Falsified Medicines Directive prescribes mandatory, harmonised European safety features on all human, prescription medicines packs (with certain risk-based exceptions). These safety features shall consist of a unique identifier combined with an anti-tampering device for each pack. The information about the safety features will be stored in a database and each pack must be verified in connection with dispensing to the customer/patient. The goal is to prevent falsified medicines from reaching patients through the legal supply chain.
The European Falsified Medicines Directive prescribes mandatory, harmonised European safety features on all prescription medicinal products (with certain risk-based exceptions). These safety features shall consist of a unique identifier combined with an anti-tampering device for each pack. The information about the safety features will be stored in a database and each pack must be verified in connection with dispensing to the customer/patient. The goal is to prevent falsified medicines from reaching patients through the legal supply chain.
The Delegated Regulation that defines in detail how the system will work was published in the Official Journal of the European Union (OJ) on February 9, 2016. It becomes legally binding three years later on February 9, 2019.
The pan-European system will consist of national databases, essentially one for each member country, that the pharmacies (and other participants) will use for verification purposes to ensure the authenticity of each pack. The national databases will be linked via a “hub” (European Hub) that serves as a router for the information in the various systems and cost-effectively enables communication between them. Consequently the system will be able to handle packs that are common to multiple markets, safeguard the integrity of parallel trade and be an efficient aid during drug recalls.
Based on a joint Memorandum of Understanding, the European organisations for research-based pharmaceutical companies (EFPIA), generic pharmaceutical companies (Medicines for Europe), parallel importers (EAECP), pharmacies (PGEU) and pharmaceutical wholesalers (GIRP), have promoted a model called the European Stakeholder Model (ESM), in order for e-verification in the European market to be cost-efficiently handled and integrate with the processes in the established supply chain. The ESM is consistent with the requirements of the Regulation.
As a result of working with the ESM, the European Hub was established and is now operational, along with the non-profit management organisation, the European Medicines Verification Organization (EMVO).
The “Blueprint” concept was also developed within the ESM. This standardized national system, which features all functionality needed to meet the requirements of the Directive, can be supplemented if necessary to meet the specific needs of different countries. This approach offers substantial cost benefits compared with each country developing its own national system.
The regulation requires the national systems to be established and controlled by manufacturers and marketing authorization holders (MAH) in consultation with other stakeholders and relevant authorities. The pharmaceutical industry is responsible for the cost of the databases under the Directive (Article 54a-e). A national non-profit management organisation will be established (National Medicines Verification Organisation, NMVO).
Each European country will determine how electronic verification in accordance with the Directive and the delegated act will be implemented in their own country. Relevant national authorities will also have oversight of the system.
Implementation of e-verification in Sweden
In Sweden, a Stakeholder Group has been working on deployment of electronic verification for several years. A Memorandum of Understanding (MOU) between LIF (The research-based pharmacy companies), Läkemedelsdistributörsföreningen, LDF (The Wholesalers Association), Läkemedelshandlarna (The Parallel traders Association) and Sv AF (the Pharmacy Association) was drafted in 2013 and revised in 2015, at which time FGL (Swedish Generic Medicines and Biosimilars Association) also became involved. In 2013 a decision was taken to choose Blueprint for Sweden. An implementation project started in the spring of 2015.
All of the key functions, such as data security, are specified by EMVO for the Blueprint solution that we chose in Sweden. Ensuring that only authorized users gain access to the system and that users are securely authenticated is naturally of utmost importance and will be specified in Standard Operating Procedures. The regulation does not require the national system to handle personal data and we prefer a design that ensures that this is not the case. Based on these grounds, the project defined some objectives for the Swedish system:
- Users must be logged in through a secure interface (API) where the information about the user is kept in the client’s system, for example in the pharmacy
- A graphical interface (GUI) will be available for emergency use and for the use of the NCA
- Administration of user information within the Swedish organisation should be avoided if possible
- Information about safety features and other interactions that the manufacturers need to carry out will be uploaded via the European Hub. Manufacturers should not have any direct access to the national IT system
These objectives have been evaluated technically, as part of the discussion with suppliers, in terms of the legal interpretation of the Regulation, and taking into account the views and existing workflows of various stakeholders.
3 January 2019