Clinical research in Brazil getting lost in regulations

Delays in obtaining approval for clinical research in Brazil has led the country to miss out on 112 opportunities to develop new medicines. The alert was raised by the Pharmaceutical Research Industry Association (Interfarma) as it launched the Clinical Research Alliance Brazil, an advocacy group which aims to urge regulatory agencies to change industry regulations.

“We're not trying to make things easier for us, we just want to speed up the process,” said Brazilian Medical Association chairman Florentino Cardoso, one of the supporters of the movement.

A key phase in the development of new drugs, clinical research is when developers test new drugs on volunteers and match the result against the effects obtained with commercially available state-of-the-art drugs administered to another group of patients.

As laboratories and universities around the world pursue partnerships in other countries to carry out their research, they drive investments to these partnering institutions (e.g. universities). Their requests for applications include protocols explaining, for example, what the research is about, what kinds of procedures subjects will be exposed to, what the potential symptoms are etc. These protocols are evaluated by the local country authorities, who can then decide whether or not to authorize the studies.

According to the Alliance, this application phase can last as long as 12 or 15 months in Brazil – the sixth largest global market for pharmaceuticals, and the 15th most largely engaged in clinical research. In the United States, the world's largest pharmaceutical market and research center, the same process takes about two months, and in most European countries, just over two and a half months. In neighboring Peru and Argentina, it lasts about four months.

“With such long delays, Brazil is missing excellent opportunities to make drug therapies available to patients, and also on opportunities for knowledge and innovation sharing. Development is closely linked with research,” said Irani Francischetto, executive director of the Center for Osteoporosis Research and Diagnosis in the state of Espírito Santo, a member of the Alliance.

The National Health Inspection Agency, Brazil's chief policymaker for the pharmaceutical industry, recognizes that clinical research plays a strategic role in bringing resources and knowledge into the country. The regulator has recently committed to submitting a proposal to the Senate designed to expedite the current timeframes. It has also pointed out that in 2012, it issued an ordinance endorsing clinical research already approved by other regulatory agencies that have similar standards in place including the US, Europe, Japan, Australia, and Canada.

Translated by Mayra Borges