AMR Benchmark Opportunities: progress update

Research-based pharmaceutical company

Novartis AG
This table is part of a November 2023 report that looks at what actions each company in scope of the Antimicrobial
Resistance (AMR) Benchmark has taken with regards to each of the Opportunities set out in its 2021 AMR Benchmark
Report Card. The full 2021 Report Card is also included in this PDF.
Since the publication of the 2021 AMR Benchmark, Novartis has completed a 100% spin-off of its generics and biosimilars
business, Sandoz. On 4 October 2023, Sandoz became an independently listed company. This report provides updates
on opportunities identified in Novartis’s 2021 Benchmark Report Card, looking at progress over the two-year period andincorporating information about both Sandoz and Novartis.
2021 O PPO RTU N IT Y

2023 U PDATE

What was the Opportunity shared in the AMR Benchmark?

What progress has been made on this Opportunity?

Engage in antibacterial and antifungal R&D including

Novartis did not report any progress on this Opportunity,

medicines and vaccines against priority pathogens.

referring to its earlier contributions to the AMR Action

Novartis contributes to the AMR Action Fund, a joint ven-

Fund.

ture that aims to bring 2-4 new antibiotics to the market
by 2030 and has a partnership with GARDP to provide
antibiotic formulations accessible for children with drug-resistant infections. Novartis can engage in in-house R&D,
through acquisition or collaboration with other companies,
or by joining existing public private partnerships, to target
resistant pathogens for which R&D is limited, such as
Campylobacter spp. and H. pylori.
Ensure compliance to antibacterial discharge limits

Novartis continues to report implementing the AMR

at suppliers sites by tracking and publicly disclosing

Industry Alliance guidelines. The company publicly reports

progress and results specific to antibacterials for all

that, in 2022, it engaged with over 100 priority suppliers tosites.

assess their discharge levels against the standards of theNovartis can expand its requirements to quantify discharge

AMR Industry Alliance. However, Novartis does not reportlevels as it does for its own sites to all its suppliers’ sites

any developments on the number of its own and supplierand track compliance with set limits. It can publicly disclosesites that are compliant with discharge limits.

the results including the discharge levels. The company

Similar to 2021, Novartis does not publicly disclose audit

currently publishes information on compliance at own sites

results containing antibacterial discharge levels for both its

with pharmaceutical limits that include, but is not specificown sites and suppliers’ sites. Furthermore, the company

to, antibacterials. Novartis can also apply limits directly indoes not disclose the names and locations of its suppliers.

effluent to fully mitigate AMR risk.
Expand registration and ensure availability ofNovartis did not report any progress related to expanding

antibacterial and antifungal medicines.

the registration of its antibiotics and antifungals to addi-

Novartis can expand registration of its antibiotics and anti-tional countries in scope of the Benchmark. In 2022, Sandoz

fungals listed on the 2021 WHO EML, such as daptomycin

announced plans to invest EUR 50M to increase manufac-

and tigecycline, to more countries, including low-income

turing capacity for finished dosage form penicillins at its

countries, with a high burden of disease.

manufacturing site in Kundl, Austria. This brings the total
investment in Sandoz’s antibiotics manufacturing networkin Europe to over EUR 250M. However, the extent to which
this expansion will increase availability of penicillins in countries in scope is unclear.

17

AMR Benchmark Opportunities: progress update

Research-based pharmaceutical company

2021 O PPO RTU N IT Y

2023 U PDATE

What was the Opportunity shared in the AMR Benchmark?

What progress has been made on this Opportunity?

Fully decouple incentives for sales agents from sales

Novartis did not report any progress on this Opportunity.

volumes.
In Novartis’ limited promotional activities directed at healthcare professionals, it links part of its sales agents’ incentives
to sales volumes of antibacterial and antifungal medicines. It
can fully decouple such incentives for sales agents.
Publicly share raw data from surveillance programme.

