Paranova - How Pfizer & Co manipulate the counterfeit debate

Big Pharma’s Counterfeit Arguments

Coincidence or Crisis? - Prescription medicine counterfeiting

Published by the Stockholm Network (2006)

By Peter J Pitts (ed.), Jonathan Harper, Julian Morris, Graham Satchwell, Philip Stevens, David Taylor and Michael Tremblay

The launch of Coincidence or Crisis by the Stockholm Network should be treated with utmost caution.

The book attempts to uncover some truths in the important and pressing matter of counterfeit medicines. Yet its obvious bias clouds the issue. The Stockholm Network receives direct funding from one of the world’s biggest pharmaceutical manufacturers, Pfizer, and unsurprisingly many of its publications strongly support positions put forward by Pfizer to damage the reputation of their legitimate competitors – in this case parallel trade. One can only surmise that producers of patent protected medicines are so determined to stamp out parallel trade of medicines in Europe that they are willing to use any means possible to harm their only competition in the market for branded medicines.

Case in point: the manner in which Coincidence or Crisis attacks parallel trade as unsafe, unregulated and dangerous.

The reality is that, time and time again, parallel trade is defended by European governments and regulatory agencies as a safe and highly legitimate business practice which fosters competition and generates savings for consumers and payers.

Coincidence or Crisis serves as a sad reminder that these kinds of smear tactics are not isolated incidences but part of a larger pattern in which parallel trade and ultimately the payers and consumers are the victims.

Take the most recent example of a counterfeit find in the UK supply chain. When counterfeit Lipitor was discovered in the supply chain this summer, Pfizer’s spokespeople wasted no time in lashing out at parallel distributors, blaming them for the incident and making grand-standing accusations against parallel distribution. And the media listened: “Pfizer calls for action against parallel trade.”[1] Of course, only a few days later, Nimo Ahmed, head of intelligence at the MHRA, ascertained that the counterfeit was completely unrelated to parallel trade.[2] Pfizer was wrong – just as in all the previous cases where it made false accusations against parallel trade. But that didn’t make the headlines.

Such tactics are highly dangerous and fail to address the crucial question of what actually needs to be done to prevent counterfeits entering the European medicine supply chain. It is irresponsible behaviour and harmful to the public debate.

Parallel trade is legal, and it is safe. If parallel distribution was unreliable, it would have long since disappeared. In fact, in more than 30 years of parallel trading in Europe, there is simply no evidence that parallel trade facilitates the entry of counterfeits into the pharmaceutical supply chain.

Parallel traded medicines are the original products from the manufacturers. The system of parallel distribution in Europe is comprised of wholesalers who act as “exporters” or “importers”. These terms are used for practical purposes only: parallel distribution takes place solely within the confines of the EU Single Market and, as such, does not involve importing or exporting.

The exporters source medicines directly from manufacturers (at the manufacturer’s price offered in their domestic market) or from other licensed wholesalers and offer some of their products to importers in another European country.

In contrast to ordinary wholesalers, parallel importers are considered distributors and manufacturers alike and are obliged to hold both a wholesaling and a manufacturing license. Thus, parallel distributors are actually subject to two sets of regulations and the corresponding inspections by the competent national authorities.

Coincidence or Crisis appears to be yet another instance of fabricated and libellous accusations by Big Pharma towards a legitimate and safe industry.

Our European trade federation, the European Association of Euro-Pharmaceutical Companies (EAEPC), representing 70 companies from 18 countries from the European Economic Area, has taken the crucial step of fighting back against the misconceptions spread by works such as Coincidence or Crisis, but also in playing a constructive role in Europe.

In September 2005, the EAEPC launched its Good Parallel Distribution Practice Guidelines, which reinforce parallel distributors’ commitment to European and national regulatory requirements and makes EAEPC membership conditional on full compliance with rigorous safety standards. The guidelines are designed to send a strong and constant signal to current and future members of our association, as well as to the outside world, that safety compliance is a top priority for our industry.

It is this spirit that also led us to engage, at our own initiative, with the Council of Europe to strengthen our dialogue and cooperation with anti-counterfeit experts and other supply chain stakeholders. Following parallel distributors’ active participation in the Council’s anti-counterfeiting conference in Strasbourg in 2005, the EAEPC was invited to become a member of the organisation’s Ad Hoc Working Group on Counterfeit Medicines. Alongside national pharmaceutical crime experts as well as representatives from the research-based and generics industries, wholesalers and pharmacies, the EAEPC has since attended a series of meetings to address safety concerns ranging from patient information to pharmaceutical crime legislation, and we have been working on solutions to the counterfeit problem.

Unfortunately, cross-industry efforts in the fight against counterfeits are repeatedly frustrated by the manufacturers’ unfounded finger-pointing towards parallel trade. And this despite the fact that there has never been a case of counterfeits entering the supply chain through parallel traders, and a recent study from the University of Southern Denmark that estimates that, for only four countries – Denmark, Germany, Sweden and the United Kingdom – direct savings generated from parallel trade amounted to euro 441 million in 2004.

This is why parallel trade is actively supported by EU member states. The sad thing is that the damage caused by Big Pharma’s smear campaign is not limited to parallel distributors. It spreads confusion among the general public about the real causes of counterfeit medicines and undermines genuine efforts to make the supply chain safer.

By hitting parallel trade, pharmaceutical companies also put on the line the benefits our industry provides to patients and national healthcare providers in Europe in terms of access to safe and more affordable, innovative medicines.

And in this, Crisis or Coincidence helps no one.

[1] Chemist&Druggist, 5 August 2006

[2] Chemist&Druggist, 12 August 2006