“Medical products should meet standards of quality, safety and efficacy. The quality of medical products is, however, a major public health concern to the World Health organization and its Member States… The illegitimate manufacture, distribution, widespread availability and indiscriminate use of substandard/spurious/falsely labelled/falsified/counterfeit medical products have serious consequences on public health.” Report of the regional taskforce on rpevention and control of substandard / surpios / falsely labelled / falsified / counterfeit medicines, WHO Regional Office for Africa, May 26, 2011.
Falsified medicines and Risks
Falsified medicines pose a direct risk to public’s health because they may contain insufficient or no active ingredients or excipients, or worse, because the ingredients that they contain are substandard and may contain impurities that are deleterious to human health.
Medicines counterfeiting (or falsification) presents a risk throughout the world that requires effective preventive responses. Indeed, there is a special need to prevent therapeutic drug falsification in order to safeguard against harm and maintain trust in doctors, pharmacists and other health professionals.
Legal Framework – EU Directive
Within the European Union, the phenomenon of falsifying medicines has reached an alarming level. From 2.4 million counterfeited pills in 2011, it has jumped to an estimated 20.7 million falsified pills in 2015. In this context and in order to meet this growing threat, the European Parliament and the Council worked out a new Directive (2011/62/EU). This EU directive contains several implementation measures (delegated acts, implementing acts, guidelines and reports) to be taken by the Commission. The Directive requires “safety features” on medicines packs enabling to identify individual packs and verify their authenticity. These safety features will be mandatory, from 9th February 2019, for most prescription-only medicine (OTC medicines excluded with some exceptions based on a risk assessment):
- Anti-Tamper Device on outer packaging, e.g. foil seal, breakable cap.
- Unique Identifiers which will be embedded in a Data-Matrix (2D barcode) on pack including some key data elements such as Manufacturer Product Code, Expiry date and Batch Number…etc.
These Unique identifiers for products placed on market will be stored in the European Medicines Verification System (EMVS) which will comprise: the European Hub and national / regional repository of those unique identifiers in each Member State.
IDMP and Implementation timelines
In a similar fashion, EU legislation is mandating the implementation of new data standards called Identification of Medicinal Products (IDMP). Compliance for IDMP is expected to begin soon and the next significant milestones is the publication of the EU implementation guides expected for 1Q/2Q 2017 and the implementation continue to evolve throughout 2017 and 2018 via iterative rollouts.
IDMP’s scope includes over 500 unique attributes that will enable consistent capture, communication, and exchange of product information among life sciences firms, global regulators, manufacturers, suppliers, and distributors. IDMPs allow for the unique identification of medicinal products on an international level by developing a method and process for generating global product identifiers that can then be used for product reconciliation and linkage across the entire product supply chain.
Some of these required identifiers are common with the FMD initiative requirements: Manufacturer Product Code, Expiry date and Batch Number, etc.
How best to take advantage of IDMP
Granted that the two initiatives will have some common key data requirements, the regulators and the pharmaceutical companies will have some benefits from the synergy between the two initiatives:
- The IDMP would be the natural repository for batch and pack data. Then the EMVS could extract all required master data from the IDMP source.
- Using the master data from IDMP means “no double entry” data which makes the EMVS more efficient.
However, the synergy could face some challenges:
- Agreement to use the same product codification for both systems.
- Timing: the full IDMP solution should be operational and the connection between the two systems implemented before Feb 2019.
Take home message
The IDMP will have a key role in the implementation of the EU Falsified Medicines Directive requirements and a positive effect on the pharmaceutical industry supply chain. Therefore, tackling these two initiatives in a synergistic and timely manner is crucial.