Continuing this short series on the presentations made during the Anti-Counterfeiting Pharma 2015 conference in London that I attended and chaired in early March, below are the remainder of the highlights that I thought may interest you. Again, many thanks to Mukesh Shant and the team at Recunnect for organising such an informative and well attended event.
The Agile approach to Serialisation Project Management – Lorraine Patridge, Head of Serialisation Programme Management, Horizon
Lorraine presented on how an Agile approach to project management can be applied to serialisation projects.
Key areas to consider an Agile approach include enhancing collaboration in process design, change management, team working, ensuring learning and continuous feedback from projects. Agile approaches can be applied within a traditional waterfall project management approach.
Authentication to your identification system – Roger Pallavicini, Sales Director Europe, Jura JSP GmbH
Roger presented on Jura’s capabilities in authentication of printed products. Their technology works by adding a secondary layer of authentication to the serialisation code or other security features, but that doesn’t impact the integrity of the code. This layer can then be used in the field to authenticate the product via a smartphone. This can then link to a database showing where and when the authentication was performed to permit identifying trends in supply of counterfeit product. The solution is primarily seen as a grey market identification solution.
Development and implementation of a successful Anti-counterfeiting strategy – Patrik Merckell, Global Packaging Technology Program and Operations Manager, Novartis Pharma AG
Patrik presented on what Novartis are doing about ensuring patient safety and supply chain security through their anti-counterfeiting activities. This is based on three pillars:
- Serialisation/track and trace
- Verification features (covert)
- Tamper evidence
Novartis see that all types of product are at risk, not just those that are high value as counterfeiters just look for opportunities. A combination of solutions need to be applied to combat this – Patrik expressed his view that serialisation without tamper evidence makes no sense as the contents of a pack can be accessed without anyone knowing. Novartis are likely to apply tamper evidence to all products as they are likely to have to equip all packaging lines with tamper evident capabilities.
Patrik outlined the main activities Novartis are undertaking to protect the product and supply chain, cooperate with authorities and other partners, promoting effective laws, educating patients and other stakeholders across the extended supply chain and identifying and applying appropriate technologies. He then discussed key challenges that they have seen during their improvements:
- Delays in legislation and the variety of legislative requirements
- Long implementation timelines
- Vendors on learning curves
- Packaging line capacity and OEE impacts
- Availability of staff for training
- Sharing of learning across sites
- How to ensure a standard product offering for the patient when a product is sourced from more than one site
- Standardisation of solutions
- How tamper evidence can be used as a counterfeit protection
- The need for effective lifecycle management as things move on.
After the Falsified Medicines Directive, what next for the counterfeiters? – Jim Thomson, Chair EAASM
Under the theme of ‘Protect the product not the packaging’, Jim presented on the phenomenon of internet pharmacies and the lengths that fake pharmacists will go to. 97% of on-line pharmacies are illicit and there are over 50,000 fake pharmacy web-sites live at any time.
Jim outlined a trial that the EAASM undertook in Germany in collaboration with some of the PharmaCos where they established a fake on-line pharmacy. In 9 weeks they had 365,000 hits making them the third highest ranked on-line pharmacy in Germany.
The latest activity to legitimise real on-line pharmacies is DOTpharmacy. The domain .pharmacy is going to be available to on-line pharmacies that have been formally approved and registered.
Preventing Poisoning – mobile technology to the rescue – Adesina Iluyemi, Executive Board Member, NEPAD Council
Adesina presented on the issues with counterfeit pharmaceutical product in Africa. The World Health Organisation estimated in 2013 that there were 100,000 deaths/year due to fake pharmaceutical product. Due to the healthcare models in Africa, this is probably underestimated.
In Africa, one of the biggest counterfeited product is anti-malarials. These are typically sold over the counter and due to the informal sales models in typical African marketplaces, secure supply chains are challenging to achieve. Most drugs are imported and there is very little control on imports and borders are very porous. There are attempts to regionalise approaches to control, but this is difficult to do.
Improved information systems are being introduced (supported by the World Bank) but in the future we will need to look to innovative technologies to ensure legitimate product, e.g. nanoparticle coating of tablets that can be checked by smartphones and GPS tracking of products. Adesina believes that until there is a ‘lab-to-mouth’ controlled supply chain, the threat of counterfeit product will remain.
