Merck & Co., Inc.
Rank 5 in 2016
Falls to 12th place from 5th. Merck & Co., Inc. delivers a below average performance in access planning for R&D, and falls in multiple areas. Yet it has increased public transparency across all Technical Areas.
Falls 6 places to 10th, with governance for access placed at the executive committee level.
Falls 4 places to 11th as its internal control framework does not meet all the criteria looked for by the Index.
Falls 4 places to 15th as it reports a below-average application of access plans to its late-stage R&D projects.
Holds 9th place as it publicly shares detailed registration information for some products, and registers them in a range of priority countries.
Rises two places to 2nd through increased transparency of its patent statuses via Pat-INFORMED and the comparatively broad geographic scope of its licence for the paediatric formulation of raltegravir (Isentress®).
Falls 10 places to 15th. Strong focus on health system strengthening, however, weak evidence of engagement in other areas of capacity building.
Falls 5 places to 7th. While it delivers a strong performance through its ivermectin (Mectizan®) programme, it publicly discloses comparatively less about the scale and impact of other programmes.
Expand equitable pricing for more products. The company can apply, for example, equitable pricing strategies to mometasone furoate (Asmanex®). This product is an on-patent first-line product on the 2017 WHO Model List of Essential Medicines (WHO EML) for the treatment of asthma. Data about the company's approach to this product has not been disclosed. The company could apply these strategies to the following priority countries where the burden of disease is high, e.g., Bangladesh, Brazil, China, Dem. Rep. Congo, Ethiopia, India, Myanmar, Nepal, Nigeria, Tanzania and Uganda.
Systematically plan for access throughout the R&D process. Merck & Co., Inc. can improve its commitment to R&D for diseases and countries in scope by considering the unique needs of low- and middle-income countries throughout development. By setting clear, time-bound targets for systematically considering and incorporating different access plans into each project at different points of development, Merck & Co., Inc. can ensure that its projects, which include novel antibiotics and therapies for maternal health, reach more patients. This includes providing post-trial access to clinical trial participants and registering all new products in every country where a clinical trial for these products has taken place, following market approval.
Further expand access via use of voluntary licensing. Merck & Co., Inc. can expand its use of voluntary licensing as a mechanism for boosting the affordability and supply of key medicines in countries in scope. This could include expanding licensing to adult formulations of raltegravir (Isentress®). It can also assess the need for elbasvir/grazoprevir (Zepatier®) in countries with a high prevalence of hepatitis C virus (HCV) genotype 1 or 4, with a view towards licensing.
Review sales incentive structures. Merck & Co., Inc. can decouple sales incentives from sales targets to better incentivise responsible sales practices. This is especially critical for a company that is a major producer of antibiotics. 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
- WHO used Merck & Co., Inc.'s investigational Ebola vaccine in the 2018 outbreak in the Democratic Republic of Congo.
- Joined Access Accelerated with two initiatives including the Access and Affordability Initiative. It has also committed to measure impact and share results publicly via Access Observatory.
- Completed the transition of management for the Informed Push Model to the government of Senegal in late 2017.
- Launched a new partnership with the Global Financing Facility (GFF), the Bill & Melinda Gates Foundation, and The UPS Foundation to improve supply chains in low- and middle-income countries, drawing on the experience of the Informed Push Model.
- Discloses publicly the patent statuses for small molecules in scope via the Pat-INFORMED platform
- Announced an expansion of its ivermectin (Mectizan®) donation programme in 2017, to reach up to an additional 100 million people annually through 2025 as part of the global effort to eliminate lymphatic filariasis.
- Working in collaboration with Ferring Pharmaceuticals and WHO through its Merck for Mothers Initiative to support the advancement of Ferring's proprietary and investigational heat-stable carbetocin for the prevention of postpartum haemorrhage. This collaboration aims to make heat-stable carbetocin available at an affordable and sustainable price in the public sector of low- and lower middle-income countries.
Pipeline and Portfolio
for diseases and countries in scope
Mid-sized pipeline: 50 R&D projects for diseases in scope (47 medicines; 3 preventive vaccines).
Clinical candidates: 27, including a preventive vaccine for Ebola and three Phase III antibiotics for the treatment of lower respiratory infections.
Regulatory approvals: 17, including raltegravir (Isentress®) for the treatment of HIV/AIDS in infants weighing more than 2 kg.
R&D focus: non-communicable diseases (cancer and diabetes mellitus), communicable diseases (HIV/AIDS, lower respiratory infections) and neglected tropical diseases (Chagas disease).
Access provisions: for 7 projects, most commonly applied through access-oriented partnerships.
Mid-sized portfolio: 58 products for diseases in scope (41 medicines; 10 preventive vaccines; 6 contraceptive methods; 1 vector control product).
Portfolio focus: non-communicable diseases (hypertensive heart disease and diabetes mellitus), communicable diseases (HIV/AIDS and viral hepatitis C) and maternal & neonatal health conditions (contraceptive methods).
Essential medicines: 58% of Merck & Co., Inc.'s medicines and vaccines are currently listed on the 2017 WHO Model List of Essential Medicines (WHO EML).
First-line treatments: 53% of Merck & Co., Inc.'s medicines and vaccines have first-line indications for diseases in scope.
Two business units: Human Health and Animal Health. Human Health is divided into pharmaceuticals and vaccines. Its pharmaceuticals unit has four therapeutic areas (primary care and women’s health; hospital and specialty; oncology; and diversified brands). Its vaccine portfolio focuses on traditional childhood vaccines and newer vaccines with few other suppliers, including for HPV and rotavirus.
M&A news: 2016 conclusion of joint vaccines venture with Sanofi in Europe to independently manage their product portfolios.
Presence in emerging markets: In 2016, Merck & Co., Inc. reported sales in 81 countries in scope. Data for 2018 not available. It reports that around 25% of its sales in 2017 came from the region of Europe, Middle East and Africa.
* Neglected Tropical Diseases, while also communicable, are highlighted separately throughout the Index. See Appendix II.
**See Appendix IV for definition.