Wisconsin’s independent voice- advocating to strengthen Wisconsin’s biohealth industry.
Public Policy Plays a Critical Role in Biohealth Industry Success
“BioForward Wisconsin’s mission to grow Wisconsin biohealth companies and unite the industry to develop integrated health solutions that define the future of healthcare is a leading force in our advocacy efforts. As an organization, we believe that improving and saving lives IS NOT a partisan issue. We work within the whole political spectrum to serve our companies and advocate for the best outcomes for patients. We champion those parties and policies that support patients and the medical technologies that save lives.”
-Lisa Johnson, CEO
BioForward works actively to:
- Shape state and federal policy through education and engaging with policymakers
- Collaborate with legislators, industry, and research institutions on critical biohealth issues and initiatives
- Monitor and inform members of legislation that will impact our industry
- Educate members on how they can be engaged in public policy
- Provide essential data to decision-makers on the economic benefit of Wisconsin’s biohealth industry
Pharma/Biotech Companies- BioForward actively engages in advocacy on your behalf
Wisconsin’s 2021 Legislature had been “in session” since January 4, 2021 and has adjourned as of March, 2022. BioForward advocacy team focused throughout the year on several key areas: Prescription Drug Pricing & Transparency, Business Issues impacting WI Biohealth industry, Education and Research, and Vaccine issues. In addition to state issues, BioForward’s advocacy team has been actively involved in monitoring & managing local ordinances that could result in major impacts to our industry.
2022 STATE LEGISLATIVE AND ADMINISTRATION ACTIONS & UPDATES
Madison Local Issue
OPPOSE: City of Madison Proposes Ban on Breeding and Selling Animals for Research.
There is a proposed City of Madison ordinance currently pending before the Board of Health that could negatively affect our local (Madison/Dane County) research and biohealth community. Two alders from the Madison City Council: Proposed Ordinance No. 68608 which would ban the breeding or selling of vertebrate animals for the purpose of medical, surgical or chemical experimentation in the City of Madison.
2022 State Issues
SUPPORT: Co-pay Accumulator Legislation (2021 SB 215/AB 184)
- FAILED TO PASS (2021 SB 215 and AB 184). This legislation requires health insurance policies that offer prescription drug benefits, self-insured health plans, and pharmacy benefit managers acting on behalf of policies or plans to apply amounts paid by or on behalf of a person covered under the policy or plan for prescription drugs to any calculation of an out-of-pocket maximum amount or to any cost-sharing requirement of the policy or plan in Wisconsin.
- The Assembly Health Committee held a public hearing on AB 184 on February 16, 2022. There was no hearing in the Senate Committee and no vote on this legislation in the Assembly Committee. BioForward will work to support this legislation again during the 2023-24 legislative session.
- SUPPORTED-Engineering School Planning Bill PASSES (AB 775 / SB 728). Legislation to require the Building Commission to allocate $1,000,000 from the state building trust fund to conduct planning and design services and prepare a design report for the construction of a new engineering building at the University of Wisconsin-Madison passed both houses and was signed by Governor Evers on March 18, 2022 https://content.govdelivery.com/attachments/WIGOV/2022/03/18/file_attachments/2107255/ab775.pdf
- SUPPORTED-Qualified New Business Venture Eligibility Changes PASSES (AB 759 / SB 729). Legislation that would help Wisconsin-based start-ups who acquire another business from outside of Wisconsin not lose their Early-Stage Investment Tax Credits due to their expansion has passed both houses and will be sent to the Governor. Current law requires companies to have at least 51% of their employees in Wisconsin in order to qualify for the credit. Under this bill, the company would be allowed one calendar year from acquisition in which they could drop below the 51% threshold and still qualify for the tax credit. Business’ headquarters must remain in Wisconsin and all current Wisconsin employees remain in Wisconsin as well.
2021 STATE LEGISLATIVE AND ADMINISTRATION ACTIONS & UPDATES
Support Co-pay Accumulator Legislation (2021 SB 215 / AB 184)
Senator Andre Jacque (R-DePere) and Representative Paul Tittl (R-Manitowoc) have introduced 2021 Senate Bill 215 and Assembly Bill 184, known as “co-pay accumulator legislation.” This legislation would require health insurance policies that offer prescription drug benefits, self-insured health plans, and pharmacy benefit managers, to apply amounts paid for prescription drugs by or on behalf of a person covered under the policy/plan to any calculation of an out-of-pocket maximum or any cost-sharing requirement of the policy or plan.
These bills have been introduced and are waiting for legislative review and action.
BioForward Supports NORD Ambassadors in the Creation of Rare Disease Advisory Council (RDAC)
NORD and the Wisconsin Rare Disease Advisory Council Coalition are working on creating a Rare Disease Advisory Council (RDAC) in Wisconsin. BioForward supports the creation of RDAC in Wisconsin.
