Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E4

3.87

2 (2021)

Novartis AG
Stock exchange: SWX • Ticker: NOVN • HQ: Basel, Switzerland • Employees: ~108,000

PERFORMANCE IN THE 2022 INDEX
4th place. Novartis ranks among the top five companies in the
Index. Novartis has comprehensive access plans in place for all
late-stage candidates in the pipeline and performs strongly inhigh-quality capacity building initiatives across all fields. The

How score was achieved
3.43

Governance of Access

3.70

Research & Development

4.08

Product Delivery

company leads in its approach to access strategies for self-

01

administered products.

2

3

Average

Leader4

5

Governance of Access: 15th place. Novartis performs below
average in this area. It has integrated access-to-medicine into
its corporate strategy under the Novartis Access Principles
and has a robust set of compliance controls to mitigate therisk of non-compliance in countries in scope of the Index.

Product Delivery: 4th place. Novartis performs strongly in thisHowever, the company was found to be the subject of a legal

area. The company has high quality access strategies in placesettlement during the period of analysis based on conduct byacross all country income classifications for a subset of its

a former subsidiary.

products. It has scaled up and piloted the highest number ofinclusive business models of all companies. It also performs

Research & Development: 3rd place. Novartis performs strongly

strongly in capacity building across all fields (i.e., manufac-

in this area. It has an access planning framework and applies

turing, supply chain and health systems strengthening). The

this to all its late-stage pipeline candidates. Novartis performs

company is engaging in non-exclusive voluntary licensing tostrongly in R&D capacity building and leads by publicly disclos-enable generic supply of a non-communicable disease prod-

ing R&D investments for priority neglected diseases.

uct in LMICs, the first agreement of its kind.

OPPORTUNITIES FOR NOVARTISCHANGES SINCE THE 2021 INDEX

Expand technology transfers to more countries. Novartis reports seven• Established an ESG Council which co-creates and oversees thetechnology transfers to build manufacturing capacity. Capacity building
is focused on countries like China, India and Brazil which have wellestablished pharmaceutical markets. The company can engage in further

development of the ESG strategy, formulates ESG targets and raises
relevant topics to the Trust & Reputation Committee.
• Created an Access Solutions Center of Excellence within Novartis

technology transfers in countries where its products address a high disease

Corporate Affairs and Global Health to provide guidance on the Accessburden, aiming to expand access and regional availability. For example,

Principles implementation across the full organisation (Pharma, Oncology,

Novartis can transfer technology for its products indicated for chronic

Global Health, R&D).

obstructive pulmonary disease or products in its oncology portfolio.

• New ESG framework will prioritise access as one of the two mostExpand the geographic scope of the CancerPath to Care initiative. In• Publicly disclosed disaggregated R&D expenses on priority diseases

important materiality topics.
2022, Novartis announced the expansion of its donation and capacity
building efforts for cancer products beyond chronic myeloid leukaemia(CML) through partnership with The Max Foundation called CancerPath toCare. Novartis will continue to support the Foundation with the delivery ofthe donation treatments for breast cancer, CML and rare cancers. Novartis
can work with partners to expand donations and capacity building efforts
through this initiative to more countries with a high disease burden.

(excluding COVID-19) and separately for malaria.
• Joined the Neglected Tropical Disease Supply Chain Forum in 2021 withits Leprosy Donation programme to the World Health Organisation.
• Entered a partnership with Save the Children to launch a pilot community
health project tackling child mortality in Kenya’s Kibera and Mathareslums.
• Joined the Access to Oncology Medicines (ATOM) Coalition, a new global
initiative that aims to improve access to essential cancer medicines in

Expand access to breast cancer and cardiovascular products. Novartis hasaccess strategies in place for its breast cancer product, ribociclib (Kisqali®),

LMICs.
• As part of ATOM Coalition, agreed to a non-exclusive voluntary license

in at least one upper-middle income country and lower-middle income(NEVL) with the Medicines Patent Pool (MPP) for nilotinib, indicated forcountry, and has committed to implementing an access strategy in at least

leukaemia, becoming the first company to have signed a NEVL for an

three low-income countries (LICs) in the future. Novartis can provide
evidence of implementing additional access strategies for ribociclib in LICs.

oncology medicine.
• Issued a EUR 1.85 billion sustainability-linked bond (SLB), reinforcing its

In addition, it can expand patient reach via non-pricing access strategies

commitment to ESG principles and the 2025 Patient Access Targets. The

such as non-exclusive voluntary licences (NEVLs). For example, Novartis

first of its kind in the healthcare industry and the first SLB incorporating

has announced a NEVL for nilotinib (Tasigna®), indicated for leukaemia.

social targets.

