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Posts Tagged ‘brand protection’

Why Imperfect Counterfeits Are Effective

Wasps are one of the hassles of the English summer and have an abiding fascination for picnics and the inside of windows. They also have something to teach us about brand protection, so bear with me as I take us on a short entomological journey. Not much eats wasps, and for good reason. Their yellow and black stripes are a visual warning of a nasty sting and an unpalatable taste. Predators quickly learn to avoid them and move on to easier prey. This fact has not been lost on harmless hoverflies, who belong to an entirely different insect group and are more closely related to houseflies. Many hoverflies look very much like wasps. The evolutionary strategy, called Batesian mimicry, gives them a survival advantage since birds and other predators largely avoid them. Hoverflies lack a sting and are thus defenceless if their bluff is called, so you would think they would evolve over time to be well nigh indistinguishable from wasps. However, it turns out that hoverflies don’t always need to make a perfect job of mimicking wasps to gain the benefit. Some are pretty good copies but some species are just vaguely yellow and/or a bit stripy. As elegantly demonstrated in an article in Nature last week (doi: 10.1038/nature10961) the similarity between hoverflies and wasps increases with body size (of the insects, not the observer). The authors show that this correlation is probably because smaller flies are less attractive to predators and so don’t get eaten as frequently as larger ones. They therefore have less selective pressure to be a perfect match to their stinging cousin. For small hoverflies, fooling most predators most of the time is apparently good enough, on average, and evolution doesn’t over-exert itself. On the flip side, birds like to eat big insects so if you’re large and juicy you’d better look pretty much identical to a wasp if you don’t have a sting to back up the visual threat. The article made me wonder if this relationship applies in pharmaceutical counterfeiting. Is there a correlation between size (of the benefit to the counterfeiter, in this case) and fidelity (the visual exactness of the counterfeit or its packaging)? If this is the case, counterfeits of expensive drugs should be more convincing than those of cheaper drugs, on average. This fits with intuition and anecdotal evidence but I’d be intrigued to see an academic study. More interestingly perhaps, can we use other elements of evolutionary theory to tackle counterfeiting? As I have pointed out before (Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs, Wiley, 2011) there are several parallels between biological evolution and the ongoing war between genuine and counterfeit manufacturers. If the hoverfly theory predicts that low priced fake goods don’t need to be good copies to gain an economic benefit, how can we change the game in favour of genuine products? How about raising predation levels? If my analogy is right, then the tactics are clear. Coordinated, collective swoops by all brand owners in a region, focused on the small flies (low priced products), should drive some counterfeiters extinct and force others to evolve more expensive mimickry to stay in the game. Life gets harder and the cost of doing business goes up. In the long run, this tactic of targeting all low priced brands should be more effective in protecting public health and in reducing the overall burden of counterfeiting than efforts by individual brand owners to protect their expensive brands with their own internal resources. This logic means that building local enforcement capacity is just as important as putting ever-more sophisticated taggants, holograms or closure seals on our packs. The arms race between criminals and genuine manufacturers is not going to be over any time soon, but we need to be systematic in how we fight the war. Its not rocket science, but it is science. If you want to discuss your brand protection needs, contact me at mark(dot)davison(at)bluespherehealth(dot)com or leave a comment below. Photo: Mark Robinson from flickr
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Pharmaceutical Anti-Counterfeiting: Lessons from Avastin