Sandoz continues to support the KOROUN surveillance pro-Novartis supports the national Diagnostics of Central

gramme. However, Novartis did not report updates in regard

Nervous System Bacterial Infections (KOROUN) pro-to publicly sharing the raw data from this programme.

gramme, which is managed by the Polish National Medicines

In 2022, Sandoz announced an AMR surveillance pro-

Institute. Either Novartis or the managing partner can pub-gramme in collaboration with Ares, a subsidiary of OpGen

licly share raw data from this surveillance programme.

Inc,. However, Novartis did not report any updates in regard
to publicly sharing the raw data from this programme.

18

Antimicrobial Resistance Benchmark 2021

NVR

Overall Performance
2020

2021

54 % 63%▲

Access to Medicine Foundation

Novartis AG
Large R&D-based pharmaceutical company
Stock exchange: SWX • Ticker: NOVN • HQ: Basel, Switzerland • Employees: 105,794

NVR
PERFORMANCE
Novartis performs above average overall in its evaluated Research Areas
compared to the other large research-based pharmaceutical companies

Performance in the Benchmark

0%

in scope.
R&D: Novartis no longer carries out R&D projects that target pathogens
in scope of the AMR Benchmark.
Responsible Manufacturing: Performs strongly. Reports comprehensive
environmental risk-management strategy for own sites and suppliers;
co-leads in reporting compliance with limits at own sites, audits external
private and public waste-treatment plants.

countries. Reports several strategies to expand access and ensuresignificant portion of its sales by using tenders. It supports a surveillance
programme in Poland of which aggregated results are publicly shared. It
reports comprehensive conflict of interest mitigation for its educational
programmes. It adapts brochures for patients.

50%

100%

Points

7%

R&D

1/ 15

87%

Manufacturing

13/ 1580%

Access12/ 1575%

Stewardship0%

15/ 2050%

100%

How Novartis was evaluatedcontinuous supply of its relevant products.
Stewardship: Performs well. It decouples sales incentives for a41/ 65

Performance by Research Area

Appropriate Access: Performs strongly. Files some of its relevant
products (on- and off-patent products) for registration in access

Points63%

Overall score

A R&D

1

2.1 2.2 2.3 2.4

3

●

●

●

●

1

2

3

B Manufacturing ●

●

●

●

●

1.1

1.2 1.3 2.1 2.2 2.3

3

C Access

●

●

●

4

5

6

7

C Stewardship

●

●

●

●

●

●

●

●

● ● ● Scored●

Not scored

OPPORTUNITIES FOR NOVARTISCHANGES SINCE 2020Engage in antibacterial and antifungal R&D including medicines and vaccines against priority• Approval secured of a OneNovartis AMR pro-pathogens. Novartis contributes to the AMR Action Fund, a joint venture that aims to bring 2-4 newgram to minimize spread of AMR by focus-

antibiotics to the market by 2030 and has a partnership with GARDP to provide antibiotic formu-

ing efforts where the company can make a dif-lations accessible for children with drug-resistant infections. Novartis can engage in in-house R&D,

ference. The program prioritises appropriate

through acquisition or collaboration with other companies, or by joining existing public private part-

access, responsible manufacturing and respon-nerships, to target resistant pathogens for which R&D is limited, such as Campylobacter spp. and H.

sible use. The initiative was launched in May

pylori.

2021.

Ensure compliance to antibacterial discharge limits at suppliers sites by tracking and publicly dis-

• In July 2020, Sandoz and the Austrian govern-

closing progress and results specific to antibacterials for all sites. Novartis can expand its require-ment formed a public-private partnership toments to quantify discharge levels as it does for its own sites to all its suppliers’ sites and track

increase production capacity at Sandoz’s anti-

compliance with set limits. It can publicly disclose the results including the discharge levels. The

biotics manufacturing site in Kundl, Austria.

company currently publishes information on compliance at own sites with pharmaceutical limits

Sandoz commits to investing more than USD

that include, but is not specific to, antibacterials. Novartis can also apply limits directly in effluent to

175 mn over the next five years to new antibi-

fully mitigate AMR risk.
Expand registration and ensure availability of antibacterial and antifungal medicines. Novartis

otics manufacturing technology.
• Novartis has expanded registration of its

can expand registration of its antibiotics and antifungals listed on the 2021 WHO EML, such as dap-

sample off patent/generic medicines to more

tomycin and tigecycline, to more countries, including low-income countries, with a high burden ofaccess countries, meeting the opportunity

disease.

provided in the 2020 Benchmark.

