Experience with the delegation of anaesthesia for disbudding and castration to trained and certified livestock owners.

BACKGROUND: Anaesthesia is mandatory for disbudding and castrating calves and lambs of any age, in Switzerland. According to the "anaesthesia delegation model" (ADM), anaesthesia for disbudding calves <3 weeks of age and castrating calves and lambs <2 weeks of age may be administered by certified farmers. Experience with this unique model is not available. The aim was to evaluate the experience of the veterinary practitioners with the ADM. The response rate was 42%. The survey consisted of one questionnaire for each procedure. Procedure I was the delegation of anaesthesia for disbudding calves and procedures II and III were anaesthesia for castrating calves and lambs. RESULTS: Procedure I was performed with local anaesthesia in all farms of 51.8% of the veterinary practices, while this was only 39.3% and 7.6% for procedures II and III (p < 0.001). Anaesthesia for procedure I was administered technically correctly by farmers in at least 66% of the farms of 58.3% of the practitioners, while this was 45.4% and only 23.6% for procedures II and III (p < 0.001). The ADM was assessed as a moderate to very good model to reinforce the legal obligations for procedures I, II, or III by 74.8%, 76.5% and 62.0% of the veterinary practitioners (p < 0.005). CONCLUSIONS: The delegation of anaesthesia to certified farmers may be a promising model to reinforce the obligation to provide local anaesthesia for disbudding and castrating calves, but to a lesser extent for castrating lambs.

Governance, veterinary legislation and quality.

This review of governance distinguishes between ends and means and, by highlighting the complexity and differing definitions of the concept, defines its scope and focuses discussion on its characteristics in order to establish an interrelationship between veterinary legislation and governance. Good governance must be backed by legislation, and good legislation must incorporate the principles and instruments of good governance. This article lists some of the main characteristics of governance and then reviews them in parallel with the methodology used to draft veterinary legislation, emphasising the importance of goal-setting and stakeholder participation. This article describes the criteria developed by the Veterinary Legislation Support Programme (VLSP) of the World Organisation for Animal Health (OIE) for assessing the quality of veterinary legislation. It then makes a comparison between the quality assurance process and the good governance process in order to demonstrate that the introduction and proper use of the tools for developing veterinary legislation offered by the OIE VLSP leads to a virtuous circle linking legislation with good governance. Ultimately, the most important point remains the implementation of legislation. Consequently, the author points out that satisfactory implementation relies not only on legislation that is technically and legally appropriate, acceptable, applicable, sustainable, correctly drafted, well thought through and designed for the long term, but also on the physical and legal capacity of official Veterinary Services to perform their administrative and enforcement duties, and on there being the means available for all those involved to discharge their responsibilities.

Optimising import risk mitigation: anticipating the unintended consequences and competing risks of informal trade.

The effectiveness of risk mitigation may be compromised by informal trade, including illegal activities, parallel markets and extra-legal activities. While no regulatory system is 100% effective in eliminating the risk of disease transmission through animal and animal product trade, extreme risk aversion in formal import health regulations may increase informal trade, with the unintended consequence of creating additional risks outside regulatory purview. Optimal risk mitigation on a national scale requires scientifically sound yet flexible mitigation strategies that can address the competing risks of formal and informal trade. More robust risk analysis and creative engagement of nontraditional partners provide avenues for addressing informal trade.

The importance of governance and reliable veterinary certification.

Good veterinary certification is possible only if a country's veterinary governance complies with the quality standards of the World Organisation for Animal Health (OIE). The standards in the OIE Terrestrial Animal Health Code stipulate that the main prerequisite for good veterinary governance is for Veterinary Services to be independent, that is to say they are able to carry out their mandate while remaining autonomous and free from any commercial, financial, hierarchical or political pressures that could lead them to make technical decisions that were contrary to OIE standards. Veterinary Services should include, in particular, a veterinary administration with nationwide jurisdiction for implementing the animal health measures and veterinary certification procedures recommended by the OIE and for overseeing or auditing their implementation. They should also include veterinary authorities and persons authorised by the veterinary statutory body to perform tasks under the responsibility and supervision of a veterinarian (veterinary paraprofessionals). This veterinary governance must be sustainable over time in order to administer long-term animal health policies. Good governance relies on appropriate legislation that is in compliance with OIE guidelines and on the requisite human and financial resources for ensuring its enforcement. The evaluation of this governance, either by an importing country in the context of international trade, as authorised by OIE standards, or by the country itself (self-evaluation or an evaluation requested from the OIE [using the OIE Tool for the Evaluation of Performance of Veterinary Services]), helps to facilitate the proper operation of Veterinary Services and to ensure the reliability of any certification granted under the authority of the veterinary administration.

