Bookmarkers beware: Bookmarks to pages other than the home page may not work after we change our server in April Editor's Choice | This Week in BMJ | Press releases BMJ No 7131 Volume 316 Letters Saturday 21 February 1998 Where is scientific evidence supporting EU policy on BSE and pharmaceuticals? Editor, Bowser is right to attempt to provide an update of European Union (EU) policies regarding bovine spongiform encephalopathy and pharmaceuticals.(1) Unfortunately his letter misses the main concern of my earlier letter(2): where is the evidence supporting any of the EU's policies on bovine spongiform encephalopathy and pharmaceuticals? Bowser is wrong to state that amendments to the EU directive on spongiform encephalopathy will not affect drugs. The commission's decision of 30 July (not 29 July as he stated) explicitly mentions the words `pharmaceuticals' and 'medicines' (for example, in points 18 and 19).(3) The EU's Committee on Proprietary Medicinal Products warned in its report on human medicinal products affected by decision 97/534/EC that if the commission's decision was enforced then more than half the drugs currently on EU markets would have to leave the market before January 1998. Bowser is incorrect in stating that `a broader commission decision on the use of materials in the food chain was adopted on 29 July 1997.' Article 2 of the commission's decision of 30 July 1997 states: `the use of specified risk materials for any purpose shall be prohibited.'(3) The decision, if applied, affects items such as medicines, foods, cosmetics, and candles. Contrary to Bowser's statement, if the decision of 30 July came into effect gelatin would be affected. Why else would the US meat rendering industry prepare to file a P64m lawsuit against the commission's decision?(4) The commission stated in July that it was banning specified risk materials in pharmaceuticals for human consumption from the EU markets from 1 January 1998. The definition of material involved has broadened to include transmissible spongiform encephalopathies (TSEs). Bowser is wrong to state that the commission's proposals to amend directive 75/318/EEC (not 75/18/EEC) have been suspended. The decision has been revised. Article 8 of the commission's decision states: `This decision shall be reviewed in the light of new scientific information with regard to the risk of exposure to TSEs resulting from infectivity in other animal species, age categories or materials. Where necessary this decision shall be amended.'(3) The ban on products containing specified risk materials or materials derived from specified risk materials is now planned to come into effect on 1 April 1998. Already some drug companies are changing the source of materials for their products. These are the facts. But where is the scientific evidence supporting any of this EU policy? Alan Earl-Slater Senior lecturer in health economics Department of Medicines Management, Keele University, Keele, Staffordshire ST5 5BG References 1 Bowser D R B. EU directive on bovine spongiform encephalopathy will not affect drugs. BMJ 1997;315:551. (30 August.) 2 Earl-Slater A. Bovine spongiform encephalopathy threatens drugs in European Union. BMJ 1997;315:426. (16 August.) 3 European Commission. Commission decision of 30 July on the prohibition of the use of material presenting risks as regards transmissible spongiform encephalopathies. Brussels: European Commission, 1997 4 Earl-Slater A. A study of pharmaceutical policies in the EU. Policy Studies 1997;18:251-67. Home | Current issue | Past issues | Classified ads | Career Focus | Feedback Collections | About this site | About the BMJ | BMA | Medline