Japanese generic compliance costs to rise

Japan's Ministry of Health Labor and Welfare has issued two notifications aimed at improving the confidence of Japanese doctors to prescribe generic drugs, as well as to deal with concerns that generic suppliers are unreliable. However, the effect of such improvements, seems likely to lead to some generic producers restricting their range of product output, because of the extra costs involved in complying with the MHLW's request, unless drugmakers can increase volume of sales as more doctors are prepared to recommend generic products.

The Japanese government is firstly asking the generic drug manufacturers to supply all specifications for their products to the same standard as for the equivalent branded products. The deadline for compliance varies according to the type of product, but the plan is for all generics to meet this standard by the end of 2011.

The second demand is for pharmaceutical firms to under-take to maintain production of specific products for at least five years, as well as for the companies to establish supply systems across Japan so that medical institutions can receive orders for generic drugs in a timely fashion.