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EC proposes streamlining national pricing and reimbursement decisions

Wants to cut the time it takes new drugs to reach the market by a third

The European Commission (EC) has proposed new measures to help medicines reach the market quicker by streamlining the pricing and reimbursement process.

Revisions to the EC's Transparency Directive would set a 120-day decision limit for national regulators on innovative medicines, and a 30-day limit for generics.

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.
He added: "Our proposal will lead to substantial savings for public health budgets, for example by allowing earlier market entry of generic products.

“It also creates a more predictable environment with greater transparency for pharmaceutical companies, thus improving their competitiveness."

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.

The EC also wants stronger enforcement powers over the new time limits, including forcing countries who 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 are 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”.

The proposals were welcomed by the European Federation of Pharmaceutical Industries and Associations (EFPIA), although the trade body suggested further measures were also necessary.

It called for changes to the way Member States evaluate the cost of pharmaceutical products, by dropping any international price referencing models, where countries set the reimbursement price of a drug based on what different countries are paying.

In their place EFPIA wants a system of differential pricing, which would allow pharma companies to charge different prices to different countries for the same product, based on what they can afford.

“Especially in times of economic crisis, the focus of Member States on pricing measures such as international or therapeutic reference pricing poses a threat to the long-term innovative capability of Europe and hinders access to medicines,” said the EFPIA's director general Richard Bergström.

“This is even more worrying if emergency price cuts under exceptional circumstances such as in Greece lead to automatic and arbitrary price cuts in 15 other Member States.”

In 2010 Novo Nordisk briefly stopped supplying its modern insulin products to Greece after the country subjected them to mandatory price cuts, and last July the country detailed a new round of cuts. These affected more than 13,000 pharmaceutical preparations.

2nd March 2012

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