Policy Brief
February 2022
Fighting substandard & falsified (counterfeit) medicines in SADC
Rethabile Molapisane & David R. Katerere
TUT Platform Chair, Pharmaceutical &Biotech Advancement in Africa (PBA2)
Southern African Academy of Pharmacy (SAAP)
Who is this aimed at
• Medicine regulatory authorities in the SADC region
• Policy makers and legislators of SADC member states and SADC Secretariat
• Pharmaceutical companies and health care workers
Key messages
• Substandard, unauthorised and counterfeit medicines (SFs) are an ongoing concern in the region and COVID-
19 has exacerbated the situation.
• Anti-counterfeit policies at institutional, country and regional level will help to combat of SFs.
• Stakeholder collaboration is key in securing SADC medicine supply chain and ensuring access to safe essential
medicines.
• Regional collaboration between regulators, law enforcement and policymakers should be enhanced because
counterfeiting of medicines is a cross border or transnational crime.
• Public awareness and education about counterfeits, their sources and the dangers associated with their use
should be considered part of public health promotion and messaging.
• Resources should be mobilized and provided to regulators and researchers for regular market surveillance
studies.
Key findings
• Absence of a pharmaceutical anti-counterfeiting strategy makes implementation of law enforcement efforts
ineffective.
• Weak penalties for being involved with the sale, distribution or manufacture of SFs are not harsh enough to
deter criminals.
• Inadequate resources in human capacity, forensic intelligence profiling, budget constraints and shortage of
testing and quality assurance laboratories is a major hurdle in the law enforcement against proliferation of SFs.
• Poor national inter-agency collaboration and regional collaboration makes information sharing and planning of
combat campaigns difficult and sporadic. Often there is duplicity of function due to competing mandates
between governmental agencies.
• Poor Post Market Surveillance and reporting of SFs creates gaps in the system in monitoring of the market.
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Executive Summary
The problem of counterfeit medicines and vaccines is a serious public health concern and needs urgent interventions.
COVID 19 has created a favourable environment for the proliferation of substandard and falsified health products
and medicines because of shortages and reduced access to medicines which have resulted from the pandemic. In
addition, there has been an increase in online sales of medicines from unregulated suppliers which lie outside
traditional and conventional pharmaceutical supply chains.
The regulation of pharmaceuticals and health products in many SADC member states is by way of Medicines and
Related Substances legislation, most of which was enacted in the 1960’s and 1970’s, and has not been regularly
reviewed and amended. Thus it lacks harmonization with other Acts and it does not explicitly allude to
“pharmaceutical crimes” nor include specific medicine counterfeiting provisions. In addition, it does not regulate
online sales of medicines and health products.
Background
Counterfeit medicines, also known as Substandard and Falsified” (SFs) are medicines which are deliberately and
fraudulently mislabelled with respect to identity and/or source (WHO, 2017). The definition also includes medicines
have failed to pass the quality measurements and standards set for them. A systematic review showed Africa to have
a higher prevalence of substandard medicines at 18.7% of the samples tested while the prevalence was much lower in
Asia at 13.7% and 14.4 % in other regions4. Shortages caused by the COVID-19 pandemic, the promotion of
unconventional treatments by social media, and the increased use of the internet to buy goods have all served to
accelerate the trade on SFs in the SADC region and elsewhere. There were reports of seizures of illegal chloroquine
in Cameroon, Niger and the Democratic Republic of Congo (DRC) 5, and water for injection marketed as COVID-19
vaccines was seized in South Africa. Operation Pangea XIII action against online SFs found 2,000 online links
advertising COVID -19 related products sold online (INTERPOL, 2020). These products included substandard and
fake Personal Protective Equipment (PPEs), screening medical devices and hygiene products like sanitisers.
The trade in counterfeits is driven in part by increased demand and the high cost of medicines and vaccines, weak
penalties for offenders compared to the profitability of the business, lack of resources and capacity to implement
existing laws, non-existent post market surveillance systems and poor stakeholder collaboration and information
sharing locally and regionally1.
What are the impacts of SFs?
SFs have many negative impacts on patients, SADC member states and companies operating in the region. These
include
• Public health threat resulting from endangering patients’ lives by either prolonging illness or resulting in
disability or death. This also further contributes to the poverty burden due to loss of income in poor communities
(Kelesidis & Falagas, 2015).
• Drug resistance and treatment failure may result in longer hospital stay and the need to use more complex
and expensive medicines.
• Loss of public trust in the health care system because there is a perception that treatments are not working.
• Loss of revenue for pharmaceutical companies and reduced tax revenue for member states.
1
An exploratory assessment of the legislative framework for combating counterfeit medicines in South Africa
(biomedcentral.com)
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Why is an anti-counterfeiting policy needed?
