2019 Policy Priorities

The CBSA team leads policy efforts on behalf of the life sciences ecosystem and our members, who dedicate their careers to changing and saving lives with health innovations, products, and services.

We work to create a pro-innovation policy environment that enables the growth of the life sciences community and the development of breakthrough treatments and cures for patients.

State Policy Priorities

Access To Capital

We champion opportunities for life sciences innovators to access needed capital. Our team fosters the growth of state-supported programs including the Advanced Industry Grant Program and the Advanced Industry Investment Tax Credit.

CBSA pushes for additional bioscience program funding, seeks opportunities for new investments, and supports funding models that could attract private and public support.

Patient Access + Affordability

CBSA members work every day to save and change lives around the world. Our team advances proposals to lower out-of-pocket costs for patients without limiting access to treatments or stifling innovation. This includes policies to enhance competition and create opportunities for negotiation.

CBSA is committed to helping patients understand their health care costs and bringing transparency to the health care conversation.

Life Sciences Innovation

CBSA advocates for a business and policy climate that encourages innovation. We seek incentives for innovators and predictability on the path from research to market.

CBSA works to ensure that any legislature or administrative proposals put forward will not impede research, place undue burden on our innovation ecosystem, or create unintended consequences for our members.

Tax and Regulatory Environment

CBSA advocates for a tax and regulatory environment that encourages business development and growth of the life sciences ecosystem and attracts companies at all stages of commercialization considering relocation to Colorado.

Workforce Cultivation

CBSA supports initiatives to create an educated talent pipeline for life sciences in Colorado.

Our team champions efforts to enhance science, technology, engineering and math (STEM) education and encourages the development of educational pathways, internship programs, and workforce development initiatives.

State Budget

As the Colorado State Legislature considers budget cuts, CBSA works to ensure key priorities and past legislative efforts remain intact.

CBSA works to prevent measures which could hamper innovation or create an unfriendly business environment. We advocate for opportunities to foster life sciences growth and prosperity in Colorado.

Federal Policy Priorities

Regulatory Environment

Funding + User Fees
A well-funded, science-based FDA and consistent, predictable and transparent product review processes are critical to and necessary for life sciences investment, innovation and improvements in patient care. Ensuring regulators have needed resources to keep pace with rapidly evolving biomedical and medical technology development will allow for sound and timely regulatory decisions.

CBSA commends Congress and the Colorado Delegation on reauthorizing the User Fees in 2018 and will continue to support policies and efforts to adequately fund the FDA through both appropriated funds and user fees.

Biosimilar Approval Pathway
The Affordable Care Act created an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product.

As the FDA continues to finalize guidance regarding the regulatory pathway for the approval of biosimilar products, CBSA will advocate for protections on product innovation and allowing originator products to receive 12 years of data exclusivity both in the United States and abroad. CBSA will continue to focus efforts on ensuring appropriate and transparent implementation of the regulatory pathway for the approval of biosimilar products.

21st Century Cures
The $6.3 billion 21st Century Cures Act will help accelerate the discovery, development and delivery of medical advancements to ensure more timely access to new treatments and cures for patients.
The act included critical research funding for National Institutes of Health programs that support early-stage innovation in Colorado. It also builds on work to incorporate patient perspectives, enhances the FDA’s ability to modernize clinical trial designs and clinical outcome assessments, and provides new authority to help the FDA improve the ability to recruit and retain scientific, technical, and professional experts. New expedited product development programs will speed the review of certain innovative medical devices, allowing Colorado medical device companies to speed up delivery of life-saving solutions for patients.

RESEARCH + FUNDING

National Institutes of Health
CBSA advocates for increased funding for the National Institutes of Health (NIH) to support breakthrough research underway at Colorado companies, organizations and research institutions.

NIH funding provides Colorado the largest source of funding for basic research within our university system. As the cost of medical product development continues to increase, CBSA advocates for additional federal funding from the NIH to ensure efficient transfer from research development to product development.

With 20+ new bioscience start-ups forming each year in Colorado from university research, ongoing research across our ecosystem leads to new discoveries.

Supporting higher education and promoting university research and technology transfer activities is a top priority for the Colorado BioScience Association.

NIH Funding in Colorado

$401 Million
In Funding
39
NIH-Funded
Institutions
1,050
Grants
55
Clinical Trials

TAX, FISCAL + IP POLICY

Medical Device Excise Tax
CBSA remains committed to working with Congress, our Colorado delegation, and CBSA members to fully repeal the medical device tax. We work closely with the Colorado delegation to communicate the adverse impact the tax has on R&D investment and job creation, which could harm Colorado’s status as a leading medical device exporter serving patients around the world.

CBSA applauds Congress and the Colorado delegation for their work to pass a two-year retroactive delay (2018-2019) of the medical device tax that was signed into law in January 2018 and adds to a previous two-year suspension of the tax, enacted in 2015.

