Low- and middle-income countries (LMICs), defined by the World Bank as having a gross national income (GNI) of below $13,995, are home to nearly 80% of the global population. Noncommunicable diseases (NCDs) disproportionately affect people in LMICs, with more than three-quarters (31.4 million) of global deaths related to NCDs occurring in LMICs. The life expectancy of someone living in a low-income country is around 18 years shorter than someone in a high-income country. [1, 2]

Essential medicines are defined by the World Health Organisation (WHO) as “those that effectively and safely treat the priority healthcare needs of the population. They are selected by taking into consideration public health relevance, evidence of benefits and harms, and with consideration of costs, affordability and other relevant factors.” Around a third of the world’s population lacks access to essential medicines that have potential to save millions of lives. Improving access to essential medicines can also reduce healthcare costs for individuals and healthcare providers and limit the impact of disease on patients, families and communities. [3, 4]

The role of pharmaceutical companies

Pharmaceutical companies can play a significant role in expanding access to essential products, according to the 2024 Access to Medicine Foundation Index. Approaches that are used by the industry include: [2, 4]

• Participating in patent pools and voluntary licensing programmes to make intellectual property available to companies developing and manufacturing drugs for underserved populations.

• Donating research resources, including staff and facilities.

• Making donations – from companies themselves, or through donor-driven procurement, for example for disease eradication programmes or emergencies.

• Taking part in patient access programmes.

• Creating partnerships with companies, institutions and non-governmental organisations (NGOs) to tackle access barriers and transfer knowledge.

• Putting in place differential (tiered) and intercountry and intracountry pricing, adapted to ability to pay.

• Strengthening health systems and supporting health and development goals.

• Working with local stakeholders to ensure that programmes meet local needs.

• Addressing health system capacity and supply chain constraints.

• Moving the product focus beyond communicable diseases, including oncology, diabetes, cardiovascular disease and contraceptives. Developing therapeutics for communicable diseases, including malaria, neglected tropical diseases, tuberculosis and bacterial infection, is still an important goal.

• Scaling up programmes long-term to include additional countries or products.

Case study: Novo Nordisk and iCARE

In 2021, Novo Nordisk launched the iCARE model to improve access to diabetes care in Sub-Saharan Africa, including Ethiopia, Ghana, Kenya, Mali, Nigeria, Senegal, Sudan and Uganda. The company expanded the project in 2023 to enable the low-cost supply of insulin to 4.1 million people with type 1 and type 2 diabetes across Africa by 2026. This supports the African Union’s Pharmaceutical Manufacturing Plan for Africa (PMPA) and was made possible through Novo Nordisk’s collaboration with Aspen. [2, 5]

Case study: Bristol-Myers Squibb and ASPIRE

Bristol-Myers Squibb’s ten-year ASPIRE strategy (Accessibility, Sustainability, Patient-centric, Impact, Responsibility and Equity) has a goal of reaching over 208,000 patients in LMICs per year by 2033. ASPIRE approaches include: [2, 6]

• Creation of Emerging Market Brands with tailored tiered pricing reflecting each country’s ability to pay.

• Collaboration with the Access to Oncology Medicines (ATOM) Coalition to improve access to cancer therapeutics in LMICs.

• Establishment of the BMS-IMAP (Bristol-Myers Squibb Innovative Medicine Access Program), including direct import and direct-to-institution pathways that support importation of drugs.

• Partnerships with healthcare providers and facilities in underserved and unserved LMICs to tackle barriers and improve the quality of care, for example Access Accelerated, the largest global collective industry effort to address inequities in chronic NCD care in LMICs.

Improving access through clinical trials

Clinical trials are a vital part of drug development. They ensure that drugs that reach the market are safe and effective. If certain populations or parts of populations are excluded from clinical trials, this runs the risk that the results will not be as broadly applicable. Clinical trials can also provide patients with access to investigational drugs, as well as providing research data to help to understand how populations respond to certain therapies and therapy types. Companies will also prioritise market access in the countries where clinical trials are conducted. According to the 2024 Access to Medicine Foundation Index, only 43% of the clinical trials analysed were conducted in LMICs, with as few as 3.5% of trials taking place in low-income countries. By carrying out studies in these countries, patients in LMICs could have better access to life-saving drugs that are more likely to be safe and effective. [1, 7, 8]

Carrying out clinical trials can be challenging in LMICs. There may be a lack of contract research organisations, clinical facilities and trained healthcare professionals, and the national regulatory frameworks can be fragmented or complex. Pharmaceutical companies can help by expanding their clinical trial networks and working with local partners to support the development of local research capabilities. This should improve access to drugs tailored to local populations and diseases. [1]

