European regulators have clamped down on protectionism in the pharmaceutical industry after complaints from the European pharmaceutical lobby.
In response to claims by the European Federation of Pharmaceutical Industries and Associations that member states were citing spurious reasons to reject drugs produced by companies from other countries, the European Commission has issued new guidelines that aim to close the loophole. The rules give a more narrow definition of what treatments can be deemed to pose a "potential serious risk to public health" and thus kept off the market.
EU member states and the drugs industry have complained that the clause has for years been used as the preferred method to veil nationalistically and politically motivated moves to protect domestic industries.
In its review of the medicines authorisation process last year, the EC warned that "if this problem is not tackled soon, some believe that [EU] enlargement will almost certainly exacerbate it to a point where the system is no longer viable".
The problem arises when companies choose to apply for authorisation for a drug under the so-called mutual recognition and decentralised procedures - rather than going to the overarching European authority - in which the findings of one regulator are expected to be respected by other national bodies.
According to research from the Mutual Recognition Facilitation Group, France and Spain are the two most active countries in opposing the findings of other regulators.
In the guidelines, published earlier this month, the EC devotes as much explanation to what does not qualify as a serious public health risk as to what does.
"The onus is now on the member states," said Anthony Warnock-Smith, a lawyer at Morgan Lewis & Bockius. "It will eliminate some of the grit in the wheel."Reuse content