Fully decouple incentives for sales agents from sales volumes. In Novartis’ limited promotional• Since 2019, Novartis supports the Diagnostics

activities directed at healthcare professionals, it links part of its sales agents’ incentives to salesof Central Nervous System Bacterial Infections

volumes of antibacterial and antifungal medicines. It can fully decouple such incentives for sales(KOROUN) study, a national AMR surveillance

agents.

programme focused on community-acquired

Publicly share raw data from surveillance programme. Novartis supports the national Diagnostics

respiratory tract infections in Poland. Before

of Central Nervous System Bacterial Infections (KOROUN) programme, which is managed by thethis programme Novartis was not involved in

Polish National Medicines Institute. Either Novartis or the managing partner can publicly share raw

AMR surveillance.

data from this surveillance programme.

14Antimicrobial Resistance Benchmark 2021

Access to Medicine Foundation

SALES AND OPERATIONS

NVR
Net sales by business segment

Therapeutic areas: Cardiovascular, renal and metabolism; Immunology,

2019

hepatology and dermatology; Neuroscience; Oncology; Ophthalmology;

2020

Respiratory.

37,71439,0130

Business segments: Innovative Medicines, Sandoz

10,00020,000Innovative Medicines

Product categories: Biosimilars, Generic medicines, Innovative medicines

9,731

30,0009,646

40,00050,000mn USD

SandozNVR
Net sales by region

M&A since 2020: In February 2021, Novartis division Sandoz signed anagreement to acquire GSK’s cephalosporin antibiotic business for USD 350
mn in addition to milestone payments up to USD 150 mn.

2019

17,933

19,7132020

18,715

19,7250

10,000EuropeAmericas20,00030,0009,799
10,21940,000Asia/Africa/Australasia

50,000mn USDPIPELINE for pathogens in scope

PORTFOLIO for pathogens in scope

Novartis is currently not developing any projects targeting the pathogens

Comparatively large portfolio: At least 109 products: 96 antibacterial med-in scope*.

icines; 13 antifungal medicines
Off-patent/generic medicines: 10 of 109 were selected for analysis*(amoxicillin [A], amoxicillin/clavulanic acid [A], clarithromycin [W], daptomycin [R], itraconazole [F], levofloxacin [W], linezolid [T], rifampicin [T],tigecycline [R], voriconazole [F])AWaRe medicines**: 21 Access group; 35 Watch group; 2 Reserve groupAnti-TB medicines**: 9NVR
Pipeline for priority pathogens
0
0

10

20

● Antibacterial vaccine● Antibacterial medicine● Antifungal vaccine● Antifungal medicine

NVR
Products on the market
96 13
0

20

40

60

80

100

120

● Antibacterial vaccine● Antibacterial medicine● Antifungal medicine

PERFORMANCE BY RESEARCH AREAA

RESEARCH & DEVELOPMENT Evaluated: medicine & vaccine pipelines for priority* bacteria & fungi

A.1

Investments in R&D

A.2.2 Novelty of pipeline

A.3

Novartis did not report investments during 2019

Novartis is not eligible for this indicator as it

Novartis is not eligible for this indicator as it has

and 2020 in R&D for antibacterial and antifun-

does not have any R&D candidates in clinicalno projects targeting pathogens in scope in late-

gal medicines and/or vaccines for pathogens indevelopment.

stage clinical development.

scope. Novartis has pledged an unknown

Access and stewardship planning

Companies are expected to have plans in placeamount to the AMR Action Fund over the next

A.2.3 Not active in vaccine development

10 years.

Novartis is not active in vaccine development

for pipeline projects in Phase II and beyond.

targeting pathogens in scope.
A.2.1 Novartis does not engage in R&D for
products in scope

A.2.4 Critical and/or urgent priorities

The company does not report any project in its

Novartis is not eligible for this indicatorpipeline targeting pathogens in scope.

as it does not have any R&D candidates indevelopment.

