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.
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:
- Educating the team. It is essential that everyone involved in the governance, design and delivery of the serialisation strategy is educated about serialisation so that they can contribute effectively to the activity and make robust decisions. Furthermore, following good change management practice, this education needs to continue throughout the serialisation journey to ensure that existing and new members of the stakeholder group stay up to date and remain effective.
- Understand the legislation. Serialisation legislation is often a moving target and ensuring that there is a joined up, agreed interpretation of the relevant pieces of legislation across the organisation as the legislation evolves is essential. It was pointed out several times that it is often too late to wait for legislation to be finalised before acting due to the long lead times associated with implementing solutions. Therefore organisations need to have mechanisms in place to define and communicate solution requirements to project teams based on a risk based assessment of where evolving legislation may end up. Be4ward have successfully used the concept of the Target Response with clients to help manage this process.
- Understand and map the impact across your organisation. Topics to consider include: Which products are supplied into which markets? What is the wider supply chain and who needs to be involved? What is the impact in those areas? This is particularly important in situations where there are multiple commercial and supply chain partners – everyone needs to know what part they have to play.
- Collaboratively designing the future state. Strategy needs to develop conceptual designs and examine the major options for delivering the overall result. These may include such topics as supply chain rationalisation, serialisation postponement, tactical solutions and IT architecture options. Therefore, companies need to ensure that the people involved in this design work have the appropriate breadth and depth of experience and responsibility.
- Define the roles and responsibilities across the programme, the governance and the extended supply chain. In designing the program of activity to deliver the appropriate solutions, topics including the following need to be addressed: Who needs to deliver what? What support is required? Who is involved in making which decisions?
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:
- Collaborating with local authorities and professional organisations
- Cooperation with official bodies
- Dedicated permanent cross-functional structure to coordinate strategies
- Proactive securing of drugs
- A dedicated product security and investigation laboratory
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:
- Detection, both proactive and reactive via patients and Doctors, Distributors and Pharmacies, mass media and law enforcement
- Analysis of issues through chemical and physical examinations in Sanofi’s lab
- Enhanced cooperation with Authorities
- Preventative strategies, through building technical strategies for products, coding solutions, overt and covert solutions, ensuring the integrity of the pack through the supply chain, education and training and secure disposal of pen devices.
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 Stephen.firstname.lastname@example.org.