Anvisa contests a bill passed in Congress that takes away the agency’s power to track drugs

Anvisa (National Health Surveillance Agency) criticized the approval by Congress of a bill that takes away the agency’s competence to track drugs.

The text removes from the regulatory agency the prerogative, in the SNCM (National Medicines Control System, still under implementation), to accompany the medicine box from production to arrival at the consumer.

Anvisa said, in a note, that it will propose a re-discussion of the theme and will endeavor to demonstrate to the Executive and the Legislature the negative impacts resulting from the approval of the project.

Senator Nelsinho Trad (PSD-MS), who was rapporteur for the project in the Senate, denies that Anvisa has lost its power to inspect medicines, arguing that it is enough for the agency to check the tracking carried out by the companies and, in cases where it deems it necessary , snakes explanations.

Approved in the Senate on Tuesday (12), the bill had already passed the House. Now, it goes to the sanction or veto of President Jair Bolsonaro (PL).

The SNCM, which was still in the implementation phase, had a deadline to be regulated until April 28.

Anvisa had sent a technical opinion to the Senate on the subject, signed by the director-president, Antonio Barra Torres, but the document was not taken into account.

In the text, the agency says that the Senate bill could jeopardize public health by making it impossible to control drug units and guarantee the integrity of the supply chain. Anvisa claims that it could reduce the risk of products being counterfeited.

In a note, he also said that it would help to combat cargo theft, facilitate the collection of batches with quality deviation, improve surveillance actions, and mitigate the risks of drug shortages.

Another argument is that public resources would be wasted, given that investment has already been made to create the SNCM. The implementation of the system alone has cost R$ 4.9 million so far.

“The implementation of the SNCM is an important strategy to mitigate the risks for the patient, in addition to economic and socioeconomic losses for Brazilians, by fighting the illegal drug market. In this sense, the agency believes that the approved text will make the controls that favor patient safety,” the regulatory agency said in a statement.

Senator Nelsinho Trad (PSD-MS) said that Anvisa continues to have the power to trace the medicines. “The sector [indústria] would not have time to adapt to the new requirements until April 28. I couldn’t try to solve one problem by creating another. The most sensible solution is to keep the current status. The company does the tracking and Anvisa checks, any more information is just to stimulate the laboratory, which it provides”, said the senator.

In the text presented, the senator established that the new conception of the SNMC has a more active participation of drug registration holders, aiming to decentralize and simplify actions.

They must have a computerized system capable of drawing up a map of drug distribution, with identification of the quantities sold and distributed for each batch, as well as the recipients of the remittances.

“It should be noted, however, that this new concept will not exempt Anvisa from austere inspection”, says the text.

In addition to this system, the project provides for companies to insert a QR Code on medication packaging to access a digital package insert. However, the printed model will still be required. Except, in cases to be defined by Anvisa.