Brussels, 17/11/2000 (Agence Europe) - The European Commission has suspended the procedure aimed at checking for the existence of obstacles to trade in pharmaceutical products in Korea. It now has at least six months to see whether the changes made by the Korean authorities to the legislation in question are adequate.
The Community's industry lodged its complaint in June 1999. At that time, the Commission notes in the decision published in the Official Journal No. L/281, "the Korean regulatory system governing pharmaceuticals was undergoing a period of change". Nevertheless, the elements of proof provided by the European Federation of Pharmaceutical Industries and Associations (EFPIA) were sufficient to initiate the examination procedure provided for by he Regulation on the Obstacles to Trade. The points raised by EFPIA concerned discriminatory practices relating to price and reimbursement, excessive regulatory requirements, intellectual property issues, as well as the general lack of transparency in the Korean system. Seoul then informed the Commission that in-depth changes had or were going to be made to the system, on each of the aforementioned points. Most of the new legislation introduced, however, "has not yet been implemented and there are indications that implementation may be delayed or that the legislation may be interpreted in a trade restrictive way", say sources in Brussels. The Commission has, therefore, preferred to suspend the procedure the time it takes to "monitor" the effect of this reshaped legislation. It thus hopes to be able, over at least a six month period, to see whether the "changes have in fact improved the situation" with regard to access for European pharmaceutical products onto the Korean market. Its conclusions will be published in April of next year, in the form of a report, possibly together with proposals for any further measures deemed necessary.