GlaxoSmithKline plc

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

A.1 Largest amount invested in R&D
GSK reports to the Benchmark the amount invested during 2019 and 2020 in R&D for antibacterial and antifungal medicines and/or vaccines for pathogens in scope. Specific investment figures were provided under confidentiality. GSK reports above average R&D investments relative to its revenues among the companies assessed. GSK reports the largest absolute R&D investment figure compared to the other companies who reported investments to the Benchmark. GSK is a contributor to the AMR Action Fund.

A.2.1 GSK has the largest R&D pipeline among the large R&D-based companies
The company reports 31 projects targeting pathogens in scope: 15 medicines and 16 vaccines, targeting bacterial and fungal pathogens. Out of the 31 projects, ten are in clinical development, 19 are in discovery/preclinical stage and 2 projects are in technical lifecycle. GSK did not obtain marketing approval for any of its products during the period of analysis.

A.2.2 Pipeline with highest number of innovative candidates
GSK’s clinical-stage medicine pipeline consists of both innovative and adaptive R&D projects. GSK has four innovative medicine antibacterial candidates in clinical development, making the company’s clinical pipeline the one with the highest number of innovative candidates among all companies evaluated in the Benchmark. This includes GSK-3036656, for the treatment of tuberculosis, which meets all four WHO’s innovativeness criteria; and gepotidacin, for the treatment of infections caused by Enterobacteriaceae and N. gonorrhoeae, which belongs to a new chemical class and has a new mode of action. GSK also has a non-traditional medicine in clinical development.

A.2.3 Largest vaccine pipeline
GSK reports 16 vaccine projects in its pipeline. It is by far the largest vaccine pipeline of the six companies active in vaccine development. It includes 13 innovative and three adaptive projects. GSK’s vaccines in clinical stages of development include candidates targeting C. difficile, S. aureus and N. gonorrhoeae. Moreover, GSK is developing M72/AS01E in collaboration with the Bill & Melinda Gates Medical Research Institute, a Phase II tuberculosis vaccine candidate.

A.2.4 Largest number of projects targeting ‘critical’ and/or ‘urgent’ pathogens
GSK has 11 projects targeting pathogens defined as ‘critical’ by WHO’s list of priority pathogens and/or characterised as ‘urgent’ threats by the US Centers for Disease Control and Prevention (CDC). In clinical development, GSK has medicine candidates against Carbapenem-resistant/ESBL-resistant E. coli and N. gonorrhoeae; and vaccine candidates against C. difficile and N. gonorrhoeae. 

A.3 Company-wide commitments and project-specific plans for access and stewardship
GSK has five late-stage R&D projects targeting pathogens in scope. It reports having project-specific access plans for most of these projects. All five projects have ongoing trials in access countries.^† 

GSK reports that it has developed an equitable pricing strategy framework for low- and middle-income countries (LMICs) that applies across its portfolio and business units. Its access plans include equitable pricing strategies, registration filings, non-exclusive licensing and supply chain commitments. GSK states that it does not file patents in Least Developed or Low-Income countries nor does it enforce historic patents. GSK does not conduct clinical trials in countries where it does not intend to pursue registration and to make the product available for use. GSK commits to conducting global surveillance studies for its new antibacterials to enable appropriate use and support 

Evaluated: antibacterials manufacturing (APIs and drug products)

B.1 Comprehensive environmental risk-management for own sites and suppliers; tracks compliance with limits at own sites and suppliers
GSK reports a comprehensive 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 at all sites using a mass balance approach, verified by chemical analysis if applicable. GSK reports that all its 20 sites, or 100%, are compliant with discharge limits.

GSK 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 reports 37 of 39 supplier sites, or 95%, are compliant with discharge limits.

GSK expects external private waste-treatment plants to comply with its general environmental standards. GSK audits these plants at least every 3 years (based on risk) which includes checking the suitability of technologies used for processing waste and protocols for preventing contamination. It requests external private and public wastewater treatment plants for 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
GSK publishes some components of its environmental risk-management strategy and is a member of the AMR Industry Alliance. It discloses that all its 20 (100%) own sites manufacturing antimicrobials and 32 of 45 (71%) of supplier sites are compliant with discharge targets set by the AMR Industry Alliance.^‡ The discharge levels themselves are not published. It 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 
GSK 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. GSK does not require its suppliers to audit their own suppliers, but do encourage them to do so. The Benchmark found no requests for official corrective action from the FDA or EMA related to non-conformities with cGMP at GSK’s own sites or any subsidiaries that manufacture antibacterials.

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

GSK is not eligible for indicators: C.1.1 and C.2.1. For more information, see Appendix VII in the 2021 AMR Benchmark report.

