Forbidden Fruit

Treachery. It's not clever, but it is big and, in pharmaceuticals at least, is definitely on the up. Civilised society will probably be plagued until the end of time by minds of questionable scruples, those people who rifle through your bins in the hope of stealing your identity, or fraudulently reproduce your credit card or bank details and take you for all you've got, sometimes more.

Yet, to risk people's health, their most valued possession, by fabricating inactive replicas of life-giving medicines? It's abhorrent; something Voldemort would be proud of. It's also worth an awful lot of pounds and hence lures some of the biggest crime syndicates into it. To banish this business of counterfeiting medicines back to the depths of perfidy will not be simple, but achieve this we must.

Of course, Shakespeare wrote in Henry IV, part ii, of `the oldest sins, the newest kind of ways', which we all recall. That he wrote a little over 400 years ago and yet even now it strikes a chord when you consider that `professional' counterfeiters are out there able to dupe, steal and defraud even in our time of health and safety priorities, where the drug supply chains are reportedly monitored and shielded against security breaches, and the pharmacists are asked to trust the wholesalers to provide them with bespoke, tamper-free manufacturer packs.

Who is producing counterfeit medicines, where, why, what damage is it causing and what can we do to fight back against the repugnant practice? Some of these questions are easy enough to answer, the `who' comprising individual and small-time groups of illicit opportunists right through to sophisticated organised crime networks around the globe.

Where? According to the latest intelligence made available outside the closed circles of security, nearest to us it is Russia that has the largest counterfeit medicines market, of which the World Health Organisation (WHO) estimates around 12 per cent to be imitation. Faking it in drugs is a truly global operation, though the authorities have also regarded a number of eastern European regions as highly probable fake makers and suppliers since the EU barriers came down.

We have been warned that as progressively more underprivileged and insecure nations join the EU guild, the incidence and depth of drug counterfeiting aimed at wealthy western markets like the UK is likely to continue to rise.

Why do these polluters of our drug supply channels choose to do it? Cold hard cash and lots of it, is the straight answer. In past times, the Food and Drug Administration (FDA) in America has stated publicly its concern that medicine counterfeiting schemes have been used to fund international terrorist organisations. The government of North Korea, which we're informed by our media news channels has recently flexed its prospective nuclear muscle, has also been linked with the sale of counterfeit drugs; this is according to a former commissioner at the FDA.

Counterfeiting is a low-risk, high-profit pursuit and, say some who believe we're leaving ourselves quite open to such intrusion, can be shockingly straightforward to undertake. The claims of `international healthcare terrorism' you can read about today might sound alarming, though even if not all of the profits are sent to support such grand manoeuvres, this unprincipled business of conning innocent wholesalers, pharmacists and, most importantly, patients into accepting drugs with a tiny or non-existent dose of active ingredient is alive, kicking and affecting business and treatment provision in this country. The chief question is, how well protected are we as patients and pharma businesses in the UK?

Lock the back door
The answer to this question is not as straightforward, in part because things are changing significantly even as you read this. Certainly it is possible to reflect general sentiments, though even then incongruity reigns as it depends on whom you ask.

On a scale of one to 10, where 10 represents the hypothetical scenario of being 100 per cent safe and protected against counterfeits, and one represents an invitation signed personally by Sir Ian Blair to sell fake drugs here, some feel that our current number could be close to zero; others would suggest three, while those security officials in the employ of the government whose jobs are to protect all of us from this pestilence might not wish to give a number, sufficing to say that it would be appreciably higher now than it was a few years ago; less than a year ago, even.

It's definitely one of the key priorities, as identified by government ministers, for the agency and we're getting better at looking for and finding counterfeits, and carrying out in-depth investigations and criminal prosecutions hand-in-hand with the police force, says Mick Deats, ex-National Crime Squad and now group manager of Enforcement and Intelligence at the Medicines and Healthcare products Regulatory Agency (MHRA).

The UK's agency for `patient protection' has reacted like a spotted fox in the last year or so to match its might with the rapid emergence of the counterfeit drugs industry, with Deats now heading up a team of 40 staff, of which most are investigators and intelligence people and many of which have a police or trading standards background.

He's frank enough to admit that the agency is not made out of titanium and hence cannot guarantee total protection for UK patients from counterfeit drugs, even in the regulated supply chain. Indeed several high profile non-MHRA industry figures have expressed opinions that the agency has not been up to the job in this respect, and some fervently believe that state of affairs to be unceasing.

However, Deats is very keen to highlight that, while you'd have a tough job finding any government agency that says it doesn't want more resources, the MHRA has a bespoke and keyed up security team with biting legislation at its fingertips and regular invitations to partner the police force on medicines-related constabulary business. The drug fakers aren't going to get away with this scot free.

We're bound by the Medicines Act of 1968 under which certain powers are conferred upon investigators in the MHRA, such as power of entry into private and business premises, and seizure and examination of computers and documents, plus whatever other items we suspect are linked to the illegal sale of medicines. But we're also permitted to pursue counterfeit drug cases under the Trademarks Act, which carries with it a 10-year maximum prison sentence [versus a 2-year maximum under the Medicines Act] and is more likely to trigger action under the Proceeds of Crime Act, he notes, explaining that the agency can take care of most things under its own steam, including not only investigation and confiscation of items, but also case preparation and prosecution of villains in court.

Pharmaceutical crime, including counterfeiting, was not a matter that, historically, wormed its way onto the top of the police's list of `things to sort', rather being bumped down the queue of other pressing issues.

