Serialisation: the outlook for late adopters

3C Integrity have been busy recently speaking at various events and conferences include The TrackTS and FlyPharma conferences. Ian spoke and attended both of these events. During his time at both events he delivered expert serialisation advice and uncovered the current state of serialisation readiness in the pharma sector. We’ve put together a short series of blog posts on our experience at the events.

At the recent TrackTS conference Ian ran a “world café” discussing the outlook for late adopters. The conference delegates organised into 4 smaller groups joined Ian at a white board and flip chart (his favourite place!) to progress a rolling discussion on the outlook for late adopters.

It was notable that there was much less “denial” amongst the delegates than has previously been the case in similar discussions. Although there were comments suggesting that the continuing lack of clarity about the regulatory requirements was creating a barrier in some organisations, the majority view was clearly that there was – and has been for some considerable time – adequate definition to allow projects to proceed confidently. The likelihood of the national systems being ready in time was questioned, but the majority of delegates were keen to explore the remaining barriers to starting projects, and then the strategies that might be employed allowing late adopters to execute quickly.

Stakeholder Engagement

As we have said many times before, the single biggest challenge in any serialisation programme is stakeholder engagement. The delegates identified the need for a “killer presentation” that could be given to senior stakeholders combined with the creation of the right external environment to break the deadlock.

The presentation would need to wave the right flag for the stakeholders in question – almost certainly this is going to be the regulatory compliance/license-to-operate flag, something that all stakeholders will recognise. At the same time it is vital that the presentation gives a realistic picture of the scale, scope and complexity of the work ahead and thus highlights the necessity to start as early as possible. Describing benefits beyond compliance was also felt to be a major part of the story – business value through improved supply chain visibility might be attractive as might be the possibility to achieve greater levels of patient engagement.

In terms of the external environment delegates felt that the national associates may not be fully on board and could play a greater role in terms of encouraging pharmas to engage. At the same time it was felt that creating some consumer pull for serialisation would be very beneficial. At this stage this pull could be generated by describing the possible benefits consumers could experience in a serialised world of medicine – far better this than wait for a counterfeit event that results in significant patient harm to create a pull from consumers. In this latter scenario the apparent reluctance of the pharma manufacturers to comply with the planned legislation would be difficult for consumers to understand.

Strategies for Late Adopters

Whilst the bulk of comment was around barriers to engagement, there were some ideas that could lead to more rapid execution of serialisation programmes. Bandwidth in the supply base was a key concern with many of the experienced vendors being badly stretched already. Key ideas in this area were to make sure you were an easy customer to work with and the following list gives some insights into what this might mean;

• • Be an educated customer – take steps to build your knowledge early
• • Get experienced help particularly when it comes to building your URS – build on the work of others
• • Act like a single customer and not many customers – employ standardisation and look for scalable templated solutions that can be deployed around your network
• • You will need to build a consortium of vendors – treat them as partners and consider pre-configured alliances between adjacent solution providers where they exist
• • Revisit your vendor selection processes – what can you afford to do – what have you got time to do? Good enough may well be good enough!

More general advice suggested the following;

• • Be realistic about what you can achieve in terms of L4 system integration
• • Get your requirements radar and impact assessment process in place early – identify your sources of intelligence
• • Consider re-investment and re-training of staff as early as possible before the arrival of the new serialisation systems
• • Identify early the need for tactical solutions where it is clear your programme will not meet the requirements on time and put these in place

As mentioned in an earlier post – be ready to do strange things and to break some rules.

For more expert advice, get in touch with 3C Integrity

At 3C Integrity we regularly run innovative, vendor-independent training events that offer a unique and invaluable chance to ensure your programme is on the right course. Our next one-day serialisation training event is taking place on the 12th November in Milan, we also provide in-house training events and consultancy for clients across the world contact events@excellishealth.eu for more information.

Download this short series of blog posts as a free white paper resource from our website. We have a wide range of additional pharma serialisation advice to download from serial number management to 10 things pharma manufacturers need to consider to be ready for the EU-FMD.