Spain's Drug Laws Deter US Generics Companies

Although Spain's market for generic pharmaceuticals is still small - valued at around $30 million and representing less than 1% of the total market - US generics companies are reportedly eyeing it, but are concerned that implementation of changes in legislation are slow and thus a deterrent to them.

Reported in the Journal of Commerce, Biocraft president Harold Snyder has said that "the Spanish market is very interesting and technically oriented as far as generics go....but they still have laws that make it difficult to register a product and get distribution." The generics market only started at all in Spain two or so years ago, when the government passed a new pharmaceutical patent law.

The registration approval process in Spain takes up to two years, and the authorities there require that any European Union-produced generics imported into the country are also registered in their country of origin, the US Commerce Department's local office in Madrid noted, adding that in 1993 only 40 generic drugs were registered overall.