The MHRA recognised that and consequently has grown its Enforcement unit over a number of years so that it has the means to deal with some of these issues itself. If we get any indication that there is counterfeit activity here in the UK, or there are people engaged in counterfeit activity which impacts upon the UK, we'll do all we can to take action, Deats states.

Hopes and fears
We are assured then that the MHRA is not lying down counting sheep. The agency plans to release its official counterfeit strategy by the end of the year alongside instigating the first of what will be a series of six-monthly consultations with pharma companies and trade associations to focus on the pinch-points, areas where we need to be more vigilant - where it's important for us to share intelligence, adds Deats.

According to other parties, however, the MHRA needs to sharpen up further still and some pharma companies operating in the UK are not doing nearly enough to protect themselves from the negative consequences of a counterfeiter trying to `steal' their products, if not unlawfully `borrow' their identities.

I'm accused of being an MHRA-basher, but nothing could be further from the truth. We should all be lobbying for a massive increase in the MHRA's budget and human resources, and there is no doubt that its stance has changed in the last 12 months, notes Jim Thomson, European liaison for the Partnership of Safe Medicines (www.safemedicines.org), a group of organisations rallied against counterfeit drug operations.

That notwithstanding, when the regulator goes on national radio and defends its decision not to issue a recall of a counterfeit medicine because it did have some of the active ingredient - or incredibly `another active ingredient' - I think we have a problem. When I ask the regulator in how many cases in 2005 where fake Lipitor was found in the supply chain did the companies involved also hold parallel trade licences and the response is `all of them, what's your point?', I think we have an equally large problem.

Thomson, who also serves as CEO of the Centre of Mental Health, points to the recent increase in counterfeit medicines discovered in the UK's regulated supply chains - something the MHRA may argue is indicative of its own intensified fervency - as part of a global growth in the crime, yet adds that the UK should be working harder to protect its patients.

There is no doubt that many UK companies are certainly not doing enough. Until fairly recently, counterfeit medicine was an issue that, if not actually swept under the carpet, was kept in a tidy pile in the corner awaiting the broom. We now know that there is a clear and present danger, but how serious is the problem?

Intensifying
The WHO thinks it is a £26.5bn-per-year problem which has so far contaminated 10 per cent of the medicines supplied to the developed world and 25 per cent of those in developing regions. America's Centre of Medicines in the Public Interest forecasts counterfeit sales to reach around £39.9bn by 2010, which would represent a 92 per cent increase over 2005.

If the WHO has got this right, that would mean some 65 million UK prescriptions each year were being filled with fakes. Even if the WHO, which is not prone to making errors, had got it wrong by a factor of 100, it would still mean that 650,000 patients each year in the UK are happily leaving their pharmacy with fake medicines, Thomson points out.

A raft of companies operating in the UK have already moved to protect themselves, their customers and the patients. Some of the technology now available to validate the authenticity of a medicine pack is quite high-tech and a bit nifty, but track and trace is not employed universally across the industry and, a good buttress though it is, still leaves a few weak points in the barricades. Other things can be done.

The world's biggest pharmaceutical company has not only allegedly brought, and I quote directly from a non-Pfizer source, scary FBI-types on board, but has in recent weeks imposed severe restrictions on who can get their mitts on its medicines between them leaving the factory and being handed over to patients; the exclusive drug handler is UniChem, which will distribute all (bar none) Pfizer medicines to the UK.

Pfizer now effectively sells its prescription medicines direct to UK pharmacists and dispensing doctors, enabling it to take full responsibility for their safe passage and authenticity. The decision to lock down in this way was, the firm says, due to deep concern over the increased incidence of counterfeit medicines in the UK supply chain through the vulnerability of the current system.

Lipitor, the world's best-selling medicine and one of Pfizer's key props, has naturally attracted counterfeiters like moths to a lamp, and while the company's limit model has incensed some pharmacist/wholesaler groups that have been excluded from this circle of trust, Pfizer has asserted openly that it should not be a moot point as it is patient safety that is paramount, a position that resonates with Thomson at the Safe Medicines Partnership.

Any measures that tighten the supply chain and make it harder for the counterfeiter are to be applauded. Critics of any measure need to ask themselves one question: is my position based solely on patient safety concerns? If they cannot answer 'yes', they should take a good look at themselves.

Over-egged or under-cooked?
But what of the public, the patients? How much need they concern themselves, and what is the right message to give them? This could be a sticky wicket, given that to over-egg the pudding may result in needless panic and even revolt and further loss of confidence in the pharma industry.

We've got to be careful about getting a balanced, proportionate message out to the public, and that message is that you are far more at risk of taking medicines obtained through the internet than you are through the usual GP and pharmacy channels, warns the MHRA's Deats.

Nevertheless, there is a very small risk of obtaining counterfeit drugs even if you do go through your pharmacy, so we need to inform the public of this in a balanced way and encourage them to contact the MHRA [via the website and/or call centre] if they feel at any risk, no matter how tiny.

So, significant counter-weights to the UK's fake drug burden are being established rapidly in the bid to mitigate the rampancy of this deceitful and dangerously risky intrusion into our medicines provision system. It may come to be that the next 12 months, looking back, were when the war against counterfeiters really started. The advice to all pharma firms in the UK is to protect products and engage proactively in the debates that will emerge in due course.

The Author
Rob Skelding is deputy editor of Pharmaceutical Marketing