The pharmaceuticals price freeze which lasted for one and a half years has been lifted on January 1, 1994. Since then, many pharmaceutical companies have requested a price increase for their products to the competent ministry.

Price setting for newly registered reimbursable prescription pharmaceutical products or price increases for existing products are determined pursuant to the Ministerial Decree of December 29, 1989 enacted in application of Title VI of the Law of December 22, 1989.

This regulation applies to all medicinal products, as defined in the Law of March 25, 1964, which qualify for the reimbursement in accordance with the Law of August 9, 1963, as well as to certain implants, as listed in the above Decree.

Price setting and price increases require the prior approval of the Minister of Economic Affairs to whom an application must be sent containing information as to the applicant, including its financial situation, the relevant product and the elements which may justify the proposed price or price increase, including the manufacturing cost and a comparison with the prices applicable in the other EU countries.

Prior to any decision, the Minister must consult the Committee for Prices of Patent Medications, composed of representatives of mutual health societies, workers' and consumers' organizations, the industry, importers and wholesale distributors, pharmacists, small businesses as well as representatives of the Ministries of Public Health, Social Welfare, Middle Classes and Economic Affairs.

The decision of the Minister must be sent to the applicant within ninety days (which may be extended for sixty days) as from the receipt of the complete application. In the absence of any decision within the required period, the applicant may apply the price level or the price increase as requested.

In addition to this procedure, the recent Law of March 30, 1994 relating to social measures has introduced a system of price-volume agreements for innovative medical products to be concluded between the administration and pharmaceutical companies. Under this Law, price increases of certain products would be granted provided that the pharmaceutical companies would undertake to maintain the annual expenses of the health care insurance within limits to be defined and to reimburse any additional expenses incurred for health insurance. The application of the Law, however, is still under discussion between the competent Ministers.

The content of this article is intended to provide general information on the subject matter. It is therefore not a substitute for specialist advice.

De Bandt, van Hecke & Lagae - Brussels. (32-2)517.94.53.

For further information contact Vincent Macq on + 32.2. 517.94.47.