NVCA Offers Recommendations to House Energy and Commerce Committee as Part of the 21st Century Cures Initiative
ARLINGTON, VA – The National Venture Capital Association (NVCA) today offered recommendations to the House Energy and Commerce Committee on how best to encourage investment in medical innovation so that new treatments and cures are available to patients and the U.S. maintains its position as the global leader in medical research and development. NVCA’s recommendations were provided to the committee as part of the 21st Century Cures initiative being spearheaded by Rep. Fred Upton (R-MI), Chairman of the House Energy and Commerce Committee, and committee member Rep. Diana DeGette (D-CO).
“In many ways, the fate of the U.S. medical innovation ecosystem rests in your hands. If more is not done to improve the drug and device development process and modernize our regulatory and reimbursement systems to keep pace with the rapid advancement in medical research, the U.S. is at risk of losing its leadership in medical innovation,” wrote Bobby Franklin, President and CEO of NVCA, in a letter outlining NVCA’s recommendations.
“NVCA believes it is critical to advance public policies that will encourage investment in medical innovation so new treatments and cures will be available to patients,” added Franklin. “Central to doing so is to continue to reform our regulatory system to make it agile and flexible to the changing pace of innovation as well as develop a predictable and transparent reimbursement system that pays for innovative medical products that provide value to patients and the overall healthcare system.”
Venture capital is one of the primary forces in translating scientific discoveries into medical advances and remains one of the few sources of capital to fund and nurture small, emerging companies focused on medical innovation. However, venture capital investment in early-stage life sciences companies is under increasing pressure, with the number of first-time financings of new life sciences companies hitting a 15-year low in 2012. A primary reason for this decline in investment of companies focused on medical innovation is the increased time, cost and uncertainty of developing new drugs and medical devices resulting from outdated regulatory and reimbursement policies.
The full letter to the Energy and Commerce Committee can be found here. NVCA’s topline recommendations include:
• Make medical innovation a national priority
• Continue to fund basic science and applied R&D
• Provide appropriate incentives for collaborative public/private partnerships that can help address key barriers to innovation
• Develop novel, interactive and flexible regulatory models for disruptive innovation
• Provide greater clarity, transparency and flexibility in the regulatory process for laboratory developed tests (LDTs) to encourage investment and development of personalized medicine that will provide value to patients and the healthcare system
• Provide greater transparency and use of clinical trial data
• Work to integrate real world data into the drug and medical device review process
• Develop coverage and payment policies that reward investment in medical innovations that provide value both to patients and the healthcare system
• Provide greater patent and intellectual property incentives for medical breakthroughs