WHO publishes guide for medicines traceability

Countries that intend to set up a traceability framework for medicinal products should focus on three main elements, according to new guidance from the World Health Organization (WHO).

First up is making sure that the governance process for the traceability system matches the capabilities of the supply chain operating in a country, taking into account issues like regulatory control capacity, how efficiently traceability information can be exchanged by trading partners, and data security.

Next is cost, i.e. who will foot the bill for implementing and maintaining the system. Some established schemes share the cost among stakeholders including medicine producers, e.g. the EU and US systems.

Other countries like Turkey and Korea have gone for a government model, while a third option – for instance, the system used in Russia – is a hybrid. The government sets up the system, but requires manufacturers to buy codes or other assets that allow their products to make use of the platform.

Thirdly, it is important to base the system on global standards for product identification, production identification, automatic identification, and data capture and data exchange to reduce set-up and operating system cost, says the WHO.

The policy paper – aimed at WHO member states – is designed to bring together the available knowledge around existing traceability systems to guide national regulatory authorities in their efforts implement medicines traceability and protect patients from falsified medicines.

The WHO also hopes the document will avoid variation in the requirements and standards deployed by member states.

The guide also advises that countries carry out a risk-benefit analysis early on in the process of setting up a traceability regulation – for example to gauge how it might affect the cost and availability of medicines – as well as a study of how the existing supply chain operates.

Any regulatory proposals should be published in draft form to allow stakeholders to comment on the plans, and it is helpful to carry out pilot studies to demonstrate the feasibility of the proposed approach.

"The world has never been better equipped to ensure the quality, safety and efficacy of medical products through to the "last mile" of the supply chain," says the document.

"Effective technologies, standards and tools to facilitate the traceability of medical products now exist with the potential for adoption in even resource-limited settings."

Expanding access to medicines, and fighting falsified and substandard drugs, is one of the WHO's top 10 urgent health challenges for the next 10 years.