- Prohibiting Step Therapy for Certain Cancer Drugs (AB745/SB 716)
- Right to Try Off Label Therapies
- Banning “White Bagging” in Wisconsin
2021-23 Wisconsin biennial budget signed by Governor Evers (view our whitepaper) (view the press release)
The 2021-23 Wisconsin biennial budget bill was $685 million in net general and categorical school aids, which will provide two-thirds of school funding for the next two years. In addition, the Governor committed to designating an additional $100 million for education from the most recent federal pandemic relief funding designated for Wisconsin. This investment is very significant compared to other recent budgets.
However, we do not believe that funding for education is a one-time commitment.
Watch for BioForward’s ongoing efforts to advocate for additional educational funding for K-12 and our higher education systems.
Issues that BioForward is advocating for/tracking:
- Talent Attraction and Retention Initiatives Funded. Requires the Wisconsin Economic Development Corporation to expend at least $3 million during the 2021-23 biennium for talent attraction and retention initiatives.
- Refundable Research Credit Increased. Increases the refundable portion of the research credit from 10% to 15% for taxable years beginning after Dec. 31, 2021. BioForward advocated an increase of 20% to this credit in our budget communications. For more information on who may qualify for the credits and on what form are they claimed, please see page 31 of Dept of Revenue Business Tax Incentives publication: https://www.revenue.wi.gov/DOR%20Publications/pb123-2020.pdf
- All Drug Transparency and Drug Pricing Provisions REMOVED.
- Funding for UW Engineering School – Not Included. BioForward will continue to advocate for these types of vital UW System funding projects that have an impact on our industry’s long term talent needs
Wisconsin PBM Legislation (Senate Bill 3, now Wisconsin Act 9)
A reintroduction of the PBM bill from the last session moved along quickly. This bill, authored by a large group of bipartisan legislators, generally requires pharmacy benefit managers to be licensed with the commissioner of insurance or to have an employee benefit plan administrator license under current law. The bill also established certain requirements on pharmacy benefit managers and certain health plans regarding their interactions with pharmacies and pharmacists.
Governor Evers signed the bill on March 26, 2021.
Legislation to Allow Pharmacy Students to Administer Vaccines Proceeds (2021 AB 4 / 2021 SB 60)
Assembly Health Committee Chairman, Rep. Joe Sanfelippo and Sen. Dale Kooyenga, introduced AB 4 / SB 60, legislation that would allow pharmacy students and pharmacy technicians to administer vaccines. The companion bills both had hearings and were recommended for passage. A number of organizations — including Walgreens, the Pharmacy Society of Wisconsin and the Medical College of Wisconsin — backed it, saying it would dramatically expand the number of vaccinators in the state. BioForward registered in support of this legislation.
Governor Evers signed the bill on February 19, 2021.
Support for Liability Protection from COVID-19 Lawsuits 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.
Supported and signed by Governor Evers.
- 2021 WI Act 3, Wis. Stat. § 895.476.
PPP Loan Deductibility
BioForward Promotes Investments Into Biohealth Economic Infrastructure as a Part of the 2021-23 Biennial Budget Bill
BioForward urged the State Legislature and Governor Evers to support Wisconsin’s biohealth economic infrastructure in the 2021-23 biennial budget bill through additional support for UW-Madison, expansion of UW-System funding and borrowing authority, and expansion of R&D tax credits and workforce development issues. Further, BioForward has requested that the initiatives related to pharmaceutical pricing and transparency be removed from the biennial budget debate.
Legislature and Administration Updates
Andrea Palm Joins Biden Administration – Karen Timberlake is New DHS Secretary-Designee
On January 18, 2021, it was announced that Department of Health Services (DHS) Secretary-designee Andrea Palm has been nominated to be Deputy Secretary of the U.S. Department of Health and Human Services in the Biden Administration. She will depart DHS to undertake this opportunity on January 20, 2021.
Gov. Evers also announced that Karen Timberlake, DHS secretary under former Gov. Jim Doyle during the 2009 H1N1 pandemic virus response, will serve as DHS interim secretary. Timberlake will officially start at the DHS on January 25, 2021. Timberlake has most recently been working for Michael Best Strategies, a contract lobby firm, in Madison.
