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Safe and Readily Authenticated Pharmaceutical dosage forms (tablets)

Periodic Reporting for period 1 - SRAP (Safe and Readily Authenticated Pharmaceutical dosage forms (tablets))

Reporting period: 2018-04-01 to 2018-09-30

Counterfeit medicines are estimated to cost the EU-pharmaceutical sector over €10 billion per year and the problem is growing significantly each year. These falsified products form a major threat to public health and safety. Furthermore, this illicit business is often controlled by criminal organisations. New serialization methods being applied with the aim to counter the threat within the EU (Falsified Medicines Directive, FMD) and elsewhere are known to provide NO TRUE authentication on the product level and are using printed codes that are open to copying. As a result, genuine items cannot be reliably authenticated along the supply chain. An opportunity to solve this problem is presented by the use of new technology and related products/solutions that truly authenticate pharmaceutical products by creating a link between the physical properties of the product itself and the codes printed on the packaging. This SRAP technology from nano4U is highly secure, and SRAP tools are available to authenticate products anywhere in the world even with a mobile phone and without the requirement of an online connection. Having fast, simple access to reliable authentication on the product level (and not just the packaging level) has the potential to greatly increase the safety and security of pharmaceutical products. The fact that SRAP does not introduce any additional materials such as taggants will help market entry for SRAP-solutions into a highly regulated industry. SRAP also allows medicines to be authenticated whilst still in the packaging. Phase 1 of this project has involved interviewing close to 20 pharmaceutical companies to better understand the needs in the context of bringing SRAP to the commercial market.
This SME-Instrument Phase 1 SRAP-project (Feasibility Phase) involved speaking with close to 20 companies using a specifically developed interview questionnaire to gather relevant information regarding the needs that these companies see in bringing new authentication methods to the commercial market, analyzing the input from these discussions, establishing typical terms of reference for future SRAP implementation projects and also an initial summary business plan. We furthermore evaluated the options for the building-up of a demonstrator in the context of a future SME-Instrument Phase 2 project.
SRAP's progress beyond the state-of-the-art is very significant as it is the only authentication system capable of verifying product along the supply chain in a non-destructive manner. SRAP's impact at EU level (and worldwide) can be massive in the sense that it is a widely shared opinion in this industry that up to 1% (some even think up to 2% or more) of FMD-coded products will have to be recalled on a rolling basis because of coding inconsistencies. Using a conservative number for the annual turnover in solid dosage forms in Europe (106 bn EUR per year), this would mean that up to 1,06 billion EUR worth of solid dosage forms may be threatened with destruction as a result. Worldwide turnover in solid dosage forms now stands at EUR 425 billion p.a. meaning that SRAP can potentially avoid the recall and partial destruction of up to 4.25 bn EUR worth of dosage forms each year. The growth potential is also huge, both in terms of geographical expansion (markets beyond Europe) and also because the solid dosage form market is seen by experts to grow at a CAGR of over 6.5% annually during the next ten years.

SRAP also shows applicability in other product markets (like OTC-drugs and nutraceuticals) where turnover is actually much higher than the turnover in prescription pharma dosage forms – and those markets also grow faster (up to 10% p.a.).

The results of this SMEI Phase 1 project show considerable promise for the worldwide application of SRAP which will create a very positive impact in the fight against counterfeit medicines, tampering, and diversion that plague the pharmaceutical industry today. As a consequence, very significant additional protection will be provided for patients.