The regulation of veterinary regenerative medicine and the potential impact of such regulation on clinicians and firms commercializing these treatments.

This article provides an overview of the US Food and Drug Administration's current and potential regulation of veterinary regenerative medicine and the various products used in the practice. This article also discusses several of the potential enforcement risks associated with the commercialization of such therapies and products and offers the reader strategies for mitigating those risks. Finally, the article concludes with a review of an important and ongoing court battle that focuses on the marketing and promotion of cellular-based therapies for humans that could have a significant impact on the regulation of both human and veterinary products.

Evolution of animal-welfare education for veterinary students.

Animal-welfare education is an evolving component of the veterinary curriculum. Although different veterinary schools may cover different elements of the subject and teach it in many different ways, it is important to recognize that this multidisciplinary subject is evolving rapidly. For example, welfare science is beginning to examine the quantification of positive welfare or a good life in addition to evaluating harms associated with different husbandry systems. Although the curriculum is under continual pressure, the drivers (policy makers, student expectations, and trade requirements) for including animal welfare in the course are likely to increase. Some core components of an animal-welfare course are important to include in all veterinary curriculums. This would include an appreciation of the difference between welfare science, ethics, and standards.

'The RCVS should not change the standard of proof in disciplinary cases'.

Gillian Nevin argues that vets would be unfairly disadvantaged if the RCVS changes to a civil standard of proof in disciplinary cases.

International regulations and standards for avian influenza, including the vaccine standards of the World Organisation for Animal Health.

For avian influenza the World Organisation for Animal Health (OIE) has laid down international standards on notification, trade, diagnosis, surveillance and the production and use of vaccine. These standards are science- and risk-based to ensure safe trade in poultry and poultry products without unjustified barriers. The European Union, with its 27 Member States, has in place harmonised legislation in line with OIE standards. Early detection, rapid diagnosis, notification and high quality Veterinary Services are crucial for ensuring a rapid response to avian influenza outbreaks and for swiftly reducing the risk of virus spread via trade. Depending on the situation, vaccination may also be a very important tool for disease control. The use of high quality vaccines and postvaccination monitoring are essential for the successful implementation of vaccination. Compliance with international standards is of paramount importance for protecting animal and human health in the global crisis of the highly pathogenic avian influenza of the H5N1 subtype.

Animal welfare: the role of non-governmental organisations.

The welfare of animals is of interest to many people in most parts of the world. Concern about the way that animals are treated will depend on many factors, including socio-economic conditions, culture, religion and tradition. The World Organisation for Animal Health (OIE) is committed to ensuring that all animal welfare standards are science-based, but recognises that these other factors must also be taken into account. The International Coalition for Farm Animal Welfare (ICFAW) was formed to represent the interests of non-governmental animal welfare organisations from most corners of the globe and opinions, comment and information from these animal welfare organisations will play a part in the OIE decision-making process. In coming together for this purpose it was recognised that the views of the various member organisations of ICFAW vary depending on which part of the world they come from. The authors provide information about the situation in three continents: Africa, North America and Europe. This information includes details of relevant legislation, farming practices, and educational and campaign programmes developed by both animal welfare non-governmental organisations and governments. The authors also look to the future to see what issues may influence the way that farm animals are reared, transported and slaughtered.

La Regulación de los medicamentos veterinarios en España / The regulation of veterinary drugs in Spain

No disponible

Expert Opinion on the Perceived Effectiveness and Importance of On-Farm Biosecurity Measures for Cattle and Swine Farms in Switzerland.

Biosecurity is crucial for safeguarding livestock from infectious diseases. Despite the plethora of biosecurity recommendations, published scientific evidence on the effectiveness of individual biosecurity measures is limited. The objective of this study was to assess the perception of Swiss experts about the effectiveness and importance of individual on-farm biosecurity measures for cattle and swine farms (31 and 30 measures, respectively). Using a modified Delphi method, 16 Swiss livestock disease specialists (8 for each species) were interviewed. The experts were asked to rank biosecurity measures that were written on cards, by allocating a score from 0 (lowest) to 5 (highest). Experts ranked biosecurity measures based on their importance related to Swiss legislation, feasibility, as well as the effort required for implementation and the benefit of each biosecurity measure. The experts also ranked biosecurity measures based on their effectiveness in preventing an infectious agent from entering and spreading on a farm, solely based on transmission characteristics of specific pathogens. The pathogens considered by cattle experts were those causing Bluetongue (BT), Bovine Viral Diarrhea (BVD), Foot and Mouth Disease (FMD) and Infectious Bovine Rhinotracheitis (IBR). Swine experts expressed their opinion on the pathogens causing African Swine Fever (ASF), Enzootic Pneumonia (EP), Porcine Reproductive and Respiratory Syndrome (PRRS), as well as FMD. For cattle farms, biosecurity measures that improve disease awareness of farmers were ranked as both most important and most effective. For swine farms, the most important and effective measures identified were those related to animal movements. Among all single measures evaluated, education of farmers was perceived by the experts to be the most important and effective for protecting both Swiss cattle and swine farms from disease. The findings of this study provide an important basis for recommendation to farmers and policy makers.