Novartis could also pursue a NEVL for ribociclib.

204

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Sandoz (generics andArctos Medical in September 2021, GSK's

biosimilars) and Innovative Medicines.

cephalosporin antibiotics business in October

Net sales by segment (2021) – in USD

Therapeutic areas: Oncology, cardiovascular,

2021, Gyroscope Therapeutics in December

Innovative Medicines

renal and metabolism, Respiratory and2021 and Kedalion Therapeutics in June 2022.

Sandozallergy, Immunology, hepatology and42.00 bn9.63 bn		dermatology, Neuroscience, Infectious diseases,

Novartis' products are sold in 72 out of 108

Ophthalmology.

countries in scope of the Index. Novartis

Product categories: Innovative medicines,

has sales offices in 43 countries, and sells via

generic medicines, biosimilars.

suppliers and/or pooled procurement in an

M&A news: Novartis acquired Vedere Bio in

additional 29 countries.

Total

51.63 bn

October 2020, Cadent in December 2020,
Sales by geographic region
60

Net sales (Bn USD)

Sales in countries in scope

50
40
30
20
10
0

In scope, has sales offices
In scope, any sales

2017

2018

EuropeIn scope, no sales

2019

United States

2020

2021

Asia/Africa/Australasia

Canada and Latin America

Not in scope

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Novartis has a total of 53 R&D projects in scope with 22 of these pro-Novartis has 46 medicines in scope, 25 of which are on patent. 48% ofjects targeting a priority disease. The other 31 R&D projects target otherthese medicines (22) are on the WHO EML. The off-patent medicinesdiseases in scope. Of the projects targeting priority diseases, the focus istarget non-communicable diseases (NCDs) (14) such as cardiovascular dis-on malaria (11 projects) and Chagas disease (5). Of the projects targeting

eases (6) mental health conditions (2) and cancer (3); neglected tropicalother diseases in scope, the focus is on oncology (22).

diseases such as leprosy (2), communicable diseases such as tuberculosis

Seventeen R&D projects are in late-stage development that target either(3); and one product for maternal haemorrhage. The on-patent medicines

a priority disease (6) or address a specific need in LMICs (11).* Evidence of

mainly target NCDs (25) such as cancer (10), respiratory diseases (6), cardi-

access planning was in place for 100% of these projects.

ovascular diseases (3) and diabetes (2). In addition, one targets hepatitis B.

53 projects in the pipeline

46 products as selected for analysis by the Index†
15

7

Maternal and neonatal 031

Non-communicable

Maternal and neonatal

1
37
2Multiple categories
0

20
30
40
50
projects in the pipeline

20
30
40
50
products on the market

Phase II

Phase III

Registration/approval

Other***

Total

10

2

4

4

1

0

1

22

Contraceptives

off patent

Addresses needs of LMICs*

8

5

6

0

0 19

Diagnostics

Other projects in scope

9

3

0

0

0 12

Other

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects inthe clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

‡

Total

Phase I

Vaccines

Medicines on patent

Other

Pre-clinical

WHO EML

Breakdown of products

Discovery

Targets established R&D priorities

10

WHO EDL

10

Breakdown of projects

205

4
2

Non-communicableMultiple categories 00Communicable**
Neglected tropical

Non-EML

Communicable**
Neglected tropical

3 22

25

19

2

21

0

0

0

0

0

0
0

0
0

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

0

Access to Medicine Index 2022 ▶ Company report cards

Novartis AG

GOVERNANCE OF ACCESSRANK 15SCORE 3.43

Has an access-to-medicine strategy with meas-

access to medicine in countries in scope of theassessment, a continuous system to monitor

urable objectives, integrated within its overall

Index. It facilitates accountability and transpar-

activities, audits (both internal and external, cov-

corporate strategy. Novartis performs strongly.

