Health professionals, consumer groups and industry trade associations have helped in shaping the new marketing authorization system for Europe. It is, in fact, a virtual networking organization, outsourcing scientific evaluation to 2,300 experts from 26 national agencies throughout the EU as well as Iceland and Norway. This was done within a time frame of 240 days. 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.