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The Falsified Medicines Directive (2011/62/EU) (FMD) requires all EU countries to put in place proportionate, effective and dissuasive penalties for those involved in the production and circulation of falsified medicines. The report on how this requirement has been met shows a wide variation in penalties across the EU. For example, maximum prison sentences for the falsification of medicines range from one year (Sweden, Finland and Greece) to 15 years (Austria, Slovenia and Slovakia); and maximum fines range from 4300 € (Lithuania) to €1 million (Spain) and 'unlimited' (UK).
Vytenis Andriukaitis, Commissioner for Health and Food Safety, said "While the report published today finds measures taken by Member States to be satisfactory, penalties are only effective if they are well-enforced. I urge all EU countries to make sure that criminals falsifying medicines are punished. After all, falsified medicines can kill. The EU Directive includes several other measures to help citizens steer clear of falsified medicines, notably a common EU logo which helps consumers identify legal online pharmacies that sell authentic and safe products. I encourage all online shoppers to stay safe by looking out for the logo (see https://ec.europa.eu/health/human-use/eu-logo_en) and ensuring that an online pharmacy is legitimate before making a purchase."
Furthermore, as foreseen by the FMD, the Commission, Member States and stakeholders are working on a pan-EU authentication system for medicines scheduled to enter into force in February 2019. This means that the authenticity of prescription medicines will be checked before they are dispensed to patients.
Background
Falsified medicines, which can be ineffective, harmful or even deadly, are a serious threat to public health. A wide range of medicines are affected by this criminal practice, including treatments for cancer, sexual dysfunction and Hepatitis C. Falsified medicines can and do enter the EU supply chain. Between 2013 and 2017, more than 400 incidents, affecting most EU countries, were reported by the EU rapid alert network.
For more information:
- Commission Report COM(2018) 49 final
- Study on the transposition measures of Member States in relation to the pharmaceutical legislation
- EU action on falsified medicines
