Aspen Pharmacare Holdings Limited
|Applicable indicator||Not applicable|
Aspen is a prominent producer of antibiotics globally by sales volume. As a generic medicine manufacturer, Aspen was evaluated in Manufacturing & Production and Appropriate Access & Stewardship only. It reported no information to the Benchmark, and publicly available information is limited. Although the company’s performance in the Benchmark is lower compared to most other generic medicine manufacturers in scope, it reports a set of environmental risk-management principles that include an auditing process. There was no evidence, however, that these principles are applied to its third-party suppliers of antibiotic APIs and drug products. It reports mechanisms for maintaining high quality of antibiotic production at its own manufacturing sites. The company reports no information regarding an equitable pricing approach, or where it files products for registration. Aspen does not report any involvement in stewardship activities that promote appropriate antibiotic use.
Sales & operations
Aspen is a global supplier and manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, as well as infant nutritionals and consumer health products. The company has a substantial presence in low- and middle-income countries in regions such as Latin America, Russia, Eastern Europe, sub-Saharan Africa (SSA) and South Asia, with 25 manufacturing facilities worldwide. Throughout SSA, it is a market leader in the antibiotics, respiratory, pain, cough and cold segments. Its primary therapeutic focus areas are thrombosis, anaesthetics, cytotoxics, and infant nutritionals. In 2016, Aspen acquired GSK’s portfolio of anaesthetic products (five medicines), as well as exclusive rights to commercialise AstraZeneca’s anaesthetics portfolio (seven medicines) in 100 countries worldwide (including, e.g., China, but excluding, e.g., the USA). In 2009, Aspen and GSK formed the “GSK Aspen Healthcare for Africa” collaboration in SSA, which came to an end in January 2017, with GSK paying Aspen GBP 45 million.
According to publicly available data, Aspen markets at least 16 antimicrobial medicines, ten of which are listed on the WHO EML (Section 6). Eleven of the company’s antimicrobials are antibiotics, with seven on the WHO EML (Section 6), including ceftazidime, in the EML’s Watch group, and ciprofloxacin, in both the Access and Watch groups. The remainder (five) of the company’s portfolio includes antifungals, antiprotozoals and the anthelminthic albendazole. The company also markets an antiseptic face wash containing triclosan.
Engage in antimicrobial stewardship. Aspen can engage in stewardship activities, e.g., through surveillance activities, educational activities for healthcare professionals on AMR (while mitigating conflicts of interest), and engage in appropriate promotion practices.
Expand environmental risk-management strategy. Aspen can ensure its antibiotic discharge limits are applied to its environmental risk-management strategy. It can also extend this strategy to the sites of third parties that manufacture antibiotic APIs and drug products on its behalf, as well as to external waste-treatment sites. Aspen currently discloses a general environmental risk-management strategy that it applies to its own manufacturing sites.
Ensure affordability and registration plans for new and existing antimicrobials. Aspen can seek to improve access in low- and middle-income countries through registration of new and existing antimicrobials, and ensure that they are priced affordably. Currently, the company does not disclose such information.
A. Research & Development
As a generic medicine manufacturer, Aspen’s main focus is the manufacturing of generic products and as such was not in scope for this research area.
B. Manufacturing & Production
B.1 Environmental risk-management principles for own sites.
Aspen has set environmental risk-management principles to minimise the impact of antibiotic manufacturing discharge. These apply to its own manufacturing sites and include auditing. There is no evidence that they are applicable to third-party manufacturers of antibiotic APIs and drug products or to external waste-treatment plants. The company reports no information about setting discharge limits.
B.2 Limited transparency regarding environmental risk management.
Aspen publishes its environmental risk-management principles in its annual report. It does not disclose audit results, or the discharge levels of antibiotics. The company also does not share the identities of its third-party suppliers of antibiotic APIs and drug products or external waste-treatment plants.
B.3 Commits to following GMP.
Aspen reports that it has mechanisms for maintaining a high quality of antibiotic production — namely following GMP standards. This commitment applies to its own manufacturing sites, but the company does not report any commitment relating to how GMP standards apply to its third-party suppliers of antibiotic drug products.
C. Appropriate Access & Stewardship
C.1 No information on filing for registration.
Aspen reports no information on where it has filed its newest antibiotics for registration in countries in scope.* This information is not otherwise publicly available.
C.2 No disclosure on equitable pricing approach.
Aspen does not disclose an equitable pricing approach for its highest-volume antibiotics and/or antimicrobial medicines.
C.3 No insight into steps addressing supply chain efficiency.
Aspen does not disclose how it works with stakeholders (e.g., governments, procurers) to align supply and demand for antimicrobial medicines, specifically to prevent or minimise stockouts in countries in scope.* The company also does not report on whether it has processes in place to respond to stock-outs in countries in scope.*
C.4-C.7 No apparent involvement in stewardship activities.
Aspen does not report any involvement in stewardship activities (from education to surveillance to appropriate promotion practices) that promote appropriate antibiotic use.
* Countries in scope are 106 low- and middle-income countries where access to medicine is likely limited.
† EML Section 6: Anti-Infective Medicines
§ Net revenue; FYE 30 June 2017