Given the attractions of Brazil, delineated in a previous article, why have large sponsors and contract research organizations (CROs) hesitated to launch projects there?
Dennis Hurley, Kendle‘s president of global clinical development for Latin America, says the regulatory environment is the reason. “Brazil has set up such a complicated regulatory system that it took, usually, between 10 to 12 months to get a trial started,” he says.
“The country has the distinction of being second slowest in the world, behind China,” he adds. “This was and is the major problem in Brazil.”
Most other countries—emerging and otherwise—designed their regulatory processes so that organizations hoping to start a study there could execute the various parts of the approvals process in parallel, at the same time. Not in Brazil.
Until recently, the process has been to start and finish each part of the multi-pronged approvals process before embarking on the next. And if there is a glitch in the paperwork along the way, almost no face-to-face or phone discussion is possible. Instead, all communications must take place by postal letter. Problems or questions can put the applicant back to square one, with a possible added delay of more than two months.
Since the clinical research market got off the ground in Brazil in the mid-1990s, the country’s regulatory structure has been its Achilles heel, holding the market back while other emerging markets like India soar ahead.
Here’s how, until very recently, the process was laid out. To start a trial in Brazil, one had to:
1. Approach and get approval from local ethics committee(s) that have jurisdiction over each investigator site you plan to use, then…
2. Approach and get approval from Brazil’s national central ethics committee, then…
3. Approach and get approval from the country’s Agência Nacional de Vigilância Sanitária, Anvisa, considered the Brazilian FDA), then…
4. Go through the importation process that’s necessary for any drug coming into the country.
Why did Brazil work sequentially? Hurley says Brazil’s heart was in the right place. It just went overboard. “Brazil has many people who are very poor,” he explains. “The government wanted to make sure they were not in trials that weren’t thoroughly approved. They wanted there to be several layers of protection. But everything became slow.”
Slow, indeed. Anvisa understood that Brazil was losing trials and thus revenue. So last year, it began meeting with sponsors, CROs, trial investigators and various other stakeholders to try to come up with a better way.
The result? In June of this year, Anvisa announced it had restructured the regulatory process. Instead of having to seek and get approval from various bodies sequentially, a sponsor or CRO can pursue many of the steps at the same time. The change was effective in July. Its effects are expected to really kick in early next year after the massive backlog of studies handled under the old rules has been processed.
Here is what sponsors and CROs now have to do to get a trial started in Brazil:
1. Approach and get approval from the local ethics committee of the “coordinator site,” which is usually the biggest, most robust site being used for the study.
2. Approach the national central ethics committee and Anvisa, in parallel, followed by the importation authorities, shaving between six and eight weeks off the process—maybe more.
With the new system in place, things should speed up in other ways. With the huge paperwork burden for each trial now, Anvisa and ethics committee workers have been snowed under with paperwork. Think 10 packets of paperwork for each site, etc. But with the new system, Hurley says, “it will be much simpler. The volume [of paperwork] will go down and they will probably catch up.”
It should also help that the ethics board is working on taking the process electronic. The “Plataforma Brasil” iniative is scheduled to be tested next year and become mandatory in 2010, says Vitor Harada, president of the two-year-old Brazilian Association of CROs (Abracro) and director of clinical operations in Brazil for Icon Clinical Research.
The pace is already quickening. Harada says the numbers of trials in Brazil has increased this year. He believes this is due to sponsors and CROs anticipating the positive regulatory changes and getting more excited about how that will speed up start-up times in Brazil.
“They feel that things are moving, that we have a plan,” says Harada.
Once all the changes are in place, Brazil should be poised to compete with other emerging markets, including those of its neighbors. Argentina, for example, has a population of 40 million people but starts about twice as many new trial sites as Brazil each year: 450 compared to Brazil’s 250, despite Brazil’s population of 190 million. Argentina’s trial ramp-up time is about six months, according to Hurley. So the balance of activity in each country may be about to change.
Better Than India?
Will its new regulatory changes help Brazil beat out India as the premier emerging market for sponsors and CROs? Probably not, says Hurley. India has a two-tiered system. Sponsors or CROs that have already gotten approval for a trial in countries like the U.S. can get on a fast track in India. That can have teams working in India after about four months. Trials that are just taking place in India, or there and in other emerging countries, have a start-up process that takes six to eight months.
That’s a very sophisticated and attractive system, Hurley says—one that Brazil is nowhere close to implementing. But he says the steps Brazil took this year are encouraging, and global research companies are watching closely.
—by Suz Redfearn
Editor’s note: This is the second article in a series. Here’s the first, an overview of research activity in Brazil; the third, about its association of contract research organizations; and the final installment, examining a large and small CRO operating in the country.