General Access to Medicine ManagementRanking: 4 Score: 4.12
Has a strong access-to-medicine strategy with executive-level responsibility. Johnson & Johnson is one of 14 companies that performs strongly with regard to its access-to-medicine strategy, which includes access-related goals, and aligns with its corporate strategies. The strategy centres around promoting access to certain medicines within the company's portfolio, utilising strategies such as equity-based tiered pricing and partnerships with local organisations. The highest level of responsibility for access sits with the executive committee.
Financial and non-financial access-related incentives to reward employees. Johnson & Johnson 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 annual performance bonuses and long-term incentives based on individual performance. Senior management has a separate incentive that supports the company's long-term access oriented objectives.
One of 16 companies working on impact measurement. Johnson & Johnson measures and monitors progress and outcomes of access-to-medicine activities. It also publicly reports on its commitments, objectives, targets and performance information. For example, it publicly shares its targets and independently verifies data in its Health for Humanity report. Furthermore, it is one of the companies that is measuring impact through a monitoring and evaluation framework that includes impact targets, for at least one access initiative, New Horizons.
Clear and transparent stakeholder engagement approach that includes local stakeholders. Johnson & Johnson publicly discloses which stakeholder groups it engages with on access issues, as well as its process for selecting who to engage with. It selects by using different processes for each stakeholder group. Johnson & Johnson does not share a specific policy for responsible engagement but it has some policies covering responsible interactions with stakeholders, namely guiding its interactions with stakeholders for improving access.
Market Influence & ComplianceRanking: 9 Score: 2.68
Has measures to ensure third-party compliance with ethical marketing and anti-corruption standards. Johnson & Johnson has a code of conduct relating to ethical marketing and anti-corruption, and provides regular compliance training for employees. The company provides evidence of having formal processes in place to ensure compliance with standards by third parties. Yet, expected performance for sales agents is based solely on sales targets. The company reports that for some products it does not deploy sales and marketing representatives to facilitate sales.
Internal control framework meets some Index criteria. Johnson & Johnson's internal control framework to ensure compliance meets some of the criteria looked for by the Index. Namely, it has an auditing and review mechanism in place. It performs regular evaluations that also apply to third parties, and it has a monitoring system for compliance. However, Johnson & Johnson does not report conducting fraud-specific risk assessments, nor does it demonstrate having procedures to segregate duties, so that decisions are checked by another party.
Above average transparency regarding access-related practices. Johnson & Johnson publicly discloses its policy positions on access-related topics (e.g., its position on universal health coverage, and intellectual property). Johnson & Johnson reports that outside the US, it only makes political contributions in Australia, Canada and Japan; and these contributions are tracked at the local level. It discloses its membership and financial contributions to relevant organisations. It also discloses its policies for responsible engagement with its charter for general oversight. Johnson & Johnson does not publicly disclose its policy approach for payments made to healthcare professionals in countries in scope.
Research & DevelopmentRanking: 4 Score: 3.19
Publicly commits to R&D to meet public health needs. Johnson & Johnson 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 based on public health targets. Further, it has time-bound strategies for completing R&D projects for diseases in scope and evaluates progress toward these targets. Johnson & Johnson has one of the largest pipelines in the Index with 138 projects. For diseases in scope where priorities exist, Johnson & Johnson is active in 58 projects; 41 of these target priority R&D gaps.
Access provisions in place for 14% (8/58) of late-stage candidates. Johnson & Johnson has a clear process in place to develop access plans during R&D. The process considers all R&D projects for diseases in scope using its Janssen Value, Access and Pricing (VAP) framework. In general, Johnson & Johnson begins to develop access plans for R&D projects in Phase II of clinical development. To date, Johnson & Johnson has project-specific access provisions in place for eight of its late-stage R&D projects. Of these, two are being conducted in partnership.
Policy to ensure post-trial access; commits to registering trialed products. Johnson & Johnson has a 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. However, this policy is not publicly available. The policy is aligned with the standards set in the Declaration of Helsinki. Once a product is approved, Johnson & Johnson commits to registering it in all countries where clinical trials for the product have taken place.
Pricing, Manufacturing & DistributionRanking: 10 Score: 2.28
Does not publicly commit to equitable pricing or report a commitment to file to register new products in scope. Johnson & Johnson does not commit to filing its newest products for registration in countries in scope within one year of first market approval. Neither does it publicly commit to implementing equitable pricing strategies. However, it does have equitable pricing strategies for some products in scope of the Index.
No new products in scope filed for registration in the majority of priority countries. Johnson & Johnson has not filed any 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). Its most widely registered product, for schizophrenia, is registered in five out of 12 possible priority countries. However, it publicly shares partial registration information for the majority of its products.
