Blue Sphere Health

EU Falsified Medicines Directive: What’s Happening Next?

The ratification of the European Union’s Falsified Medicines Directive marked the beginning of the end, or at least the end of the beginning of a long process. This was the first time that such a large economic bloc had passed clear legislation aimed at securing the supply chain for pharmaceuticals. Cautious rejoicing all round. The next stage is that remaining details of the Directive will be converted to law by a “delegated acts” process. A fairly new legal procedure, this will be where the deal-making is done and the detail is finalised. There are lots of critical details to discuss, even before the lawyers get involved with drafting the wording itself. Who pays for what? Where does the data go? Who has access to it? What security features need to be used? etc, etc, etc. Two key tasks are being conducted in parallel. Firstly, an economic impact assessment is being conducted to look at what this will cost and who will bear the burden. This is likely to take some time. At the same time, a stakeholder group will examine technical issues under the oversight of the Directorate General for Health and Consumer Policy (commonly abbreviated to DG SANCO) the Brussels directorate responsible for the process. This stakeholder group, which includes trade bodies representing drug makers, distributors, repackagers, pharmacists etc, will try to thrash out a pragmatic, affordable solution which allows the implementation of traceability and security features at a reasonable cost. There are five main themes to be covered: Unique identity (serialisation): technology choice and implementation Governance of the system: deciding who sees what data and on what terms Modalities of verification: deciding how packs will be verified and what level(s) of authentication feature(s) will be required Whitelist and blacklist criteria: determining which prescription drugs are excluded from key requirements (deemed safe) and which non-prescription drugs are included (deemed risky)? Mechanism of notification: of whitelisting and blacklisting Prickly issues like ownership and use of information will need creative solutions. Drug traceability data is a boon for anti-counterfeiting but it contains very valuable commercial information and potentially could be linked to very sensitive patient data. One idea mooted is to use a not-for-profit vehicle to “own” the central repository or data exchange mechanism, with 15 or more national databases linking in. Public sector leadership has also been proposed. The timescale for the technical evaluation process is expected to be similar to the impact assessment, so the output for both is likely to be during 2014. There will be a three year implementation window once the Delegated Act is published. So the main activity in terms of capital expenditure and equipment installation by the pharmaceutical industry is likely to be geared towards being ready for roll-out from 2017-2018. Given the remaining uncertainties, and the other mandatory serialisation requirements in a similar or earlier timeframe (USA, Brazil, China etc) the best course of action for drug manufacturers is to be flexible in their approach. They need to ensure that their technical response (hardware, software and processes) stands the test of time and is able to respond to potential geographical variances. So take the time to work out a coherent strategy, but don’t wait too long or the queue for the most sought-after vendors might get a bit too long. Blue Sphere Health is helping several drug companies to formulate their thinking in this area. For more information on how we can help, please get in touch.

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Pharmaceutical Anti-Counterfeiting

Combating the Real Danger from Fake Drugs has become a must-have primer on anti-counterfeiting and is widely used by drug companies, regulators and others. The book covers the legal, strategic and political issues as well as the technical counter-measures such as process control, digital serialisation and physical security.


Pharmaceutical Anti-Counterfeiting book