COUNTERFEIT DRUG PRODUCTS - ACTION IN DEFAULT?
Talking about counterfeit drug products often directly leads to a discussion about what sort of products are actually classified under the general term of counterfeit drug products. In this context, the definition of the World Health Organization (WHO) is helpful. The German Federal Government also referred to this definition in its report from February 20071:
- Products without active pharmaceutical ingredients (API)
- Products with insufficient APIs
- Products with wrong ingredients
- Products with fake packaging
- Exact copies
It is impossible to clearly differentiate the definitions, though, and there may be overlaps. In 2005, for example, batches of Ciprofloxacin were recalled in Germany because the product contained only 250 mg (genuine drug product) of APIs instead of 500 mg. Hence, the counterfeit package contained a product with insufficient active ingredients - and this may have fatal effects in antibiotics. This also shows that counterfeiters don't care about meeting GMP standards and that safety, efficacy and quality of the drug are not important to them. Counterfeiting drug products is a pure criminal act.
Not a European problem?
As one of the largest pharmaceutical markets, Europe is interesting for every counterfeiter. Pure counterfeits of products as in third-world countries are still seldom, but the (mostly illegal) mail-order business represents an increasing problem. In most cases, the counterfeits are of bad quality (anabolic drugs, somatotrophic hormones, lifestyle drugs) but cases of illegally repackaged original drug products are increasing and counterfeits have access to the market via parallel imports. One recent example for this is the British Drug Regulatory Authority's (MHRA) major recall in May/June 2007. Several socalled blockbusters of renowned firms were recalled because of counterfeits which appeared on the market. It seems that the counterfeit drug products were produced in China and reached the European Union via Mauritius. Repackaged as French original products they were imported into the United Kingdom presumably via Luxembourg. But also in Germany, the number of cases is increasing. And everybody is aware of the Heparin case in 2008.
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According to estimations of the WHO dated 2006, about 8-10% of all drug products on the global market are counterfeits. In some countries this figure can even go up to 25% or more (Nigeria: 50%). In Russia about 12% are counterfeit, and the tendency is rising. This also affects the European market, causing a direct economic damage of 30 Billion Euros. Even more dramatic, but almost impossible to capture, is the macroeconomic damage due to the loss of confidence in drug products, in manufacturers' reputation and esteem as well as to the loss of jobs.
But the most important problem is another and should by no means be neglected: the threat to patient health.
As an Analytical Assessor of the British regulatory authority MHRA, Andy Charvill is directly involved in the investigation of potentially counterfeit drug products. For him, it is undisputable that "Nobody can say that it is not our problem". This problem concerns everybody: license holders, distributors, authorities and patients. A great deal of criminal energy is invested in the attempt to make money. And the counterfeiters are getting faster and faster. In the case of Viagra, it took more than six months until the first counterfeits reached the market. Meanwhile, it is possible that they appear at the same time as the original drug product is introduced in the market - and not only socalled lifestyle-products are concerned, but rather all drug products in the high to very high price category. Practically every week, the MHRA receives suspected counterfeit drug product samples. They come from all areas of the supply chain but rarely from pharmacies. This is a clear indication that further information and education is necessary. In most cases, it is impossible to confirm counterfeits without the help of the license holder. Samples of the genuine product are needed as well as the complete specifications and methods, reference materials and exact information concerning wording and packaging. In the end, it is often only possible to recognize a counterfeit by methods of examination which destroy the actual sample.
Approaches for solutions
In the first place, it is necessary to increase awareness and education. This concerns all stakeholders in the value chain: starting with the manufacturer and supplier of the substances through the marketing authorisation holder to transport firms and pharmacies. Many counterfeits remain undetected because of a lack of awareness and, unfortunately, because of ignorance.
Implementation of enhanced sanctions and penalties by legislation is an absolute must. It is mandatory to expand the scope of punishment. For example, the drug law in the United Kingdom doesn't even comprise a paragraph relating to drug product counterfeiting. Usually counterfeiters are sentenced for patent and trademark law infringements.