Environmental risk assessment of veterinary medicinal products in the EU--a regulatory perspective.

The pharmacological nature of veterinary medicinal products, frequent application rates and use on a large scale for livestock production sensitizes regulation authorities for environmental concern. Consequently, in the European Union legal requirements plus guidance for an Environmental Risk Assessment of veterinary pharmaceuticals have been established. Applicants of new veterinary medicinal products have to provide an ecotoxicity report according to a guidance document which rests upon a logical, tiered approach with a cut-off trigger between a basic characterisation of the veterinary medicinal product and an in-depth assessment of its fate and ecotoxic effects. The outcome of this assessment is the establishment of the environmental risk that may arise from the use of the VMP under question. Contamination of the environment can be reduced by appropriate risk mitigation measures, e.g. limiting the application rate, the amount of contaminated manure being spread on agricultural lands or the access of treated pasture animals to surface waters.

European medicines and feed additives regulation are not in compliance with environmental legislation and policy.

Environmental legislations for water and soil aim at the protection of quality of these compartments. This legislation has major consequences for product registration, amongst others the setting of environmental quality standards. A thorough risk assessment at registration of all products is crucial for the proper operationalisation of the environmental policy. A regulatory problem arises when the registration procedure is harmonised at a European level by the communautarian authority, while the authorities at the national level are responsible for maintaining the desired environmental quality. This problem can be tackled in two ways: firstly, the environmental risk assessment (ERA) should be based on common principles based on EU regulations and policy that steer the national authorities; secondly, the ERA should be developed under the supervision of competent authorities. Both options are not reflected in the forging of the ERA for medicines and feed additives. The formalisation of the contents and the procedure is not transparent nor open to input by scientists and other interested parties; the formalisation has no legal status, and European legislation cannot provide common protection goals in a global setting. The VICH Phase I and the EMEA Phase II guidance do not contain all communautarian environmental quality criteria, nor clear acceptability standards, nor harmonised methodology. Assessments are not made for all products, and the decision-making principles and practical procedures are not operational. It is therefore unlikely that any result of an ERA can be taken into consideration at registration, which undermines the legitimacy of the process. Both applicants and assessors are uncertain how to perform the risk assessment. The current developments may ultimately not only compromise product availability but also fail to protect the environment.

Environmental risk assessment of veterinary pharmaceuticals in the EU: reply to Montforts and de Knecht.

This paper is in response to a previous article in a Special Issue of Toxicology Letters. That article criticised the current regulatory framework in the European Union for the environmental risk assessment of veterinary medicinal products (VMPs) and feed additives (FAs), in particular the ongoing process of international harmonisation of guidance. This response addresses the concerns raised in relation to veterinary medicinal products and demonstrates that the VICH process has been brought within the scope of current EU regulatory processes for veterinary medicines and therefore is not separate to them. Consultation with stakeholders takes place throughout the VICH process, with an additional period of open public consultation before guidance is adopted and implemented.

Prioritisation of veterinary medicines in the UK environment.

A wide range of veterinary medicines is used to treat animals in the UK. Whilst the environmental impact of selected substances (particulary the sheep dip chemicals, anthelmintics and fish farm chemicals) has been well studied, limited information is available in the public domain on the other groups of substances (e.g. antifungals, coccidiostats, antiprotozoals, hormones and growth promoters). There is therefore a need to identify other substances that may impact the environment in order to design national monitoring programmes, target experimental work and develop pollution prevention methodologies. In this study, a simple two-stage prioritisation scheme was developed and applied to veterinary medicines in use in the UK. In the first stage, those substances that have high potential to enter the environment in significant amounts were identified on the basis of amounts used in the UK, treatment type and metabolism. In stage 2, the hazard of the identified substances to terrestrial and aquatic organisms was assessed. Using the approach, a total of 56 substances or groups were assigned to a 'high priority' category. For eleven of these substances, sufficient data were available to characterise their risk, these were: oxytetracycline, chlortetracycline, tetracycline, sulphadiazine, amoxicillin, diazinon, tylosin, dihydrostreptomycin, apramycin, cypermethrin and sarafloxicin. For the remaining 45 substances, full datasets were not available and it is recommended that in the first instance, attempts are made to fill these data gaps.