The upcoming Global Fund Replenishment drive, 19-21 September, will be critical to holding onto and advancing progress against infectious diseases in multiple ways – among them ensuring the flow of quality-assured medicines to low-income countries and fighting falsified and substandard medicines that can comprise up to 70% of drugs on the market in some parts of Africa.

At Rwanda’s Kigali Summit on Malaria and Neglected Tropical Diseases (NTDs) held in June on the margins of the Commonwealth Heads of Government meeting, world leaders and representatives from the private sector, civil society organisations, philanthropists and trusts recommitted to combat the scourge of malaria and Neglected Tropical Diseases (NTDs).

Those commitments were made despite the unprecedented challenges facing the world from the COVID-19 pandemic, the war in Ukraine and the climate crisis.

Commitments are encouraging and important, but to deliver real progress in the fight against NTDs they must be backed by funding.

One of the biggest single-donor organisations in public health is the Global Fund to fight AIDs, Tuberculosis (TB) and Malaria, a partnership that has invested more than $55 billion to date to help defeat these three diseases and others in more than 100 countries through commodity procurement.

It has helped to strengthen health systems and provided support for specific programmes, helping save an estimated 44 million lives, mostly vulnerable people. This month, the Global Fund meets for its 7th funding replenishment from donor governments, and the outcome will have a decisive impact on global public health in the coming years.

Global Fund’s role fighting fake medicines is less well known

While the Global Fund’s work is familiar to many, perhaps less well known is its critical role in protecting patients from fake medicines. Only quality-assured medicines may be procured with Global Fund financing – those cleared by stringent regulatory authorities, the World Health Organisation’s Prequalification Programme, or Global Fund’s Expert Review Panel. 

Why does this matter? Simple: because counterfeits are a global problem. Estimates suggest that in some parts of Africa, up to 70% of all medicines may be falsified or substandard. The World Health Organization (WHO) says 1-in-10 medicines in lower-and middle-income countries (LMICs) are falsified or substandard, particularly in sub-Saharan Africa. And according to one field survey in South-East Asia, 53% of all antimalarials sampled did not contain the correct level of active ingredients.

These “medicines” can kill due to little to no active ingredients or toxic substances that are poisonous. If they don’t kill, they are likely to have little or no therapeutic impact. That results in additional morbidity from treatment failure and significant economic impact due to the costs of re-treatment, hospitalisation and lost working days.

Fake Medicines can also foster antimicrobial resistance

There have been too many preventable deaths caused by falsified and substandard medicines.

Falsified and substandard medicines can also facilitate the emergence of antimicrobial resistance through exposure of pathogens or parasites to sub-therapeutic doses of active pharmaceutical ingredients.

This is a very serious problem that can result in drug failure and potentially millions more deaths. Producing and distributing counterfeits is not a victimless crime. Perpetrators are perfectly aware of the likely consequences and are criminally responsible for deaths on a potentially vast scale. Children and vulnerable people are disproportionately affected.

Malaria medicines are among those most commonly counterfeited

Malaria control is one of the therapeutic areas most affected by falsified and substandard medicines.

A WHO-commissioned study found counterfeit malarials cause an additional 72,000 to 267,000 deaths every year in sub-Saharan Africa. At the same time, a 2019 review showed up to 155,000 children a year die from falsified or substandard antimalarial drugs – a staggering figure that seems to have passed almost unnoticed.

One cannot help but wonder what the public reaction would be in higher-income countries to a news headline such as this: “FAKE DRUG HORROR– 155,000 CHILDREN MURDERED.” Without a doubt it would capture the attention of news outlets and law enforcement agencies alike.

In reality, of course, there is no simple solution to this issue. Combatting this scourge requires coordinated efforts between regulators, law enforcement and customs agencies.

There must be stronger penalties for perpetrators, stronger regulatory systems, improved detection and verification technologies, better public and professional awareness of the issue, and action by drug manufacturers to incorporate anti-counterfeiting measures into packaging.

And all of these efforts need to be supported with adequate funding for effective, high-quality medicines.

Fake meds blocking achievement of the UN Sustainable Development Goals for 2030

One of the Sustainable Development Goals (SDGs), target 3.8, calls for “access to safe, effective, quality and affordable essential medicines and vaccines for all”.

The widespread availability of falsified and substandard medicines is a substantial and important barrier to the achievement of this goal in the immediate future, and adequate funding for quality medicines is an essential prerequisite if it is to be delivered.

Given that the Global Fund provides 56% of all international financing for malaria programmes alone, this is a critical safeguard against the scourge of counterfeits and reinforces the crucial importance of a full replenishment of its funding.

