The European Commission published a proposal today designed to speed up decisions by national administrations on pricing and reimbursement of medicines. The aim is to bring new medicines to the market faster.
The proposal would require decisions to be taken within 120 days for innovative medicines. For generic medicines copying another drug, the limit would be 30 days. The existing limit is 180 days under rules agreed in 1989.
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The Commission says that even the existing limit is often exceeded by member states. For this reason, the proposal would also introduce new enforcement measures. A Commission report in 2009 found “long and cumbersome” pricing and reimbursement procedures in member states.
“Our proposal will lead to substantial savings for public health budgets, for example by allowing earlier market entry of generic products,” said Antonio Tajani, the European commissioner for enterprise and industry. “It also creates a more predictable environment with greater transparency for pharmaceutical companies, thus improving their competitiveness.”
Since 1989 the complexity of national procedures for pricing medicines and setting their reimbursement under national health schemes has increased. Delays in pricing and reimbursement decisions can now last as long as 700 days for innovative medicines and up to 250 days for generics .