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ANVISA issues new regulation allowing the Government to procure non-approved drugs even if an approved-product is available in the country

Like in the US and Europe, the regulation of pharmaceuticals in Brazil is conducted by a regulatory entity, who is statutorily responsible for reviewing marketing applications and conduction GMP inspections. These are the cornerstones under which ANVISA1 (Brazilian Food and Drug Agency)ensures the safety and efficacy of drugs and biological products 2.There are, however, two exceptional situations in which ANVISA allows products with no marketing authorization to be used by the Brazilian population. The first is when a patient’s specific condition cannot be treated by existing ANVISA-approved products available in the country. In this case, upon the prescription of the patient`s physician, the agency allows the non-approved product to be imported by the patient for personal use only3. The second exceptional situation is when the Federal Government through its Ministry of Health (MoH) procures pharmaceuticals from multilateral international organizations (such as PAHO) to be distributed within the Brazil’s public healthcare system (SUS). This exception is provided by article 8, paragraph 5, of Statute #9,782/19994. Despite the lack of wording restricting its scope, the provision was always interpreted in a way to only allow such procurements of non-approved products if there isn’t an ANVISA-approved product available in the country to treat SUS’s patients. For example, most vaccines used in SUS’s immunization programs were acquired under Statute #9,782.Notwithstanding, the Federal Government has already shown its intention to use Statute #9,782’s deviating from its purpose, as a way to reduce costs by procuring non-approved drugs from India and China5. In Brazil, due to constitutional provisions, every person is entitled to receive from SUS the drugs necessary for their treatment, for free. For this reason, a substantial part of the MoH`s budget is spent on drug procurements6. Thus, getting the lowest price possible is a priority for the MoH. Using Statute #9,782’s exception may be an alternative, especially in view of the recent regulation issued by ANVISA to deal with this matter.On December 27, 2017, after submitting the regulation’s draft to two consecutive public consultations7, ANVISA issued its Board of Director`s Rule #203/2017 laying out the procedure and setting the requirements for the MoH to use the exception provided by Statute #9,782. ANVISA justified the new regulation in view of the increasing number of requests from the MoH to use Statute #9,782`s exception and the need to have a standardized procedure to review them. However, instead of creating requirements to assure the exception`s proper use, ANVISA Board of Director`s Rule #203/2017 allows the MoH to use it in two situations not at all related to a lack of approved-products in the country8. The first situation is a national or international public health emergency9. The urgency for solutions arising from these situations may reduce the wiliness of authorities to scrutiny the procurements of drugs by the MoH. Nevertheless, the fact is that it’s hard to imagine any reason other than reducing cost that would justify importing non-approved products when there are products with marketing authorizations granted by ANVISA and more quickly available to be procured in the country. The second situation is receiving donations from international multilateral organizations or foreign official cooperation agencies10. Once again, a clear cost-reduction motivation.No one questions the Government`s efforts to reduce cost related to drug procurements for SUS. The inefficiency of government`s spending is one of SUS`s major problems. Nevertheless, such reduction can never be achieved at the cost of patient safety, which the Brazilian regulatory system relies on ANVISA’s approval process to accomplish. Even if this was not the agency’s intention, the fact is that Rule #203/2017`s gives room to interpretation towards the use of Statute 9,782`s exception in situations for which it was not created, nor it`s necessary. If one can argue that Rule #203 is in accordance with the wording of article 8, paragraph 5, of Statute #9,782, it most certainly is not when it comes to a systematic interpretation of the Brazilian regulatory system, which has ANVISA’s approval process as one of its cornerstones. Thus, while legislative11 solutions are still on paper, it will be the courts’ job to ensure the MoH’s and ANVISA’s compliance with the true purpose of Statute 9,782`s exception.Ricardo Campello is a senior attorney at Licks Attorneys, LL.B from the Federal University of Rio de Janeiro (UFRJ) and LL.M from Getulio Vargas Foundation (FGV).----1 ANVISA is the Portuguese acronym for National Sanitary Surveillance Agency.2 The marketing authorization and GMP Certificate issued by ANVISA are both legal requirements set by the Brazilian Food and Drug Act for the commercialization of pharmaceuticals in Brazil (Statute #6,360/1976, articles 12; 18, second paragraph; and 51). Only products manufactured and storage in GMP compliant facilities can receive marketing authorizations.3 For example, in 2015 this procedure was substantially used by patients seeking to import cannabidiol-based and tetrahydrocannabinol-based products. The requests were so many that ANVISA had to issue a regulation dealing specifically with the matter (ANVISA’s Board of Directors Rule #17/2015).4 Paragraph 5 of article 8 of Statute #9,782: The agency can exempt from mandatory regulatory approval (marketing authorization) immunobiological, insecticides, medicines and other strategic products when procured through multilateral international organizations for use in public health programs by the Ministry of Health and its related entities.5 For example, in November 2015, although Janssen`s Prezista (darunavir) was approved and available in Brazil, the MoH procured through Mercosur and PAHO a darunavir-based product from a manufacturer in India with no marketing authorization. This procurement was conducted under Brazil’s Cooperation Agreement with PAHO, through which the parties agreed to assist mutually in favor of SUS. The acquisition procedure through PAHO is one of its instruments. The agreement was approved by Brazil’s Congress through Senate’s Executive Order #11 of 1956 and #108 of 1983. The specific provision dealing with the acquisitions of high-cost drugs is article 2 of the Complementary Agreement, which was internalized in Brazil in 2000, through President’s Executive Order #3,594.6 In 2015, the MoH spent almost BRL 15 billion in drug procurements (approx. USD 4,4 billion).7 The first Public Consultation (#327/2017) started on April 17, 2017, ending on June 16, 2017. In view of the substantial changes in the draft, a second Public Consultation (#414/2017) was opened, starting on October 26, 2017, ending on the 24th of November.8 The situations under which ANVISA can allow the MoH to use Statute #9,782’s exception are listed in article 3rd of ANVISA’s Board of Directors Rule #203/2017. Item “I” refers to the lack of an approved-product or an approved-therapeutic alternative within the country. In the first draft of the regulation submitted to Public Consultation #327/2017, this was the only situation for which Statute #9,782’s exception was allowed. Item “III” refers to procurements of vaccines through PAHO, which historically has been done under the exception provided by Law 9,782. Items “II” and “IV” are mentioned below.9 Article 3rd item “II” of ANVISA’s Board of Directors Rule #203/2017 sets forth the national or international public health emergency situation.10 Article 3rd item “IV” of ANVISA’s Board of Directors Rule #203/2017 sets forth the donation from international multilateral organizations or foreign official cooperation agencies situation.11 Congressman Mr. Marcus Pestana from the House of Representatives proposed Bill #5994 of August 2016, seeking to amend article 8, paragraph 5, of Statute #9,782. The Bill aims at limiting literally the circumstance under which the MoH can procure under the exception of Statute #9,782 in two situations. The first is if no ANVISA-approved drug (with the same API) is available in Brazil. The second is when the available approved drugs do not sufficiently meet the MoH’s needs.

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