Counterfeit medicines are not an entirely new thing in the American consciousness but when fake Avastin was reported this week it sent a larger than usual ripple through the news media.  I have been interviewed in the past 24 hours by Al Jazeera (see link or at right) and the Wall Street Journal. Why the fuss? Maybe it was because Avastin is a Swiss-designed, injectable cancer drug used only in hospitals.  This is a long way from dodgy Viagra bought over the internet or on a foreign trip, which is the image most people associate with fake drugs – if they even consider the issue at all.  Somehow, counterfeits have breached what should be a super-safe hospital supply chain and may have put patients at risk (although exactly how many patients received the medication is unclear).  Roche and Genentech were not directly at fault in this case but are there lessons that can be learned from their misfortune? How and why did this event happen and what can companies do to stop it happening to their products? The simple answer to the “how?” question is that plausible-looking fake Avastin packs, bearing familiar brand names and logos and containing authentic-looking vials, were good enough to fool professional medics.  It might be impossible for doctors and nurses to check the chemical composition of the active ingredients, but closer inspection would have revealed that the packs were apparently French in origin and bore the hallmark of parent company Roche, not the livery of the US-licensed manufacturer (and Roche subsidiary) Genentech.  The appliance of common sense should then have started alarm bells ringing, and indeed it may have been user vigilance that picked up this event in the first place.  FDA is now investigating. The “why?” question is more complex but the answer boils down to organisations trying to shave dollars off their drug bill by buying from grey market channels.  The French packs were supplied by a foreign distributor to at least 19 practices in the USA. Where exactly the distributor got them from will be established (I hope) during the investigation.  If hospitals and medical systems stick to the standard, regulated supply chain there is very little risk of receiving counterfeit products but it is precisely when people go “off-piste”, as appears to have occurred in this incident, that they put patients’ welfare at risk. If you’re a drug manufacturer or distributor, how do you stop a counterfeiting incident damaging your reputation and harming your customers? The first stage is to have a strategic approach and to act before you have to.  Don’t wait for the calls from FDA, CNN and concerned patients.  As they say in aviation, if you think safety is expensive try having an accident. I have written here several times about our DRASTIC framework for approaching anti-counterfeiting in a planned way.  The current move to serialization, epedigree and other traceability systems is soaking up a lot of budget and management time this year. There are legislative deadlines coming up in the USA, the European Union and elsewhere that will require manufacturers to code every single pack they make.  This will enable far greater supply chain transparency than we have today and will make it far harder for counterfeiters to insert industrial quantities of product into the legitmate supply chain.  But the dash for codes should not obscure the role played by old-fashioned authentication.  Visual inspection and the use of physical features – intrinsic or added, visible or covert – to reliably differentiate real from fake products is still a valuable tool in the arsenal.  An integrated anti-counterfeiting strategy needs both digital coding and physical authentication.  Neither is sufficient in isolation but together they are a strong deterrent against all but the most determined criminals. For those who would seek to delay mandatory compliance deadlines such as those in California (2015) or the EU (2016-17), ask yourselves whether it wouldn’t be a better strategy to get organised and get moving with your own initiatives so that the next Avastin-type incident doesnt happen on your patch. If you don’t know where to start, or you need help fine-tuning your strategy and tactics, we can help.  Blue Sphere Health are worldwide specialists in serialization, epedigree, authentication and related aspects of product security.  Contact us today for a confidential discussion or get in touch with me personally right now at mark(dot)davison(at)bluespherehealth(dot)com.      
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Safeguarding America’s Pharmaceuticals Against Counterfeiting and Diversion

