OR WAIT 15 SECS
Mark Davison is CEO at Blue Sphere Health Ltd and the author of Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs and Pharmaceutical Serialisation: Opportunity or Perfect Storm.www.bluespherehealth.com
It is very difficult to measure the problem of counterfeiting accurately from year to year; by definition criminals don?t file tax returns or publish quarterly earnings.
It is very difficult to measure the problem of counterfeiting accurately from year to year – by definition criminals don’t file tax returns or publish quarterly earnings. Data compiled by the Pharmaceutical Security Institute seem to show only a small increase in reported counterfeiting incidents during 2010 (1), but there are many caveats. The breakdown of the same data by region implies that Africa has around 2% of the counterfeit problem (2), but as the PSI acknowledges, this is likely to be an underestimate due to lack of enforcement infrastructure. In my opinion, formed by travelling in the region and by talking to local regulators and those working in the field, such as Roger Bate, Paul Newton and others, there is a largely unreported tragedy occurring in Africa and other developing regions because of the high prevalence of fake and substandard drugs.
Mark Davison is CEO at Blue Sphere Health Ltd and the author of Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs and Pharmaceutical Serialisation: Opportunity or Perfect Storm.
With the EU’s Falsified Medicines Directive and similar legislation under discussion in the US, legislators are at last moving to tighten the security of the drug supply chain in our developed economies. However, we need to remember that medicine is global and so is organised crime. Drug-resistant pathogens are emerging in Africa and Asia, partly due to the use of counterfeit sub-potent drugs supplied by international crime syndicates, and there is potential for these resistant forms of previously treatable diseases to spread to Europe and the US. As well as our moral obligation to help, enlightened self-interest should encourage us to equip developing nations with the necessary tools to protect themselves against fake drugs.
At Blue Sphere, we spend much of our time advising companies on technology choice and implementation, so we see a lot of proposals and claims from vendors. Many of these technologies are excellent (and I discuss the key approaches in my book “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs”, Wiley, 2011) but none are a “solution” on their own. In general, we advise companies to use a layered approach combining several different security technologies. In our view, all packs should carry at least one covert technology, such as taggants, and a traceability data carrier such as a 2D barcode. These two features can often be applied in one combined step. Packs should also have tamper-evident security seals wherever feasible.
There will always be new technologies coming along that claim to be counterfeit-proof, but the key is wide-scale implementation. The need for new technologies is less critical than the need to universally adopt what we already have.
Packaging security is still critical. Digital traceability systems, whether full track and trace or end-to-end verification as proposed by EFPIA and others, are only one element of security. A visible printed code can be copied easily and the copy is indistinguishable from the original unless additional features are present on the pack or in the physical features of the code itself. However, there are many challenges in putting physical security on packs: available space, tools needed for verification etc. In Europe, where repackaging is common, a feature on an outer box may be discarded during parallel trade. The closer the authentication feature is to the active ingredient the less likely it is to become dissociated from the product during transit through the supply chain. We work with our customers to devise secure, risk-adjusted strategies that are compliant with upcoming regulations without breaking the bank.
Cost is undoubtedly still a critical factor when implementing a security solution because no one has an unlimited budget. Often, the cost of a new security feature is borne by the product and adds to the cost of goods sold, but this can be counterproductive because it leads to resistance from local market managers who have to bear the price rises. Most companies have poorly-connected management silos so the cost-benefit arguments for product security are often incomplete. Costs are incurred in manufacturing and distribution, and benefits are poorly quantified and only recognised in sales. Best-practice companies have seen that a centrally-coordinated and budgeted approach to product security works better in helping to join up these dots.
We also help companies to think the unthinkable: “How could a criminal break my product security?” rather than just “How can I get this technology to work?” This analytical approach often throws up major process improvements that more than pay for the new system. We also encourage clients to have a Plan B in place that enables a security feature to be rapidly replaced if it becomes compromised.
In my view, the universal application of a robust system today is better than waiting for a perfect solution in the future. We already have the tools today to make a big impact on the fake drug problem. There are also new technologies such as the “fingerprinting” of surfaces (based on intrinsic or printed features), which may offer additional potential, but for now at least, these are secondary systems.
Serialisation (coding of packs at the unit level) is the big step forward and is just around the corner. The arguments over data standards are largely a thing of the past: GS1 will be the underlying format, but there will be a rush to comply with serialisation deadlines of 2015 onwards so companies should not leave it too late to conduct feasibility studies and select vendors. We are already working with some companies on these studies now because they recognise that three years is not a long time to prepare.
Some companies have also realised that the need to equip lines for serialisation is a catalyst for rationalisation. I predict an accelerated move to newer, more efficient lines because older lines may not be cost effective to convert for unit-level pack coding.
In terms of a global or even simply a universal European anticounterfeiting strategy, the Falsified Medicines Directive is a giant leap forward towards a European system for digital security. The US will follow suit and we are already seeing other regional initiatives in India, China and elsewhere. I see the move towards universal traceability inevitable, although there will be bumps along the way.
For physical authentication features (e.g., holograms, inks, taggants), companies must be free to specify which technology they use, guided by legal requirements, rather than governments telling them exactly what to do. As soon as you a make a specific proprietary security feature mandatory, it becomes an easier target for counterfeiters.
A legislative strategy needs to be loose enough to be flexible to changing threats, but specific enough in that it creates a fair competitive environment. We also need to bear in mind the developing countries I mentioned earlier. We owe it to them to make sure they are included in global strategies. Governments and the big aid programmes need to be donating scanners and training regulatory officials, as well as continuing to provide drugs and vaccines.
1. Pharmaceutical Security Institute, “Incident Trends” (2011), www.psi-inc.org
2. Pharmaceutical Security Institute, “Geographic Distribution” (2011), www.psi-inc.org
Mark Davison is CEO at Blue Sphere Health Ltd and the author of Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs and Pharmaceutical Serialisation: Opportunity or Perfect Storm. www.bluespherehealth.com