We are fortunate to be living in a time when most major diseases can be prevented by effective and safe vaccines. According to CDC and every medical professional organization, the United States has the safest vaccine supply in history. The stage is set for success, but it is our responsibility to take advantage of the scientific advances that have already been made by getting vaccinated now for those diseases that can be controlled. It is important to get as many people vaccinated for COVID-19 as possible so that we can get past this pandemic.  We do this for ourselves and for each other.

• Vaccination of biohealth companies’ employees: the following is a sequence of events related to the COVID-19 vaccine distribution-
  • December 8, 2020: BioForward proactively requested that Wisconsin’s biohealth industry be eligible for Phase 1b vaccinations since many of our companies should be designated as frontline workers in the fight against this pandemic due to our critical products and services related to the treatment, prevention and testing of COVID-19.
  • January 14, 2021: BioForward responded to the State Disaster Medical Advisory Committee’s (SDMAC) recommendations for Phase 1b COVID Vaccination, which the recommendations excluded manufacturing that encompasses the biohealth industry. BioForward sent the SDMAC a comment letter and also made our companies aware they too could comment if they felt strongly about having our industry in Phase 1b.
  • January 27, 2021. BioForward reached out to member companies after Wisconsin’s Department of Health Services finalized Phase 1b COVID vaccinations. The following category would apply to many Wisconsin biohealth companies:
    • Health care critical supply chain functions, including the production, manufacturing, and distribution of vaccine
  • Companies located in Dane County were able to register through this site: https://publichealthmdc.com/coronavirus/covid-19-vaccine

• Vaccine Facts and Vaccines 101:
  • Get the fact on COVID-19 Vaccines: https://www.covidvaccinefacts.org/
  • COVID Treatment Progress: https://phrma.org/Coronavirus/Activity-Tracker
  • Vaccines 101
• Educating our members and state

Biohealth Companies Allowed to Operate Under Wisconsin’s Safer at Home Order

The BioForward state advocacy program proactively engaged Governor Evers in order to support the needs of Wisconsin biohealth companies throughout the COVID-19 public health emergency. In mid-March, BioForward requested that Wisconsin biohealth companies be allowed to continue to work under any forthcoming stay-at-home order.  On March 25, Wisconsin’s original “Safer-at-Home” order was released and it preserved Wisconsin biohealth, biotechnology, pharmaceutical, medical device, healthcare IT and related supply chain entities as “Healthcare and Public Health Operations,” allowing them to remain open during the term of the order.

BioForward Engaged in Proactive Vaccine Education of Wisconsin State Legislators

Throughout the summer and fall of 2020, BioForward and our members, Pfizer and Flugen, hosted video conference meetings with numerous state legislators in leadership roles to provide them with background on vaccine development and specific updates on the development of COVID-19 vaccine. These meetings were very well-received and have strengthened the understanding of vaccine science within the Capitol.

Written Vaccine Educational Communication. This fall, BioForward worked with UW Health, Children’s, Marshfield Children’s Hospital, WI Chapter of the American Academy of Pediatrics and the Wisconsin Hospital Association to send written vaccine educational communications to every legislative office in September and October 2020. These memos are intended to build on trusted resource relationships within the Capitol in anticipation of vaccine distribution and access discussions that will inevitably take place in 2021, as COVID-19 vaccine becomes available. See 2021 COVID-19 Vaccines & Updates

Governor Ever’s Vaccine Proclamation

Governor Evers Task Force on Prescription Drug Pricing Concluded Work

The Governor’s Task Force on Reducing Prescription Drug Prices began its work in November 2019 and concluded its work at the end of August 2020. For most of 2020, the Task Force met virtually to develop a set of legislative recommendations aimed at reducing prescription drug prices in Wisconsin.  These policy recommendations were sent to the 2021 legislature and some may be included in the Governor’s 2021-23 biennial budget bill.

We monitored each task force meeting, have reviewed the final report, and will advocate either in support or in opposition to these recommendations depending on how they are drafted. In 2021, the BioForward GA Committee will be reviewing any legislation based on these recommendations very carefully.  The Task Force recommendations included:

• Capping the copay amount an insurer can charge for insulin;
• Increasing transparency in the pharmaceutical supply chain to help identify excessive profits and eliminate waste that harms consumers;
• Strengthening consumer protections and anti-trust enforcement of pharmaceutical companies;
• Advocating for federal action to end anti-competitive practices that drive prescription drug unaffordability;
• Creating a prescription drug purchasing entity to leverage the purchasing power of public sector employers in order to drive down the price of prescription drugs;
• Establishing a statewide repository for unused or discontinued prescription drugs to help provide needed medications for uninsured or under-insured Wisconsinites; and
• Ensuring that critical safety net providers and community health centers can continue benefitting from discounted drug programs to support patient wellness and community care activities.

