France Setback on EU Drug Import Licensing Case

The European Court of Justice (ECJ) has ruled that French import licenses on drugs contravenes European Union (EU) trade laws. Although the case referred to a homeopathic product, the ruling could affect France's ability to control drug imports, potentially impacting the significant parallel market.

France's Public Health Code requires a license for all medicines imported for personal use which have not been transported by the individual consumer. France's legal advocates argued that import licenses were necessary for certain products with marketing approval in France and the country of origin. However, the court held that existing health protection laws were invalid as a grounds for preventing the free movement of approved goods in this instance.

Despite the ruling, France is likely to preserve some control over drug imports, if only on the basis of the potential threat to public health. However, it remains to be seen whether the case will affect the thriving trade in high-quality, price-controlled parallel drug imports manufactured inside the EU. European research-based pharmaceuticals association EFPIA estimates that the practice amounts to 5% of all European drug sales, and is currently worth EUR4bn (US$4.9bn) per year.