Medical Products Bill aims to strengthen drug safety, production

A new bill before Parliament seeks to tighten control over the quality and supply of medicines in Barbados, with the government moving to guard against counterfeit drugs and reduce reliance on external sources.

In an historic first appearance of a senator on the floor of the House of Assembly under new constitutional arrangements passed late last year, Minister of Health Senator Lisa Cummins piloted the Barbados Medical Products Bill through its second reading in the lower legislature.

She told lawmakers the proposed law is intended to establish the island’s medical products sovereignty, with a primary focus on protecting the public from the dangers of counterfeit pharmaceuticals.

Senator Cummins drew attention to section 6 of the bill, which governs the registration and marketing authorisation of medical products. She said regulation is essential to safeguard the community from fraudulent drugs and those marketed under false pretences about their efficacy.

She said: “One of the things that this legislation is meant to do is to protect this community by way of regulation from counterfeiting drugs and drugs that are marketed to do one thing but really are not doing what they’re said to do.”

Describing it as “landmark” legislation, Senator Cummins said it arose from the island’s experience during the COVID period and the challenges it faced in accessing medical supplies. She also pointed to ongoing issues in the global supply chain linked to international tensions.

“In the case of medical supplies and drugs, we import 47 per cent of all that we consume in this country. That has created a combination of the things that I have just raised – what happened during COVID, export restrictions, countries hoarding, as well as global supply chain disruptions; those things have collided to create what we describe as a perfect storm, but also a perfect opportunity.

“That opportunity is to introduce a series of entities and initiatives in this country to be able to ensure that Barbados is able to secure not just its energy sovereignty, not just its food sovereignty, not just its agricultural sovereignty, but also our health and medical products sovereignty. Having control over our own production and ensuring that we have a regulatory framework around it to make sure that Barbados never finds itself 100 per cent at the behest of another country and their willingness to help, or as we saw in COVID, not willing to help.”

On the creation of Barbados Pharmaceutical Inc., a pharmaceutical production company, the minister said this would provide a base for Barbados to evolve “from just a logistics hub to a pharmaceutical hub to a distribution hub, and to a regulatory hub” for the region.

She noted that the facility is currently working with one of its primary partners in Nigeria to engage pharmaceutical companies on the African continent.

Referring to the Barbados Living Lab for research and development, she said the proposed Barbados Medical Products Regulatory Authority under the new bill would provide the framework under which manufacturing and research are carried out.

She said: “This really is the layman’s equivalent of what, in Barbadian terms, you look at the back of any product that you have, and it says, ‘US Food and Drug Administration approved’. If I were to break that down in very simple language, that’s really what we’re doing here in Barbados, because in order to have a domestic manufacturing space, in order to collaborate with other countries in the way that we’re doing now, there must be regulation around it.

“So this bill sets up the regulatory authority to be able to do that. This bill is driven very heavily by the regional frameworks, not just here in the Caribbean, but also in the African region that have been driving pharmaceutical manufacturing and the regulatory authorities at the highest level.”

Senator Cummins noted that the Barbados Drug Service and the Barbados Medical Products Regulatory Authority will be separated, with the latter carrying full regulatory oversight.

Regarding surveillance, she said the bill provides for pharmacovigilance, including quality monitoring, recalls, and withdrawals.

“So from the Customs Department, from the Department of Commerce, from the Barbados Medical Products Regulatory Authority, and the broader apparatus of the Ministry of Health, this is where it is colliding in this section of the legislation because they all have a role to play. From the time they land at the border, from the time they’re cleared and an import license is granted until the time they hit the shelves, the regulatory oversight and surveillance is meant to be extensive.”

Under section 53 of the Constitution of Barbados, ratified last December, “a minister who is a member of the House of Assembly and a minister who is a member of the Senate may attend any sitting of the Senate or the House of Assembly, respectively”.

Last week, Criminal Justice Minister Michael Lashley and Attorney General Wilfred Abrahams became the first MPs to make a ministerial cross-chamber appearance when the Criminal Gangs (Prevention and Control) Bill went before the Senate for its second reading.

(JB)