NR ADRR
AU Earl-Slater,A.
TI Bovine spongiform encephalopathy threatens drugs in European Union
QU British Medical Journal 1997 Aug 16; 315(7105): 426
KI British Medical Journal 1997 Aug 30; 315(7107): 551. PMID: 9329333
PT letter
VT
Editor, While the debates about bovine spongiform encephalopathy periodically have a high profile in public health, food safety, and agricultural and political environments, the pharmaceutical environment is now becoming seriously entangled in the web of controversy. On 20 February this year the pharmaceutical council of the European parliament accepted the European Commission's proposed revisions to directive 75/18/EEC.
If the revisions are accepted by the European Union's Council of Ministers it will mean that drugs for human consumption that have bovine, ovine, or caprine ingredients, or ingredients derived from such, will (with one exception) not be allowed on any member state's market after 31 December. Over 200 drugs with gelatin capsules will be affected, as will specific products such as HibTITER (Haemophilus influenzae type b vaccine), Hyalase (hyaluronidase), and Hypurin (insulin).[1]
The only exception to the ban will be drugs with such ingredients that have or secure a pan-European Union product licence through the European Medicines Evaluation Agency's centralised route and for which no alternative drug is available. This escape route shows another aspect of the growing importance of the pan-European Union drug licensing system.[2]
On 10 June this year Emma Bonino, the commissioner for fisheries, consumer policy, and the European humanitarian office, announced the creation of another committee of the European Union, the scientific steering committee. This will act as the supreme source of expertise for the commission and offer excellence, independence, and transparency.
The first task for the scientific steering committee must be to make available the scientific evidence and rationale underpinning the decision to revise directive 75/18/EEC. If there is a scientific basis for the policy the committee should, being excellent and independent, produce it for all to see. The more obvious reason for the commission's actions is that the European parliament had earlier threatened by 422 votes to 49 to force the commission to resign in a body if it did not act on the crises over bovine spongiform encephalopathy. Whether the emerging responses are justified or prudent remains questionable. Who is going to benefit from this malaise in policy and this lack of evidence based decision making: the millions of consumers of meat, jellies, sweets, and drugs?[3-5]
References
1 Association of the British Pharmaceutical Industry. Compendium of data sheets and summaries of product characteristics. London: ABPI, 1996.
2 Earl-Slater A. Recent developments in regulating the pharmaceutical business in the EU. European Business Review 1996; 96(1): 17-25.
3 Belcher P, Mossialos M. Health priorities for the European intergovernmental conference. BMJ 1997; 314: 1637-8. (7 June.)
4 Coghlan T. New Labour, new Europe. BMJ 1997; 314: 1506. (24 May.)
5 Davis P. Managing medicines: public policy and therapeutic drugs. Buckingham: Open University Press, 1997.
ZR 5
MH Animal; Bacterial Proteins; Cattle; Chemistry, Pharmaceutical/*legislation & jurisprudence; Encephalopathy, Bovine Spongiform/*epidemiology; European Union; Gelatin; Haemophilus Vaccines; Human; Hyaluronoglucosaminidase; Insulin
AD Alan Earl-Slater Senior lecturer in health economics, Keele University, Department of Medicines Management, Keele, Staffordshire ST5 5BG
SP englisch
PO England