Regulatory Roadblock: Senasa Suspends Crucial Vaccine Trial

Tecnovax, an Argentinian veterinary medicine company, has voiced strong objections to the National Agrifood Health and Quality Service (Senasa) following the suspension of critical control tests for its proposed AFOSA vaccine.This suspension has ignited a debate about fair competition within Argentina’s livestock health sector.

The company’s CEO, Diego La Torre, articulated these concerns in a letter addressed to Nicolás Pino, president of the Argentine Rural Society (SRA). The letter details the alleged arbitrary nature of the suspension,which occurred despite tecnovax fulfilling the necessary procedural requirements outlined in RG 609/17 for vaccine approval. La Torre stated that Pablo Cortese, president of Senasa, cited unspecified issues of opportunity and convenience as the rationale behind halting the trial on January 21st.

Competition Concerns and Allegations of Market Dominance

The suspension of Tecnovax’s trial comes amidst a backdrop of escalating tensions with established players in the AFOSA vaccine market. Last year, Tecnovax filed a formal complaint with the National Commission for the defence of Competition (CNDC), alleging cartelization and abuse of dominant position against Biogenesis Bagó and CDV, two other prominent firms marketing AFOSA vaccines. These accusations suggest a struggle for market share and raise questions about potential anti-competitive practices within the industry.

In these complaints, abundant tests of the abuse suffered by producers from all over the country. However, I regret to inform you that, despite our efforts, the competition is still far from reaching the vaccine market against Afitosa fever in Argentina.

diego La Torre, CEO of Tecnovax, in a letter to Nicolás Pino, president of the Argentine Rural Society (SRA)

Industry Dynamics and the Push for Deregulation

Tecnovax’s concerns extend beyond the immediate suspension of its trial. The company suggests that existing regulations inadvertently favor established vaccine manufacturers, creating an uneven playing field. This sentiment was echoed in their letter to Pino, where they argued that regulations have historically facilitated a resources transfer for more than two decades, from all the Argentine livestock to the vaccine makers.

According to sources close to Tecnovax, the company has also reached out to Federico Sturzenegger, Minister of Deregulation and Change of the State, expressing concerns that bureaucratic hurdles are impeding the progress of deregulation efforts. The company fears that entrenched interests are actively resisting changes that would foster greater competition.

Senasa’s Perspective and the Approval Process

While Senasa has not yet issued an official statement regarding the Tecnovax situation, recent reports shed light on the agency’s handling of new vaccine applications. In response to an access request, Senasa detailed the progress of various companies seeking authorization for new AFOSA vaccine formulations. according to these details, Biogenesis Bagó and CDV are currently in the field test stage, while Tecnovax remains in the documentary evaluation stage, awaiting the submission of additional information before proceeding to field trials. This discrepancy in progress further fuels Tecnovax’s concerns about potential bias.

The AFOSA (Foot-and-Mouth Disease) is a highly contagious viral disease that affects cloven-hoofed animals, including cattle, swine, sheep, and goats. According to the World Organisation for Animal Health (WOAH), controlling and preventing FMD outbreaks is crucial for safeguarding animal health, trade, and food security. The development and approval of effective vaccines are therefore of paramount importance.