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
Pharmaceutical Companies- BioForward actively engages in advocacy on your behalf
Wisconsin’s 2020 legislative recap started with the legislature effectively adjourning mid-March 2020, when the pandemic abruptly ended the 2020 legislative session. The Assembly had finished its regular business, but the Senate, which was scheduled to finish its actions the last week of March, never returned to act on regular session business. As such, our advocacy efforts during most of 2020 were focused on our companies’ ability to continue to operate during Safer-at-Home and proactive preparation related to vaccines and prescription drug pricing. As expected, these issues immediately were addressed at the start of the 2021 session.
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.
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 watching:
- 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
- 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
2020 STATE LEGISLATIVE SESSION & COVID ACTIVITIES RECAP
Biohealth Companies Allowed to Operate Under Wisconsin’s Safer at Home Order
The BioForward state advocacy program proactively engaged Governor Evers 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 the COVID-19 vaccines. 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 the COVID-19 vaccine became available.
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 include:
- 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 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 vaccines 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; 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 the 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
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.
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).
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.
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
2020 FEDERAL LEGISLATIVE RECAP
- 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.
- 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/
Public Policy Team
Government Affairs Committee
Director State Government Affairs, GSK
Director, Government Relations, Pfizer
Deputy Vice President, State Advocacy, PhRMA
Dee (Dodge) George
Assistant Director, State Govt. Affairs, Novartis
Director of Licensing, WARF
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
Associate Director, Corporate Affairs, Exact Sciences
Director, State Govt. Affairs, Abbvie
Executive Director, State Govt. Affairs, Bristol Myers Squibb
President, Neider & Boucher, S.C.
CEO, Morgridge Institute for Research
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.