Full House at TOPRA New Medicines Legislation Conference

6th April 2006 - Tuesday saw TOPRA host another highly successful conference: New Medicines Legislation - six months post implementation - How does it affect me and what is the future direction? Delegates were updated on the scope and status of new European legislation from the perspectives of the patient, the industry and the legislator.

A wide range of speakers presented including representatives from the EMEA, the industry, the European Commission, national competent authorities and patient groups. The panel contemplated some key topical questions from the floor; the exact nature of transparency was debated as were potential solutions to conflict of interest cases and non-transposition of EU directives by many member states.

Brenton James, Consultant in Strategic Regulatory Affairs in the EU and TOPRA Board Director, opened the meeting. He made it clear that although procedurally some member states have not transposed the new directives into the domestic law, or have at least failed to communicate the stage of implementation they are at to the European Commission, the industry is encouraged that all member states do seem to be operating in practice according to the new legislation.

On the issue of transparency Nikos Dedes of the European AIDS Treatment Group believes it will mean a better overall understanding of how the system works. Other agency representatives agreed that a move to full openness should occur though there was warning that the side effect of being swamped in useless information would require management.

A further point put to the panel of speakers was that changing scientific advice in Europe has much to do before it 'catches up' with regulatory procedure in the USA. To this, Daniel Brasseur, Chairman of CHMP, emphasised that the agencies must be utilised to their maximum potential to ensure the very best in European standards is achieved.

Presentations by Peter Bogaert of Covington & Burling, Belgium, on financial penalties and Agnes Saint Raymond of the EMEA on the success of orphan drugs legislation drew to a close another triumphant conference for TOPRA. The organisation now looks forward to combining its European regulatory affairs expertise with that of regulatory affairs professionals in America through its first ever US conference, Scientific Advice, to be held on May 9th in Washington DC.