Anticounterfeiting measures could harm generics industry, says EGA

Measures to combat counterfeiting, proposed in the European Commission's pharma package will not help in the fight against fake medicines but could damage the generics industry due to increased manufacturing costs, according to generics industry leaders.

Proposals in the package of reforms could allow the Commission to bring in obligatory specific safety features (such as a serial number or a seal) on drug packaging, as well as placing "certain obligations" on companies involved in the pharmaceutical distribution chain.

But at the annual meeting of the European Generic Medicines Association (EGA) in Barcelona, director general Greg Perry said the association believes wholesale distribution and safety features recommended by the commission "will not add value to the fight against counterfeiting".

While Perry agreed counterfeiting is an issue, he said it was not a significant problem for the generics sector, since illegal drug-makers tend to target well-known, high-priced, branded drugs; furthermore, counterfeiters cannot compete with the manufacturing efficiencies of the generics sector.

He said the EGA feels the generics industry is being unfairly penalised in the European Commission's proposals by increasing production and manufacturing costs. "We believe the proposal is not correctly focused ... Seals and traceability systems could result in Euro 20bn in costs to the industry," he claimed.

An EGA statement stated that seals and traceability systems "could substantially increase the manufacturing costs of generics medicines" and will not stop counterfeit medicines from reaching patients. In addition they will provide a "false sense of security".

It said attention should be focused on avoiding any increase in the financial burden on companies that already comply with requirements, and consideration should be given to the resources needed for implementation of the proposals, for both the industry and the authorities.