In this article, Mark Usher of Solidsoft Reply, explains the challenges of deploying multiple connected national systems for the large-scale European pharmaceutical industry.
Challenging scale
Computer systems are never simple but when the application needs to scale to facilitate the entire EU it needs a special kind of management, especially if this applies to falsified medicines, which have been infiltrating the supply chain for years.
Fighting back — the EU FMD
Falsified or counterfeit medicines represent a serious threat to public health and target those in society who are already in need. The pharmaceutical industry has decided to fight back and has created a stakeholder model that has been enshrined in law by an EU delegated regulation to a falsified medicines directive that was finally published in February 2016.
The delegated regulation places a number of obligations on all stakeholders in the supply chain, including the requirement to add tamper proof safety features to all prescription medicines and to establish a European wide verification system that will allow the authenticity of the medicine to be determined before dispensing to the public.
European hub
To fight the problem, Solidsoft Reply on behalf of the European Medicines Verification Organisation, NMVO, decided to build a European hub — a data hub where medicine manufacturers and parallel traders can upload their product, batch and pack data. The hub’s responsibility is to route the data to all the connected national systems in which the product is licensed to be sold. Solidsoft Reply are also one of three national blueprint system providers that have been endorsed by the NMVO and are able to provide the national repository systems to the individual EU nation states.
One of the main challenges is that the hub alone needs to process over 10 billion packs of medicines on an annual basis and distributes this data to over 25 national systems. The system is further complicated by the fact that many medicines are licensed to be sold in multiple markets: Luxembourg is an example where the majority of their medicines are imported from markets other than their own.
Both the Solidsoft Reply European hub and their national blueprint system have been built to create enterprise class application that automatically scale to meet the demands of the users. The system has been built as a modern application suite using micro services, creating a robust, always-on service. In addition, the application is restricted to run only on Microsoft data centres within the EU boundary to comply with the EEU directive.
Key to the success of the system rollout is Solidsoft Reply’s partnership approach with existing pharmaceutical and wholesaler IT system vendor, as it was important to not disrupt an already mature ecosystem of IT system providers in each country. The implemented system allows the verification functionality to be accessed via a secure interface, and the current IT system suppliers are an integral part of the nation’s programme. Itis important to ensure that they have all the technical resources they need to adapt their existing applications.
NMVO implementation
Each EU nation will create its own national medicines verification organisation (NMVO). It’s the responsibility of the NMVO’s to select a blueprint supplier and to ensure that the stakeholders adopt the system. The delegated regulation mandate that each nation must be fully operational by 9 February 2019. Solidsoft Reply’s implementation programme includes a pilot period before ramping up adoption, to ensure that the newly formed operation is running smoothly.
Solidsoft Reply are also participating jointly with NMVO’s to promote awareness of the national programme to all stakeholders to ensure everyone understands their role in what is a significant undertaking across all of the EU.