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Wednesday, 2 October 2019. 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 timeframes. 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, CARHA’s Executive Director.
Guyana’s successes related to regulatory strengthening was recently highlighted by the Director of the Guyana National Regulatory Authority, Marlan Cole, at the biannual WHO International Conference of Drug Regulatory Authorities (ICDRA) in Dublin, Ireland.
Director Cole indicated that a key to Guyana’s strategy has been to rely on the Caribbean Public Health Agency's Caribbean Regulatory System's (CARPHA/CRS) recommendations for market authorization of imported medicines, seeking approval in Guyana. This has decreased the workload on the national regulatory staff and permitted faster market entry of quality products.
In addition, the CRS has not issued recommendations for unqualified products, effectively filtering lower quality medicines from entering the Guyana market. Director Cole stated the CRS has been valuable in helping to improve market surveillance.
A recent workshop for CARICOM States on use of the WHO Global Surveillance and Monitoring Systems for Substandard and Falsified products, revealed an unregistered and falsified biosimilar on the Guyana market. The implicated company is now facing enforcement action. Director Cole said that part of the country’s success in implementing the CRS was educating the local industry and maintaining a public health position in the face of a court challenge by one company.
According to CARPHA’s Director, Dr James Hospedales, "The CRS is a great example of how CARPHA is delivering needed public health services to CARICOM member states, and the collaboration with Guyana is a model for others.” He also said that "The mechanism will only gather strength over time, as awareness and uptake builds."
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