CMED defines rules for pricing drugs used to combat Covid-19

 The Technical-Executive Committee of the Drug Market Regulation Chamber (“CMED”) published Resolution CTE-CMED nº 4/2021 in the Federal Official Gazette (“DOU”) on 3.29.2021, thereby establishing procedures for the analysis of the Price Informative Document (“DIP”) referring to the request for pricing of drugs intended for the treatment of Covid-19.

The norm regulates, from an economic perspective, the measures that the Brazilian Health Surveillance Agency (“Anvisa”) implemented in the recent Resolutions RDC No. 483 and 484/2021, which respectively outline, in an extraordinary and temporary way, the requirements for:

• The import of new medical devices and priority drugs for use in health services to combat Covid-19; and

• Emergency authorization for the manufacture of anesthetic drugs, sedatives, neuromuscular blockers and other hospital products used for life support of Covid-19 patients.

The drugs used to treat the disease are classified by the CMED in the category of omitted cases, according to Resolution CMED Nº 2/2004. Therefore, the deadlines for the analysis of the DIP will be those defined in the Communiqué CMED No. 10/2016, which stipulates a period of 90 days for the Executive Secretariat to analyze the drug pricing request.

Pharmaceutical companies will be able to start commercializing the drugs immediately after they have been submitted the DIP, until they receive the CMED decision regarding pricing. During the term of Resolution CTE-CMED No. 4/2021, provisional prices will be set for the commercialization of the drugs, in light of the following criteria:

• The price will be calculated based on the arithmetic average price of the versions of the drug currently available on the market, with the same active ingredient and the same concentration, in the same pharmaceutical form.

• If the drug used to combat Covid-19 has other versions in accordance with the Drugs Market Monitoring System (“SAMMED”), then the provisional price cannot be set higher than the arithmetic average of those versions with the same concentration and pharmaceutical form, already sold by the same company.

• In the absence of versions with equal concentrations, the arithmetic average price will be calculated based on all versions of the drug already sold by the company, as long as these drugs have the same pharmaceutical form, according to the criterion of direct proportionality of the concentration of its active ingredient.

The rules established by the Resolution apply to the following list of drugs, which may be updated by the Technical-Executive Committee of CMED, upon request by the Ministry of Health or Anvisa:

The CMED Resolution came into force on the date of its publication and has an initial term of 120 (one hundred and twenty) days, applicable to the price-fixing processes already ongoing before CMED. The agency may extend it as long as the public health emergency related to the new coronavirus is recognized by the Ministry of Health.

This article is intended exclusively to provide information and does not contain any opinion, recommendation or legal advice from Kestener & Vieira Advogados concerning the matters herein addressed. Specific legal advice may be provided by one of our lawyers. Copyrights are reserved to Kestener & Vieira Advogados.