Case study: Novartis/Merck KGaA and PAMAfrica

Novartis and Merck KGaA are working with the PAMAfrica consortium, led by the Medicines for Malaria Venture, to develop antimalarials. Novartis is carrying out trials of an IV formulation of cipargamin for severe malaria in Burkina Faso, the Democratic Republic of Congo, Rwanda and Uganda. The company has put together an access plan, including equitable pricing, for the drug if it gains approval. [1]

Merck KGaA is carrying out clinical trials of cabamiquine for the treatment and prevention of Plasmodium falciparum malaria in Burkina Faso, Mozambique and Uganda. The company has put a regulatory strategy in place, along with an access plan to ensure sustainable supply. [1]

Changing the approach

According to the Access to Medicine Foundation, pharmaceutical companies are adopting more responsible business practices, but there is still an access gap and more needs to be done. Access strategies cover fewer essential products in low- and middle-income countries (39% and 76% respectively) compared with upper-middle income countries (85%).

To bridge that gap, companies need to start by measuring and reporting patient reach in order to identify the issues. The next step is to allocate resources to create strategies that are tailored to local needs and challenges. Collaboration with governments and charities and between industries will make the most of shared expertise and resources. [2, 9]

References

1.           Patients in low- and middle-income countries largely left out of clinical trials, limiting access to new treatments. Access to Medicine Foundation. Last accessed: 19 November 2024. Available from: https://accesstomedicinefoundation.org/resource/patients-in-low-and-middle-income-countries-largely-left-out-of-clinical-trails-limiting-access-to-new-treatments.

2.           Pharma companies are taking steps to address access in low-income countries, but significant gaps remain. Access to Medicine Foundation. Last accessed: 19 November 2024. Available from: https://accesstomedicinefoundation.org/resource/pharma-companies-are-taking-steps-to-address-access-in-low-income-countries-but-significant-gaps-remain.

3.           Essential medicines. World Health Organization. Last accessed: 25 September 2024. Available from: https://www.who.int/news-room/fact-sheets/detail/essential-medicines.

4.           Leisinger, K.M., L.F. Garabedian, and A.K. Wagner, Improving access to medicines in low and middle income countries: corporate responsibilities in context. South Med Rev, 2012. 5(2): p. 3-8.

5.           Novo Nordisk announces new partnership to supply human insulin to millions of people living with diabetes in the African continent. Novo Nordisk. Last accessed: 19 September 2023. Available from: https://www.novonordisk.com/news-and-media/latest-news/new-partnership-to-supply-human-insulin.html.

6.           ASPIRE: Our commitment to address health inequities in low- and middle-income countries. Bristol Myers Squibb. Last accessed: 22 May 2024. Available from: https://www.bms.com/life-and-science/news-and-perspectives/addressing-health-inequities-in-lmics-through-aspire.html.

7.           Pharma companies still not maximising their potential to reach more patients in low- and middle-income countries. Access to Medicine Foundation. Last accessed: 19 November 2024. Available from: https://accesstomedicinefoundation.org/news/pharma-companies-still-not-maximising-their-potential-to-reach-more-patients-in-low-and-middle-income-countries.

8.           Elvidge, S., Why Diverse Representation in Clinical Research Matters. Pharma Sources: An eye on the biopharma industry, 19 March 2024. Available from: http://www.avbaike.cn/industryinsights/why-diverse-representation-in-clinical-r-76347.html.

9.           Martínez, C., Patient centricity: How is the pharma industry addressing patient reach? Access to Medicine Foundation. September 2024. Available from: https://accesstomedicinefoundation.org/news/what-pharma-companies-can-do-to-ensure-their-products-reach-underserved-populations.

About the Author

Based in the north of England, Suzanne Elvidge is a freelance medical writer with a 30-year experience in journalism, feature writing, publishing, communications and PR. She has written features and news for a range of publications, including BioPharma Dive, Pharmaceutical Journal, Nature Biotechnology, Nature BioPharma Dealmakers, Nature InsideView and other Nature publications, to name just a few. She has also written in-depth reports and ebooks on a range of industry and disease topics for FirstWord, PharmaSources, and FierceMarkets. Suzanne became a freelancer in 2006, and she writes about pharmaceuticals, consumer healthcare and medicine, and the healthcare, pharmaceutical and biotechnology industries, for industry, science, healthcare professional and patient audiences.