EC releases guidance on transporting generics across Europe
Customs can only seize drugs if they infringe EU patent rights
The European Commission has told European Union (EU) customs officials not to seize generic drugs being transported across the EU, if they think they will not be diverted for illicit sale in member states.
The advice follows World Trade Organisation (WTO) complaints brought by India and Brazil against the EU over seizures of generic medicines transiting the EU, which are protected by intellectual property rights if they were actually sold to EU consumers. India and Brazil argued the seizures broke WTO rules, because the medicines were destined for sale outside the EU.
The European Commission has now issued guidelines saying when ‘medicines are in transit through the EU territory, and there is a patent right applicable to such medicines in the EU…[that] does not…constitute enough grounds for customs to…suspect that the medicines…infringe patent rights.’ It added that seizures could only be made where ‘there is adequate evidence that there is a substantial likelihood of diversion of such medicines onto the EU market’.