C.1.2 Filed to register off-patent/generic medicines in 16 access countries on average
GSK performs above average, filing eight of its nine relevant off-patent/generic medicines for registration in 16 access countries on average. Its most widely filed relevant product is the antibiotic amoxicillin/clavulanic acid filed in 62 access countries including 19 LICs. Seven of its relevant products are filed in less than 10 access countries.

C.1.3 Filed to register on-patent vaccines in 17 access countries on average 
GSK has an average performance, filing seven of its eight relevant on-patent vaccines for registration in access countries. Its most widely filed relevant vaccine is the pneumococcal conjugate vaccine Synflorix^®, filed in 45 access countries followed by Infanrix^® Hexa, its vaccine used to protect against diphtheria, tetanus, pertussis, hepatitis B, polio and bacterial meningitis (Hib), filed in 31 access countries. Two of its eight relevant vaccines are filed for registration in at least one LIC.

C.2.2 Several strategies to expand access to off-patent/generic medicines 
GSK performs above average. It aims to expand access to its off-patent/generic medicines in access countries through donations, second-brands, patient support programmes, tenders, and equitable pricing policies. GSK provides evidence of patient reach and geographic reach for all its reported approaches. For example, GSK donated more than 200,000 units of its branded amoxicillin/clavulanic acid antibiotic in 2020 through humanitarian partnerships, including one with Save the Children.

C.2.3 Several strategies to expand access to on-patent vaccines 
GSK performs above average, with access strategies reported for all its eight relevant on-patent vaccines in scope. It aims to expand access to its on-patent vaccines in access countries through tiered pricing policies and public or private partnerships. GSK partners with MSF and UNICEF to provide Synflorix^® at the lowest price tier during humanitarian situations. GSK provides evidence of patient reach and geographic reach for some of its reported approaches. For example, it estimates that 56 mn doses of Synflorix® were supplied to Gavi-eligible countries in 2020, through its partnership with Gavi The Vaccine Alliance.

C.3 Leader in strategies to ensure continuous supply 
GSK performs above average, with strategies reported in all four areas assessed. GSK ensures accurate demand planning and data sharing by conducting 3-year forecasts and annual long-term demand forecasting (up to 10 years). GSK mitigates against shortage risks by keeping buffer stocks for both APIs and finished products. It ensures dual sourcing for critical APIs. GSK reports three capacity building or technology transfer initiatives in access countries, such as its support to the Strategic Training Executives Programme (STEP) in GAVI-eligible countries. To mitigate against substandard and falsified products, GSK works closely with local law enforcement, conducts online and offline investigations or uses security features such as serialised barcodes and tamper-evident packaging.

Evaluated: stewardship activities relating to antibacterial & antifungal medicines globally 

C.4 Broad COI mitigation strategies in place for its educational programmes
GSK performs well in conflict of interest (COI) mitigation for the five AMR-related educational programmes for HCPs assessed by the Benchmark. 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. The remaining programme has two COI mitigation strategies: in some countries where these programmes were presented the content could be branded.

C.5 Engages in sales and marketing practices to address appropriate use
GSK is middle-performing in sales practices. It reports that it partly decouples incentives for sales agents from sales volumes of its antibacterial and/or antifungal medicines. Its percentage of variable pay linked to sales volumes is 25%, and this is set at the smaller group level.

GSK engages in marketing practices that aim to address the appropriate use of its antibacterial and/or antifungal medicines. Its marketing materials reflect emerging resistance trends and/or include treatment guidelines for healthcare professionals. In some countries these include GSK SOAR surveillance data for the antibacterials amoxicillin/clavulanic acid (Augmentin™) and cefuroxime (Zinnat^®).

C.6 Makes five types of brochure and/or packaging adaptations to facilitate appropriate use by patients
GSK adapts brochures and packaging to facilitate the appropriate use of amoxicillin/clavulanic acid (Augmentin™) by patients. GSK is the leader in this measure, taking account of language, adherence to treatment, literacy, the environment and paediatric use. For example, it has translated a Patient Knowledge Card into English, French and Portuguese. This card highlights information to improve adherence to treatment. Moreover, GSK has created blister packaging with a specific lidding foil that is sensitive to moisture for high humidity environments. Further, it has created oral suspensions and flavoured dosing syringes for paediatric patients in 35 countries.

C.7 Active in one AMR surveillance programme; openly publishes aggregated results
GSK runs the multinational Survey of Antibiotic Resistance (SOAR) programme, which is focused on community-acquired respiratory-tract infections in more than 30 countries and has been running since 2002. GSK only shares the aggregated results through peer-reviewed open-access journal articles. In addition, it will be sharing SOAR data with the University of Oxford and University of Washington (as part of the GRAM project) as well as on the AMR Register, an open-access data platform, with these projects aiming to complete in Q4 of 2021.