Initiatives to Improve Access to Medicines

Eisai is committed to improving access to medicines to deliver necessary pharmaceuticals to people in need. We aim to create a world where all individuals equally enjoy healthy life and realize their fullest lives regardless of healthcare system and income level in each country.

Our Concept for Access to Medicines

Despite remarkable advances in healthcare and medical treatments in recent years, many diseases still lack effective medicines, and there are regions where essential healthcare services remain out of reach. In fact, due to the lack of appropriate treatment and diagnosis methods, poverty, inadequate healthcare systems, and disparity in access to medical information, more than two billion people unable to receive the care they need or obtain necessary medicines. *1

Under our hhc concept, “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides”, Eisai is committed to improving access to medicines to deliver necessary pharmaceuticals to people in need. We strive to create a world where all individuals can equally enjoy a healthy life and realize their fullest lives.

Please see here for more details,

Our Initiatives

This section outlines our initiatives to improve access to medicines.

R&D Toward Improving Access to Medicines

As a leading global R&D-driven pharmaceutical company, Eisai engages in drug discovery and research by applying cutting-edge knowledge and technologies to various disease areas. Based on our hhc concept, we believe that our R&D activities should effectively achieve social good by understanding the emotions of patients, and by swiftly providing innovative treatment and preventive measures for both the explicit and implicit challenges patients face, thereby relieving the anxiety over health that patients and the people in the daily living domain experience every day, reducing health disparities, and supporting patients to live their fullest lives.

In addition to the areas of dementia and oncology, we consider drug discovery for neglected tropical diseases (NTDs), which have high unmet needs in developing countries but are often overlooked by pharmaceutical companies in developed nations, and malaria, which still claims many lives and urgently requires new treatment options, as essential R&D activities to improve access to medicines.

To effectively achieve social good through drug discovery for these diseases, it is necessary to develop the tools and techniques to research them, as well as experience in conducting clinical trials in disease-endemic regions and established networks with clinical sites. Many of our projects on NTDs, malaria, and other diseases are driven by Product Development Partnerships with academic researchers and international non-profit research institutions with high quality clinical trial capabilities in disease-endemic regions and a global research network. We believe that by fully leveraging our collective strengths in these partnerships while tapping into public–private partnership funds and external global health financing, we can advance R&D more quickly and efficiently, diversify development risks, and secure the necessary resources.

Eisai will continue conducting R&D to deliver our products to more patients and people at the risk of infection around the world.

Please see here for more details on our R&D pipeline for NTDs and the three major infectious diseases.

Intellectual Property and Access to Medicines

Under our “hhc (human health care)” concept, Eisai is dedicated to providing innovative treatments to patients through research and development of new medicines. In order to do so, Eisai engages not only in in-house R&D projects but also in “Open-Innovation” opportunities, collaborating with external partners to translate research outcomes into treatments. Furthermore, Eisai seeks to contribute to the pharmaceutical R&D industry as a whole by leveraging the patent system to promptly disclose R&D outcomes as new technologies.

Launching innovative new medicines requires enormous amounts of time, effort, and expenses. Aiming to ensure that critical inventions are disclosed and protected properly, the patent system encourages such commitment of resources to rapidly deliver medicines to patients and their families.

1.Relationship between Patent System and Access to Medicine

Some critics argue that the patent system itself disadvantages patients’ access to medicine. However, without the early disclosure of technological information enabled by the patent system, the development of innovative medicines would stagnate. Without appropriate time-limited patent protection for inventions, research-based pharmaceutical companies, including Eisai, would be unable to invest substantial resources in research and development for medicines. This, in turn, would stall the development of innovative medicines, and eventually hinder access to new medicines. We believe that the challenges in access to medicine among low-income patients can be addressed through patient support programs, such as the Patient Assistance Programs which we implement in emerging countries, and other policies such as items 2 and 4 below.

2.Improvement of Access to Medicine

Eisai sincerely considers granting non-exclusive licenses to qualified third parties wishing to manufacture our patented products for supply to patients in countries where the pharmaceutical market is still at a very early stage1) or countries which lack the infrastructure to manufacture medicines themselves2) within the disease scope covering infectious diseases, Neglected Tropical Diseases, and maternal/neonatal diseases.

3.Ever-greening

Research-based pharmaceutical companies are often criticized for extending lifecycle of pharmaceutical products through multiple patents (“ever-greening”). Eisai disagrees with the practice of securing patents simply to extend the lifecycle of medicines. However, in line with our hhc concept, Eisai will maintain patents that remain in effect after the expiration of the basic patent, such as those related to new formulations or new indications, which contribute to a higher public benefit for patients.

4. Patent Enforcement in Countries and Regions with Limited Access to Medicines

Based on our hhc Concept, Eisai firmly believes that access to medicines must be ensured for all those in need. In countries where the pharmaceutical market is underdeveloped1), improving access to medicines is of utmost importance. For this reason, Eisai refrains from enforcing our patent rights for treatments addressing infectious diseases, Neglected Tropical Diseases (NTDs), and maternal/neonatal conditions. In World Bank-designated lower-middle-income countries (LMIC) and upper-middle-income countries (UMIC), Eisai also considers refraining from enforcing patent rights within the scope of these diseases, taking into consideration situations surrounding the countries such as access to medicine and economic conditions.

