Washington, D.C., February, 2025 (PAHO) – The Pan American Health Organization (PAHO) is collaborating with the Ministry of Health to modernize Bermuda's regulatory framework. This initiative began with the creation of a National Pharmaceutical Importation Policy, aimed at enhancing the national regulatory system to ensure better access to medicines and health technologies through the national health system.
PAHO support through capacity building for policy adoption and implementation
On 24 February 2025, a primary stakeholders’ consultation was held by the Ministry of Health on the proposed national importation policy as part of good regulatory practices. It was conducted virtually and included over 20 representatives from the Ministry of Health, Pharmacy Council and the Customs Department. It also saw the participation of PAHO/WHO Country Representative and PAHO Innovation and Access to Medicines and Health Technologies (IMT) department. This consultation focused specifically on the context of Bermuda’s regulatory system. It emphasized the importance of strengthening the regulatory system, particularly in relation to the importation process, to improve access to medicines and health technologies. The approach was guided by international standards and best practices for developing regulatory frameworks, including the adoption of good reliance practices.
Over a five-month period, a collaborative methodology was employed to enhance Bermuda's regulatory framework. This approach included periodic virtual workshop meetings and the use of a shared collaborative platform. Discussions focused on best practices for the pre-marketing evaluation of products, guidelines for medicine import procedures, and regulatory practices based on risk assessments and regulatory reliance.
This effort culminated in the development of a new importation policy, which is currently under public consultation. The Bermuda core policy team demonstrated exceptional commitment to enhancing their regulatory framework. The new policy represents a significant opportunity for Bermuda, enabling the creation of comprehensive databases on health technologies entering the market. Additionally, it aims to enhance surveillance and oversight, ultimately improving the safety and quality of health technologies available to the population.
PAHO remains committed to Bermuda to advance the proposed national importation policy towards the implementation and related activities.
Strengthening Bermuda’s Regulatory Systems
Strengthening regulatory systems remains a public health priority for the Member States. In 2022, the 30th Pan American Sanitary Conference, 74th Session of the Regional Committee of WHO for the Americas endorsed the Policy to Strengthen National Regulatory Systems for Medicines and Other Health Technologies (CSP30.R12), which urge Member States to “adopt sustainable State policies with a view to strengthening regulatory system governance and stewardship to ensure the efficacy, safety, and quality of health technologies that enter the health system and promote access to them; and, strengthen subregional and multinational regulatory initiatives, seeking synergies among participating NRAs to ensure greater efficiency and complement and enhance the development of regulatory functions in resource-limited contexts…”
Bermuda is excelling in enhancing its regulatory framework, significantly improving access to essential medicines and health technologies. This initiative showcases Bermuda's continued commitment to providing affordable, high-quality pharmaceuticals, vaccines and other health technologies to its residents.
