Novartis AG

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

A.1 Investments in R&D
Novartis did not report investments during 2019 and 2020 in R&D for antibacterial and antifungal medicines and/or vaccines for pathogens in scope. Novartis has pledged an unknown amount to the AMR Action Fund over the next 10 years.
 
A.2.1 Novartis does not engage in R&D for products in scope
The company does not report any project in its pipeline targeting pathogens in scope.  

A.2.2 Novelty of pipeline
Novartis is not eligible for this indicator as it does not have any R&D candidates in clinical development.

A.2.3 Not active in vaccine development
Novartis is not active in vaccine development targeting pathogens in scope.

A.2.4 Critical and/or urgent priorities
Novartis is not eligible for this indicator as it does not have any R&D candidates in development.

A.3 Access and stewardship planning
Novartis is not eligible for this indicator as it has no projects targeting pathogens in scope in late-stage clinical development.

Companies are expected to have plans in place for pipeline projects in Phase II and beyond.

Evaluated: antibacterials manufacturing (APIs and drug products)

B.1 Comprehensive environmental risk-management for own sites and suppliers; audits external private and public waste-treatment plants
Novartis reports a comprehensive strategy to minimise the environmental impact of wastewaters and solid waste from antibacterial manufacturing at its sites, including audits every 2-4 years. It reports setting discharge limits in the receiving environment for all antibacterials manufactured at its sites, based on PNECs to limit AMR, as recommended by the AMR Industry Alliance. Discharge levels are quantified at all sites using a mass balance approach or chemical analysis, as applicable. It reports that compliance of own sites with discharge limits is tracked. It also publicly reports that 80% of its own sites are compliant with discharge limits for pharmaceuticals which include, but are not specific to, antibacterials.

Novartis requires third-party suppliers of antibacterials to follow the same standards, including limits based on PNECs. It reports conducting on-site audits every three years. It requests and reviews the discharge levels of its suppliers. It is undisclosed how many of the 160 supplier sites report to have quantified discharge levels.

Novartis expects external private waste-treatment plants to comply with its general environmental standards. It audits external private and public waste-treatment plants at least every three years, based on risk. It requests external private and public wastewater treatment plants to provide dilution and flow rate data to inform the mass balance approach and employs conservative measures when needed.

B.2 Publicly discloses some information on environmental risk management and compliance with limits for pharmaceuticals including antibacterials
Novartis publishes some components of its environmental risk-management strategy. It is a member of the AMR Industry Alliance, which publishes a list of recommended antibacterial discharge targets. Novartis publishes its commitment to setting discharge limits, at own and suppliers’ sites, for pharmaceuticals in the environment which include but go beyond antibacterials. It publicly discloses that 80% of its own sites are compliant to these general limits. The discharge levels themselves are not published. Novartis also does not publish: (1) the results of environmental audits, conducted at its own sites, the sites of suppliers and/or external private and public waste-treatment plants; or (2) a list of these suppliers and plants.

B.3 System in place to maintain production quality for own and suppliers’ sites; no requests for official corrective action 
Novartis reports that its own sites and suppliers have a system to maintain high-quality antibacterial production consistent with international GMP standards. This includes periodic risk-based audits and tracking of corrective and preventive actions. Novartis also requires its suppliers to audit their own suppliers. The Benchmark found no requests for official corrective action from the FDA or EMA related to non-conformities with cGMP at Novartis’ own sites or any subsidiaries that manufacture antibacterials.

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, C.2.1 and C.2.3. For more information, see Appendix VII in the 2021 AMR Benchmark report.

C.1.2 Filed to register off-patent/generic medicines in 30 access countries on average
Novartis performs above average, filing nine of its 10 relevant off-patent/generic medicines for registration in 30 access countries on average. Its most widely filed relevant product is amoxicillin/clavulanic acid, filed in 70 access countries. Three of its relevant products are filed in less than ten access countries. Six of its relevant products are filed for registration in at least one LIC. 

C.2.2 Several strategies to expand access to off-patent/generic medicines
Novartis performs above average, with access strategies reported for four of its ten relevant off-patent/generic medicines. It aims to expand access to its off-patent/generic medicines in access countries through equitable pricing, tenders and competitive prices. It provides evidence of patient reach and geographic reach for all its reported approaches. Novartis Access pricing 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 the patient reach. Novartis has set public goals to increase the patient reach twofold by 2022 and fivefold by 2025 through its SSA unit. In 2020, Novartis, through its Sandoz division, committed to sell some of its medicines, of which antibiotics used to treat patients with COVID-19-related symptoms, at zero-profit to governments in up to 79 eligible low-income and lower-middle-income countries.

C.3 Several strategies to ensure continuous supply
Novartis performs above average, with strategies reported in all four areas assessed. Novartis ensures accurate demand planning and data sharing by following a monthly rolling process from one to 36 months in advance and ensures weekly data sharing for anti-infectives. Novartis mitigates against shortage risks by keeping buffer stocks for key starting materials, drug substance and drug products. It ensures dual sourcing when possible. It has set daily, weekly, and monthly KPIs to monitor its supply chain performance. Novartis reports one technology transfer initiative in Pakistan, to locally produce its penicillin portfolio. To mitigate against substandard and falsified products, Novartis monitors online platforms, uses data analytics, spectrometry technologies, anticounterfeiting packaging features and mobile applications. 

Evaluated: stewardship activities relating to antibacterial & antifungal medicines globally 

C.4 Comprehensive COI mitigation strategies in place for its educational programmes
Novartis performs strongly in conflict of interest (COI) mitigation for the five AMR-related educational programmes for HCPs assessed by the Benchmark. To mitigate COI for one programme, it provides financial resources to an independent third party (MedShr) to develop the programme. The remaining four programmes have all three COI mitigation strategies looked for by the Benchmark: (1) content is developed independently from its marketing department; (2) a pledge not to provide financial or material incentives to participants; and (3) it does not use branded materials.

C.5 Engages in sales and marketing practices to address appropriate use
Novartis performs above average in sales practices. It reports that it sells a significant portion of its antibacterial and/or antifungal medicines through tenders and does not have sales incentives linked to the sales volume of these tenders. Outside of these tenders, promotion of antibacterial and/or antifungal medicines is limited and the focus of such promotional activities is not on these medicines.

Novartis engages in marketing practices that aim to address the appropriate use of its antibacterial and/or antifungal medicines. Its marketing materials include emerging resistance trends and/or include treatment guidelines for healthcare professionals: for azithromycin, cefixime, amoxicillin/clavulanic acid and cefpodoxime by including antimicrobial stewardship guidelines for healthcare professionals and by combining the most recent information from WHO’s AWaRe categorization with information on resistance closely aligned with national guidelines for its top ten global antibacterial medicines.

C.6 Makes one type of brochure and/or packaging adaptation to facilitate appropriate use by patients
Novartis adapts brochures to facilitate the appropriate use of amoxicillin/clavulanic acid by patients. Novartis is middle-performing in this measure, taking account of paediatric use. It has created paediatric guidance for amoxicillin/clavulanic acid that focuses on correct dosing for children.

C.7 Active in one AMR surveillance programme; openly publishes aggregated results
Novartis is active in the national Diagnostics of Central Nervous System Bacterial Infections (KOROUN) programme, which is managed by the Polish National Medicines Institute with support from Novartis and has been running since 2019. It is focused on community-acquired respiratory tract infections in Poland. Only the aggregated results are shared through open-access journal articles and the KOROUN website.