Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page

9. Check if this filing amends a previously filed version of this report

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code HCR

16. Specific lobbying issues

S.2543 - Prescription Drug Pricing Reduction Act of 2019
HR 1499: Protecting Consumer Access to Generic Drugs Act
Cell, gene and radioligand therapies
340B Drug Discount Program
Drug Importation
Outcomes based Contracting/Value based arrangements
Orphan Drugs
Medicaid Payment Reform
AMP Cap
S 1895 - Lower Health Care Costs Act
HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act
H.R.478 - Safe and Affordable Drugs from Canada Act of 2019
H.R.2011 - Protecting Access to Biosimilars Act of 2019
H.R.2296 - FAIR Drug Pricing Act of 2019
S.61 - Safe and Affordable Drugs from Canada Act of 2019
S.1140 - Protecting Access to Biosimilars Act of 2019
S.1384 - Prescription Drug Rebate Reform Act of 2019
S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019
S.1227 - Prescription Pricing for the People Act of 2019
H.R.447 - Affordable and Safe Prescription Drug Importation Act
H.R.1922 - Restoring Access to Medication Act of 2019
H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes
H.R.5304 - PBM Transparency in Prescription Drug Costs Act
S.97 - Affordable and Safe Prescription Drug Importation Act
S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits
Transparency policy issues
Drug cost and pricing policy issues
PDUFA, BSUFA, GDUFA
Drug vial size policy issues
Pharmaceutical supply chain
H.R. 4710 - Pharmaceutical Independence Long-Term Readiness Reform Act
S. 3635 - Protecting our Pharmaceutical Supply Chain from China Act of 2020
S. 3538 - Strengthening Americas Supply Chain and Medical Security Act
H.R. 6431 - Made in America Emergency Preparedness Act
HR 6080 - Prevent Drug Shortages Act
S. 3432 - Securing Americas Medicine Cabinet Act of 2020
H.R. 6670 - Prescription for American Drug Independence Act of 2020
H.R. 6930 - MADE in America Act
HR 4439 - Creating Hope Reauthorization Act
Pharmaceutical quality
COVID 19
H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020
H.R. 6201 - Families First Coronavirus Response Act
H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act)
H.R. 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019
S. 3370 - Coronavirus Vaccine Act
CARES Act, Pub. L. 116-136
H.R. 6080 - Preventing Drug Shortages Act
Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Drug shortages policy issues
Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45)
Diversity in Clinical Trials
FY 2021 Labor-HHS Appropriations
Cures 2.0 Energy and Commerce RFI
Part B Home Infusion
Notice of Benefit Payment Parameters (NBPP)
Priority Review Voucher (PRV)
H.R. 4400 - The Advancing Education on Biosimilars Act of 2019
Vaccines
Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues
Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020)
Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020)
Medicaid Generics Penalty fix
HR 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act
H.R.2374 - Stop STALLING Act
H.R. 5239 - Prescription Drug Price Reporting Act
H.R. 6258 - Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019
H.R. 6390 - To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak
H.R. 6410 - To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19
H.R. 6395/S. 4049 - National Defense Authorization Act for Fiscal Year 2021
HHS PREP Act declaration relating to COVID-19
Drug importation and counterfeiting policy issues
HHS Safe Importation Action Plan
Expanded access policy issues
FDA modernization policy issues
Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions
Patient assistance program policy issues
Foreign manufacturing policy issues
Biosimilar approval and reimbursement policy issues
Drug shortages policy issues
Regulatory efficiencies policy issues
FDA mandatory recall authority policy issues
COVID-19 policy issues
Transparency Issues Policy Issue
H.R. 2477 - Beneficiary Enrollment Notification and the Eligibility Simplification (BENES) Act of 2019
H.R. 6800 - Heroes Act

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Food & Drug Administration (FDA), White House Office, Centers For Medicare and Medicaid Services (CMS), Office of Management & Budget (OMB)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code TRD

