Falsified medicines

Falsified medicines are fake medicines that pass themselves off as real, authorised medicines.

Falsified medicines may:

• contain ingredients of low quality or in the wrong doses;
• be deliberately and fraudulently mislabelled with respect to their identity or source;
• have fake packaging, the wrong ingredients, or low levels of the active ingredients.

Falsified medicines do not pass through the usual evaluation of quality, safety and efficacy, which is required for the European Union (EU) authorisation procedure. Because of this, they can be a health threat.

Increase in falsified medicines

Until recently, the most frequently falsified medicines in wealthy countries were expensive 'lifestyle' medicines, such as hormones, steroids and antihistamines. In developing countries, they have included medicines used to treat life-threatening conditions such as malaria, tuberculosis and HIV/AIDS.

The phenomenon of falsified medicines is on the increase, with more and more medicines now being falsified. These include expensive medicines, such as anti-cancer medicines, and medicines in high demand, such as antivirals.

Falsified vs. counterfeit medicines

Falsified medicines are not the same as counterfeit medicines:

• Falsified medicines are fake medicines that are designed to mimic real medicines;
• Counterfeit medicines are medicines that do not comply with intellectual-property rights or that infringe trademark law.

EU laws on falsified medicines

The EU has a strong legal framework for the licensing, manufacturing and distribution of medicines. At the end of the distribution chain, only licensed pharmacies and approved retailers are allowed to offer medicines for sale, including the legitimate sale via the internet.

In July 2011, the EU strengthened the protection of patients and consumers by adopting a new Directive on falsified medicines for human use.

This Directive aims to prevent falsified medicines entering the legal supply chain and reaching patients. It introduces harmonised safety and strengthened control measures across Europe by applying new measures, including:

• obligatory features on the outer packaging of medicines to demonstrate that they are authentic;
• strengthened requirements for the inspection of the manufacturers of pharmaceutical ingredients;
• the obligation for manufacturers and distributors to report any suspicion of falsified medicines;
• an obligatory logo that must be placed on the websites of legally operating online pharmacies, with a link to official national registers.

The Directive came into force on 21 July 2011. Member States will have to start applying these measures from January 2013.

Role of the European Medicines Agency

The European Medicines Agency is working closely with the European Commission and the EU Member States to implement this Directive.

This co-operation also includes the European Directorate for the Quality of Medicines and Healthcare (EDQM) and the World Health Organization's International Medical Products Anti-Counterfeiting Taskforce (IMPACT).

The Heads of Medicines Agencies have identified falsified medicines as being a key issue facing the European regulatory network for the five years to 2015. They have stressed that the enforcement of this legislation is the competency of Member States, but that co-ordination between the national and international bodies involved in fighting falsified and counterfeit medicines is necessary:

• A strategy for the Heads of Medicines Agencies, 2011-15

International co-operation

The protection of patients from the dangers of falsified and counterfeit medicines is a global effort. The Agency is also co-operating with international anti-counterfeiting trade agreements and other criminal-law instruments, such as the Council of Europe's Medicrime convention and the Organisation for Economic Co-operation and Development (OECD) project on counterfeiting and piracy.