Falsified medicines, also known as counterfeit medicine, are substandard or fake medicines that deliberately appear to be a genuine, authorised product. However falsified medicines have not been properly evaluated to confirm their safety, efficacy and quality, as required by European law, and may therefore be harmful. Their use could potentially poison you, or may mean your treatment does not work. In extreme cases they can cause death. They are always illegal.
Falsified medicines may be contaminated, may contain incorrect ingredients, or the ingredients may be correct but in the wrong dose. Some medicines look so similar to the genuine product that even healthcare professionals may be deceived. The only definitive way to tell the difference is for the packaging and ingredients to be analysed by the original manufacturer who holds the medical product licence.
Falsified medicines are found all over the world and are recognised by the WHO and EU institutions as a growing and serious threat as counterfeiters use ever more sophisticated means. Some people think that falsified medicines are limited to lifestyle drugs but this is not the case. Counterfeits include common prescription medicines such as Parkinson’s medications, antibiotics, and medicines for dementia as well as cancer for example.
The role of EAASM and ASOP EU
The European Alliance for Access to Safe Medicines (EAASM) is a not for profit patient safety organisation established in 2007 that works to ensure people are aware of unsafe medical practices and falsified, sub-standard medicines, and that national governments have put in place mechanisms to protect the population. The Alliance members include patient groups, pharmaceutical companies and other medical stakeholders involved in healthcare.
Established in 2014, the Alliance for Safe Online Pharmacy in the EU (ASOP EU) manifesto is “Together we will create an environment that enables patients to buy their medicines online safely”, where it is permitted by law.
ASOP EU consists of various groups: patient organisations, healthcare providers, pharmacists, pharmaceutical companies, distributors, wholesalers, parallel traders and online intermediaries (such as logistics and postal companies), internet service providers and platforms, search engines and financial service providers that transact payments. All participants are dedicated to increasing patient safety online and campaigning for tough action against illegal online pharmacies. It aims to make real and positive change to improve patient safety online, ensuring that Europe plays its important part in securing practical solutions to this growing global problem. ASOP EU is the sister company to ASOP Global which has other chapters and affiliations which can be seen in the company website under the Jurisdictions drop down box.
Why are falsified medicines so widespread?
A counterfeiter may make 2,000 times more profit from selling falsified medicines than would by selling Class A narcotics, with far less risk of capture or prosecution. The reality is, with 50,000 dollars’ worth of raw materials, tablet pressing, blister-packing and printing equipment – all easily available online – the counterfeiter is in business. Marketing is equally straightforward, with an attractive website easily drawing in vulnerable purchasers from across the world who are not aware that the medicines they will purchase will be falsified.
As to why falsified medicines are so widely purchased, it seems that the main reasons people go online to buy their medications include convenience, to save time and money, not realising that in so doing they risk their health whilst also supporting criminal activity whose proceeds may fund other more sinister crimes, such as terrorism.
It is impossible to accurately quantify the extent of falsified medicines. But it has been estimated that one percent of medicines in the developed world, including the USA and Europe, may be falsified, whilst in developing nations it has been suggested that between 10 percent and 50 percent of medications may be counterfeit.
Why is it dangerous to buy medicines on the internet?
When buying through an online pharmacy or medicines website, it is difficult to establish the authenticity of the website or its products. The internet knows no borders or boundaries. A counterfeiter in China can register a domain name in Chile, host it in Colombia, and bank in Grand Cayman, using a Canadian address and phone number (likely to be fictitious), designed to access the lucrative American market.
The sophistication, functionality and look of these websites can often be better than genuine medication sites.
Cases of patient harm
It is difficult to detect the extent of patient harm caused by falsified medicines. By nature the criminal wants repeat business and for some therapies it may be difficult to tell if there is a problem leading to longer term issues and lack of effective treatments.
Within the ASOP website, a very useful set of infographics covering the whole area of falsified medicines and patient information is available. Of particular concern is the catalogue of patients that have been harmed that can be found in the ASOP website factsheets section.
New EU legislation
A new piece of EU legislation called the Falsified Medicines Directive has been introduced. It features important elements regarding prescription medicines, namely:
- Active pharmaceutical ingredients to manufacture medicines are now more tightly controlled.
- Intermediary distributors now have to ensure that any changes to packaging be authenticated by a unique serial bar code on the prescription pack.
- The requirement for all EU Member States to allow medicines to be sold online; but any entity willing to do this must be registered and each page of their website must display a common logo such as the one below.
- As of 9 February 2019, each prescription medicine in all EU Member States must at point of production be given a unique and identifiable bar code that can be scanned at point of dispensing by the pharmacist. If the medicine is deemed not genuine then the supply stages are investigated to identify what the problem is.
However, this Directive is designed to protect the legitimate supply chain. It of course does not affect the websites that offer medicines that are not licensed in Europe; therefore, the unwitting patient is still vulnerable to being duped in to buying substandard or falsified medicines. It is then necessary to be extra vigilant.
Top tips for staying safe
Simple steps may help you avoid buying falsified medicines.
Check the packaging
- Familiarise yourself with every aspect of the packaging, the blister-pack (if there is one) and the medicine itself.
- Each time you renew your prescription, compare the packaging against your previous pack. You are looking for even the tiniest difference in clarity of print, colour, seals, etc.
- Check that the medicine is in date and that the dosage is correct. Check that it has a patient information leaflet in the correct language.
- If you notice any differences in appearance, report them to your pharmacist and your national regulator immediately.
Check the medicine
- Check carefully that it is consistent in colour and texture with your previous prescription. Does it crumble now, or did it before? Does the colour differ from your normal medicine?
- Be aware of the medicine smelling or tasting differently.
- Consider keeping a diary of effects or side effects. If your medicine does not seem to be working as normal or if you notice new (or absent) side effects, you must report these to your doctor as soon as possible.
You may also find this leaflet very useful as it provides concise and valuable advice about how to avoid buying a fake medicine online.
The chance of you receiving a falsified medicine is relatively small, but counterfeiting incidents are increasing at a rapid rate. The internet is a very risky way of buying your medicines unless you can be sure that the online pharmacy is genuine. By checking your medicines on a regular basis, you can reduce the risk of taking a falsified medicine.
Content last reviewed: January 2020
We would like to thank Mike Isles (Executive Director, EAASM) for his help in compiling this information