Falsified medicines are fake medicines that pass themselves off as real, authorised medicines. The European Union (EU) has a strong legal framework for the licensing, manufacturing and distribution of medicines, centred around the Directive on falsified medicines for human use, so that only licensed pharmacies and approved retailers are allowed to offer medicines for sale, including legitimate sale via the internet. The European Medicines Agency is working closely with its partners on the implementation of these laws.
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 that is required for the 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 anticancer 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.
The Directive came into force on 21 July 2011. Member States had to start applying its measures in January 2013.
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, which can be grouped into four main pillars:
1. Safety features of medicines
On 9 February 2016, the European Commission published a delegated regulation (Commission Delegated Regulation (EU) 2016/161) that introduces two safety features to be placed on the packaging of most human medicines: a unique identifier (a 2-dimension barcode) and an anti-tampering device. Marketing authorisation holders must place these on the packaging of most prescription medicines and certain non-prescription medicines no later than 9 February 2019. The annexes of the regulation include the list of medicines subject to the new requirement.
These safety features will guarantee medicine authenticity for the benefit of patients and businesses, and will strengthen the security of the medicine supply chain, from manufacturers to distributors, pharmacies and hospitals.
EMA and the European Commission have prepared an implementation plan, including regulatory requirements and timelines, to guide applicants and marketing authorisation holders of centrally authorised medicines in meeting the requirements:
- Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human use
EMA has revised the product information templates for human medicines to enable companies to implement the new rules.
2. Supply chain and good distribution practice
The Directive introduces new responsibilities for wholesalers and a definition of brokering activities as well as new responsibilities for brokers. The Agency's revised good-distribution-practice guideline includes specific provisions for brokering activities.
The EudraGMDP database now also includes information on good distribution practice (GDP).
3. Active substances and excipients
From July 2013, all active substances manufactured outside the EU and imported into the EU have had to be accompanied by a written confirmation from the regulatory authority of the exporting country.
These statements are issued per manufacturing site and per active substance and ensure that standards of good manufacturing practice (GMP) equivalent to those in force in the EU are upheld. A number of countries have already committed to issuing written confirmations.
Exporting countries with an 'equivalent' regulatory framework will not need to issue these written confirmations. The European Commission, together with the Agency and Member States, is assessing the regulatory frameworks of countries applying for 'equivalent' status.
The European Commission maintains a webpage detailing the status of the requests received: Quality of medicines and GMP.
4. Internet sales
The Directive has introduced an obligatory logo that will appear on the websites of legally operating online pharmacies and approved retailers in the EU.
The logo will allow patients and consumers to identify authorised online pharmacies and approved retailers providing authentic, authorised medicines. Clicking on the logo will link to the national regulatory authority websites, where all legally operating online pharmacies and approved retailers in their respective countries will be listed.
For more information, see Buying medicines online.
The Implementing Regulation establishing the new logo entered into force in July 2014, giving Member States until July 2015 to prepare for its application.
Once the Regulation has been implemented, Member States will conduct campaigns to raise awareness of the logo and the dangers of falsified medicines.
- For more information, see EU logo for online sale of medicines.
Role of the Agency
The Agency is working closely with the European Commission and the EU Member States to implement this Directive.
This cooperation 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:
The Agency is also cooperating 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.
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