The European Commission has set out new clearer guidelines on how the parallel trade of medicines between member states should work.

The free movement of goods is a central tenet of the European Union, but court cases and conflict between manufacturers on one side, the traders and Commission on the other have added to widespread confusion about how the practice should be regulated.

Internal Market Commissioner Frits Bolkestein has now restated that parallel imports must be identical or 'sufficiently similar' to that already on sale in the country, and that the needs of patients and healthcare providers remains paramount.

"The ultimate aim is to ensure patients and healthcare providers can benefit from parallel imports, without taking any risks with patient safety," said Mr Bolkestein.

A new document restates many of the fundamental principles of parallel trade, and includes information from recent European Court rulings which have clarified contentious issues - including the question of 'similarity' - and a ruling which means parallel importers can operate even when the original national licence has been withdrawn.

These grey areas have been exploited by the pharmaceutical industry to protect its revenues, which it says are severely undercut in higher-priced countries such as the UK and Germany.

The ABPI director general Dr Trevor Jones recently went head-to-head with Donald MacArthur, secretary general of the parallel traders association the EAEPC in a Social Market Foundation seminar at the House of Commons.

The industry says the erosion of profits - which it says cost UK companies £1 billion a year - is threatening their ability to re-invest in R&D.  Meanwhile the actual value of parallel trade to healthcare systems such as the NHS has become a matter for fierce debate.

The two sides backed rival studies published last year which attempted to settle the matter; a EAEPC-commissioned study by the York Health Economics Consortium claimed the trade resulted in E630 million in direct savings for European health systems (£228 million or E342m in the UK) but was countered by a London School of Economics (LSE) study which claimed savings were negligible.

The LSE study found NHS savings, including a government system of 'clawing back' savings from pharmacists amounted to £39 million, while parallel traders made around £325 million.

"Ask the parallel traders how much money they are investing in medical research for new products from the profits they are making. I think you will find them silent on this issue!" Dr Jones told the seminar.

The industry recently won a potential test case when Bayer's use of supply quotas to restrict parallel trade were found to be legal, overturning an earlier decision. A backlog of similar cases are waiting to be heard, but their outcome remains uncertain despite this latest ruling.

In its new communication, the Commission conceded that there could be no 'definitive' guide to parallel imports, and that new questions and continued need for clarification would be best dealt with by co-operation between stakeholders.

pharmafocus@pharmafile.co.uk