ency by consistently sharing the outcomes of

ering third parties and in all countries where it

Its strategy is embedded in its Novartis Accessits access-to-medicine activities in a centralised

operates) and has formal processes to ensure

Principles and has a tailored approach for sub-Sa-

manner within its Novartis in Society Integrated

third-party compliance with company standards.

haran Africa. The strategy covers all therapeutic

Report.
Does not publicly take a position of support

areas in which Novartis is involved. The highest
responsibility for access at Novartis lies directly

Performs above average in responsible pro-on the Doha Declaration on TRIPS and Publicwith the board, namely with the Governance,

motional practices. Novartis’ sales agents are

Health. Novartis does not publicly take a position

Sustainability and Nomination Committee

not solely incentivised on sales volume targets.

of support of the Doha Declaration on TRIPS and(GSNC).

However, the company sets sales incentives at

Public Health as a whole, but it does publicly sup-the individual level for agents. Novartis does not

port, and/or adopts policies that it states exceed,

Evidence of access-related incentives at the

publicly disclose information related to transfers

several of the individual flexibilities embodied byexecutive level. Novartis performs strongly.

of values to healthcare professionals in countries

the Doha Declaration. Novartis also supports theNovartis incentivises its senior executives andin scope of the Index (e.g., payments for attending

use of compulsory licensing in exceptional cir-in-country managers to take action on access toevents or promotional activities), unless required

cumstances to address situations that require an

medicine with financial and non-financial rewards.

by law or by local regulations, but it does haveextraordinary or urgent response to a pressing

The CEO and Executive Committee havepolicies and procedures in place limiting transfers

public need. There is evidence of industry asso-

access-related incentives included in their perfor-of values to healthcare professionals.

ciation lobbying on intellectual property and themance targets.

usage of TRIPS flexibilities, namely of compulsory
Has a robust set of compliance controls tolicensing, by national governments in some coun-

Publicly discloses outcomes of its

ensure that governance efforts are not under-tries in scope of the Index. As a member of theaccess-to-medicine activities. Novartis performs

mined by non-compliant or corrupt activities.

industry association, Novartis, like all other mem-strongly in transparency of access activities.

Novartis performs strongly, demonstrating evi-ber companies in scope of the Index, is by default

It publicly discloses commitments, measura-dence of all components looked for by the Index:

connected to this activity.

ble goals, objectives and targets for improving

fraud-specific risk assessment, country risk-based

RESEARCH & DEVELOPMENTRANK 3SCORE 3.70

Access planning processes encompass all pro-access to products in LMICs by involving national

Publicly discloses disaggregated R&D invest-

jects in the pipeline. Novartis has a structured

regulatory authorities in sub-Saharan Africa who

ment data for priority diseases, neglected

process in place to develop access plans dur-

will participate actively in the assessment in order

tropical diseases and stages of development.

ing R&D. The process is intended to be applied

to reduce approval timelines.

In addition, Novartis also discloses fully disag-

to all R&D projects (both in-house and collabora-

206

gregated R&D investment data to Policy Curestive) for diseases in scope of the Index. In general,

Many projects address a public health need in

Novartis begins developing access plans for R&D

LMICs,* with 100% (11/11) of late-stage projects

projects in Phase II of clinical development.

covered by access plans. In this analysis, Novartis

Four of the five R&D capacity building ini-has 11 late-stage R&D projects that target a dis-tiatives included meet all Good Practice

An average-sized priority R&D pipeline com-ease and/or product gap not yet established as aStandards. Novartis' performance is above aver-pared to its peers, with access plans in placepriority by global health stakeholders. These pro-age in this area. The number of initiatives meetingfor 100% (6/6) of late-stage projects. Novartis

jects are all deemed by the Index to offer a clear

all inclusion criteria is higher than average andhas 22 projects, including six late-stage candi-

public health benefit for people living in LMICs.*

more initiatives meet all Good Practice Standards

dates in its pipeline, that target a priority productPrimarily, these projects concern clinical trials inthan what is average for this indicator. For exam-

gap. These projects mainly focus on malaria.

countries in scope of the Index and/or are first-

ple, for the Ghana Sickle Cell Disease (SCD)

Novartis' six late-stage candidates targeting a pri-in-class molecules or first-in-formulation projects.

