SAO PAULO, Brazil – Latin America is rife with opportunities to undertake clinical trials, but regulatory adjustments are needed for companies to fully take advantage of them. As the largest market in the region, Brazil, for one, is in dire need of those adjustments, said experts gathered in Sao Paolo last week for the annual BIO Latin America conference.

"We also need to take advantage of those opportunities, and it is important to put on the table that Brazil can increase its participation in clinical trials," said Carlos Murillo, country manager of Pfizer Inc. in Brazil. "Compared to other parts of the world, we are really, really behind, and it all has to do with regulations."

And the maze of regulations for clinical trials in Brazil is made worse by the long time it takes to get approvals, which are considerably longer than in other parts of the world.

"Clinical trials here are a big problem, and not because of the quality. The physicians are great, but approval times in Brazil are the main problem," said Rogerio Vivaldi, CEO of Sigilon Therapeutics Inc. of Cambridge, Mass. "You get the approval in Ukraine in 27 days, in three months in the U.S. or in 30 days in the U.K. It could take up to one year in Brazil."

And beyond the red tape, there is also the issue of cost, which can be significantly higher in Latin America than elsewhere.

"Besides hepatitis and other special diseases, you have to pay import duties; this could mean more than the cost of the trial itself," said Vivaldi.

"You really want to be persistent to really want to do a clinical trial in the region. And [it has also to be considered that] there are regulations that make it mandatory to provide the trial drug to participants for life," he added.

Considerations of whether – or how – to provide drugs for a lifetime for patients enrolled in clinical trials, is something that has triggered global debate. However, industry stakeholders insist that this requirement often plays against research and development in countries like Brazil and others across the region.

"We need to have clear rules. Long-term treatments, especially in complex diseases, is a bad policy for enhancing clinical trials in Latin America," said Roberto Bobadilla, CEO at Cells for Cells, of Santiago, Chile.

Meanwhile, for Sigilon's Vivaldi, the delay in approvals for clinical trials in Brazil is not an issue of lack of resources at Anvisa, the Brazilian health surveillance agency, but a matter of attitude from the government. President Jair Bolsonaro took office eight months ago and many believe he has already begun putting his stamp on many areas, including Anvisa's work.

"The timelines from Anvisa are there. It is not a question of resources in my view. The government needs to help in terms of not making things more difficult," he said.

An example of the inefficiencies that exist in Brazil is the huge backlog of patent approvals. According to Luiz Montaury, of the law firm Montaury Pimenta Machado & Vieira de Mello, the backlog means that it can take up to 14 years to get a patent examined in Brazil.

"The government has recently announced a plan to combat the patent backlog in order to expedite the examination of nearly 170,000 patent applications pending examination (with new applications still entering Brazil), which was implemented just a few weeks ago," he wrote in August in an op-ed published in Lexology.

Despite those downsides of bureaucratic delays and costs, many experts at the conference in Sao Paolo agreed that Brazil and the region have much to contribute in regards to clinical trials.

"We should promote the region, not only Brazil, in the genetic diversity that we have," said Vivaldi. "Patient enrollment in Brazil is always the fastest in the world. Patients go in the minute they learn that there is something that can cure their diseases.

"While the approval of a clinical trial can take up to a year, enrollment is very quick and this has also to be considered," he said.

However, even with the rapid enrollment rates, it is important to put more emphasis on patient education to overcome fears and rumors.

"Patients are afraid of clinical trials and that there is some conspirator U.S. company testing drugs in Latin Americans," said Wadih Arap, director of the Rutgers Cancer Institute of New Jersey, of New Brunswick, N.J., and co-founder of Phagenova Bio. "There needs to be an education, a grassroots movement, to have patients participating in clinical trials."

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