FOI release

FOI2026/00995 - Librela and Solensia Specific Fees and Estimated Animals Treated

Published 12 August 2026

1. Your request

Following your response to FOI2026/00379, I request the following information relating specifically to the veterinary medicinal products Librela and Solensia.
Please provide, for each of the last five financial years (2020-21 to 2024-25 inclusive):
  1.  The total amount of fees, charges, levies, or other payments received by the Veterinary Medicines Directorate (VMD) in relation to:

• Librela
• Solensia

  2.  A breakdown of those amounts by category, including but not limited to:

• Initial marketing authorisation fees
• Variation application fees
• Renewal fees
• Annual authorisation fees
• Pharmacovigilance-related fees
• Inspection fees
• Post-authorisation surveillance fees
• Any other regulatory or administrative charges associated with these products

  3.  Please confirm if you hold and provide records identifying:

• the total number of UK doses of Librela sold
• the total number of UK doses of Solensia sold
• the estimated number of animals treated with each product and how this is calculated

  4.  Please provide full details of the methodology used by the VMD when calculating:

• “estimated animals treated”
• frequency of adverse events
• frequency of deaths
            in relation to Librela and Solensia.

This should include:

• formulas used
• assumptions applied
• multipliers or conversion factors
• whether estimates are based on doses sold
• whether estimates are based on doses administered
• whether the VMD assumes 1 dose = 1 animal treated
• how repeat monthly injections are accounted for
• the source data relied upon for such calculations

If the VMD does not hold some or all of this information, please clearly identify which information is not held.

If any part of this request is considered exempt from disclosure, please specify:

• the exemption relied upon
• the reasoning for applying the exemption
• the public interest considerations where applicable

2. Our reply

The VMD confirms that it holds information within the scope of your request. However, we consider that the requested information is exempt from disclosure under Section 43(2) of the Freedom of Information Act 2000 (commercial interests).

Section 43(2) provides that information is exempt from disclosure if its release would, or would be likely to, prejudice the commercial interests of any person or organisation, including the public authority holding it.

The information you have requested includes:

• Product-specific financial information relating to fees and charges received by the VMD
• Detailed breakdowns of those fees by regulatory activity
• Information relating to product volumes (doses sold) and estimates of animals treated
• Methodologies underpinning those estimates

This information is commercially sensitive as it relates directly to identifiable products and, by extension, the commercial activities of the relevant Marketing Authorisation Holder.

Disclosure would be likely to prejudice commercial interests in the following ways:

• Revealing market activity and strategy: Product-level fee income and associated breakdowns would enable competitors to infer the scale, lifecycle stage, and regulatory activity associated with these products.
• Insight into commercially valuable operational data: Information on doses sold and estimated animals treated represents commercially sensitive market intelligence that is not otherwise publicly available.
• Competitive disadvantage: Disclosure could be used by competitors to inform pricing, development, or regulatory strategies, thereby disadvantaging the company concerned.
• Impact on the VMD’s regulatory functions: The release of detailed fee and activity information could undermine confidence in the regulatory framework and affect how commercial stakeholders engage with the VMD.

For these reasons, we consider that Section 43(2) is engaged.

2.1 Public Interest Test

Section 43(2) is a qualified exemption and requires us to consider whether the public interest in disclosure outweighs the public interest in maintaining the exemption.

Arguments in favour of disclosure

• Promotes transparency and accountability in how the VMD is funded
• Supports public understanding of regulatory oversight of veterinary medicines
• Contributes to informed public debate on animal health and medicine usage

Arguments in favour of maintaining the exemption

• Protects commercially sensitive information relating to identifiable products and their manufacturer
• Prevents unfair commercial disadvantage arising from disclosure of market-sensitive data
• Safeguards the integrity of regulatory systems by ensuring that commercially confidential information is appropriately protected
• Avoids disclosing information that could be used to infer commercially valuable insights regarding regulatory strategy, product performance, or market share

2.2 Balance of the public interest

While the VMD recognises the importance of transparency, we consider that disclosure of product-specific financial, commercial, and usage data would cause real and significant harm to commercial interests.

We are satisfied that this harm outweighs the public interest in disclosure, particularly given that the VMD already makes available higher-level information about its activities and funding which supports transparency without causing such prejudice.

We have therefore decided to withhold the requested information under Section 43(2) of the Freedom of Information Act 2000.

2.3 Advice and Assistance

Where possible, information may be provided in a more aggregated or anonymised form that does not identify individual products. If you would like to refine your request on this basis, we would be happy to consider it.

It may be useful to know that we published in February 2026 an In-depth assessment of selected adverse events for ‘Librela Solution for Injection for Dogs’ - GOV.UK. This assessment specifically includes the frequency of death.

Also, information about how dose factors are calculated are available on our website, Calculation of adverse event incidence for veterinary medicines - GOV.UK and Technical_guidance_for_completion_of_the_Pharmacovigilance_Sales_Submission__PSS.pdf.