NR ABON
AU Bowser,D.R.
TI EU directive on bovine spongiform encephalopathy will not affect drugs
QU British Medical Journal 1997 Aug 30; 315(7107): 551
KZ BMJ. 1997 Aug 16;315(7105):426. PMID: 9277612
KI BMJ. 1998 Feb 21;316(7131):629-30. PMID: 9518935
PT comment; letter
VT
Editor, In his letter Alan Earl-Slater states that if certain European proposals go ahead then, with effect from 31 December 1997, certain categories of drugs will not be allowed on the market in the European Union.(1) He goes on to name two of my company's products, Hyalase and Hypurin (insulin). This is not the case. Both products will continue to be available in Britain and in the rest of the union.
The commission's proposal to amend directive 75/318/EEC (not 75/18/EEC, as stated in the letter) has been suspended. This directive is specific to pharmaceuticals. A broader commission decision on the use of materials in the food chain presenting risks in relation to transmissible spongiform encephalopathies was adopted on 29 July 1997. This decision referred to the banning of the use of specified risk materials, defined as the skull, including the brains and eyes; tonsils; and spinal cord of cattle, sheep, and goats over 1 year of age, and the spleens of sheep and goats over 6 months of age. Additionally, the use of the vertebral column of cattle, sheep, and goats for the production of mechanically recovered meat is banned from 1 January 1998.
Hypurin (beef and pork insulins) and Hyalase (hyaluronidase) are derived from beef or pork pancreases (Hypurin) and sheep testes (Hyalase). None of these organs are included in the commission's recent definition of specified risk materials. Furthermore, it is unlikely that any future amendment to directive 75/318/EEC, if indeed there is one, will encompass these organs. Incidentally, Earl-Slater's conclusions on the impact of the proposed legislation on gelatin will also not apply: gelatin will continue to be available for pharmaceutical use. Only the use of specified risk materials in the manufacture of the gelatin will be limited.
David R B Bowser Sales and marketing
CP Pharmaceuticals Ltd, Wrexham LL13 9UF
References
1 Earl-Slater A. Bovine spongiform encephalopathy threatens drugs in European Union. BMJ 1997;315:426
ZR 1
MH Animal; Cattle; Drug Industry/*legislation & jurisprudence; *Encephalopathy, Bovine Spongiform; European Union; Human; Hypoglycemic Agents; Legislation, Drug
SP englisch
PO England