The CARPHA Caribbean Regulatory System (CRS) has announced that it will begin charging modest user fees to the companies that apply for medicines recommendation through the CRS, starting November 15, 2019. The CRS became operational in early 2017 and has performed these duties free of charge for over two years.
Companies have increasingly used the system and to date have submitted over 100 medicines applications, with the CRS recommending roughly 55 of these for accelerated registration in CARICOM Member States. All are verified to be the identical medicines approved in a reference agency like the US Food and Drug Administration. This ensures the availability of the same medicines as found in highly regulated markets in CARICOM.
User fees are an important part of a regulator’s budget because they pay for the services which ensure that operations are efficient and accountable, that decisions on whether or not to approve medicines occur on reasonable time frames. Most pharmaceutical companies welcome user fees because, it usually improves the performance of the regulator. This is especially important in the small states of CARICOM, which struggle to process the medicines applications they receive due to lack of human resources and adequate financing. Ultimately these efforts are to reduce harm and improve patient access to quality medicines.
“Today is an important milestone in the history of our cooperative efforts. Charging user fees to the industry that uses the CRS is a down payment on its sustainability and will ensure that we have an efficient and effective mechanism for regional regulation in the future. It is another step towards the fulfillment of a Caribbean Single Market Economy”, said Dr. Joy St. John, Executive Director at the Caribbean Public Health Agency.
The CRS helps Member States perform key regulatory functions. The CRS does this using efficiencies, such as reliance on reference authorities and a focus on essential medicines, to enable a sustainable enterprise in the resource-constrained environment of small states. This contributes to CARPHA’s mandate to prevent diseases, promote health and respond to public health emergencies.