GlaxoSmithKline plc
Rank
1
Rank 1 in 2016
Score
4.01
Performance
Retains 1st place. It continues to outpace peers by building on a strong foundation of strategies that are applied to both R&D projects and products on the market. GSK leads in five out of seven Technical Areas.
Management
Retains third place. Access strategy is clearly linked to business rationale, with incentives for senior management aimed at long-term objectives.
Compliance
New to 1st place, it discloses all components of an internal control system looked for by the Index.
R&D
Retains top place, by creating an integrated Global Health R&D unit, and the largest number of projects targeting priority R&D gaps.
Pricing
Holds top place, with one of the highest proportions of equitable pricing strategies being applied to priority countries.
Patents
A new leader, with its voluntary licence for dolutegravir (Tivicay®) having the largest geographic spread.
Capacity
Leads for the first time with the highest number of initiatives meeting all good practice standards.
Donations
Falls to 2nd place. Maintains strong performance, but falls short compared to the leader in endemic country-coverage.
Opportunities
Ensure sustainability of established access systems while shifting to a distributor-led model. During the period of analysis, GSK reviewed and restructured its product deployment strategy for its pharmaceuticals business to a distributor-led approach in several countries within the scope of the Index, including sub-Saharan Africa. GSK should ensure that access to products is maintained and response to need and supply are addressed.
Continue to register key HIV products in countries in scope. GSK should work through ViiV Healthcare to register HIV/AIDS products in all priority countries, for example abacavir/dolutegravir/lamivudine (Triumeq®), dolutegravir/rilpivirine (Juluca®), and Dolutegravir (Tivicay®). Dolutegravir (Tivicay®) is GSK’s most widely registered new product, registered in 50% of the possible priority countries. GSK can also file its paediatric formulation of dolutegravir (Tivicay®), for broad registration in priority countries. To help improve registration of HIV/AIDS medicines in priority countries, GSK can consider participating in the WHO Collaborative Registration Procedure.
Expand HIV voluntary licensing agreements. GSK can look to expand its non-exclusive voluntary licence for dolutegravir (Tivicay®) for HIV/AIDS, which currently covers 70% of middle-income countries in scope with the highest burden of HIV/AIDs. Middle-income countries with a high burden of HIV/AIDS excluded from the licence agreement are: Brazil, China, Mexico and Suriname.
Develop equitable pricing strategies prior to Phase III. GSK can work to ensure that all R&D projects have access plans during Phase II and continue to refine this process to allow for the earlier establishment of these provisions. In particular, it can work to establish equitable pricing strategies at Phase II of clinical development.
Change since 2016
- Partially reverses company ban on payments to healthcare professionals as of October 2018.
- Joined Access Accelerated with its Africa NCD Open Lab initiative. It has also committed to measure impact and share results publicly via Access Observatory for two of its projects.
- Discloses publicly the patent statuses for small molecules in scope via the Pat-INFORMED platform.
- Improved its access planning process to consider all R&D projects in scope, with access plans in place, after proof of concept, during Phase II of clinical development.
- Established a Global Health R&D Unit (part of the new Global Health Unit) that encompasses GSK's open innovation initiatives for maternal and neonatal health, non-communicable diseases in Africa and neglected tropical diseases while systematically incorporating access into these projects.
- Shifts to distributor-led model in key regions (e.g. Sub Saharan Africa, Southeast Asia) within the Index scope.
Pipeline and Portfolio
for diseases and countries in scope
Pipeline
Comparatively large pipeline: 86* R&D projects for diseases in scope (59 medicines; 26 preventive vaccines; 1 diagnostic; 1 therapeutic vaccine; 1 vector control product).
Clinical candidates: 53, including tafenoquine for the treatment of Plasmodium vivax malaria in children and adults and a paediatric indication for dolutegravir/rilpivirine (Juluca®) for the treatment of HIV/AIDS.
Regulatory approvals: 7, including influenza H5N1 pre-pandemic vaccine (Prepandrix™) for paediatric usage.
R&D focus: communicable diseases (HIV/AIDS, malaria and lower respiratory infections) and non-communicable diseases (cancer, asthma and COPD).
Access provisions: for 45 projects, most commonly registration commitments.
Portfolio
Comparatively large portfolio: 102 products for diseases in scope (77 medicines; 25 preventive vaccines).
Portfolio focus: communicable diseases (lower respiratory infections and HIV/AIDS) and non-communicable diseases (asthma and hypertensive heart disease).
Essential medicines: 64% of GSK's medicines and vaccines are currently listed on the 2017 WHO Model List of Essential Medicines (WHO EML).
First-line treatments: 65% of GSK's medicines and vaccines have first-line indications for diseases in scope.
Business context
Three business units: Pharmaceuticals; Vaccines; and Consumer Healthcare. Its pharmaceutical business segment has five therapeutic areas (respiratory; HIV/AIDS; oncology; rare diseases; and immuno-inflammation). Its vaccine portfolio focuses on traditional childhood vaccines (e.g., DTaP-containing combination vaccines) and newer vaccines with few other suppliers (e.g., HPV, pneumococcal disease and rotavirus). GSK holds a 78.3% equity share in ViiV Healthcare - a joint HIV/AIDS medicine venture with Pfizer and Shionogi.
M&A news: 2018 buyout of Novartis 36.5% stake in its Consumer Healthcare joint venture.
Presence in emerging markets: In 2018, GSK reports sales in 74 countries in scope; 18 less countries than in the 2016 Index. It reports that a large portion of its sales in 2017 came from regions outside of Europe and the USA.
*Projects that target multiple product types are counted more than once.
**Figure excludes 5 projects that do not fall into the listed phases of development: e.g., technical lifecycle projects, diagnostics, platform technologies, vector control products, investigator sponsored trials and Phase IV projects.
***Neglected Tropical Diseases, while also communicable, are highlighted separately throughout the Index. See Appendix II.
†See Appendix IV for definition.