The Pig Site Backroom
Regulatory Aspects of Porcine Serum Therapy in the UKThis document is a letter from Steve Dean BVetMed, DVR, MRCVS, Director of Licensing at the UK Veterinary Medicines Directorate outlining the regulatory aspects of using Serotherapy in the UK.
7 Mansfield Street
London W1M 0AT
11 February 2002
REGULATORY REQUIREMENTS FOR 'SERUM THERAPY' IN PIGS AS A TREATMENT FOR PMWS/PDNS
We are aware of reports from other EU countries of the use of 'serum therapy' as a means of reducing the impact of PMWS/PDNS in pig herds affected with these conditions. The procedure involves the preparation of serum from blood collected from older pigs within a herd and administered to young piglets within the same herd. The purpose of this letter is to inform veterinary surgeons, who might be considering carrying out serum therapy in the UK of the veterinary medicinal regulatory requirements and controls that apply, based on the Veterinary Medicines Directorate's (VMD) interpretation of the relevant legislation. The letter does not address the desirability or otherwise of this procedure from an animal health perspective, nor its efficacy.
Under Section 8 of the Medicines Act 1968 and the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (as amended) respectively, a manufacturer's licence is required to prepare serum for administration to animals and a marketing authorisation is required to place the serum on the market.
In situations where a veterinary surgeon seeks to treat a condition for which no authorised product exists for use in that species, and where no alternative products authorised for veterinary or human use are available, then he/she may prescribe an extemporaneously prepared product under the provisions of the prescribing 'cascade' laid out in the Medicines (Restrictions on the Administration of Veterinary Medicinal Products) Regulations 1994 (as amended). In the case of PMWS/PDNS, the administration of serum therapy would only be considered as an extemporaneous treatment if the veterinary surgeon confirms for each batch that:
In these circumstances, a marketing authorisation for the serum would not be required provided that:
In any other situation, it is an offence to market the serum in any way or for it to be administered to animals without a marketing authorisation. A manufacturer's licence is not required to prepare serum as an extemporaneous preparation, provided that the serum is prepared by:
In the context of modern pig husbandry it is important to clarify the definition of a herd for the purposes of 'serum therapy'. A herd is taken to mean animals under the same management and located on the same site. Collection of serum from a finishing unit for administration to piglets on a nursery or growing unit on a separate site would require both a marketing authorisation for the serum and a manufacturer's licence for its preparation. Likewise, if a finishing unit receives pigs from more than one growing unit, both a marketing authorisation and a manufacturer's licence would be required to administer serum sourced from the finishing unit to piglets on any of the growing units.
Veterinary surgeons who may be considering carrying out trials of serum therapy would need to apply to the Veterinary Medicines Directorate (VMD) for an Animal Test Certificate (ATC). Details of the requirements and procedures to be followed are available in the advisory leaflet AMELIA 13 on the VMD website (http://www.vmd.gov.uk). Veterinary surgeons are not exempt from the requirement for an ATC in situations where they are conducting the trial on behalf of the owner of the herd. The VMD will only consider an application for an ATC to be valid if the trial protocol is clearly designed to evaluate the efficacy of the therapy, if it is statistically based, and if appropriate control groups of untreated pigs are included. If the protocol incorporates any regulated procedures or, the withholding of normal veterinary care in any way, an application would also need to be made to the Home Office for a licence under the Animal (Scientific Procedures) Act 1986.
In view of the nature of the procedures involved in 'serum therapy' and the recent experience in the UK with regard to swine fever and foot-and-mouth disease, the VMD will follow up any reports of veterinary surgeons or manufacturing facilities acting outside of the terms of the exemptions indicated above and will take appropriate legal action against them.
To read a response to this letter from Richard Potter, President of the UK Pig Veterinary Society, highlighting a number of concerns, CLICK HERE
(Issued on behalf of The Pig Veterinary Society, Southview, East Tytherton, Chippenham, Wiltshire, SN15 4LX Richard Potter President, Pig Veterinary Society, Larkmead Veterinary Group, Ilges Lane, Cholsey, Wallingford, Oxon OX10 9PA)