Establishments that don’t comply with the new regulation might face fines of up to 1.5 million reais (US$ 817,000).
The Anvisa resolution in an effort to curb self-medication would force pharmacies to place behind the counter several products including common drugs like analgesics and antacids. Government numbers indicate that self-medication kills about 20,000 Brazilian every year due to intoxication and allergies.
Despite the threats of heavy fines most pharmacies and drugstores will not follow the new norms. They were able to get court injunctions against the resolution.
In late January, a court rule had granted almost 60,000 pharmacies all over the country to continue selling any product without restriction. Moreover, some states already have their own laws determining what may or may not be sold in drugstores.
The Anvisa argues that pharmacies are health facilities and not convenience stores and went to court to repeal all the injunctions.
In the state of Paraná, for example, the sale of other goods beyond medicine will be allowed as long as some rules are followed. Products such as sweets, soft drinks, cookies, moisturizers, shampoos and many others may be sold as long as they are kept separated from the medicines.
The new rules are part of the RDC 44, an Anvisa resolution from August 17, 2009, which provides for Good Pharmaceutical Practice. One of the stipulations is that only perfumery and herbal medicines can be displayed on the shelves accessible to the public.
For the purchase of drugs such as painkillers or antacids, the customer will have to ask the pharmacist, as these drugs should be behind the desk. Fines will start at 2,000 reais (US$ 1,100). Establishments may be penalized with the seizure of goods and even cancellation of business licenses.
For Sergio Mena Barreto, CEO of the Brazilian Association of Pharmacies and Drugstores Networks (Abrafarma), the measure will be bad for their affiliates. He said that there are 15,000 pharmacies, for example, that also offer banking services.
“There are several municipalities in Brazil that have no public bank. The most affected is the citizen, because if pharmacies don’t get that revenue anymore, they will cut costs or raise prices, and besides there will be less jobs.”
According to Barreto no pharmacy needs to comply with the Anvisa’s regulation. Besides Abrafarma, which got a court order last October other pharmacies affiliated to ABC Farma and Febrafarma also have obtained judgments in their favor.
“There is no legal basis for Anvisa to prevent pharmacies from selling convenience products in stores,” says Barreto. This had to be presented as a law and it is not. Anvisa went beyond its legal capacity, and therefore, this decision is not valid and we have several legal remedies.”
“In all cases, one thing is understood. The Anvisa has no power to imposed such determinations. It is a federal agency and has no power to legislate. There’s no law forbidding pharmacies from selling convenience products in the country,” he added.
Anvisa sees it differently. The government agency says its resolution will be in effect this Thursday and shall be complied by all pharmacies and drugstores in Brazil. They argue that no injunction was granted that would allow those establishments to disobey the regulation.