14 DAY TRIAL // If the European Union adopts the “priority review voucher” reward system, it will stimulate drug companies to develop treatments for neglected diseases like tuberculosis, malaria or Leishmaniasis.
Professor David Ridley of Duke University's Fuqua School of Business and Alfonso Calles-Sánchez, a patent expert with the Spanish Patent Office and former pharmaceutical policy maker at the European Commission, are suggesting a European Union version of the priority review voucher system that was successfully instituted in the United States in 2007.
The initiative would provide priority regulatory examination of one of its other drugs by the European Medicines Agency, as well as rapid pricing and reimbursement decisions by EU member states, as a reward for developing a treatment for a neglected disease.
Even if diseases like malaria, tuberculosis or Leishmaniasis affect over a billion people worldwide, pharmaceutical companies do not have a serious incentive to create and test new treatments because the diseases occur mostly in developing countries.
The US voucher was originally proposed in a 2006 article in the journal Health Affairs, by Ridley and Duke colleagues Jeff Moe and Henry Grabowski, was authorized by Congress in 2007 and was sponsored by Sens. Sam Brownback and Sherrod Brown.
In 2008, at the World Economic Forum in Davos, Bill Gates explained the way the voucher works: “if you develop a new drug for malaria, your profitable cholesterol-lowering drug could go on the market a year earlier.”
“This priority review could be worth hundreds of millions of dollars," the global health philanthropist said.
Calles-Sánchez talks about the European voucher and says that “by allowing a company to sell its profitable drug sooner, an EU voucher system also would increase the time during which the company could enjoy patent-protected sales.”
And as it would not extend the patent expiration date, the voucher would not delay generics.
Also the US and the European voucher systems combined would only “provide an extraordinarily powerful incentive for companies to invest in treatments for neglected diseases,” added Calles-Sánchez.
This is actually because approval for a new neglected disease treatment in both the US and EU would mean that the company would have vouchers in both regions, which translate into hundreds of million of dollars in sales of a future blockbuster product, according to the researchers' estimations.
Furthermore, the vouchers could be sold or transferred between companies, giving them a potential revenue source status and make them more attractive as buyouts targets.
Ridley said that “scientists are aware of molecules that could potentially treat neglected diseases, but they have been mostly unable to make a business case for spending millions of dollars testing those molecules.”
“A European voucher would provide a strong incentive for organizations to use their knowledge and resources to treat conditions that might otherwise be ignored.”
In 2009, Novartis received the first US priority voucher after the company's malaria treatment, Coartem, was approved by the FDA.
The scientists wrote in the Sept. 11 issue of The Lancet, e! Science News reports.