I attended and spoke the Anti-Counterfeiting Pharma 2015 conference in London this past week. Many thanks to Mukesh Shant and the team at Recunnect for organising such a great and well attended event.
Over the next two weeks, I will provide you with a quick overview of the presentations that were held during this conference.
Presentations included:
Developing your Serialisation Strategy - Stephen McIndoe, VP, Be4ward Ltd and David Yates, Technical Manager and EMEA Serialisation Lead, Eisai
I presented with David, one of Be4ward’s clients, on the development of a comprehensive serialisation strategy and the learnings they have gained in Eisai. Steps to be taken in defining the strategy include:
Please do not hesitate to contact me if you would like to discuss how to develop, enhance or review your serialisation strategy.
Market trends: Anti-counterfeiting and Brand Protection - Stephen Harrod, Consultant, Smithers Pira
Stephen presented on the trends that will be impacting the global Pharmaceutical market-place over the next few years. An ageing population, emerging markets, increased legislation and environmental concerns are all factors that will impact Pharmaceutical packaging markets.
The growth of the internet is changing how people purchase and this increase in on-line trading makes brand protection both more necessary and more demanding. Counterfeit drugs is now the largest black market in the world with complex global supply chains. Technologies to support brand protection are varied and Smithers Pira see the market size of countermeasures is set to double in the next five years.
Key Strategies for combating counterfeiting - a pharma industry engagement - Edmond D'arvieu, Chief Security Office, Sanofi
Edmond presented on Sanofi's approach to combating counterfeiting and protecting patient safety. It is based around the following key elements:
Key threats to product security that Sanofi see are cargo theft, counterfeit product and illicit diversion of product. The major risks to products that may result include reduced/absent active ingredient present, substandard product, manipulation/refilling, poor storage, expired labelling and cold chain interruption. Counterfeiting is a global issue with counterfeiters looking for opportunities around the world and products moving worldwide.
Sanofi are building a strategy to ensure a secure end-to-end supply chain through a systematic risk based approach. This is likely to be a 3 year programme delivered by a multi-functional internal group and based on four main activities:
IPM - A WCO global initiative to fight against counterfeiting - Sophie Molle, IPM Private Sector - Senior Manager, World Customs Organisation
Sophie presented on the activities the WCO are undertaking to help secure international supply chains. Due to the enormous volume of shipments, it is not viable for customs officers to inspect every shipment, so they need help to understand how to perform time efficient, risk based inspections. WCO undertakes training, particularly in Africa so that customs officials are more aware of what is going on in their areas.
The global problem in counterfeit goods is very serious. In one 10 day operation across Africa, 460 containers were inspected and 1 billion fake products were intercepted, half of which were pharmaceuticals. The main categories were pain killers, anti-inflammatory and anti-tuberculosis.
The WCO IPM tool is a secure on-line tool to improve communication between the private sector and customs officers. The information shared will help customs officers understand the risks and identify suspicious product. Launched in 2011, it is expected to be rolled out to 120 countries by 2017. It is a web based tool where companies can provide information on their products including the presentations available, comparisons with counterfeit product, expected trade routes and contact information. The objective of the tool is to help the customs officer carry out risk assessments on shipments and then effectively inspect suspect containers. It also provides opportunity to recognise customs officers for work they have done.
It is not practical for a customs officer to have to repeatedly go back to the office to check IPM and therefore WCO is developing a mobile version of the tool that can be used on a smartphone. It will also be able to scan product barcodes to retrieve information and it is being investigated if the system can be integrated with other authentication systems.
How to make your Serialisation project a success - Jean-Luc Lasne, International Business Development and Alliance Director, Adents Pharma
Jean-Luc presented on Adents experiences with Serialisation projects. He outlined Adents solutions for serialisation and highlighted the need for collaboration between solution providers to provide comprehensive solutions, as no suppliers provide a one-stop-shop solution. He recommended a top down approach to developing serialisation solution architecture to ensure that standard solutions are developed, as scaling up standard solutions is easier than developing multiple dedicated solutions.
Linking Corporate Strategy, Brand Protection and Patient Safety - Mark Davison, CEO Blue Sphere Health Ltd
Mark discussed how serialisation is part of the broader brand security strategy. Companies need to ensure robust processes are in place to manage brand protection and assure knowledge flow across companies about requirements, incidents, solutions and issues. This needs to include all supply chain partners.
Whilst brand protection has been seen as a manufacturing issue and a cost of supply, the cost of failure is significant and has ramifications on the whole organisation.
When it comes to serialisation, the development of standards has been a major step forward from where we have been and should make application more straightforward. However it is more than just putting barcodes on packs. Managing the virtual information is as important across the extended supply chain. This makes delivery of solutions complex due to the broad range of stakeholders involved. However serialisation projects present great opportunities to drive standardisation and rationalisation across your equipment, facilities, data and supply chains.
Whilst the return flow of information to the PharmaCos is not likely, the provision of unique codes opens the opportunity of communication from patients to help facilitate further patient safety and adherence solutions.
Be sure to check in next week for the continuation in this series on the presentations given at Anti-Counterfeiting Pharma 2015.
Should you wish to receive our recently published booklet below or if you have any questions about this or would like any contacts for the above topics, please don’t hesitate to contact me at [email protected].