16. Specific lobbying issues

Free Trade Agreements - Intellectual Property and Transparency Provisions - Free Trade Agreements
China Agreement
UK Agreement
Intellectual Property
Access to Medicines Issues
Global Health Issues
India, China and Canada IP and Market Access Issues
Sub-standards Medicines
Quality of Medicines
International Market Access and Intellectual Property Issues
Biopharmaceutical Innovation Policies
Regulatory Cooperation
USTR Special 301 Report/National Trade Estimate
Trade Policy
Tariffs
CFIUS
USMCA
Pharmaceutical supply chain
H.R. 2209 - Fixing Global Freeloading Act
H.R. 6049 - Medical Supply Chain Security Act
H.R. 6482 - Protecting Our Pharmaceutical Supply Chain from China Act of 2020
H.R. 6690 - Bring Entrepreneurial Advancements To Consumers Here In North America Act
H.R. 6731 - Securing America's Pharmaceutical Supply Chain Act
H.R. 6879 - Buy American Medical Supply Chain Act of 2020
H.R. 7492 - To designate all of Puerto Rico as an opportunity zone
H.R. 7505 - American Innovation Act of 2020: Provisions related to manufacturing tax incentives
H.R. 7574 - Strengthening America's Strategic National Stockpile Act of 2020
H.R. 7955 - 21st Century Buy American Act
S. 3343 - Medical Supply Chain Security Act
S. 3478 - To establish a commission to assess, evaluate, and address the dependence of the United States on medications, devices, and medical equipment from foreign countries
S. 3537 - A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes
S. 3942 - Securing America's Medical Supply Chain and Advancing the Production of Life Saving Medicines Act
S. 3945 - A bill to amend the Internal Revenue Code of 1986 to provide incentives for relocating manufacturing of pharmaceuticals and medical supplies and devices to the United States
H.R. 4710 - Pharmaceutical Independence Long-Term Readiness Reform Act
H.R. 6393 - Strengthening America's Supply Chain and National Security Act
H.R. 6930 - MADE in America Act of 2020
H.R. 8943 - Pandemic Supplies Production Act
H.R. 8987 - Enhancing the Security of the U.S. Pharmaceutical Supply Chain Act of 2020
H.R. 8905 - Supply Chain Security and Pharmaceutical Authentication Act of 2020
S. 3635 - Protecting Our Pharmaceutical Supply Chain from China Act of 2020
S. 4175 - Pharmaceutical Supply Chain Defense and Enhancement Act
S. 4194 - National Institute of Manufacturing Act
Pricing and reimbursement policy issues
Supply chain and China Task Force policy issues

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, U.S. Trade Representative (USTR), Commerce - Dept of (DOC), State - Dept of (DOS), U.S. Agency for International Development (USAID), Health & Human Services - Dept of (HHS)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code BUD

16. Specific lobbying issues

Certified Importer Program (CIP)
Biosimilars
Importation
Drug Pricing
Value of Medicine
Fiscal year 2021 Appropriations
H.R. 6395/S. 4049 - National Defense Authorization Act for Fiscal Year 2021
S. 4320 - Coronavirus Response Additional Supplemental Appropriations Act, 2020
S. 4775 - Delivering Immediate Relief to America's Families, Schools & Small Businesses Act
S. 4800 - The Heroes Act
CARES Act, Pub. L. 116-136
H.R. 133 - Consolidated Appropriations Act, 2021
H.R. 6800 - Heroes Act
S. 4049 - NDAA
H.R. 7614 - FY 2021 Labor-HHS Appropriations

