General Access to Medicine ManagementRanking: 3 Score: 4.26
Has a strong access-to-medicine strategy with board-level responsibility. GSK is one of 14 companies that performs strongly with regards to its access-to-medicine strategy, which includes access-related goals, and aligns with its corporate strategies. The strategy centres around improving access to medicine and strengthening health systems in countries in scope by developing partnerships focused on access, such as ViiV Healthcare. The highest level of responsibility for access sits with a board-level committee.
Financial and non-financial access-related incentives to reward employees. GSK performs strongly in encouraging employees to work towards access-related objectives. It is one of 14 companies to have both financial and non-financial incentives in place to motivate employees to perform on access-related issues. These incentives include a variable pay system linked to long-term results, bonuses and rewards. Senior management has a separate incentive that supports the company's long-term access oriented objectives.
One of the 16 companies working on impact measurement. GSK measures and monitors progress and outcomes of access-to-medicine activities. It also publicly reports on commitments, targets and performance information. For example, for its partnerships with Amref Health Africa, CARE International and Save the Children, GSK reports reaching its goals on helping underserved people by training 65,000 frontline health workers. Furthermore, it is one of the companies that is measuring impact by reporting on the progress of its Save the Children partnership.
Clear stakeholder engagement approach that includes local stakeholders. GSK performs well when it comes to the disclosure of its stakeholder engagement. It publicly discloses which stakeholder groups it engages with on access issues, but does not publicly share its process for selecting who to engage with. It does incorporate local stakeholder perspectives into the development of access strategies. It has some policies covering responsible interactions with stakeholders, namely to operate with integrity and transparency with local stakeholders, following its standard for interacting with patient organisations.
Market Influence & ComplianceRanking: 1 Score: 4.01
Has measures to ensure third-party compliance with ethical marketing and anti-corruption standards. GSK leads in the area of ethical marketing and anti-corruption governance. It has a code of conduct relating to ethical marketing and anti-corruption, and provides annual compliance training for employees. The company provides evidence of having formal processes in place to ensure compliance with standards by third parties. Sales agents' rewards are not solely based on sales targets. Instead, it rewards other qualities such as technical knowledge and quality of service.
Internal control framework meets all Index criteria. GSK has all the components of an effective internal control framework to ensure compliance. Namely, it reports that it regularly conducts fraud-specific risk assessments. It also has a monitoring system in place to track compliance in the workplace; it conducts audits involving both internal and external resources—that also applies to third parties. GSK also demonstrates evidence of having procedures to segregate duties, so that decisions are checked by another party.
Above average transparency regarding access-related practices. GSK publicly discloses its policy positions on access-related topics. For example, it has a policy on intellectual property and access to medicine for developing countries. It is one of the few companies in scope to have a policy that prohibits political contributions. GSK discloses its membership of relevant institutions and whether it provides financial support. It discloses its policies for responsible engagement, including responsible lobbying. During the period of analysis, GSK was the only company to have a policy prohibiting payments to healthcare professionals to attend and speak at conferences.
Research & DevelopmentRanking: 1 Score: 4.00
Publicly commits to R&D to meet public health needs. GSK has publicly committed to R&D for diseases and countries in scope. Its R&D strategy for low- and middle-income countries is informed by an evidence-based public health rationale with each commitment developed in response to public health needs in these countries. Further, it has time-bound strategies for completing R&D projects for diseases in scope and evaluates progress toward these targets. GSK has one of the largest pipelines in the Index with 86 projects. For diseases in scope where priorities exist, GSK is active in 60 projects; 58 of these target priority R&D gaps.
Access provisions in place for 68% (32/47) of late-stage candidates. GSK has a clear process in place to develop access plans during R&D. The process considers all R&D projects for diseases in scope when possible. In general, GSK develops access plans for R&D projects in Phase II of clinical development, and it develops equitable pricing strategies in Phase III. To date, GSK has the highest number of project-specific access provisions, with 32 in place for its late-stage R&D projects. Of these, 19 are being conducted in partnership.
Public policy to ensure post-trial access; commits to registering trialed products. GSK has a publicly available policy for ensuring post-trial access to treatments for clinical trial participants and has provided a detailed example of this policy in action in countries in scope. The policy is aligned with the standards set in the Declaration of Helsinki. Once a product is approved, GSK commits to registering it in all countries where clinical trials for the product have taken place.
Pricing, Manufacturing & DistributionRanking: 1 Score: 4.11
Commits publicly to equitable pricing and reports a commitment to file to register new products in scope. GSK commits to filing its newest products for registration in countries in scope within one year of first market approval, where possible. It also publicly commits to implement inter-country equitable pricing strategies for the majority of its products for diseases in scope. However, this does not explicitly apply to future products. Its public commitments also apply to intra-country equitable pricing strategies.
Some new products in scope filed for registration in the majority of priority countries. Although GSK newly commits to filing its newest products for registration in countries in scope within one year of first market approval, it has filed 10% of its newest products for registration to date in more than half of the relevant priority countries (disease-specific subsets of countries with a particular need for access to relevant products). However, it publicly shares some registration information for the majority of its products.
