Request for review in RDC 327 was providential

It's a good thing it didn't pass. The approval of this new RDC 327 proposal would be a resounding victory for the national pharmaceutical industry. Which would be great, if it didn't happen at the expense of patients who need - or may need - Cannabis for medicinal purposes.

The draft sent for voting is not the same as the one presented in March for public consultation. The changes were significant and the main ones serve to undermine the competition of national manufacturers. An article in the draft proposes to prohibit the manipulation of any cannabinoid by compounding pharmacies and another, almost in a footnote, gives a 12-month deadline to limit the import of products via RDC 660 - a formal demand presented to Anvisa by the Pharmaceutical Industry Syndicate.

These measures are not good for the Brazilian citizens

The manipulation of cannabinoids is important for patients who need customized formulations and even for those who need typical products, it is another supply option. The argument that they cannot guarantee safety, standardization, or quality simply does not hold up. Compounding pharmacies manipulate and dispense all kinds of controlled products, such as antibiotics, anxiolytics, black-label antidepressants, opioids, and stimulants that require a yellow prescription, the most restrictive of all. Why couldn't they do the same with cannabidiol, which the draft itself proposes to dispense with a white prescription? There is no clear technical justification in the regulatory process to prohibit the manipulation of cannabinoids.

Ending RDC 660 is all the industry needs to keep the price of CBD high in pharmacies. Since 2015, the importation of Cannabis-derived products without registration in Brazil has ensured access to this type of treatment for Brazilians when the national industry found the market too small to be worthwhile. For about seven years, manufacturers just watched. Now, with clear regulations and established demand, they decided to play the game, but they can't win fair and square.

Since last year, the growth of their market share has weakened because, contrary to what Sindusfarma alleged in a letter to Anvisa, imports are cheaper. Therefore, to grow, the industry would need to reduce its profit margins and lower prices on the shelf. Or use the revision of RDC 327 to disrupt the competition. In other words, without RDC 660, the industry will have no incentive to reduce the cost of products, even as scale increases. The ones who lose are the patients.

The mechanism resembles the old import substitution strategy, an economic policy used by the Brazilian State in the 1930s and during the military dictatorship to encourage the development of poorly developed national industry sectors, unable to compete with their international counterparts.

However, Anvisa's role is not to protect the national industry. Its mission is sanitary. And from this point of view, the Agency has no responsibility for RDC 660 products. The resolution itself establishes that it belongs to the patient and the doctor. Period. Restrictions on this access mechanism could even be interpreted as an attempt to interfere in the market.

The Brazilian pharmaceutical sector is not an incipient industry that needs this type of support. Quite the opposite: it is a true powerhouse, with tens of billions of reais in annual revenue. It has sales force, communication with doctors, and sufficient investment power to develop in the market regardless of the existence of other supply channels.

The industry plays a fundamental role in democratizing access to Cannabis products in Brazil. And it will perform this role better while coexisting with imported products, compounded products, and - let's not forget - patient associations.

Therefore, the request for review by director Thiago Lopes Cardoso Campos, recently appointed, was providential. Now let's hope that Anvisa's new board reconsiders these articles of RDC that, in practice, create a market reserve for the industry. And that it can produce a Resolution draft more aligned with the public interest.

Regarding the Brazilian pharmaceutical industry, the hope is that it demonstrates, in practice, its ability to produce with quality, efficiency, and low prices. And, who knows, even manage to demonstrate the effectiveness of the products for which it demands so many privileges.

The columnist's opinion does not necessarily reflect the editorial line of the portal.