Pipeline targeting priority pathogens: 0 As at 24 September 2021
Discovery

Pre-clinical

Phase I

Phase II

Phase III

Approval

Novartis is currently not developing any projects targeting the pathogens in scope*.

* See Appendix V for information about
eligibility for R&D projects and Appendix
VII for eligibility criteria of products.
** Listed on the 2019 WHO EML.

15

Antimicrobial Resistance Benchmark 2021

Access to Medicine FoundationB

RESPONSIBLE MANUFACTURING Evaluated: antibacterials manufacturing (APIs and drug products)

B.1

Comprehensive environmental risk-man-

suppliers. It is undisclosed how many of the 160

terials. It publicly discloses that 80% of its own

agement for own sites and suppli-

supplier sites report to have quantified discharge

sites are compliant to these general limits. The

ers; audits external private and public

levels.

discharge levels themselves are not published.

waste-treatment plants

Novartis expects external private

Novartis also does not publish: (1) the results ofNovartis reports a comprehensive strategy towaste-treatment plants to comply with its gen-environmental audits, conducted at its own sites,

minimise the environmental impact of waste-eral environmental standards. It audits exter-

the sites of suppliers and/or external private andwaters and solid waste from antibacterial man-nal private and public waste-treatment plants at

public waste-treatment plants; or (2) a list ofufacturing at its sites, including audits every 2-4

least every three years, based on risk. It requests

these suppliers and plants.

years. It reports setting discharge limits in theexternal private and public wastewater treat-

receiving environment for all antibacterials man-ment plants to provide dilution and flow rate

ufactured at its sites, based on PNECs to limit

data to inform the mass balance approach and

AMR, as recommended by the AMR Industry

employs conservative measures when needed.

Alliance. Discharge levels are quantified at all

B.3

System in place to maintain production
quality for own and suppliers’ sites; norequests for official corrective action

Novartis reports that its own sites and suppliers
Publicly discloses some information on

have a system to maintain high-quality antibac-

analysis, as applicable. It reports that complianceenvironmental risk management andterial production consistent with internationalof own sites with discharge limits is tracked. Itcompliance with limits for pharmaceuti-

GMP standards. This includes periodic risk-

also publicly reports that 80% of its own sites

cals including antibacterials

based audits and tracking of corrective and pre-sites using a mass balance approach or chemical

B.2

are compliant with discharge limits for pharma-

Novartis publishes some components of its envi-

ventive actions. Novartis also requires its suppli-

ceuticals which include, but are not specific to,ronmental risk-management strategy. It is a

ers to audit their own suppliers. The Benchmark

antibacterials.

member of the AMR Industry Alliance, whichfound no requests for official corrective action

Novartis requires third-party suppliers of

publishes a list of recommended antibacterial

from the FDA or EMA related to non-conformi-

antibacterials to follow the same standards,

discharge targets. Novartis publishes its com-ties with cGMP at Novartis’ own sites or any sub-including limits based on PNECs. It reports con-mitment to setting discharge limits, at own andsidiaries that manufacture antibacterials.

ducting on-site audits every three years. It

suppliers’ sites, for pharmaceuticals in the envi-

requests and reviews the discharge levels of its

ronment which include but go beyond antibac-

C

APPROPRIATE ACCESS & STEWARDSHIP – ACCESS

Evaluated: access activities relating to antibacterial & antifungal medicines & vaccines in 102 access countries***
Novartis is not eligible for indicators: C.1.1, C.1.3,

to sell some of its medicines, of which antibiot-

C.2.1 and C.2.3. For more information, see

ics used to treat patients with COVID-19-related

Appendix VII.

symptoms, at zero-profit to governments in up
to 79 eligible low-income and lower-middle-in-

C.1.2 Filed to register off-patent/generic med-come countries.

icines in 30 access countries on average
Novartis performs above average, filing nine ofits 10 relevant off-patent/generic medicines for

C.3

Several strategies to ensure continuous
supplyregistration in 30 access countries on average.