But prosecuting criminals means that they have to be apprehended first. The channels must be detected via which counterfeit drug products reach the supply chain. This goal requires co-operation between all of the responsible stakeholders in the supply chain and above all, the creation of a network to improve collaboration between pharmaceutical firms, the authorities, the countries and all inter-sectoral agencies such as health, customs and prosecution and/or judicial authorities. The same was recommended by the German Government in the report referred to above.
Ultimately, the supply chain also needs to be protected by using new technologies. Examples include barcodes, RFID2, CDP (copy detection pattern), incorporation of anti-counterfeiting technologies into packaging and labeling, genetic coding or improved physical protection. Unfortunately, these techniques not only offer advantages but are also associated with some disadvantages. Economic efficiency and simple integration in existing processes are an absolute must, though.
Another problem arises from the fact that counterfeitingproof signs get lost during repacking (parallel imports). Furthermore, the verifying person must be endowed with the necessary techniques and skills to read and recognize the signs.
Using EDP-based systems such as RFID, questions need to be answered concerning data security, validability and management of the immense amount of data. This is not the only reason why the American Food & Drug Administration (FDA) dissociated itself somewhat from the request of a widespread implementation of RFID as an exclusive solution. FDA Deputy Commissioner Scott Gottlieb: "We believe that RFID is further developed than other technologies and that it might offer more security. But RFID as an exclusive solution does not present the security measures we hoped for." (The Gold Sheet July 2006). The German Government accentuates in its report that "implementation of counterfeit-proof technologies such as holograms, 2D data-matrix systems or RFID technology, for example, only makes sense at a European level." Any solos should therefore be avoided. Comprehensive coding solutions rather require a co-operation between all involved parties, including suppliers and authorities.
In response to rising concerns by governments and the business community, the OECD has launched an investigation to assess the effects of counterfeiting and copying on economies. This examination focuses on counterfeit and copied products from an intellectual property perspective (i.e. products that infringe trademarks, design rights, copyrights and patents). The objective is to improve understanding and awareness of the effects that counterfeiting and copying have on governments, business and consumers.
In its annual report dated March 2007, the International Narcotics Control Board (INCB) also warns of counterfeit drug products flooding the markets. The problem is described directly in the first chapter of the report which stresses its importance. Unsuspecting patients risk serious health problems or even death. For instance, in Niger the use of counterfeit vaccines in 1995 resulted in 2,500 deaths.
Dr. Philip Emafo, President of INCB, stresses that the problem of counterfeit drug products and the abuse of drug products bought without prescriptions has been in existence for some time but that the rapid expansion of unregulated trade with drug products has dramatically worsened the situation.
A further initiative is IMPACT! by the WHO (International Medical Products Anti-Counterfeiting Taskforce) which was launched in February 2006 by the WHO and is a co-ordinated global network of various public authorities, associations and interest groups. (For further information: www.who.int/medicines/services/counterfeit/en/)
The European Federation of Pharmaceutical Industries and Associations (EFPIA) published a White Paper in November 2005 emphasizing the role and responsibility of the manufacturer and in which the opinion is expressed that all stakeholders in the supply chain are responsible. This White Paper includes various recommendations such as auditing the supply chain.
In September 2006, the European Parliament appealed in a resolution to the European Commission to combat drug products counterfeiting within the EU more intensively. As a result, the European Commission issued a public consultation in preparation of a legal proposal to combat counterfeit medicines for human use (see the following article by Tony Scott).
It can be predicted that the demands on counterfeit-proof packaging and proof of origin will further increase as well as the demands on control and qualification of transport. In order to achieve this, the co-operation between authorities and industry must be intensified. One prerequisite is to improve information among all stakeholders.
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It will only be possible to successfully combat drug product counterfeiting if all pharmaceutical entrepreneurs and all stakeholders in the supply chain face up to the responsibility this entails.
1 Report of the German Federal Government about the effects of the measures designated in the 12th AMG-Amendment to combat counterfeit drug products and about improvements in the discussion at a European level.
2 RFID - Radio Frequency Identification: Possibility to read and store data without touching or seeing them. The process works with the help of a transponder (microchip with antenna) and permits automatic identification over a short distance in real time.