E-DRUG: Lessons from COVID-19: Does Africa have a Path toward Medicines Supply Security?
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Lessons from COVID-19: Does Africa have a Path toward Medicines Supply Security?
Article written for E-drug by:
Dr. Patrick Lukulay, President, Technology Solutions for Global Health (Tech4Health),
Dr. Paul A. Lartey, La Gray, Inc., and
Emmanuel Mujuru, Chair, Federation of African Pharmaceutical Manufacturers Associations
The COVID-19 pandemic is wreaking untold havoc on human health and national economies. It has tested the capacity and capabilities of public health systems to respond in times of emergency. It has also exposed the vulnerabilities of many countries to provide needed medical products for their citizens in times of crisis. This includes developed countries with sound economies and the most advanced and seemingly resilient healthcare systems in the world.
One thing has become clear during this pandemic, that as pressure mounts on health systems and supply chains globally, countries will resort to knee-jerk nationalistic actions, limiting the supply of raw materials and finished products to other countries in an attempt to stockpile supplies for their own citizens. Some of these restrictions may be for political expediency, but they could result in the collapse of health systems in developing and under-developed countries, mostly in Africa.
In the face of these export restrictions and in the interest of national security and survival, it is now urgent more than ever that Africa reviews the status of its health security. Of paramount importance is Africa’s preparedness to secure the supply of critical medical products needed in times of public health emergencies.
What is Africa's game plan for pharmaceutical manufacturing?
Demand for pharmaceuticals in Africa continues to increase, with an estimated annual growth rate of about 10% between 2010-2020, to meet the needs of its 1.3 billion population. Moreover, the middle class is growing at an impressive rate and with increased demand for medicines including life style drugs, it is therefore perplexing that Africa continues to import about 70% of its medicines.
Currently, Africa's pharmaceutical manufacturing capacity is weak and cannot meet the need for critical high-quality medical products. As a result, undue reliance is placed on imports from regulated and unregulated markets, with the predictable consequence of proliferation of sub-standard medicines. With the health systems of a majority of African countries depending excessively on imports of pharmaceutical products and a fragmented supply chains, with a number of intermediaries between the manufacturer and the pharmacy, medicines in Africa continue to be subject to increasing cost, vulnerability to counterfeiting and falsification.
In recognition of the critical importance of the pharmaceutical manufacturing sector to Africa's health and sustainable development, in 2005 the Heads of State and Government of the African Union (AU) mandated formulation of the Pharmaceutical Manufacturing Plan for Africa (PMPA) and subsequently approved the business plan (PMPA-BP) for its implementation (Addis Ababa, 2012). The vision of PMPA is to strengthen Africa's ability to produce high quality, affordable medicines that will contribute to improved health outcomes, and produce both direct and indirect economic benefits.
Significant progress has been made toward implementation of the PMPA, such as the African Medicines Regulatory Harmonization initiative that has led to the establishment of the African Medicines Agency (AMA). AMA is intended to level the playing field and ensure the quality of pharmaceutical products on the continent. Adoption of the African continental free trade agreement will also create a robust common market that should help grow the industry and improve access to medicines.
While progress has been made in implementing aspects of the plan, critical components, such as attainment of international standards of Good Manufacturing Practices (GMP) and building of the requisite capacity in the industry are lagging behind. These activities are capital intensive and require long-term low-cost financing, which currently fall outside the scope of most facilities of the African banking and financial systems. The full and timely implementation of PMPA is therefore at risk of failure and leaves Africa still incapable of self-sufficiently addressing perennial health problems such as HIV/AIDS and malaria, or responding to health emergencies, such as COVID-19 and Ebola outbreaks.
What will it take to advance Africa's pharmaceutical manufacturing sector?
It is in view of this rather perilous situation that the 2nd Session of the Specialized Committee on Health, Population and Drug Control of the African Union Commission (March 20, 2017, Addis Ababa) adopted a proposal to establish a fund called The Fund for African Pharmaceutical Development (FAP-D).
