The pharmaceutical sector in Africa is moving towards a regulatory transformation by planning to create African Medicines Agency. But the unstable government in each country acts as a hurdle towards its formation. Offering a ray of hope, SAATM and AfCFTA pacts are expected to open new horizons to boost the pharma industry.

"Women make up 50% of the global AIDS epidemic and in Africa that figure is now 58%. Today, AIDS has a woman's face," remarked the late Kofi Annan, former UN secretary general and Nobel Peace Prize winner, upon receiving an honorary doctorate from the University of Cape Town at a ceremony held at Columbia University, New York in December 2002.

The continent with 54 countries still continues to be a victim of life-consuming epidemics like malaria, yellow fever, AIDS, tuberculosis, etc. Africa’s tropical climates makes it the largest reservoir of infectious diseases. As per the World Health Organization (WHO), 274 Ebola cases and 174 related deaths in the Democratic Republic of Congo have been confirmed this year, after recording 11,000 deaths between 2013-2016 in West Africa.

According to Frost & Sullivan report, Africa’s pharmaceutical market is estimated to touch a business opportunity of $45 billion in 2020. Even the dynamic shift to adopting the western lifestyle is becoming the burden of illness towards noncommunicable diseases (NCDs), propelling the demand for chronic prescription drugs. The WHO projects that the proportional contribution of NCDs to the healthcare burden in Africa will rise by 21 percent through 2030.

Meanwhile, the pharmaceutical sector in Africa is moving towards a regulatory transformation, which will pave way for a faster market access for industry and at economical price to the consumers. Here, the debate lies in the individual country regulators, who are volatile at every stage of development, thus the setting up of a new African Medicines Agency (AMA) by African Union (AU), remains uncertain. The task of AMA is to cooperate and strengthen healthcare activities to harmonise medicine regulation of member states of the Union in line with European Medicine Agency (EMA).

At the same time, Single African Air Transport Market (SAATM) and the African Continental Free Trade Area (AfCFTA) are at the centre stage which is expected to give a makeover to the pharma industry. Fitsum Abadi, managing director, Ethiopian Cargo & Logistics Services, states, “The pacts will boost intra-African business and improvise innovation in the industry. To avoid obstacles like aviation permits and traffic rights, single air transport agreement is important. Africa’s growth is not a matter of choice it is a matter of survival.”

Lifeline in air

When it comes to ensuring the quality of medicines, manufacturing and transportation are the two elements which have to move in tandem. The conditions under which medicines are transported and stored have a critical role in maintaining the quality. This situation is all the more urgent when several lives are at stake.

Ethiopian Airlines imports a major share of medicines to Ethiopia and its efforts in securely transporting these medicines demonstrate, how a transportation company helps in protecting public health. Abadi says, “Many would agree that air cargo industry in Africa suffer from multitude of challenges ranging from insufficient infrastructure to lack of basic commitment throughout the supply chain. In the meantime, understanding the state of urgency in such operation and seamless communication, lot of coordination when and where it is necessary with the host country along with commendable knowledge in what you are engaged, is highly required and we managed that way. The main challenge is broken supply chain mostly due to infrastructure.”

Ethiopian Cargo & Logistics Services, one of the seven business centres of the Ethiopian Airlines, offers a capacity of around one million tonnes per annum, the largest in Africa. The state-of-the-art cargo terminal-II is equipped with enhanced cold chain facility that helps in boosting the airlines’ capacity for storage and handling of temperature-sensitive and life science products. Abadi comments since the opening of the terminal in June last year, the volume has reached 450,000 tonnes per annum and is expected to double once it is fully operational. As part of ensuring good storage and distribution practices, capacity building training was also provided to Ethiopian Airlines staff, in partnership with the promoting the quality of medicines (PQM) programme, funded by the US Agency for International Development (USAID) and implemented by the United States Pharmacopeia (USP).

At the same time, Emirates SkyCargo has helped to deliver lifesaving medical equipment from Seoul to several countries in Africa. Since 2015, the carrier has transported over 800,000 units of malaria tester kits and other associated equipment from South Korea to countries including Malawi, Zambia, Tanzania, Zimbabwe and Nigeria.

Even though the airlines are meeting the expectation of pharma needs in Africa, there are several challenges, such as cancellation of commercial flights, air space closures, remote locations with poor infrastructure, civil unrests, capacity limitations given volume of traffic on routes and application process for permits. Commenting on these lines, DHL spokesperson says, “In many parts of Africa, delivery to health facilities is an enormous challenge, due to poorly developed infrastructure. Appropriate use of drones could close this gap. We are convinced that we can create tangible value for the logistics industry with the DHL Parcelcopter 4.0, also in Africa. This could come in the form of providing emergency medical services or supplying regions with geographically demanding conditions, such as islands.”

