It's official: safety feature deadline in EU will be 2018

Companies will have a year longer to comply with the EU's forthcoming safety feature requirements for medicines than previously thought.

For months commentators have been talking about a deadline of the start of 2017 for the implementation of the delegated act that will spell out the features that must be added to medicine packs under the auspices of the Falsified Medicines Directive (FMD), but it has now been confirmed as the start of 2018.

The safety features delegated act represents the first time that this legislative vehicle has been employed in the EU, so the confusion has arisen as a result of a lack of understanding of the process.

In a nutshell, the act will be adopted later this year as expected, notes Christoph Krähenbühl of serialisation consultancy 3C Integrity. However, the clock will not start ticking on the implementation deadline until it is published in the official journal a few months later.

The publication of the recent impact report on drug safety features largely confirmed what has been predicted for some time: that packs will carry serialised 2D codes, with mandatory pharmacy verification and risk-based checking at wholesalers rather than a full track-and-trace model and a data repository set up and managed by stakeholders.

"There has been clarity on where this is heading for quite a long time," Krähenbühl told SecuringIndustry.com, noting that there also appears to be openness to the concept of using the data for purposes such as pharmacovigilance and reimbursement.

The realisation that companies have a few more months to play with is unfortunately already having an impact on the willingness of some pharma companies to press ahead with plans to serialise their packaging lines, according to 3C Integrity's Ian Haynes.

While big pharma is well on the way to serialising its packaging lines to come into compliance - and even though some early projects have had to be re-assessed as the nature of the requirements has evolved, such as the nature of the data repository - there is still a lack of engagement by smaller pharma companies and other organisations such as contract packagers.

"Since the delegated act schedule information has come out, we've seen a number of tier 2 and 3 companies sitting back again," said Haynes.  "I would be concerned that given the time it takes to implement serialisation they may be placing themselves at risk of missing the deadline."

Haynes believes that to some extent pharma does not see manufacturing and supply chain as its core business, focusing instead on research and new product development. The changing nature of pharma's business however - with a shift towards higher volume, lower margin business as a result of patent expiries - may force a rethink.

One issue seems to be that in some companies, senior-level management are adopting a stance of doing as little as possible, as late as possible for as little money as possible to come into compliance.

To some extent that is understandable, given estimated costs of $300,000 to $1m-plus per packaging line to implement serialisation, not including the cost of information systems, but it does ignore other benefits of modernising systems.

"Serialisation could be a catalyst for implementing a step change in pharma's business approach, with innovation extending right through the healthcare supply chain," added Krähenbühl.

Implementation can lead to multiple additional benefits, including in patient safety, for example from the avoidance of medication errors, greater visibility of manufacturing effectiveness, and a much higher level of customer relationship management (CRM) capability.

The bottom line is that small players who leave it too late will not only miss out on the benefits of serialisation, but could also place their businesses in jeopardy.

Haynes believes that some smaller companies in the contract packaging and even the pharma manufacturing space who have not started the ball rolling yet may disappear, in some cases swallowed up by larger competitors who have grasped the opportunity.

"2018 may seem a long way off but given the complexity of these implementation projects, the experience of early adopters and … the limited capacity of vendors and solution providers, you would be well advised to press ahead with your implementation and not take your eye off the ball," said Krähenbühl .

3C Integrity is running a two-day training event next week (April 203) in Manchester, UK, designed to help pharmaceutical companies design and implement effective serialisation programmes. More details can be found here.