Pharmaceutical Industry Announces Launch Of Anti-counterfeit Medicines Pilot Project In Sweden

Main Category: Pharma Industry / Biotech Industry
Article Date: 20 May 2009 - 7:00 PDT

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EFPIA, the voice of the pharmaceutical industry in Europe, of which the Irish Pharmaceutical Healthcare Association (IPHA) is a member, has announced an important step in the industry's efforts to protect Europe's citizens against counterfeit medicines. EFPIA has agreed to run a pilot of its coding and identification solution (1) in Sweden later this year in partnership with Swedish retail pharmacy chain Apoteket AB and local wholesalers Tamro and KD.

Under the EFPIA solution, pharmacists will check a unique identification code on each individual pack when it is dispensed to the patient. These codes are generated and applied by manufacturers using a simple 2D data matrix barcode, which contains a unique serial number. The scan will reveal any duplication of data on packs and will trigger the system to immediately alert the pharmacist to the possibility of a counterfeit product, who can take the necessary steps.

"The threat posed by counterfeit medicines is real and growing," said David Brennan, CEO of Astra Zeneca. "As an industry, we are focused on patient safety and ensuring the public can have confidence in their medicines. This coding system represents a major step forward towards that goal".

"We are pleased to partner with EFPIA in this project" said Director General of Apoteket AB, Stefan Carlsson. "The 2D matrix coding solution contributes not only to the improvement of patient safety with regards to counterfeiting, but also to more effective ways of managing pharmaceutical products in pharmacies in the future."

Director General of EFPIA, Brian Ager, added, "Obviously we share the European Commission's concerns on counterfeit medicines. Therefore we are committed to making proactive contributions to reduce the risk; this initiative further underlines our commitment to patient safety."

The coding solution is being developed in collaboration with GIRP (the European Federation of full line wholesalers). It has the potential to provide an efficient and cost-effective method to meet the new traceability requirements, being proposed by the European Commission, to combat the infiltration of counterfeit medicines into Europe.

The pilot is expected to last between three and four months and will be entirely financed by the pharmaceutical industry. It will be a scaled-down version of a full EFPIA solution: a key goal is to demonstrate that it is a practical and effective solution for manufacturers, pharmacists and patients alike, providing a standardised and interoperable system throughout Europe. The system is designed to ensure product identification from point of manufacture to point of dispensation, ensuring that the authenticity of each unit can be ascertained before it reaches the patient.

(1) For more information on the coding and identification solution visit here.

What are counterfeit medicines?

Counterfeit medicines are any brand (or generic) medicines and active pharmaceutical ingredients (APIs) that are deliberately and fraudulently mislabelled by unauthorised parties with respect to source, and / or composition and / or therapeutic quality. They include products without active ingredients, or with the wrong active ingredients, or with insufficient active ingredients, or with fake packaging. Sometimes they contain substitutes, or are diluted with foreign or toxic bodies, to increase the quantity of the original medicine.

The World Health Organisation (WHO) estimates that 8% to 10% of medicines in the global medicine supply chain are counterfeit, reaching as high as 25% in some countries. The largest counterfeit market with close proximity to the EU is Russia, where it is estimated that 12% of medicines are counterfeit. Counterfeit medicines are entering Europe's legitimate supply chain in increasing numbers. More than 4.081 million counterfeit medicines packs were seized at Europe's borders in 2007, a 51% increase on the previous year. According to the World Health Organisation, around one percent of medicines in Europe are now counterfeit.

To date Ireland has had few incidences of counterfeits attempting to enter the legitimate supply chain however continued vigilance is required. The reality is that as long as repackaging and breaking of seals in the distribution chain is allowed, patient safety will be at risk and the potential for more incidences will only increase.

http://www.ipha.ie/alist/counterfeit-medicines.aspx

IPHA advisory on the dangers of purchasing prescription medicines online

IPHA encourages patients to purchase prescription medicines through authorised distribution channels only and continues to raise awareness of the dangers of purchasing prescription medicines online. A report published in 2008 revealed that a frightening 62% of medicines purchased on the internet were fake or substandard. The pharmaceutical industry spends billions in developing reliable, safe, life-saving and life-enhancing medicines. The system that enables such medicines to reach patients, through the collaboration of regulators, pharmacists, healthcare professionals and the manufacturers of medicines, has protected Irish consumers very successfully.

Source
EFPIA

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