September 22nd, 2011 saw the introduction of HR 3026 or the ‘Safeguarding America’s Pharmaceuticals Act of 2011’ into the US House of Representatives. Itself an update of an earlier bill, the document contains some interesting elements that could have big repercussions. Taking the Fifth… First of all, let me give the standard caution that most bills don’t make it out of the committee stage so this is a long way from being law. However, assuming for a moment that it represents current Democrat thinking, let’s examine what it would mean if passed. Pedigrees The bill is based on the ‘pedigree’ model, with (broadly) every transaction recorded for every pack as items travel through the supply chain from Authorised Distributors of Record (ADRs) or manufacturers right through to pharmacists. This is in contrast to the likely model in Europe, where end-to-end verification is favoured as a more workable option. In the latter, so-called ‘bookend’ systems, the pack is coded and checked at the manufacturing or packaging step and again at the pharmacy before dispensing but all intermediate code checks during distribution are optional. Big Pack, Little Pack, Cardboard Box Pedigree imposes a much higher burden on the supply chain, partly because the most practical coding technology is visible printed codes – usually in a two-dimensional matrix format. These codes require line-of-sight: the scanner must be able to ‘see’ the code optically with no intervening opaque packaging. This is an obvious problem when packs are aggregated into shipping case and pallets. It is simply not feasible for distributors to unpack, scan and repack large volumes of material, so a workaround known as ‘aggregation’ is used. In this process, the unit pack codes that go into a larger box are associated together in a database together with a secondary code that is applied onto the bigger container. The process is repeated as necessary up to pallet level. Mongrels Thus by scanning a single code on the pallet, an operator can (in theory) find out the codes on all of the unit packs contained within. This all works well. Until it doesn’t. The pharmaceutical distribution process is complex and for many reasons shipments are broken down, mixed with other products and reaggregated before being sent onwards. There are multiple opportunities for someone to fumble the ball and when they do the whole consignment could become unsaleable due to lack of a viable pedigree. Return-to-Sender Encouragingly, the returns process is also addressed in the Bill and included in the pedigree requirement. The ‘reverse logistics’ operation of returning expired or unwanted goods back up the supply chain has been vulnerable to fraud in the past. Code but no Enigma Standardized numerical identifiers will be needed for a coherent coding and tracking system and this is also addressed although FDA thinking on this has been provided already. The danger of a non-globally-aligned numbering format seems to have passed and any implemented system is likely to be a GS1-harmonised structure based on existing National Drug Codes. California, USA The timetable for applying codes to packs is pretty much that of the existing California pedigree deadlines, i.e. starting on 1 January 2015, and (sensibly) any Federal regulations would automatically supersede state provisions. So no shocks there on timing but a much bigger scale of challenge to comply nationally on the same timescale. This timeline also ties in broadly with the anticipated schedule for the implementation of traceability provisions in the EU Falsified Medicines Directive. SWOT Team The Bill also calls for a study into threats, technology choices and gaps in current government processes. This is to include ‘consultation with technology developers, drug manufacturers and other interested parties’. Time to make your thoughts heard. Conclusions This is just my initial reading of a Bill that may well not come to pass. There are no easy ways through this serialization / pedigree problem but we owe it to patients to try to seal the supply chain against fake drugs. Any traceability system will be complex, but I think going for a full pedigree model in one step is not the way to go. It is technically feasible, but it will be needlessly expensive and risky compared to the alternative model. Next steps If your company is struggling with these issues and you need some advice on strategy, technology choice or other aspects, then contact Blue Sphere Health. We help customers to solve these traceability challenges cost-effectively and in a way that adds value rather than just raising costs. For a fuller discussion of supply chain issues, authentication and other elements of the fight against counterfeit drugs, see my new book “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs” (Wiley, 2011) reviewed here.
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Global Anti-counterfeiting: Coordinated Action Against Fake Drugs

Globally-coordinated action involving 81 countries has led to dozens of arrests and the removal of websites believed to be selling counterfeit drugs. Operation Pangea 4 was coordinated by Interpol and involved regulatory and law enforcement authorities from around the world including the Metropolitan Police and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Like previous operations, close coordination was the key to success. The internet is a critical battleground in the war on fake medicines and the scale of cooperation involved in Pangea 4 and its precedents is encouraging. I know from personal contacts how much individual toil and commitment lies behind these initiatives, and we should congratulate all concerned. The same level of cooperation is starting to happen in the the authentication and traceability of genuine drugs. Serialization and epedigree initiatives, such as the measures outlined in the EU Falsified Medicines Directive this year, will gradually improve supply chain security. A layered authentication approach to security features on packaging and (where appropriate) the addition of physical-chemical identifiers in the formulation itself will make it harder for counterfeiters to keep up. I have discussed strategic frameworks here before and my new book has some discussion of the wider issues and available counter-measures. You can buy it direct via the button on the right of this page. There are no magic bullets against counterfeit drugs and we will probably have to accept that this crime can never be fully stamped out, but let’s take a moment to focus on what we CAN do. Operation Pangea 4, and the other coordinated initiatives now starting to happen, are a major step in the right direction. Photo: Interpol
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Book Review on

I am delighted that Dirk Rodgers of influential pharmaceutical industry blog has written a full review of my new book “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs”. I recommend you read the review and then look around Dirk’s blog for inspiration. Several of his in-depth essays were very useful in preparing the book. The sharp-eyed amongst you will notice a “buy now” button on this page if you want to get hold of a copy. The link takes you to a secure Amazon site. I am keen to get more reviews, feedback and suggestions for additional content in the next edition. Please leave a comment below or get in touch via the Contact Us page.
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Anti-Counterfeiting as a Commercial Challenge : Five Forces of Competition

