The International Coalition of Medicines Regulatory Authorities (ICMRA) adopted on 25th October 2017 the new β€œRecommendations on alignment of existing and planned track and trace (T&T) systems to allow for interoperability”.

Interoperability is a central issue to reach an efficient operational flow along the entire life cycle of medicinal products. From the active ingredient entering the production plant to the distribution of the finished dosage form to the single patient, each step of the process has to be tracked and registered in order to ensure quality, reduce risks and achieve compliance. Interoperability is defined as β€œthe ability of T&T systems to exchange information and make use of the information received from other systems”. While track-and-trace systems are already requested from the regulatory point of view at the international level and as a mean to fight counterfeiting of medicines, there is still lack of uniform standards to develop them.

A still fragmented framework

The fragmentation is not limited to different systems put in place by different countries: it might occur also at the national level, where different authorities may implement different T&T systems. The result is the impossibility, or a lower capacity, to rapidly exchange relevant regulatory information among different authorities, something that might undermine the integrity of the supply chain and the protection of patient safety.

ICMRA recommends establishing β€œa common language among the supply chain regulatory and industry actors” in order to directly support β€œthe identification and management of risks associated with counterfeit or substandard health products” and improve pharmacovigilance. The Coalition identified supply-chain integrity as a priority in November 2015. The Annex to the Recommendations provides further details on the current implementation of T&T systems for medicines at the global level.

Issues and targets to achieve interoperability

The establishment of a minimal global set of technical features or standards should be the fundamental target to be pursued to achieve alignment of T&T systems and interoperability. A further issue highlighted by the document are the different rules governing confidentiality of business information and legal ownership of information, which may limit interoperability and transparency to be shared among different jurisdictions via T&T systems. ICMRA focused on the possible exchange of information only in cases where there is a serious threat to public health.

The Recommendations also discuss different types of T&T systems, i.e. full systems (which allow full traceability of the product transactions from beginning to end of its supply-chain, including the agents in the middle e.g. distributors), end-to-end systems (systems which allow verification of the product status only at the beginning and at the end of its supply-chain) and systems in-between (partial verification between the beginning and the end of its supply-chain, in addition to end-to-end).

Costs of development represent another barrier to implement T&T systems in some jurisdictions. Last, but no less important, a political consensus is needed to reach interoperability between T&T systems.

How to achieve the benefits of interoperability

The final goal is the traceability of products and batches throughout the global supply-chain, in order to minimise patients’ exposure to risks derived from defective products. Interoperable T&T systems would allow to track (in real time) movements of the product across different jurisdictions, something essential to identify the origin of quality and safety issues, to support pharmacovigilance or scrutiny of falsified incidents, and to inform mitigation measures. The management of drugs shortages might also benefit from interoperability.

Among the suggestions made by ICMRA is the standardization of the information present on packs of medicinal products. An International Common Product Identifier (independent from the name of the product in the different regions), the International Batch Number and the expiry date are the features that should always be present, while other information (e.g. serial numbers, reimbursement numbers etc.) can be included according to national/regional requirements. The Coalition suggests the use of ISO Identification of Medicinal Products (IDMP) standards to uniformly build the relevant information.

Data coding standards should also be common to different jurisdictions, and the same kind of data carrier should be used throughout the interoperable systems. An example of an economic solution suggested by the Recommendations to achieve this is the use of 2D data-matrix code.

The next steps

The needed consensus among ICMRA members, states the document, should be reached using the instrument of technical international fora to discuss common standards for T&T systems and identify technical solutions to enable interoperability. The Recommendations also suggest to better evaluating possible synergies with other related topics, such as big data and pharmacovigilance or the adoption of IDMP standards. The introduction of new technologies should be only a target for the future, but it is now essential to focus on already existing systems. To proceed towards these goals, ICMRA will identify a technical expert body that should address how to implement the principles described by the Recommendations.