Faced with long waits for Brazilian good manufacturing practice certificates, some devicemakers are turning to the courts to speed up product registrations — and seeing their time to market cut in half, an expert says.
In the past year, roughly half of all companies with a pending BGMP application have sued Anvisa, a step they can take once they have paid the agency for a GMP inspection, Ann Marie Boullie, director of business development at Emergo Group, said recently.
Manufacturers must have a BGMP certificate in order to place their products in Brazil’s roughly US $10 billion device market. The standard cost of the certificate is $16,000, and going the court route can add on $9,000 or more in legal costs. But the faster time to market — one-and-a-half to two years versus three to four years for companies that wait it out at Anvisa — likely makes up for the higher fees, Boullie said.
While there’s no guarantee that suing Anvisa will result in an earlier inspection, the courts have tended to side with manufacturers. Still, time frames for Anvisa to conduct inspections vary from judge to judge, Boullie said.
Marcelo Antunes, a regulatory affairs strategist with SQR Consulting in São Paulo, says Brazilian devicemakers typically don’t have a problem acquiring the BGMP and look down on this practice. But for importers, while not fans of the legal approach, taking Anvisa to court may be “their last option” for securing entry in the market, he says.
Brazilian trade group ABIMO recommends against devicemakers suing Anvisa. “We know some of our companies choose this way, but most of them prefer to wait for certification, since the process to sue is really very expensive,” association President Paulo Fraccaro says.
Boullie says companies may want to consider an alternative option: utilizing a class action lawsuit initiated by Abimed, another device trade group.
A higher court upheld a ruling that requires Anvisa to accept international quality system certification if it fails to inspect the manufacturer within six months of the original request. But, Boullie warns, the agency has the right to revoke a registration should the devicemaker fail a future BGMP inspection.
Devicemakers frustrated with Anvisa’s snails-pace certification process may soon have one more option. In October, the International Medical Device Regulators Forum is set to negotiate further details of its single-audit program, with a pilot set to start in January. The program will allow Anvisa, an IMDRF member, to acknowledge inspections done by other, recognized auditing organizations.
In August, Brazilian President Dilma Rousseff signed a decree giving Anvisa additional authority to implement a new GMP framework. The action was spurred, in part, by the logjam stemming from the BGMP requirement.
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