Barricade upgrade

As the MHRA unveils its inaugural anti-counterfeiting strategy, a new report highlights the weak spots in Europe's supply chain

An exacting, byzantine question is keeping intelligence and enforcement officers at the Medicines and Healthcare products Regulatory Agency (MHRA) awake into the small hours. It might sound simple but is heinously complex and can mean the difference between a patient in the UK receiving a safe, effective medicine or being handed a dangerous counterfeit product, albeit inadvertently, by their trusted, local pharmacist - on the back of a prescription written by their trusted, local GP. The latter can and does happen, begging the question: is our medicines supply chain fit for purpose?

In November 2007, the fight against drug counterfeiters was stepped up markedly in the UK as well as on the international stage. In a full-to-bursting meeting in London, the biggest names in international pharmaceutical safety and security supported the launch of the MHRA's inaugural anti-counterfeiting strategy (2007-2010) in front of TV crews, journalists, commentators and key stakeholders in healthcare. Just two days earlier, the European Alliance for Access to Safe Medicines (EAASM) had been in Brussels to present the European Parliament with one of the most fundamental and inclusive reports yet compiled into the weaknesses of Europe's perforated drug supply and distribution system. Altogether, the salvo was aimed squarely at tackling the increasingly pervasive threat in the UK and elsewhere in Europe of fake medicines harming normal, everyday people.

As we know, the majority of counterfeit products invading Europe's markets are ordered online. Some internet pharmacies are reputable and trustworthy, and measures to mark these out to innocent consumers are in place. However, it remains quite possible for a 40-something lawyer, for example, suffering from an embarrassing condition (and not keen on an examination by the doctor bordering on the intrusive) to click 'add to basket' for what he thinks are UK-sourced medicines that might offer discreet help. The service is simple, inexpensive and seemingly safe. It's a direct order to a UK outlet like any other, similar to those used commonly for popular consumer goods in this country.

Hardly might he expect that somewhere in south China his 'medicines' are being ferried covertly by road across the border to Hong Kong, where the relabelled fakes will then be shipped by air - via Dubai, as cargo from the United Arab Emirates to the West is abundant, hence insignificant packages are likely to escape zealous investigation - to London. Now in a British box and freshly stamped with a UK postmark, the package seemingly made and sent from a factory in Britain is soon to be torn open by another victim of drug fraud. If his health did not already hinge on the contents being totally safe and effective, it does now.

ON COMMUNICATION
One of the toughest challenges for the MHRA is education and awareness, so that members of the British public don't do this. Communication of this advice, however, requires an astute sensitivity, as it would be easy to scare people off taking medication altogether. Get it wrong and confidence in the NHS, regulatory bodies and broader pharma industry would fail.

A complicating factor is that fake drugs, now almost indiscernible without chemical testing even to experts, have breached the UK's regulated supply chain; therefore, trusting the system can also seemingly let one down, unlikely as it might be.

Of the three strands in the MHRA's new anti-counterfeiting strategy - Communication, Collaboration and Regulation - communication is ranked as the highest priority. In terms of raising awareness among the public, this is a balancing act that needs to be managed carefully, comments Nimo Ahmed, head of intelligence at the agency. On the one hand, a clear, simple message is promoted by the MHRA to those purchasing, or considering purchasing, medicines over the internet or through other such means: people simply should not buy from these sources, especially prescription medicines without a prescription.

On the other hand, trying to get a clear, concise message out to members of the public without causing alarm that counterfeit medicines do, on extremely rare occasions, appear in regulated pharmacies is very risky. In terms of potential public reaction, a parallel might be drawn with the MMR episode.

The most effective communication vehicle could be specialised, as well as lay media, healthcare professionals, patient information leaflets or something else, but the agency will naturally consider whichever means negate or reduce panic. One key activity is an immediate communication to distributors to be aware that counterfeiters are targeting legitimate supply chains, so thorough due diligence is imperative when purchasing medicines.

Dawn Primarolo MP, Minister for Public Health, noted at the conference the government's clear commitment as a partner with the MHRA and international bodies against this attack on public safety. Public trust in the quality and safety of human medicines has to be safeguarded at all costs. She added that proportional investigation and prosecution is key.

ON REGULATION
During the launch meeting, a delegate from pharma asked why legal provision in Europe could not be changed to put the online sale of prescription medicines outside the law, therein closing entirely a significant channel for the request and subsequent dissemination of counterfeit products in Europe.

In answer, Dr Martin Terberger, head of the pharmaceuticals unit at the European Commission's Directorate-General for Enterprise and Industry, emphasised that effective as it might be with specific regard to the issue of counterfeited medicines, any change in legislation requires a thorough and long-term impact assessment on the region's economy and inter-State trade avenues as a whole. He urged caution in seeking a change in law as a 'quick fix', despite exigency for action, adding however that the EC has identified several policy options and is currently undertaking comparative impact assessments, the results of which (coming in mid-2008) will inform future strategy.

