Counterfeit Medicines - Report Urges No Compromise And No Concession Of Principle In Maintaining Patient Safety

Main Category: Pharma Industry / Biotech Industry
Article Date: 10 Oct 2008 - 4:00 PDT

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EFPIA, the voice of the research-based pharmaceutical industry in Europe, welcomes the release of the Europe Economics report on 'Safe Medicines Through Parallel Trade'i. The report clearly highlights the risks posed to the legitimate EU pharmaceutical supply chain by counterfeit medicines concluding that "on an assessment of social, economic and environmental impacts, the clearly preferable policy option would be to legislate to prohibit repackaging and re-labelling, and to ensure that the original packaging is not opened before the pack reaches the patient"

'For too long we have underestimated the phenomenon of counterfeit medicines and their threat to EU patients said Jean-François Dehecq, EFPIA Vice-President and Chairman of Sanofi Aventis. 'We are faced with organised crime gangs operating on an international scale and playing with human lives in the name of profit. Therefore we, the political opinion leaders and industrialists, must work together to act effectively against this threat. We need a three-pronged approach that will improve the efficiency of international police enquiries, establish adequate civil and penal sanctions and effectively monitor those distribution channels that facilitate the entry of counterfeit medicines'.

There has been recent alarming evidence that counterfeiters are increasingly targeting the licensed pharmaceutical distribution chain, including authorised wholesalers, parallel traders and pharmacies. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) reported that incidents affecting the legitimate distribution chain have increased steadily since 2004. Counterfeit medicines have actually reached patients on nine separate occasions, and on a further five covered occasions at wholesaler levelii.

A major risk factor for counterfeits entering the legitimate supply chain is via the repackaging of medicinal products. This is endangering patient safety. Brian Ager, the Director General of EFPIA said "We have moved from the precautionary principle to genuine risk. Recent seizures of counterfeit medicines in the EU have shed light on where the pharmaceutical supply chain is vulnerable and on those practices which deliberately undermine the best efforts of the industry to ensure patient safety".

The key to ensuring security of the supply chain is maintaining the integrity of the original pack from manufacturer to the point of dispensing. This permits the identification, authentication and traceability of products throughout the distribution chain. EFPIA aims to introduce a unique coding system that would extend this traceability throughout Europe. A pilot plan, enabling the pharmacist to verify the integrity of each pack at the point of dispensing, will be launched by early 2009. The technology - which uses a 2 dimensional data matrix - is considered the best option today and should be used as an EU standard. Clearly, however, this system will only work effectively if the original packaging is maintained.

For those who claim that 'the issue of parallel trade is used as a scapegoat for counterfeits, Brian Ager pointed out that maintaining pack integrity is not about a ban of parallel trade, merely on the dangerous issue of repackaging. "We, as consumers would not find repackaging acceptable for other products, such as food. Why should medicinal products be different? To allow breaking one seal and replacing it with another just amplifies the level of risk to the end user".

i Safe Medicines Through Parallel Trade, Contribution to an Impact Assessment, Europe Economics, released 6 October, 2008: here.

ii Commission's public consultation on 'Key ideas for better protection of patients against the risks of counterfeit medicines'

About EFPIA

EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 32 national associations and 43 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 2,200 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world.

The pharmaceutical industry accounts for no less than 19,3% of global business R&D expenditure. It is the sector with the highest ratio of R&D investment to net sales (15,9%). However, between 1990 and 2007, R&D investment in United States grew 5.2 times whilst in Europe it only grew 3.3 times, and there is rapid growth in the research environment in emerging economies such as China and India.

Today around 645,000 people work in this sector and it is estimated that three to four times more employment is generated indirectly both upstream and downstream. A significant proportion of people employed are highly skilled and 107,000 work in research and development. The European research-based pharmaceutical industry generates a substantial trade surplus, which was estimated at about €49,000 million for 2007. It has contributed significantly to reducing the European Union's trade deficit in high-tech products - today almost a quarter of the EU's high-tech exports are pharmaceutical products.

EFPIA