Het Europees registreren van geneesmiddelen; consequenties voor voorschrijver en patiënt

– Since the European Medicines Evaluation Agency (EMEA) in London started its activities, the registration of medicines in the European Union (EU) has gained momentum, and its relevance to national drug registration procedures is steadily increasing. Its main objectives are centralization and standardization of assessments and promoting free trade within the EU. From its early beginning the EMEA has promoted transparency and full disclosure of expert opinions. Since the EMEA is largely operating beyond the scope of the average prescriber and patient, an attempt was made at improving information, based on interviews of a number of responsible or interested persons and parties. Though the overall opinion seems favourable, the quality of the assessment reports has notably improved, and the implementation of decisions has gained speed, this has made little impact on medical practice. The approach towards collating reports of adverse drug reactions has been divisive, and feedback to reporting physicians has been largely neglected. The eventual introduction of the Eudrawatch database and further improvements in transparency will hopefully correct these initial problems. So far as legally possible national drug agencies should follow the example of EMEA by offering public disclosure of documents and expert opinions.