Everyone was waiting for Bill 2552 of 2021 to be passed: it was to amend the legal deadlines for drug traceability (Law 11903 of January 14, 2009) in Brazil. To the surprise of the market, it was Bill 3846, which provides for a digital package insert that ended up directly impacting the National Drug Control System (SNCM).

HOW HAS BILL 3846 IMPACTED DRUG TRACEABILITY?

Establishment of the National Drug Control System (SNCM) in Brazil has been under discussion for over a decade, but what happened in the end? Bill 3846, which proposes including a QR code for a digital package insert, also contains text that revokes the requirement to individually serialize a drug. This Bill was approved by Senate on April 12, 2022, thus establishing that drug serialization will no longer be necessary in Brazil. In addition, the Bill revokes the requirement on Anvisa to create the National Drug Control System itself.

WHAT IS ANVISA’S POSITION ON THE VOTE ON BILL 3846?

According to the website of Anvisa, the agency expresses concern at the government’s decision to revoke the law on drug traceability. Brazil could lose a lot from this decision, which goes in the opposite direction from other regions like the United States and the European Union. The main points against the decision include: (1) the risk to public health, as it prevents the tracking of units of drugs and the assurance of supply chain integrity; and (2) the waste of public resources already invested in developing the SNCM (R$ 4.9 million).

In its notice, Anvisa says it will propose another discussion of the matter and seek to demonstrate the negative impacts of approving the Bill to the Executive and the Legislature.

WHAT INFORMATION MUST STILL BE ON THE PACKAGING?

Taking into account the fact that Bill 3846 revoked serialization, the information remaining in the traceability law is as follows:

  • Global Trade Item Number (GTIN);
  • Registration number;
  • Batch number;
  • Expiry date.

In addition to the above information, it is now also necessary to put in a QR code linking to the digital package insert.

WHAT SHOULD WE DO NOW?

The future direction for the Brazilian pharmaceutical industry is still not very clear. Bill 3846 will now go to be approved or vetoed by the President. If approved, the market expects some kind of response from Anvisa. It is unclear whether Anvisa will continue with the SNCM even though it is no longer mandatory.

Some argue that in order to meet the online monitoring of drugs required by RDC 658 of March 30, 2022 (Good Practice in Drug Manufacture) and continue printing variable batch and expiry data, the system required is practically the same as what traceability required. There is therefore an understanding that little has really changed for the industry and that, in practice, traceability will end up being implemented.

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