§ Mr. Cashasked the Secretary of State for Social Services if he has decided the scope of protection for innovative products under article 1(iii) of European Community directive 87/21/EEC.
§ Mr. NewtonYes. This directive was adopted last December and comes into force by 1 July this year. Among other matters, it amends the requirements for the submission of test and clinical trial results when applying for licences for medicinal products. In particular, where products are essentially similar to earlier "high technology" medicinal products detailed results have to be supplied for a period of 10 years from the licensing of the earlier product. The directive allows member states, if they judge it to be in the interest of the public health, to extend this 10-year period to apply to all medicinal products marketed in its territory. We have decided that this extension should apply in the United Kingdom, in line with similar decisions which we understand have been made by the majority of the major pharmaceutical-producing states in the European Community.