent was to create an EC regulatory process that would reflect community, rather than local, interests.
In December 1992, the Council of Ministers (the council) broke a political deadlock that at one point threatened the withdrawal of the whole legislative package from further consideration. The problem had been national sovereignty and the manner in which a final decision under the binding central decision making process was to be made. In its common position, the council added formidable political checks and balances that guarantee Member State influence in every nook and cranny of the process.
In the post-1995 EC, the success of the new system will depend on Member States finding a new sense of mutual trust and collective action. For companies, success will depend on their ability to review and reassess existing product development and marketing strategies now, in light of the changes wrought by the council's common position.
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