Counterfeiting and illegal diversion of drugs are criminal activities that should be pursued with the full force of the law. The rise in counterfeit drugs and fake food isn’t due to lots of canny entrepreneurs making a fast buck locally. It is often organised crime syndicates operating globally and risking people’s health and lives on a large scale. The need for strengthened legal sanctions against counterfeiters of ingestible products has been obvious for some time. In many countries, the punishment for peddling fake medicines is the same as for selling fake clothing. But if my t-shirt fades or falls to pieces there is a lot less danger to my health than if my painkiller contains lead, rat poison or leftovers from yesterday’s batch of penicillin. Strengthening enforcement by making these crimes a separate offence rather than an intellectual property infringement issue is a key step in the war against counterfeit ingestibles like food, drink, medicines etc. However, as business people we also need to play our part in fighting back. We need to stop procrastinating, choose the battlefield and use our weapons. To do that, we need to think of counterfeiters as commercial competitors and figure out ways to beat them as business rivals. There are a number of ways to look at competition, but I’m going to use the classic “Five Forces” approach as a framework for this discussion. If you haven’t read “Competitive Strategy” by Michael Porter I fully recommend it. Professor Porter argued that competition in any given industry can be characterised by the same five market forces. These five forces – which shape the competitive environment for steel, semi-conductors and soap powder – all have their parallels in anti-counterfeiting. Porter’s classic Five Forces model is summarised in the diagram below, taken from the Harvard Business review.

Threat of New Entrants: How are you preventing counterfeiters entering your market? Are your procurement processes robust enough to prevent leakage of IP when outsourcing? Is your supply chain secure? This category is mostly an internal improvement challenge. Anti-counterfeiting is not just about fairy-dust taggants and serialization. Old fashioned business common sense and process control are also critical. Kaizen isn’t a Japanese beer. Bargaining Power of Buyers: This is a trickier force to deal with. Social healthcare systems or other large payors have significant negotiating muscle when dealing with drug companies. Supermarket chains have the same power over food and other FMCG suppliers. The key is defensible pricing and unique offerings. If your price is higher than an (apparently) equivalent competing product but your perceived value proposition is no different then you will be vulnerable to price pressure. On the other side, major purchasers who only chase cost reduction are in danger of attracting less scrupulous suppliers and counterfeiters and in turn damaging their own brands. Threat of Substitute Products or Services: This is the category where most of the brand protection technologies try to make a difference. Making your product or service demonstrably and visibly unique is a good tactic in preventing counterfeits. It is still surprising how many brand owners are content to sell high value items in low complexity packaging. This may be due to the mind-set of some R&D based industries like pharmaceuticals – the function is more important than the form. Consumers think the other way round, very often. They assume that something that looks the same as the original will do more-or-less the same thing. This logic applies to medicines, food or Louis Vuitton bags. Ask yourself whether you have made your product or service truly unique. Is your packaging hard to duplicate or can it be sourced on the open market at How difficult is it for someone to copy your form factor (tablet shape, device components, bottle design etc)? Bargaining Power of Suppliers: In situations where supply of raw material is insufficient to meet demand, the supplier has an opportunity to make very easy money by adulterating or counterfeiting their material. This is the root of the heparin tragedy of 2008 which probably caused the deaths of over a hundred people. If one of your raw materials is often in short supply or is only made by one or two suppliers then ask yourself how you could engineer that dependency out of your production process. Rivalry Amongst Existing Competitors: This last category should be irrelevant to counterfeiting. Rivalry between legitimate suppliers only affects their businesses, surely? Well, no. Misplaced rivalry can create perfect conditions for counterfeiting. If I want my brand to dominate against a competitor’s similar product, then I might be prepared to tolerate a high level of fakes on the basis that it is “free advertising”. In the public consciousness, brand ubiquity often means brand reliability. If everyone is using it then it must be safe. Counterfeiting is breaking down that connection and some of the big global brands are playing Russian roulette by tolerating fake versions of their products. Off-label usage of drugs is another example of commercial rivalry that invites counterfeiting. Although it is usually not illegal for a physician to make a personal judgement and prescribe a drug for a condition for which it was not licensed, it is generally illegal to promote that use. Several companies have been heavily fined in the past for knowingly selling their products (or tolerating their promotion by others) for indications in which they were not licensed. The commercial advantages of this are obvious. In time of lean sales growth it can bring much needed revenue and may help keep the stock buoyant versus the competition. However, the market buzz about such products can create an opportunity for illegitimate suppliers to use the internet to supply that growing demand. Look in the mirror and ask yourself if all your company’s commercial practices are compatible with anti-counterfeiting and consumer safety. Even if your own products are top quality, could your commercial activities be encouraging the proliferation of fake, diluted, diverted, expired or adulterated versions? There are no magic answers against counterfeiting. It is simply too lucrative and low risk for criminals to avoid the temptation. That doesn’t mean that there is nothing we can do about it. Start treating it like any other business problem and address the competitive challenges in the normal way. Blue Sphere Health works with companies large and small to address the issues raised above. If we can help, please get in touch. If you enjoyed the post please tweet, like or comment.
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Baseline Data for Risk-Based Anti-Counterfeiting