The bill ensures that medical device manufacturers will continue to be exempt from paying the 2.3% excise tax on medical device sales, which first took effect on January 1, 2013.

The tax is projected to cost U.S. medical device innovators $30 billion over the next ten years, putting 43,000 jobs at risk, stifling R&D investments and medical innovation, eroding U.S. global leadership, and jeopardizing patient access to breakthrough devices and therapies.

Tax Reform
CBSA advocates to maintain the Orphan Drug Tax Credit and the R&D tax credit, repeal the medical device excise tax and to offer incentives for pre-revenue innovation. Our team monitors and advocates for tax reform to support Colorado’s leadership in life sciences innovation.

Tax reform has the opportunity improve U.S. competitiveness, create new jobs, and boost the U.S. biopharmaceutical industry with the development of lifesaving treatments and cures.

Patent Law
A strong and robust patent system allows Colorado companies and research institutions to capitalize on their research and pursue innovation that leads to potential breakthroughs for patients in Colorado and around the world.

CBSA supports efforts to bring an end to abusive patent litigation but urges Members of Congress considering policy solutions to craft a narrowly drawn approach that targets the practices of those parties abusing the system while maintaining the right of legitimate patent holders to assert their intellectual property rights in court.

Intellectual Property
Protecting intellectual property is a critical priority for Colorado’s life sciences ecosystem. Strong IP rights found in current U.S. law include twelve years of data exclusivity for biologics which encourages progress, risk-taking, and efforts to deliver new treatments to patients. Lack of enforceable incentives for innovation will undermine the work underway in Colorado to develop new treatments for patient’s unmet medical needs around the world.

CBSA continues to monitor ongoing efforts to protect the rights of U.S. patent holders.

PUBLIC HEALTH INSURANCE PROGRAMS

Medicare Part D
Medicare Part D, created through the Medicare Prescription Drug Improvement and Modernization Act, was established to provide seniors and individuals living with disabilities with access to affordable prescription drug coverage. Part D is structured on a private-market, competitive bidding approach which encourages plan competition and increases the incentive to offer lower premiums. Part D has consistently performed better than projected in the federal budget, costing the government 45% less than projected and saving beneficiaries about $1,200 year.

CBSA opposes proposals to enforce rebates and price controls in Medicare Part D, which would likely destabilize the program and decrease life sciences incentives to invest in new research and development.

Medicare Part B
Medicare Part B provides coverage for physician office visits, outpatient care, ambulance services, some medical devices and medicines administered by a physician.

Medicines covered by Part B include treatments for complex conditions.
Reimbursement relies on a market-based mechanism by calculating the Average Sales Price (ASP) plus 6%, to cover both overhead costs and the therapy. As a result of sequestration, in 2013 reimbursement rates for Part B decreased to Average Sales Price (ASP) +4.3%, resulting in thin or non-existent margins for physicians and practices.

CBSA opposes additional cuts and changes to reimbursement rates in Medicare Part B, which would make it harder for physicians to provide Part B therapies and ultimately impact patient care.

IMPORTATION

Due to the U.S. Food and Drug Administration’s (FDA) comprehensive drug approval process and its ability to track and trace medications through the pharmaceutical supply chain, medicines on the U.S. market are regarded as the safest in the world. Legalizing importation would open up that drug supply to unapproved foreign drugs and create multiple avenues for counterfeiters to enter the U.S. market.

CBSA opposes importation because it would jeopardize patient safety.

AG Bio

2018 Farm Bill
CBSA advocates for the funding and passage of the bipartisan 2018 Farm Bill to support AG bio innovators in Colorado.

Under this bill, key funding is allocated to critical programs and initiatives (including a vaccine bank, Growing American Food Exports, and biostimulants) that our nation’s farmers and rural communities rely on as they develop new renewable chemicals, bio-based products, advanced biofuels, and other products of industrial biotechnology.

Food + Product Labeling
CBSA promotes accurate and informative food labeling that communicates scientifically significant information relevant to health, safety and nutrition to consumers.

CBSA is a member of the “Coalition for Safe and Affordable Food,” which supported the passage of H.R. 1599, the Safe and Accurate Food Labeling Act, helping to create a national labeling standard rather than a state-by-state patchwork of requirements.

TRADE

CBSA supports establishment of trade agreements that expand market access for U.S. companies in global markets. International trade provides new opportunities for Colorado companies to make a positive impact on the health of people around the world. With 95% of the world’s consumers outside the United States, Colorado fully recognizes and supports the benefits of the United States expanding commercial ties with other countries.

DIGITAL HEALTH

Life sciences and technology propel Colorado’s robust economy and create a convergence of innovators integrating technology and health innovation in our state. Health information technology (IT), wearable devices, telehealth and telemedicine, and offer great promise to reduce inefficiencies and costs, increase quality and access, and tailor medical treatments to individual patient needs.
CBSA monitors digital health efforts at the FDA and in Congress ensuring that aspects of the bioscience industry are protected and provide patients increased access to life-saving technologies.