Generics manufacturers concerned over older drug exemptions from new EU regulations

The European generic sector has voiced disappointment as the European Parliament moved closer to approving new regulations on variations to drug approvals.

The European Generic Medicines Association (EGA) said the new regulations to standardise the treatment of drug labels and other changes, which have been adopted by the Environment, Public Health and Food Safety (ENVI) Committee of the European parliament, have changed since they were referred to the parliament in July.

The association had been expecting new regulations, which would include timelines governing how long individual member states had to approve changes to drugs, to apply to all medicines.

However, the version now set for approval applies only to drugs that gained marketing authorisation after December 1997, meaning changes to older products - both generic and branded - may still be subject to the whims of individual states.

"The amendment allowing the exclusion of national products authorised before 1 January 1998 is seen by the EGA as a step backward in the full harmonisation process initially proposed by the European Commission," said Beata Stepniewska, director of regulatory affairs at the EGA.

The EGA was specifically concerned that with products approved before January 1998, member states would not be expected to meet standardised timelines in approving changes for drugs. As such, a manufacturer could be left waiting for up to year for a slower country to approve a change when that change may already have been approved by all other countries in which the drug is marketed.

This had potentially serious implications for the manufacture of products and could also potentially slow down improvements in medicines reaching patients.

Despite the ruling applying largely to older drugs, Stepniewska said the EGA was not alone in hoping for harmonisation for all drugs. There was strong support for universal change from the branded industry as well, she said.

Gunter Verheugen, vice-president of the European Commission and commissioner responsible for enterprise and industry claimed that the proposals would reduce bureaucracy. Officials from the Commission said that it is striving to make the system "simpler, clearer and more flexible, without compromising public health".

They added that the present system required significant administrative and regulatory resources both for public authorities and pharmaceutical companies to make even small changes to medicines, including a change in the address of the manufacturer.

According to Commission sources, the new regulations are likely to come into effect in the fourth quarter of next year.