Pharma opposed to Japan's recalculation method with market expansion

The major drug industry organizations in Japan, including the Federation of Pharmaceutical Manufacturer Associations of Japan, Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industry Associations Japan, have expressed strong opposition to a proposal whereby the applicable scope of drugs already listed and whose prices are reduced based on the recalculation following an increase in their sales beyond expectations at the time of launch, should be expanded (Marketletter December 3). Their views were aired at the public hearing of the Chuikyo (Central Social Insurance Medical Council) on the proposal made by the Ministry of Health, Labor and Welfare for the 2008 reform of National Health Insurance drug pricing on December 5.

Under the current rule, only a listed drug, whose comparator's sales exceed twice those expected upon listing and over 15.0 billion yen ($135.0 million) annually since its launch, should be recalculated. However, the Ministry proposes all drugs of the same class should be subject to the rule in the new plan.

All the associations were strongly against the new proposal, saying: "we cannot accept the rule because it is inconsistent with the evaluation of innovation."