The Continent of Africa with 1.3 billion people will witness the greatest advancement in healthcare whereby the wellbeing and economy of its nations will be significantly enhanced in the 21st century. The Bio Supply Management Alliance (BSMA), a global community of supply chain professionals in Life Sciences based out of San Francisco (USA), Europe (Brussels) and Asia (New Delhi), will launch an effort to build the supply chain backbone for a self-sufficient healthcare system for the continent of Africa. Founded 15 years ago, BSMA’s mission has been to accelerate affordability and accessibility of scientific and technological advancements by fostering collaboration among the stakeholders of the industry to include the government, world health organizations, public and private enterprise, academia, research organizations, foundations and NGOs.
In order to establish and sustain the missionary objective of BSMA in Africa, it is proposed to collaborate with the pioneering endeavor of Kigali Pharma Hub and determine the best way to augment and enhance its operational plans. BSMA will build upon the support of the Ministry of Health of Rwanda and associated agencies. The strategy of BSMA Africa is to organize volunteer Subject Matter Experts and build resources/organizations with available investments. The long term scope of BSMA Africa is to embrace other countries of Africa as deemed fit to achieve Pan Africa Self Sufficiency in Healthcare through ongoing efforts to be coordinated by BSMA with Local, State, Country, NGO, World Health Organizations and other agencies. BSMA will bring its global community to the inaugural BSMA Supply Chain Management Conference in Kigali, Rwanda, on October 31 and November 31, 2022, at the Kigali Marriott Hotel. The Conference is designed to help build the end-to-end supply chain for the emerging bio-pharmaceutical industry of Rwanda and the continent of Africa to improve the delivery of healthcare. The strategic intent is to leverage and augment the available resources of Rwanda with those of USA and BSMA and USA, multinational bio-pharmaceutical companies, universities, research institutions, and Agencies of Healthcare.
Basic Initiatives envisioned at this stage are enumerated as follows for the review and consideration of the Kigali Pharma Hub and the Ministry of Health of Rwanda.
In conjunction with universities of Rwanda, Africa and abroad, facilitate the cooperation of universities, which teach supply chain management, to become centers for imparting knowledge and experience in the science of supply chain management (SCM). Supply chain management is a “set of approaches utilized to efficiently integrate suppliers, manufacturers, warehouse, and stores, so that merchandise is produced and distributed at the right quantities, to the right locations, and at the right time, in order to minimize system-wide costs while satisfying service level requirements”. Source: David Simchi-Levi, Philip Kaminsky, Edith Simchi-Levi, “Designing and Managing the Supply Chain – Concepts, Strategies and Case Studies”, McGraw Hill Irwin, 2008. ISBN 978-0-07-298239-8.
The objective of the educational program will be to develop a holistic view of supply chain management, which integrates other functions of manufacturing, procurement, sales and marketing, finance, distribution, quality and customer service of an enterprise in the context of the trading partners of the industry, enhances managerial skills for increased productivity and customer service, and equips one with principles and tools to solve problems. An initiative to foster collaboration between universities, industry and the Government will form the foundation for such an effort. The mode of delivery will be universities, online courses, conferences, workshops and webinars.
BSMA Africa will support the training of the Life Sciences industry in Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). GMP are the practices required to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. Good manufacturing practices, along with good agricultural practices, good laboratory practices and good clinical practices, are overseen by regulatory agencies in the United Kingdom, United States, Canada, Europe, China, India and other countries. Good manufacturing practice provide guidance for manufacturing, testing, and quality assurance to ensure that a manufactured product is safe for human consumption or use.
The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over one hundred countries worldwide, primarily in the developing world. The European Union’s GMP (EU-GMP) enforces similar requirements to WHO GMP, as does the FDA’s version in the US. Similar GMPs are used in other countries, with Australia, Canada, Japan, Saudi Arabia, Singapore, Philippines], Vietnam and others having highly developed/sophisticated GMP requirements.]
