Senate Fails to Fix Flawed PRV Program Intended to Promote Innovation for Neglected Diseases

Statement by Judit Rius Sanjuan, Doctors Without Borders/Médecins Sans Frontières’ (MSF) US Access Campaign Manager and Legal Policy Adviser 

New York, March 18, 2016 — The U.S. Senate voted yesterday to add Zika to the list of diseases eligible for the U.S. Federal Drug Administration Priority Review Voucher (PRV) program for neglected diseases, but did not fix major loopholes that make the PRV program for neglected diseases ripe for abuse by pharmaceutical companies. The vote means that any company that successfully registers a treatment or vaccine for the disease is one step closer to receiving a voucher that allows the company to accelerate the FDA review of a subsequent product. The bill must still be voted on by the U.S. House.

The Priority Review Voucher was intended to create incentives to develop medicines and vaccines for neglected diseases and patients. Unfortunately, the PRV is rewarding companies without helping to stimulate development of urgently needed new products for neglected diseases and make them available and affordable for patients. In its current form, a company can receive a PRV for simply registering a product in the U.S.; it does not have to be a new product and it does not have to ensure that treatment is accessible and affordable to patients and medical treatment providers. In fact, instead of using these vouchers to motivate companies to bring lifesaving new medicines and vaccines to market, they’re being sold to the highest bidder, diluting the value of the incentive for innovation and leaving people in communities across the world to fend for themselves. The last PRV sold had a price tag of $350 million, which is three and a half times the total amount of money USAID committed to neglected tropical diseases in FY 2015.

“When we faced the deadliest Ebola epidemic ever, Doctors Without Borders was trying to treat patients virtually empty-handed. Nearly two years later, the global health community is facing another epidemic, Zika, without safe and effective vaccines or treatments to help patients. Ebola should have taught us not just about the urgent need for research for neglected diseases, but also that people in affected communities must have affordable access to any new treatments or vaccines that are developed. By adding Zika to the list for which companies can receive a PRV without first ensuring that the program rewards true innovation and that the people most in need benefit from any scientific breakthrough, we are repeating our mistakes.

"As this bill now moves to the U.S. House, U.S. government representatives must take this opportunity to immediately fix the critical flaws with the program. They must ensure that companies rewarded with a voucher are actually creating new products that are available and affordable to patients and treatment providers. This program should help people suffering from fatal neglected diseases instead of companies just looking to rake in huge profits.”