New Pro-Competitive Recommendation in Antitrust

 

1. Introduction

Resolution 333/2025 was published in the Official Gazette[1] on May 15, 2025, by means of which the Argentine Agri-Food Health and Quality Service (SENASA) authorized the commercialization in Argentina of veterinary products registered in certain foreign countries, by implementing a sanitary equivalence mechanism. With this regulation, the Government seeks to encourage the entry of importers of veterinary products, who will no longer be subject to the local authorization process, provided they hold approval from any of the countries listed in Resolution 333/2025.

The Resolution has been implemented as a result of a pro-competitive recommendation the Argentine Antitrust Commission issued to SENASA and the Secretariat of Agriculture, Livestock, and Fisheries (SAGyP), aimed at deregulating the foot-and-mouth disease (FMD) vaccines market. This sets a new the Antitrust Commission precedent for removing potential barriers to market entry.
 

2. The Antitrust Commission’s Intervention

The pro-competitive recommendation arises from a complaint filed by Tecnovax SA and the Sociedad Rural del Sur de Salta before the Antitrust Commission in July and October 2024, respectively, alleging collusive anti-competitive conducts in the FMD vaccine market. Along with the complaint, Tecnovax highlighted the need for the Antitrust Commission to issue a pro-competitive recommendation to SENASA to eliminate regulatory barriers in the market.

Following these complaints, the Antitrust Commission decided to analyze the FMD vaccine market to assess the feasibility of issuing a pro-competitive recommendation, pursuant to the powers granted to it under article 28, paragraphs (h) and (i) of the Antitrust Law 27442.

The Antitrust Commission analyzed the facts and concluded that there could be significant regulatory barriers such as:
 

1. the requirement of the Protection against Podal Generalization (PPG) test to register and import FMD vaccines,
2. limitations in the recognition of equivalences with countries that have effective sanitary programs,
3. restrictions on the operation of sanitary agencies.

 

1. Requirement of the PPG Test

The PPG test is used to evaluate the safety and efficacy of a vaccine before it is authorized. This is a direct testing method that involves the systematic vaccination of animals to generate immunity against FMD.

According to Tecnovax, this method would entail very high costs for laboratories. Additionally, it would require a lengthy execution time, as it should be carried out individually and sequentially, that is, each company submitting a vaccine should undergo the test separately, and only one test can be conducted at a time. Performing the tests simultaneously would require specialized facilities that SENASA currently does not have. Pursuant to the Antitrust Commission, these characteristics turn the method into a significant entry barrier for new competitors in the FMD vaccine market.

The Antitrust Commission also noted that the international scientific community has been recommending alternative methods to the PPG test for decades. These allegedly show that indirect testing methods offer significant advantages in terms of animal welfare and efficiency.
 

2. Limitations in Cross-Border Equivalence Recognition
    

The Antitrust Commission criticized the equivalence criteria SENASA implemented to validate vaccines authorized abroad. In particular, it pointed out that, although there is a list of registered countries that are granted automatic equivalence to submit Good Manufacturing Practices (GMP) certificates, neighboring countries such as Uruguay, Brazil, Paraguay, and Bolivia—classified as “FMD-free” and with sanitary programs similar to Argentina’s—have not been included.

Furthermore, the Antitrust Commission highlighted that Argentina is party to the Agreement on the Application of Sanitary and Phytosanitary Measures of the World Trade Organization (WTO), which establishes that countries must recognize the sanitary measures of others as equivalent even if they differ, provided they ensure an adequate level of protection. According to the Antitrust Commission, SENASA quoted this regulation when applying equivalence criteria in other areas.
 

3.  Restrictions on the Operation of Sanitary Agencies
    

The Antitrust Commission also highlighted the structure of the market of sanitary agencies. These agencies are responsible for carrying out sanitary and phytosanitary actions, research, public oversight, and/or certification of agri-food products under programs managed by SENASA. They are also in charge of implementing and ensuring compliance with vaccination campaigns. As such, this market is vertically integrated with the production of FMD vaccines. According to the applicable regulation, any entity wishing to carry out some of said actions in Argentina must register in the Argentine Registry of Sanitary Entities and obtain an authorization from SENASA to operate.

The Antitrust Commission thus considered that the requirements established for an entity to be registered in such registry is excessively strict. In particular, it criticized that:
 

1. the entities must have non-profit legal status as a condition to be authorized as a sanitary entity,
2. veterinarians cannot offer guarding and inoculation services,
3. the fees charged by sanitary entities are fixed by SENASA,
4. there are geographical restrictions that prevent the coexistence of more than one sanitary entity in the same district, department or defined geographical area.

 

3. Conclusion
    

On May 7, 2025, the Antitrust Commission released an opinion advising the Secretariat of Industry and Trade (SIyC) to issue a series of pro-competitive recommendations for SENASA and the SAGyP to review the regulatory framework governing the FMD vaccine market.

The most relevant recommendations include:

• reviewing the PPG test requirement and considering its replacement by validated indirect tests,
• evaluating the possibility of “equivalency” recognition,
• flexibilizing the requirements for registering in the Argentine Registry of Sanitary Agencies and eliminating some specific ones,
• eliminating geographical restrictions, allowing more than one sanitary agency to coexist in the same district, department, or defined geographic area,
• allowing vaccine producers to freely choose their supplier,
• liberating the fees sanitary agencies charge, without SENASA’s intervention.

These recommendations intended to open doors to international companies and encourage the increase of local players, to generate greater competitiveness in the market.

A few days after the Antitrust Commission issued its pro-competitive recommendations, SENASA partially responded by publishing Resolution 333/2025 (mentioned above), which automatically authorizes the commercialization and import of veterinary products that have been authorized in the jurisdictions listed in the “list of countries”.[2]