The EC's analysis of what would be a response proportional to need is made more difficult by the fact that pharmaceutical legislation is not harmonised across the EU, though harmonising internet trade is a current focus. While counterfeit products are ordered online, the EC cannot assume that the internet is therefore a dangerous medium for trade, even of medicines. Safe medicines are also traded legally and securely online everyday. In any case, a total ban on a particular activity is the toughest legislative action possible, and is therefore one of the most unlikely to be achieved in the international trade of any goods.

The watchword on the lips of those with legal and political power is proportionality - ie, fitting the punishment to the crime. Earlier this year, four men conspiring to sell fake medicines were convicted and sentenced at Kingston Crown Court in the UK; altogether they were given 14.5 years in the clink and Mick Deats, head of enforcement at the MHRA and the brains behind its new anti-counterfeits strategy, was there to see them go down, warning others that the full force of the law will be used to protect the UK's patients.

In other parts of Europe, however, the imitation of medicines is not even acknowledged to be a crime, but seen by some as nothing worse than a 'misdemeanour' and treated more as a breach of a manufacturer's trademark than a dangerous and immoral criminal act warranting court appearances and jail sentences. At the other extreme, a life sentence in prison awaits those convicted of counterfeiting in India, while in China one can still face the death penalty. This disparity is a focus of attention for the EC in ensuring that legislative action, in Europe at least, is proportional and appropriate whereupon it is brought to bear.

In spite of his tempering a discernible fervour by delegates for new or amended law, Dr Terberger emphasised that the EC is proactively creating a market environment that is safe, secure and which protects the quality of products for the public, as well as the profit margins necessary for pharma's future innovations.

Findings from the EC and MHRA's respective analyses of the problem (and its solutions) will be made known in due course from 2008, the EC's study informing future European policy and the MHRA setting out recommendations for the government.

AN FBI FOR EUROPE
Chief in the war against counterfeiters for every Member State is collaboration - mainly international intelligence sharing - between stakeholders. In the first instance, this necessitates a thorough appraisal of European drug supply and distribution protocols with regard to patient safety.

The system is currently far from secure, with myriad trade routes opened up through the legal practice of parallel pharmaceutical trade (PPT) but with little or no concerted effort by an official pan-EU authority to get a firm grip on the spreading invasion of counterfeit products.

Until greater achievements are made in forming a unified European pharmaceutical market, the disjointed and, in part, feebly regulated supply of medicines enabling the manipulation of trade lines across Member State borders will continue to jeopardise patient safety. This is one of several powerful assertions made in a new report, European Patient Safety and Parallel Pharmaceutical Trade - a potential public health disaster?, written by Dr Jonathan Harper and presented in partnership with the European Alliance for Access to Safe Medicines (EAASM) to European Parliament (EP) in late November.

he author, a UK-trained medic who subsequently completed an MBA and spent several years working for the EC, conducted a broad analysis of Europe's drug trade and distribution practices, focusing in particular on the intertwining of PPT with the direct manufacturer trade lines - something he argues is, in its current guise, an incongruous mix being exploited increasingly by organised international counterfeiting operations.

At the EP, Pharmaceutical Marketing asked Bill Newton Dunn, MEP, whether Europe's current regulatory provision is sufficient to deal with the problem: Existing laws are certainly not enough. Also needed is better cross-border enforcement against the criminal gangs - which means, as far as I can see, creating an FBI for Europe. We need a new way of fighting them; they cross borders, so we need police who can also cross borders.

FIGHTING TALK
The Harper report draws 10 conclusions on patient safety in Europe plus a further 15 specifically on PPT, from which the author has distilled eight recommendations around the practice and concept of PPT and a further 12 specific challenges regarding PPT and supply chain security. In short, PPT takes a heavy blow in terms of its contribution, or otherwise, to patient safety.

Quick to defend its practices is the European Association of Euro-Pharmaceutical Companies (EAEPC), the body for parallel traders. Secretary general Heinz Kobelt comments: This report is not about supply chain security but about attacking legitimate competition. If the EAASM was concerned about patient safety, their report would focus on the real threats to public health. He contends that the author's alarmist arguments were without substance behind their claims. Further, referring to the report as black propaganda, Dr Kobelt is keen to emphasise that it was a parallel trader's discovery of a counterfeit batch which led to the MHRA taking protective action earlier this year.

Jim Thomson, EAASM founder and CEO for the Centre of Mental Health, countered that as the Alliance is registered as a community interest company, its activities must be for the public good. The Harper report contains a plethora of findings, conclusions and recommendations, but I think the key finding is that the concept that PPT benefits patients is fallacious. The four most recent counterfeit prescription medicines that reached UK patients via the legitimate supply chain all entered via parallel trade routes. That is not propaganda, black, grey, pink-and-white polka dot or otherwise.

Stuart Hurst, director of EU government and public affairs at Pfizer, defended the staunch but comparative minority involvement (to patient groups, MEPs and other non-funding bodies) of pharma with the EAASM. Pfizer is willing to support all initiatives that will lead to improved safety in the European supply chain. The EAASM keeps full control of its objectives and the independent research and expertise it commissions. Dr Harperís report, for instance, was independently written and represents his expert view.

For the new MHRA strategy and the Harper report, contact respectively: www.mhra.gov.uk and enquiries@eaasm.eu

The Author
Rob Skelding is a freelance pharmaceutical journalist