EFPIA demands tough action against counterfeits

The European Federation of Pharmaceutical Industries and Associations has issued a plea for the strengthening of sanctions against counterfeit medicine trafficking in the European Union.

In a speech to the EFPIA's annual general meeting in Paris, France, the group's vice president and chairman of Sanofi-Aventis, Jean-Francois Dehecq, said: "it is time for Europe to act as the driving force in the fight against this deadly crime."

"Counterfeit drugs represent a revenue loss of 2 per cent to 3 per cent in Europe," he added. "That should be about the same at Sanofi-Aventis."

Dehecq said that a key problem is that EU member states do not have consistent or sufficiently stringent penalties for the sale of counterfeit prescription drugs.

There are insufficient resources in place for existing enforcement powers to be fully deployed and the different rules in EU member states, especially on penalties, hamper efforts to tackle the problem.

"Organized crime gangs operating on an international scale and playing with human lives in the name of profit must be dismantled through determined action, systematic prosecution and appropriate sanctions, civil and penal."

The latest figures indicate that there has been another substantial increase in the number of fake drug seizures at EU borders, according to EFPIA.

In 2006, 2.7 million medicinal articles were confiscated at the region's borders, an increase of 384 per cent on the previous year. For 2007, the EU's statistics agency reports that 4.1 million products were seized, a rise of about 52 per cent.

Repackaging ban

At the AGM EFPIA reiterated its call for a ban on repackaging, arguing that the practice means that that any effort to put isecurity features on medicine packaging are wasted as product can be re-boxed or re-labelled after it leaves the production site.

"One essential component of any effective anti-counterfeiting strategy is the development of security features on medicine packaging," said Dehecq. "The original package should remain untouched throughout the entire supply chain."

Of course, a ban would also have the added benefit for branded drugmakers of making parallel trade within the EU virtually illegal and could boost revenue in some markets.

The European Association of Euro-Pharmaceutical Companies, which represents the interests of parallel traders and released a briefing document on the issue to coincide with the EFPIA event, believes that stifling parallel trade is the real agenda behind EFPIA's stance on repackaging.

"Parallel distribution - the only form of intra-brand price competition in the European pharmaceutical market - makes expensive, innovative medicines more affordable for patients and governments," it said.

It cites a study carried out by the University of Southern Denmark which found that in four countries - Denmark, Germany, Sweden and the UK - €4410m euros in savings were generated in 2004.

Although the EAEPC supports tightening of some of the existing regulations covering parallel trade, for example with regard to the licensing of wholesalers, which would incidentally hit non-members, both the manufacturers and the parallel traders consider the main source of fake drugs to be Internet pharmacies.

An idea of the scale of the illegal pharmaceutical business came from a recent study by Pat Peterson, an Internet security expert who is a fellow at network equipment giant Cisco Systems.

Peterson found that one on-line pharmacy identified in the study, which claimed to be based in Canada, had an annual turnover of $150m offering product which in reality was sourced from India or China.

Serialisation solution

A harmonized EU-wide system for identifying drugs is also demanded by the industry, although there are problems with determining how it will be funded and what standard to adopt.

Dehecq pointed out that 10 different systems coexist in Europe today (with different types of barcode and with or without unique pack identification).

"This fragmentation increases the difficulty to track and trace medicines effectively at a European level and constitutes a substantial cost for the pharmaceutical industry," he said.

EFPIA recommends the implementation of a standardized and unique coding system for medicines in Europe.

The group is planning to launch a pilot scheme of a unique bar code system, which will enable the pharmacist to verify each medicine pack before dispensing it to the patient, by the end of the year.

The technology used – the 2 dimensional data matrix – is considered the best option today and could be used as an EU standard, said Dehecq.