EU-FMD: Draft Delegated Act publicly released by EC for comments

No one who needs to take an interest in Pharma serialisation and traceability – and it could be argued that this includes everyone in the industry – can by now be unaware of the latest draft of the EU-Falsified Medicines Directive Delegated Act that was posted on the EU Commission website late last week.

Indeed, the appearance of these two documents – a draft of the Safety Features Delegated Act and the Annex covering the Black-/Whitelist criteria – has been greeted by a flurry of excitement on twitter, linked-in and industry blogs. However, plentiful as these brief updates have been, they are short on detail and may well create confusion for the many who are not in a position to follow the intricacies of what is proposed in detail.

As an observer who is close to these developments and having previously commented on DA updates and developments – EU-FMD Delegated Act: The wait is nearly over and DG Sanco updates on safety features for medicines – I thought it might be useful to add a few observations, conclusions and recommendations.

DA published? – No, not yet

The first thing to note, of course, is that this is a late-stage draft and not yet the (formal) “publication” in the official journal of the European Union which will be the significant date that starts the compliance implementation countdown. Just to remind readers: This will be three years for almost all EU Member States, apart from Belgium, Italy and Greece that are deemed to have pre-existing features in place which will earn them an extended compliance deadline. And as has been set out previously, this is a ‘hard’ deadline, with transitional arrangements limited to a two-year grace period to flush out stock in the pipeline that does not carry the safety features. After the deadline you will not be able to put anything into the supply chain that does not carry the necessary safety features.

The date of formal publication has not yet been announced but adoption is foreseen for mid-October so the previously announced intention to publish the Delegated Act before the end of this year remains a distinct possibility. Even if the formal publication should slip into Q1 2016, this means that that compliance with the EU-FMD Safety Features measure will be required in Q1 2019 if not by the end of 2018. The message to the last lingering FMD-Deniers must therefore be that the decision to continue ignoring these developments is to be considered “courageous” (in the sense used by the fictional Permanent Secretary Sir Humphrey Appleby advising his hapless Minister Jim Hacker in the BBC sitcom Yes Minister: “a courageous decision will lose the election”).

Good news: No surprises

The second things to note is the lack of surprises. There is a reassuring feeling of being underwhelmed: Nothing in this draft DA that we have not had visibility of before. The key features have indeed been set in stone since the publication of the Directive itself in 2011:

• Unique identifier on each pack plus Tamper-Evidence
• Mandatory verification at the point-of-dispense plus verification in the supply chain in some cases, based on risk criteria
• Europe-wide system with full interoperability across central and national systems
• Cost-effectiveness a key consideration with obligation on pharma manufacturers to bear the cost of the measures

The subsequent refinement of the thinking around the technical and practical details that we have seen, through consultation exercises and – official and unofficial – glimpses of working drafts, has never veered off course from the general direction set by the Directive. What we have seen has been a steady refinement and clarification which this latest draft brings to a solid conclusion.

In earlier drafts there were still some details left open to interpretation and areas of uncertainty. What we now see is that these have been systematically addressed and clarified, for example the question who would set up and assume responsibility for the repositories and the upload of the serialised pack data: Earlier versions talked about “manufacturers” which left open the interpretation that this would oblige Contract Manufacturers to take on this responsibility on behalf of their customers, but we now have clarification that this should be the Marketing Authorisation Holders, i.e. the Brand Owners (items 28 and 32).

ESM – fully endorsed and Details clarified

The draft DA also fully endorses the Europe-wide medicines verification approach proposed by the ESM (European Stakeholder Model) coalition, i.e. a system landscape consisting of one European Hub and multiple National (or “supranational”) repositories.

Discussion following the release of previous drafts pounced on perceived problems such as how the verification step would be carried out if medicines were dispensed outside the ‘normal’ retail pharmacy context and made much of the challenge of imposing a European standardised approach on the widely diverse health care supply chains and practices seen across Europe. The draft DA restores common sense by acknowledging that while achieving the intended protection of patients and the supply chain critically depends on adherence to the core principles underlying the end-to-end approach, Member states may, where it makes sense, allow for pragmatic arrangements.

Member States may, for example, move the verification step forward to the wholesaler who supplies “persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy”, for example in the case of nursing homes, hospices, prisons, universities and other research establishments etc. (article 23). Similarly, item 25 allows for the scan to be performed at an earlier point in time “in order to avoid an excessive impact on the daily operations of healthcare institutions…. allow(s) persons … operating within healthcare institutions to
perform the verification of the authenticity and the decommissioning of a unique identifier earlier than the time the medicinal product is supplied to the public”. This would suggest, for example, that the formal medicines verification scan would be carried out at the point of feeding the medicines into a robotic hospital dispensing system rather than at the point where the drug is actually dispensed to the patient.

Other details that are clarified in a sensible manner regard the requirement for packs to also carry the human readable form of the data carried in the 2D DM: It is recommended to apply the data adjacent to the barcode but if this is not possible the human-readable data can be printed separately. Similarly, where small pack sizes make it impractical to apply that data (sum of the two longest dimensions of the pack is less than 10cm) the pack is exempt from this requirement.

The EU-FMD: On track

In conclusion, after increasing speculation (the traditional summer silly season in the British press seems to survive in unlikely places) that the implementation of the EU-FMD was going to be further delayed, the publication of the draft DA has brought welcome confirmation that the EU-FMD project remains firmly on track: The proposed timeline to formal publication of the act looks like it will be adhered to which means that the 3-year countdown may well begin before the end of this year; the DA offers more details without any nasty surprises and it is clear that for any remaining pharma companies that have doubt about whether or not they should progress their EU-FMD readiness programme, any suggestion that they should further delay would certainly be considered ‘a courageous decision’.

Sensible decisions have included the initiation of steps to:

• To determine the in-house and extended supply chain readiness and identification of gaps;
• To gain an overview of the requirements, EU and beyond, and what is necessary to meet these;
• To formulate a high-level business plan in order to gain senior stakeholder support and secure the necessary budget and, finally,
• To – simply – get started!

If you are not in that position, then things may be getting quite uncomfortable, soon.