One of the hidden costs to patients of controlling prescription drug prices -- ostensibly to make them more "affordable" -- can be doing without new drug therapies. For many years, the U.S. Food & Drug Administration has been criticized for delaying final approval of new drugs' safety and effectiveness after the completion of clinical trials.

But in many European countries, after new drugs have been approved by the national ministries of health in each country or by the European Agency for the Evaluation of Medicines, patients must wait while drugs clear another hurdle.

This additional regulatory delay is a side effect of drug price controls. Before they can market a new medicine, pharmaceutical companies must obtain approval from each national government for the prices they charge. Then, in an often in a separate process, they must get approval of reimbursement rates without which the drugs are inaccessible to most patients.

As a result, access to breakthrough drugs is delayed sometimes four years or more in many European Union countries, according to two new studies by the London-based research organization, Europe Economics. For example,

• Patients in Spain, Greece and Portugal waited nearly three years for access to a major new cardiovascular drug after it was available in other EU countries.

• Patients were forced to wait more than four years in Greece and Portugal and for three years in Belgium and France before they could use a major new anti-infective therapy already available in other EU countries.

• Patients who needed a major new nervous system medication were denied access for nearly six additional years in Portugal and three years in France.

In 1995, EU Members began a centralized, marketing authorization process intended to ensure "rapid access" to new medications. But centralized approval has not reduced delays in the pricing and reimbursement processes.

Source: "In Europe, Access to New Medications Takes Time," September 28, 2000, Galen Institute, P.O. Box 19080, Alexandria, Va. 22320, (703) 299-8900; "Patient Access to Major Pharmaceutical Products in EU Member States," and "Patient Access to Pharmaceuticals Approved through Mutual Recognition," Europe Economics, Chancery House, 53-64 Chancery Lane, London, WC2A 1QU, United Kingdom, +44 (0)20 7831-4717.