EU simplifies medicine trade diversion legislation
The revised law has now been sent to EU ministers and the European Parliament
The European Commission has proposed a codified and simplified European Union (EU) regulation on preventing medicines sold in poor countries at low prices being diverted back into EU markets. The problem has long been a concern of the EU, and it passed a regulation to prevent these grey imports in 2003, but this was subsequently amended in 2004, 2005 and 2014, creating complexity and the potential for confusion among pharmaceutical firms, their customers and regulators.
'In the interests of clarity and rationality, that regulation should be codified,' noted the Commission.
The revised law has now been sent to EU ministers and the European Parliament. Its assessment will include a review of lists of diseases and developing countries covered by the regulation, as well as the formulae used to identify lower-priced products targeted at such markets.
The new law also confirms that the Commission can continue expanding the list of medicines controlled by its procedures. It stresses that when customs teams seize medicines destined for cut-price sale in poorer markets wrongly exported into the EU, they can be offered to developing countries listed in the law’s annexe. But if customs officers or regulators decide otherwise 'the seized products should be destroyed,' said an explanatory memorandum.