Brazil’s dilemma in the sales of OTC healthcare

Starting in 2003 Brazilian regulatory authorities looked for a reason to increase the regulation on the advertising of OTC products. In late 2008 and during 2009 the rules of the advertising game changed that could potentially affect the future of the OTC healthcare industry in one of the hottest economies in the world.

Stricter regulation brewing for a few years

In November 2005, ANVISA, the National Agency for Sanitary Control carried out a 120-day public consultation period to discuss preliminary rules established by the health agency on the advertising of prescription and OTC medicines. ANVISA’s goal was to reduce the health risks caused by overdose and false health claims used in advertising. By December 2007, there had been three public meetings to discuss the contributions made during the public consultation.

The preliminary regulation on advertising presented by ANVISA outlawing most of the advertising of medicines in Brazil, led to protests from the pharmaceutical and advertising industries.

On December 2008 ANVISA issued an updated legislation on advertising under the resolutions of Regulamentação da Propaganda de Medicamentos – RDC n.º 96/08, followed by the Instrução Normativa n.º 05/09 published in May 2009. These resolutions provide the latest guidelines on the advertising of OTC products in Brazil.

Among the most interesting new guidelines are that companies selling OTC products preferably promote them at a doctor’s office or pharmacies using proper “visual aids”. It is not permitted the use of images with children under the age of ten and any endorsements by celebrities are banned. Companies wishing to use scientific claims need to disclose the full scientific report to avoid any promotion or marketing language that could deceive consumers. The images of people taking a medicine or of fruits to imply flavour are prohibited.

Through these actions, ANVISA’s goal is to protect Brazilians from deceit, risks and false health claims derived from non-approved OTC products and advertising campaigns.

Implications of stern advertising directives

ABIMIP, the Brazilian Association of Non-prescription Medicines, fears that severe restrictions on OTC advertising might impact self-medication for the
treatment of minor headaches and colds. In response to ANVISA’s concerns, some companies invested in educational advertising campaigns. Bayer, for instance, ran an advertising campaign for Aspirina in 2008 which emphasised that the product is safe to take in cases of muscle pain, as aspirin is commonly purchased to alleviate headaches.

In a stunning move, ANVISA decided to temporarily ban all the advertising and promotion of OTC analgesics containing acetylsalicylic acid ,and cold/cough remedies under the resolution RDC n.º 43/09 published in August 2009. The H1N1 influenza epidemic forced ANVISA to take such a radical approach to
protect consumers.

In spite of this particular circumstance, preliminary figures on the retail value sales of cold, cough and allergy remedies point at an estimated R$3 billion in 2009, a 12% growth from the previous year.

Looking into 2010

Recent speculation in Brazil states that all OTC products will become behind-the-counter (BTC) products. This is terrifying news for an industry that is working intensely to promote self-care and condemn self-prescription. Brazil is not the only country where BTC is being discussed. Also, in the US the Consumer Health Product Association (CHPA) is lobbying regulatory agencies to prevent any further BTC practices to be imposed in more OTC products.

The Brazilian industry believes that if more consumers were to self-medicate, the effect could be positive on public health expenditure. Instead of an obstacle, a wider availability of OTC products should be good news for the government. People suffering from minor ailments easy to diagnose could go directly to the drugstore and buy the product instead of consulting a doctor. This situation would drive government-subsidized healthcare costs down.

Euromonitor will expand the analysis on Brazil and the OTC industry in an upcoming publication scheduled for early 2010. Be on the alert.