Guyana participated in the recent 7th Meeting of Member State Mechanism on Substandard and Falsified (SF) medical products, which took place from the 27th to the 30th November and will step up its fight against fake and substandard drugs.
The meeting was hosted at the headquarters of the World Health Organization (WHO) in Geneva, Switzerland and Director of the Government Analyst-Food and Drug Department (GA-FDD), Marlan Cole, was Guyana’s representative at the event.
According to a GA-FDD press release, the WHO meeting targeted issues 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 “fake” medical products published by WHO in 2017 and reports received by the WHO’s Global Surveillance Monitoring System (GSMS) for SF “fake” medical products. The surveillance system was launched in July 2013.
The meeting also focused on significant work done by the Member State Mechanism to fight SF medical products in the following areas: distribution or the supply of SF 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 insight, data, engagement, action and solution (IDEAS), the GA-FDD release added.
The WHO Global Surveillance Monitoring System, provides National Regulatory Authorities (NRA), with a portal to report SF medical products with the result that after four years, over 2,000 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.
According to the study by WHO, 1 in 10 medical products sampled was SF and when the estimated market value of US$300 billion in middle and low-income countries was factored in, it equated to over US$30 billion in costs 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 deaths could be attributed to SF antibiotics with reduced antibiotic activity and 169,271 deaths to SF antibiotics with no antibiotic activity.
In Guyana, 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, where 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 US, the UK, Canada or Australia. In 2017, an additional pathway for registration was created when the MoPH 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 the health care system and that of the region.
The GA-FDD stated that it has been faced with issues regarding the sale, release, registration, and distribution of medical products that are not registered or do not wish to be registered, and the department has commenced litigation in this regard. In their ongoing effort to protect the Guyanese consumers from SF medical products, the department says it has the full support of the MoPH and the Attorney General Chambers.