5. Amendment of TRIPS Article 31bis

We understand that the amendment of TRIPS3) Art. 31bis4) serves as an access provision measure for countries lacking adequate pharmaceutical manufacturing capacity, enabling provision of medicines to those countries while striking reasonable balance between calls for IP protection and safeguarding public-health interests.

6. TRIPS plus5)

Most TRIPS provisions ensure minimum levels of intellectual property (IP) protection and do not prevent World Trade Organization (WTO) Member States from tightening their IP protection as part of their industrial policies. Each WTO member state should develop its legal framework in line with WTO’s principles to maximize public health benefits and ensure that medicines reach all people in need.

  • 1)
    “Least Developed Countries” (LDC) and “Low Human Development Countries” (LHDC) as identified by the United Nations, and “Low-income Countries” (LIC) as identified by the World Bank, are examples of the countries where the pharmaceutical medical market is still at a very early stage.
  • 2)
    LDC, LHDC, LIC and Sub-Saharan African countries (excluding South Africa) in “Lower-middle-income Countries” (LMIC) and “Upper-Middle-Income Countries” (UMIC) as identified by the World Bank, are examples of countries where the pharmaceutical market is still at a very early stage or lacks the infrastructure to manufacture medicines themselves.
  • 3)
    TRIPS (Agreement on Trade-Related Aspects of Intellectual Property Rights): Multilateral agreement of general intellectual property rights. It is validated in all the WTO member states (164 states/regions as of September 2022).
  • 4)
    TRIPS Article 31bis: The draft amendment decided by the general council of TRIPS on December 6, 2005. It allows export of certain pharmaceutical products manufactured under the compulsory license by exempting Art. 31(f) with conditions.
  • 5)
    TRIPS plus: It is commonly understood that WTO member states can conduct their policy to protect broader IP than required by TRIPS. TRIPS per se allows such protection in Art.1.

Flexible Pricing Policy in Emerging and Developing Countries

The pharmaceutical industry has contributed to improving benefits of patients through continuous efforts in the development of innovative medicines, stable supply of quality products, and the provision of appropriate medical information. Despite recent progresses in drug development, research and development remain important as many diseases still lack established treatments or medicines.

In some emerging and developing countries, demand for medicine is rapidly increasing as population growth and economic development lead to rapid expansion of the middle-income class. However, in many of these countries, adequate access to medicines remains limited due to underdeveloped healthcare service systems, including infrastructures and medical insurance systems, low awareness of diseases and treatments, and economic challenges.

Eisai formulates and implements organizational growth strategies in each region. For the East Asia and Global South regions where we believe improving access to medicines is especially critical, Eisai has established core strategies rather than just contributing patients through the development and distribution of innovative new medicines. The core strategies consist of 1) patient assistance programs, 2) providing disease solutions, 3) public-private partnerships, and 4) local partnerships, addressing the challenges in medicine access in an integrated manner.

1. Patient Assistance Program Patient Assistance Program

In many emerging and developing countries, the out-of-pocket share of medical expenses is high due to underdeveloped medical insurance systems, limited number of policyholders, and restricted coverage of reimbursable medicines. Compared to developed countries, average income levels are lower, leaving many people in difficult circumstances where many of them are unable to access sufficient medicines.

Eisai has promoted Patient Assistance Programs to provide emerging and developing countries with our pharmaceutical products at affordable prices. With a primary focus on anticancer drugs such as Lenvima® and Halaven®, we are committed to reducing the patient’s financial burden by implementing programs to provide medicines based on patient’s income levels or insurance status. We will support access to medicines for patients facing financial difficulty by covering medication costs through Patient Assistance Programs in Asian countries and the Global South region.

2. Providing Disease Solutions including Branded Generic Products

Eisai has primarily focused on central nervous system disorders, including Alzheimer's disease and epilepsy, through providing new medicines developed in-house or licensed from external partners, thereby accumulating knowledge in these therapeutic areas. From the patient perspective, we are expanding our product lineup to create disease solutions, including the provision of branded generic medicines as part of this effort.

3. Enhancing Access using Public-Private Partnerships (PPP)

In many emerging and developing countries, a lack of sufficient awareness about certain diseases and their treatments prevents numerous potential patients from opportunities for diagnosis and treatment. To address this challenge, we are committed not only to our own initiatives but also collaborating with range of organizations, including government affiliated public agencies, private companies, and non-profit organizations, by complementing each other’s knowledge and resources. Through these efforts, we contribute to disease awareness initiatives, as well as to the development and provision of diagnostic methods.

4. Leveraging Local Partnerships

In emerging markets, where business and healthcare environments vary markedly from country to country, Eisai actively collaborates with local partners to swiftly deliver medicines that align with patients’ needs to as many as people possible. By actively collaborating with organizations who have broad knowledge about medical needs and extensive experience within unique business practices, we aim to improve access to medicines. Beyond sharing our product information, we also support the enhancement of local manufacturing capacity through technology transfers.

Third-Party Assessment (Access to Medicine Index)

An external assessment implemented by Access to Medicine Foundation.
Please see here for more details.