7 minute read
Kenya’s preparedness in the war against counterfeit pharmaceutical products
By Dr Robi Mbugua Njoroge Executive Director, Anti-Counterfeit Authority
1. What role does ACA play in protecting intellectual property rights and ensuring genuine medicines for consumers?
The Anti-Counterfeit Authority (ACA) plays a critical role in safeguarding intellectual property rights in Kenya by enforcing laws that prevent the manufacture, importation, distribution, and sale of counterfeit goods, including medicines�
To fulfill its mandate, the ACA collaborates with various stakeholders such the Kenya Police Service, Kenya Revenue Authority, and Ministry of Health to ensure that counterfeit products are identified, seized, and removed from the market This not only protects the rights of intellectual property owners but also helps maintain a fair trading environment, fostering innovation and economic growth
In ensuring genuine medicines for consumers, the ACA works closely with the Pharmacy and Poisons Board (PPB) and other healthrelated authorities to monitor and control the pharmaceutical supply chain By conducting inspections, market surveillance, seizures, and public awareness campaigns, the ACA ensures that consumers have access to safe and genuine medicines This proactive approach reduces the risks associated with counterfeit medicines, such as adverse health effects or treatment failures, thereby protecting public health and reinforcing consumer trust in the healthcare system�
2. What is the biggest challenge the ACA faces in combating counterfeit pharmaceuticals in Kenya?
The biggest challenge the Anti-Counterfeit Authority (ACA) faces in combating counterfeit pharmaceuticals in Kenya is the sophisticated and rapidly evolving nature of the counterfeit trade Counterfeiters use advanced technologies and intricate supply chain networks to produce and distribute fake medicines that closely resemble genuine products, making detection and interception difficult for regulators and law enforcement
The rise of online platforms for selling medicines has further complicated enforcement, enabling counterfeit products to be sold anonymously and across borders, bypassing traditional regulatory controls These challenges are compounded by the ACA’s limited resources and capacity constraints, as well as insufficient public awareness about the dangers of counterfeit medicines, which together hinder effective enforcement and protection of public health
3. What specific regulatory measures have been implemented to prevent the entry and distribution of counterfeit medicines?
To prevent entry and distribution of counterfeit medicines, Kenya has implemented several regulatory measures The Pharmacy and Poisons Board (PPB) requires all pharmaceutical products and distributors to be registered and licensed This ensures that only authorized entities can import, manufacture, or distribute medicines, thereby reducing the risk of counterfeit products entering the market
A recent significant step by the AntiCounterfeit Authority includes the recordation of Intellectual Property with the Authority� This process facilitates enforcement as it strengthens the ability of of customs officials to control the borders and helps deter counterfeiters This measure together with the requirement for acquisition of IPR import license helps in tracking and verifying the legitimacy of imported medicines
Additionally, the recent signing of a Memorandum of Understanding (MOU) between the ACA and PPB has strengthened their collaborative efforts in combating counterfeit medicines Both agencies conduct regular inspections and market surveillance, including random sampling, testing of pharmaceutical products, and inspections at entry points such as ports and airports, to monitor the supply chain and identify counterfeit medicines The use of track and trace technologies, such as serialization and barcoding, have also been introduced to monitor the movement of medicines throughout the supply chain, allowing regulators to verify the authenticity of products at every stage
4. How does ACA collaborate with other agencies, such as the Pharmacy Poisons Board to counterfeit pharmaceuticals?
The Authority works in collaboration with international, regional and national private and inter-governmental bodies
At an international level, the Authority collaborates with World Health Organisation (WHO), World Intellectual Property Organisation (WIPO), International Criminal Police Organization (Interpol) and World Customs Organisation where joint operations like “Operation Pangea” are carried out in multiple countries simultaneously� In June 2024, we held an international Symposium on Intellectual Property Protection and Enforcement, bringing together delegates from the three international bodies and 16 countries, during which presentations and insights for better global collaboration on fighting counterfeiting of pharmaceutical were shared
At the regional for instance, the Authority is a member of the PharmaCrime Working Group The group brings together law enforcement authorities from most of the 55 African countries The group shares statistics of incidents of counterfeit medicines seized and related prosecutions It also shares insights on IP protection and enforcement
At the national level, the Authority works in collaboration with other government agencies like Pharmacy and Poisons Board to tackle counterfeit pharmaceuticals The PPB collaboration is anchored on a Memorandum of Understanding between the two government agencies that entails joint inspection and enforcement, information sharing, public awareness campaigns, regulatory frameworks to develop and refine policies that address counterfeiting
5. What initiatives are in place to educate the public about the dangers of counterfeit medicines and how to identify them?
The Anti-Counterfeit Authority (ACA) has a legal mandate to educate the public about the dangers of counterfeit products including medicines and how to identify them
ACA collaborates with pharmaceutical manufacturers, like Novartis, to conduct product training sessions for its law enforcement and public awareness officials In turn, the officials develop public awareness and education
The Authority uses different platforms including digital media and legacy media like newspapers, television, and radio to inform the public about the risks associated with counterfeit trade The authority also provides educational materials to educate members of the public on the risk in supporting counterfeit trade
Additionally, ACA collaborates closely with healthcare professionals, pharmacists, and law enforcement agencies to improve the detection of counterfeit medicines and spread awareness The authority organizes workshops and seminars to train both professionals and the general public on identifying counterfeit products and understanding relevant regulations
6. Are there any new technologies being used or developed to detect and prevent counterfeit pharmaceuticals?
Yes, several new technologies are being used and developed in Kenya to detect and prevent counterfeit pharmaceuticals These technologies are designed to enhance the ability of regulators, healthcare professionals, and consumers to verify the authenticity of medicines and ensure that counterfeit products are kept out of the supply chain
ACA has rolled out the recordation of Intellectual property rights programme to aid custom officers to easily detect importation of counterfeit products This is on top of the requirement for acquisition of IPR import license for all imports entering into the country�
Other measures taken by other government agencies include the adoption of advanced technologies for traceability and authentication of drugs throughout the supply chain This ensures that medications reaching consumers are genuine Additionally, authentication devices, such as portable scanners and smartphone apps, allow consumers and healthcare professionals to quickly verify the authenticity of medicines by scanning their packaging These technologies are enhancing the ability of Kenya’s regulatory authorities and health sector professionals to safeguard public health by effectively addressing the issue of counterfeit medicines
Kenya's Anti-Counterfeit Authority is committed to protecting consumers from counterfeit pharmaceuticals through robust enforcement, international collaboration, and public education. By leveraging new technologies and partnerships with global agencies, we aim to ensure that only safe, authentic medicines reach Kenyan patients, fostering trust in our healthcare system.
7. How does the ACA work with international bodies to combat the global issue of counterfeit pharmaceuticals?
The Anti-Counterfeit Authority (ACA) works closely with international bodies such as WIPO, WHO, WCO and Interpol
At continental level, ACA is part of the founder members of the Africa Pharmacrime Working Group based in Abuja, Nigeria, which uses multifaceted strategies to collaboratively tackle the global issue of counterfeit pharmaceuticals� This includes extensive intelligence and information sharing on counterfeit drugs, emerging trends, and counterfeiters’ tactics, which aids in tracking and dismantling global counterfeiting networks
The Africa PharmaCrime Working group collaboration has yielded several capacity building, training and development programmes targeting regulatory authorities to gain skills and knowledge needed to better detect and manage counterfeit pharmaceuticals ACA also participates in joint operations and task forces with East African countries and agencies, focusing on disrupting counterfeit networks through coordinated raids, seizures, and investigations.
