HL Deb 01 March 1999 vol 597 cc166-7WA
The Countess of Mar

asked Her Majesty's Government:

How many of the 43 reports of serious suspected adverse reactions cited in the Appraisal Panel for Human Suspected Adverse Reactions to Veterinary Medicines Report to the Veterinary Products Committee of Appraisal Panel Meetings in 1997 were reported to the European Agency for the Evaluation of Medicinal Products under the terms of Article 42f of Council Directive 93/40/EEC; and, if they were not reported, the reason why. [HL1158]

Lord Donoughue

The arrangements to enable member states to report serious human suspected adverse reactions (SARs) to the EMEA strictly in accordance with the terms of Article 42f of Directive 93/40/EEC are not yet in place. Nonetheless, serious human and animal SARs are reported to the Pharmacovigilance Working Party of the Committee on Veterinary Medicinal Products of the EMEA. The UK has also provided the EU Commission with data on human SARs to organophosphorus (OP) sheep dip which was co-ordinated through the Pharmacovigilance Working Party of the EMEA.

The Countess of Mar

asked Her Majesty's Government:

How many reports with symptomology of serious suspected adverse reactions in humans to individual veterinary medicines are required before the Veterinary Products Committee considers that the product is not safe to be used according to the manufacturer's instructions. [HL1159]

Lord Donoughue

There is a range of actions that may be necessary depending on the circumstances of the case, and it is essential that expert judgment is used in assessing the importance of trends in serious suspected adverse reactions. It would not be appropriate to set a definite figure, which could discourage early action.

The Countess of Mar

asked Her Majesty's Government:

Whether members of the public and farmers are encouraged to report any suspected adverse reaction (SAR) to an organophosphate sheep dip; and whether the advice of Professor D. H. Lawson, in his 1996 report to Ministers to the effect that self-reporting of SARs should not be recognised, has been accepted by Ministers. [HL1161]

Lord Donoughue

All reports of suspected adverse reactions (SARs) to veterinary medicinal products are taken in to account by the Suspected Adverse Reactions Surveillance Scheme (SARSS) of the Veterinary Medicines Directorate (VMD). Although, as Professor Lawson's report indicated, self-reporting may lead to a lack of objectivity, individuals are not discouraged from reporting. Indeed, we actively encourage reporting by supplying report forms to veterinary practices, pharmacies and agricultural merchants and saddlers for use by their clients and to farming organisations. Anyone suffering a suspected adverse reaction is strongly advised to consult their doctor before reporting the incident to the SARSS.