DRUG INDUSTRY TAKES JAPAN REFORM PLAN TO REGULATORS

Representatives of the European, Japanese and US drug industries have submitted reform proposals for Japan's National Health Insurance (NHI) reimbursement system. Meeting with regulators in the Chuikyo pricing system, the groups again recommended replacing current structures with a manufacturer's reimbursement price. Selling prices would then be set in consultation with an "expert committee," including representatives of government, academia and companies.

Under the new proposals, drugmakers would submit prices for their products, along with relevant evidence, to Japan's drug pricing panel. The new prices would then be calculated according to a number of factors such as the price of competitors' drugs, comparable prices on foreign markets and manufacturing costs.

Drugmakers also proposed a 100 percent rise in the maximum selling price, with smaller rises allowed for paediatric drugs. In this regard, it was also suggested that the present premium on innovative paediatric drugs be standardised at 10 percent, with price rises obtained for drugs which obtain a new paediatric indication. This measure would reflect developments elsewhere, as companies attempt to gain benefits from new paediatric indications in order to gain patent or pricing advantages.

Meanwhile, in the same meeting, Itsuro Yoshida, head of the Japan Generic Pharmaceutical Manufacturers Association, called for the government to support the sector. Suggested policies included the introduction of twice-yearly generic drug lists, changes to prescription forms and premiums for prescribing and dispensing generics.

In 2003, generic drug sales accounted for only 16.4 percent of the Japanese market, compared to 51 percent in the US. Incentives for generic prescribing were introduced in 2001, but Japanese patients have proved reluctant to end their preference for branded drugs, even beyond patent expiry.