Efforts taken by Europe’s key pharmaceutical supply chain players to secure the legal supply chain and protect patient safety are outlined below
Camilla Kent Hansen
European Federation of Pharmaceutical Industries and Associations (EFPIA),
The threat of counterfeit medicines is substantive and growing. Counterfeit medicines have been documented in every therapeutic category and in every region of the world. Recent cases of, for example, counterfeit oncology treatments underline the urgent need for action and stringent measures to protect patients worldwide.
In its annual report on EU Customs Enforcement of IPRs, released on 24 July 2012, the European Commission puts forth numbers and statistics clearly highlighting the increasing threat of counterfeit medicines entering the EU – with medicines appearing among the top categories of articles stopped by customs in 2011 (24%).(1)
The World Customs Organization (WCO), in its Customs & IPR Report of June 2012, brings forth additional statistics reinforcing the worrying trend. The report highlights in particular that there has been: (i) an increase in the seizures of counterfeit pharmaceutical products both with respect to the number of cases (33.1% increase) and to the quantity (129% increase); and (ii), an increase in counterfeit items moved by means of small parcels (55% increase in terms of seizures made at mail centres).(2)
To fight this growing threat to public health and enhance patient safety, EFPIA (European Federation of Pharmaceutical Industries & Associations), EAEPC (the European Licensed Parallel Distribution Industry), GIRP (Groupement International de la Répartition Pharmaceutique) and PGEU (Pharmaceutical Group of the European Union), the respective European organisations of research-based manufacturers, parallel distributors, wholesalers and pharmacists at EU level, have joined forces to secure pharmaceutical distribution through 2D barcoding at the level of secondary medicinal packaging. The four stakeholders are in regular dialogue with hospital pharmacies, represented by HOPE (European Hospital and Healthcare Federation) and EAHP (European Association of Hospital Pharmacists) and aspire to establish a more formal relationship, in order to ensure that all dispensing points are taken duly into account, including hospital pharmacies.
Protecting the legal supply chain: Falsified Medicines Directive
Following adoption by the Council and the European Parliament, the Falsified Medicines Directive (FMD; 2011/62/EU) was published on 1 July 2011 in the Official Journal of the European Union. It aims to prevent the entry of counterfeit medicines in the legal distribution chain, a major threat to public health and patient safety. One of the main concerns of the FMD is to increase responsibilities of all actors in the supply chain, for example, including wholesalers, community and hospital pharmacists and parallel distributors. To reach this goal, the European Commission asks for an EU-harmonised system of mandatory safety features for prescription-only medicines allowing verification of the authenticity and identification of individual packs by a ‘unique identifier’. Finally, the FMD calls for the application of tamper evidence to the outer packaging of individual medicine packs. The European Commission will define the mechanics of how this system will work in Delegated Acts that are to be adopted by mid 2014. The Delegated Acts will define the characteristics and technical specifications of the unique identifier, which will enable identification of individual packs, and the accessibility of national product databases or repositories to verify each dispensed pack.
At EU level, the FMD is an important step in better protecting patients from counterfeit medicines. Our objective, as ESM stakeholders, is to develop a system that provides a high level of security for patients while being cost effective and integrating into existing structures and practices in the distribution chain.
To this end, EAEPC, EFPIA, GIRP and PGEU have, since early 2011, been proactively engaged in developing a project to identify concrete options for establishing a system for the verification of pharmaceutical products in Europe to secure the legal supply chain, in compliance with the FMD. This pan- European product verification system is to be run by stakeholder organisations on a non-profit basis.
European Stakeholder Model
The EAEPC-EFPIA-GIRP-PGEU serialisation project, the European Stakeholder Model (ESM), ensures verification of product authenticity by professionals at the point of dispensing (Figure 1) and provides a modern technology solution, using 2D barcoding, that will enhance patient safety as well as having the potential to generate additional spillover benefits in the future. Potential advantages include the possibility of allowing for the automated checking of expiry dates, better pharmacovigilance, a reduction in the number of fraudulent reimbursement claims, higher effectiveness in preventing recalled products from being supplied to the patient, more efficient handling of product returns and improved stock management processes for pharmacies (Figure 2).
The project builds extensively on the experience gained from a previous EFPIA pilot, which ran successfully from September 2009 until February 2010 in Sweden. Key learnings from the pilot pertain amongst others to system availability and performance allowing the pharmacists to work at a normal pace and without any significant additional effort. The pilot used a 2D datamatrix encoded with a product code, serial number, batch number and expiry date. Amongst key takeaways, pharmacists expressed high interest in getting expiry date and batch number in machine-readable form, as this can facilitate product recalls, as well as prevent the dispensing of out-of-date medicines.