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code MMM

16. Specific lobbying issues

Medicare Part A, B and D
AMP Cap
H.R 3
S.2543 - Prescription Drug Pricing Reduction Act of 2019
H.R. 1046/S.377 - Medicare Negotiation and Competitive Licensing Act of 2019
Innovative pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics
Drug Pricing
Outcomes Based Contracts/value based arrangements
Medicaid
H.R.275 - Medicare Prescription Drug Price Negotiation Act of 2019
H.R.448 - Medicare Drug Price Negotiation Act
H.R.19 - Lower Costs, More Cures Act of 2019
H.R.107 - To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs
H.R.4455 - BIOSIM Act
H.R.4619 - Pharmaceutical Rebates for Excessive Pricing Above Inflation Act
HR. 3772 - The Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019
HR. 4597 - Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019
S.3466 - ACCESS for Biosimilars Act of 2020
HR. 6179 - Increasing Access to Biosimilars Act of 2020
HR. 4629 - Star Rating for Biosimilars Act
S. 3129 - Lower Costs, More Cures Act of 2019
S. 3384 - Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020
S. 3457 - Preserving Patient Access to Home Infusion Act
H.R.5741 - Strengthening Innovation in Medicare and Medicaid Act
Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues
Transparency policy issues
Center for Medicare and Medicaid Innovation (CMMI) policy issues
ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM)
Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)
Proposed Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-P)
Reimbursement for cell therapy products
S. 3353/H.R. 5534 - Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act
Patient Cost-Sharing and Smoothing
S. 4134 - Increasing Access to Biosimilars Act of 2020
S. 102 - Prescription Drug Price Relief Act of 2019
CMS Proposed Rule: Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) or Drugs Covered in Medicaid, Revising Medicaid Rebate and Third Party Liability (TPL) Requirements (CMS-2482-P)
H.R. 8624 - Protecting Access to Innovation During COVID-19 Act
H.R. 8702 - Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020
S. 1895 - Lower Health Care Costs Act
S. 4199 - Prescription Drug Pricing Reduction Act of 2020
S. 4274 - Legalizing Drug Discounts for Seniors Act of 2020
Anti-Kickback Statute policy issues
Center for Medicare and Medicaid Innovation (CMMI) policy issues
Medicaid rebates and waiver policy issues
Medicare prescription drug payments cards and related issues
ASP reporting policy issues
Non-covered drugs policy issues
Drug wastage rebates policy issues

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code TAX

16. Specific lobbying issues

OECD Digital Tax
ACA Pharmaceutical Industry Fee Exclusions
Orphan Drug Tax
Mobile Workforce
Thin Capitalization Rules 163(j)
Base Erosion Anti-Abuse Tax (BEAT)
Tax Cuts & Jobs Act Implementation
Innovation Box
Tax Treaties
Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (HR 748)(S. 3548)
Pharmaceutical supply chain incentives
U.S. Corporate Tax

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code CPT

16. Specific lobbying issues

Biopharmaceutical Intellectual Property
Data exclusivity
Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO
BPCIA
Patents
Inter Partes Review at PTO
Biosimilars
S 1416 - Affordable Prescriptions for Patients Act of 2019
H.R.465 - Prescription Drug Price Relief Act of 2019
H.R.938 - BLOCKING Act of 2019
H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act
H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019
Bayh-Dole Act
Section 101
H.R.3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019
H.R.4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019
S.1617 - Second Look at Drug Patents Act of 2019
HR 4712 - Fairness in Orphan Drug Exclusivity Act
HR 4850 - Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures
HR 5133 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019
Intellectual Property Issues in Response to coronavirus
S.2387 - We Protect American Investment in Drugs Act of 2019
S.64 - Preserve Access to Affordable Generics & Biosimilars Act of 2019

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code FOR

16. Specific lobbying issues

CFIUS Reform
Foreign Agents Registration Act (FARA) Reform
S.1762 - Foreign Agents Disclosure and Registration Enhancement Act of 2019

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code SCI

16. Specific lobbying issues

Artificial intelligence
Data and digital technologies

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code VET

16. Specific lobbying issues

Health care collaboration opportunities

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Veterans Affairs - Dept of (VA)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.

Information Update Page - Complete ONLY where registration information has changed.

20. Client new address

21. Client new principal place of business (if different than line 20)

22. New General description of client’s business or activities

LOBBYIST UPDATE

23. Name of each previously reported individual who is no longer expected to act as a lobbyist for the client

ISSUE UPDATE

24. General lobbying issue that no longer pertains

AFFILIATED ORGANIZATIONS

25. Add the following affiliated organization(s)

Internet Address:

26. Name of each previously reported organization that is no longer affiliated with the registrant or client

FOREIGN ENTITIES

27. Add the following foreign entities:

28. Name of each previously reported foreign entity that no longer owns, or controls, or is affiliated with the registrant, client or affiliated organization

CONVICTIONS DISCLOSURE

29. Have any of the lobbyists listed on this report been convicted in a Federal or State Court of an offense involving bribery, extortion, embezzlement, an illegal kickback, tax evasion, fraud, a conflict of interest, making a false statement, perjury, or money laundering?
No Yes