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Veterinary Medicines: Human Suspected Adverse Reactions
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.
Sheep Dip Container Design
The Countess of Mar asked Her Majesty's Government:
- How they propose to persuade all manufacturers of sheep dip containers to resolve any outstanding deficiencies in container design; and which sheep dips are sold in defective containers.[HL1160]
Lord Donoughue: It is not that sheep dip containers are defective. However, some designs have been in use for a long period and it may be possible to improve them, given currently available materials and knowledge. This possibility has been discussed with manufacturers' representatives, and a number of them are looking at ways in which the design of containers might be improved to reduce the risk of spillage and to increase the accuracy of measurement. In addition, the Health and Safety Laboratory is conducting research into new methods of transferring dip concentrate to the dip bath.
Controlled Goods: Production Overseas
Lord Hylton asked Her Majesty's Government:
- For what items of controlled production equipment/technology or controlled components or sub-assemblies export licences are currently required before a United Kingdom company can conclude an agreement for production in a third country.[HL1096]
The Parliamentary Under-Secretary of State, Department of Trade and Industry (Lord Sainsbury of Turville): Production equipment and technology, components and sub-assemblies whose export from the UK is subject to control are set out under a range of headings in the Export of Goods (Control) Order 1994, as amended, the Dual-Use & Related Goods (Export Control) Regulations 1996, as amended, and Council Decision 94/942/CFSP, as amended (which has effect through Council Regulation (EC) 3381/94). While a valid export licence is needed for the export of controlled goods or technology, exporters are not
required to obtain one before they conclude an agreement for production overseas.Medical Research Council Funding for Small Projects
The Countess of Mar asked Her Majesty's Government:
- Whether it is now the policy of the Medical Research Council to fund only large, multicentre research projects; if so, from where they anticipate funds for small and basic medical research projects will be derived.[HL1163]
Lord Sainsbury of Turville: The MRC mission continues to be: to promote and support by any means high-quality basic, strategic and applied research and related postgraduate training in the biomedical and other sciences with the aim of maintaining and improving human health.
It is not the MRC's policy to fund only large multicentre research projects. The range of new research grants introduced by MRC in 1997 provides a variety of forms of support for response mode funding for research in universities. The combination of centre, co-operative group, programme, innovation, strategic project and new career establishment grants should provide sources of funding to suit scientists at different career stages.
The Co-operative Group Grant scheme in particular allows individual scientists to apply for funds on a small scale to work on their own project within a group where there are shared interests and facilities. Some 48 co-operative groups have already been established, widely spread geographically, and more are planned. The MRC has also modified its long-standing Programme Grant scheme to permit smaller scale resources than have hitherto been available.
MRC is monitoring closely the impact of the new schemes to ensure that they are operating effectively and that an appropriate balance is maintained between providing long term stability for research and new opportunities for young researchers.
English Nature: Letter to Dr. Cunningham
Lord Jopling asked Her Majesty's Government:
- Whether they will publish the letter from English Nature which the right honourable Dr. Jack Cunningham MP referred to, and asked to quote from, in the " Today " programme on 12 February.[HL1132]
The Minister of State, Cabinet Office (Lord Falconer of Thoroton): A copy of the letter has been placed in the Libraries of the House.
New Statutory Powers
The Earl of Northesk asked Her Majesty's Government:
- What new powers, in the form of statutory instruments, codes of practice and other rules have been conferred upon central government departments
- as a result of legislation enacted since 1 May
1997; and how the volume of such new powers
compares numerically with the equivalent figure for the 1964-65 session of Parliament.[HL976]
Lord Falconer of Thoroton: I regret that the information requested is not held centrally and could only be obtained at disproportionate cost.
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