https://oci.wi.gov/Documents/AboutOCI/RxTaskForceFinalReport.pdf

Ensuring Safe and Efficient Transportation, Distribution and Administration of COVID-19 Vaccine in Wisconsin

Wisconsin developed a state vaccine priority distribution plan for the COVID-19 vaccines. BioForward worked with our Wisconsin providers to identify any legislative barriers to the safe and efficient distribution of vaccine within the State. This included reviewing whether statutory changes were needed to allow pharmacists and/or pharmacy students to administer the vaccine; ensuring that the vaccine is included on the State Immunization Registry; and ensuring that there are penalties in place for any deliberate interference or disruption of vaccine delivery. We will work with the legislature, as needed, to seek any changes that are required to support the delivery and administration of COVID-19 vaccine in Wisconsin.

Support for Liability Protection for Wisconsin Businesses and Universities

In the fall of 2020, Wisconsin legislators introduced legislation that would provide safe harbor protection for businesses, homeowners, and government entities such as schools or universities from COVID-19 litigation. LRB 6434/2, the legislation authored by Senator Kapenga and Representative Born, would create a safe harbor against lawsuits for those who are acting in good faith and working to protect against COVID-19 exposure at their locations – so long as they follow public health orders and take reasonable precautions to protect the public. This liability exemption does not protect bad actors who knowingly violate public health orders or act in a manner that is reckless, willful, or wanton. BioForward supports this legislation and expects it to be introduced early in the 2021 legislative session. 2021 WI Act 3, Wis. Stat. § 895.476.

2020 November Election Summary

State Assembly

All 99 seats in the Wisconsin State Assembly were up for election on November 3rd. Going into election night, Assembly Republicans held a 63-34 majority (2 vacant seats) and sought a veto-proof super-majority. The Assembly Republicans retained the majority easily in Wisconsin, but the Assembly Democrats picked up two seats in the 13th and the 23rd, both Milwaukee suburbs. Democratic challenger Sara Rodriguez (D-Brookfield) defeated incumbent Republican Rep. Rob Hutton (R-Brookfield) in the 13th and Democratic challenger Deb Andraca (D-Whitefish Bay) beat incumbent Jim Ott (R- Mequon) in the 23rd. The Assembly Republicans will return in 2021 with a majority of 61-38.

State Senate

The even-numbered half of the State Senate seats were up for reelection on November 3. The Senate Republicans held an 18-13 majority (2 vacant seats) heading into the election. The Senate Republicans maintained their majority but came one seat short of securing a super-majority of 22 seats. The Republicans picked up two seats. Eric Wimberger captured the seat of retiring Democratic Sen. Dave Hansen’s in the 30th (Green Bay) and current State Representative Rob Stafsholt (R-New Richmond) has won the 10th Senate District, currently held by Senator Patty Schachtner (D-Somerset). The Senate Republicans will start the 2021 session with a 20-12 majority. (There will be a special election for the Senate seat vacated by Scott Fitzgerald in SD-13).

2019—2021 State Biennial Budget and Legislative Priorities

Our 2019-2021 legislative agenda focused on economic development-based initiatives, workforce development, policies that promote innovation and improve patient access and outcomes, entrepreneurship, and protecting and supporting our exceptional research institutions.

STATE LEGISLATION 2019

Improving Patient Access and Outcomes

Step Therapy Protocols for Prescription Drug Coverage

Wisconsin Governor, Tony Evers, signed the 2019 Wisconsin Act 12, Wisconsin’s new Step Therapy legislation, on July 9, 2019. This legislation specifies the development and use of step therapy protocols for prescription drug coverage in Wisconsin and established parameters for exceptions to these protocols. Signed Into Law

Governor Evers’ Executive Order on Reducing Prescription Drug Prices

On August 21, 2019, Governor Evers issued Executive Order #39, creating a Task Force on Reducing Prescription Drug Prices in Wisconsin. This Task Force met monthly throughout 2020 and will present a report and recommendations for legislation to the Legislature in 2021.  Ongoing Executive Action

Variety of Patient Access Bills that BioForward has been monitoring

There are several bills and proposed legislation that BioForward and its Government Affairs Committee have tracked. These range from PBM transparency to vaccine bills to reimbursement of cancer trial costs to biennial budget proposals. Pending Legislation

