Executive Summary

The Swiss Federal Council adopted an amendment to the Animal Disease Act (TSG) on 5 June 2026. The reform creates a legal basis to temporarily market unapproved vaccines and immunological veterinary medicines in animal disease emergencies. The prerequisite is that no approved alternatives are available in Switzerland or abroad. The Federal Food Safety Office (BLV) will be responsible for approval and will work with Swissmedic and the Federal Office for the Environment. The regulation closes a legal gap that became apparent during outbreaks of bluetongue virus in 2024 and Lumpy Skin Disease in 2025.

Persons

Topics

  • Animal disease control
  • Drug approval
  • Emergency regulations

Clarus Lead

Switzerland is responding to repeated supply gaps in animal disease control: First bluetongue virus in 2024, then Lumpy Skin Disease in 2025 forced the BLV to take emergency measures without explicit legal basis. With the new TSG amendment, this improvised practice is legalized and structured – an important signal for veterinary policy at a time when animal disease outbreaks are becoming more frequent. The regulation already corresponds to existing EU standards and prevents potential disadvantages for Switzerland in international animal trade.

Detailed Summary

The previous legal situation was insufficient: Although the Animal Disease Act allowed the Federal Food Safety Office to issue general ordinances, there was no specific legal basis for temporary approval of unregistered immunological veterinary medicines. In the recent disease cases, the BLV had to activate this emergency solution twice – a sign of the regulatory gap.

The new regulation defines clear conditions: Temporary approval for unapproved vaccines is only possible if no equivalent, approved veterinary medicine is available in Switzerland and no import of a preparation approved abroad is possible. The BLV decides, but consults Swissmedic for technical assessment. If the product contains genetically modified or pathogenic organisms, the Federal Office for the Environment is also involved. Approval remains temporary and does not replace the standard approval process.

Vaccinations are generally voluntary by animal keepers. Only in exceptional cases can an authority order vaccination if it is the only way to contain the disease. With this regulation, Switzerland closes a gap compared to the European Union and creates planning certainty for future emergencies. Animal suffering and economic damage can thus be more effectively limited.

Key Statements

  • The Federal Council creates an explicit legal basis for temporary approval of unregistered animal disease vaccines in emergencies.
  • The new regulation is based on clear criteria (availability of alternatives in CH and abroad) and multiple regulatory reviews.
  • The measure corresponds to EU standards and prevents competitive disadvantages for Switzerland in international animal trade.

Critical Questions

  1. Evidence/Data Quality: What specific data on bluetongue virus 2024 and Lumpy Skin Disease 2025 justify the need for this regulation – infection numbers, economic damages, time delays in previous emergency solutions?

  2. Conflicts of Interest: What role do pharmaceutical manufacturers play in assessing whether a vaccine is "unavailable," and how is Swissmedic's independence ensured in this assessment?

  3. Causality/Alternatives: Would faster activation of existing emergency measures (general ordinances) have solved the 2024/2025 problems, or was the legal gap truly the bottleneck?

  4. Feasibility/Risks: How long does BLV approval actually take in an emergency, and is there a risk that the new regulation will cause delays through multiple agency involvement (BLV, Swissmedic, BAFU)?

  5. Transparency: Will approvals for emergency vaccines be publicly documented, and how is monitoring of side effects of such unapproved products ensured?

  6. Proportionality: Under what conditions can an authority mandate vaccination, and what control mechanisms prevent misuse of this exception clause?

Sources

Primary Source: Federal Council Creates Legal Basis for Emergency Vaccines for Animal Diseases – news.admin.ch, 05.06.2026

Supplementary Sources:

  1. Message on the Amendment to the Animal Disease Act – Federal Food Safety Office (BLV)
  2. Report on the Results of the Consultation – BLV

Verification Status: ✓ 05.06.2026

This text was created with the support of an AI model. Editorial responsibility: clarus.news | Fact-checking: 05.06.2026