Development of the European Veterinary Medicines Gaps and Needs Compass for Sheep and Goats Based on Online Survey and Expert Knowledge Elicitation

Abstract

Simple Summary Sheep and goats often lack essential veterinary medicinal products (VMPs) across Europe as these are either not authorized, not marketed or not developed yet. This mixed-methods study involves surveying European veterinarians working with small ruminants, analysis of the EMA Union Product Database for VMPs, and expert-led prioritization of VMP needs gaps. For all reported problems, experts provided specific root causes and potential solutions. This combined approach identifies the following most frequently recorded VMP lack of availability: vaccines; pain relief medicines (analgesics); and specific antimicrobials against mastitis and dewormers (anthelmintics). Furthermore, only one third of authorized medicines for sheep and goats were found to be recorded as available in the EMA Union Product Database. Additionally, experts indicate that many required medicines critical for daily practice are not authorized in European countries, necessitating veterinarians to resort to “the cascade” to meet certain pharmaceutical requirements. The described European Veterinary Medicines Gaps and Needs Compass for sheep and goats may support and guide relevant stakeholders in increasing availability of authorized VMPs. In this way, current data and knowledge may be better understood and usefully translated into action.Abstract Limited availability of veterinary medicinal products (VMPs) for small ruminants is a long-standing challenge. This mixed-methods study provides the first systematic definition and assessment of (i) shortages, (ii) lack of availability and (iii) unmet needs for sheep and goats across Europe. Survey data from 96 European veterinarians in 13 European countries (the majority of whom were from Spain, Germany, France, and Greece), a market analysis of authorized and available VMPs via the EMA Union Products Database (UPD) and expert knowledge elicitation (EKE) by 23 specialists were combined. Antimicrobials (36.7%) and nonsteroidal anti-inflammatory drugs (NSAIDs) (19.9%) were identified as the VMP categories most commonly perceived as critically important. Although nearly 5000 VMPs are authorized for small ruminants at the EU level, UPD market research reveals that there is a reported market availability of 28.9% of ovine and 32.7% of caprine authorized VMPs. Validation by EKE confirmed lack of VMP authorization to be the leading root cause of the lack of availability of ovine (31%) and caprine (43%) VMPs at both the national and EU level. The European Veterinary Medicines Gaps and Needs Compass identifies four highest-priority medicine groups lacking in availability for sheep (anthelmintics and endectocides, bacterial and viral vaccines) and two for goats (anthelmintics and bacterial vaccines). Moreover, 13 highest-priority unmet needs were identified for sheep and 14 for goats across antibacterials, analgetics and anti-inflammatories, antiparasitics and vaccines. Potential actionable solutions advised through EKE include harmonized market access pathways and targeted development (especially for vaccines, NSAIDs, and antibiotic teat injectors) to secure animal health, welfare, and One Health objectives.