Guyana participates in WHO meeting on substandard, false medical drugs

The Government Analyst-Food and Drug Department (GA-FDD) recently participated in the Seventh Meeting of Member State Mechanism on Substandard and Falsified (SF) medical products hosted by the World Health Organisation (WHO) at its Geneva, Switzerland headquarters.
Guyana was represented at the meeting, which lasted from November 27 to 30, by GA-FDD Director Marlan Cole.
According to a statement from the Department, discussions at that meeting targeted problems associated with SF medical products entering the global supply chain, particularly in middle and low-income countries.
This problem was highlighted in a Study of the Public Health and Socioeconomic Impact of SF medical products published by WHO in 2017 and reports received by the WHO’s Global Surveillance Monitoring System (GSMS) for SF medical products, a surveillance system that was launched in July 2013.
According to the Study by WHO, 1 in 10 or 10.5 per cent of medical products

sampled was SF and given the estimated market value of US$300 billion in middle and low-income countries, it equates to over US$30 billion in cost to these countries.
In addition, the University of Edinburgh developed an Impact Model for WHO, which was used to estimate the impact of SF antibiotics for the treatment of childhood pneumonia in Sub-Saharan Africa. The model revealed that as many as 72,430 excess deaths can be attributed to SF antibiotics with reduced antibiotic activity and 169,271 excess deaths to SF antibiotics with no antibiotic activity.
With regard to WHO’s Global Surveillance Monitoring System, it provides National Regulatory Authorities (NRAs), with a portal to report SF medical products and after four years, over 2000 SF medical products reports were received from 111 countries. Reports were in all therapeutic categories, ranging from cancer medicines to contraceptives and from antibiotics to vaccines. Reports were also evenly split between generic and innovator products with antimalarial and antibiotics being the most frequently reported.
Moreover, the meeting also focused on significant works by the Member State Mechanism to fight SF medical products in the following areas: distribution or the supply of SF or “ fake” medical products via the Internet and medical products in-transit; strengthening of regulatory systems to prevent, detect and respond to SF medical products in health systems; guidance for manufacturers, importers, and distributors’ registration; the authorisation of medical products by Member States; and the advancement of a global communication campaign framework to combat the threat of SF medical products using IDEAS – insight, data, engagement, action, and solution.
In Guyana, according to the GA-FDD, the first line of defence against SF medical products is enshrined in the Food and Drug Act, Chapter 34:04 and its accompanying regulations, particularly Regulation 78, whereby registration and authorisation of drugs are required based on the reliance (full assessment) for efficacy, quality, and safety by one or more of the following countries: the United States, the United Kingdom, Canada or Australia.
In fact, in 2017, an additional pathway for registration was created when the Public Health Ministry and the GA-FDD signed a Memorandum of Understanding (MoU) with the Caribbean Regulatory System (CRS) for assistance with medical products registration. This was in an effort to ensure SF medical products do not enter our health-care system and that of the region.
The GA-FDD said too that it has been faced with and also simultaneously advanced litigation regarding the sale, release, registration, and distribution of medical products that are not registered or intended for registration. In this regard and in efforts to protect Guyanese consumers from SF medical products, the Department has received key and critical support from the Public Health Ministry and the Attorney General (AG) Chambers with matters before the courts.
On this note, the Department thanked the Government through its Public Health Ministry for its support in efforts to combat this problem with public health and economic implications.
“The magnitude of this problem in Guyana is currently unknown; however this exposure and alliance will allow us to double our efforts to prevent, detect and respond to Substandard and falsified-SF medical products in our health-care delivery system, by scaling up wharf and facility inspections, medical products examination and sampling,” the GA-FDD said in its missive on Wednesday.