ANVISA has about R$6bn in new drugs waiting for analysis and another R$11bn under consideration

04/22/2024

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Ricardo Cappelli — Foto: Gesival Nogueira Kebec/Valor

The pharmaceutical industry has nearly R$6 billion in potential investments pending analysis by the National Health Surveillance Agency (ANVISA). Another R$11 billion is being analyzed, but there has been no response so far.

The survey was carried out by Grupo FarmaBrasil, the trade association representing companies in the sector. The calculation took into account two factors: requests for approval of medications under review or halted, and the average market value for each category of products.

By categories, R$9.4 billion of the drugs under analysis or awaiting analysis are biological, R$4.1 billion are new and innovative, R$4 billion are generics, R$205 million are non-synthetic, and R$31 million are herbal medicines.

Brazilian Development Bank President Aloizio Mercadante was the first to draw public attention to the issue in February. At the time, he suggested hiring reviewers to speed up the evaluation process. “There are R$17 billion in investments in ANVISA,” he said at the inauguration ceremony of the president of the Brazilian Agency for Industrial Development (ABDI), Ricardo Cappelli. At the time, Mr. Cappelli also advocated greater “efficiency” of regulatory agencies “to leverage private investments in Brazil.”

Measures such as expanding the number of ANVISA employees are necessary to “generate a workflow and regular approval” of medicines in order to offer “predictability” to the industry, said Adriana Diaféria, vice president of FarmaBrasil. She said the federal government “is committed to strengthening research, technological development, and innovation in the country.” She also sees the public test announced to hire 50 specialists in health regulation and surveillance by ANVISA as positive. “But it’s not enough to meet all demands,” she said.

In a note, ANVISA also attributes the sluggishness to the lack of employees. “The long queue periods to which drug candidates are submitted in the country are not the result of inertia of the agency’s managers and employees, but of the number of workers incompatible with the size of the Brazilian drug market,” the regulator said, highlighting “the drug development and manufacturing capacity of the companies operating in the country.”

ANVISA said that between 2007 and 2023, the number of employees fell to 1,491 from 2,360. Of this group, only 187 work to approve or not drugs. The U.S. Food and Drug Administration (FDA) has 6,815 “employees with regulatory and authorization skills,” according to ANVISA. Thus, the average time for drug approval is 776 days in Brazil, compared to 245 days in the U.S. The Brazilian queue is also longer than in Japan and Canada (301 days) and Australia (350 days).

Despite the insufficient number of servers, ANVISA “has been adopting mechanisms” to accelerate approvals, “maintaining the international standard of quality, effectiveness, and safety verification.” Among the measures, it highlights the use of agency evaluations “with standards and regulatory practices equivalent” to those of ANVISA; joint evaluation with foreign agencies; and implementation of the company’s pre-qualification program, a model similar to that of the Federal Revenue’s Authorized Economic Operator.

In a statement, the Ministry of Management and Innovation in Public Services highlighted that the government will hire 50 specialists in health regulation and surveillance. In addition, at the end of last year, the ministry started a debate with “the workers of the regulatory agencies, including ANVISA, as part of the negotiation process to handle specific demands of the category.”

*Por Estevão Taiar — Brasília

Source: Valor International

https://valorinternational.globo.com/