BIO Initiatives

BIO member companies are committed to investing in, developing, and delivering innovative biopharmaceuticals that are transforming how we treat and cure patients with once-devastating diseases – giving them hope, extending survival, and saving millions of lives. The value that these innovative medicines offer to patients and their caregivers, the healthcare system, and society at large is truly a game-changer.

To further this mission, in February 2016, BIO released Principles of the Value of Biopharmaceuticals. These Principles represent the first-ever systemic, industry-endorsed set of commitments by research based biopharmaceutical companies to support comprehensive and sustainable solutions to improve patient access to and affordability of innovative medicines.

BIO Principles on the Value of Biopharmaceuticals:

BIO and its members commit to:

1.Invest in developing and delivering innovative biopharmaceuticals that offer value to patients and to society;

2.Help patients obtain access to the most appropriate therapies for them when the insurance industry fails to provide such access;

3.Work collaboratively with payors, providers, and policymakers to realize the full potential of 21^st century medicines to maximize patient benefit and drive smarter overall healthcare spending;

4.Engage all stakeholders, including patients, on the ongoing, iterative discussion of the meaning of value; and

5.Remove current legal barriers that can limit the full potential of these commitments (including with respect to value-based communications and contracting arrangements).

Visit TimeIsPrecious.life for more information.

Entrepreneurial biotechnology companies are at the cutting edge of a new and revolutionary understanding of the genetic and biomolecular  underpinnings  of  disease,  and are committed to developing the next generation of medicines to transform patient care. However, this goal can only be realized in a public policy environment that sustains scientific discovery and biomedical innovation.

The tradition of public investment in the NIH has helped establish the United States as a global leader in medical research and innovation. This commitment has laid the foundation for the development of many breakthrough drugs and therapies that have extended and improved the lives of countless patients and their families in the United States. This investment also serves to drive the innovation pipeline that is critical to ensuring that the medical research and biopharmaceutical industry, which provides high-paying jobs and makes significant contributions to the U.S. economy, continues to grow in the United States.

The NIH is the nation’s premier research agency for the study of human health conditions, diagnostics, and treatments. The United States has historically been the foremost leader in the world for biomedical research and development. Breakthroughs in biomedicine and health over the past 50 years are largely due to the research and development that occurs within the biotechnology and pharmaceutical industries, as well as the publicly- funded biomedical research enterprise centered at the NIH. At a time when global completion has intensified from China and the European Union, the United States should not abdicate its role as global leader or diminish its competitive edge.

Since the doubling of the NIH budget between 1998 and 2003, funding levels for the NIH have consistently remained flat over the past decade, and sustained cuts as a result of sequestration in 2013. When NIH funding is measured against the rising cost of conducting medical research (known as the biomedical research and development price index, or BRDPI), NIH funding has decreased by 22% between 2003 and 2013. The FY 2016 budget provided a much needed 5% increase in biomedical research funding, reflecting the strong bipartisan recognition that maintaining the United States position as the global leader in medical innovation is a priority for Americans. The discoveries that result from NIH research are critical to the ability of the biopharmaceutical industry to deliver the next generation of medicines and provide new solutions to address our nation’s most pressing health care needs.

In addition to the NIH’s role of supporting medical research, it also provides critical early-stage funding opportunities to small U.S. biotechnology companies developing innovative medicines through the Small Business Innovation Research and Small Business Technology Transfer programs. NIH’s Cures Acceleration Network also offers collaboration and funding opportunities for public-private partnerships to advance the development of high-need cures and reduce significant barriers between research and clinical trials. The National Center for Advancing Translational Sciences is doing important work to facilitate medical innovation and enable partnerships between government and industry to transform the translational science process in order to better enable industry to develop and deliver treatments and cures to patients faster. Finally, the President’s Precision Medicine Initiative Cohort, the Vice President’s National Cancer Moonshoot initiative and the White House Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative all have the potential to advance biomedical science and potentially improve the drug development process, thus improving the ability of the biopharmaceutical industry to develop and provide modern medicines to the patients who need them.

 

After the 2001 terrorist attacks, the Congress mandated a dedicated effort to develop and stockpile drugs and vaccines needed to protect the American people from chemical, biological, radiological, and nuclear (CBRN) and pandemic threats. Because medical countermeasures (MCMs) to protect against threats like anthrax, Ebola, and plague have little or no commercial market, in 2004, Congress passed the Project BioShield Act which created the Special Reserve Fund (SRF). Subsequently in 2006, Congress created the Biomedical Advanced Research and Development Authority (BARDA), which has additional responsibilities for MCM development and pandemic influenza funding.

