Ethical.Reflections.and.Economic.Perspectives

· Pharmaceutical Research and Development (R&D)

These approaches aim to make neglected disease R&D more commercially attractive by increasing profits, though increasing financial returns (“pull” incentives), decreasing R&D costs (“push” incentives), or both

Pull incentives (consumer-funded)

· Orphan legislation gives 10 years of market exclusivity on sales of a neglected disease product registered in the United States or Europe. However, it has a very low incentive value as there are so few consumers (patients with neglected diseases) in these regions. 


· In the United States, PRVs reward companies who register a new drug for neglected diseases with rapid regulatory review of an unrelated commercial drug, which can then get to market sales more quickly. The estimated value of a PRV ranges from $50 million to $300 million (Ridley et al. 2006). 


· Transferable IPR (TIPR) is a proposal to give several years of additional patent life on an unrelated commercial product as a reward for making a neglected disease product. Its estimated value is in the tens of billions if the extension were on a “blockbuster” product.

Push incentives (government funded) 


· R&D grant programs – such as the US Small Business Innovation Research Pro- gram and the UK Small Business Research Initiative – give research grants to small businesses to support their neglected disease programs. 


· Some governments give companies a tax credit for a fixed proportion (e.g., 50%) of their neglected disease R&D expenses. 


· Orphan legislation normally also includes some push funding in the form of grants, faster regulatory review, or tax credits.