However, DHL’s primary motivation was to gain additional insights into the logistical requirements for supplying medicines by air in countries like Tanzania. At this time, there are no specific plans for routine operations of DHL Parcelcopters as drone regulations vary widely on a country-by-country basis in Africa.

The cooling specialists

Every logistics service provider must ensure that every medicine, from a simple tablet to a complex infusion, completes its journey safely and on time. Although logistics is only one step in pharma supply chain, the shipping processes involved in it can represent nearly 40 percent of total operating expenses.

Envirotainer’s first-ever African relationship with Ethiopian Airlines is expected to enhance the connectivity for pharmaceutical companies to their customers. “Ethiopian Cargo & Logistics Services has signed a master lease agreement (MLA) with Envirotainer & DoKaSch-TS, well-known for supplying of temperature-controlled air cargo containers. Such containers have undeniably changed the face of air pharma logistics in the industry by eliminating wastage of the service being provided till today. In this highly sensitive market, the product such as active temperature-controlled containers play vital role for the protection and safety of time and temperature sensitive healthcare products both onboard and on the ground throughout the supply chain,” says Abadi.

DoKaSch’s Opticooler has been designed especially for conditions, where infrastructure is not yet available or not always reliable. Andreas Seitz, managing director, DoKaSch, says, “We see a lot of progress in the airport and logistics infrastructure in many countries in Africa, but it takes time.

Our temperature-controlled containers are able to buffer electricity outages and run independent from external power for days. That is why many pharmaceutical companies entrust their life-saving products to be transported in Opticoolers. We are happy that many countries in Africa are developing well and demand for reliable transport for pharmaceuticals is rising. We are glad that due to our temperature-controlled containers, sensitive pharma products can reach the hospitals more reliable, for the benefit of the patients all over Africa.”

The classic challenge lies in regulating temperature of pharma products when they run through different jurisdictions, land, sea and air, which means containers are exposed to various environment and temperature. DSV, the only freight forwarder with dedicated facilities at O R Tambo International Airport in Johannesburg, offers DSV COLD for inbound pharma supply chain.

With GDP rules, the cargo is transported from the plane to DSV COLD warehouse in their exclusive Polar Cabin, ensuring that pharma items are not exposed to extreme changes of temperature or direct sunlight. The cabin is pre-conditioned according to the required temperature a cargo needs, prior to the arrival of the aircraft.

Commenting on setting up temperature-control in drones, DHL spokesperson says, “For DHL Parcelcopter 4.0 in Tanzania, we used a passive cooling without temperature-control, since the time of flight was short enough (40 minutes). However, in future, temperature-control solutions for drones would be possible.”

Tech smart

Rolling out from a cardboard box to a sophisticated temperature-controlled container is just one wing of the pharma logistics. Data analytics, which track important information about the condition of products in transit is the second wing. Modern containers monitor conditions of the cargo it holds using internet of things (IoT), artificial intelligence (AI) or blockchain technologies. The shipment owner can detect whether his products are being treated in accordance with global policies.

Seitz opines, “Opticoolers are tracked by our own system, but due to airline restrictions it is not yet possible in flight. Our sophisticated electronics is monitoring the internal and external conditions without a pause, so that we can verify that all systems run smoothly. Every container has several heating and cooling machines, so that even when one system fails the medications inside are safe.” Opticooler, the flying ‘smart warehouse’ only needs one electrical outlet to fully charge the energy storage after a flight and to ensure that always enough power is available to deal with unexpected events. A full charge, from 50 to 100 percent, can be achieved approximately within two hours.

At Ethiopian Airlines, they are able to track and trace shipments, with data from checkpoint scans. “SMS push is the first step towards digitisation that Ethiopian Airlines has started. It will enable customers to know their shipment destination, both on passenger and cargo side. On multimodal logistics front, when customers produce their products on industrial parks they do not need to bother. We visit their production centre and provide a single document to the customer for shipments by air, sea or road. As it is digitised, the customer will need to follow a single document,” Abadi says.

The collaboration between DuPont Safety & Construction and SkyCell on technical and market development will lead to major innovations across temperature monitoring, shipment tracking, asset management and smart data-driven services. The mutual effort is aimed at maintaining the physical and clinical integrity of pharmaceuticals in transit. Under the terms of the agreement, DuPont will gain access to SkyCell’s remote temperature-management solutions and expertise and acquire marketing rights to the SkyCell portfolio of insulated shipping containers. The SkyCell containers will be marketed by DuPont alongside its ‘Tyvek’ products.

