Daiichi Sankyo Co. Ltd.
Rank 18 in 2016
Holds 18th place, with a continued lack of an overarching access-to-medicine strategy, and a weak performance in the Capacity Building, Pricing, Manufacturing & Distribution, and Product Donations. However, the company has made key gains in areas such as Patents & Licensing and R&D.
Rises 1 place to 19th. Lacks a coordinated access-to-medicine strategy and responsibility for access governance is not at board level.
Falls 3 places to 18th. Its internal control framework performs poorly against peers e.g., lacking procedures to segregate duties.
Rises 2 places to 7th. Has access plans in place for 38% of its late-stage projects, despite lacking a process for access plans during R&D.
Falls 4 places to 17th. Weak commitments to ensure equitable pricing and registrations, with no new products filed for registration in the majority of priority countries.
Rises 7 places to 12th. Improves transparency with a public commitment not to file patents in countries in scope, and new disclosure of patent status via Pat-INFORMED.
Falls 8 places to 19th. Two included initiatives focused on manufacturing, which fail to meet all good practice standards.
Rises 1 place to 17th, with no structured donation programmes, but working with trusted partners to make ad hoc donations.
Establish an overarching access strategy. Daiichi Sankyo can consolidate its various access approaches into an overall strategy, clearly aligning it with its corporate strategy and assigning board level responsibility for it. The company can focus on priority countries, and develop appropriate mechanisms, e.g., through equitable pricing and licensing strategies, for ensuring its products reach those most in need. Daiichi Sankyo is one of three companies in scope that does not have such a strategy.
Develop a process to establish more access plans for R&D projects. Daiichi Sankyo can develop a clear approach to establishing access provisions for R&D projects during development that takes into account the specific considerations necessary for each project. It can develop this approach for both in-house and collaborative projects for all diseases in scope, with a clear timeline for developing, refining and executing access provisions to ensure broad and rapid access. This includes developing access provisions for projects such as its late-stage vaccines for measles and DTaP-IPV-Hib.
Strengthen compliance framework. Daiichi Sankyo can strengthen its framework to ensure compliance by incorporating additional processes to mitigate the risk of non-compliance with ethical standards. For example, it can develop a fraud-specific risk assessment, a monitoring system for compliance and procedures to segregate duties. The company could expand its existing auditing mechanism to third parties it engages with in countries in scope. It can apply formal processes that help to ensure third-party compliance with the company's standards.
Review incentive structures. Daiichi Sankyo can strengthen its access governance by providing access-specific incentives (financial or non-financial) for staff at all levels. Alongside this , Daiichi Sankyo can decouple sales incentives from sales targets to better incentivise responsible practices. Removing the emphasis on sales targets is recognised as a mechanism for reducing the impact of unethical marketing on, for example, rational prescribing. Removing an emphasis on sales targets is recognised as a mechanism for reducing the impact of unethical marketing on, for example, rational prescribing.
Change since 2016
- Established a new global code of conduct for marketing in 2016 and a policy for anti-bribery and anti-corruption in 2017.
- Joined Access Accelerated with two initiatives in Tanzania and China. It has also committed to measure impact and share results publicly via Access Observatory.
- Discloses public commitments to not file or enforce patents in sub-Saharan African countries (except South Africa), Least Developed Countries, low-income countries and some middle-income countries.
- Discloses publicly the patent statuses for small molecules in scope via the Pat-INFORMED platform.
- Launched new Access to Healthcare policy in April 2018, establishing a strong commitment to conducting R&D for diseases and countries in scope.
Pipeline and Portfolio
for diseases and countries in scope
Mid-sized pipeline: 73 R&D projects for diseases in scope (66 medicines; 4 preventive vaccines; 3 diagnostics).
Clinical candidates: 36, including a preventive vaccine for measles and a preventive vaccine for Haemophilus influenzae, pertussis and tetanus.
Regulatory approvals: 0 for diseases in scope.
R&D focus: non-communicable diseases (cancer and kidney diseases) and communicable diseases (diarrhoeal diseases and tuberculosis).
Access provisions: for 10 projects, most commonly registration strategies.
Comparatively small portfolio: 22 products for diseases in scope (19 medicines; 3 preventive vaccines).
Portfolio focus: communicable diseases (lower respiratory infections) and non-communicable diseases (ischaemic heart disease).
Essential medicines: 59% of Daiichi Sankyo's medicines and vaccines are currently listed on the 2017 WHO Model List of Essential Medicines (WHO EML).
First-line treatments: 68% of Daiichi Sankyo's medicines and vaccines have first-line indications for diseases in scope.
Three business units: Pharmaceuticals; Vaccines; and Over-the-Counter Medicines. Its pharmaceutical business has two therapeutic areas (oncology; and cardiovascular and metabolic diseases) and its vaccine portfolio covers traditional childhood vaccines, including for diphtheria, tetanus, pertussis, measles, mumps and rubella (including four combination vaccines).
M&A news: 2017 consolidation of Kitasato Daiichi Sankyo Vaccine subsidiary into wholly owned subsidiary via acquisition of shares from The Kitasato Institute, a private research institute in Japan.
Presence in emerging markets: In 2018, Daiichi Sankyo reports sales in 43 countries in scope; one less than in the 2016 Index.
* Figure excludes three 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.