Novartis performs above average, with strate-

Its most widely filed relevant product is amox-

gies reported in all four areas assessed. Novartis

icillin/clavulanic acid, filed in 70 access coun-ensures accurate demand planning and data

tries. Three of its relevant products are filed insharing by following a monthly rolling processless than ten access countries. Six of its rele-

from one to 36 months in advance and ensuresvant products are filed for registration in at least

weekly data sharing for anti-infectives. Novartis

one LIC.

mitigates against shortage risks by keeping
buffer stocks for key starting materials, drug

C.2.2 Several strategies to expand access tosubstance and drug products. It ensures dual

off-patent/generic medicines

sourcing when possible. It has set daily, weekly,

Novartis performs above average, with accessand monthly KPIs to monitor its supply chain

strategies reported for four of its ten relevant

performance. Novartis reports one technology

off-patent/generic medicines. It aims to expand

transfer initiative in Pakistan, to locally produce

access to its off-patent/generic medicines in

its penicillin portfolio. To mitigate against sub-access countries through equitable pricing, ten-standard and falsified products, Novartis moni-ders and competitive prices. It provides evidence

tors online platforms, uses data analytics, spec-of patient reach and geographic reach for all its

trometry technologies, anticounterfeiting pack-reported approaches. Novartis Access pricing

aging features and mobile applications.

policy ranges the prices from USD 1 per treatment per month or at tailored prices. Novartis
Sub-Saharan African (SSA) Unit takes a high-volume, lower-price approach to increase thepatient reach. Novartis has set public goals toincrease the patient reach twofold by 2022 andfivefold by 2025 through its SSA unit. In 2020,
Novartis, through its Sandoz division, committed*** 102 low- and middle-income countries where better access to medicine ismost needed.

16

Antimicrobial Resistance Benchmark 2021

C

Access to Medicine Foundation

APPROPRIATE ACCESS & STEWARDSHIP – STEWARDSHIP

Evaluated: stewardship activities relating to antibacterial & antifungal medicines globally
C.4

Comprehensive COI mitigation strategies

antibacterial and/or antifungal medicines. Its(KOROUN) programme, which is managed by thein place for its educational programmesmarketing materials include emerging resist-

Polish National Medicines Institute with support

Novartis performs strongly in conflict of interest

ance trends and/or include treatment guide-from Novartis and has been running since 2019.

(COI) mitigation for the five AMR-related edu-

lines for healthcare professionals: for azithromy-

It is focused on community-acquired respiratory

cational programmes for HCPs assessed by thecin, cefixime, amoxicillin/clavulanic acid and cef-

tract infections in Poland. Only the aggregatedBenchmark. To mitigate COI for one programme,

podoxime by including antimicrobial steward-

results are shared through open-access journal

it provides financial resources to an independ-

ship guidelines for healthcare professionals andarticles and the KOROUN website.

ent third party (MedShr) to develop the pro-by combining the most recent information fromgramme. The remaining four programmes haveWHO’s AWaRe categorization with informa-

all three COI mitigation strategies looked for bytion on resistance closely aligned with national

the Benchmark: (1) content is developed inde-

guidelines for its top ten global antibacterial

pendently from its marketing department; (2) amedicines.

pledge not to provide financial or material incentives to participants; and (3) it does not use

C.6

Makes one type of brochure and/or
packaging adaptation to facilitate appro-branded materials.

priate use by patients
C.5

Engages in sales and marketing practices

Novartis adapts brochures to facilitate theto address appropriate use

appropriate use of amoxicillin/clavulanic acid

Novartis performs above average in sales prac-by patients. Novartis is middle-performing intices. It reports that it sells a significant portion

this measure, taking account of paediatric use.

of its antibacterial and/or antifungal medicines

It has created paediatric guidance for amoxicil-

through tenders and does not have sales incen-

lin/clavulanic acid that focuses on correct dosing

tives linked to the sales volume of these tenders.

for children.

Outside of these tenders, promotion of antibacterial and/or antifungal medicines is limited andthe focus of such promotional activities is not onthese medicines.

C.7

Active in one AMR surveillance programme; openly publishes aggregatedresults

Novartis engages in marketing practices

Novartis is active in the national Diagnostics ofthat aim to address the appropriate use of its

Central Nervous System Bacterial Infections

17