EUROPEAN DIRECTIVE ‘FALSIFIED MEDICINAL PRODUCTS’
In May 2011, the European Council adopted a new Directive aimed at guaranteeing a high level of protection for public health against falsified medicinal products.
Amending Directive 2001/83/EC, Directive 2011/62/EU institutes ‘a Community-wide code on medicines for human use aimed at preventing the introduction of falsified medicinal products into the chain of legal procurement’. By means of harmonized measures of controls and security at the borders and within the European Union, the Directive will make it possible to facilitate detection of falsified medicinal products, improve the quality of verifications and controls of the chain of production and distribution in order, in the end, to avoid introduction of falsified products into the legal chain of medicines. It also includes new requirements to be met by online pharmacies, and this in order to counter the illegal sale of medicines through the Internet.
1. THE CONTEXT FOR IMPLEMENTATION OF DIRECTIVE 2011/62/EU OF 8 JUNE 2011
Within the European Union, the phenomenon of falsifying medicines has reached an alarming level. Falsified medicinal products reach the patient not only through networks of illegal distribution but are also introduced into the legal chain of procurement, thus constituting a serious threat for public health.
2. FIRST DEFINITION OF FALSIFIED MEDICINAL PRODUCT
Directive 2011/62/EU provides a first definition of falsified medicinal product and distinguishes clearly between the following:
- ‘counterfeited’ medicine designates a medicine which is not compliant with the legislation of the European Union as regards intellectual and industrial property rights, particularly registered trade names and patents. The notion of falsified medicinal product is thus released from intellectual property in order to focus on the false medicine and its dangers for public health;
- licit medicine containing unintentional defects of quality attributable to errors of manufacturing or distribution.
3. AFFIXING OF SECURITY AND TRACEABILITY DEVICES
In order to verify the authenticity and identification of individual boxes of medicines and to verify whether the outer packaging has been violated, the Directive provides for affixing devices for security and inviolability. The obligation to affix these security devices on the packaging applies to all medicines delivered on prescription, barring exceptions (in cases in which evaluation makes it possible to demonstrate the innocuousness of the product in question). In principle, non-prescription drugs will be exempt from this mention of authenticity, and this due to their low risk of falsification.
4. IMPROVED CONTROL OF THE DISTRIBUTION CHAIN
The Directive lays down new requirements for improving the distribution chain and is now aimed at a new player: the broker who takes part in transactions but without entering into physical contact with the medicines.
5. NEW REQUIREMENTS CONCERNING RAW MATERIALS AND EXCIPIENTS
The Directive provides for improving the quality of the supply, manufacturing and distribution of raw materials.
6. CONTROL AND HARMONISATION OF THE SALE OF MEDICINES ONLINE
In order to counter the illegal sale of medicines to the public through the Internet, a major threat for public health, the Directive includes the minimal conditions to be met by online pharmacies to be authorized so as to engage in distance selling: