The World Health Organisation WHO defines counterfeit medicines as follows:
- A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect or identity and/or source. The fake information may relate to the composition and origins of the medicinal product or it can be in the form of mislabelling or other false information related to the product.
Counterfeit medicines are always health risks. The substances or other ingredients in a counterfeit product may be false, inefficient or outright dangerous. In the worst-case scenario, the counterfeit medicine may be lethal.
All medicine types are counterfeited
Counterfeit medicines are often well made. It may be impossible for the user to recognise a counterfeit based on the appearance of the product or its package. Therefore, it is always advisable to purchase the medicines in a safe place. Nicotine replacement therapy products can also be sold by authorised stores.
Authentic and legal medicines are never sold online at discount prices. If the offer sounds too good to be true – that is exactly what it is.
Counterfeits cause considerable damage
Counterfeit medicines constitute a serious health risk not only for the individual but also from the national health perspective. Moreover, anyone ordering medicines from an illegal online store is guilty of illegal importation of medicines. In 2015, the Customs recorded over 800 medicines-related offences or violations.
Besides the health risk, counterfeits
- undermine the consumers’ trust in medicine safety
- violate the pharmaceutical industry’s intellectual property rights, damaging its reputation
- decrease the country’s tax revenue as counterfeit medicines are sold outside the legal distribution channels.
The operations behind the counterfeit medicines are run by organised crime – similarly to the trading in doping agents and drugs. Counterfeit medicines constitute a lucrative business for the criminal organisations, with a small risk of getting caught. Through your own actions, you can make a difference and not generate demand for the counterfeits produced by criminals.
Legal distribution channels must be protected against counterfeits
The most alarming scenario is the entry of the counterfeits into the legal distribution channels. Work is done both nationally and internationally to prevent this. However, there are two known cases in Finland where a counterfeit cancer medicine was detected in the legal distribution chain. According to the authorities, the patients have not suffered any harm from the counterfeits.
The EU takes efforts to prevent the entry of counterfeits into the legal medicines distribution chain which includes the pharmaceutical plants, wholesalers and pharmacies. These actors have a permit granted by the Finnish Medicines Agency Fimea and are also covered by the controls of the authorities.
The medicines verification system improves patient safety
Based on an EU directive, the medicines verification system under construction will improve the medicines-related patient safety. The purpose of the system is to prevent counterfeit medicines from ending in consumer use through the legal distribution channels.
Once the system is introduced, medicine packages will have safety markings which make it possible to identify the packages throughout the distribution chain. The safety markings in the packages will also reveal if the package has been tampered with. An EU-wide database will be established for tracking the progress of the medicines in the distribution chain.
In line with the timetable set by the counterfeit medicines directive, the system will be introduced in Finland in February 2019.
EFPIA European Federation of Pharmaceutical Industries and Associations
The European Stakeholder Model (ESM)