Brussels Watch: TSE And Specified Risk Materials

The European Commission's July 30 decision (97/534/EC) to ban the useeffective January 1, 1998 of all materials presenting risks of transmissible spongiform encephalopathy (Specified Risk Materials; SRMs) looks set to have massive, unpredicted and counter-productive effects on European public health - the precise consideration which led to the adoption of the decision in the first place.

The potential scope of the decison, and its interpretation, remains extremely unclear. On a strict interpretation, there is a very real possibility that it could lead to the recall of up to 80% of medicines on the market in Europe.

Not surprisingly, the pharmaceutical industry is urgently seeking from the European Union authorities clarification of the decision, particularly with regard to its prospective or retrospective effect, and the possibility of an exemption for tallow, gelatins and derivatives used in the manufacture of medicines.