Tax Policy

Repeal of Wisconsin’s Personal Property Tax

The 2017-19 biennial budget bill included a partial repeal of Wisconsin’s personal property tax for “machinery, tools, and patterns.” 2019 Assembly Bill 288 and Senate Bill 257 would provide a complete repeal of Wisconsin’s personal property tax. This small business tax reform legislation is supported by a large number of businesses from across the state.  Bills Pending

Protecting & Supporting Wisconsin’s Research Institutions

More Efficient UW Research Contract Review

Governor Evers signed 2019 Wisconsin Act 36, which changes the review period for research contracts involving the University of Wisconsin System. Signed into Law

Oppose Restrictions on Biomedical Research

Over the last several state legislative session, BioForward and its partners in the Cures for Tomorrow Coalition have worked together to prevent legislation from passing that would restrict the types of cells used for research in Wisconsin. Bills Pending

Economic Development Priorities

Wisconsin Workforce and Innovation Network for Success (WWINS)

WWINS legislation would transform Wisconsin’s economic development programs by creating an Innovation Fund and Council charged with engaging the private sector with solving issues of statewide concern.  Future 2021 Biennial Budget Initiative

BioForward-UW Health-UW Madison School of Medicine and Public Health-Cancer Action Network

On September 25th, the BioForward-UW Health-UW Madison School of Medicine and Public Health-Cancer Action Network hosted a special event- Research in Your Backyard: Pediatric Cancer Treatments and Emerging Therapies in Wisconsin. BioForward and our partners recognized the importance of educating our legislators and their staff on the amazing research and advanced disease treatments we have in Wisconsin. 

STATE LEGISLATION 2018

Economic Development Priorities

Support Cluster-based Economic Development Legislation-The WINS Act

BioForward worked on bipartisan legislation with industries from across Wisconsin business sectors, such as water, food & beverage, energy, to develop legislation that would provide a continuing source of economic development funding. This legislation was known as the Wisconsin Workforce and Innovation Network for Success (WINS) Act, or 2017 SB 525, as amended by SSA 1. Simply stated, this legislation would:

• Create an evergreen fund by allocating 95% of the withholding taxes within Wisconsin’s industry clusters allocable to each new job created in our clusters annually. The annual contribution is capped at $50 million total and the funding ceases entirely once the fund reaches $500 million.
• Provide grants to support private sector industry groups across Wisconsin that are looking to help their member companies grow their industry cluster by providing start-up support, rapid prototyping and pilot testing of new products and services, partnering with educational institutions for industry-specific research and skills training, etc.
• Award challenge grants to companies that are developing new technological solutions to current problems facing the state and nation, creating innovative product development through competition
• Support expanding upon an already successful Small Business Innovation Research (SBIR) matching grant program, SBIR Advance, to help further launch exciting new technologies and companies providing them with much-needed early-stage financing.
• Distribute the above grants and payments from the fund only from the fund earnings, thereby preserving an evergreen fund for continued investment.

Data Collection on Job Sector Growth for Wisconsin

During the course of the development of the WINS Legislation listed above, we discovered that the State of Wisconsin does not collect any data on which industry sectors are growing (i.e. which sectors are hiring NEW employees). While we believe that the entire WINS Act would be a valuable economic development budget initiative, at a minimum, including a provision in the 2019 biennial budget that requires the state to collect data on industry sector growth would be essential first step to identifying and capitalizing on those sectors of our state economy that are driving the most economic impact to the state. 

Workforce Development Initiatives

Support New Wisconsin Worker Signing Bonus—Income Tax Exemption

We propose that the State of Wisconsin allow a one-time income tax exemption for any signing bonus provided to a new employee who moves to Wisconsin to work in the biohealth sector. This would be limited to the signing bonus only; limited to new hires only; limited to workers who move into Wisconsin for the position. Importantly, this is a tax benefit to the individual worker, not the company offering the bonus.

Improving Patient Access and Outcomes

Support Step Therapy Protocols for Prescription Drug Coverage under Health Benefit Plans

Wisconsin Governor, Tony Evers (D), signed 2019 Wisconsin Act 12 (https://docs.legis.wisconsin.gov/2019/related/acts/12.pdf), Wisconsin’s new Step Therapy legislation, on July 9, 2019. This legislation, which went into effect on January 1, 2020, not only specifies the development and use of step therapy protocols for prescription drug coverage in Wisconsin, but it also establishes parameters for exceptions to these protocols. 

