Francisco A. Laguna
In October, I gave a lunch presentation at Keller and Heckman’s TSCA and International Chemical Regulatory Law Seminar in Washington, DC. The discussion centered on 5 Latin American countries: Argentina; Brazil; Colombia; Mexico; and Venezuela. We’re converting my speech into a five-part blog series. The second article focuses on Brazil.
For those of you working in Brazil, it’ll be no surprise that this emerging economic powerhouse is a hot legal and regulatory mess.
Brazil is good at inventing and publicizing efforts to achieve an open access government; the reality, however, is that Brazil remains a highly bureaucratic, rule-oriented state. The bureaucracy affects all levels of government – municipal, state and federal, not to mention the notary system. The two biggest challenges of doing regulatory work in Brazil are certainty and consistency. A couple of years ago, I participated in the Brazil round table at the Bio Conference in Boston. Industry representatives, mostly from the pharma sector, complained to government officials about the lack of clarity, and the often changing nature, of Brazilian regulations. Apparently, the government is still working on that.
Brazilian regulations appear clear and straight-forward on their face. It’s the implementation process and the agency interpretation of its own rules that can be tricky. I’m sure you’re all familiar with applications filed with the Ministry of Agriculture or the Environment or with Anvisa. Each agency has extensive information and documentary requirements. Typically, the regulations provide a laundry-list of required data; however, that list is subject to review by individual technical staff.
In our experience, the technical staff is competent and as up to date as they can be. The problem is that personnel are low, and staff is overworked. This often results in initial cursory reviews that generate requests for additional information as a simple means of paper pushing. As with all Latin American officials, Brazilian government employees have ample discretion. We’ve heard of cases in which an agency issues 2 or 3 document requests before beginning to consider the substance. As a result, application processes can take twice or three times the statutory limit. When we are on the receiving end of these requests, we keep track of the additional documents asked for and, next time, try to file them with the original application. Some times that works; sometimes not so much.
Another challenge to doing regulatory work in Brazil is access to Brazilian officials. It can be quite difficult to get a meeting with government personnel, even ones who are reviewing your applications. Increasingly, government relations are becoming an important part of doing business in Brazil, and Brazilian industry is using US-style lobbying techniques. For that reason, TransLegal has offices in Sao Paolo and Brasilia.