"Our work will significantly improve"

Created almost ten years ago, the National Health Surveillance Agency, known as Anvisa, has made several executives of the pharmaceutical industry complain about restrictions and regulations of new products.

During an interview to Top Team, the director president of Anvisa, Dirceu Raposo de Mello, defends himself from complaints and talks about some some changes about to happen in 2008. He adds: "We have worked with several proposals of new rules that affect the industry very positively". Follow it below:

Top Team: Several brazilian executives complain about Anvisa restrictions, what can you say about it?

Dirceu Raposo de Mello: Anvisa restrictions are the same restrictions applied by all agencies in developed countries. The FDA and the European Agency, for instance, also have complaints. From the businessman point of view, he wants freedom to do his business. From Anvisa and Healthcare system points of view, we have to guarantee that the services are offered safely and with narrow range of risk. Anvisa also cares about the consumers rights and protection.

Top Team: Does Anvisa differentiate national and foreign laboratories?

Dirceu Raposo de Mello: Absolutely. All the processes at Anvisa are analyzed by order of arrival. We do have some rules that privilege medicines for public use. For instance, if tomorrrow a medicine against malaria comes to our hands, it wil be undoubtfully considered differently in terms of time. However, this is the only distinction that we make. There is no distinction concerning the nationality and size of the laboratories.

Top Team: Will the regulation period for medicines be shorter?

Dirceu Raposo de Mello: The period required by Anvisa are compatible with the one required abroad. It will depend on the quality of the documents that are sent to the Agency. The pharmaceutical industry businessmen complain, however, the regulating sector of the laboratory didn't work well on the documentation by sending wrong information. This will duplicate work for the Agency, which has to meet the laboratories requirements. As the precesses are dynamic, those who are not correct end up coming back to the end of the waiting line. The processes that are well instructed leave with no problems, though.

Top Team: Will there be any policy or rules changes for 2008?

Dirceu Raposo de Mello: We have worked with several proposals of new rules that affect the industry very positively. The Agency and the industry makes an effort to fight against forgery and to guarantee that the consumer can have access to real medicine. For that, we have changed the implementation of autenticity mechanisms of pharmaceutical products. Such process ends in March and, from that moment on, we will discuss with society the opportunity of introducing this new mechanism of safety all over the country.

Top Team: How do you evaluate the quality of the Brazilian pharmaceutical products?

Dirceu Raposo de Mello: The industrial park installed in Brazil can be paired with any other in the world. The Brazilian industry, both the national and the multinational ones, are highly qualified. Brazil has been qualified due to the generic medicines; competition, which has expanded all over the market; and the financing system offered by Lula's government, which stimulated the development of the Brazilian pharmaceutical industry. Nowadays, Brazil is much more skilled to manufacture medicines.

Top Team: To wrap up, what does Anvisa expect for 2008?

Dirceu Raposo de Mello: We expect to develop our work better. In Brasília, we have unified Anvisa, which was previously segmented in three units. By the second semester of this year all 1,600 servers will be located at the same place. Such change will guaratee more efficacy to the processes as the delivery of orders and products will be at the same place. The logistics will also be easier. Therefore, I believe our work will significantly improve.