FAP-D is to provide the financing needed to build capacity and attain international standards of GMP in the African pharmaceutical development and manufacturing sector. The fund will also provide technical advisory services, oversee efficient use of financing, support partnerships and collaborations to enable private sector engagement in the development of herbal and traditional medicines. Overall, FAP-D will help find solutions through African technological advancement and innovation.
Precedence for the success of such funding mechanisms in the development of an indigenous pharmaceutical sector was set by India, which after mandating its fledgling industry to comply with international standards, established a dedicated fund to transition the sector into the 4th leading pharmaceutical industry in the world. Another example is the International Fund for Agricultural Development (IFAD), established by the UN, which has been successfully used for the development of that critical sector as an approach to rural development and poverty alleviation.
What are the benefits of a developed African pharmaceutical sector?
The benefits of a sustainable Medicines production capacity in Africa include:
a. Public health benefits
Availability of cost-effective quality assured medicines will reduce disease burden and help improve quality of life. A vibrant and robust pharmaceutical industry on the continent will meet the challenges of combatting infectious diseases as well as emerging non-communicable diseases such as diabetes, cancer and hypertension.
b. Economic and industrial development
Currently, over 70% of medicines are imported into Africa and local manufacturing meets only 30% of the needs on the continent. This heavy dependence on imports will be reduced as a result of a growing knowledge based pharmaceutical sector and the consequent benefits from import substitution realized. Developing the pharmaceutical sector will also contribute to the diversification of the African economy and improve the continent's global competitiveness.
In addition, the bulk of funds provided by development partners and donors to procure medicines for Africa often goes to Indian and Chinese companies because these have attained the requisite GMP compliance. Increasing the number of GMP compliant facilities in Africa will therefore go a long way in enabling access to donor markets, thus improving opportunities for achieving the economies of scale and the overall growth of the domestic industry.
c. Harnessing the demographic dividend
With the youth increasingly making up a larger percentage of the African workforce, there is an urgency to create rewarding knowledge-driven jobs. A thriving pharmaceutical industry will create higher-wage jobs and harness this demographic dividend, thereby contributing to an increase in Africa’s GDP.
d. Africa's security
Lack of access to technology and know-how to develop medicines that meet critical needs, especially in times of disease outbreaks like Ebola, COVID-19, dengue, Lassa, Zika, SARS and COVID-19, puts the continent at a security risk. Lack of access to critical and timely interventions during health emergencies is an existential threat and a security concern that will be mitigated by a vibrant pharmaceutical industry.
e. Wealth creation
The pharmaceutical industry is supported by a number of auxiliary and allied industries. These industries include those providing services for equipment installation, maintenance, tooling, qualification and calibration. In addition, allied industries, including manufacture of raw and packaging material, as well as fabrication of manufacturing equipment will emerge and grow as the pharmaceutical industry grows, leading to multiple job creation beyond the pharmaceutical industry itself. This will provide an exponential contribution to technological growth, poverty reduction and GDP growth.
A clarion call to action
In view of the above, the 19th Conference of African Ministers of Industry (Algiers, 2011) adopted a resolution recognizing the potential role of the pharmaceutical sector in the overall industrial growth of Africa. The sector was thus identified as a priority area in the plan for Accelerated Industrial Development of Africa.
With the glaring weakness of global health systems currently being exposed by the COVID-19 pandemic and the stated benefits of FAP-D, it is imperative for AU Heads of State and Government to take the next steps toward its implementation. These include adoption of a resolution establishing FAP-D as a treaty-based organ, which would commit all AU member states to its successful implementation.
Lessons from COVID-19 are a clarion call to action, as the next public health threat could be just around the corner.
submitted by:
Patrick H. Lukulay, Ph.D
President , Technology Solutions for Global Health
Email: phl@tech-4health.com