The European Federation of Pharmaceutical Industries and Associations (EFPIA) reported that more than 11 million illegal medicines were stopped at EU borders in 2009. Fast forward to 2011 and the situation hadn’t improved, with medicines among the top categories of articles stopped by customs, and figures showing a significant increase in detained postal packages, 36% of which contained medicines.

In the US, it’s a similar story; despite its stringent regulatory system, the nation is far from immune to the threat posed by counterfeit medicines, as evidenced by the introduction of counterfeit cancer therapy Avastin into the supply chain earlier this year.

But, thanks to a flurry of recent activity in Europe and the US – on the parts of both regulators and industry stakeholders – the legitimate pharmaceutical industry’s war against fake drugs is slowly starting to gain ground.

New regulations: Europe and US introduce tougher anti-counterfeit measures

"EFPIA has already begun to make headway on a verification system that could be used: the European Stakeholder Model (ESM)."

In the US, the FDA Safety and Innovation Act (FDASIA), which was signed into law in July 2012, includes several provisions for counterfeit drugs, such as enhanced penalties for trafficking these products, and according to Kendra Martello, assistant general counsel at the Pharmaceutical Research and Manufacturers of America (PhRMA), this can only be seen as a positive step.

"We’re pleased with the outcome of the act," she said. "The new criminal penalties for counterfeiting pharmaceuticals are certainly a positive thing. It gives prosecutors another tool they can use to go after people who are intentionally counterfeiting legitimate medicine."

And Europe has certainly not been lagging behind. Although the European Parliament rejected the International Anti-Counterfeiting Trade Agreement (ACTA) in July 2012, arguing that it would have given an unfair advantage to patented medicines and restricted access to affordable generic medicines, several other initiatives are underway to safeguard patients from the threats posed by counterfeit drugs.

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For Heinz Kobelt, director of European affairs at the European Association of Euro-Pharmaceutical Companies (EAEPC), the Falsified Medicines Directive (FMD), which was adopted by the EU in July 2011, and will become law as of January 2013, is one of the most important.

The aim of the FMD is to strengthen existing quality control and health protection measures relating to medicines, and to introduce new measures aimed at preventing falsified medicines and their components from entering the legal supply chain. One of the most important of those measures is the introduction of ‘unique identifiers’ on pharmaceutical packaging, which will replace ‘the multitude of national measures’ currently in place.

And, although the exact nature of these unique identifiers is not yet known, as legislators need to consult with industry and national regulators before a decision is made, EFPIA has already begun to make headway on a verification system that could be used for this purpose: the European Stakeholder Model (ESM).

Track and trace: innovative serialisation project underway

Initiated in collaboration with the European Association of Euro-Pharmaceutical Companies (EAEPC), the European Association of Pharmaceutical Wholesalers (GIRP) and the Pharmaceutical Group of the European Union (PGEU), the serialisation project aims to ensure verification of product authenticity by professionals at the point of dispensing, thereby securing the legal supply chain and enhancing patient safety.

"The aim of the FMD is to strengthen existing quality control and health protection measures relating to medicines."

"Manufacturers or parallel distributors would attribute a code number to their packages, that code number would be uploaded onto the database, and pharmacies would then be able to verify that the number being scanned at the pharmacy desk is on the system in a split second," Kobelt noted. "Although the project is still in the early stages, it’s advancing as a joint effort."

However, there is still one key stakeholder missing: the generic pharmaceutical industry. "They are afraid of the cost implications on them," Kobelt explained. "But the law does say that all prescription medicines should be subject to these rules, so the question will be, how do the stakeholders find an adequate cost sharing model and how much will the whole project cost in the first place?"

While this is certainly a challenge to the success of the serialisation project, for Kobelt, it can be overcome. "There is a push from several forces to bring the generic industry into the stakeholder model and my personal opinion is that this has a good chance of succeeding," he said.

Internet pharmacies: impossible to regulate?

Yet, although this initiative has great potential for increasing the security of the European pharmaceutical supply chain, there remains one key area that is almost impossible to regulate: the internet.

"There remains one key area that is almost impossible to regulate: the internet."

According to the European Alliance for Access to Safe Medicines (EAASM), 60% of medicines purchased online are sub-standard or counterfeit, but the illegal internet pharmacies that sell these products are almost impossible to track down. "We know about the risks, but there’s nobody we can really police," Kobelt admitted. "These guys aren’t necessarily in Europe."

However, headway is slowly being made. "Raising awareness about the risks is written into the Falsified Medicines Directive and a coalition driven by the EAASM is trying to find something more effective," Kobelt remarked. "But what that might be is still under discussion."

Similarly, in the USA, FDASIA includes a provision related to internet pharmacies, whereby the US Government Accountability Office (GAO) is required to ‘submit a report to Congress that describes the problems post by internet pharmacies that violate federal and state law.’

"We’re often asked what the data is around counterfeit products sold online, but the problem is you just don’t know," Martello noted. "Generating that data is going to be a really helpful and important step."

Alongside this, a group of private US companies launched the Center for Safe Internet Pharmacies (CSIP) initiative to target illegal internet pharmacies in July 2012. A partnership between multiple US Government agencies and several worldwide internet and e-commerce organisations, the project aims to educate consumers about the dangers of unsafe counterfeit or contaminated prescription drugs through its website, awareness videos, social media presence and educational search engine ads, as well as promoting and encouraging safe online pharmacies through education, enforcement and information sharing.

"A counterfeit drug is intentionally falsely labelled to look like the real thing so people don’t presume automatically that it’s something that could harm them," Martello commented. "This voluntary coalition of internet service providers and payment processes to try to crack down on illegal sites that are selling counterfeit medicines is a very positive step."

So, what’s next in the battle against counterfeit medicines? Not only will the measures outlined in the Falsified Medicines Directive shortly be coming into play, the recently-established projects designed to raise awareness about illegal internet trade are only set to become more effective.

But for Martello, none of these anti-counterfeiting campaigns has a chance of working unless industry stakeholders continue to co-ordinate their efforts. "It’s critical for everyone to work together," she concluded. "We’re seeing a lot more of that now and I think that’s a very positive thing."

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