GlaxoSmithKline plc

Places 1st, scores 4.59

Has an access-to-medicine strategy with measurable objectives, integrated within its overall corporate strategy. GSK performs strongly. It has a comprehensive access to medicines and vaccines strategy. The strategy covers all therapeutic areas in which the company is involved. The highest responsibility for access lies directly with the board, namely with its Corporate Responsibility Committee (CRC) which is responsible for global health and access strategies. 

Provides evidence of financial and non-financial access-related incentives at the executive level. GSK performs strongly. It incentivises its senior executives and in-country managers to take action on access to medicine with financial and non-financial rewards. The CEO also has access-related incentives included in its annual bonus plan.

Publicly discloses outcomes of its access-to-medicine activities. GSK performs strongly in transparency regarding access activities. It publicly discloses commitments, measurable goals, objectives and targets for improving access to medicine in countries in scope. It consistently shares outcomes of its access-to-medicine activities for example with its ESG Performance Summary. 

Performs above average in responsible promotional practices. For countries in scope GSK’s sales agents are not solely incentivised on sales volume targets. In addition, GSK does not set sales incentives at the individual level for agents in these countries. It does not publicly disclose information related to transfers of values to healthcare professionals in countries in scope, but it has a policy limiting such transfers, i.e. prohibiting payments for promotional activities in certain countries based on their scores in the Transparency International Corruption Perceptions Index

Has a robust set of compliance controls to ensure that governance efforts are not undermined by non-compliant or corrupt activities. GSK performs strongly, demonstrating all components looked for by the Index: fraud-specific risk assessment, country risk-based assessment, a continuous system to monitor activities, audits (both internal and external, covering third parties and in all countries where it operates) and has formal processes to ensure compliance with company standards by third parties.

Publicly supports the Doha Declaration on TRIPS and Public Health. GSK publicly shares support of the Doha Declaration on TRIPS and Public Health and acknowledges that the flexibilities can allow countries to address their public health needs. GSK has a policy to dissent from industry association positions on these, if it does not agree with a public policy position, it will not participate in related advocacy activity. 

Places 1st, scores 3.67

Access planning processes encompass all projects in pipeline. GSK has a structured process to develop access plans during R&D. The process is intended to be applied to all R&D projects for diseases in scope. In general, GSK begins developing access plans for R&D projects in Phase II of clinical development. The process is for both its in-house and collaborative R&D projects. 

GSK has the largest priority R&D pipeline compare to peers, with access plans in place for 80% of the late-stage candidates. GSK has 81 projects including 25 late-stage candidates in its pipeline that target a priority product gap. The company focuses mainly on HIV/AIDS and other infectious diseases. Of GSK’s 25 late-stage candidates targeting a priority product gap, 20 have evidence of having an access plan in place. These plans range from commitments to ensure access; to product registration in several countries in scope; to equitable pricing strategies wherein prices are linked to the country’s ability to pay (i.e. GNI per capita). GSK (as ViiV Healthcare) applies a non-profit pricing approach in lower-income countries, least-developed countries and sub-Saharan Africa for its antiretroviral products. ViiV Healthcare plans for a broad registration plan for this product and considers where appropriate, local manufacturing partnerships. Notably, ViiV Healthcare’s paediatric dolutegravir dispersible is the first integrase inhibitor available as a dispersible tablet for oral suspension for children.

Many projects address a public health need in LMICs*, with 80% of the late-stage projects covered by access plans. In this analysis, GSK has 15 late-stage R&D projects in its pipeline that target a disease and/or product gap not yet established as a priority by global health stakeholders. These projects are all deemed by the Index to offer a clear public health benefit for people living in LMICs.* Primarily, these projects are first-in-class molecules and/or clinical trials are conducted in countries in scope. Most target cancer. GSK provides evidence of access plans for 12 of these projects. 

Public policy to ensure post-trial access; commits itself to registering trialled products. GSK has a publicly available policy for ensuring post-trial access to treatments for clinical trial participants. This policy applies on a case-by-case basis. GSK does not conduct clinical trials in countries where, at the time of the trial, GSK knows it will not pursue registration and make the product available for use. The policy considers affordability for the wider population in the country where the trial(s) took place.

