By Simon Zekaria - 19th January 2004
Brussels has moved to clarify rules for the trade in EU medicines in a bid to support the unfettered flow of drugs across Europe.
The EU executive backs so-called ‘parallel importing’ of drugs, where medicines are transferred from high to low-cost countries under the free movement of goods principle.
This standpoint puts the European Commission at odds with European pharmaceutical companies and drug distributors who try to control the market through an agreed distribution network.
"This communication makes clear to national administrators the conditions under which parallel imports of medicinal products must be allowed, and to those marketing medicinal products, how they must proceed if they wish to undertake such parallel imports," said EU internal market commissioner Frits Bolkestein on Monday.
The text summarises the changes in parallel imports law after rulings delivered by the EU courts.
Since the last EU ‘communication’ on parallel import drugs in 1982, the European Court of Justice in Luxembourg has ruled that EU member states should grant licenses for parallel import medicines on the same basis as drugs entering the market for the first time.
The court has also ruled that the protection of a drug trademark can be reduced providing the re-packaging after importing does not affect the original condition or commercial reputation of the trademark owner.
“We are not formulating new policy, but merely setting it out,” said an EU official.
The commission received a court setback earlier this month over parallel imports of German pharmaceutical group Bayer’s heart medicine Adalat.
Sanctions worth €3 million levied by the EU executive were scrapped by the courts because Brussels failed to provide concrete evidence of an illegal agreement between Bayer and pharmaceutical wholesalers in France, Spain and the United Kingdom.
Have your say...
Please enter your comments below.