Anvisa opens a Public Consultation to propose authorization for the skinny label practice

Anvisa opens a Public Consultation to propose authorization for the skinny label practice

As previously informed in the client alert sent on December 23, Anvisa opened a Public Consultation (PC 1,137/2022) to amend Resolution-RDC 47/2009 – which sets forth rules for the elaboration, harmonization, updating, publication, and availability of labels of medicines for patients and health care professionals.
The proposed text in Public Consultation seeks to exclusively amend art. 14 of RDC 47/2009 to the following wording: 

Art. 14.
§1 The labels for generic and branded generic drugs may differ from the respective label of the reference listed drug in the specific information for each product that must comply with the pharmacotechnical characteristics approved in the registration contained in the parts.
§3 In addition to the items mentioned in the previous paragraph, labels for generic and branded generic drugs may differ from the label of the reference listed drug (RLD) in relation to the therapeutic indications protected by patent.  

According to Technical Opinion No. 7/2022/SEI/DIRE2/ANVISA, Anvisa has identified the regulatory problem from the need to make compatible, on the one hand, the patent protection of the “new use” (new therapeutic indications) – a situation known as “patent protection for second medical uses” – and, on the other hand, the adequacy of the label for generic and branded generic medicines to the standard label for the Reference Listed Drug (RLD).
According to the Opinion above, the restriction imposed by the current text of RDC 47/2009 would imply an indirect impediment to the entry of generic and branded generic drugs into the Brazilian market due to the inclusion of therapeutic indications for second medical use under patent protection.
In light of this overview, Anvisa asked its Public Prosecutor’s Office regarding the possibility that generic and branded drugs have therapeutic indications different from the RLD. 
The Public Prosecutor’s Office expressed its support for the legality of the proposal to amend RDC 47/2009 in the following terms: 

In this sense, from the analysis of the provisions of Law No. 6,360/76, it is observed that there is no obstacle from a legal point of view to the differentiation between the labels, as provided in the proposal for the introduction of art. 14, §3, of RDC 47/2009. Before, in fact, The Public Prosecutor’s Office observed that the intended alteration meets what remains enshrined in Law No. 6,360/76, which establishes the requirements of generic and branded generic medicines, allowing the expansion of access to the population’s health. Thus, in response to the questioning presented by Anvisa’s Board of Directors, it is understood that there is no illegality in the insertion of § 3 in article 14 of RDC. 47/2009 in light of the definitions established by Law No. 6360/1976.

The legal opinion issued by the Federal Prosecutor’s Office highlighted that the use of skinny label practice should be previously analyzed from a technical-sanitary point of view by the Agency, which may, reasonably, and from the point of view of public health, understand the relevance of maintaining some information in the label, without this, by itself, implying a breach of IP rights.
The Reporting Director, Meiruze Sousa Freitas, highlighted in her favorable vote for the opening of the PC 1,137/2022 that “there is no impediment to the registration of generic drugs and the like resulting from the establishment of second medical use patents, which could, ultimately, favor the market reserve and harm the interests of public health”.
The companies will have until March 6, 2023, to send contributions to the Public Consultation.
Our Life Sciences & Healthcare team remains at your disposal if you need further assistance. Please reach our team via email:

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