Four R&D capacity building initiatives meet all Good Practice Standards. GSK leads in this area. GSK submitted the maximum of five initiatives. Four initiatives met all criteria for inclusion and all Good Practice Standards:* 

- Africa NCD Open Lab, providing funds and additional in-kind support for research into Non-Communicable Diseases in sub-Saharan Africa. 
- Institute for Infectious Diseases and Public Health.
- Trust in Science, enabling scientific exchange with and suppporting research organisations in Latin America and Asia.
- PENTA’s EPIICAL Consortium, advancing the science of HIV remission in children for clinicians and  researchers and enabling technology and expertise transfers. 

Places 2nd, scores 4.36

Public commitment not to enforce patents in the majority of countries in scope. GSK publicly pledges to neither file for nor enforce patents. This commitment applies in Least Developed Countries and low-income countries.

Publicly discloses detailed information on patent status. Like most of its peers, GSK discloses the patent statuses for small molecules in scope via the Pat-INFORMED database. The information is periodically updated and includes detailed information about patents, including filing date, grant number, grant date and jurisdiction.

Shares some IP assets with third-party researchers. During the period of analysis GSK has newly shared some IP assets with third-party researchers developing products for diseases in scope. This includes five IP assets shared with research institutions, including sets of target-specific compounds in discovery stage and molecule libraries. GSK also joined the drug discovery initiative COVID-19 Therapeutics Accelerator launched by the Bill and Melinda Gates Foundation, Wellcome and Mastercard.

Uses licensing to enable generic supply. The company has two non-exclusive voluntary licensing agreement in place for one compound (for diseases in scope). Its adult licence for dolutegravir (Tivicay®) encompasses 91 countries in scope including 63 middle-income countries. Its paediatric licence for dolutegravir (Tivicay®) encompasses 102 countries in scope including 74 middle-income countries. It has not issued any non-assert declarations for products in scope.

Filed to register some new products in the majority of high burden countries. GSK has filed 30% of its most recently registered products in more than half of the relevant top 10 high burden countries (disease-specific subset of countries with the highest burden of disease). For example, dolutegravir (Tivicay®) for HIV/AIDS has been filed for registration/registered in 63 countries in scope, from which many with large populations of HIV patients such as South Africa, Mozambique, Tanzania and Zimbabwe.

Has access strategies for all supranationally procured products in scope of this analysis. GSK leads in securing access for products procured supranationally.§ For the five products assessed in this category, the company demonstrated strategies both in countries eligible for supply from such procurers and also in at least one non-eligible country. For example, through its price freeze commitment GSK offers the same terms to former GAVI countries such as Angola for two vaccines: Cervarix®, a HPV vaccine, and Rotarix®, a rotavirus vaccine, as they do in GAVI-eligible countries.

Has access strategies for both of the healthcare practitioner administered products in scope of this analysis. GSK performs well in this area. The company provides examples of access strategies which consider affordability in UMICs and LMICs for the two products assessed in this category. It makes efforts to reach additional patients through equitable pricing strategy and patient assistance programmes. For example, in Colombia, for mepolizumab (Nucala®), a treatment for asthma, the company use equitable pricing strategies and implemented a patient support programme to increase access, while strengthening the health system by providing nurse home visits for patients. GSK forecasts that access to this medicine will have increased by 100% by the end of 2020. GSK is able to provide evidence of how patient reach has been increased through the approaches used.

Has access strategies for its self-administered products for some countries in scope of this analysis. GSK performs above average in this area. The company provides examples of access strategies which consider affordability in countries of all assessed income levels (UMIC, LMIC, LIC) for two of the five products assessed. For the other products the company falls short to provide example for LMICs and/or LICs. It makes efforts to reach additional patients through the use of equitable pricing strategies. For example, in Thailand, the company reduced the price of fluticasone propionate/salmeterol xinafoate (Seretide®), a treatment for asthma, for inclusion for reimbursement on the national list of essential medicines and launched a second discounted brand to increase affordability and access for patients. 380,000 patients access this medicine every year in Thailand. GSK is able to provide evidence of how patient reach has been increased through the approaches used.

