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Introduction to the Drug Living Lab

Supply chain security and control are key issues for the pharmaceutical industry. Counterfeit drugs have been recognised as a serious public health risk, while regulatory requirements constantly increase the administrative burden and cost to all. The question is how to enhance the security and control of complex pharmaceutical supply chains, while also reducing administrative red tape and facilitating trade.

The ITAIDE Drug Living Laboratory

Register your interest in the ITAIDE Drug Living Lab here

A number of technical building blocks have been developed in order to strengthen supply chain security, reduce risk exposure and support product tracking and authentication processes. These include product serialisation and authentication on a single drug level, using e.g. a digital copy detection pattern, smart and secure labelling, based on RFID or 2-D bar codes, as well as an information infrastructure to check products, serial numbers or labels. Although these technical building blocks are in place, the pharmaceutical sector has yet to produce a co-ordinated response to the stringent compliance issues and the threat posed by counterfeit drugs. No single player can solve the problem. What is needed is an industry-wide, inter-organisational approach, involving the co-ordinated action of a large number of stakeholders, including industry, governmental and third party representatives.

A Co-ordinated Response

The ITAIDE Project investigates these issues through the Drug Living Lab. The Drug Living Lab is a pilot project set up to study the feasibility of innovative technologies in a live pharmaceutical supply-chain setting. The Living Lab involves multiple stakeholders, including pharmaceutical producers, warehousing and distribution operators, distributors, shipping companies, wholesalers and pharmacies, alongside technology providers and operators. The Living Lab also includes governmental agencies such as customs, taxation and health authorities.

What is the Drug Living Lab?

The Drug Living Lab is an experimental pilot project that uses innovative technologies (e.g. package & container security, tracking devices, electronic invoices and data pools) in real world settings, in order to develop secure distribution channels and simplified electronic customs procedures for the pharmaceutical industry. The project brings together multiple stakeholders, drawn from the pharmaceutical sector, governmental agencies and third party providers, to explore:

  • Linking technical building blocks with ongoing standardisation activities involving key standardisation organisations such as UN/CEFACT and GS1
  • Interoperation with existing systems (ERP, customs systems) and third party services and products
  • Extending tracking and tracing capabilities by building an information infrastructure for continuous monitoring of the flow of (selected) pharmaceutical products
  • The design and development of inter-organisational control procedures
  • To demonstrate how supply chains in the pharmaceutical sector can be redesigned to maximise security and control, while minimising the administrative burden on individuals and organisations.

What happens next?

The Drug Living Lab is organising a series of workshops and site surveys to scope the ‘as is’ situation in the industry, with particular emphasis on shipping, logistics and compliance issues. The ‘as is’ situation will be used to identify and define secure exchange and administrative challenges for partners taking part in the Drug Living Lab demonstrator.

Workshops involve partners collaborating on the application, and further development, of Drug Living Lab technology. Partners invited to take part in the workshops will gain advance knowledge of the impact and adaptations necessary to operate in a secure pharmaceutical supply chain.

The Drug Living Lab also hosts briefing sessions for industry and communities with interests in pharmaceutical anti-counterfeiting initiatives.

The Drug Living Lab briefing document is available online here.

The Drug Living Lab is co-ordinated by University College Dublin and the University of Muenster. They are working with SAP and other technology partners, representatives of national customs and taxation bodies, standards organisations, pharmaceutical companies, third party organisations and representative groups in order to mobilise collective action on the issues of supply chain security and the reduction of risk exposure.