The European Federation of Pharmaceutical Industry Associations (EFPIA) is piloting a harmonized coding system for detecting counterfeit drugs in the European Union.
Speaking on EFPIA's behalf, Andrew Bonser, director of European government affairs for Pfizer, described the pilot at an Oct. 13 meeting in Berlin sponsored by the Parenteral Drug Association and the European Medicines Agency. He also sought to dispel some "myths" of drug counterfeiting.
The coding system EFPIA is piloting would likely cost much less to implement than the counterfeit drug directive the European Commission has proposed. That proposal is part of a larger package on pharmaceutical reforms ('The Gold Sheet,' December 2008, p. 20).
The proposal would subject all parties in the distribution chain to pharmaceutical legislation. It would clarify that the obligations for wholesalers apply to all parties in the distribution chain, except for those directly distributing or administering to the patient. Brokers, traders and agent would be considered as wholesalers, with the respective obligations stemming from the pharmaceutical legislation.
It would also require prescription medicines to have covert, overt and forensic devices, identification at the individual pack level to trace their movement in the supply chain, and tamper-resistant packaging.
High-risk products would be subject to all three criteria listed above, while lower-risk products would only be subject to the tamper-evident packaging requirement.
EFPIA disagrees with the risk-based approach espoused in the Commission's proposed directive as well as the full track-and-trace system for higher risk products, Bonser said. EFPIA contends that all drugs, regardless of their risk class, should be subject to verification at the point of dispensing.
Instead, EPFIA supports the use of an end-to-end product verification system of each individual unit at the point of dispensing and intends to demonstrate the viability of using such a system in the pilot.
Bonser explained that the pilot establishes a harmonized coding system for pharmaceuticals that allows pharmacists to verify each medicine pack before it is dispensed through the use of 2D barcodes. Plans for the pilot were first announced by EFPIA in June 2008 ('The Gold Sheet,' July 2008, p. 10).
Fourteen manufacturers and 25 pharmacies in the greater Stockholm area are participating in the pilot, which began in September 2009 and concludes this month.
The coding is based on the existing GS1 standard and has four items of data. The four fields include the product code, the serial number, the expiration date and the batch number. The product code contains 14 numeric digits, the serial number is 20 numeric digits, the expiration data six digits, and the batch number, which appears at the end of the field, includes up to 20 alphanumeric digits.
The code will be verified at the point of dispensing in the pharmacy. Under the pilot, product verification is defined as comparing the data held within the product code with a secure product record on a database confirming that the product record, or the product code and serial number, exists and matches the data held on the product itself, the product record has not been previously marked as dispersed, and that the product record does not contain any warnings that the product is subject to a recall.
Sabine Atzor of the European Commission's Directorate-General Enterprise and Industry told conference participants that the proposal is being discussed in the Council of Ministers and that discussion in the European Parliament has already begun.
However, there are reports that the cost of the proposal - as well as the fact that some EP officials would like to see Internet drug wholesalers subject to regulation - is holding up approval of the directive.
Bonser noted that the counterfeit proposal is a "much needed piece of legislation."
Citing statistics from the Pharmaceutical Security Institute, he noted that the total number of counterfeit incidents a year worldwide grew from 1,216 cases a year in 2006, to 1,513 in 2007 and 1,585 in 2008.
PSI also reported that in 2008, Germany had the worst counterfeiting problem at 75 reported cases, followed by the UK at 58, Austria with 49, France with 23 and Poland had 21.
Bonser also wanted to dispel some counterfeit medicine "myths." He noted, for example, that not just patent-protected medicines but off-patent medicines as well are being affected by counterfeiting. "Pfizer is seeing increases in counterfeiting of its off-patent medicines such as Lincocin, an antibiotic, Cyotec, used to protect against stomach ulcers caused by pain medication, and Xanax, used to treat panic disorders.
Another myth, said Bonser, is that counterfeiters are only targeting lifestyle medicines. Biological drugs are also being targeted. "Pfizer has seen its growth hormone Genotropin counterfeited in Sweden in 2007 and in South Africa in 2008."
The last misperception is that only high-value medicines are being counterfeited. "Recent seizures have included the Medi-fake EU-wide operation in which over 34 million illegal medicines were seized in only a two-month period. This included the biggest single seizure of illegal medicines ever recorded in Europe at Brussels airport: reportedly 2.2 million tablets, including 1.6 million painkillers."
The Medi-fake program was unveiled by the Commission in 2008 to stop illegal medicines from entering the EU and is a multi-agency government initiative involving the participation of customs officials.
- Joanne S. Eglovitch (j.eglovitch@elsevier.com)
This article first appeared in The Gold Sheet, Jan 1, 2010
