THE Government Analyst Food and Drug Department (GA-FDD) recently took part in the 7th Meeting of Member State Mechanism on Substandard and Falsified [SF] medical products, which was hosted at the headquarters of the World Health Organization [WHO] in Geneva, Switzerland.

The forum, which spanned the period November 27 to 30, 2018, was attended by Director of the GA-FDD, Mr. Marlan Cole. Cole’s participation was made possible through key and critical support from the Ministry of Public Health (MoPH).
Discussion at this meeting targeted problems associated with Substandard and Falsified [SF] medical products or fake drugs entering the Global Supply Chain, particularly in middle and low-income countries.

This problem was highlighted in the study of the Public Health and Socio-economic Impact of SF “fake” medical products published by WHO in 2017 and reports received by the WHO’s Global Surveillance Monitoring System (GSMS) for fake medical products which was launched in 2017.

According to the study, one in 10 or 10.5 per cent of medical products sampled was fake, and when the estimated market value of US$300 billion in middle and low-income countries is factored against the 10.5 per cent, 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 antibiotic 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 antibiotic with reduced antibiotic activity and 169,271 of excess deaths to fake antibiotics with no antibiotic activity.

With regard to the WHO – 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 anti-malarial and antibiotics being the most frequently reported.
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 authorization of medical products by member states; and the advancement of a global communication campaign framework to combat the threats of SF medical products using [IDEAS] – insight, data, engagement, action and solution.

Guyana’s first line of defence against SF “fake” medical products is enshrined in the Food and Drug Act Chapter 34:04 and its accompanying regulations, particularly Regulation 78. This, therefore, means that registration and authorization of drugs are required, based on the reliance [full assessment] for efficacy, quality, and safety by one or more of the following countries: the US, the UK, Canada and Australia.

In the recent past—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 fake medical products do not enter the health care system and that of the region.

The GA-FDD has been faced with, and has also simultaneously advanced litigations regarding the sale, release, registration, and distribution of medical products that are not registered or wish to be registered or wished to be registered.

“In our effort to protect the Guyanese consumers from SF medical products, the department has received key and critical support from the Ministry of Public Health and the

Attorney General Chambers with matters before the courts,” Cole said.
Cole expressed appreciation for astute leadership from the MoPH in their effort to combat the SF ‘fake’ medical products 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 SF “fake” medical products in court health care delivery system, by scaling up wharf and facility inspections, medical products examination and sampling” Cole explained.