This article is more than 5 years old. Information may no longer be current.
EC issues 'major' pharmaceutical reforms
Click Here to Manage Email Alerts
LONDON — The European Commission (EC) unveiled reforms today meant to speed up the drug approval process and allow pharmaceutical companies to advertise certain products directly to consumers.
The EC has been reviewing its drug regulatory procedures since it issued a final version of a review of pharmaceutical legislation in January. Among the objectives in the final version: Set up a legal framework that fosters competitiveness in the European pharmaceutical industry and simplifies the system. EC officials have voiced concern that Europe is at a competitive disadvantage to the United States because of its highly regulated system.
On average, pharmaceuticals are approved in about 14 months in the European Union (EU); the new proposal would shorten that time to less than 12 months. At the proposed pace, the approval time process would be quicker than that of the U.S. Food and Drug Administration.
A spokesman for Erkki Liikanen, European Commissioner for Enterprise and Information Society, also noted the proposals would allow companies to promote drugs for certain chronic illnesses, including AIDS, diabetes and asthma, directly to consumers for a trial period of 5 years. Mr. Liikanen's spokesman said U.S.-style television advertising would not be part of the consideration, but that the goal was to get information to those patients who ask for it. The increased use of the Internet for research has led some EU patients to uncover "false" information because drugs marketed outside the EU are sometimes approved for indications other than what they have been approved for inside the EU, even if the product name is identical. The EC will issue a code of conduct on the issue before proceeding, Mr. Liikanen's spokesman said.