Anti-counterfeiting policy\ies at company, member state and SADC levels will highlight the issue of SFs and create a
bulwark against counterfeiters. It will provide a structure and system for improved monitoring, tracking and tracing
medicines through the supply chain from raw materials all the way to dispensary shelf. Such policies will also create
better in-country and regional co-ordination and create more efficient use of resources.
What is an Anti-Counterfeit Policy?
It is a document that gives directive on the prevention of counterfeiting. Anti-counterfeiting measures are used
to deter, detect and control counterfeiting activities. Different packaging related approaches include the use of
smart covert and overt technology, track and trace systems as well as code authentication (Soon & Manning,
2019). There are key elements ensuring effective implementation of a policy which are strong leadership,
stakeholder engagement, resource mobilisation and monitoring and evaluation (Mthethwa, 2012).
Why might governments want to implement such a policy?
What are the benefits of implementing an Anti- Counterfeit Policy?
● Government creates conditions that foster stakeholder collaboration.
● The pooling of resources will create maximum potential value which can lead to more efficiency,
and better stewardship of public funds towards a common goal of combating SFs.
● Increased visibility and education on the dangers of counterfeit medicines will improve treatment
outcomes, prevent deaths and harmful adverse reactions and save the pharmaceutical industry and
government from financial losses associated with the illegal trade of SFs.
● The Public will have access to information about SFs and how to identify them and report them to
the NMRA.
● There will also be a better climate for private public partnerships with Pharma and all stakeholders
in combat efforts.
● Better transparency will be cultivated as all stakeholders will be mandated to disclose counterfeiting
of medicine incidents.
● Academic institutions and health care workers will be forced to include counterfeiting of medicines
in their educational curricula.
Do intergovernmental organisations support national-level adoption of anti-counterfeiting policies?
Yes. The WHO has been spearheading combat strategies since the Declaration of Rome on the 8th February
2006 (Mackey, 2013). This has led to the setting up of the International Medicinal Product Anti-Counterfeiting
Taskforce (IMPACT), in partnership with several organisations in both trade and industry such as the German
Pharma Fund, and the World Customs Organisation (IMPACT, 2008). They created a blueprint which has been
successfully adopted globally at national level. The five key areas in IMPACT’s blueprint were to re-inforce
legislative and regulatory infrastructure, communication aimed to raise awareness, regulatory implementation,
enforcement and technology (Siddiqi et al., 2009).
Where have anti-counterfeit polices been adopted?
A number of countries, and regions have also adopted anti-counterfeit policies or laws. Kenya implemented an
anti-counterfeit law in 2008 (Kenyan Ministry of Health, 2008). A review by the East African Community
(EAC) led to an initiative to harmonise laws within its member states, as a result Kenya passed its “Anti-
counterfeiting Act” in 2008. The Act in section 23 empowers regulatory officers with policing powers from a
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wide pool of sectors and departments like customs, police, trade and industry and health as “inspectors” to
enforce the law (Forzley, 2012).
The United states, Food and Drug Authority formed the FDA Counterfeit Drug Task Force in July 2003 to
prevent the introduction of counterfeit medicines and biologics into the U.S. distribution chain; to facilitating the
identification of counterfeit drugs and biologics; to minimise the risk and exposure of consumers to counterfeit
medicines; and to reduce unnecessary costs to the prescription medicine distribution system and restrictions on
lower-cost sources of medicines (generics) (US FDA, 2009).
What can governments do to combat the manufacture, trade and distribution of SFs?
Governments can incorporate the recommendations in the World Health Organization’s: Counterfeit drugs:
guidelines for the development of measures to combat counterfeit drugs. (World Health Organization, 1999).
a) Foster awareness and promote public engagement concerning substandard and falsified medicines.
b) Facilitate information sharing and stakeholder collaboration with multiple agencies and departments involved
in the enforcement of against SFs.
c) Promote the development of policies and guidelines for the combat of SFs in line with best practice
recommendations.
d) Promote the incorporation of education about SFs in the curricula of schools and academic institutions.
e) Support capacity building for the sustainable development of anti-counterfeiting combat strategies nationally
and regionally.
f) Foster strategic alliances with international organisations involved in the combat of SFs globally.
g) Encourage and support further research on counterfeit medicines.
h) Mandate data collection and use risk based assessment systems and trend analysis for combat efforts.
i) Regulate online trade of medicines and pharmacies.
Conclusion
Based on our study, there are gaps in medicine legislation in member states of SADC which allow for the
infiltration of counterfeits. We propose that there be anti-counterfeit policies at company, member state and
regional level and a law reform process which provides for the incorporation of these policies as well as
codifying pharmaceutical crime into the penal code.
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