Initiatives to Improve Access to Medicines
Despite the rapid progress in technology and knowledge of modern medicine, unmet medical needs remain in a wide range of therapeutic areas, and every R&D-driven pharmaceutical company is charged with the mission of addressing these issues by creating innovative new medicines. Furthermore, there are many countries and regions where people are unable to equally access adequate medical treatment due to immature medical systems and/or poverty. To solve these issues, which are recognized as "access to medicines" or "access to healthcare," in addition to our R&D efforts on innovative medicines, Sumitomo Pharma is actively working to improve access by strengthening health systems with international organizations, governments and research institutions, and civil society.
Partnership Initiative "Access Accelerated"
Sumitomo Pharma participated in a partnership initiative called "Access Accelerated." Access Accelerated as a member of the global community of R&D-driven pharmaceutical companies. Access Accelerated is a coalition of more than 20 pharmaceutical companies and six international institutions including the World Bank around the world formed to improve access to healthcare for non-communicable diseases in low- and low-middle-income countries.
Access Accelerated has also worked with Boston University to develop a common measurement framework for individual access programs implemented by each company to promote these efforts effectively. We registered its health improvement program for mothers and children in Cambodia registered under this framework. We participated in Phase 1 from the launch in fiscal 2017 to 2019, and in Phase 2 from fiscal 2020 to 2022.
• Report on activities for the period from fiscal 2017 to fiscal 2022: 'Key Lessons in Advancing Access to NCD Care'
For more information on our efforts to strengthen healthcare systems in developing countries, please see「Contribution to Global Health」
Participation in Humanitarian Aid
In conjunction with our domestic and foreign partners, we participate in the delivery of humanitarian aid in countries and regions where access to medicines is made difficult due to disasters and conflicts.
In fiscal 2022, we have decided to donate our antiepileptic drug, EXCEGRAN® 100mg tablets (generic name: zonisamide), to Ukraine and neighboring countries. The drug was delivered to those in need in partnership with local governments and industrial associations etc.; as of June 2022, 3.5 million tablets were donated to Ukraine, and 20,000 tablets were donated to the Republic of Moldova, which is accepting many refugees from Ukraine. In relation to the donation to the Republic of Moldova, swift delivery to the Moldovan national medicines warehouse was made possible thanks to the assistance from Inabata & Co., Ltd.
Medicines donated to the Republic of Moldova
Responding to Demands for Development of Unapproved or Off-Label Drugs
Japan's Ministry of Health, Labour and Welfare (MHLW) invites requests for the development of unapproved or off-label drugs that have been approved for use in Europe and the United States but have yet to be approved in Japan. Upon receipt of such a request, MHLW, through a meeting of the Evaluation Committee on Unapproved or Off-Label Drugs with High Medical Needs, evaluates the medical need for the drug concerned and ascertains the validity of clinical studies required to support an application for approval and the drug's eligibility for an Application Based on Public Knowledge, thus promoting the development of such drugs by pharmaceutical manufacturers.
We also act on requests for the development of unapproved and off-label drugs. Thus far, we have obtained approvals for 6 such drugs, among them a partial change to the approval details for the biguanide oral hypoglycemic agent METGLUCO® in September 2022, to include the additional indications of induction of ovulation in polycystic ovary syndrome and regulated ovarian stimulation for assisted reproduction in polycystic ovary syndrome. In addition, we are working on a development request for the use of RETHIO®, an alkylating anticancer agent belonging to the ethylenimine family, in the treatment of CNS lymphomas (including primary and other lymphomas with CNS invasion).
Sumitomo Pharma’s responses on invitations/requests for development
| Invitation /request for development |
Product name | Indication(s) | Development status |
|---|---|---|---|
| 4th round | METGLUCO® | Ovulation induction for patients with polycystic ovary syndrome | Approved on September 16, 2022 |
| Controlled ovarian stimulation in assisted reproductive technology for patients with polycystic ovary syndrome | |||
| 2nd round | RETHIO® | Conditioning treatment prior to autologous hematopoietic stem cell transplantation for pediatric malignant solid tumors | Approved on March 26, 2019 |
| Conditioning treatment prior to autologous hematopoietic stem cell transplantation for malignant lymphoma | Approved on March 25, 2020 |
||
| 1st round | Amlodin® | Additional indication of hypertension in pediatric patients | Approved on June 22, 2012 |
| 1st round | METGLUCO® | Additional indication of type 2 diabetes in pediatric patients | Approved on August 29, 2014 |
Advocacy for Environment to Improve Access to Medicines
As an R&D-driven pharmaceutical company, we are committed to continuously generating and implementing innovation, and to ensuring a stable supply of high-quality medicines. To strengthen the business environment that supports these efforts, we actively engage in dialogue with government agencies and relevant ministries through industry associations such as the Japan Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).
We advocate for policies that appropriately reflect the value of medicines in pricing and promote understanding of the importance of investment in drug discovery and research and development. These efforts aim to enhance patients' access to medicines and improve the overall quality of healthcare. By prioritizing dialogue with stakeholders and contributing to policy development that addresses social challenges, we strive to realize a sustainable society while enhancing our corporate value.
Fight against Counterfeit Pharmaceuticals
Illegally manufactured or distributed pharmaceuticals (counterfeit pharmaceuticals) not only provide no therapeutic effects but could pose fatal risks to the patient because of their unknown adverse drug reactions. The threat is expanding throughout the world in terms of both quantity and the targeted areas. The problem of counterfeit pharmaceuticals has another international dimension: their trading could be a lucrative business for organized crime and international terrorist organizations.
To ensure safety of and trust in our products, we join together with peer pharmaceuticals companies in the initiatives of industrial associations and international organizations to collect and exchange up-to-date information in the fight against counterfeit pharmaceuticals. Specific actions are detailed below.
Initiatives to Fight against Counterfeit Pharmaceuticals
Membership in PSI: Pharmaceutical Security Institute
As a member of the Pharmaceutical Security Institute (PSI), the Company maintains close contact with other global pharmaceutical manufacturers in information gathering and promoting anti-counterfeit enforcement operations. PSI is a U.S.-based not-for-profit organization founded in 2001. It liaises between pharmaceutical companies and public health authorities and transmits information on counterfeit pharmaceuticals.