Scientist Training Program, Novartis partners

ority product gap have access plans in place. The

Projects target several diseases in scope of thewith the Sickle Cell Foundation of Ghana to trainplans consider the availability and affordability ofIndex including cancer, chronic obstructive pul-scientists that are working in the field of SCD.

projects in development. For two projects target-monary disease and sickle cell disease. Novartis

Training includes remote mentoring of scientists

ing malaria, Novartis plans to expediate access byprovides evidence of access plans for all 11 late-

and a Postdoctoral Fellowship in natural productregistering via the Marketing Authorization forstage projects which mainly focus on equitable

drug discovery at Novartis research labs.

Global Health Products (MAGHP) procedure in

pricing strategies and registration preparation in

Switzerland. This aims to improve and accelerate

countries relevant to the Index.

*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Research.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 4SCORE 4.08

Public commitment not to enforce patents inthis analysis. Novartis' performance is above

countries in scope. Novartis publicly pledges toaverage is this area.* For two of the four prod-

neither file for nor enforce patents. This commit-

ucts assessed, the company provides examples

All five health systems strengthening initiatives

ment applies in all Least Developed Countries,of access strategies which consider affordability

included for analysis meet all Good Practice

LICs and a subset of LMICs.

in countries of all assessed income levels (UMIC,

Standards. Novartis is one of the leaders in this

LMIC, LIC). Novartis makes efforts to reach addi-

area. The number of initiatives meeting all inclu-

Publicly discloses information on patent sta-tional patients using pricing strategies consideringsion criteria is higher than average and moretus. Like most of its peers, Novartis discloses therelevant payers' ability to pay. For example, theinitiatives meet all GPS than what is average forpatent statuses for small molecules in scope via

company launched an Emerging Market Brand of

this indicator. For example, in the Strengthening

the Pat-INFORMED database. Novartis discloses

crizanlizumab (Adakveo®), a treatment for sickle

the Translational Ecosystem for Lifesaving Local

patent information, including filing date, grantcell disease in India. Known as Ryverna, the prod-

Access initiative, Novartis and academic part-number, grant date and jurisdiction.

uct is currently available at a lower price than theners have developed and are piloting a logistics

original brand in several Indian national accounts,

management information system with the aim

Performs above average in terms of sharing

in accordance with the Novartis Global Oncology

to reduce supply chain bottlenecks and improve

intellectual property (IP) assets with third-

Pricing Tiers Guidance, and the company isaccess to medicines.

party researchers. Novartis engaged in threeworking for inclusion in further state tenders. In

new IP-sharing agreements with third-party

addition, Novartis implemented a patient support

Has engaged in scaling up four and piloting threeresearch institutions or drug discovery initiatives

programme to supply the medicine at no cost to

inclusive business models. Novartis leads in theestablished during the current analysis period

eligible patients. Novartis provides evidence ofuse of inclusive business models aimed at meet-that meet all inclusion criteria for evaluation. The

how patient reach has been increased throughing the access needs of populations at the base ofcompany does have existing agreements of thisthese approaches.

the income pyramid (including other underserved

nature in place that were established before thepopulations) in LMICs. The Novartis Biome SSA iscurrent period of analysis and meet all inclusion

Has access strategies for the majority of

an innovation hub that was initiated in November

criteria for evaluation.

self-administered products in scope of this2021 and spearheads the development of inno-

analysis. Novartis leads in this area. For four ofvative local sustainable business models andUses licensing agreements to enable generic

the five products assessed, the company provides

technology-driven solutions to improve access to

supply. After the period of analysis, Novartis

examples of access strategies in countries of allhealthcare in the sub-Saharan Africa region.

signed a non-exclusive licensing agreement withassessed income levels (UMIC, LMIC, LIC), includ-

the Medicines Patent Pool (MPP) for its oncology

ing efforts to reach additional patients applying

Performs above average in terms of ensur-

medicine, nilotinib (Tasigna®), the first agree-

pricing strategies considering relevant payers'

ing continuous supply of medicines in LMICs.

