Brazil Tightens Rules On Drug Companies’ Influence On Physicians

RIO DE JANEIRO – The interaction between pharmaceutical companies and physicians has been discussed intensely in the last three years in Brazil, and recently has come under heightened scrutiny.

The Agência Nacional de Vigilância Sanitária (the National Health Surveillance Agency) – a Health Ministry unit – drafted Resolution 96/08, which passed on 3 January, was introduced into an intense debate in Brazilian society. More than 800 people joined the discussion of the issue through various means.

Pharmaceutical companies use multiple marketing methods which are targeted at physicians: advertisements, visits by representatives, distribution of free drug samples or other gifts, sponsoring of meetings and seminars. It has been shown that this interaction can influence physicians’ prescriptions inappropriately.

As the interaction is inevitable, the National Health Surveillance Agency wants this relationship regulated to minimise non-rational prescribing. Then, the resolution aims to regulate propaganda, promotion, and drug information to restrict patient self-medication, promote the rational use of medicine and avoid poisoning.

There are nine items that treat this subject in the Brazilian resolution, including provisions on free drug samples, visits of pharmaceutical representatives and sponsoring of physicians to participate in national and scientific congresses. Researcher Roberto Soares de Moura, a member of Brazilian Academy of Medicine told Intellectual Property Watch of the case of a multinational food company that sponsored, every year, a paediatric congress on a ship, for one week.

Article 5 of Resolution 96/08 prohibits distribution of gifts or publicity in prescription form. Artists and laypeople are not allowed to do drug merchandising or advertisements. Another important resolution affirms that free samples cannot be offered for drugs that do not need a prescription. Free samples of contraceptives and antibiotics are allowed if the multinational company includes the whole treatment. In these two cases, the industry will have 360 days to adapt.

Another polarising topic is the support to health professionals to participate in conferences and seminars. Now, the scientist or physician must inform a conference if they received financial support. The rule determines that the sponsor could not condition the support on an obligation to prescribe any medicine.

If a pharmaceutical company sponsors symposia or scientific events, this support must be clear in all materials of communication (such as posters or annals of the congress). And a speaker who is associated with a company needs to communicate this fact to event coordinators.

According to Soares de Moura, this resolution is important because it is essential to be clear on ethical limits. “The industry cannot be the guideline of the physician decision,” he said. “Nowadays, the guideline is inadequate.” He confirmed that he received flight tickets to an international congress, but he did not feel bad because he does not prescribe drugs.

Guilherme Caldas, a specialist from Associação Nacional de Laboratórios Farmacêuticos (Alanac, the National Association of Pharmaceutical Laboratories) said that the association had participated in the whole process of public discussion on this subject and after dozens of meetings with National Health Surveillance Agency, some points with importance to the pharmaceutical industry remain unresolved. He told Intellectual Property Watch that one of the main problems is the prohibition on distribution of free drug samples.

For him, this prohibition provoked a limitation in many pharmaceutical companies’ marketing actions. Drug samples are distributed exclusively to physicians, pharmacies, dentists and others. Patients do not have access to these products, said Caldas. Also, a patient can be familiarised with a drug brand or laboratory name, but not be allowed to acquire it without a prescription.

In his opinion, the free drug sample distribution to physicians and dentists is not enough to induce the prescription. The drug sample has a low price (less than US$5) and, according to Caldas, Brazilian professionals follow the ethical code and have responsibility for these actions and their consequences. A representative from Alanac said that the drug sample distribution is not intended to lead to a prescription or sale. The goal of free drug samples is only to remind people of the brand, he said.

On the time to adapt to the new rules, Douglas Duarte, technical coordinator at Alanac, said it is insufficient. “We need more time for the work of revision and to modify propaganda of the whole material. Also, we need more time to distribute the material in stock.”

According to the National System of Toxic-Pharmacological Information, a unit of the Fundação Oswaldo Cruz, medicine in Brazil is responsible for three accidents every hour, or 28 percent of all poisoning, (which also includes pesticides, poisonous animals and plants).