Shionogi Global Health Access Policy Statement

Shionogi's purpose is to supply the best possible medicine to protect the health and well-being of the patients we serve. Providing access to these medicines can be a significant challenge for much of the world and one that Shionogi takes very seriously. As a Japan-based company, Shionogi believes that effective partnerships with global organizations are essential to expanding reach and improving access. Shionogi is focused on the three following areas:

Shionogi's primary contribution to improving global health is through the creation of innovative medicines that deliver significant advances compared to the current standard of care. Shionogi is committed to investing in the research and development of novel, needed medicines, both independently and in collaboration with academic institutions, start-up companies, investors and other partners. The core therapeutic areas for Shionogi are infectious diseases and CNS/pain; obtaining adequate treatment for both can be challenging, even in developed markets.

In response to the global coronavirus pandemic, Shionogi is accelerating the development of potential COVID-19 vaccines and therapeutics. In March 2020, Shionogi began a project to discover and develop a recombinant protein vaccine for COVID-19 using its unique Baculovirus Expression Vector System technology; clinical trials are expected to start in 2020. Additionally, Shionogi has initiated a research collaboration with Hokkaido University Research Center for Zoonosis Control to discover and develop novel therapeutics.  As a company with a strong commitment to corporate social responsibility and a successful history developing new treatment options for infectious diseases, Shionogi is committed to bringing forward new tools and technologies for the early diagnosis, treatment and prevention of COVID-19.

In developing countries, access to innovative medicines is often hindered due to affordability. Shionogi considers the value and affordability of a medicine carefully and tailors the pricing strategy for each product to the dynamics of the country and healthcare system. Shionogi utilizes tools like patient assistance programs, product donations, and patent pools to improve affordability. 

Shionogi intentionally does not file patents for its medications in developing countries facing economic challenges. This allows other organizations to leverage Shionogi's research to address the needs of patients in these selected markets. 

In regions where Shionogi does not have a physical presence and access to Shionogi products is needed, Shionogi will seek to provide access through partnerships with organizations that have a suitable infrastructure in place.

For investigational products, Shionogi’s Compassionate Use program considers individual expanded access requests when a patient with a serious or life-threatening disease or condition may not be eligible to enroll in a clinical trial sponsored by Shionogi, but the patient’s physician may believe the patient could potentially benefit from access to the investigational drug before it is approved by a regulatory agency. For example, with cefiderocol, Shionogi’s antibiotic for multi-drug resistant Gram-negative infections, Shionogi has in place an international compassionate use program to allow patients in need in countries where cefiderocol is not currently commercially available to access treatment when their physician considers it appropriate. 

Effective healthcare systems are critical to improving the well-being of the patients Shionogi aims to serve. Shionogi believes the best way to address complex healthcare infrastructure challenges is through targeted partnerships with on-the-ground organizations.

The growing problem of antibiotic resistance is a key concern for Shionogi and, as such, Shionogi is involved in global efforts to educate healthcare providers on stewardship of antibiotics.  Shionogi is an active member of several related industry groups, including the Antimicrobial Resistance Industry Alliance and International Federation of Pharmaceutical Manufacturers & Associations.