I had the opportunity to attend and chair the first day of the 2nd Anti-Counterfeiting Pharma 2016 Conference in London last week. Many thanks to Pranita Nangia, Jasneet Gulshan and the team at Recunnect for organising the event.
Presentations from Day 1 of the event were:
Comparing European, US and Middle East counterfeit markets
Bawan Ahmed, Senior Pharmaceutical Assessor, Kurdistan Medical Control Agency
Bawan presented on the counterfeit market in Iraq in comparison to the rest of Middle East, Europe and the US. The Kurdistan region is an autonomous part of Iraq and has its own Medical Control Agency. There are 500 registered pharmacies and 6000 unregistered pharmacies which is an outcome of the many years of sanctions against Iraq. This informal supply base is uncontrolled, with pharmaceutical product being sold in market stalls, shops and even butchers! Product may be manufactured locally or imported and is shipped around the region in taxis.
Bawan and his team are seeing around 1000 cases of counterfeit medicines a year but with only 5 staff in a dangerous and fluid environment, it’s difficult to police. The situation is improving through greater collaboration between enforcement parties and the pharmaceutical companies and improved training of staff.
GS1 Standards – a tool to combat counterfeiting?
Glen Hodgson, Head of Healthcare, GS1 UK
Glen discussed the GS1 standards and how they can help combat counterfeiting. GS1 standards underpin most serialisation and authentication solutions. He explained the requirements of authentication and traceability, gave an overview of the overall responses from Interpol, WHO and WCO and outlined GS1’s involvement in the Joint Initiatives Council which is shaping solutions to the counterfeit drug challenge.
Tamper Evidence Implementation in Packaging Lines
Andreas Brandt, Business Development Manager, Baumer HHS GmbH
Andreas presented on the other main aspect of FMD – tamper evidence. He explained the solutions that are available and issues to consider when selecting tamper evidence solutions. He showed the various examples of tamper evident solutions and focussed on the types of glue solutions. Using a combination of hot melt and cold glue gives the benefit of quick adhesion but without the risk of re-opening that you get with hot melt only.
Andreas highlighted that all products must have tamper evident features applied by 2019. The lead-time to get new tamper evidence equipment installed and products produced is short so it is an issue that needs to be addressed soon.
2D Barcodes: Implications on Branding, Patients and Anti-counterfeiting
Aaron Barzey, CEO, ADB Medical
Aaron discussed some of the recent counterfeit issues that have happened around the world. He explained some of the different coding solutions and in particular the use of QR codes in Europe and the US. He also discussed some other types of covert and overt brand protection solutions, for example micro-taggants applied to the drug product.
Challenges of Serialisation and Track and Trace applications on a company level
Michael Urso, Product Manager Pharma & Packaging Solutions, Atlantic Zeiser GmbH
Michael presented on the concerns about serialisation that they have seen at various clients in the projects they have been involved in. He gave an overview of different options for incorporating the equipment necessary for serialisation into packing lines. He also discussed the architecture options for the level 3 and 4 systems that can be required and the impacts of managing number allocation to multiple locations and packing lines.
Anti-counterfeiting Technology – An investment not a cost
John McKeon, Technical Director, Portalis Ltd
John outlined the capabilities that Portalis have developed to help companies implement serialisation solutions. He discussed the various components of a packing line that are impacted by serialisation and how to ensure these requirements were built-in in a cost effective way. Understanding the overall architecture is critical to ensure that data flows between Level 1 and Level 4 as necessary. There are many variations possible, but the cheapest solution is not necessarily the most appropriate.
Strategies to mitigate risk in the supply chain
Elizabeth Haveman, Director, Anti-counterfeiting, Global Product Protection, Abbott
Elizabeth’s presentation covered the activities Abbott undertake globally to address the threat of counterfeit products. Presented as a list of 20 tips she covered topics including what to do to monitor activities in markets and across the supply chain, management of external partners, laboratory capabilities required, influencing and engagement with authorities, and use of anti-counterfeiting technologies. She gave examples of some of these activities in use and the benefits delivered to Abbott.
Towards the digitisation of pharmaceuticals
Prof. Lee Cronin, Regius Chair of Chemistry, School of Chemistry, University of Glasgow
The subject of Lee’s presentation was the vision of being able to create chemical entities automatically from code rather than through traditional chemical processing. Drawing parallels to digital printing where objects can be created from a digital instruction using standard machinery and building blocks, he discussed a future where standard chemical processing machines could take base materials and through a standardised digitised methodology or recipe, could create chemical and pharmaceutical entities.
Whilst this technology is some way in the future he explained some of the development work being executed under his stewardship to develop conceptual and prototype machines.
Understanding Global Regulatory Laws
Ewan Townsend, Associate, Arnold & Porter (UK) LLP
Ewan discussed the development of the legal framework for pharmaceutical regulation, as legislation evolved from numerous significant patient safety events, and leading to the Directives seen in the EU today. From this, he showed how this has resulted in numerous and sometimes inconsistent laws regarding counterfeit medicines around the world that have had to incorporate the views of many different stakeholders. This slows progress and requires much cooperation between partners.
He also discussed some potential future trends:
- Porous borders where there is a difference in price
- Targets will diversify to where enforcement is low if organised crime still manages to make high margins
- Increased global cooperation and a harmonisation to global responses and solutions
- Increased involvement of charities and philanthropists in driving for solutions
Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email.