Smart healthcare spending and the Falsified Medicines Directive in Europe

Home/Reports | Posted 06/11/2020 post-comment0 Post your comment

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a white paper on ‘Strengthening health systems through smart spending’ and a ‘Benefits beyond the EU Falsified Medicines Directive - The hospital setting’ report.

79 MD002389

Strengthening health systems through smart spending
The EFPIA’s white paper on bringing smart spending to health systems was published on 15 October 2020. It highlights that health systems are facing unprecedented challenges brought about by the COVID-19 pandemic, these are on top of ageing populations and the burden of chronic diseases. They need to be designed to meet healthcare demands in a way that is sustainable in the future.

Smart healthcare spending offers the opportunity to improve health outcomes without increasing overall costs. It also creates the potential for savings that can be reinvested. In light of this, EFPIA examined areas where good healthcare practices have improved outcomes for patients. For example, it identified that in the Basque Country, a screening programme for colorectal cancer has reduced the mortality rate by 26%. This has resulted in reduced treatment costs and net savings of Euros 93 million. An Office of Health Economics study highlighted that, if this success was replicated across Europe, this would correspond to an additional 331,000 healthy life years gained per year, and savings of Euros 9.9 billion. Such case studies are outlined in more detail in the white paper [1].

EFPIA have determined that, to achieve efficiency gains the plan should not be to cut budgets but to reinvest in innovation and higher-value care. To inform national and European policymakers of how smart spending and health system planning can improve outcomes while keeping the systems sustainable and flexible in order to respond to future challenges, EFPIA has developed a number of policy recommendations which are outlined in detail in their white paper. It notes that the way forward should see EU health systems: measure outcomes and publish data; improve care coordination, including through health data and digital health; promote efficiency through smart pharmaceutical spending; strengthen prevention, early detection and intervention, including health literacy; move to payment models that reward outcomes over volumes; integrate budgets across the care cycle; and share best practices.

EU Falsified Medicines Directive in the hospital setting
The EU Falsified Medicines Directive (FMD) legislation came into force in February 2019. It aims to prevent falsified products entering the supply chain and reaching patients. Implementation meant that prescription medicines now have two new features, a unique identifier (UI) and tamper evidence [2].

The FMD needed the development of IT systems that securely hold millions of UIs so that the medicines barcodes can be scanned, and UI verified. This led to the creation of the European Medicines Verification System (EMVS) which checks 160 million UIs per week and has successfully detected falsified products. 2D DataMatrix barcodes are now present on all prescription medicine packs in the EU and they contain four important pieces of data: product code, serial number, batch/lot and expiry date.

Now that the FMD has been in place for over a year, it has been possible to see how it is being implemented in hospitals. This has highlighted the challenges of implementation, particularly on an operational level, and also demonstrated how the new 2D DataMatrix is opening up opportunities for hospitals. For example, through hospital visits, it was possible to follow the flow of the product through the hospital supply chain. This showed benefits existing at all points; where the product is handled, stored and processed.

It has also now become clear that barcoding and product identification brings significant financial benefits to hospitals. For example, one hospital saved over Euros 4 million by reduced over-ordering products. These savings can offset the costs of implementing and operating the EU FMD.

The standardized 2D barcodes also increases patient safety as it impacts clinical effectiveness and new payment models. They also allow products to be digital web-enabled that provides live data and services directly to the healthcare provider.

With the EU FMD now firmly in place and helping to address the issue of falsified products, healthcare providers can continue to leverage 2D DataMatrix to bring additional benefits to the hospital setting.

Related articles
Country scorecards show biosimilar sustainability 

Government policies to maximize social benefit of biosimilars in countries with restricted access to biologicals

European Commission publishes new rules on falsified medicines

Falsified medicines law approved by European Parliament

1. EFPIA. Strengthening healthcare systems through smart spending [homepage on the Internet. [cited 2020 Nov 6]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. New safety requirements for EU-medicines []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 6]. Available from: 

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2020 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010