Letters
VETERINARY MEDICINES
‘Recognised veterinary practice’ in the context of clinical field trials The Veterinary Medicines Directorate (VMD) has recently completed a public consultation (on April 24, 2015) on new draft guidance (VMGN6), which aims to streamline the authorisation process for the issue of Animal Test Certificates (ATCs) for the conduct of clinical trials in animals. We would like to acknowledge the steps the VMD has taken, which go a long way towards clarifying when an ATC suffices for field trials, and when a study should be conducted under the Animals (Scientific Procedures) Act 1986 (ASPA). However, there is still considerable ambiguity and uncertainty around whether an ATC will be granted, as the decision is dependent upon the RCVS agreeing that the content of the proposed field trial is consistent with ‘recognised veterinary practice’ (RVP). Clinical field trials are a necessary part of the regulatory process which ensures that safe, efficacious medicines are available for the animals under our care, and are conducted to international scientific and ethical standards. Current RCVS guidance on practice-based research (www.rcvs.org. uk/publications/ethical-review-for-practicebased-research) implies that such trials can be conducted under RVP only if they benefit the individual animal or group, without regard for the long-term benefit for the broader population. We consider this narrow interpretation inappropriate for regulatory field studies conducted in compliance with EU directives. The EU Directive 2010/63 and ASPA specifically exclude veterinary field trials conducted under ATC from their scope, as the welfare of such animals is safeguarded in the relevant EU trials directives. If the proposed draft VMGN6 were to be adopted as it stands, it would mean that the UK would operate differently from the general principles applied by all other EU member states. The additional time and cost in obtaining clarity and permission for an ATC 552 | Veterinary Record | May 23, 2015
has already driven clinical trial sponsors to go instead to other EU member states, where the regulators and veterinary governing bodies are entirely comfortable that trials constitute a RVP under clinical field trial conditions. This has led to the situation in which the majority of the clinical field trial data that support the registration of new veterinary medicinal products (VMPs) in the UK market is obtained in other EU and non-EU countries, despite the internationally recognised excellence of our clinical research. The ambiguity and uncertainty in the UK ATC process will continue to have a significant negative impact on our businesses and the veterinary profession as a whole. It jeopardises the ability of the veterinary research community in this country to perform veterinary clinical field trials to assist in the development of VMPs. We therefore request that the RCVS reviews and clarifies its guidance on what constitutes RVP in veterinary field trials to be consistent with EU directives and UK legislation under ATC authorisation. We request that the RCVS supports a streamlined process that safeguards the welfare of our animal populations by ensuring robust and ethical field testing of new medicines, while removing the current disadvantage to our veterinary and research industries. Clear guidelines will secure the continuing availability of safe and efficacious medicines developed and tested in the UK. Ian Nanjiani, Head of Clinical Research, Westpoint Veterinary Group, Dawes Farm, Bognor Road, Warnham, West Sussex RH12 3SH e-mail: [email protected] David Hume, Director of the Roslin Institute and Chair of the National Institutes of Biosciences, Roslin Institute, University of Edinburgh, Easter Bush, Midlothian EH25 9RG Julie Fitzpatrick, Scientific Director, Moredun Research Institute, Chief Executive Officer, Moredun Group, John Murray, Managing Director, Moredun Scientific, Pentlands Science Park, Bush Loan, Penicuik, Midlothian EH26 0PZ doi: 10.1136/vr.h2718
Copyright of Veterinary Record: Journal of the British Veterinary Association is the property of BMJ Publishing Group and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
VETERINARY MEDICINES
‘Recognised veterinary practice’ in the context of clinical field trials The Veterinary Medicines Directorate (VMD) has recently completed a public consultation (on April 24, 2015) on new draft guidance (VMGN6), which aims to streamline the authorisation process for the issue of Animal Test Certificates (ATCs) for the conduct of clinical trials in animals. We would like to acknowledge the steps the VMD has taken, which go a long way towards clarifying when an ATC suffices for field trials, and when a study should be conducted under the Animals (Scientific Procedures) Act 1986 (ASPA). However, there is still considerable ambiguity and uncertainty around whether an ATC will be granted, as the decision is dependent upon the RCVS agreeing that the content of the proposed field trial is consistent with ‘recognised veterinary practice’ (RVP). Clinical field trials are a necessary part of the regulatory process which ensures that safe, efficacious medicines are available for the animals under our care, and are conducted to international scientific and ethical standards. Current RCVS guidance on practice-based research (www.rcvs.org. uk/publications/ethical-review-for-practicebased-research) implies that such trials can be conducted under RVP only if they benefit the individual animal or group, without regard for the long-term benefit for the broader population. We consider this narrow interpretation inappropriate for regulatory field studies conducted in compliance with EU directives. The EU Directive 2010/63 and ASPA specifically exclude veterinary field trials conducted under ATC from their scope, as the welfare of such animals is safeguarded in the relevant EU trials directives. If the proposed draft VMGN6 were to be adopted as it stands, it would mean that the UK would operate differently from the general principles applied by all other EU member states. The additional time and cost in obtaining clarity and permission for an ATC 552 | Veterinary Record | May 23, 2015
has already driven clinical trial sponsors to go instead to other EU member states, where the regulators and veterinary governing bodies are entirely comfortable that trials constitute a RVP under clinical field trial conditions. This has led to the situation in which the majority of the clinical field trial data that support the registration of new veterinary medicinal products (VMPs) in the UK market is obtained in other EU and non-EU countries, despite the internationally recognised excellence of our clinical research. The ambiguity and uncertainty in the UK ATC process will continue to have a significant negative impact on our businesses and the veterinary profession as a whole. It jeopardises the ability of the veterinary research community in this country to perform veterinary clinical field trials to assist in the development of VMPs. We therefore request that the RCVS reviews and clarifies its guidance on what constitutes RVP in veterinary field trials to be consistent with EU directives and UK legislation under ATC authorisation. We request that the RCVS supports a streamlined process that safeguards the welfare of our animal populations by ensuring robust and ethical field testing of new medicines, while removing the current disadvantage to our veterinary and research industries. Clear guidelines will secure the continuing availability of safe and efficacious medicines developed and tested in the UK. Ian Nanjiani, Head of Clinical Research, Westpoint Veterinary Group, Dawes Farm, Bognor Road, Warnham, West Sussex RH12 3SH e-mail: [email protected] David Hume, Director of the Roslin Institute and Chair of the National Institutes of Biosciences, Roslin Institute, University of Edinburgh, Easter Bush, Midlothian EH25 9RG Julie Fitzpatrick, Scientific Director, Moredun Research Institute, Chief Executive Officer, Moredun Group, John Murray, Managing Director, Moredun Scientific, Pentlands Science Park, Bush Loan, Penicuik, Midlothian EH26 0PZ doi: 10.1136/vr.h2718
Copyright of Veterinary Record: Journal of the British Veterinary Association is the property of BMJ Publishing Group and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
