Are you ready for serialisation? Three experts give their perspectives

After a preview of TraceLink’s second annual Global Drug Supply, Safety and Traceability survey has revealed disparity in terms of readiness for the falsified medicines directive between pharma companies and CMOs, three experts give us their perspectives on serialisation.

In a preview of the results of TraceLink’s second annual Global Drug Supply, Safety and Traceability survey, it emerged that business leaders throughout the EU pharma industry do not have true insight into each other’s readiness when it comes to meeting the falsified medicines directive (FMD) serialisation deadline.

The results showed that in the EU:

• Only 4% of pharma companies with EU FMD requirements have not yet begun preparations for serialisation.
• However, not one of the EU FMD pharma companies that feel ‘very ready’ for serialisation are fully integrated with their contract manufacturing organisations (CMOs).

When EU FMD CMOs were asked about their serialisation readiness:

• 94% of CMOs serving customers with EU FMD requirements stated that they felt somewhat or very prepared for serialisation, 42% of them have not yet begun their preparations.
• Over half (53%) of those that responded felt that brand owners were ready.
• Nearly half (48%) said they had integrated with pharma companies.
• This again contradicts the responses from pharma companies with 68% reporting that they felt somewhat or very prepared for serialisation.

With the deadline for the EU FMD now less than a year away and pressure mounting on businesses to start implementing their serialisation solutions and integrating with partners, this disparity between internal and external perceptions of preparedness has the potential to create more tension in the sector.

Three experts from businesses that have successfully implemented serialisation programmes, reveal what they think are the challenges around serialisation, what is causing scepticism in the industry and what can be done to resolve it.

Participants:

• Dexter Tjoa — director of corporate strategy, Tjoapack
• Michael Unbehaun — manager of engineering projects and serialisation team lead, R-Pharm
• Staffan Widengren, director of corporate projects, Recipharm

The challenge for CMOs and CPOs

Tjoa: When it comes to serialisation, timing is crucial and is the obvious challenge. There are no shortcuts to compliance and less prepared CMOs and CPOs are now facing an uphill struggle to meet track and trace deadlines. It is vital that they decide to put in the necessary work or engage with well-prepared trading partners who can provide a compliant solution for them.

Unbehaun: During the planning and implementation of R-Pharm’s serialisation project, we encountered several challenges linked to resourcing and access to expertise. We found that there were gaps in technical and IT knowledge and vendor service availability was poor due to the demand created by time constraints.

We found that there were insufficient process definitions and security across the site, with issues identified in areas from master data management and production planning to regulatory change management and data integrity gaps. When testing and subsequently implementing our solution we found that there were decreases in line efficiency and extended ramp-up phases that had to be considered.

These roadblocks all required additional dedicated resources for the project to be a success. Lesser prepared businesses that haven’t built some flex into their serialisation budgets would be well advised to do so.

Widengren: One of the biggest challenge we’ve encountered at Recipharm in our preparations for serialisation has been the on-boarding of smaller and mid-sized virtual market authority holders and brand owners. There remains a lack of understanding among these companies when it comes to the complexity of connecting with their partner CMOs and the EU-Hub subsequently.

A healthy dose of scepticism

Widengren: Scepticism when it comes to readiness has many root causes. There remains a lack of understanding among some marketing authorisation holders (MAHs) and brand owners as to the complexity of implementing a serialisation programme.

There’s also a belief (or hope) in some quarters, that the EU will extend the implementation deadline as happened in the US. Extending the deadline in the EU would require agreement from all member states as opposed to a singular central government in the US. Given that some countries are very advanced in their preparations, this agreement is very unlikely.

The recently passed track and trace law in Russia is also likely to affect serialisation programmes across the EU. The requirements are still uncertain however the law has allowed for intermediate deadlines for implementation and the governing body in Russia has inferred that these may be very short — potentially being sooner than those of the EU’s FMD.

Tjoa: Industry readiness has been widely discussed and the lack of preparation has been evident, particularly in the FDA’s decision to delay the active enforcement of the Drug Supply Chain Security Act (DSCSA). It is therefore easy to see why companies throughout the supply chain would be unsure of each other’s levels of preparedness for serialisation requirements.

The industry has, in many quarters, underestimated the task of serialisation. Companies have been slow to react and are now scrambling to get their programmes in place as they begin to recognise the scope of the task at hand and the urgency to get started.

Unbehaun: Insufficient knowledge of each other’s related organisational and technical procedures can lead to a high-risk project readiness situation between CMOs and MAHs.

Resolution before solution

Unbehaun: To resolve these issues, it is important that the MAH is building up the right level of transparency on project milestones and deadlines together with the CMO. The MAH should be able to specify and monitor the CMO’s progress and level of readiness in relation to single projects steps, including equipment, IT and organisational readiness. For this to be possible, a decision tree with the most important milestones including escalation situations is helpful.

Tjoa: As a rule, serialisation takes an unprecedented amount of cooperation and information sharing between all trading partners and the pharmaceutical industry is struggling to tackle this task. However, as we move past the initial implementation phase, companies will begin to realise the obvious efficiency benefits to this kind of transparency. As a result, we will inevitably see communication between partners improve.

For more information

To read the full 2017 Global Drug Supply, Safety and Traceability Survey Report, visit https://www.tracelink.com/global-drug-supply-report/2017-report.

The results of the report and their implications for the pharmaceutical industry will also be discussed at FutureLink Munich, which will take place 5–7 June 2018. The event will see leaders from across the pharmaceutical and healthcare industries gather to discuss regulatory compliance and shaping the future of digital drug supply with information sharing networks