European regulators take steps to speed pricing, reimbursement decisions

The European Commission is taking steps to speed up national drug pricing and reimbursement decisions. Under a new proposal, such decisions should be made within 120 days for innovative medicines and 30 days for generic drugs. Currently, the time limit for both is 180 days.

In addition, delays in pricing and reimbursement decisions can be up to 700 days for innovative medicines and up to 250 days for generics, according to studies.

As the EC notes in a statement, the complexity of trying to price medicinal products has increased since 1989, when the transparency directive for pharmaceutical products was adopted. It is hoped the new proposal will help make pricing more transparent. Many have complained that local drugmakers are sometimes favored and of a general lack of clarity in terms of government pricing decisions, Pharmalot notes.

Regulators herald the new approach as more cost-effective--something cash-strapped European governments should like. "Our proposal will lead to substantial savings for public health budgets, for example by allowing earlier market entry of generic products," says EC Vice President Antonio Tajani in a statement. "It also creates a more predictable environment with greater transparency for pharmaceutical companies, thus improving their competitiveness."

And there will be consequences for those countries that don't comply, the EC warns, including financial penalties and damages awarded to the applicant.

Representatives from the EU generic community were swift to react to the news. "...[G]eneric medicines and biosimilars are major contributors to the sustainability of European healthcare systems, providing over 150,000 jobs and bringing savings of more than [€35B] per year, while increasing patient access to affordable treatments," explains European Generic Medicines Association Director Greg Perry in a statement. He adds that the proposals show the EC recognizes this.

- read the EC's statement
- check out the release from the EGA
- see more from Pharmalot