Protecting and Supporting Wisconsin’s Research Institutions

Oppose Restrictions on Biomedical Research

Over the past several sessions, BioForward and our partners in the Cures for Tomorrow Coalition have battled against legislative initiatives that would restrict the types of cells and tissues that our researchers can use to conduct life-saving research in the State of Wisconsin. BioForward opposed any legislative initiatives in the 2019 biennial budget bill, or elsewhere, that would restrict biomedical research in the State of Wisconsin.

Support Legislation that Stimulates Research, Entrepreneurship and Jobs

The UW-Madison sought an amendment to Wisconsin’s restrictive self-dealing law that included an overly cumbersome and lengthy process for allowing research companies to contract with the university when a faculty or staff member had an interest in the company. In 2018, AB 758 / SB 671 authored by Rep. Dave Murphy and Senator Dan Feyen, along with Senators Risser and Rep. Berceau, promoted a more workable system within the UW for development of management plans that would identify and manage any potential conflicts of interest. This legislation was signed into effect on November 21, 2019. https://docs.legis.wisconsin.gov/2019/proposals/reg/asm/bill/ab38

Provide Capacity Building to UW-Madison in Support of Developing a Talent Pipeline in Data Science, Nursing, Entrepreneurship and Engineering

College of Letters & Science: Computer and Data Science. BioForward supported UW-Madison’s request for $2.5 million/year for additional faculty, staff, advisors, and support services would permit another 800 to 1000 students to major in Computer and Data Sciences in the 2019-21 biennial budget bill.

School of Business. BioForward supported UW-Madison’s request for $2 million/year for additional faculty, staff, and support services that would grow enrollment by 300 students and expand entrepreneurship courses in the 2019-21 biennial budget bill.

School of Nursing. BioForward supported UW-Madison’s request for $1.2 million annually to increase number of faculty and instructional staff, and essential technological replacements to allow the School of Nursing to admit more approx. 40 additional undergraduate students in the 2019-21 biennial budget bill.

College of Engineering. BioForward supported UW-Madison’s request for $3 million/year to focus on workforce development, talent retention, and entrepreneurship and innovation. 

School of Veterinary Medicine. BioForward supported UW-Madison’s 2019-21 biennial budget request for bonding authority to renovate the School of Veterinary Medicine.

Innovation Investments

• Support: Endless Frontier Act- A bill to establish a new Directorate for Technology in the redesignated National Science and Technology Foundation, to establish a regional technology hub program, to require a strategy and report on economic security, science, research, and innovation, and for other purposes. Congressman Gallagher (GB) co-sponsor of house bill
• https://archive.bio.org/sites/default/files/docs/toolkit/BIO_100_Days_of_Innovation.pdf?_ga=2.250526670.953036990.1613613996-1402783213.1607108879
• • On May 13^, 2021, the Senate Commerce Committee approved the Endless Frontier Act. More information on highlights of the bill can be found here:
  • https://www.commerce.senate.gov/services/files/2347CF3E-6795-494E-9640-F415FF7986C7

Investing into expansion of COVID testing, therapeutics and vaccines

• Support: President’s Biden plan to expand  COVID-19 testing capabilities as outlined in his national strategy: https://www.whitehouse.gov/wp-content/uploads/2021/01/National-Strategy-for-the-COVID-19-Response-and-Pandemic-Preparedness.pdf

Protecting and Expanding Patient Access to Treatments

• Educating on precision medicine that allows doctors to find a person’s unique disease risks and treatments that will work best for each individual. Includes expanding biomarker and genetic testing, gene editing, and gene and cell therapies
• Oppose: CY22 Part D Payment Modernization Model RFA. Concerned that these policies can have significant impacts on patient access to new and novel treatments.

Protecting Intellectual Property Rights

• Support: Defending the University & Small Business Patent Proclamations Act, better known as Bayh-Dole Act: https://bayhdole40.org/about/#members

COVID-19 Response

• Educating on industry’s vaccine response to the pandemic

Lowering Regulatory Burdens for Small Biotech Companies

• The Securities and Exchange Commission (SEC) adopted regulatory changes to provide small public companies with a temporary exemption from Sarbanes-Oxley 404(b) compliance.

Protecting and Expanding Patient Access to Treatments

• Oppose: Importing foreign price controls in Medicare would be detrimental to patients and America’s scientists and researchers who are trying to develop new cures and treatments. Foreign price controls would stifle investment and research into tomorrow’s cures and would lead to a 90% reduction in medicines developed by small U.S. biotech companies.
  • Of the 74 cancer drugs launched between 2011 and 2018, 95% are available in the United States. Compare this with 74% in the United Kingdom, 49% in Japan, and 8% in Greece. o Nearly 90% of all new medicines launched since 2011 are available in the U.S., compared to just 50% in France, 48% in Switzerland, and 46% in Canada.

