Pennsylvania is a global leader in researching and developing new therapies, cures, and devices that help patients live longer, healthier lives. This innovation is due in part to the policy and regulatory ecosystem we enjoy in the United States.
Life Sciences PA works with its Federal Policy Committee and national partners to develop a shared set of recommendations and strategies that will support and enhance the entire ecosystem of the life sciences in the United States, and in Pennsylvania in particular.
Education on the Value of Innovation
Successfully healing patients or providing them with enhanced quality of life is the passion behind innovation. With only one in ten drugs surviving the development process a successful commercial drug can cost over two billion dollars and take 10-15 years before reaching a patient.
Life Sciences PA works to ensure that the Pennsylvania Congressional Delegation, comprised of two senators and eighteen members of congress, understands that process and that patient access to groundbreaking therapies and cures through appropriate reimbursement in our market-based system are what has led the United States to produce over 50 percent of the new medicines throughout the world.
The cost of medicines is the cause of much debate in our Nation’s capital and determining who pays for what medicines and at what cost is an important discussion to have. Life Sciences PA believes all parts – pharmacy benefit managers (PBMs), health insurance companies, pharmacies, healthcare providers, and manufacturers – of our complex drug pricing system have a role to play in this debate. It is incumbent upon all of us to ensure that all parts of the prescription drug supply chain are acting in good faith and working to keep costs, especially those out-of-pocket costs borne by the patient, at an accessible level. For more information on the complex system of pharmaceutical pricing, payment and distribution please visit the PhRMA website for the “Follow the Dollar” report.
Improving Patient Access
Patients provide critical testimony on the effect of policy and regulations in their treatment and quality of life. Remaining focused on the voice of the patient is at the core of all innovation in the life sciences. Especially as medicines have become more individualized, the role of the patient in researching and developing new medicines has become increasingly important. Life Sciences PA works with our more than 40 patient advocacy group members to amplify the voice of the ultimate beneficiary of our member company research and development. Some of the policies that impact patient access includes:
Preserving Medicare Part D
Medicare Part D was created as part of the Medicare Modernization Act of 2003, and is an optional program to help Medicare beneficiaries pay for self-administered prescription medicines. In 2018 approximately 43 million (72 percent) of the 60 million Medicare beneficiaries utilize a Medicare Part D plan. The success of Medicare Part D, which continues cost less than Congressional Budget Office projections and enjoys an almost 90% satisfactory rating among beneficiaries, is due largely to the private-sector competition and robust negotiation the program utilizes. Additionally, it has ensured largely unfettered access to groundbreaking therapies and cures for beneficiaries facing debilitating and deadly diseases.
Life Sciences Pennsylvania has serious concerns about proposals, like striking the non-interference clause, that could ultimately hurt a patient’s ability to access novel medicines.
Protecting Medicare Part B
Medicare Parts A and B, sometimes referred to as “original Medicare,” provide coverage for beneficiaries in the hospital/inpatient setting and outpatient services, respectively. In particular, Medicare Part B covers physician-administered prescription medicines, such as vaccinations, and injectable and infused drugs/biologics.
Life Sciences PA is opposed to proposals that disrupt access to biopharmaceuticals for patients in Medicare, such as indexing medicines to international price controls. Policies like this simply import prices from foreign countries where strict government-controlled prices limit patient access to the breakthrough medicines available to Americans. Additionally, policies like this can adversely affect patients in rural areas where cutting reimbursements to community providers could shift patients to more expensive, and farther away, care settings such as hospitals.
Insurance Benefit Design and Access Restrictions
Life Sciences PA is committed to educating legislators on the impact insurance benefit design can have on the out-of-pockets costs patients pay at the pharmacy. As noted above, the drug pricing, payment and distribution system is complex and includes many stakeholders. Life Sciences PA believe that all of those stakeholders must be included in any and all discussions around lowering the cost of prescription medicines.
Additionally, Life Sciences PA has significant concerns about insurance policies, such as step therapy (sometimes referred to as “fail first”) and prior authorization, which can delay or deny patient access to new medicines.
Importation of Prescription Drugs
Life Sciences PA is opposed to proposals that allow for the importation of prescription medicines. Though a common idea to lower the price of prescription drugs, policies that promote this idea could severely undermine the safe, closed drug-supply chain we enjoy in the United States. Several past FDA commissioners, from both Democrat and Republican administrations, have warned of the potential consequences of allowing drug importation, and the Congressional Budget Office has found that importation will do almost nothing to actually lower drug costs. Finally, former FBI Director and federal judge, Louis Freeh, released the findings of an investigation (with a more recent addendum) that note the ways drug importation would affect public health, safety and law enforcement.
Robust Research Funding
Life Sciences PA is a strong supporter of robust research funding that is the foundation for innovation in the life sciences. As home to two of the top-five recipients of NIH funding – the University of Pennsylvania and the University of Pittsburgh – Pennsylvania is one the U.S. leaders in basic research to advance human health. This critical funding provides our academic research institutions and small, start-up companies with funding for research that private investors would find far too risky, and it is the launching point for the science that has led to a number of new therapies and cures.
Additionally, Life Sciences PA supports the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, created in 1982 and 1992, respectively. While not life sciences specific, these two programs fund domestic small businesses engaging in research and development on the path to technology commercialization. This funding has helped many of our small member companies thrive while in-between financing rounds or when encountering the uncertainties present in life sciences research and development.
With more than 330 medical device and diagnostic companies, Pennsylvania is home to a significant number of entities working on developing new technologies to help patients live longer, healthier lives. As innovators and manufacturers, these companies benefit from policies that incentivize both of those endeavors.
To that end, Life Sciences PA strongly supports permanently repealing the Medical Device Tax, and has advocated for that repeal since its inception as part of the Affordable Care Act, colloquially known as “Obamacare.” The Medical Device Tax imposed a 2.3% excise tax on any company, many of whom are pre-revenue, manufacturing a medical device. This tax inhibits innovation, and while it is currently under a two-year suspension, it will go back into effect in 2020. Permanently repealing this tax before it is back in effect will give medtech manufacturers certainty and ensure they can continue to devote significant resources to developing novel devices and diagnostics.
Strong intellectual property protections are the foundation for innovation in the life sciences. The U.S. patent system, though now ranked 12th worldwide by the U.S. Chamber of Commerce, maintains important protections for companies researching and developing new medicines and technologies. These protections are especially important for the many small life sciences companies that call Pennsylvania home, and for the technology transfer offices that many of our academic institutions operate to move inventions from the lab to widely-available treatments and cures for patients.
For these reasons, Life Sciences PA supports legislation like the STRONGER Patents Act (not yet reintroduced in the 116th Congress), and opposes measure such as compulsory licensing and march-in rights that undermine innovative companies and the substantial research and development resources needed to bring novel therapies to patients.
Addressing the Opioid Crisis
The opioid epidemic is one of the worst public health crises the Commonwealth of Pennsylvania and our country have faced in the past century. Its affects are far-reaching and community agnostic. Pennsylvania’s life sciences community is committed to doing everything in its power to curb this tragic epidemic, and as a public advocacy organization, this issue is one of our top priorities in discussions with legislators at all levels of government. As an organization, Life Sciences PA (1) supports robust biomedical research on the biology of pain and addiction, which is still not well understood; (2) advocates for policies that encourage research to move from the lab to the patient; (3) works with entities in our complex health care system to ensure patients can obtain the medicines they require.
Additionally, Life Sciences PA has over 15 member companies that are working on innovative products, such as novel, non-opioid pain medications and abuse deterrent formulations, that will help alleviate the opioid crisis.