The estimated total financing need for HIV, TB and malaria for the 2024-26 timeframe is US$130.2 billion, of which at least US$18 billion needs to be funded by the Global Fund.

The minimum US$18 billion replenishment is, therefore, of huge importance, especially because the Global Fund only procures quality-assured medicines and medicinal products for low-and middle-income countries.

If the replenishment is not met in full, it increases the likelihood that countries will procure non-quality assured medicines. That raises the likelihood of falsified and substandard medicines reaching patients through formal or informal supply pathways.

This risks undermining the progress made so far in halting the progression of these diseases, and directly puts patients’ health and lives in jeopardy. With a successful replenishment, the Global Fund will also be able to increase its efforts to strengthen health systems more broadly over the next three years.

Given the extraordinary financial strains placed on national governments by the COVID-19 pandemic and the economic consequences of the Ukraine war, it is understandable that governments have competing priorities and domestic pressures that may be viewed as more urgent than international aid and supporting the Global Fund.

Nevertheless, disruptions caused by the pandemic to the legal supply chains and limited regulatory enforcement helped spawn a surge in fake medicines, according to the Organization for Economic Co-operation and Development. Interventions to support the fight against HIV, TB and malaria (stronger health systems, improved disease surveillance, more health care worker training, improved laboratory capacity for diagnosis, etc.) are also the foundation of future pandemic preparedness.

Resourcing the battle against these diseases is also, therefore, equivalent to resourcing future health crisis readiness. And since pandemics, by definition, affect us all, this should be viewed as investment in future global health.

Climate change is already affecting virtually every part of the world, with more extreme weather events recorded across our planet. The already record levels of internally displaced people and refugees will increase, and poverty, food and water insecurity will create immense negative pressures on health, increasing the risk of future pandemics and altering the dynamics of diseases such as HIV, TB and malaria. Between 2030 and 2050, climate change is expected to cause approximately 250 000 additional deaths a year, including 60,000 from malaria alone.

Business as usual is no longer good enough

Someone far wiser than I once said: “Do what you’ve always done, and you’ll get what you’ve always got”. Business as usual isn’t going to cut it in the interconnected set of challenges posed by climate change, emerging pandemics and global public health that we will face over the coming years and decades.

Neither is merely “responding” good enough – proactive planning and preemptive interventions are going to be crucial.

That’s why the Fight the Fakes Alliance strongly endorses the Global Fund’s philosophy of a “One Health” ethos that envisions an integrated approach: “… positioning human health interventions within the context of a broader planetary health agenda, encompassing animal, human, plant health and the shared environment.”

The question is not whether the world can afford to, but rather if we can afford not to support the crucial public health programmes that are financed by the Global Fund. Public health investments in LMICs have a direct impact on the quality of life in developed and high-income countries too. We are all in this together.

As the global health challenges we face together continue to grow, so does the opportunity for counterfeiters and criminals.

While the market size for fakes medicines is, by its very nature, difficult to quantify accurately, it is worth an estimated US$70-$200 billion. During a single operation (Action Against Counterfeit and Illicit Medicines, ACIM) carried out in 16 African countries in 2016, 113 million “suspect” medicines worth an estimated €52 million were seized over a 10-day period.

Increased public awareness of the issue is clearly essential, and one positive consequence of the COVID-19 pandemic is the attention it brought to the problem of falsified and substandard medicines and PPE, including masks, gloves, hydroxychloroquine and vaccines.

Almost any pharmaceutical product can be falsified, but those used to treat malaria, tuberculosis and HIV/AIDS are amongst the most widely abused. For this reason, the Fight the Fakes Alliance calls upon governments to be bold and increase pledges so the global programmes to tackle HIV, TB and malaria are fully funded. That will help avoid millions of preventable deaths, accomplish the SDGs, and ensure preparedness for future health crises.

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The author of this article is Chair of the Fight the Fakes Alliance (commonly referred to as ‘Fight the Fakes’), a multi-stakeholder non-profit association based in Geneva, Switzerland, that aims to raise awareness and influence change about the proliferation of falsified and substandard medicines. He is also Senior Director, Access & Product Management at Medicines for Malaria Venture, a leading product development partnership engaged in the discovery, development and delivery of novel antimalarials.

 

 

Image Credits: The Global Fund , WHO Medical Product Alert 10/2019, Pyzik, O.Z., Abubakar, I. Fighting the fakes: tackling substandard and falsified medicines. Nat Rev Dis Primers 8, 55 (2022)., Emmanuel Museruka/ MMV.