Authors: Alma D. Möller, Minister of Health, and Rúna Hauksdóttir Hvannberg, Director General of the Icelandic Medicines Agency

Earlier this year, customs authorities seized illegal peptides. Chemical analysis could not confirm the presence of the claimed active pharmaceutical ingredients in a large proportion of the samples. However, substantial impurities were found, as is common when products are manufactured under poor conditions. Using such medicines can cause a range of health problems, particularly when the substances are injected into the body.

This example confirms that people who buy medicines from unauthorised sellers cannot be certain that the product contains the substance stated on the packaging. The active substance may be present at a different strength from that stated, may be entirely absent, or the medicine may contain completely different substances in harmful quantities.

This was the case in the United Kingdom last autumn, when a woman bought what she believed to be an authorised weight-management medicine from a legitimate pharmaceutical manufacturer at a beauty salon. The injection pen instead contained insulin, and the woman died after injecting herself with it.

Medicines handled under unacceptable conditions

Martin Burman chairs the European Working Group of Enforcement Officers (WGEO), which monitors threats in the manufacture and distribution of medicines. He spoke at the Icelandic Medicines Agency’s anniversary symposium last November. The medicines most commonly falsified include narcotic and psychotropic medicines, controlled substances, cancer medicines, medicines for erectile dysfunction and, not least, weight-management medicines. These are all medicines that are expensive, in high demand, or both.

At the symposium, he described an operation in Sweden in the second half of last year that dismantled an extensive medicine manufacturing operation, with sales likely running into millions of euros. The substances were purchased from China, and injection vials were then prepared in an abandoned house in a forest under unacceptable conditions.

Around the same time, reports emerged of an illegal medicine factory in the United Kingdom producing diabetes and weight-management medicines on a large scale. The enforcement division of the UK Medicines and Healthcare products Regulatory Agency (MHRA) worked with police to seize a large stock of these medicines at the factory, along with an even larger stock of various raw materials and tens of thousands of empty injection pens.

Legitimate medicines sold illegally also pose risks

Medicines obtained lawfully are known to have been resold to third parties. Sought-after medicines are offered at prices below those generally charged by pharmacies, as are medicines subject to various prescribing restrictions.

Even medicines obtained from a pharmacy and subsequently sold illegally can be unsafe. Medicines are sensitive products, and correct handling and management are essential. For example, different medicines require different storage temperatures and humidity levels. Careless handling can alter their chemical composition, potentially causing harm. This is particularly relevant to injectable medicines, which bypass the body’s natural defences in the digestive tract or skin. Prescription-only medicines are also intended solely for the person for whom they were prescribed and may be unsafe for others.

Buying medicines legally online

European medicines agencies cooperate in various ways. One joint initiative is the common European logo for online medicine retailers. Under this system, each medicines agency authorises the legal sale of medicines online, subject to certain conditions. The Icelandic Medicines Agency’s website provides a list of pharmacies authorised to sell medicines online and explains how to check whether an online medicine retailer can be trusted. The common European logo is central to this process. It displays the flag of the country concerned, and clicking on it opens a list of pharmacies in that country authorised to sell medicines online. If the logo is absent from a website claiming to sell medicines, the sales are not legal. It should also be emphasised that selling medicines on social media is strictly prohibited.

Strict legislation and public awareness are essential

There are compelling reasons for strict legislation governing the manufacture, handling and sale of medicines. Medicines are not ordinary goods that can be freely traded in the world’s marketplaces. They may contain substances that can cause serious harm to health if used incorrectly. Medicines produced outside legal processes may even contain life-threatening substances. The manufacture and sale of medicines are therefore permitted only under the strict supervision of the medicines authorities in each country.

Falsified medicines pose a serious threat to health. Strong oversight to prevent them from reaching the market is vital, but the public must also be informed and aware of the risks of using medicines whose origin is unclear or unknown. People should only use medicines prescribed for them by a healthcare professional and obtained through safe channels. Using medicines bought from anyone other than an authorised seller is a dangerous gamble that can cause serious harm to health, as these examples demonstrate.