The production and trade of falsified medicines are a major threat to public health. The term 'falsified' is used to distinguish the issue from intellectual property rights violations, so-called 'counterfeits'.
Falsified medicines are a growing illegal business worldwide. From 2006-2009, the number of fake drugs seized at EU borders (not including drugs representing patent violations) tripled, reaching 7.5m items.
The problem used to be confined to 'lifestyle' medicines. But now, innovative and life-saving medicines (to fight heart disease, for example) are increasingly being falsified. They are also finding their way into the legal supply chain in the EU, meaning that the sale of falsified medicines is not limited to channels such as illegal online sales.
On 16 February, the European Parliament approved a law to fight falsified medicines that introduces harmonised, pan-European safety and control measures. The measures will ensure easier identification of falsified medicines, and tougher verifications and controls inside the EU and at its borders.
New measures include:
- obligatory safety features on medicines' outer packaging
- tougher requirements for control and inspections of plants manufacturing active pharmaceutical ingredients
- stricter record-keeping requirements for wholesale distributors
- stronger rules on inspections
- obligatory reporting by manufacturers and distributors of any suspected falsified medicines.
National governments and the Commission – following consultations with relevant stakeholders – will take the necessary measures to transpose and implement this new legislation.
