European Generics Makers Condemn Draft EU Rules

The European Generic Medicines Association (EGA) has harshly criticised European Union (EU) draft regulations, which would offer six months' additional patent protection to producers which opt to carry out paediatric clinical trials on existing or prospective drugs.

The proposals, which oblige all drug firms registering new products or seeking patent extensions to conduct paediatric clinical trials unless a special waiver is granted, effectively bring EU norms into line with the US FDA. However, the corresponding ability to secure EU Supplementary Protection Certificates providing six-month extensions is a significant incentive for producers of originator drugs to carry out the trials.

The EGA has argued that the extension should apply only to low-volume products, with blockbuster drugs receiving only three months' extra protection. Further, the association proposes that older patented products should receive only a one-month extension if paediatric clinical trials are carried out. The EGA's argument is based on the likely resulting increase in healthcare costs, as ethical drugmakers would be able to secure extensions to patents, facing only the comparatively minimal costs of carrying out trials on drugs already approved for adult use.

Unsurprisingly, at a time when several key blockbuster drugs are facing EU patent expiry, the generics industry will not be eager to see yet more possible delays to launches of cheaper generic alternatives.