A number of issues are critical to the success of a product verification system at European level. Such a system must be robust, able to handle many thousands of queries simultaneously, and be based on harmonised standards. Fragmentation will limit the ability to verify a product’s provenance and may cause problems in identifying counterfeit products that cross borders.
The verification system proposed by EAEPC, EFPIA, GIRP and PGEU comprises a European hub connected to a series of national data repositories that serve as the verification platforms, which pharmacies and other registered parties can use to check a product’s authenticity (Figure 3). The system will be interoperable between the various countries and will allow for the reconciliation of products traded between EU Member States (known as parallel traded products) through the European hub. In addition, it will also offer those countries that do not want to set up their own national system the opportunity to join an existing product verification infrastructure (Figure 3).
The verification system incorporates the requirements set out in the FMD as regards repackaging of products for sale into other EU markets. Where a product is repackaged, the original serial number should be replaced in the database with a new one by the parallel distributor. The original and new packs should be linked electronically at the batch level in order to ensure that the product can be traced in the event of a safety issue arising or a recall. The proposed system should accommodate different needs in different regions, while being based on common principles to ensure mandatory coding and verification of products in line with a harmonised coding system.
Following our ESM joint submission to the European Commission public consultation on the Delegated Act for safety features (April this year), we are now looking forward to further engaging with interested parties such as additional supply chain actors, patients and national public authorities in order to explore opportunities for further collaboration.
In this respect, EFPIA and EAHP have recently stepped up communication with a view to jointly explore ways forward to ensure patient safety in hospital care under the ESM system. The two organisations have been and will continue exchanging information on a variety of issues in order to increase mutual understanding and advance patient safety in hospital care. Exchanges have so far evolved around the country-by-country practice of bedside scanning in European hospitals, the regulatory and non-regulatory solutions to the problem, and the opportunity for the ESM medicines verification system to facilitate single unit bar codes in the future. EFPIA recognises the potential for patient safety improvement that could be made by using medicines bar coding in this way, and we stand ready to cooperate with hospital pharmacists in exploring ways to achieve systematic single unit bar coding.
Global solutions for a global threat
EFPIA is actively following serialisation initiatives beyond the EU and stands ready to work in partnership with international stakeholders on establishing interoperable systems, based on internationally recognised standards such as GS1, securing the pharmaceutical supply chain in the interest of greater patient safety. It is important to note that serialisation can only help to protect the distribution chain against penetration of counterfeits when operating together with other measures that provide clarity and transparency over the roles and responsibilities of all players in the supply and distribution chain. Without these conditions being in place serialisation is unlikely to provide robust protection and may indeed introduce a false sense of security for patients.
At EFPIA, and within the ESM partnership, we are convinced that patient safety must come first. Using counterfeit medicine represents a health risk and there is therefore an inherent need to focus on ensuring that the supply chain is as safe as possible and encourage patients to buy from reliable sources. EFPIA is proactively engaged in ensuring patients have access to safe medicines.
- The threat of counterfeit medicines is substantive and growing and counterfeit medicines have been documented in every therapeutic category and in every region of the world.
- Following adoption by the Council and the European Parliament, the Falsified Medicines Directive (FMD) was published on 1 July 2011. It aims to prevent the entry of counterfeit medicines in the legal distribution chain, a major threat to public health and patient safety.
- To this end, EAEPC, EFPIA, GIRP and PGEU have, since early 2011, been proactively engaged in developing a project to identify concrete options for establishing a system for the verification of pharmaceutical products in Europe to secure the legal supply chain, in compliance with the FMD.
- Via a central European hub and based on internationally recognised standards, the ESM ensures interoperability across the EU.
- The ESM will apply to all EEA Member States, allowing for flexibility at national level to accommodate specific situations.
- The ESM is being built on thorough cost estimates and will, based on know-how from supply chain players involved, avoid gold-plating and set up the most cost-effective
- system for the benefit of patient safety.
- European Union. Report on EU Customs Enforcement of Intellectual Property Rights, 24 July 2012. http://ec.europa.eu/taxation_customs/resources/documents/customs/customs_controls/counterfeit_piracy/statistics/2012_ipr_statistics_en.pdf (accessed 5 November 2012).
- World Customs Organization. Customs and IPR report; July 2011.