The nature of their developing products means that BIA members will usually be concerned with the centralised procedure for authorisation, rather then the mutual recognition route. Within CPMP, the random choice of rapporteurs and co-rapporteurs leads to an undesirable element of chance in their recommendations. Disagreements between rapporteurs and co-rapporteurs is not unknown. The present situation provides for the individual national attitudes to influence decisions which should be based only on good science. It has been proposed that a single centralised decision-taking agency in Europe, using its own staff rather than the staff of other national authorities, would solve this problem.
Uncertainty is exacerbated because opportunities for discussion are limited.
Members have noted that the willingness of the FDA to have pre-submission meetings contrasts with that of the European system. MCA has indicated its willingness to participate in scientific discussions but with the proviso that resources must permit this. A separate issue is the unwillingness of EMEA to discuss issues with national trade associations, preferring instead to talk to Europe-wide bodies. There can be no doubt that local experience is vital in representing the views of smaller companies. Interaction between companies and regulators is limited by the resource available to regulators.