Pharmaceutical products only have meaning as medicine if they can be delivered to patients, and if these patients are able to use them properly. It was recognized that there are many patients with insufficient access to pharmaceuticals due to inadequate supply chains or counterfeit medicines in developing countries and issues with healthcare systems or other factors not only limited to developing countries, but throughout many regions in the world. While considering the economic and market conditions in each country/region, the Daiichi Sankyo Group approaches and works together with various organizations with the aim of improving availability of pharmaceuticals.

Regional Access & Affordability

We are committed to improve patient access to healthcare by setting fair prices that reflect the value of medicines, taking into consideration differences in healthcare systems, income levels, and other factors that affect access to healthcare in each country and region. We also strive to provide timely and appropriate support to patients who need our medicines and face difficulties to obtain access due to coverage limitation.

Drugs Expanded Access Program (EAP)

We offer Expanded Access Programs (EAPs) to provide investigational (unapproved) medicines to patients who are unable to participate in clinical trials and have serious medical conditions, before a medicine is approved or commercially accessible. Availability depends on the regulatory and healthcare systems of each country or region, and each case is evaluated individually, considering factors such as legal requirements and the feasibility of manufacturing and supply.

Expanded Access Program

Patient Assistance Programs

The Daiichi Sankyo Group will appropriately support patients, healthcare professionals, and other stakeholders, based on the understanding of local regulations and circumstances , so that patients are encouraged to take their prescribed medications correctly. The Daiichi Sankyo Open Care Program offers free pharmaceutical products to those prescribed Daiichi Sankyo Inc.’s (DSI’s) products and who are under-insured or uninsured. American Regent, Inc., a member of the Daiichi Sankyo Group, also has a support program targeting some pharmaceuticals for patients who are either uninsured or lack sufficient coverage. Furthermore, the DSI participates in Partnership for Prescription Assistance (PPA) program as a member of Pharmaceutical Research and Manufacturers of America. The PPA is a national coalition of pharmaceutical companies, doctors and other healthcare providers, patient advocates, and community groups etc. The PPA helps patients identify potential assistance programs, assess potential eligibility, and support their enrollment.

Patient Assistance Programs

Patents in Countries and Regions Where Access to Healthcare is Insufficient

We prioritize improving access to healthcare in Countries and Regions Where Access to Healthcare is Insufficient so that we are flexible in applying and/or exercising patent rights within the minimum necessary scope not to hinder access to healthcare.

Daiichi Sankyo Group Policy on Intellectual Property Rights and Access to Medicines in Developing Countries

Generic Drugs

We are committed to offering affordable generic drugs that accurately address healthcare professional and patient needs. As it supplies these generic drugs, we take precautions to ensure quality and stable supplies while providing information to guarantee appropriate usage and maximum effectiveness.

American Regent, Inc.(US)

Supply Chain Management

We ensure a stable global supply of high-quality pharmaceuticals through close collaboration between domestic and international manufacturing sites, with a strong focus on safety management.

Quality & Steady Supply

Sustainable Procurement

Measures for Combating Counterfeit Pharmaceuticals

In response to the growing threat of counterfeit pharmaceuticals, we are reviewing sealing materials and updating packaging specifications for our manufactured and marketed products. To strengthen traceability of pharmaceutical and medical narcotic products, we have completed compliance with mandatory GS1 code labeling, which includes expiration dates and serial numbers, on both sales and original packaging units. We continue to collaborate with industry stakeholders and relevant organizations to assess the roles expected of manufacturers and distributors, and to develop enhanced measures based on product-specific risks. Additionally, we actively promote compliance with GDP^*1 to ensure the quality and integrity of our products during storage and transportation We remain committed to responding appropriately to the regulations and risks of each country and region, and to delivering safe medicines to patients through ongoing efforts and continuous improvement.

*1Good Distribution Practice