The European Parliament and Council will conduct a wide-ranging discussion to review the drug authorization system in the coming years, in parallel to the setting up of the future European Food Safety Authority. Enlargement to a European Union of some 30 Member States will bring many new challenges. Market access is essentially a patient issue worldwide. The European system is designed to encourage research-based companies to develop and bring to market innovative drugs that meet patient needs. This now includes a new policy on orphan drugs for rare diseases, involving the EMEA, very similar to the US Orphan Drug Act.
Innovation brings with it risks.
Protecting and promoting public health needs to carefully balance the benefit and risk of new treatments and to verify that their safety profile remains acceptable in wide-scale use after authorization through an integrated Pharmacovigilance network. This harmonization process has been largely completed at the ICH5 meeting in San Diego in November 2000. In addition, the negotiation of Mutual Recognition Agreements on Good Manufacturing Practice for inspections has made significant progress between the EU and Australia, New Zealand and Canada. A similar confidence-building exercise is about to start with the US FDA inspection teams. All these joint efforts will prevent unnecessary duplication, promote the quality, safety and efficacy of drugs and help contain pharmaceutical Research and Development costs, in the interest of patients worldwide.