• Support: Centers for Medicare & Medicaid Services’ (CMS) proposed rule on Medicare Coverage of Innovative Technology (MCIT) Support a more streamlined approach to Medicare coverage of innovative medical devices and diagnostics that improve health outcomes for patients with debilitating or life-threatening illnesses.
• Support: Ensuring that America’s seniors have timely access to multi-cancer early detection. Early detection and diagnosis of cancer saves lives, costs less to treat, and improves quality of life. Yet routine cancer screenings exist for only five cancers: colorectal, breast, prostate, cervical, and high-risk lung cancer. Barriers to Medicare coverage should be removed to cover multi-cancer early detection tests soon after approval by the FDA.

COVID Resources

• Madison and Dane County Quick Links: https://publichealthmdc.com/  Learning who is eligible for vaccinations, registering companies for vaccinations, etc.
• Wisconsin Department of Health Services. Information on vaccines, testing, contact testing, COVID data, etc. https://www.dhs.wisconsin.gov/covid-19/vaccine-about.htm
• BIO’s https://www.covidvaccinefacts.org/

Federal Policy Advocacy

Tax and Fiscal Policies

Repeal of the Medical Device Tax- 2019

A bipartisan bill was signed into law on December 20, 2019, as part of the federal spending package that eliminates the medical device tax. Major support for this repeal came from Representative Ron Kind of Wisconsin’s Third District. Medical device companies have created more than 11,500 direct jobs in Wisconsin, and this sector has a major impact on Wisconsin’s statewide supply chain. Legislation Signed into Law

Medical Excise Tax- 2018

Repealing the Medical Device Excise Tax has been one of BioForward’s top priorities. The Wisconsin delegation has been supportive of this call to action with Senator Ron Johnson and Congressmen Ron Kind, Sean Duffy, Jim Sensenbrenner, and Glenn Grothman all helping lead the effort to repeal the tax.

Health Innovations

Gene Editing/Gene Therapy- Human Gene Editing- 2019

Human genome editing is a process by which a DNA sequence is modified to elicit a desired outcome within a living cell. Though DNA modification techniques have existed for decades, recent advances in genome editing technology have provided scientists and researchers with far more precise and efficient genome editing tools. Wisconsin has several biohealth companies focused in this area, as well as our major research institutions. As scientific developments progress, we support continued discussion with key stakeholders to define regulations and which conditions that the status quo should be changed. No pending legislation

Patent Reform

Stronger Patents Act- 2019

The STRONGER Patents Act will bring important fixes to the patent system that prevent abuse, protect legitimate patent rights, and improve our patent examination process. Investment in innovation requires stronger patent rights. Pending bi-partisan legislation

Intellectual Property- 2018

BioForward commends the U.S. Patent and Trademark Office (PTO) rule change that went into effect late 2018 that significantly improved the fairness of post-issuance patent challenge proceedings, such as Inter Partes Review (IPR), for patent owner. The action by the PTO will help ensure that patent claims are construed consistently, whether they are reviewed by the PTO, a federal court, or the International Trade Commission. In its final rule, the PTO decided to apply the rule change only prospectively to all patents filed after November 13, 2018.

Strengthening Healthcare System

Maintaining Patient Access to Therapies- 2019

BioForward supports our national partners, the Biotechnology Innovation Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA), in urging federal policymakers to adopt responsible solutions that would make prescription drugs more affordable for American’s patients. We oppose legislation such as H.R. 3 Drug Price Negotiation Bill that has many aspects to the legislation that would have disastrous effects on small and emerging biotech companies, and patients would have fewer cures in the future. 

Research Funding

The National Institutes of Health (NIH) is responsible for research in the study of human health, diagnostics, and treatments and helps to maintain the U.S. stronghold as a national leader in the development of biomedical research. As the cost of medical product development process continues to increase, the funding for this research through the NIH must increase to ensure there isn’t a lag between research development and product development. BioForward continues to advocate for increased funding of the NIH, which will help advance biomedical innovation and ultimately improve patient care.

• We are opposed to any efforts to reduce funding for science and medical research
• We are opposed to restrictions that would further impede the use of federal funding for fetal tissue research

Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Funding: As venture capital monies decreased through the recession and moved to support later-stage technologies, these grants have helped to spur new research and discovery at its earliest stages. BioForward advocates for increased funding for the Small Business Administration to support the SBIR and STTR grant program to encourage new medical innovations.