Patients Assured Safe, High Quality Drugs with the Establishment of the Caribbean Regulatory System

[dropcap]T[/dropcap]he establishment of a Caribbean Regulatory System (CRS) will improve conditions for patients in the Region to receive safe, efficacious, high quality drugs.  Speaking at the recently held Opening Ceremony of a Capacity Building workshop on the Regulation of Medicines earlier this week, Executive Director of the Caribbean Public Health Agency (CARPHA), Dr. C James Hospedales, stated, “Access to safe, efficacious and good quality drugs is a human right which CARPHA as the regional public health organization is committed to facilitating.” 

 CARPHA, in collaboration with CARICOM and World Health Organization/Pan American Health Organization (WHO/PAHO), has established a Caribbean Regulatory System (CRS). Dr. Hospedales explained that the CRS will focus on providing regulatory assurance to essential generic medicines for the Region.  He said “through the CRS, CARPHA will be able to help countries perform functions such as reviewing, approving and monitoring medicines, in a timely manner, allowing patients faster access to quality drugs.”  He added that It would also help to reduce cost of medicines to consumers and the health system, thereby improving accessibility and affordability.

With only five CARICOM countries currently conducting a review of safety, quality, and efficacy of drugs, PAHO Country Representative for Trinidad and Tobago, Dr. Bernadette Theodore-Gandi, emphasized the need for strong regulatory systems for medicines.  She pointed out that limited capacity in the regulation of medicines can have several negative results, including the proliferation of substandard and falsified medicines.  This, she said “can injure and kill people”. 

Chief Chemist and Director, Chemistry Food and Drugs, Ministry of Health, Trinidad and Tobago, Mr. Farz Khan, was confident that the CRS could add value to the Region.  He drew reference to inadequate legislative frameworks, lack of policies, human and institutional constraints as some of the issues facing regulatory systems in CARICOM Member States and believed that the CRS would play a significant role in mitigating some of these situations. 

Mr. Khan said there is a need to “support all areas of medicine regulation, ensuring that local assessment and registration processes are based on international best practices, harmonized requirement and guidelines.”

The best international practices recommend transparency and accountability in regulatory operations, including reasonable timelines for granting marketing authorization, clear systems for stakeholders and for regulators to prevent products which do not satisfy established standards from being offered for use to people.

The CRS is a new value added service provided by CARPHA and endorsed by the CARICOM Ministers of Health.  It is not intended to replace already established national regulatory authorities, but rather to augment and support them.  It will also coordinate reporting and analysis on medicine safety and quality issues within CARICOM.