Good Distribution Practices (GDP) in the pharmaceutical industry manage the quality of medical products as they are stored and distributed. Different storage requirements and expiry dates mean medicines cannot be handled according to a general rule. And the risk to consumers is all the greater because it is often impossible to tell from appearance, taste or smell if a drug has degraded in transit or has been contaminated. Formalized GDP is essential to ensure that when potent but sensitive products arrive in the hands of patients both suppliers and customers can be confident that they are effective, unadulterated and safe to use. In the US, the world’s biggest pharmaceutical market, the FDA enforce GDP, which are codified in the Current Good Manufacturing Practices (CGMP) regulation for human pharmaceuticals – specifically in Title 21 of the Code of Federal Regulations (CFR). These regulations state it is the responsibility of all stakeholders along the supply chain to control their operations to ensure the identity, strength, quality, and purity of drugs they are responsible for manufacturing, importing or delivering. The adoption of GDP across the pharma and medical device supply chain is improving traceability, accountability and reliability of the products that end up in the hands of customers.
Rwanda is currently privatizing the pharmaceutical sector because the current regulations restrict MPPD from contacting and importing pharmaceuticals directly from international manufacturers. MPPD uses intermediate suppliers that import drugs and other pharmaceutical products from manufacturers and sell them with increased prices that make health commodities quite expensive for public sectors. It is reported that any assistance required by the Rwanda Medical Supply (RMS) will be provided in its introductory phase to replace MPPD. RMS will serve as the central medical store that has its full authorization to negotiate prices and import directly from international manufacturers. District pharmacies will continue to serve as a distribution points and warehouses of RMS, and public health institutions will obtain all pharmaceutical products and medical equipment directly from there. District pharmacies will no longer be commercial entities, and this will reduce the pharmaceutical costs as well as public healthcare cost in general. The adaptation of the privatization policy will reduce the lead-time of pharmaceuticals as well as mitigate the country’s drug supply shortage.
In this context, BSMA Africa will augment the effort by providing the following services over time:
Establish a network of suppliers, domestic and foreign, for drugs, supplies, APIs and services, who have been comprehensively vetted. Activities will be organized to enable knowledge and information sharing among members
Establish membership of the Group Called BSMAA PURCHASING.
Provide Purchasing Contracts with Suppliers for prioritized products and services demanded by the Life Sciences industry, such as Laboratory Equipment and Supplies, Transportation Services, CROs, etc. This will deliver significant cost reduction to members for aggregated purchasing volumes, in addition to reliable delivery of quality goods and services.
Facilitate the funding of projects.
Serve as a voice for the Life Sciences industry for advocacy with the Government.
Assistance will be provided where needed to the currently operating initiative(s). It is understood that in Rwanda, the pharmaceutical sector relies heavily on imports. In 2019, Rwanda spent around $ 97.6 million on drugs import alone, and it is expected to increase by $102.5 million in 2024. About 20% of these import expenses are expected to be reduced by the establishment of the first pharmaceutical factory in the country. Public and private sectors preserve the drug supply chain in Rwanda. In public sector, the drug supply chain system allows public health institutions to obtain health commodities directly from central medical store and/or district pharmacies. The Medical Production and Procurement Division (MPPD) under Rwanda Biomedical Centre (RBC), performs the procurement, storage, and distribution of health commodities to public health institutions and it is regarded as central medical store. MPPD is the main supplier of all pharmaceutical commodities ranging from essential medicines to laboratory reagents. However, district pharmacies serve as the distribution point of pharmaceutical products to district hospitals and health centers. Public sector also gets an authorization from the Ministry of Health or/and district pharmacies that allow them to buy pharmaceutical commodities from private wholesalers in case they are not in their stores. In private sector, many wholesale pharmaceutical companies import drugs directly from international manufacturers, and local drug compounding pharmacies. Community pharmacies and private health clinics or hospitals get medical commodities from these private wholesalers. Any assistance to the current initiative will be provided.
Assistance will be provided where needed to the currently operating initiative(s). Africa has witnessed since the COVID-19 pandemic, the commitments of nations to establish manufacturing facilities. Many pharmaceutical companies are currently investing in the build an Authority (RFDA) to start its operations, and it is currently in the final establishment phase. BioNtech and Pfizer plan to build a vaccine manufacturing plant in Rwanda in 2022. Moderna is investing in building a vaccine plant in Kenya and the list goes on. Cipla already has two plants in South Africa and Uganda. South Africa is the most advanced in biopharma manufacturing and distribution. The opportunity to grow indigenous manufacturing of drugs appears unlimited in Africa because of the population of the continent.
