BPA president: Caribbean Regulatory System not needed for NPDP drug procurement

Bahamas Pharmaceutical Association (BPA) President Dr. Marvin Smith told Guardian Business that the Caribbean Public Health Agency’s (CARPHA) Caribbean Regulatory System (CRS) is ill-equipped to provide drug procurement standards for the National Prescription Drug Program (NPDP).

Smith, who has been working with Minister of Health and Wellness Dr. Michael Darville, and teams from the National Health Insurance Authority (NHIA), which is scheduled to take over the operation of the NPDP in February 2026; and KPMG, the accounting firm providing consulting services for the prescription drug program, said: “We still have concerns with the role of CARPHA, CRS, and the unrealistic influence they are trying to have, particularly as it relates to the quality and accessibility of pharmacy products in the country.”

The Caribbean Regulatory System (CRS), managed by the Caribbean Public Health Agency (CARPHA), is a regional mechanism for the assessment and monitoring of medicines, vaccines, and in vitro diagnostics in Caribbean Community (CARICOM) and CARPHA member states. It provides recommendations for market authorization, rational use, and quality/safety monitoring of medical products in the Caribbean. The CRS also facilitates reporting of adverse drug reactions and helps ensure access to safe medicines.

The CRS also assists member states in the process of granting marketing authorization for medicines and vaccines, relying on reference authorities and focusing on essential medicines in addition to supporting the monitoring of the safety of medicines after they are marketed, including the reporting of adverse drug reactions.

CARPHA and the CRS in 2021 signed an agreement with the Pan American Health Organization (PAHO) to share information, including non-public information, on products that have been recommended by PAHO for procurement processes through the PAHO Strategic Fund. It is expected that this will improve access to quality assured medicines and biologics, enhance post-market surveillance, and support regulatory system strengthening in CARPHA’s member states, which are also PAHO member states.

“We still believe that that while the Pan American Health Organization (PAHO) does some good things, that this particular aspect of its affiliation with CARPHA, particularly with the Caribbean Regulatory System (CRS), we believe that agency is grossly underfunded and grossly understaffed, both in terms of people and qualifications to do the things that they’re claiming they can help us with,” said Smith.

The government announced in March that it will expand healthcare access by providing free prescription medication under the NHIA, with Darville telling the Parliament at the time that people with hypertension, diabetes, heart disease, certain cancers, renal insufficiency, and mental illness will be able to access medication.

The National Insurance Board’s Chronic Drug Prescription Plan provides free medication to just over 44,000 Bahamians, primarily government workers and their families, and this will also be transferred over to the NHIA.

Smith also said: “We think the system that the government has used for years in qualifying companies to participate in the supply of products should be the standard system throughout the whole country.

“And while there is talk about the use of counterfeit drugs and safety and all that stuff, we know for a fact that in the public system, that is a rare occurrence, and we believe that if we add bar code vigilance as a program, step monitoring, as well as the pedigree system for tracking pharmaceutical goods, that we can do this internally without any need of a region-wide set of standards that, quite frankly, the majority of the CARICOM countries have rejected.”

Process monitoring, or step monitoring, refers to the collection of information on the use of inputs, the progress of activities, and the way these are carried out. Process monitoring looks at why and how things have happened; it looks at relevance, effectiveness and the efficiency of processes. A drug pedigree system identifies each prior sale, purchase, or trade of a drug, including the date of those transactions, and the names and addresses of all parties to them

Smith continued: “Jamaica’s not using [CRS]. Barbados isn’t using it. The Organization of Eastern Caribbean States just went to tender for all the countries in the Eastern Caribbean, they aren’t using it. Trinidad – where CARPHA’s head office is – does not use its regulatory system for pharmaceuticals.

“There is no sense for us to become a guinea pig when we already have companies here that bring good products, that we can properly pre-qualify and get products at much better pricing. We’ve indicated that to the government, and we have sent some documentation to that effect. We are working on some additional documentation to send to them to support that.”