The EU is cracking down on the production and distribution of fake medicines that are a major threat to patients’ health.
The European Parliament on Wednesday agreed to the introduction of a directive on falsified medicines, set to come into force within two years, guaranteeing the origin and quality of the medication available in member states.
Falsified medicines are fake medicines that pass off as authentic and authorised, however, they may contain ingredients, including active ones, that are of poor quality or in the wrong dosage – either too high or too low.
Since they would not have passed through the necessary evaluation of quality, safety and efficacy as required by the EU authorisation procedure, they can be a major health threat.
Falsified medicines have nothing to do with counterfeit medicines, which are drugs that do not comply with EU law on intellectual and industrial property rights, such as registered trademarks or patent rights.
According to the new directive, an obligatory authenticity feature will be introduced on the outer packaging of all medicines and requirements for control and inspections of plants manufacturing active pharmaceutical ingredients will be introduced.
The directive also requires strict record keeping by EU wholesale distributors and introduces the obligation for manufacturers and distributors to report any suspicion of falsified medicines.
The directive imposes the introduction of a “trust mark” on websites of legally operating online pharmacies that sell medicines via the internet, a growing method of distributing false medicines. A click on the trust mark links the user to an official national register with a list of all legally operating pharmacies. If the user clicks again on the register, s/he is linked to the website of the legal online pharmacy.
However, the directive does not harmonise the rules and regulations for online pharmacies in the EU and the question of whether and how medicines can be sold over the internet remains a decision for each member state to take within the limits of the treaty.
Malta has no registered online pharmacies and the sale of medicines through the internet is not yet regulated. Sources close to importers said many Maltese patients were using the internet to buy medication.
“Since they buy from the EU, the goods are delivered to the individual’s address by the postman. However, few are aware that what they are buying could be counterfeit or false,” the sources said.
Welcoming the directive’s approval, the European Commissioner for Health and Consumer Affairs, John Dalli said this would increase the protection of EU citizens from the dangers of falsified medicines.
“Since falsified medicines may contain ingredients in the wrong dosage or no active ingredients at all, they are a serious public health risk in the EU. They have not been subject to an authorisation procedure where aspects of quality, safety and efficacy of the medicine are verified,” he said.
The EU has been witnessing a huge growth of this criminal activity, with a rise of 400 per cent in seizures of fake drugs since 2005.
It is estimated that one per cent of medicinal products sold to the European public through the legal supply chain are falsified and the share is growing. In other parts of the world, up to 30 per cent of the medicines on sale may be fake.