Technology issues such as serialization, epedigree and traceability initiatives are going to command the attention of executives in several industries over the next few years. As I mentioned in a previous post, the summer months are a good time to think about how you can improve processes for anti-counterfeiting, authentication and brand protection activities. One of the most effective actions is to take a Reality check. It constantly surprises me how many corporations don’t pro-actively look for fake products. They rely on consumer complaints, customs seizures etc. Find out what is really happening in the market place by designing and conducting surveys and buying back your own products for analysis. By getting a picture (however fuzzy) of your risk profile by product and geography, you will be much better placed to prioritise your anti-counterfeiting activities on a quantitative footing. Don’t just make a guess based on the few incidents that get reported to HQ. This is probably the tip of the iceberg since most people don’t complain about bad products they just don’t buy them again. You don’t have to actually implement your survey now but you can take the time to get it properly designed and planned. You might want to delay implementation until after the summer anyway to get a more representative commercial picture of what’s happening and to have more field resources available to conduct the survey. Making test purchases involves sending people to buy your branded products on your behalf (almost always anonymously to avoid sample bias) and then checking the authenticity of those products using field tests or in the laboratory. It sounds simple but this is not a trivial exercise and must be planned and executed carefully. Some companies therefore outsource this monitoring task to specialist companies. Design and conduct the survey as scientifically and as systematically as possible to avoid skewed results and bias. Some impressive-looking official surveys have used flawed methodology and given unreliable results that do not stand up to close scrutiny. This may be due to naivety, political motives or incompetence. If in doubt, get independent experts to conduct the survey. Surveys by reputable independent groups (whether academic or commercial) will give much more accurate results than those conducted by governments or sales representatives. Some of the most common methodological flaws are those that alert store owners to the true nature of the purchasing exercise. This forewarning may therefore skew the results and result in a falsely low estimation of counterfeits. To avoid tipping off the seller or distributor, sensible survey tactics are needed and shortcuts are likely to be counter-productive. Sending foreigners to conduct the survey is clearly going to be a red flag. When I (an obvious Caucasian) went into an Asian pharmacy recently I was shown a completely different set of products to those displayed to my local colleague when he went in on his own a few minutes later. Another common error is asking the surveyor to purchase six or seven unrelated products from your company at a single store. Although it cuts down the number of stores in the survey, this is an obvious signal of a corporate surveillance exercise rather than a private purchase. The design principles of surveys and the practical techniques required are a specialist skill and it is worth getting experts involved. The cost of a proper market survey is small compared to potential revenue erosion from counterfeits and the cost of anti-counterfeiting technologies. A final reason to be careful and professional about surveys is that there is a lot of profit to be made from fake products. Those who are complicit in the trade can be expected to defend their business – violently when necessary. There are therefore real safety concerns in conducting ‘mystery shopper’ exercises in some locations and thorough risk assessments should always be conducted beforehand. Survey staff should not be put in compromising positions. This is not an activity for amateurs (students etc) or the untrained. Spending the time to get quantitative information on your counterfeiting and diversion problem – where it is, what the prevalence is, what products are most affected, etc – will pay dividends when you come to make a business case for anti-counterfeiting. The traceability, serialization and epedigree initiatives that are on the horizon in several industries will be a mandatory compliance issue, but savvy companies will underpin their system-based security activities with real, before-and-after, market survey data. Only that way can we know if all this investment is making a difference. Photo: The Consumerist via flickr
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Anti-Counterfeiting: Six Summer Actions

