Reema: Too much red tape in drug approvals for region

Carmona was speaking on Thursday last at a sub-regional consultation for the English and Dutch speaking Caribbean on the Global Strategy for Women’s, Children’s and Adolescents’ Health - 2016 to 2030 in Bridgetown, Barbados.

She said not enough is being done to address the unwieldy, bureaucratic process of drug approvals in the Caribbean with some sense of speed and institutional urgency.

“Why must a country in the Caribbean go through the tedious process of a drug approval regime after approval of that same drug by, for example, the United States Food and Drug Administration (FDA)?” she asked.

“The United States FDA approval, represents, I would hope, international benchmark standards for the operationalisation and use of new drugs. They have the resources, infrastructure and finance beyond the capacity of the many burgeoning democracies in the Caribbean. It begs the question, ‘Why then, are US FDA-approved drugs for the terminally ill and other patients years away from being approved locally and regionally?’ This inability to provide pain relief and other medications may well constitute an infringement of a person’s basic human rights.” Carmona said she has been told by several stakeholders that the non-approval of new drugs is further burdened by an environment that makes no comprehensive, informed provision for the execution of clinical trials involving new and experimental drugs.

“I am reliably informed that there are boxes of drugs and dossiers, waiting to be approved at the food and drugs laboratories throughout the Caribbean and even the GRULAC region. These labs are simply overwhelmed due to lack of resources, weak infrastructure and insufficient personnel, to fully and competently carry out its mandate. The region may be right for the harmonisation for the registration of drugs through its umbrella bodies, CARICOM and CARPHA.” She suggested that the Bahamian Pharmacy Act of 2009, supported by the Pharmacy (Import and Export) Regulations 2010, may be a legislative template for that proposed harmonised registration of drugs.

“Regarding the standard and importation of drugs, any drug to be imported into the Bahamas and hopefully in the future, in the Caribbean, must meet one of the following prescribed international standards — the British Pharmacopeia; the United States Pharmacopeia; the European Pharmacopeia; the International Pharmacopeia; or any other Pharmacopeia as approved by the Minister of Health.

“This not only saves time, but also money, as the authorities will be saved the expense of paying experts to approve the many dossiers submitted to them.

The availability of drugs would decrease patient morbidity and mortality, easing the suffering of our loved ones. By allowing US FDA approved experimental drugs, we can also begin supervised clinical trials in collaboration with the various foreign entities and university hospitals - possibly resulting in a decrease in our medical brain drain and patients leaving the country to access US FDA approved drugs and experimental drugs.” Carmona said drugs like Oxycodone and Vicodin, approved by the US FDA for years but not available in local markets, will then be accessible.