Four manufacturing capacity building initiatives meet all Good Practice Standards. GSK is a leader in this area, with five manufacturing capacity building initiatives included for analysis. GSK submitted the maximum of five, which all met all criteria for inclusion. Four initiatives met all Good Practice Standards.|| Examples include: 
- Providing manufacturers of tafenoquine for the prevention treatment of malaria, in India with Environment, Health and Safety (EHS) risk and quality support.
- Technology transfer and development support for paediatric dispersible formulations of dolutegravir (Tivicay®) in India.
For the initiative ‘Implementation of Child Resistant Senior Friendly packaging in India’, GSK does not demonstrate that it is measuring outcomes. 

Five supply chain capacity building initiatives meet all Good Practice Standards. GSK leads in this area with the highest number of initiatives that meet all Good Practice Standards.|| GSK submitted the maximum of five initiatives, which were all included for analysis and met all Good Practice Standards.|| Examples include: 
- PULSE Volunteer Partnership, supporting CHAI in Sierra Leone to deliver a supply system that supports Sierra Leone’s Free Healthcare Initiative.
- Nigeria Vaccines Supply and Cold Chain Integrity initiative, supporting the Murtala Muhammed International Airport in Lagos, Nigeria to maintain stable temperatures to ensure safe vaccine storage.

Five health system strengthening initiatives meet all Good Practice Standards. GSK is one of the leaders in this area. The company submitted the maximum of five initiatives, which all met the criteria for inclusion and all Good Practice Standards: i.e. they address local needs, have local partners, mitigate risk of conflict of interest, are guided by clear goals and objectives, (plan to) measure outcomes, have a governance structure in place and aim for sustainability/integration in the local health system. Examples include:
- GSK and Save the Children partnership, reaching nearly 3 million children under the age of five between 2013 and 2018. 
- Frontline Health Worker Programme, strengthening health infrastructure and improving access to healthcare in Least Developed Countries. Since 2010, GSK’s investment has reportedly enabled the training of more than 100,000 health workers and reached over 16 million people in 44 countries.

Has engaged in the development and implementation of scaled up inclusive business models. GSK performs above average when it comes to implementing scalable inclusive business models that aim to meet the access needs of populations at the base of the pyramid in countries in scope of the Index. During the period of analysis, it has scaled up its Live Well social enterprise model aiming at building and supporting local distributor networks in Zambia. 

The company has multiple mechanisms in place to ensure continuous supply in countries in scope of the Index. GSK performs well in this area, disclosing multiple strategies to ensure continuous supply in countries in scope. For example, GSK manages global and regional supply & demand hubs, overseeing forecasts of countries including some Least Developed Countries. GSK maintains a dual sourcing policy which supports supply of key medicines. In 2019, it set up a supranational organisation service platform to improve forecast accuracy and supply planning. 

Has a policy for reporting substandard and falsified (SF) medicines in Index countries in less than 10 days. GSK has a policy for reporting SF medicines to national health authorities and WHO within 5 days. It distinguishes reporting time frames for cases which only require visual inspection to be confirmed. In urgent situations where there is a significant risk of patient harm, the policy enables GSK to respond quickly. 

Donates in response to an expressed need and monitors delivery to end user. GSK has a policy in place to ensure ad hoc donations are carried out in response to an expressed need, and it monitors how it is delivered the end user.  For example, it donated antibacterial medicine in 2018 in response to the conflict in Syria.

Publicly commits to the achievement of elimination, eradication or control goals in its structured donation programmes for NTDs. Two structured donation programmes for NTDs were included for analysis where elimination, eradication or control goals are possible. In one programme, GSK publicly commits itself to eliminating lymphatic filariasis by donating albendazole (Zentel®) in 39 Index countries since 1998.