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.
At the European level, the Directive strengthens the effort to harmonize legislation for which the Medicrime Convention* was created in late 2010, the first legal instrument criminalizing fraudulent imitation as well as the manufacturing and distribution of medicines marketed without authorization or in violation of the safety standards.
Directive 2011/62/EU is broken down into several large measures that redefine prevention of introducing falsified medicinal products into the legal procurement chain, among which are the following:
- Introduction of a first definition of falsified medicinal product;
- Affixing of safety and traceability devices;
- Improved control of the distribution chain;
- New requirements concerning companies in the pharmaceutical sector and raw materials and excipients;
- Control and harmonization of the sale of medicines online.
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.
- its identity, including its wrapping and labelling, its name or its composition, and this on all of its components, including the excipients, and the dosage of these components;
- its source, relating to its manufacturer, its country of manufacturing, its country of origin or holder of the marketing authorization; or
- its history, including registrations and documents relative to the distribution circuits used.
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.
Information relating to the identification devices can be included in a mutualized data base, thus making it possible to detect a falsified code or a possible double reading that might cause one to suspect the presence of a falsified medicinal product.
The Directive is also aimed at one of the vectors of risk of falsification: parallel importers. Such importers, which are required to hold an authorization to import, must be ensured as to the authenticity and integrity of the product, on the one hand, and on the other affix a security device of a level equivalent to the original level. Unpacking/repacking of the inner packing will be subject to control by the competent authorities.
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.
- Be in possession of an authorization for wholesale distribution;
- Notify the intention to import the medicine to the holder of the marketing authorization and to the competent authority of the member State where the medicine will be imported;
- Ensure that the supplier meets the requirements of good distribution practices (or the requirements laid down by the Directive in case of activity in brokerage) and that the medicines are covered by a marketing authorization;
- Ensure that there is no falsification except, as the case may be, for brokers and inform the competent authorities in case of a falsified medicinal product;
- Have an emergency plan making it possible to recall falsified medicinal products.
As for the competent authorities, they must do as follows:
– Register the information bearing on the authorizations to work as wholesaler or broker;
– Control and inspect the suppliers and issue certificates of good distribution practices;
– Take measures aimed at preventing the circulation of falsified medicinal products.
5. NEW REQUIREMENTS CONCERNING RAW MATERIALS AND EXCIPIENTS
The Directive provides for improving the quality of the supply, manufacturing and distribution of raw materials.
- Upgrading the requirements on verifications applicable to the manufacturers of medicines: manufacturers are required to ensure: that European manufacturers, importers or distributors of the active substances used are registered with the competent authority of the member State in which they are established; that, through audits, the active substances used have been manufactured and distributed in keeping with the good manufacturing and distribution practices.
- Application of good manufacturing practices applied to the manufacturing of active substances in the European Union as well as in third countries exporting to the European market (practices equivalent at least to those of the European Union);
- Setting up of regular controls as well as repeated and unexpected inspections during which certificates of good practices for active substances can be issued;
- The manufacturer’s certificate of good practices for any new marketing authorization.
- that European manufacturers, importers or distributors of the active substances used are registered with the competent authority of the member State in which they are established;
- that, through audits, the active substances used have been manufactured and distributed in keeping with the good manufacturing and distribution practices.
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:
- Benefiting from authorization or approval to deliver medicines to the public, including from afar, in application of the national legislation of the country in which the natural person or the legal entity is established;
- Notifying information on the online pharmacy to the competent authorities of the member State (address of the Internet site, name and permanent address of the place of business from which the medicines are supplied, etc.);
- Conformity of the medicines with the national legislation of the Member State to which they are destined;
- Specifying on the Internet site the contact data of the competent authority;
- Adding a hypertext link to the website of the Member State;
The logo may appear elsewhere. We can also put a page with all the logos in all languages.
Furthermore, each Member State agrees to set up an official national register providing information on national legislation, the purpose of the logo, a list of online pharmacies, the Internet site and general information drawing attention to the risks linked to the falsification of medicines. These various websites, developed by the member States, will then be centralized by a parent site of the European Medicines Agency, which will provide the essential information bearing on the sale of medicines online.
