Public Health and Socio-Economic Impact of Substandard and Falsified Medical Products

Published on 12th December 2017

Quality medicines are essential to human health, and a vital part of every health system. Those of us who live in developed nations take it for granted that the medicines we use will do what we expect them to do. But in many parts of the world, buying medicine can be a risky business.

Low and middle income countries are hit the hardest, but this is a growing threat in wealthy countries too, because of the sale of substandard and falsified medicines over the internet. In other words, it’s a problem for all of us. Imagine taking a pill that you thought would save your life, only to get gradually sicker and die. This is an all-too-common reality.

In 2011, more than 200 patients died and 850 were hospitalized in Pakistan after taking contaminated heart medicine. In 2015, 11 people died and more than 1000 patients were hospitalized in the Democratic Republic of the Congo after taking falsified diazepam – a common sedative.

Substandard and falsified medicines undermine human health and weaken the health systems on which people rely. But they also undermine trust in health care and health professionals. When trust is compromised, people avoid seeking care when they need it, leading to longer-term problems for the individual and the health system. The scope and scale of this problem is notoriously difficult to estimate. Substandard and falsified medicines are hard to identify, and tough to trace.

Of almost 50,000 samples of products from 88 countries, about 1 in 10 in low-and middle-income countries is substandard or falsified. At best, these products do nothing but prolong sickness, waste money and erode hope. At worst, they kill, cause serious harm, and fan the flames of drug resistance.

It is especially concerning that the two classes of drugs that are most affected by substandard and falsified medicines are anti-malarials and antibiotics. People’s lives depend on these medicines. Artemisinin-based therapies are the backbone of the fight against malaria. They are also the last line of defense. If we lose the artemisinins, we will lose the gains we have made against malaria. But beginning in the Mekong, resistance to this class of drug has been growing for some years.

Substandard and falsified medicines are part of that story. Drugs that contain sub-therapeutic amounts of active ingredient pour fuel on the fire of resistance. The same is true for antibiotics.

Every year, people spend billions of dollars on substandard or falsified medical products. We know that the countries with the biggest burden of falsified and medical products are the same countries in which out-of-pocket health spending is greatest. So the people who spend money on medicines that either don’t work, or that actually harm them, are the people who can least afford it.

So why does this happen? For several reasons. The lack of access to affordable, quality medicine drives demand for substandard and falsified products. When people can’t get the drugs they need from reputable sources, or can’t afford them, they will go elsewhere. Many countries are also hampered by low levels of awareness about the threat of substandard and falsified medicines, even among health professionals. The lack of strong regulations, or the lack of enforcement of regulations, creates a legal vacuum that criminals are all-too happy to exploit. And the sale of medicines online creates a largely unregulated and invisible market.

So what can be done? We must take action on three fronts: we have to prevent, detect and respond.

First, we must prevent substandard and falsified medicines from reaching patients in the first place.  We need more awareness-raising campaigns to alert both the public and health professionals to this threat. We need to ensure the integrity of the supply chain, and eliminate opportunities for the wrong medicines to enter the system. And we need a strong legal framework so that police and customs officials have the tools they need to protect people.

Second, we must detect substandard and falsified medicines. This requires investments in stronger border controls, better reporting systems, smarter inspections, and greater access to laboratories and field screening equipment.

Thirdly, we have to respond, by issuing alerts and recalls when substandard and falsified products are detected; by strengthening regulations; and by making legal processes more transparent. Underpinning all of this, we need strong political will, and we have to work together. This is not just a health issue. It’s an issue that involves regulators, law enforcement, customs, logistics, and others.

We need political leaders to translate policy into concrete action, by committing the necessary human and financial resources. These commitments are not costs; they’re investments that protect businesses and markets, and the integrity of health systems. But more importantly, they’re investments in human capital.

By Dr Tedros Adhanom Ghebreyesus            

WHO Director-General.

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