Getting Quality Medicines to Patients Faster in Africa: How to Solve Access Issues

Africa is home to 1.2 billion people, about 11% of the world’s population. In addition to this demographic burden, the continent also carries a disproportionate burden of disease, with 60% of Africans living with HIV/AIDS and more than 90% of annual global malaria cases in Africa.1. The continent is plagued by significant communicable diseases and increasingly non-communicable diseases (NCDs). Over the years Africa has faced significant public health challenges due to inadequate access to quality, safe, effective and affordable medical products.2 In 2022, some children reportedly died of acute kidney injury in The Gambia after consuming imported adulterated cough syrup. Incidents like these are not only tragic, but painful to know that could have been easily avoided

Why is it difficult for Africa to get timely access to quality medicines?

Weak regulatory systems and limited availability of financial and technical support in several African countries limit timely access to quality medicines; Details can be found below:

  1. Weak and fragmented regulatory system: Several African countries have unclear policies and incomplete or inconsistent legal and regulatory frameworks. A 2012 study found that it took an average of 4 to 7 years to register a new product in sub-Saharan Africa, compared to only 6 to 12 months in high-income regions.3. Furthermore, there is a lack of skilled regulatory professionals with an underdeveloped regulatory infrastructure. Ineffective regional cooperation exists within the National Medicines Regulatory Authority (NMRA).
  2. Presence of some local and regional drug manufacturing companies: There are approximately 375 pharmaceutical manufacturers on the continent serving more than 1.1 billion people, and these companies are mostly concentrated in North Africa. Clustered in 9 of the 46 countries in sub-Saharan Africa. When one compares this number to 10,500 drug manufacturers in India and 5,000 in China with a population of 1.4 billion, the difference becomes quite clear.4.
  3. Limited financial and technical assistance: Most African countries operate on limited social benefits or universal health coverage. Additionally, there is a lack of sophisticated healthcare provision capable of handling innovative global health products. There is a huge digital divide within African health systems. In most countries, weak linkages between different information systems and solutions are seen as they are not designed to capture robust data across multiple sectors.
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Case-in-point: significant delays in accessing new molecule contacts

Data from Francophone West Africa and South Africa show that, although they have gained access to quality diabetes medication, access has been significantly delayed compared to other countries.

The graph below shows that the number of new molecules introduced in different countries has decreased. Francophone West Africa has had fewer new product launches in the past 12 years than South Africa and India.

Taking the US as a reference country, South Africa experiences product introduction delays of 1-6 years, while FWA experiences a minimum of 8 years.

Africa is taking the right steps to address inefficiencies and improve access to medicines

Recognizing the delays, obstacles and barriers to healthcare product accessibility, Africa has initiated developments to address gaps and inefficiencies in regulatory systems to improve access to medicines, as evidenced by the following positive developments:

  • Establishment of the African Medicines Agency (AMA): Recently, 15 African Union (AU) member states ratified the agreement to create the AMA – a continent-wide regulator to complement national and regional efforts and optimize regulatory processes on the continent. It is predicted that, instead of negotiating 54 times for each African country, drug and medical device companies will be able to tackle one evaluation process and get a recommendation that all African countries can use to approve products nationally. Significantly reduced product/drug introduction time.
  • Introduction to African Pharmaceutical Technology Foundation: The African Development Bank created the African Pharmaceutical Technology Foundation (APTF) to increase access to technology to develop medicines and vaccines. Until now, African pharmaceutical companies have lacked the scouting and negotiating capabilities, and bandwidth to engage with global pharmaceutical companies, and as a result have been marginalized and left behind in complex global pharmaceutical innovation. The African Pharmaceutical Technology Foundation aims to fill this critical gap. However, APTF will take some time to be fully staffed and fully operational.
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What more can be done?

Africa is diverse and consists of many different countries with different cultures, market characteristics and economic conditions. While there is no single key to accelerating regulatory and access to medicine timelines, addressing common barriers at the country level is a good place to start.

IQVIA’s 2022 White Paper on Assessment of Access-to-Medicine Timelines in Selected Countries in the Middle East and Africa highlights key reforms to improve regulatory and access-to-medicine timelines. These include:

  • Holistic and Comprehensive regulatory and reimbursement policy/Guidelines, which are in line with the best practices followed by developed countries. Active and passive surveillance should be enhanced to control the quality of drugs.
  • Performing emergency use authorizations and fast-track reviews Improving accessibility is the need of the hour. Many countries under scope have shown sustained performance on regulatory and access-to-medicine timelines by issuing fast-track registration procedures for new drugs that are already approved by regulators in developed countries such as the US and/or Europe.
  • Formal evaluation of pharmacoeconomic or cost-effectiveness data plays a limited role in current reimbursement decisions in the MEA region. Several countries in the region have realized the need for this Strengthens their HTA abilities To enable local decision makers to take sound decisions. For example, Ghana has a working group to review Health Technology Assessments (HTAs) – a defined framework for presenting health economic assessments.
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Ghana has made great strides in its HTA journey. The country currently has a working group to review HTAs that have been used to approve indications such as childhood cancer for national reimbursement. This has led the country’s pharma companies to try to demonstrate the value of their products to stakeholders with evidence-based evaluation.

We hope that more countries in the region will begin building their capacity to evaluate such technologies. In an increasingly resource-constrained post-pandemic world, we expect an increasing need for real-world evidence to optimize health spending decisions and ensure access to the most important health care products.

IQVIA has been supporting its clients by providing unmatched data resources, sharing in-depth healthcare knowledge and advanced analytics to meet specific customer needs. IQVIA has a dedicated public-health practice that actively engages with government, national/international donors and multilateral healthcare organizations and private sector stakeholders to support evidence-based decision-making. For more information, please contact Deepak Batra or Mridu Bhutani

formula:

  1. Establishing an African Medicines Agency: Progress, Challenges, and Regulatory Readiness, Journal of Pharmaceutical Policy, and Practice, 2021
  2. Prevalence and estimated economic burden of substandard and falsified drugs in low- and middle-income countries, National Library of Medicine, 2018
  3. Africa needs strong African regulators to protect health, Africa Report, 2022
  4. Africa’s Shot at Local Pharma Production, IFC, 2021
  5. How Clinical Development Can Address Africa’s Unique Health Needs, World Economic Forum, 2022
  6. What do we need to know? Data sources to support evidence-based decisions using health technology assessment in Ghana, National Library of Medicine, 2020

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