Traceability and Serialisation

Pharmaceutical product serialisation legislation is being developed and approved across the world to ensure patient safety and prevent fraud. Meeting the legislation across the supply chain is a complex and very costly undertaking. Failure to comply with these legislative requirements will mean that pharmaceutical companies will not be able to sell products in the affected markets.

Traceability and serialisation legislation requires product packs and, depending on the legislation, shippers to be uniquely identified with serial numbers. Information about the product, its serialisation, its status and in some cases its movement in the supply chain are then exchanged between supply chain participants and/or authorities.

Whilst some pharmaceutical companies understand this legislation and have a clear strategy and programme of capability implementation under way, others do not.

Having successfully dealt with legislative drivers, many companies are now realising the secondary benefits serialisation has brought to their supply chain.

It is highly likely that one or more parts of your organisation are already working on this issue, perhaps in a coordinated way, perhaps not. Initially, we would recommend continuing this work until the appropriate course of action has been decided.

However, companies are faced with several specific issues when managing traceability and serialisation related legislation, including:

• Identifying and interpreting the emerging and evolving legislation
• Understanding the full impact of these multiple pieces of legislation on the company and product supply chain
• Defining optimal solutions and implementation plans which strike the optimal balance between ensuring product supply and the caution that is prudent with this evolving legislation
• Understanding the immature and evolving solution supply base and selecting appropriate implementation partners
• Resourcing implementation projects with sufficient traceability and serialisation-specific knowledge to minimise the risk of wasted resources, delays and implementation failure

As a first step we would recommend a small and focussed piece of work which has the following objectives:

• Understanding the issue as it relates to your business
• Understanding the likely impact across your organisation
• Identifying, educating and mobilising an effective cross-functional governance team
• Establishing an effective legislative monitoring capability
• Understanding non-legislative benefit areas
• Defining a plan of action
• Identifying any initiatives that are currently under way and defining how they should proceed
• Understanding the high level budgetary implications

From here, a programme of activity can be managed by the governance team to effectively manage the legislative risk.

Cross-functional governance is critical

Given the cross-functional and cross-organisational nature of the impact of traceability and serialisation legislation, coupled with the significant product supply risk it presents, many organisations establish a cross-functional governance to ensure that:

• Decision making is taken with all impacted parties, at the right levels in each of the organisations involved
• A “Target Response” is defined that specifies what the organisation must achieve and by when, given the current state of legislation and the organisation’s considered view of how and when capabilities will be required
• Changes to the Target Response are carefully managed and cascaded to all impacted groups
• Appropriate cross-functional and cross-organisational resources are mobilised to address the issues in a coordinated and timely manner
• Timely approval and funding of the programme of activities is achieved
• Progress, priorities, risks and issues are managed in an optimal way for the organisation as a whole

Wider opportunities

Whilst the initial objective of many organisations will be to meet the requirement of the new legislation, there are also opportunities which will result from this. From a commercial perspective, for example, traceability, serialisation and product coding can be used to provide additional services to patients by linking information and services to the coding on the pack through such things as cell phones. This provides opportunities to improve patient safety, through the likes of improving adherence, increasing the knowledge about patient and product use and improving supply chain visibility, leading to improved customer service efficiencies.

• Legislative and Business Drivers
• Strategy Development
• Programme and Project Implementation
• Operation and Support
• Governance
• Resources
• Education