In May the European Commission outlined a series of measures to its Transparency Directive that would help new medicines reach the market quicker by streamlining the pricing and reimbursement process.
Its proposals included setting a 120-day decision limit for national regulators on innovative medicines, and a 30-day limit for generics.
Speaking earlier this year, Antonio Tajani, the EC’s VP responsible for industry and entrepreneurship, said fast decisions were needed to “maintain a dynamic pharmaceutical market” and improve patient access to new medicines.
“It also creates a more predictable environment with greater transparency for pharmaceutical companies, thus improving their competitiveness,” he added.
Individual countries currently have up to 180 days to decide whether or not a drug can be marketed, but a 2009 EC report found pricing and reimbursement delays could reach 250 days for generics and stretch to 700 days for innovative medicines.
Source: Booz & Co analysis
The EC also wants stronger enforcement powers over the new time limits, including forcing countries that do not comply with the rules to designate a body entrusted with the powers to take national measures. These, it suggests, could even include awarding damages to the company trying to market the product.
The EC said such changes were necessary as the current directive, which was introduced in 1989, ‘no longer reflected the increased complexity of the pricing and reimbursement procedures in the Member States’.
Read the full proposal on the EC’s website via: http://bit.ly/z8RtQz