Transparency in Partnerships with Patient Groups and Medical Institutions
Transparency in Partnerships with Patient Groups and Medical Institutions
The mission of an R&D-oriented pharmaceutical company is to contribute to the health of people and medical care around the world through continually researching and developing new drugs and providing a stable supply of pharmaceuticals, under the objective of creating "patient-participated" medical care.
In order to fulfill this mission, it is essential to collaborate with research organizations including medical institutions and universities in all stages from drug discovery to postmarketing information provision activities ensuring the proper use of pharmaceuticals.
With representatives of patient groups sitting on an increasing number of government committees and investigative commissions as governments and the medical community put greater emphasis on the "voice of the patient," patient groups have become important stakeholders in the mission to improve medical care.
In this circumstances, Sumitomo Pharma believes that it is critical to raise awareness and increase understanding throughout society that activities designed to improve coordination between medical institutions and patient groups are undertaken in accordance with high ethical standards.
The Japan Pharmaceutical Manufacturers Association (JPMA) issued its Transparency Guideline for the Relation between Corporate Activities and Medical Institutions on January 19, 2011, and its Transparency Guideline for the Relation between Corporate Activities and Patients' Groups on March 14, 2012.
As a member of the JPMA, we established our own Guidelines for Transparency in Partnerships with Medical Institutions in October 2011 and Guidelines for Transparency in Partnerships with Patients' Groups in April 2013. In accordance with these guidelines, we publicly disclose information on our corporate website on such issues as payments that we make to medical institutions, healthcare professionals, patient groups and patient advocacy groups.
Guidelines Concerning Transparency in Collaborations with Medical Institutions (since April 2019)
Guidelines Concerning Transparency in Collaborations with Patient Groups
Our approach to promotional activities for healthcare professionals
Promotional activities for prescription drugs (hereafter, "drugs") are important activities for providing accurate information of the drugs to healthcare professionals and patients in an appropriate manner so that the products can be used safely and properly.
In compliance with the IFPMA Code of Practice, the JPMA Code of Practice, and Guidelines for Prescription Drug Marketing Information Provision issued by the Ministry of Health, Labour and Welfare, Sumitomo Pharma has drawn up the "Rules for Marketing Information Provision" and established the "Department Responsible for Supervising Marketing Information Provision." The Department Responsible for Supervising Marketing Information Provision supervises and provides guidance to departments that implement detailing activities, examines and approves materials, carries out monitoring as well as education and training for officers and employees, operates a complaints desk and handles complaints. As an advisory body to the Department Responsible for Supervising Marketing Information Provision, we have established the "Review and Supervisory Committee," which is held regularly. It has an external chairperson who is completely independent of our company.
Sumitomo Pharma has drawn up internal rules for the examination of materials for use in promotional activities titled "Rules for Examination of Materials Used in Marketing Information Provision" and created an internal structure for examination and approval of such materials.
Points focused on in examination of materials
- Accuracy, fairness and objectivity
- Scientific rationale
- Balance between efficacy and safety information
- No information regarding indications, or dosage and administration not approved by regulatory authorities
The department in charge of medical science examines whether materials are accurately created based on a scientific rationale, and the department in charge of governance examines and approves materials based on whether they comply with the respective local laws and regulations, industry codes and internal policies. Sales & Marketing Division using the materials is not involved in any way in examination or approval. The use of unexamined, unapproved materials is forbidden in all departments and they conduct promotional activities in a proper manner.
In addition, Sumitomo Pharma makes efforts to conduct fair promotional activities in compliance with the Fair Competition Code Concerning Restriction on Premium Offers in Ethical Pharmaceutical Drugs Marketing Industry which is specified by the Fair Trade Council of the Ethical Pharmaceutical Drugs Marketing Industry, the IFPMA Code of Practice, and the JPMA Code of Practice.