Pharmaceutical product serialisation legislation is being developed and approved across the World to ensure patient safety and prevent fraud. Achieving this across the supply chain is a major 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.
Serialisation legislation requires that every product pack is uniquely identified and registered in an external agency database, together with information about the product contained in the pack. Depending on the particular legislation, it may also be necessary to update the external agency database with product movement and change of ownership information, a significantly more complex requirement.
Whilst some pharmaceutical companies understand this legislation and have a clear strategy and program of capability implementation under way, others do not.
This series of articles outlines the requirements of serialisation and related product coding legislation, discusses what needs to be done to address it and identifies some next steps to effectively manage the risk.
This is one in a series of articles outlining the requirements of serialisation and related product coding legislation, discussing what needs to be done to address it and identifing some next steps to effectively manage the risk. Please help me improve the thinking by adding your comments and share this with others who may have a view.
To obtain an e-copy of our paper on the topic, go to www.be4ward.com or contact me directly at [email protected].
Whilst the primary objective of many organisations will be to meet the requirements of the emerging serialisation legislation, serialisation presents other opportunities. I have listed a few below, but please feel free to add others if you have them.
Improved Compliance and Persistence
Linking additional electronic information, tools and services to the coding on the pack allows Pharma companies to help patients improve compliance and persistence. One approach to this would be to create a smart phone application which allows a patient to scan the machine readable coding on the pack via the smart phone camera and then not only gain access to product authentication information, but also to additional information and tools to help compliance and persistence.
Clearly, improved compliance and persistence not only leads to benefits for the patient, but also increased sales for the Pharma Company.
Reduced Impact of Recalls
Unfortunately, recalls do occur and their impact on all stakeholders in the supply chain is significant, distracting organisations from their primary objective of providing efficient and effective supply of products to patients.
Serialisation, particularly in the track and trace models, provides a number of significant opportunities:
Patient Information
At the same time as providing useful additional services to the patient, Pharma Companies have the opportunity to gather information about product and patient use. This information is very valuable to Pharma Companies to help them ensure that their activities are targeted correctly.
More Effective Returns Reimbursement
The models for payment of Pharma products are complex in many supply chains, often involving many discount and rebate schemes. This in turn leads to a difficulty for Pharma Companies in knowing exactly how much to reimburse for returned product.
Product serialisation, particularly in the track and trace models, offers the opportunity to significantly improve the ability of Pharma Companies to reimburse the correct amount to the correct parties when product is returned for whatever reason.
Improved Supply Chain Effectiveness
From a supply chain perspective, particularly in track and trace models, serialisation capabilities can be harnessed to provide improved supply chain visibility, leading to:
This is one in a series of articles outlining the requirements of serialisation and related product coding legislation, discussing what needs to be done to address it and identifing some next steps to effectively manage the risk. Please help me improve the thinking by adding your comments and share this with others who may have a view.
To obtain an e-copy of our paper on the topic, go to www.be4ward.com or contact me directly at [email protected].
Pharmaceutical product serialisation legislation is being developed and approved across the World to ensure patient safety and prevent fraud. Achieving this across the supply chain is a major 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.
Serialisation legislation requires that every product pack is uniquely identified and registered in an external agency database, together with information about the product contained in the pack. Depending on the particular legislation, it may also be necessary to update the external agency database with product movement and change of ownership information, a significantly more complex requirement.
Whilst some pharmaceutical companies understand this legislation and have a clear strategy and program of capability implementation under way, others do not.
This series of articles outlines the requirements of serialisation and related product coding legislation, discusses what needs to be done to address it and identifies some next steps to effectively manage the risk.
This is one in a series of articles outlining the requirements of serialisation and related product coding legislation, discussing what needs to be done to address it and identifing some next steps to effectively manage the risk. Please help me improve the thinking by adding your comments and share this with others who may have a view.
To obtain an e-copy of our paper on the topic, go to www.be4ward.com or contact me directly at [email protected].