According to Professor David Ridley, Fuqua School of Business, Duke University and Alfonso Calles-Sanchez, patent expert in Spain's Patent Office, a "priority review voucher" award system in the EU would favor development of treatments for neglected diseases like tuberculosis, malaris, leishmanaiasis - as reported in MNT.
The voucher's would award a company expedited regulatory review through the EMA for one of its other drugs in return for developing a treatment for a neglected disease -- an innovative swapping concept. Currenlty, these diseases effect more than 1B people but largely in poor and developing nations. Historically, the financial incentive hasn't been strong enough to spur development of treatments.
For example, "If you develop a new drug for malaria, your profitable cholesterol-lowering drug could go on the market a year earlier," global health philanthropist Bill Gates explained at the 2008 World Economic Forum in Davos. "This priority review could be worth hundreds of millions of dollars," Gates said.
With expedited review, a company's drug not only reaches the market faster but preserves patent life for its drug in a commercial stage. This is potentially worth hundreds of millions too. The proposed EU system would mirror a system already adopted in the US in 2007. Novartis received the first priority review in the US in 2009, following development of its drug Coartem for malaria.
"A European priority review voucher system, combined with the U.S. system, would provide an extraordinarily powerful incentive for companies to invest in treatments for neglected diseases," Calles-Sánchez added.
Posted by Bruce Lehr September 11th 2001.
More on topic from WSJ today (September 21st 2010)
http://blogs.wsj.com/health/2010/09/21/need-for-speed-how-to-get-faster-drug-reviews-in-europe/
Posted by: bigredbruce | 09/21/2010 at 04:16 PM