Healthcare / Pharmaceutical

Software applications relating to the healthcare supply chain which promote the effective management of supply chain resources.

How Solidsoft Reply is helping make medicines safer across Europe

The FMD is new legislation passed by the European Union Parliament to improve the security of the medicine manufacturing process

Mark Usher (pictured)
Partner, Solidsoft Reply
How Solidsoft Reply is helping make medicines safer across Europe
The Falsified Medicines Directive (FMD) is new legislation passed by the European Union Parliament to improve the security of the medicine manufacturing process. Its aim is to protect patients across Europe by preventing counterfeit medicines from entering the pharmaceutical supply chain. Solidsoft Reply has helped several European countries prepare for the FMD.

To tell us more about Solidsoft Reply’s role, we sat down with Mark Usher, Partner at Solidsoft Reply.

About the FMD and EMVS
The European Medicines Verification System (EMVS) represents the pharmaceutical industry’s response to the European Union’s Falsified Medicines Directive (FMD). The FMD harmonizes legislation across Europe to protect 520 million European citizens from falsified and counterfeit medicines. Paid for by drug manufacturers, FMD calls for a European-wide system to detect, identify, and eliminate falsified medicines. The European Commission worked with pharmaceutical industry stakeholders to agree to an approach. In early 2016, additional legislation mandated the use of the EMVS.

Solidsoft Reply won the contract to build and operate the EMVS. Starting in February 2019, every pack of prescription medicine entering the European pharmaceutical supply chain must, by law, bear a unique identifier (a two-dimensional Data Matrix barcode). The EMVS verifies every pack identifier at the point where the pack dispenses. Every drug manufacturer, parallel distributor, wholesaler, hospital, and pharmacy operating across 32 nation states must connect to the EMVS.

Solidsoft Reply is part of the Reply group and is a Microsoft Gold certified partner. The organisation has over 20 years of experience in developing custom business applications and integration solutions with Microsoft BizTalk Server and the Microsoft Azure cloud platform.

What role did Solidsoft Reply play in the introduction of the FMD?
The FMD required the creation of a distributed database repository across Europe. Initially Solidsoft Reply worked with the European Federation of Pharmaceutical Industries and Associations to design and build the European Hub; a critical central component that allows manufacturers (and parallel distributers) of prescription drugs to upload their serialised product details. These details are then distributed to a network of connected National Data Repositories, depending on each product’s licensing agreements. The EMVO (European Medicines Verification Organisation) administers this system. Solidsoft Reply currently operates the European Hub on behalf of the EMVO.

Solidsoft Reply was also one of three National Blueprint System suppliers (approved by the EMVO) who were able to provide National Medicines Verification Systems to Europe’s 32 markets. Solidsoft Reply now operates systems on behalf of 13 countries.

They have also created a light-touch verification application; VeriLite, used by pharmacies (high street, hospital, dispensing doctors, and all healthcare organisations who dispense prescription drugs) and wholesalers, to fulfil the needs of the FMD’s delegated regulation.

The Microsoft Azure Cloud platform implements these systems, providing world class security, resilience and elasticity.

What territories did you coordinate?
Solidsoft Reply maintains and operates the European Medicines Verification System’s European-hub for the Belgium-based EMVO.

In addition, Solidsoft Reply operates and maintains National Systems for Iceland, Ireland, Switzerland, Liechtenstein, Denmark, Slovenia, the Czech Republic, Sweden, Lithuania, Croatia, Cyprus, Bulgaria and Malta.

VeriLite is live in the UK, Bulgaria, Iceland, Ireland, Denmark, Sweden and Cyprus. It will soon also be live in Netherlands, Slovakia, Spain, Norway and Finland.

What did that involve?
The provision of National Systems to the markets in Europe was competitive. It required Solidsoft Reply to enter and reply to multi-stage tendering processes in each European market. The process involved submitting detailed proposals, system presentations and competency demonstrations.

Solidsoft Reply won Microsoft’s first Cloud Partner of the Year Award for developing the EU-Hub in 2013/14. It won Microsoft’s Worldwide partner of the Year for Health this year (2018/19).

What does the FMD mean to European pharmaceutical suppliers?
The Delegated Regulation to the FMD (2011/62/EU) requires that pharmaceutical manufacturers place safety features on all prescription medicines. This means that from 9 February 2019 onwards, these medicines must contain a unique identifier in the form of a 2D data matrix barcode. These unique identifiers include a product ID, batch ID, serialised pack number and expiry date. They must also have an anti-tamper device on the physical pack.

Additionally, the stakeholder model obliges manufacturers to financially contribute to the establishment and continuation of the European Medicines Verification System.

What does it mean to consumers?
Consumers can be assured that before receiving a prescription drug that it has been checked. The packaging will have been checked for any indication of interference. The medicine will also have been digitally verified against the National Medicines Verification Systems. These authentication methods are designed to prevent falsified medicines from reaching patients.

What are the benefits and drawbacks we can expect to see from the FMD?
The risk of falsified medicines is growing on a global scale, as is the infiltration of falsified medicines in the European supply chain. Both pose a major threat to citizen health and security. Because of the implementation of the EMVS, over 10 billion packs of medicines dispensed each year will be able to be legitimately identified. This will combat the threat of counterfeit medicines.

The EMVS also notifies pharmacies when medicines have expired, been withdrawn, or previously marked as being stolen.

The system automatically identifies potential risks and alerts, which enables medication providers to launch their own investigations based on the information supplied by the EMVS.

Those who have supervisory rights for this system include:
  • National Medicine Verification Organisations
  • Central European Medicine Verification Organisation
  • Original manufacturer
  • Each market’s National Competent Authority

As the system provides direct improvements to public safety and other benefits, there are no real drawbacks to the system.

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