SSA Region (sub-Saharan Africa) Overcoming Import / Export and Distribution Challenges
This is an outline of the workshop presented at GCSG US 2023 by Regional Director, Rob van den Bergh and
Chief Commercial Officer, Zayheda Khan
The African continent is anticipated to rise to at least 2-billion people within 5 years. It makes up over 17% of the global population, has an ethnically diverse population and bears 25% of the Global Disease Burden. There are 54 Countries on the Africa continent, each with their own regulatory agencies.
Africa is home to the highest genetic diversity of humans on the planet, and is filled with potential participants who are urbanised and drug-naïve.
GlobalData.com provides an analysis, where Africa is home to over 130,000 Experienced Investigators, 45,000 Trial sites who have conducted more than 36,000 Clinical Trials over the past 10 year period.
Regulatory requirements can positively influence clinical supply chain outcomes.
Regulatory agencies are not only limited to MoH’s, DoH’s, (Ethics Committee, etc ) in each of the 54 countries – but also includes Health, Customs, Standards, Revenue and Transport Authorities – amounting to over 160 regulators across the African Continent, and hence a deeper understanding of their processes, document requirements and most importantly ‘Approval Time-Lines’ will influence clinical supply chain outcomes.
Case Study – Import Control
I relate to East Africa business community whereby the control of imports is managed through on-line platforms which are interlinked between Health Dept, Customs and Revenue Departments, each requiring unique sign-on, passwords and payment uploads from DIFFERENT local registered entities.
in Kenya, only a Registered Healthcare professional has access to PPB portal to ‘kickstart’ the import / export process and only a Freight Clearing agent, registered with KRA, may finalise the on-line process. Knowledge of up-to-date Value Added Tax and Import Duty regulations and obligations, together with the correct value of the consignment, must be met for each shipment to ensure time-scales are met. This typically creates a bottleneck if we are not in full command of the processes.
We did have a HUGE issue when a -20’C consignment had arrived and we hadn’t a clue where it was, which Freight company, Freezer location, can’t access Customs Warehouse, systems were Off-Line. The Sponsor’s Export Division’ sent without pre-notifications.
Oximio located it within the 11th hour – saved the day – pre-empted more stringent control mechanisms.
Language – English
Then there are the many different languages spoken and understood across Africa. Thus documents, submissions, product labelling and so on must be clearly understood and accepted from country to country.
Drug from a study in Lithuania was needed in Ghana. However, required to be translated – so this was routed to Kenya Customs Bonded depot, whilst the labels were verified by Ghana FDA so that GMP relabelling could be performed, approved and despatched to sites in Ghana.
Differences in regulatory requirements can affect shipping and distribution channels.
Covid-19 was certainly a stress test for change for all of us, however lack of supply chain visibility was exacerbated by the fact that knowledge of the supply chains in the African continent was not deep enough.
Increasing Multi-Site, Multi-Country studies will have fundemental differences in regulatory requirements from country to country which can affect the supply chain if the shipper/research company is not acutely aware of each country’s regulations resulting in customs clearance delays, temperature excursions and loss of clinical trial continuity.
Case in Point:
More Multiple Country, Multiple trials are being conducted in Africa because we have the disease burden similar to the rest of the world. Non-communicable diseases such as hypertension, cardiovascular disease, chronic respiratory diseases, diabetes and cancers are considered high – and presents opportunities to the research companies.
We need to take a proactive approach and prepare for changing regulatory landscapes by understanding and adopting more advanced supply chain risk management practices by ensuring compliance with future regulations by keeping up-to-date with supply chain changes and expectations with visibility and continuous risk monitoring.
We need to understand each country’s Customs processes as this is directly related to imported clinical products as too is the description of clinical material, ambiguous meanings, HS Code misclassifications, PVoC ( Pre-Verification of Conformity ) to name a few.
Case Study: HS Codes
Simply put – The Harmonization Code can differ by ONE digit and get stopped by Customs. Lab Kits are typically susceptible to intense scrutiny, as too are Medical Devices made up of multiple components.
CoC’s are typically only accepted for medicines – all allied product, (ancillaries, devices, etc.) need to be inspected in the country of origin, by a recognised entity who have been approved in country of import.
The best way to be aware of and access changing regulations for clinical supplies used in global clinical trials.
Third-party coalitions and collaborations with experts, excellent relationships with all regulators and carriers keeps us up-to-date in supply chain risk management – so that we can rapidly adapt and keep up with the changing regulatory landscape to make timely and effective decisions to improve supply chain outcomes.
More specifically, a centralised customs bonded distribution facility in Africa, which provides state-of-the-art storage and distribution is essential in maintaining the clinical supply chain across all African states which too, has a reciprocal financial cost benefit.
We too need centralised procurement with the added value to rapidly move clinical trial material, manage biospecimen transportation, perform re-labelling and so on, to contribute positively to clinical supply chain outcomes.
This, we believe, will go a long way to provide robust supply chain solutions, build trust and attract more clinical trials IN2Africa, address the disease burden issues and create more opportunities for clinical research companies throughout sub-Saharan Africa.