Teva Pharmaceutical Industries Ltd

Evaluated: antibacterials manufacturing (APIs and drug products)

B.1 Environmental risk-management for own sites and plans implementation at supplier sites
Teva reports a strategy to minimise the environmental impact of wastewaters and solid waste from antibacterial manufacturing at its sites, including audits every three 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 using a mass balance approach. It reports 22 of 32 sites have quantified discharge levels and 10, or 31%, are compliant with discharge limits.

Teva started requiring third-party suppliers of antibacterials to follow similar standards. It reports a goal to audit 50% of all >250 suppliers by the end of 2030***. It does not yet require suppliers to set discharge limits or quantify discharge levels.

Teva expects external public and private waste treatment plants to comply with its general environmental standards. There is limited information on the requirements Teva makes of external private and public waste-treatment plants, in terms of audits and antibacterial discharge limits and levels.  

B.2 Publicly discloses some information on environmental risk management and quantifying discharge levels at own sites
Teva 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. Teva publicly commits to quantifying discharge levels at 20 of its 34 own sites that manufacture antimicrobials by the end of 2020†. The levels themselves are not published. Teva also does not publish: (1) the results of environmental audits, whether conducted at its own sites, the sites of suppliers 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; regulator requested official corrective action
Teva 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. There is limited information on whether Teva requires its suppliers to audit their own suppliers. In January 2020, an FDA drug quality inspection identified non-conformities with cGMP at one Actavis site (a Teva subsidiary in Davie, FL, USA) producing antibacterial drug products, resulting in an official request for corrective action. Teva reports that the oral antibacterial products manufactured at this site were not impacted by the observations and that the site is taking corrective actions.

Evaluated: access activities relating to antibacterial & antifungal medicines & vaccines in 102 access countries‡

Teva 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 3 access countries on average
Teva has an average performance, filing three of its 10 relevant off-patent/generic medicines for registration in three access countries on average. Its most widely filed relevant product is the antibacterial azithromycin, filed in 19 access countries. Two of its relevant products are filed in less than ten access countries. One of its relevant product (azithromycin) is filed for registration in seven LICs.

C.2.2 Some strategies to expand access to off-patent/generic medicines
Teva has an average performance, with access strategies reported for three of its ten relevant off-patent/generic medicines. It aims to expand access in access countries through donations and tenders. In 2020, Teva, together with its partners, reports having donated more than 17 mn units of antibiotics and antifungals to access countries. In Malawi, Teva is partnering with Global HOPE and Direct Relief, to donate antibiotics for pediatric immunosuppressed cancer patients. The initiative aims to treat 4,000 new patients in Malawi over the next five years. Teva participates to the GDF and IDA Foundation global tenders for tuberculosis, to provide linezolid to all GDF eligible countries.

C.3 Some strategies to ensure continuous supply
Teva has an average performance, with strategies reported in three of four areas assessed. Teva mitigates against shortage risks by maintaining a certain volume of products ready to donate. Teva has a flexible safety stock management process within its Enterprise Resource Planning (ERP) system. It reports keeping buffer stocks. Teva does not report capacity building and technology transfer initiatives. To mitigate against substandard and falsified products, Teva directly donates its medicines to certified partners and uses security features such as serialisation.

Evaluated: stewardship activities relating to antibacterial & antifungal medicines globally 

C.4 Educational Stewardship Activities
There is no information regarding Teva’s involvement in AMR-related educational programmes aimed at healthcare professionals and it is therefore not eligible for this indicator as there is no conflict of interest mitigation to be assessed.

C.5 Does not promote its antibacterial and/or antifungal medicines
Teva performs strongly in sales practices. It does not deploy any sales agents to promote its antibacterial and/or antifungal medicines to healthcare professionals. Since Teva does not develop or use marketing materials for antibacterial and/or antifungal medicines to promote such medicines to healthcare professionals, the company is not eligible to be assessed on marketing materials.

C.6 Makes one type of brochure and/or packaging adaptation to facilitate appropriate use by patients
Teva adapts packaging to facilitate the appropriate use of azithromycin, linezolid and pyridoxine by patients. Teva is middle-performing in this measure, taking account of language. The packaging contains information translated into English, Spanish, French and/or Portuguese.

C.7 AMR Surveillance
As a generic medicine manufacturer, Teva is not assessed in this indicator nor does it report any involvement in AMR surveillance activities.