By Frederick R. Ball, Partner, Duane Morris LLP.
From September 9-12, , members of the US food and drug law bar met with their Brazilian counterparts for the Food and Drug Law Institute’s conference US & Brazil: Navigating New Frontiers in Pharmaceutical, Medical Device & Food Law & Regulation in São Paulo. Participants included industry representatives, top regulators from the U.S. Food and Drug Administration (FDA) and the Brazilian National Health Surveillance Agency (ANVISA) as well as members of the legal community from both countries.
The sessions focused heavily on the state of doing business in Brazil. A common theme across panels was that Brazil is ranked as one of the most difficult countries in which to do business. Primarily, it appears ed to be an issue of simple bureaucratic inertia. Many panelists pointed out that because the government is a major purchaser of health care, it plays an inordinate role in price-setting. Panelists also noted that ANVISA sometimes pursued policies that favored local industry over their foreign counterparts.
The conference kicked off with a keynote address by Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy at the FDA. Autor emphasized that, given the global reach of the pharmaceutical industry, the FDA could not go it alone in protecting the health of the American consumer. She stated that the agency must (1) form global coalitions with regulators in other countries, (2) develop global data systems. (3) rely on advanced risk analytics, and (4) work to develop strong relationships with third-party inspectors both private and public. She pointed out that ANVISA and the FDA have already taken steps in this direction by agreeing to share information related to manufacturing and product risk pursuant to a confidentiality agreement. She also noted that ANVISA, FDA, Health Canada, and Australia are working on developing a single audit pilot program for medical devices that all four regulatory agencies will be able to rely on.
Participants did make clear that Brazil is a ready market for clinical trials. It has a large diverse population that mirrors the rest of the world. It has a well-developed national health care system that is capable of helping to identify appropriate patients for such trials However, there was broad agreement that there remain significant bureaucratic challenges to getting a clinical trial approved. My conversations with conference participants confirmed both these points.
The evening of September 10, N. Gerard Zapian, a specialist with the U.S. International Trade Administration, convened an off-the-record roundtable for American companies seeking to import medical technology into Brazil Well over twenty industry representatives participated and held a frank discussion of the challenges they faced importing those products, including the current backlog of GMP facility inspections at ANVISA, a recent worker strike, and the challenges of helping the country’s regulators understand the benefits of advanced technology.
The second day of the conference began with a plenary session on trade associations in the two countries.. Panel participants focused on the importance of supply chain safety, including voluntary codes of conduct. Panelists discussed the rise of consumer groups in both countries and the influence they have on supply chain issues, such as environmental degradation, child labor issues and forced labor.
The conference concluded with closing remarks by Michael Rogers, director of the FDA’s Latin American Office. Rogers pointed out that 50 percent of fresh fruit, 20 percent of fresh vegetables, 80 percent of seafood and 80 percent of API consumed by Americans was imported. He noted that Brazil made up 41 percent of the regulated imports from Latin America to the U.S., of which the largest two categories were medical devices and food. Rogers reiterated a conference theme: there is a great need for international cooperation due to the globalization of the supply chain. He pointed out this was a jointly shared responsibility: of regulators, industry and consumers.
Frederick R. Ball is a partner in the Boston office of international law firm Duane Morris LLP. He is the head of the firm’s Pharmaceutical, Pharmacy and Food Industry Group . He can be reached at FRBall@duanemorris.com.