§ The Countess of Marasked Her Majesty's Government:
Whether post-marketing surveillance of humans is carried out by the manufacturers of organophosphate sheep dips, and whether reports of results are published.
The Parliamentary Secretary, Ministry of Agriculture, Fisheries and Food (Earl Howe)Under the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971, as amended, pharmaceutical companies marketing veterinary medicinal products, including organophosphate sheep dips, are required to maintain records of all suspected adverse reaction reports they receive. Those affecting humans have to be reported to the licensing authority within two working days of receipt. These are assessed, along with all other suspected adverse reaction reports involving humans, by an appraisal panel of government doctors and scientists before consideration by the Veterinary Products Committee. Summary reports of suspected adverse reactions are published regularly, and the first report by the appraisal panel will be published shortly.
In addition, the Institute of Occupational Medicine in Edinburgh is currently undertaking a surveillance project for the National Office of Animal Health, the representative organisation for the veterinary pharmaceutical industry. This is to assess exposure to organophosphates and the effectiveness of protective clothing to operators when dipping sheep. The study is scheduled to be completed at the end of 1993 when the results will be published.