SkyCell portfolio

A Ray of Hope

Africa is in a transition phase, on its way to achieving adherence to global standards, such as the WHO pre-qualification for manufacturing. DHL spokesperson comments, “We will monitor the demands for pharma transport and continue to innovate in order to meet the needs of our customer and the industry. Given the forecast of strong demand growth for medicines and medical equipment between 6 to 11 percent p.a., as per sources, pharma transport is certainly on the agenda. However, it would be very much dependent on the infrastructure within the country i.e. the ability of the inbound country to support the product in terms of customer locations, clearance process, product registration, import regulations, storage capability and delivery footprint and capability.”

DoKaSch’s Opticoolers mainly export pharmaceuticals from the European Union and the US into Asia and Africa through the Middle East hubs. Due to this reason, master agreements with carriers like Ethiopian Airlines, Saudia Cargo and Qatar Airways Cargo enable them to spread wings to different routings.

According to Frost & Sullivan, local production is regarded as a key strategy for sustained access to quality-assured medicines for a long term in Africa. The regulatory environment for manufacturing in regions such as East Africa seems to grow rapidly, owing to regional harmonisation. South Africa remains as the best-established region for pharmaceutical manufacturing in sub-Saharan Africa. However, the local manufacturing markets in East and West Africa are relatively well developed and positioned to grow. Technology transfer is paramount to developing the manufacturing sector in Africa, particularly as the disease burden is changing.

To eliminate the factors such as power outages, data monitoring and connectivity, which continue to cripple the continent, Africa Power Vision is envisioning at generating power from sustainable sources such as solar and wind energy.

Similarly, at the Temperature Controlled Logistics Europe 2018, Professor of Medicine Harvey Rubin from the University of Pennsylvania presented the Energize the Chain’s sustainable solution projects for vaccine cold chains that have been initiated in Zimbabwe and Ghana. These projects have co-located refrigeration sites with cell phone towers as they have a surplus of electricity. As the towers are locally managed, responsible stakeholders can intervene to protect the controlled environment of the vaccines, if necessary.

Action plans

The World Health Organization (WHO) and the African Union Commission (AUC) through its Africa Centres for Disease Control and Prevention (Africa CDC) are strengthening their ties as they team up to tackle the health challenges facing the continent. A joint task force with five technical working groups will guide the efforts in the areas of partnership and resource mobilisation; monitoring the progress in implementing international health regulations; addressing the African Union Agenda 2063; public health emergency preparedness and response; strengthening surveillance and laboratory capacities; and antimicrobial resistance.

Moreover, after the completion of the second phase of the Ethiopian Cargo & Logistics Services, it will add 600,000 tonnes annual uplift capacity. It will be Ethiopian’s largest cargo terminals capability equivalent to terminals in Amsterdam Airport Schiphol, Singapore Changi and Hong Kong Air Cargo Terminals Limited. Even it has invested to create massive cargo facilities along with the purchase of six modern B777F and two B757Fs. It has also ordered for four B777Fs and two B737Fs, which is expected to develop adequate air cargo transporting capacity for the fast-growing export and import demand in the African continent. Abadi declares, “The full package of the service that is planned to be launched soon will be with a product name called Ethiopian Cargo Pharma Wing, which is armed with dedicated team, facility and best logistics technologies of our time.”

Recently, Airbus through #Africa4Future has invited African tech startups that are actively working on solutions related to unmanned logistics and remote sensing technology, including automation and drones, electrification, blockchain, AI, data analytics and material composites and manufacturing. Meanwhile, Airbus’ White paper, ‘Great Enabler: Aerospace in Africa’, which was launched stressed on the role of aerospace technologies and their impact on socio-economic development in Africa. The extensive report looks at how different segments of the industry can address a core set of challenges on the continent by increasing access to healthcare; empowering businesses with innovative products and solutions; and breaking down barriers to the movement of people and goods across Africa.

Few months ago, Soteri Gatera, chief of the industrialisation and infrastructure, Economic Commission for Africa urged the need to develop African pharma sector to reduce import dependency on medical products and pharmaceuticals. He said that Africa bears a disproportionate burden of disease with, for example, more than 70 percent of the world’s HIV/AIDS cases and 90 percent of deaths due to malaria raising the need to encourage local production of drugs. He also enunciated a number of measures taken by the AUC and its partners to promote the manufacture of medicines in Africa in line with the accelerated industrialisation initiative for the continent’s socio-economic transformation.

Quality cooperation between all the parties and new innovations continue to expand this ever-growing market and helps to deliver lifesaving drugs to the people. Initially, the investments must be made into the facilities, training and certification required to transport pharmaceuticals efficiently. To march on equal pace with the ongoing trends, continued investments are required in pharma transport through air in Africa.