The move could be used by originator companies to delay the introduction of generics, says the EGA. This could have a knock-on effect on companies supplying the generic sector.
The EC proposal would effectively bring the European Union into line with the US, which has offered this patent term extension as an incentive to companies to conduct studies in children. Younger patients are often deliberately excluded from clinical trials in order to keep the patient population under study as homogenous as possible. But this limits the safety and efficacy data available for children, who can sometimes exhibit different responses to treatment than adults.
The FDA's system, while clearly well intentioned, has been criticised for allowing originator firms to conduct sometimes unnecessary clinical trials - for example for drugs that are unlikely to find much use in the paediatric setting - in order to secure extra patent life for their products.
The EGA says that six months' patent extension should only be available for smaller-volume products, while bigger sellers should receive just three months' additional protection. And for blockbuster products, the patent extension should be limited to one month, it says.
An across-the-board six-month extension would be unnecessarily costly for healthcare payers and, except in a limited number of cases, would give disproportionate returns in cases where the trial costs are low compared to the revenues generated.
Under the draft regulation on medicinal products for paediatric use, published last September, all new medicines or line extensions for older products still under patent would require studies in children, unless a waiver or deferral is granted.