ment of its kind for a non-communicable diseaseability to pay. For example, in India, Novartis sup-Novartis is involved in technology transfers withproduct.

plies nilotinib (Tasigna®) and ribociclib (Kisqali®)third-party manufacturers in LMICs, and has a sys-

through national tenders. In addition, the com-

tem in place to work with relevant stakeholders

Filed to register new products in 15 countries

pany provides access to nilotinib to patients

to communicate issues that may affect the supply

in scope on average. Novartis has filed one out

in out-of-pocket segments via the Novartis

chain, works with several active pharmaceuti-of ten of its most recently registered products in

Oncology Access program, a contributions

cal ingredient (API) suppliers/produces in-househalf of the relevant top 10 high burden countries.

model where the company bears the majority

APIs, manages a buffer stock of relevant products

Among new products, Erenumab (Aimovig®), indi-of the cost. The programme also includes dis-and is involved in supply chain capacity building

cated for migraine, has been filed for registrationease counselling activities to improve complianceinitiatives.

in five high burden countries in scope of the Index

and adherence to the treatment. Novartis pro-(Brazil, Egypt, Indonesia, Thailand and Vietnam).

vides evidence of how patient reach has been

Has a policy for reporting substandard and falsi-

Among old products, its most widely registered

increased through the approaches used.

fied (SF) medicines in countries in scope of theIndex in less than ten days. Novartis has a pol-is sacubitril/valsartan (Entresto™), indicated for
ischaemic heart disease, filed for registration in

Four of the five manufacturing capacity build-icy for reporting SF medicines to both national

48 countries relevant to the Index, including fiveing initiatives included meet all Good Practice

health authorities and the WHO within seven days.

high burden disease countries (Armenia, Egypt,

Standards. Novartis' performance is above aver-

The policy classifies incidents following categories

Republic of Moldova, Ukraine and Uzbekistan).

age in this area. The number of initiatives meeting

according to the impact or potential impact andall inclusion criteria is higher than average anddegree of severity, which may enable faster action.

Has access strategies for all supranationallymore initiatives meet all Good Practice Standards

procured products in scope of this analysis.

(GPS) than what is average for this indicator. For

Donates in response to expressed need andNovartis has an average performance in secur-

example, since 2019 Novartis has worked on themonitors delivery. Novartis has public policies

ing access for products procured supranationally.

Hibiscus transfer project, supporting contractand supply processes in place to ensure ad hoc

For two of the four products assessed in thismanufacturers to improve the quality of their pro-donations are carried out rapidly in response tocategory, it demonstrated strategies both induction and reduce their carbon footprint.

expressed need, and it shows evidence of mon-countries eligible for supply from such procurers

207

pharmacies and non-governmental organisations.

itoring the delivery of donations to recipient

and in at least one non-eligible country. For exam-

All five supply chain capacity building initi-

ple, the company offers the same price in South

atives included for analysis meet all Good

Africa for the malaria medicine artemether/lume-

Practice Standards. Novartis is one of the lead-

Publicly commits to the achievement of elim-

fantrine (Riamet®/Coartem®) as it does in theers in this area. The number of initiatives meeting

ination, eradication or control goals in two

Global Fund eligible countries. Novartis provides

all inclusion criteria is higher than average andstructured donation programmes for neglected

evidence of patient reach, reporting that approx-

more initiatives meet all GPS than what is aver-tropical diseases or malaria. In one programme,

imately 26,000 patients in South Africa haveage for this indicator. Through the Value Chain

Novartis publicly commits itself to contribut-

received the product through the public channel

Academy, Novartis offers educational workshops

ing to the elimination of leprosy by donating thein the period from April 2020 to February 2022.

for quality in supply, falsified medicines and sup-combination of clofazimine (Lamprene®), dap-

ply chain management. These courses are offeredsone (Dapsone) and rifampicin (Rimactane®)

Has access strategies for its healthcare prac-

to several supply chain stakeholders includingfrom 2000 to 2025 in 83 countries in scope oftitioner- administered products in scope ofgovernmental associations, distributors, hospital

the Index.

* The description of Novartis’ performance in PP4 (HCP-administered products) was corrected from "average" to"above average" on 1 Dec 2022. This typographical error did not impact the underlying analysis or scoring.

organisations.