Legislative Leadership in 2021-22
All of the legislative caucuses have met and elected the following leadership for
Assembly Republican Leadership 2021-22
- Speaker – Robin Vos
- Speaker Pro Tempore – Tyler August
- Majority Leader – Jim Steineke
- Assistant Majority Leader – Kevin Petersen
- Caucus Chair – Tyler Vorpagel
- Assistant Caucus Chair – Cindi Duchow
- Caucus Secretary – Jessie Rodriguez
- Caucus Sergeant at Arms – Sam Kerkman
Assembly Democratic Leadership 2021-22
- Minority Leader – Gordon Hintz
- Assistant Minority Leader – Dianne Hesselbein
- Caucus Chair – Mark Spreitzer
- Assistant Caucus Chair – Lisa Subeck
- Caucus Secretary – Beth Meyers
- Caucus Sergeant at Arms – Kaylan Haywood
Senate Republican Leadership 2021-22
- Senate Majority Leader – Devin LeMahieu
- Senate President – Chris Kapenga
- Senate President Pro Tempore – Patrick Testin
- Senate Assistant Majority Leader – Dan Feyen
- Senate Caucus Chair – Van Wanggaard
- Senate Caucus Vice-Chair – Kathy Bernier
Senate Democratic Leadership 2021-22
- Minority Leader – Janet Bewley
- Assistant Minority Leader – Janis Ringhand
- Caucus Chair – Jeff Smith
- Assistant Caucus Chair – Melissa Sargent
2021 COVID-19 Vaccine Activities & Updates
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 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:
- Educating our members and state
Federal Legislative Activities
A key value we bring our members is to advocate not only on a state level but on federal issues that affect Wisconsin’s biohealth industry and research institutions. We have strategic collaborations with partners such as the Biotechnology Innovation Organization (BIO), Pharmaceutical Research and Manufacturers of American (PhRMA), and the Advanced Medical Technology Association (AdvaMed) who serve to advance legislative policies having the greatest impact on Wisconsin’s biohealth ecosystem.
2022 FEDERAL LEGISLATIVE ACTIONS
2022 Federal Issues
Ongoing-Support SBIR/STTR Reauthorization
Currently, Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are set to expire on September 30, 2022. SBIR and STTR are an essential part of America’s Innovative high-tech ecosystem. Any disruption to this system could have a severe effect on R&D-focused small businesses. BioForward supports both AdvaMed and BIO’s legislative advocacy to achieve the reauthorization of these vital programs. Wisconsin’s stats: Over $114,000,000 in SBIR/STTR grants from 2017—2021. Please contact your Wisconsin representative and senators to stress the importance of these critical programs.
7/22 Oppose Drug Price Control Legislation that would alter the Medicare program
Supporting BIO’s coalition in opposition. https://www.bio.org/press-release/new-drug-pricing-deal-could-propel-us-light-years-back-dark-ages-biomedical-research. Helpful information pertaining to this subject can be found at:
6/22. Supported BIO’s legislative advocacy to restore the longstanding deduction for R&D expenditures which was recently changed to a mandatory five-year amortization for domestic R&D
4/22. Supported The Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 1946) a S. 1873
Aimed to overcome access hurdles by allowing a pathway for timely coverage of multi-cancer early detection tests once they are approved by the Food and Drug Administration (FDA).
3/22 Supported The Bayh-Dole Coalition, arguing against government-imposed arbitrary price controls
Joined the coalition in urging the Department of Health and Human Services to reject once again the petition asking the federal government to grant march-in rights for the patents on Xtandi, a prostate cancer drug, because of its price.
2021 FEDERAL LEGISLATIVE ACTIONS
- Oppose: World Health Organization’s proposal and the Biden Administration support of Trade-Related Aspects of Intellectual Property Rights (TRIPS).
- Wisconsin biohealth businesses employ more than 119,000 people statewide and are extremely dependent on research and development with intellectual property rights in place to appropriately protect the successes of this industry. Unfortunately, President Biden is proposing giving away similar rights globally pertaining to COVID-19 vaccines.
- Please see BioForward’s Op-Ed in opposition to TRIPS
- Oppose: H.R 3.
- This legislation introduces international reference pricing and foreign price controls as a strategy to reduce prescription drug costs. Proposals like H.R. 3, and similar bills that introduce price controls, particularly foreign reference pricing, into government and private healthcare programs will consequentially threaten patient access and choice, cede America’s global leadership in biomedical innovation, and will have a disproportionately disastrous impact on small, emerging biotech companies.
- By imposing artificial price controls tried to what other countries pay for their medicines, H.R. 3 would significantly erode the U.S.-based biopharmaceutical economy. In countries where reference pricing and price controls are already used, patients face limited access and significant wait times for those medicines that are approved.
- Please read more information at: https://www.bio.org/savecures
- 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
- On May 13, 2021, the Senate Commerce Committee approved the Endless Frontier Act. More information on highlights of the bill can be found here:
Investing in the 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
Education on precision medicine 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
Public Policy Team
Government Affairs Committee
Director State Government Affairs, GSK
Director Quality and Compliance, Eurofins
Director, Government Relations, Pfizer
Senior Director, Regional Lead, State Govt. Affairs, Bristol Myers Squibb
Deputy Vice President, State Advocacy, PhRMA
Dee (Dodge) George
Assistant Director, State Govt. Affairs, Novartis
CHAIR, CTO, MICT and GM, HW Platforms, GE Healthcare
Senior Manager, State Govt. Affairs, Genentech
Senior Manager, State Govt. Affairs, Amgen
Legislative Counsel, DeWitt LLP
Government Affairs, Exact Sciences
Director, State Govt. Affairs, Abbvie
President, Neider & Boucher, S.C.
CEO, Morgridge Institute for Research
Public Affairs Analyst, WARF
Find Your Legislators & Legislative Committees
BioForward periodically sends out legislative alerts asking members to contact their senators or representatives on issues of importance to the biohealth industry. You can find them on the map or via these links.