Article: The ANVISA task must be to \”give life\” to the RDCs

Text by Antônio Britto

Introduction

For the first time in 15 years, the pharmaceutical productive sector was invited to discuss and present to the new servers of the National Health Surveillance Agency (Anvisa) the agenda by the pharmaceutical industry and its challenges. The initiative was part of the Anvisa Servers Applied Training Program, conducted by the Agency, in partnership with the Competitive Brazil Movement (MBC) in May 2014.

In addition to the meeting, the Agency also gave all lecturers the opportunity to be part of the Program Annals, through scientific articles. Therefore, the purpose of this text is to register the presentation of Antônio Britto, executive president of the Association of the Pharmaceutical Industry of Research (Interfarma), as a way of disseminating messages and expectations of the entity and contribute to encourage dialogue with all Anvisa servers, whether they are newcomers or veterans.

The regulating role

Firstly, Interfarma wants to state with great conviction: the regulating role, especially healthcare, must be exercised with rigor. In other words, Interfarma will not defend the reduction of requirements from the technical point of view, nor does it seek for any kind of facility for the authorization of studies, obtaining records or licenses. Interfarma believes that the regulating role means being rigorous, as it is linked to the preservation of the sanitary quality standard in the country, in particular of biological products, which bring a new challenge to all – and one much more delicate and much more complex.

Interfarma also notes that in these 15 years, Anvisa has earned respect for the quality of its technical staff, even if it was a very small group, and for the rigor of the regulation it wrote. Anvisa has passed the first phase of its existence, producing a rigorous and high standard regulation, a fact that protects citizens and elevates the regulator\”s level of performance, qualifying the pharmaceutical industry and putting the country at an excellent level of safety and quality, even to compete in international markets.

This evaluation leads to the conclusion that it is necessary to dispel the idea that Anvisa\”s preferential role should be to serve as an arm of government policies. The main role of Anvisa is to ensure sanitary quality in the country. The Agency\”s unavoidable and desirable participation in supporting Brazilian development projects cannot precede, replace or disregard the preservation of sanitary quality. A concrete example is the issue of the Productive Development Policy (PDP). Support for PDPs is important, but as important as PDPs is the assurance that the companies involved will maintain quality and comply with health regulation.

The rigor will only be effective if it is based on technical decisions. There is no rigor, for example, if one of those responsible, a technician from any agency, submits to an interest other than the level of the sanitary standard. Therefore, in order to maintain this rigor, we all have a common task: to establish a \”sanitary protection cord\” that protects Anvisa from any influence or interest coming from the industry, from parties, from anywhere, and that threatens the sanitary issue. If this environment is not ensured, rigor cannot be exercised.

The greatest compliment that Anvisa can receive is that it is technical. And in this context, being technical means: being directed to the public interest. And what does public mean? Public stands for: complying with the Agency\”s mission, especially with the health defense.

Another point to be addressed is referred to as \”castles\” here. Rigor, in the understanding of Interfarma, is not confused with keeping away from dialog or discussion. A technician only improves when they try to listen, to know, to explain and to dialog. When technician shut themselves down, isolate them, their technical level can become impoverished and outdated, causing the whole country to lose with the lack of dialog. The power of technicians is only strengthened when they come down to the parlor, when they avoid summary decisions, which in the end will cost everyone more, including technicians themselves.

If we compare the technician to a judge, what is the procedure? Before giving judgment, the judge is obliged to hear the parties, to consider the positions of each of the parties involved, and then to make an assessment based on their conscience, their knowledge and the law. And it is from the meeting of these three criteria that the good sentence is born. If this is true for the judges, for the ministers of the Supreme, we understand that the technicians are strengthened in establishing processes where there is dialogue. Therefore, the regulated learn, the Agency becomes more accurate, the regulatory environment becomes clearer and safer, if there are no \”castles”.

