LEGAL (UN)CERTAINTY

 

Marcos Lobo de Freitas Levy* and Silvia V. Fridman**

  

Under the argument that there would be need “to analyze the regulatory impact on the amendments to Resolution - RDC 010, of March 21, 2011, that regulates the quality assurance of imported drugs”, ANVISA published in the Official Gazette of December 20, 2018, RDC 257/2018 materializing, once again, the agency’s unjustifiable desire to interfere in the manner in which the regulated companies decide to manage their businesses.

 

Resolution RDC 257/2018 backs down on the procedures related to the adequacy process in the Brazilian regulatory scenario, pertaining to the activities of the manufacturing and the importing of drugs. This Resolution cancels and/or suspends rules that had been set forth by 234/2018, published less than six months before that represented an important advancement in matters related to outsourcing.

 

It is important to stress that ANVISA had already, more than once, publicly recognized that the restrictions to the outsourcing of business activities was not justified and needed to be updated.

RDC 257/2018 maintains the restrictions to the outsourcing of activities related to production, storage and quality control of drugs. (quality testing of imported biological products are regulated by a different Resolution.

Although RDC 257/2018 also impacts production related activities, the greater impact falls on the importation of drugs, requiring that they maintain their own warehouse and demanding that they reproduce, in Brazil, the analytical profile performed by the manufacturer abroad.

Since 2007 with the enactment of RDC 25/2007, discussions on the outsourcing of business activities have been intense and passionate. The regulation that restricts the outsourcing of activities seeks, perhaps, the “protection” of local manufacturers by imposing difficulties to importers. However, such mean of protection may be construed as a “Non-Tariff Barrier”, which violates international commerce rules, set forth by the World Trade Organization – WTC.

The restrictions imposed by the regression introduced by RDC 257/2018, present an even greater impact on the importation of drugs for the treatment of rare diseases, that is, those that affect up to 65 in 100.000 people. In this case, due to the extremely reduced volume and to the high manufacturing costs, it is easy to understand that this type of drug is manufactured in one single plant in the world and, from there exported to the rest of the world.

It is important to point out that RDC 234/2018, now amended by ANVISA, was in perfect alignment with international rules in respect to the quality and safety of drugs. RDC 234/2018 required, for instance, the compliance with procedures aimed at guaranteeing the quality of drugs, such as:

(a)    Companies outsourced for quality control activities must:

 

Ø   Hold authorization granted by the National Network of Analytical Laboratories (REBLAS) for the contracted tests;

Ø   Observe the rules set forth in RDC nº 11/ 2012 as amended;

Ø   Hold GMP certificates, when they are manufacturer of synthetic or biological drugs;

Ø   Hold accreditation as per ISO 17025 for the contracted tests; or

Ø   Proof of compliance with Good Laboratory Practices, as per internationally recognized directives; and

Ø   Have the final approval for the final clearance of the product issued and signed by an individual appointed by the outsourcing company.

 

(b)   In the case of the outsourcing of storage, the following rules must be observed:

 

Ø The outsourced company must comply with Good Storage Practices;

Ø Only batches of drugs that have been cleared for commercialization by the holder of the Market Authorization may be sent to the outsourced company;

Ø Batches of drugs under quarantine, can only be sent to the outsourced company when both companies have integrated computerized material management systems or that have interface between them; and

Ø The computerized materials management, as well as the communication interface between them, must be validated to attend to the requirements of the Resolution.

 

After the enactment of RDC 234/2018 the regulated companies had adjusted their planning for the management of their businesses in Brazil. However, in a new and colossal expression. Of the legal uncertainty that makes Brazil internationally known (in the bad sense), ANVISA succumbed, yet again, through the new RDC 257/2018, to the latent desire to interfere in the way in which the companies manage their business and prohibited, again, the outsourcing of storing and quality control testing by importers, only months after it had allowed it.

Based on the above, it is clear that the grounds presented by ANVISA for the return to the “status quo ante”, that is, “the need to verify the impact of the new rules on the quality assurance of imported drug” is clearly indefensible. ANVISA seems to disregard its own regulatory framework in what refers to drug quality.

That said, we are driven to conclude that the new Resolution is but a new chapter in the regulatory “comes and goes” that makes investors, whether local or foreign, systematically postpone (or desist) the much-needed investments in the Brazilian arena.

In conclusion, the regulated sector waits for ANVISA to respond, with the due plausible justification to the following question:

What is the technical justification to require that drug importers have their own warehousing facilities and their own QC labs, especially when there is a network of quality control labs and of warehouses, duly qualified by the very ANVISA and, even more so, when the volume of imported products does not justify any of them?

*Marcos Lobo de Freitas Levy – Senior Partner of A. Lopes Muniz Advogados Associados.

**Silvia V. Fridman – Pharmacist.