In the fight against pharmaceutical crime, violations of control and harmonization of the sale of medicines online, as for any activity linked to falsified medicinal products, are liable to efficient, proportioned and dissuasive sanctions under the competence of the States.
The Directive calls for efficient and improved coordination and international cooperation, particularly in the area of distance selling, in order to increase the performance of strategies in the fight against fraudulent imitation. In particular, it provides for campaigns to inform and sensitize the general public as to the dangers of falsified medicinal products, the meaning of the common logo, the websites of the competent authorities and of the European Medicines Agency as well as the risks linked to falsified medicinal products provided illegally from afar.
7. HISTORY AND IMPLEMENTATION OF DIRECTIVE 2011/62/EU
28 November 2001: Publication of Directive 2001/83/EC instituting a Community-wide code on medicines for human use.
10 December 2008: Proposed directive on falsified medicinal products by the European Commission within the scope of the ‘European Pharmaceutical Package’.
15 February 2011: Vote on the Directive by the European Parliament.
27 May 2011: Adoption of the Directive by the European Council (without debate and without the support of Latvia).
8 June 2011: Signature by the European Parliament and by the Council in Strasbourg of Directive 2011/62/EU (amending Directive 2001/83/EC) instituting a Community-wide code on medicines for human use as concerns preventing introduction of falsified medicinal products into the legal supply chain.
1st July 2011: Publication of Directive 2011/62/EU in the Official Journal of the European Union.
20 July 2011: Coming into force of Directive 2011/62/EU.
18 November 2011: Proposed document for reflection submitted for public consultation by the European Commission: ‘Delegated act on the methods of a single identifier for medicines for human use and their verification’.
7 December 2011: Proposed document for reflection submitted for public consultation by the European Commission: ‘Implementation of the law on the requirements of evaluation of the regulatory framework applicable to the manufacturing of active substances of medicines for human use’.
20 January 2012: Proposed document for reflection submitted for public consultation by the European Commission: ‘Delegated act on the principles and guidelines of good manufacturing practices of the active substances of medicines for human use’.
2 January 2013: End of the period for transposition and application by the member States of the principal provisions (legislative, regulatory and administrative) necessary for compliance with the Directive.
2 July 2013: Implementation of the provisions relative to the principles and guidelines for good manufacturing practices of active substances.
2013-2014: Implementation of the Internet provisions (no more than one year following the date of publication of the implementing acts).
24 June 2014: Adoption of the Commission implementing regulation (EU) No 699/2014 of 24 June 2014, in conformance with the directive on falsified medicines (2011 / 62 / EU), on the design of the common logo to identify persons offering medicinal products for sale at a distance to the public.
1st July 2015: The logo applies.
2017: Implementation of the security devices in countries provided with an already existent system which is compatible.
2023: Implementation of the security devices in countries without an already existent system which is compatible (given the technical adaptations required for certain measures, member States have a period of up to five or six years at the latest after the application date of the delegated acts).
* See the file Medicrime Convention.
To go further
- DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 instituting a Community-wide code relative to medicines for human use. Official Journal of the European Communities. L311/67-L311/128. 28 November 2001.
- LEEM (Pharmaceutical Companies). The stakes of implementing the ‘Falsified Medicinal Products’ Directive. Circular No. 11-0464. 23 September 2011.
- – COMMISSION STAFF WORKING DOCUMENT accompanying document to the proposal for a Directive of the European Parliament and of the Council (Brussels, 10 December 2008, SEC (2008) 2674).
- – REPORT filed by the Commission of European Affairs on the medicines package (E 4184, E 4185, E 4186, E 4187 and E 4188) and presented by Ms Valérie Rosso-Debord, Deputy.
- – IMPACT STUDY of the bill on improved health security of medicines and health products, Social Questions and Health, July 2011 (text E 4188 ; COM – 2008 – 668 final).