The global network of BSMA for Drug Development will be extended to Africa as practical for the business development for African enterprises is unlimited. Most of the global service companies (CROs, CDMOs and CMOs) in the field are not adequately rooted in Africa. Clinical Research Organizations rely on conducting clinical trials for various therapies and significant potential exists to enable them in Africa. The success factors of patient enrollment, drug delivery, compliance, monitoring and returns can be significantly enhanced by promoting the multiple stakeholders engaged in drug development. People, processes and technology in the complex process of innovations will yield huge dividends for Africa.
BSMA has three decades of workforce development for Life Sciences which can be brought to Rwanda and Africa through its association with the California Life Sciences (CLS), https://www.califesciences.org/.
Workforce development from the organizational centric perspective is defined as training programs that provide existing and potential workers with the skills to complete tasks needed by employers to let the organizations stay competitive in a global marketplace. The goal of workforce development is to enhance the skills of those already in the workforce as well as provide tangible and relevant skills to those looking for employment.
Assistance of SMEs will be provided to Rwanda’s Ministry of Industry for the development, oversight, and continuous improvement of the country’s workforce development system. The workforce development system typically consists of Local Workforce Development Areas (Local Area), each with its own business-led Local Board. These Local Boards work together with the state and their local Chief Elected Officials to oversee the delivery of workforce services relevant to their residents and businesses. The job centers typically provide 1. Recruiting, screening, and referring a variety of job seekers, ranging from entry level workers to highly-skilled professionals, 2. Hosting job fairs and providing office space for on-site screening and interviewing, 3. Providing access to human capital and untapped labor pools, 4. Offering workforce information about wages, employment trends, and national comparison, 5.Training and Education, 6. Offering industry-recognized certifications, 7. Developing customized training programs, such as pre-employment training, 8. Connecting to apprenticeships programs with a mix of instruction and on-the-job training, and 9. National Emergency Grants for significant dislocation events to expand service capacity.
Healthcare agencies of nations of Africa will be introduced to the importance of building the supply chain infrastructure in the planned delivery of healthcare to the masses. This will encompass warehousing, logistics, distribution and customer service.
Collaboration will be fostered among the institutions of transportation across Africa, for the modes of Airlines, Ocean Freight, Trucking, Railways and River Cargo to expand and technologically advance the transportation and logistics network, while simplifying the custom regulations.
BSMA Africa is prepared to help implement the Strategic Plans of MINNICT as required. Technology is a strategic enabler to achieve a leapfrog in the advancement of the supply chain in the continent of Africa. Mobile phones, Internet, IT Systems and Networks, eCommerce and eLearing, Digitalization, Artificial Intelligence, Machine Learning, Blockchain and Drones are the major technologies that will be furthered through conferences, trade shows and businesses. BSMA, with its global company members if Life Sciences, is a tremendous resource for the leaders of Africa to pursue. Collaborating with MINICT of Rwanda will establish the foundation for the effort.
This endeavor will require the leadership of the Health Ministers of nations of Africa under the aegis of the Africa Union. Currently exceptional work is being done by POHER, the non-governmental organization (NGO) with a focus on the soundness of the health sector as the cornerstone of social and economic development of all African countries. Its objectives are 1. Improve health awareness in African communities, 2. Promote and advocate the creation of partnership between health professionals in Africa and overseas irrespective of country of residence, 3. Introduce and promote the use of new and adapted technologies in healthcare and education in Africa, and 4. Mobilize material resources for healthcare services in Africa. Similarly, the Pan African Health Systems Network (PAHESN) has the mission and purpose to strengthen health systems through promotion and advocacy for evidence-based implementation of digitalized health innovations towards health equity in underserved communities.
A comprehensive discussion with the Ministry of Health of Rwanda, MINICT, University of Rwanda and the Medical Production and Procurement Division (MPPD) is required to develop a Game Plan with a Timeline, Resources and Investments.