60% of products have equitable pricing strategies targeting priority countries. GSK's overall performance is strong compared to peers in equitable pricing. It demonstrates evidence of having equitable pricing strategies for 60% of its products for diseases in scope. These strategies apply to an average of 35% of priority countries. The majority of these strategies apply both inter- and intra-country pricing; these take into account an average of four socioeconomic factors. GSK also applies equitable pricing strategies to 19 further products informed by a public health rationale.
Has both globally consistent recall guidelines for countries in scope and processes to track products. GSK has guidelines for drug recalls that apply to all countries in scope. It has processes to track the distribution of products in countries in scope to facilitate rapid and effective recalls.
Patents & LicensingRanking: 1 Score: 3.10
Publicly discloses detailed information on patent statuses. Like most of its peers, GSK publicly discloses the patent statuses for small molecules in scope via the Pat-INFORMED platform. This will be periodically updated and includes detailed information about patents, including filing date, grant number, grant date and jurisdiction.
Uses licensing to enable generic supply. GSK performs strongly in this area. The company has non-exclusive voluntary licensing agreements in place for two compounds (for diseases in scope). Its broadest licence, for dolutegravir (Tivicay®), encompasses 102 countries including 71 middle-income countries in scope. It has not issued any non-assert declarations for products in scope.
Shares some IP assets with 3rd-party researchers. Compared to its peers, GSK shares some IP assets with third-party researchers developing products for diseases in scope. This includes four shared with UK research institutions such as the University of Keele and the University of Dundee. The assets shared include molecule libraries.
Public commitment not to enforce patents in countries in scope. GSK commits publicly to neither file for nor enforce patents related to diseases within the scope of the Index. This commitment applies in Least Developed Countries and low-income countries.
Capacity BuildingRanking: 1 Score: 4.40
23 initiatives included for evaluation. GSK has 23 capacity building initiatives that were included for analysis by the Index: i.e., the initiatives demonstrably address a specific local need and involve local partners. Companies could submit a maximum of 25 initiatives across all areas for assessment; GSK submitted the maximum.
Strong focus on local manufacturing and strengthening health systems. GSK has initiatives which meet inclusion criteria in all five areas of capacity building. It has at least two initiatives in each area which meet all good practice standards. GSK performs strongest in manufacturing capacity building and health system strengthening.
18 initiatives meet all applicable good practice standards:
- Water Scarcity in India and Bangladesh
- Building Quality, company Good Manufacturing Practice (cGMP) and Environment Health and Safety Capability (EHS) in Finished Dose Contract Manufacturing Organisations
- Harmonising Quality Standards at a Contract Manufacturer of Dolutegravir
- Product Lifecycle Management
- Vaccines Manufacturing Transfer to Brazil
- Africa NCD Open Lab
- China Institute for Infectious Diseases and Public Health/Centre for Global Health
- Live Well
- Outbound Temperature Controlled Transportation in Morocco
- Academic Research Chair
- Pharmacovigilance enhancement capacity building in Sub Saharan Africa (SSA)
- Health Systems Engineering & Innovation Hub
- GSK and Save the Children partnership
- Comic Relief – GSK malaria partnership
- STEP (Strategic Training for Executives Programme)
- GSK Reinvestment Initiative to improve Healthcare Infrastructure in the Least Developed Countries (LDCs)
- Positive Action programmes
Out of GSK's five remaining included initiatives, three are in the area of pharmacovigilance. These initiatives typically fall short on having good governance structures in place and processes for mitigating conflicts of interest.
Timely approach to confirming and reporting substandard or falsified medicines. GSK provides evidence that it systematically confirms suspected cases of substandard or falsified medicines and then reports confirmed cases to relevant authorities or WHO Rapid Alert within the period recommended by stakeholders (maximum seven days for each, confirmation and reporting).
Product DonationsRanking: 2 Score: 4.54
Responds to emergencies and humanitarian crises and tracks delivery. GSK donated medicines on the request of relief agencies. For example, during the period of analysis, it donated various products such as amoxicillin/clavulanic acid (Augmentin™) in response to the 2016 hurricane in Haiti. The company discloses that such ad hoc donations are aligned with international guidelines (issued by WHO), and it works, for example, with Save the Children, Direct Relief, Americares and Map International to ensure products are rapidly delivered. It also monitors the delivery of the product until received by end user.
Two donation programmes covering diseases and countries in scope. GSK's programmes are focused on neglected tropical diseases (NTDs), namely lymphatic filariasis (LF) and soil-transmitted helminthiases (STH). Both programmes are carried out in partnership with WHO. Its programme for STH supplies albendazole (Zentel®) in 50 countries and has been ongoing since 2011. In 2017, GSK reported donating 123.7 million albendazole(Zentel®) tablets for STH and 770 million albendazole (Zentel®) tablets for LF.
Addresses long-term access by aiming to eliminate disease. GSK commits to long-term structured donation programmes by aiming to eliminate the diseases targeted. For example, its albendazole (Zentel®) donation programme aims to eliminate lymphatic filariasis in 39 countries.