9% of products have equitable pricing strategies targeting priority countries. Johnson & Johnson's overall performance is below average compared to peers in equitable pricing. It demonstrates evidence of having equitable pricing strategies for 9% of its products for diseases in scope. These strategies apply to an average of 70% of priority countries. All of these strategies apply inter-country pricing; these take into account an average of two socioeconomic factors.
Globally consistent recall guidelines for countries in scope but no processes to track products. Johnson & Johnson has guidelines for drug recalls that apply to all countries in scope. It does not demonstrate evidence of having processes to track the distribution of products in countries in scope to facilitate rapid and effective recalls.
Patents & LicensingRanking: 5 Score: 2.49
Publicly discloses detailed information on patent statuses. Like most of its peers, Johnson & Johnson publicly discloses the patent statuses for small molecules in scope via the Pa-INFORMED platform. This will be periodically updated and includes detailed information about patents, including filing date, grant number, grant date and jurisdiction.
Uses licensing and non-assert declarations to enable generic supply. Johnson & Johnson has a non-exclusive voluntary licensing agreement in place for one compound (for diseases in scope). Its licence, for rilpivirine (Edurant®), encompasses 88 countries, including 58 middle-income countries in scope. It has also issued a non-assert declaration for one patented compound in scope, darunavir (Prezista®).
Shares some IP assets with 3rd-party researchers. Compared to its peers, Johnson & Johnson shares some IP assets with third-party researchers developing products for diseases in scope.This includes four shared with research institutions, such as the University of Toronto and the Walter and Eliza Hall Institute of Medical Research. The assets shared include molecule libraries.
Public commitment not to enforce patents in countries in scope. Johnson & Johnson commits publicly not to enforce certain patents related to diseases within the scope of the Index. This commitment is limited to darunavir (Prezista®), for the treatment of HIV/AIDS, in sub-Saharan Africa and in Least Developed Countries.
Capacity BuildingRanking: 2 Score: 4.24
23 initiatives included for evaluation. Johnson & Johnson 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; Johnson & Johnson submitted the maximum.
Strong focus on strengthening capacity of local R&D, manufacturing and health systems. Johnson & Johnson has initiatives which meet inclusion criteria in all five areas of capacity building. It has at least one initiative in each area which meets all good practice standards. Johnson & Johnson performs strongest in manufacturing capacity building, R&D capacity building and health system strengthening.
11 initiatives meet all applicable good practice standards:
-GPH R&D Training Fellowship Program
-Asia Regional Pharmacovigilance Workshop
-Connect for Life™
-The Private Provider Interface Agency
-Born on Time
-Darunavir Technology Transfer
-Golimumab Technology Transfer
-Darunavir Technology Transfer - Porton
-Ugandan Academy for Health Innovation and Impact
-University of Cape Town Drug Discovery and Development Center (H3D)
-Cold Chain – GAVI –Vaccine Leadership and System
Its remaining included initiatives typically have goals & objectives and good governance structures in place. However, it commonly falls short on measuring progress and outcomes in areas outside of health system strengthening.
Does not provide evidence of reporting substandard or falsified medicines within the recommended timeframe. Johnson & Johnson has a policy of reporting cases of substandard or falsified medicines to relevant authorities or WHO Rapid Alert. However, it does not require reporting to occur within the time frame of seven days looked for by the Index.*
Product DonationsRanking: 9 Score: 3.10
Responds to emergencies and humanitarian crises and tracks delivery. Johnson & Johnson donated medicines on the request of relief agencies. For example, during the period of analysis, it donated various products in response to the 2016 hurricane in Haiti. The company discloses that such ad hoc donations are aligned with international guidelines (issued by WHO, PQMD), and it works with various organisations to ensure products are rapidly delivered. It also monitors the delivery of the product until received by end user.
Four donation programmes covering diseases and countries in scope. Johnson & Johnson's programmes are focused on neglected tropical diseases (NTDs), communicable and non-communicable diseases. All four programmes are carried out in collaboration with partners such as WHO, Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), Fracarita International and USAID. Its programme for soil-transmitted helminthiases supplies mebendazole (Vermox®) in 26 countries and has been ongoing since 2006. In 2017, Johnson & Johnson reports that 202 million doses of mebendazole (Vermox®) were donated.
Ensures longer-term access through transition planning. Johnson & Johnson has transition plans in place for two programmes to ensure ongoing access for patients once the programmes end. For example, its paediatric HIV donation programmes for darunavir (Prezista®) and etravirine (Intelence®), ensure that patients who are about to age out of the programme are able to transit into adult care without interruption of treatment. In addition to this, the company is working with the Paediatric HIV Treatment Initiative, to develop a generic fixed-dose combination of darunavir/ritonavir (120/20mg), to ensure affordability in the long term.
*Defined as a recommended time frame through consultation with stakeholders during Index methodology development.