BARDA and the Assistant Secretary for Preparedness and Response (ASPR) are charged with the prioritization and development, through partnerships with industry, of vaccines, treatments, and diagnostics for CBRN and pandemic influenza threats for use during a man-made, natural, or accidental emergency. The funding for these vital national security products comes, in large part, from the Project BioShield SRF and pandemic influenza budgets.

The SRF was originally funded through an advanced appropriation of $5.6 billion over 10 years, which successfully created a “guaranteed market” to incentivize biopharmaceutical companies to develop and produce civilian MCMs for which there is a limited or no commercial market. This funding expired at the end of Fiscal Year (FY) 2013 and since FY 2014, the SRF has been funded through the annual appropriations process, receiving $255 million both FY 2014 and 2015 and $510 million in the FY 2016 Omnibus. While BIO was pleased with the increased funding in FY 2016, we were concerned by the President’s request of $350 million for the SRF in FY 2017.

 

Intellectual property is the lifeblood of the biotechnology industry. Strong patents, and an efficient, predictable, and objective patent system, are critical to ensuring a steady stream of capital to biotechnology companies developing innovative medicines, alternative energy sources, insect- and drought-resistant crops, and a wide range of other innovative biotechnologies that are helping to feed, fuel, and heal our planet. This quintessentially-American industry leads the world in innovation, providing the United States with a global competitive advantage and spurring economic growth and the creation of high-paying jobs here at home.

Despite their well-intentioned efforts to curb abuses, proponents of patent litigation reform are pressing for sweeping ideas to remake the patent litigation system in fundamental and untested ways, based on questionable data and without sufficient consideration of the impact of those changes on the vast majority of patent owners and licensees who engage in legitimate and good faith patent licensing, partnering, and enforcement activities. Instead of surgically targeting abusive practices, they support general, far-reaching patent litigation changes, such as:

• Vastly increased amounts of detailed information would be required in order to file a patent infringement suit; insufficiencies could lead to dismissal right away;
• Patent infringement lawsuits would be prevented from getting underway if the accused infringer files certain motions, potentially creating long, business-crippling delays;
• Infringing manufacturers and sellers of patent infringing products could inappropriately deflect patent lawsuits away from themselves towards their suppliers; and
• Patent infringers could threaten the patentee’s business partners – investors, licensors, development partners and others with a financial interest in the patentee’s business –by adding them to the litigation as unwilling co-plaintiffs to pay the other side’s costs under a new “losers pay” approach

 

BIO believes it is vital for the United States to have a tax code that allows it to be competitive on the global stage. Currently, the U.S. corporate tax rate is the highest among countries in the OECD. High tax rates can impede growth, and this is particularly true in the biotechnology industry, where it can take more than a decade and cost more than $1 billion to develop a single breakthrough technology.

BIO supports efforts to streamline the tax code in order to facilitate lower rates and international competitiveness. At the same time, there are provisions in the current code that stimulate biotech R&D and early-stage commercialization, and these provisions are vitally important to the scientific progress of BIO members. These provisions, including the Orphan Drug Tax Credit and the Second Generation Biofuel Producer Tax Credit, should be retained in any reformed tax code. In combination with lower overall rates, these incentives will support breakthrough research and foster commercialization to bolster the economy.

Additionally, Congress has the opportunity to take new steps to inspire innovative research, development, and commercialization. Many biotech companies operate without product revenue to fund their scientific progress, which means they have little or no taxable income in early years, so provisions in the current code designed to incentivize research actually function as a potential future benefit rather than providing immediate support for R&D. Congress should bear in mind the needs of these pre-revenue innovators, which depend almost entirely on external capital to fund the typical decade-long, billion-dollar biotech development program.

 

To grow America’s 21st Century bio-based economy, BIO supports stable government policies that drive private sector investment and commercial scale production within the U.S. industrial biotechnology sector. BIO members use biotechnology to produce better performing and higher yielding feedstocks and to convert those feedstocks into advanced biofuels, renewable chemicals and biobased products. Economic data shows that these applications of biotechnology create high quality jobs, ignite domestic manufacturing of renewable materials, and improve energy security.