EMEA reports sharp rise in parallel import requests

Requests for authorisation to parallel trade drugs in the EU are continuing to rise sharply, according to the EMEA's annual report.

While the report shows only the number of requests and not the volume of stock moving between countries, the rise in figures for both initial applications and variations indicates the branded industry is not winning its battle against the trade.

According to the regulator's report, initial applications for parallel imports increased from 874 in 2005 to 1,578 in 2006 to 1,937 in 2007. The agency says the rise in initial applications exceeded its expectations by 8%.

So many initial applications have been received over the past three years that backlogs have developed at times. The number processed and granted was only 659 in 2005, 1,629 in 2006 and 1,927 in 2007.

The report also looks at "notifications of a change", which parallel traders must submit when they wish to modify their permission to trade in a particular product. These include the EU country in which the product originates and changes to packaging.

These applications increased from 2,201 in 2006 to 3,518 last year - exceeding the EMEA's forecast by 45%.

In the report, the EMEA concedes it has missed its target of processing 70% of parallel import notifications within 35 working days. The target was achieved in only 46% of cases and the average time taken was 72 days.

Big pharma across Europe has fought hard against parallel trade, introducing several initiatives designed to restrict the supply of drugs in countries where prices are cheap. The branded sector has also claimed that the trade encourages the supply of counterfeit products - an accusation rejected by the parallel traders.