The evolution of the online counterfeiting threat to branded pharmaceuticals – Daniel Bennett, CEO, Yellow Brand Protection
Daniel spoke about on-line brand protection technologies developed by Yellow Brand Protection that look at sales of counterfeit products being sold on-line and detect and monitor hot-spots and enforcement activities.
With the global Pharma market forecast to top $1.1tr in 2015 and with a 40% growth rate in China it is understandable why pharmaceutical products have become attractive to counterfeiters. India and China are responsible for most of the manufactured volume of legitimate product but unfortunately also counterfeit product.
Mail order and internet pharmacies are not new. The first mail order capability was established in 1870 and the first internet pharmacy was in the UK in 1999. However, as an example, we are now faced with a situation where 90% of Canadian internet pharmacies are fake and targeting US consumers, and as authorities try to control this, social media platforms are quickly appearing as an alternative sales channel. China has recently lifted a ban on on-line pharmacies and this is expected to make the situation even more challenging.
Future proofing a secure supply chain – Martin FitzGerald, Deputy Director General, The European Association of Pharmaceutical Full-time Wholesalers (GIRP)
Martin presented an update on EMVO, the European Medicines Verification Organisation, a stakeholder governed organisation who will run the European Medicines Verification System on behalf of ESM. The European hub, as the system is known, in place and working with a German pilot. A blueprint national system has also been defined and negotiations are currently under way with a number of potential providers to facilitate adoption of this model by national authorities. In parallel, the European Commission is looking at how to define the delegated acts, which it is understood will be published in quarter two 2015.
Martin also reminded the audience of the legislative requirements to be met (the need for a randomised serial number and tamper evident packaging by 2018) and reviewed the progress in developing solutions.
Tamper evidence – Solution in practice – Andreas Brandt, Product Manager, Baumer hhs GmbH
Andreas presented on the issues associated with implementing tamper evidence on pharmaceutical packaging as required by EU Directive 2011/62/EU. HHS manufacture a range of gluing equipment for use across many industry sectors and have been participating in industry groups to develop standards for tamper evidence.
Using a gluing solution for tamper evidence means that there will be a visible fibre tear to the packaging on opening, making reuse of the pack unlikely. Two potential gluing solutions are available – hot melt and a hot melt/cold glue combination. Holt melt is very easy to do, but the challenge is that it can be reactivated by heating the box, so the carton can be tampered with. The hot melt/cold glue combination requires additional application heads on the packing line, but the cold glue cannot be reactivated and so provides an effective tamper evident solution.
Child resistant packaging with ease of opening for older people – the building blocks for anti-counterfeiting – Stephen Wilkins, Secretary, The Child Safe Packaging Group
Stephen presented on the issue of ease of opening of pharmaceutical packaging. With an ageing population and the issues of declining vision and grip, older people can struggle to open packaging. The introduction of tamper evidence and child resistant packaging will make this an increasing issue. To combat this, standards on ease of opening are being developed in Europe and will include advice on how to test products.
EU and US anti-counterfeiting legislation – Paul Abbott, Arnold and Porter (UK) LLP
Paul discussed the legal framework for cross-border trade. He explained the responsibilities of the rights-holder, the owner of goods and the customs organisations across EU, US and International. Some practical points raised by Paul included:
- Ensure IP rights are in place
- Decide what you want registered with customs authorities
- Maintain market intelligence to identify risks
- Keep customs authorities updated
- Update databases used by customs officers
- Educate customs authorities so they are best placed to identify counterfeits
- Ensure timely customs issue response capabilities are in place
GS1 Standards: A tool for fighting counterfeiting – Janice Kite, Traceability Director Healthcare, GS1 Global Office
Janice presented on the activities undertaken by GS1 to facilitate the development of global standards. She explained the GS1 system for defining codes through use of identifier keys incorporated in the carrier (barcode and number). These codes can then be used to support track, trace and authentication processes.
Opportunities exist in pharma to leverage the standards that have been developed in retail, and most countries that are requiring authentication or track and trace solutions are basing their regulations on GS1 standards.
Beyond serialising cartons, GS1 foresee that there is a probability for the need to develop single unit dose serialisation standards for numbering of individual blisters. This has been in discussion for a number of years and is a key request from the European Hospital Association.
I hope you enjoyed this short series on the presentations given during the Anti-Counterfeiting Pharma 2015 conference. To read the first part of this blog, please follow this link:
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