And just to recap, as the words \”rigor\” and \”castle\” were mentioned, now it is the turn of the word \”essential.\” I was a constituent, so I hit my chest one, two, three, four times, for the number of useless words I helped put into the Constitution. Sometimes I read and think to myself: my God, what does this mean? But, this is a Brazilian cultural tradition.

The regulation of Anvisa is also made in Brazil, also made by Brazilians and is also the sum of excellent technical settings, absolutely essential, surrounded by a voluptuousness for insignificant details, sometimes even useless, from a sanitary point of view. So, I think, and I am talking about the moment in which almost 300 technicians enter the Agency, or if two thousand technicians enter, or if 20 thousand technicians enter it, and the processes in Anvisa are not changed, all these technicians will not be enough.

Reviewing the cases, in my opinion, is a very simple matter:

Is this important from a health point of view? If the answer is positive, the conduct should be regular and act with the utmost rigor and maximum technique. Now, what is the influence or importance of hundreds of details, of secondary issues that go into regulation?

How much time and resources are devoted to it, what is not important and has nothing to do with any health risk? Therefore, I am using this reasoning to express that Anvisa\”s strength comes from taking good care of the essential. When I dilute my strength, treating what is essential and unnecessary in the same manner, do you know what I am doing? I\”m not taking care of the essential right.

Interfarma is aware of Anvisa\”s problems, the limitation or insufficiency of many of its material resources, such as information technology, for example. For this reason, because of Anvisa\”s immense responsibility and lack of resources, Interfarma insists that it wants neither less rigor nor less bureaucracy.

The entity believes that the Agency is now starting a new phase. And the success of Anvisa from now on is related to the ability of new technicians and former servers to \”bring to life\” Resolutions of the Board of Directors (RDCs). The almost endless task of editing regulation is basically complete, but most of the important DRCs have not yet been put into practice, in real life.

Interfarma acknowledges that Anvisa, in 15 years, has produced many quality texts, albeit with details not always necessary, and wishes to reinforce the request, so that this regulation is now really applied and monitored, that what is on the paper is fulfilled and \”come alive\”. Just to exemplify: on paper, every medicine marketed in Brazil is good, as it had the request for registration forwarded, analyzed and approved. However, Anvisa is working hard to establish pharmacovigilance in the country, which is overcoming the enormous distance between the dedication and rigor used in the analysis for the approval of the dossiers and the post-market supervision. That is: everything that is being traded/consumed should be supervised, but this still does no
t happen.

Another example is medical prescription. Anvisa defines that there is some sanitary risk in relation to a particular product and it starts to demand a stripe on the packaging and, consequently, if it has a stripe, the prescription is required. However, it is common knowledge that there is no respect for prescriptions. Therefore, the issue of the red or black stripe, once again, is an example of something solved in the RDSs, but that is not put into practice, it will not become a reality in the country. A few months ago, Interfarma released a survey that proves the level of self-medication in Brazil and the fact that doctors keep losing more and more importance in the decision and prescription of medicines.

Finally, three more themes that Interfarma understands as fundamental. The first one is the clinical research. Without it, there is no innovation; the country has no technology; Brazilians are deprived of access to modern and efficient therapies; and the trade balance is impaired.

The second theme is related to deadlines. The Agency has made very correct decisions in recent times, has been very concerned and is seeking to reduce bureaucracy, through a partnership with the Competitive Brazil Movement (MBC). The direction is correct, but the delay is still too great. To illustrate that, an article on the post-registration queue of new medicines has recently been published in the press. There are 1,873 requests awaiting reviews, not including similar and generic ones. Obviously, this challenge will not be solved by reducing rigor, but it probably will not be solved by maintaining unnecessary bureaucratic requirements.

The third and final theme is drug traceability, a blow to forgers, thieves and tax evaders, and which, due to advances in this year 2014, is ready to become a great success.

To conclude, Interfarma expresses its acknowledgment for this historic opportunity to dialog with Anvisa technicians. And it reiterates its commitment to maintain this professional relationship in an extremely ethical and respectful manner.