Dutch Call To Add PMS, PE To EU Drug Approvals

The Dutch Sickfund Council has stated that the Netherlands should useits presidency of the European Union to implement a significant revision of European drug approval requirements. Post-marketing surveillance should become part of the procedure, it says, and pharmaceutical companies should be required to supply pharmacoeconomic studies to indicate their new products' advantages over existing ones.

Pharmaceutical manufacturers should be required to supply more proof of efficacy than is now the case for new and very expensive drugs, and a new criterion of quality of life should be introduced, according to the Council. If pharmacoeconomic studies show that use of the drug can increase not only the patient's life but also its quality, then the the product should be rewarded with financial benefits, it adds.

Advice Sought On Reimbursing Anticancer Drugs The Council made its proposals in draft recommendations sent to Health Minister Els Borst, at her request, regarding the economic implications of reimbursing the anticancer drugs Taxol (paclitaxel) and Taxotere (docetaxol). Mrs Borst had asked the Council for its advice on this matter last October, and its final recommendations are expected soon. The draft advice from the Council comments that there are significant differences in the information required to register a new drug product in Europe and that which is needed to judge whether or not it should be reimbursed.