New legislation is needed to outlaw the repackaging and relabeling of medicines, and to ensure that the original packaging is not opened before the pack reaches the patient, concludes a report on parallel imports conducted for the European Commission.
Introducing such legislation would lead to a “dramatic reduction” in the level of parallel trade and the loss or redeployment of around 10,000 jobs, but would also remove the harm to patients that results from parallel trade, improve the operation of the European Union single market by enabling poorer EU member states to buy more medicines and contribute positively to other EU objectives, says the study, which was carried out by independent consultancy Europe Economics.
The report acknowledges that parallel traders do, on occasion, identify mistakes in original packaging and meet specific supply shortages but, it says, apart from “such minor exceptions,” there are no benefits to patient safety as a result of parallel trade, only disadvantages. A law protecting original packs of patented medicines from being altered or opened before they reach the patient would be clear, practical and unambiguously beneficial to EU citizens, it adds.
Under present legislation, patients are being damaged by parallel imports because: – repackaging and relabeling bring inherent risks to patient safety; out-of-date package leaflets can mean patients and medical staff receive inaccurate information and may make wrong decisions; – patients risk confusion when packages are changed during treatment; – the effectiveness of product recalls may be reduced; – the risk of interruptions to supply is increased; – there may be a greater risk of counterfeits entering the supply chain; – pharmacovigilance arrangements become less effective; and – delays are more likely before new drugs are introduced in poorer EU member states, says Europe Economics.
Turning to the effects on the market, the report adds that parallel imports: – cause prices to converge at far higher levels than would otherwise be available to poorer member states, seriously reducing affordable access for them; – bring, at most, only very small price reductions to patients, the gains accruing almost entirely to intermediaries; and – damage the EU economy in various ways, including reducing the value of products to consumers.
The report’s conclusions have been welcomed by the European Federation of Pharmaceutical Industries and Associations (EFPIA), whose vice-president, Jean-François Dehecq, said: “for too long we have underestimated the phenomenon of counterfeit medicines. We are faced with organised crime gangs operating on an international scale and playing with human lives in the name of profit.” Mr Dehecq, who is chairman of Sanofi-Aventis, called for “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.”
Maintaining pack integrity is not about a ban of parallel trade, merely on the dangerous issue of repackaging, added EFPIA’s director-general Brian Ager. “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,” he said.
– Maintaining the integrity of the original pack from manufacturer to the point of dispensing permits the identification, authentication and traceability of products throughout the distribution chain, says EFPIA, which aims to introduce a unique coding system extending this traceability throughout Europe. A pilot plan, enabling the pharmacist to verify the integrity of each pack at the point of dispensing, is due for launch by early 2009. The technology, which uses a two-dimensional data matrix, is considered the best option today and should be used as an EU standard, says EFPIA, although it adds that, clearly, this system will only work effectively if the original packaging is maintained.
