Washington, DC, June 12, 2017 (PAHO/WHO) - Four essential generic medicines for HIV treatment were assessed and recommended for sale in May by the Caribbean Regulatory System in one of its first actions advising governments on medicines regulation in the Caribbean Community (CARICOM).
The Caribbean Public Health Agency/Caribbean Regulatory System (CARPHA/CRS) recommended manufacturer versions of four products, including Emtricitibine/Tenofovir and Tenofovir tablets, used in the treatment of HIV.
The regional initiative to help Caribbean states perform key regulatory functions is a collaboration between CARICOM and CARPHA, with the support of the Pan American Health Organization/World Health Organization (PAHO/WHO).
The states of CARICOM can be individually limited in their capacities to assess medicines for safety, quality and efficacy. They can sometimes struggle with having the resources to conduct assessments, including for quality, and in a timely fashion.
The CARPHA/CRS requires that the medicines it examines have already gone through rigorous regulatory scrutiny, and are approved by a trusted regulatory entity, such as the US Food and Drug Administration, or the Brazilian Authority, ANVISA. The four recommended HIV products are approved by the WHO Prequalification of Medicines Program. The CARPHA/CRS also requires that the medicines it assesses are listed on the WHO Essential Medicines List, most of which are generic.
After recommendation, the process then continues at the State level, where the CARPHA/CRS assessment helps governments make a decision on authorization within an accelerated timeline, speeding access for patients.
As more pharmaceutical companies use CARPHA/CRS, a list of favorably evaluated products will be created, which governments can use in authorization and procurement decisions.
Because the CARPHA/CRS system focuses on assessing generic medicines, this increases competition and lowers prices for patients and governments. It also ensures the quality of medicines to prevent substandard and falsified drugs from proliferating in the market.
The CARPHA/CRS creates a single portal of entry to the different markets in the Caribbean Community, which comprises some 17 million people, with one set of requirements, facilitating economies of scale.
The CARPHA/CRS was endorsed by CARICOM's ministerial body for health. PAHO-designated National Regulatory Authorities of Regional Reference provide technical and financial support. Other entities, such as the Bill and Melinda Gates Foundation, have contributed financial resources as well. PAHO/WHO facilitated the exchange of experiences with regulatory authorities in other countries and provided training, to strengthen the creation of this mechanism within CARPHA.