Today is Independence Day in the United States. It is also the first Monday in July and the start of the summer vacation season. Getting anything done that involves teamwork seems to get inordinately difficult. I used to get frustrated by this period of the year – the benefit of two weeks holiday offset by reduced productivity for two months – but now I use the time to address the fundamentals of my company. When we are busy ploughing the furrow in the daily activity of our businesses or jobs it is easy to lose sight of the strategic factors that underpin them but the quieter summer months are a good time to focus on the long-term tasks that will really improve your performance for the rest of the year. If July and August are a less busy time for you, here are a few ideas for things to work on in the gaps. They will really improve your brand protection and anti-counterfeiting activities for the rest of the year. 1. Check your strategy: Do you have an agreed, signed-off brand protection strategy? Have you reviewed it lately? Unless you answered yes to both, then now is the time to write a draft or check and revise the existing document ready for discussion and approval when the boss is back from Hawaii. 2. Measure your risks: Have you looked hard at the prevalence of fake or diverted products recently? Don’t assume that because you didn’t have a problem last year then you’re safe this year. If you haven’t done a market survey for a while then now is the time to design one. 3. Build your internal network: Email or (better) call the managers of the local affiliates in all the countries where you operate (some of them will be at their desks) and say hello. Build your international network ahead of time and make it work for you – get views and suggestions and generate dialogue. Local eyes and ears are a much more effective (and cheaper) surveillance tool than your occasional long-haul trips from HQ. Next time something suspicious happens, you are more likely to get a timely alert if the manager knows you by name. 4. Reach out externally: The same principle applies to external contacts. In a busy customs office, vigilance is thinly spread. If they know your voice, have your number, and you gave them a training manual on how to recognise fakes of your product, then they are much more likely to help you. Make the contacts before you need them. 5. Train yourself and your staff: Summer is a good time for training small groups of people. Although budgets for general “soft skills” training are under pressure, there is still money available in most organisations for specialist training with defined outcomes. Brand protection courses provide direct and immediate benefits for a very modest outlay. We provide bespoke courses for corporate clients covering all aspects of anti-counterfeiting and brand protection. Make time to “sharpen the saw” as Stephen Covey’s seventh habit says. 6. Predict the future: Some events are beyond our control. They just spring out from nowhere and we have to deal with them as they occur. Most things are more predictable and they can be planned for in advance even if we have to adjust along the way. What legal initiatives, regulatory changes or quality trends will affect your business in the next five years? What preparations and benchmarking initiatives could you be putting in place today? Are there any useful reports you could buy that will give you a head start? Ironically, at Blue Sphere Health it looks like we’ll be having a busy summer this year, with the launch of my book on Friday, some great new training material we’re finalising, and ongoing consultancy projects. But if you hit a quiet patch and you’re getting frustrated by “out-of-office” email auto-replies and “call me back in four weeks” voicemail messages, try doing the six things above. I guarantee you’ll hit September in better shape to protect your brands from counterfeiting. Photo: StuSeeger from flickr
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EU Falsified Medicines Directive: What’s Happening Next?

The ratification of the European Union’s Falsified Medicines Directive marked the beginning of the end, or at least the end of the beginning of a long process. This was the first time that such a large economic bloc had passed clear legislation aimed at securing the supply chain for pharmaceuticals. Cautious rejoicing all round. The next stage is that remaining details of the Directive will be converted to law by a “delegated acts” process. A fairly new legal procedure, this will be where the deal-making is done and the detail is finalised. There are lots of critical details to discuss, even before the lawyers get involved with drafting the wording itself. Who pays for what? Where does the data go? Who has access to it? What security features need to be used? etc, etc, etc. Two key tasks are being conducted in parallel. Firstly, an economic impact assessment is being conducted to look at what this will cost and who will bear the burden. This is likely to take some time. At the same time, a stakeholder group will examine technical issues under the oversight of the Directorate General for Health and Consumer Policy (commonly abbreviated to DG SANCO) the Brussels directorate responsible for the process. This stakeholder group, which includes trade bodies representing drug makers, distributors, repackagers, pharmacists etc, will try to thrash out a pragmatic, affordable solution which allows the implementation of traceability and security features at a reasonable cost. There are five main themes to be covered: Unique identity (serialisation): technology choice and implementation Governance of the system: deciding who sees what data and on what terms Modalities of verification: deciding how packs will be verified and what level(s) of authentication feature(s) will be required Whitelist and blacklist criteria: determining which prescription drugs are excluded from key requirements (deemed safe) and which non-prescription drugs are included (deemed risky)? Mechanism of notification: of whitelisting and blacklisting Prickly issues like ownership and use of information will need creative solutions. Drug traceability data is a boon for anti-counterfeiting but it contains very valuable commercial information and potentially could be linked to very sensitive patient data. One idea mooted is to use a not-for-profit vehicle to “own” the central repository or data exchange mechanism, with 15 or more national databases linking in. Public sector leadership has also been proposed. The timescale for the technical evaluation process is expected to be similar to the impact assessment, so the output for both is likely to be during 2014. There will be a three year implementation window once the Delegated Act is published. So the main activity in terms of capital expenditure and equipment installation by the pharmaceutical industry is likely to be geared towards being ready for roll-out from 2017-2018. Given the remaining uncertainties, and the other mandatory serialisation requirements in a similar or earlier timeframe (USA, Brazil, China etc) the best course of action for drug manufacturers is to be flexible in their approach. They need to ensure that their technical response (hardware, software and processes) stands the test of time and is able to respond to potential geographical variances. So take the time to work out a coherent strategy, but don’t wait too long or the queue for the most sought-after vendors might get a bit too long. Blue Sphere Health is helping several drug companies to formulate their thinking in this area. For more information on how we can help, please get in touch.
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Anti-Counterfeiting: Picking Your A-Team

