The regulatory challenges that Swiss companies encounter in Brazil related to innovation

02/Jul/2019 - Breakfast, Café da Manhã

On August 19, SWISSCAM organized a breakfast with the Head of International Affairs of ANVISA (Brazilian Health Regulatory Agency), João Paulo Ortega, at the Cantaloup restaurant. Prior to the start of the event, Gold members had the opportunity to hold a private meeting to ask questions, share suggestions and learn about future changes at Anvisa. Afterwards, the event was opened to other associates and guests.

The representative of Anvisa gave a lecture in which he highlighted the relevant participation of the Agency in International Organizations, bilateral and plurilateral negotiations, in order to gain mutual recognition from other countries in the regulatory field.

Alignment with foreign agencies is in line with the claims of member companies seeking a faster regulatory process to facilitate business. João Paulo Ortega said that Anvisa has effectively sought to create an agenda that is more sensitive to economic repercussions and more “business friendly”.

Currently, Brazil participates in the main International Organizations that deal with the subject, among them: the International Council on Harmonization (ICH) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

He pointed out that Swiss companies could benefit from the recent agreement between Mercosur and EFTA (European Free Trade Association), as Anvisa can now deepen its dialogues with Swissmedic, which is the Swiss agency equivalent to Anvisa.

Internally, Anvisa also undergoes changes to modernize and become more effective. In the last two years 1/3 of the pending cases have been revoked. “Anvisa is on the right track, working hard to speed up regulatory processes. However, it is no use for companies to want Anvisa to act quickly on topics that are not yet on the Regulatory Agenda. The agenda is already set for the coming years. New issues will have to wait, ”said the speaker.

During the event, a very interesting point was also raised about how the advancement of technology has accelerated the emergence of new substances and products, thus making the work of the Anvisa team more difficult. After all, how to keep up with this pace and be able to regulate all subjects? For João Paulo Ortega, the tendency is less regulation and more supervision. “The product will go to market faster, but there will be more inspection; This is called self-regulation. The tendency is to create a more general regulation and not one for each segment. ”

He also cited that in March 2019, an agreement was signed between the Brazilian Federal Revenue and the OAS (Brazilian Authorized Economic Operator Program) to facilitate international trade processes. Companies wishing to participate in the Program must apply to the site for an AEO certificate.

We thank João Paulo Ortega for his dedication to sharing with our associates the work of his team and Anvisa’s advances. SWISSCAM, as a business promoter, also congratulates Anvisa for its position closer to the private sector.