SEAE Public Consultation – Draft Resolution on Medicine Regulation

We inform you that the Public Consultation regarding the criteria for pricing new products and presentation characteristics of new drugs is being conducted by the Secretariat for Competition and Competitiveness Advocacy (“SEAE”), of the Brazilian Ministry of Economy.

The SEAE intends to collect market impressions on the draft of a Resolution that will establish the criteria for pricing and presentation of drugs.

Please find attached the draft Resolution of the Council of Ministers of the Medicines Regulation Chamber (CMED), which establishes the criteria for defining prices of new products and new drug presentations. Such draft is the result of a Regulatory Impact Analysis being conducted by the Chamber.

According to the proposed Resolution, pharmaceutical companies will have to inform the Chamber whenever they intend to sell new products and new presentations, applicable to situations in which there is increased use of the drug, new indications, a change in concentration of the active ingredients, a new pharmaceutical form in the country, new association of active ingredients already existing in the country and new association in which one of the active ingredients is new in Brazil.

In these cases, drug manufacturers must send a Price Information Document to the authorities, which must contain the brand name of the drug, as well as its registration number, the substances in its composition, package insert, the price at which the company intends to commercialize each presentation, manufacturer’s price, name of the local manufacturer, potential number of patients, among others.

The Resolution also establishes ways to calculate the price of the products. It is noteworthy that, for certain drugs, the Resolution provides that the price proposed cannot be higher than the factory price practiced in Australia, Canada, Spain, United States of America, France, Greece, Italy, New Zealand and Portugal. For the calculation of such price, the average exchange rate of the period of sixty (60) working days prior to the date of approval of the technical opinion by the Board will be used. Regarding other drugs, the Resolution establishes “bonus” percentages that would be applicable to the prices. The criteria, which extend beyond those mentioned here, vary according to the product.

The deadline for submitting contributions to the Public Consultation is August 27.