3.18 Counterfeit medicines – a threat against the patient safety
In large parts of the world, patients experience problems with counterfeit medicines. Counterfeit medicines are also called pirated copies or just counterfeits. Counterfeit medicines are often products with too much, too little, wrong or no active substance at all. At best, counterfeits have no serious consequences for the patient, but at worst their use might lead to death.
According to WHO the official definition of a counterfeit medicine is:”Deliberately and fraudulently mislabelled with respect to identity and/or source”. This means that a counterfeit medicine is produced without the consent of the original licensee, but will be sold as if it was the original product.
Until now no counterfeits are identified in the Danish authorized distribution channels e.g. at the pharmacy or other authorized distributors of medicinal products, but counterfeits have been found among products at pharmacies in our neighbouring countries in e.g. England, Germany and the Netherlands.
To buy products at Internet outlets is easy, quick and discrete. That is the reason why it is so popular to buy medicinal products on the Internet, but it might present a significant risk to your health. Very few distributors who sell pharmaceuticals on the internet are serious. WHO estimates that about 50 per cent of the pharmaceuticals that are sold at Internet outlets are counterfeit medicines. This trade is in the nature of organized crime, often with the same backers who manage the traffic with narcotics. It is very easy to buy pharmaceuticals on the Internet but also the same as gambling with your own life and money.
The trade of pharmaceuticals is often organized by use of spam mails. The American company MarkMonitor - the global leader in Internet fraud prevention and brand protection has examined 60 million spam mails offering the most popular products. In addition to products for men with erectile dysfunction (ED), they offered tranquilizers and antidepressant medicines. These spam mails were traced back to 110,000 advertisements that were showed on 11,000 web sites that were ran by 3,160 online pharmacies. Only four of these tuned out to be to legal distributors of medicinal products.
The trade with counterfeit medicines is an increasing problem both internationally and in Europe.
Therefore Lif takes actively part in national and international initiatives in order to secure that it is safe for patients to buy medicine through the authorized channels in the future. Lif thinks that we need an improved legislation, a close cooperation between stakeholders, an intensified supply chain and a safe identification of pharmaceuticals and safe traceability through the distribution network.
Lif believes:
- that it is important to maintain a safe supply chain for distribution of medicines, so that patients can by medicine safely.
- that internet commerce of medicinal products must be allowed only through certified Internet outlets.
- that patients are informed, on an ongoing basis, about the health risks associated with buying medicines on the Internet.
- High patient safety is provided on the condition that the authenticity of pharmaceuticals is verifiable in a safe way and that all links in the distribution chain should be traced back to the manufacturer. This is only obtainable through a prohibition of repacking of pharmaceuticals and use of a more safe and standardized coding of pharmaceuticals in Europe (2D matrix bar codes).
- that counterfeit medicines must be fought in close cooperation between authorities, pharmaceutical companies and distributors.
- A central unit should be established within the public sector. All stakeholders, also consumers communicate to this unit and all information about counterfeit medicines is available here.
- that regular spot checking is introduced in the authorized supply chain.
- That the maximum penalty for manufacturing and selling counterfeit medicines should be harmonised within the EU and be the same as for infringement of the Copyright Act. A more severe penalty will better reflect the health risks to which the citizens might be exposed and give the police access to personal data, letters, e-mails, telephone calls etc.
- The original licensee should demand a compensation corresponding to the violator’s profits from the sales of the medicinal product (instead of proving his/hers own loss) just as the rules for legal venue should be changed in order to be used in injunctions also (e.g. hawker's markets and fitness centres).
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