Pharma Integrates

FMD deadline 'not the end’ of serialization process

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Who_I_Am)
(Image: Getty/Who_I_Am)

Related tags: Serialization, FMD, DSCSA

Europe’s FMD will see further revisions in the coming years, developing as a ‘never-ending’ process, experts predict.

Pharma Integrates took place this week in London and the takeaway message from the panel discussion on serialization and Europe’s falsified medicines directive (FMD) is that the deadline of February 9, 2019, cannot be considered the end of the process.

Jerome Bertin, general manager of SecurMed – a not-for-profit organisation set up to manage the UK’s serialization process – advised attendees to be prepared for further work.

"The implementation of serialization is February 9, 2019. Is that the date everyone should be aiming for? I don't think so. February 9 is the start, not the end [of the process],”​ he said.

Etorre Cuchetti, CEO of ACG Inspections Systems concurred, "Just a reality check: this is an expensive process. If you think that you've just finished [the process] then really, no, you've just started."

Rather than having any defined endpoint, Cuchetti predicted that regulation would continue to be adapted, "This is a long process. I think the timescale has been overlooked. This is [a] never-ending [process] – the regulator will change and the regulation itself will evolve."

What progress has been made

With only three months until implementation in the European Union, and only two weeks away in the US​, there was a mixed view on preparedness.

Speaking in regards to the situation in the UK, Bertin explained, “On October 31, the UK has announced that our national system, the UK National Verification System, is open for business. It is open to the manufacturers and marketing authorisation holders to load their serialized pack data onto the system.

“As of [November 9], we have had just over one and a half million packs on our system. We are expecting this to grow rapidly in the coming weeks."

Despite the UK’s progress on its verification system, other actions suggest there is not industry-wide confidence in readiness for the FMD across the board.

For example, Recipharm has developed a standalone serialization service​ for companies that have not arranged solutions prior to the FMD deadline. There are also reports of a ‘wait and see’ approach​ taken by some companies.

During the panel discussion, Cuchetti responded to Bertin’s by questioning how well the supply chains of those companies that had submitted packs really were.

"You mentioned the number of packs registered, are [the companies responsible] fully compliant? Are all their lines, all their CMOs [contract manufacturing organisations], all their CPOs [contract packaging organisations], all their distributors compliant? I don't think so.”

The endgame

As highlighted by Cuchette, the costs of introducing serialization are significant, which has led to solutions having been put forward to recoup some of the industry’s investment.

A Medicines for Europe representative, for example, has suggested that the value of the data collected by national repositories could be explored for commercial purposes​.

During the discussion, Mark Davison, senior operations director for Europe, rfXcel, took a long-term view of what the industry-wide investment pointed towards.

"This is all about a global traceability system for drugs – that's the end game […] You'd be very unlucky [in Europe] to go to a local pharmacy and receive a falsified medicine. If you go to a pharmacy in Africa then your chances of getting a fake medicine are one in seven, according to a recent study.

"That's the endgame – protecting those lives by making the learnings we've made here cheaply available in markets where it's a life and death issue."

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