The previous post looked at how to get senior (CEO/COO) involvement in your anti-counterfeiting initiative. Once you have achieved this absolutely critical step you need to go ahead and pick a cross-functional team to examine all the issues, propose solutions, and drive the implementation process. The team members may change over time as the project goes from strategy to tactics to implementation. I have given a list below of some of the roles that may be needed, and the issues they need to consider. The functions are not in order of importance. Your organisation may have different names for these departments or they may put them in different groupings, so take this as a guide not a prescriptive list. It is taken from a real-life pharmaceutical industry example but with the exception of a few specific references (GMP, GDP etc) it is generic to any industry or brand owner. I have listed Product Security as a separate function. This generally works best, especially if they have a separate budget. However, some companies have this responsibility within manufacturing, security or QA functions. The critical point is that the group or person responsible must have the gravitas and authority to coordinate product security across departments. For advice on how to select the A-team your organisation, please get in touch for a confidential discussion. As well as strategic consultancy, we provide workshops, facilitation and coaching on the practical aspects of these processes, so you don’t have to go it alone. Chief Operating Officer (Sponsor) Ultimate decision maker and process owner for the corporation. If not the COO then it needs to be C-level or a direct report. Product Security (Process facilitator) Coordinate serialisation, traceability and authentication processes across functional silos. Report progress and ensure continued management buy-in. Prioritise sub-projects and balance risks with counter-measures. Coordinate security features across products and geographies. Ensure efficient use of security vendors. Manufacturing and Technical Operations Product components (e.g. dosage form), primary and secondary packaging, Good Manufacturing Practice, serialisation, implementation of tamper evident closures and security features, securing supply chain, transport security, third party certification, use and monitoring of sub-contractors, enforcement of Good Distribution Practice, security vendor selection and management (coordinated by Product Security) Legal Liability issues including corporate insurance, legal investigation, contracts and agreements, compliance with local laws, global monitoring for future mandatory requirements. Regulatory Affairs Liaison with national authorities, control and reporting of labelling changes, Good Manufacturing Practice reporting, etc. May include post-marketing surveillance activities (such as pharmacovigilance in the drug industry) Quality Assurance Ensure quality of product, safeguard patient safety. Product analysis (routine, complaints, returns), product recall actions, compliance with statutory quality requirements Security Enforcement, incident reporting, web surveillance, personal safety, site security, coordination with other brand owners, liaison with law enforcement authorities etc Audit Internal audits, external supplier audits, fraud investigations Information Systems (IS) IS requirement for implementation of serialisation and traceability, link to Manufacturing Execution Systems (MES) and Enterprise Resource Planning (ERP), link to existing legacy IS, implementation of incident reporting tools etc Marketing & Sales Pack design and integration of security features, local market knowledge, market surveillance, commercial agreements with third parties, training of sales staff to recognise and report counterfeits R&D Security by design, integration of taggants and tracers into the product itself (where possible and appropriate) Conclusion If you bring the right people together, under the leadership of someone who is their collective boss, and with the day-to-day coordination of someone who has genuine delegated authority to get things done, then you are on the right path to success in your fight against counterfeiting. The best friend of the counterfeiter is our own incompetence and confusion, so fix internal processes first before fighting back.
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Pharmaceutical Anti-Counterfeiting

Combating the Real Danger from Fake Drugs has become a must-have primer on anti-counterfeiting and is widely used by drug companies, regulators and others. The book covers the legal, strategic and political issues as well as the technical counter-measures such as process control, digital serialisation and physical security.

Pharmaceutical Anti-Counterfeiting book