The German pharmaceutical sector has been rocked by the emergence of counterfeit medicinal products in the legal supply chain.
Authorities have filed charges against pharmacies in the north of the country that have been suspected of purchasing cheap and illegal active ingredients, which they have used to manufacture in-house cancer treatment preparations and then sold them to the general public.
The German media outlet, NRD, cited Frank Keller, the chief investigator of the Technician's Health Insurance Fund (TKK), as saying that the fund had been tipped off that a Danish wholesaler - police haven't disclosed the name - had been supplying German pharmacies with an unauthorized active ingredient for the preparation of an infusion used in cancer treatment. Some 100 of the 400 pharmacies authorized to manufacture the preparation in-house are suspected of having purchased the cheap, illegal product from the wholesaler.
Separately, Alexander Retemeyer from the Office of Public Prosecution in Osnabruck, revealed that he had tracked a local wholesaler, which had sourced illegal products from Eastern Europe and then sold them to pharmacies.
Trading in counterfeit drugs is an ongoing problem in Europe and may be one reason why local industry groups have reacted so strongly to what may seem like an isolated case.
The Federal Union of German Associations of Pharmacists (ABDA) said counterfeiting through regional pharmacies is rare in the country and it reacted with alarm to the suggestion that some of its members are engaged in the illegal activity. "Pharmaceutical counterfeiting must be relentlessly cleared up. If it can be established that individual pharmacies have been counterfeiting medicines, they must be harshly punished - including the loss of their pharmacy authorization," said Heinz-Guenther Wolf, ABDA's president. He stressed that in Germany the majority of cases of pharmaceutical counterfeiting occurred through transactions over the internet.
GIRP, the umbrella organization of pharmaceutical full-line wholesalers in Europe, also expressed concern at the developments in Germany. It said that in order to secure the legal supply chain, full-line wholesale distributors must abide by appropriate standards of good pharmaceutical distribution practice. "No member is admitted to the association without holding a valid wholesale distribution authorization granted by the national authorities. It is the competent national authority of the countries in which our members operate that are responsible for the licensing, control and inspection of our members activities," a spokesperson for the association said.
GIRP doesn't have authority to enforce local laws, but if a member of GIRP trades in counterfeit medicines, that company is at risk of suspension or expulsion from the association, the spokesperson said. The association also requires members to implement a comprehensive range of measures to minimize the risk of counterfeit medicines entering into the supply chain at the wholesale level. Some of these involve risk-based auditing procedures, product approval procedures, and staff training.
Counterfeiting In Germany Pharmacies Is Rare
The German government acknowledges the problem but believes that it is under control. "Luckily, in Germany, counterfeit medicines in the legal supply chain do not appear very often," says the federal Ministry of Health. According to the federal criminal police office, since 1996 authorities have detected only 40 cases of counterfeit medicines in the legal supply chain. The concern is, however, that the numbers may be rising; customs border control counterfeits seized 30 percent more counterfeits in the last year than the previous year.
The pharmaceutical industry association, VFA, points out that these figures do not apply purely to counterfeits. They also cover cases in which original products with the correct active ingredients have been taken from their packaging and placed in smaller, counterfeited packages, with false patient information leaflets.
"This is certainly a worrying development," says Joachim Odenbach a spokesperson for BPI (Bundesverban Pharmazeutische Industrie), the German association representing smaller pharmaceutical companies. Although a few pharmacists had acted illegally, no reason exists to suspect that the legal supply chain was rife with counterfeit medicines, he added. The BPI stresses that as long as the business chain (manufacturer to wholesaler to pharmacist) conforms with the law, end-users should not be concerned. "It would become dangerous if the chain were opened up to outsiders - creating a grey market - or if individuals started criminal activities out of greed," the spokesperson said.
In September 2009, the European Federation of Pharmaceutical Industries and Associations ran a pilot project for its 2D data-matrix barcode system in Sweden in partnership with Swedish retail pharmacy chain Apoteket AB and local wholesalers Tamro and KD. Each barcode contains a unique serial number, which is used to generate unique identification code on each individual medicine pack. Pharmacists scan the code when the product is dispensed and this reveals any duplication of data on packs. If a copy is detected, the system immediately alerts the pharmacist to the possibility of a counterfeit product.
The pilot continued for approximately four months in 25 pharmacies, a period in which more than 95,000 medicines packs supplied by 14 leading pharmaceutical companies were scanned and verified before they were dispensed. Results showed that the model worked and allowed for effective identification of fake packs as well as expired or short dated packs and recalled products.
EFPIA notes that coding solutions are already in place in a number of Member States, but suggests that the coexistence of these different systems constitutes an obstacle to enhanced tracking of medicines at an European Union level and adds production costs for manufacturing. The association believes that a single solution would be more efficient.
However, although it has proved that its system works in a country that has a low level of counterfeiting activity and an effective anti-counterfeiting program, it has yet to be fully implemented in a Member State in which falsified medicines are more prevalent.
In the latest revision to the Pharmaceutical Act, the German government has put in place measures to sanction those who introduce counterfeits into the health system. The European Union is also concerned about the increase of falsified medicines emerging in the Member States. Figures from the Directorate General for Taxation and Customs show that counterfeit medicines accounted for 10 percent of goods seized upon entering the EU. Almost 75 percent of these were shipped from the United Arab Emirates.
In April, the European Parliament's Environment Committee approved the European Commission's proposal for fighting the counterfeit medicine menace. The committee added a stipulation to the draft, which insists that in addition to preventing counterfeits from entering the legal supply chain and introducing mandatory safety features for prescription medicines, the legislation should prohibit internet sales of detrimental products. After setting aside a July deadline, the parliament will vote on the draft proposal in October.
"But all this can only have an effect if those involved in the supply chain adhere to the law and patients do not use dubious sources for their medicines purchases but instead trust the overwhelmingly large number of honest and trustworthy pharmacists," said the BPI spokesperson.
-Faraz Kermani (f.kermani@elsevier.com)
This article is reprinted from "The Pink Sheet" DAILY – August 11, 2010
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