Transparency Guidelines for Relationships between Corporate Activities and Medical Institutions On the Formulation of "Transparency Guidelines for the Relationship between Corporate Activities and Medical Institutions, etc.
Japan Pharmaceutical Manufacturers Association
March 2, 2011
Mission of R&D-oriented pharmaceutical companies - Contribution to the health of the public and patients
The mission of R&D-oriented pharmaceutical companies is to contribute to the realization of "patient-participatory medicine" by contributing to global healthcare and human health through continuous R&D and stable supply of new drugs. To fulfill this mission, pharmaceutical companies collaborate and cooperate with universities and other research and medical institutions to conduct a variety of activities, including basic medical and pharmaceutical research, clinical development, post-marketing information provision and collection activities, and safety measures, and contribute to improving the health of the public and patients by providing medicines and vaccines. In carrying out these activities, collaboration between pharmaceutical companies and research institutions such as universities and medical institutions is indispensable.
The creation of innovative new drugs requires a process based on the Pharmaceutical Affairs Law that includes basic research, non-clinical testing, and clinical trials. Efficacy and safety are examined, and new drugs are born only after further review by the Pharmaceuticals and Medical Devices Agency and approval by the Minister of Health, Labor and Welfare. The development of a new drug takes from 9 to 17 years, and the probability of success is extremely low.
Collaboration between pharmaceutical companies and medical institutions - Efforts to create new drugs and safety measures
In recent years, pharmaceuticals have made remarkable progress and have been useful in the medical field to save patients from many diseases. For example, drugs have been created to treat diseases that had no cure and a high mortality rate, drugs that can cure diseases that once required surgery with just medication, and drugs that are much more effective than conventional treatments for cancer and rheumatoid arthritis. The creation of new drugs that meet the needs of patients and medical care is not something that can be done by pharmaceutical companies alone. Nor can it be done by academic research institutions such as universities and medical institutions alone. It can only be done through collaboration between both parties. Cooperation between pharmaceutical companies and academic research institutions (industry-academia collaboration) includes joint research, commissioned research, and subsidies for academic research activities through donations. These industry-academia collaboration activities contribute greatly to the return of research results from academic research institutions to society in the form of improved medical care in Japan, and are also promoted in the government's Basic Plan for Science and Technology.
In addition, new drugs are approved and launched only after their safety and efficacy are confirmed under strict legal regulations. Therefore, pharmaceutical companies are obliged to collect, analyze, and review further safety and efficacy data and provide information to medical professionals after the launch with the cooperation of medical institutions, medical professionals, and others. Through these activities, the more reliable efficacy and safety of new drugs are clarified, more appropriate usage methods are examined, and the results are communicated to medical institutions and others.
Provision and collection of information for proper use of drugs - Efforts to foster pharmaceuticals
Pharmaceuticals are said to be "chemical substances with information. This is because the purpose of a drug is achieved only when it is used appropriately based on information such as efficacy, dosage, mechanism of action, and side effects. In recent years, new drugs have become highly specialized, and in order for them to be used properly, there is a greater need than ever before for educational activities to be conducted by specialized physicians. To this end, pharmaceutical companies cooperate with specialists in various settings, such as academic lectures and research meetings, to disseminate information on the proper use of pharmaceuticals to a large number of medical professionals, share information for safer and more effective use, and provide opportunities to exchange information on the latest findings. In addition, pharmaceutical companies sometimes contract with experts and researchers in various disease areas to provide advice from a professional perspective when companies plan the development of new drugs and the provision of post-launch information. These activities are very important to ensure that already marketed drugs are provided to patients in a safer and more appropriate manner.
Necessity of Transparency Guidelines
These industry-academia collaborative activities, which are essential for medical and pharmaceutical research, practical application, and dissemination of appropriate use, are carried out based on contracts and other agreements with medical institutions and healthcare professionals. Some of these activities require the payment of money as compensation, and pharmaceutical companies are required to comply with the Pharmaceutical Affairs Law and other laws and regulations, as well as with the Pharmaceutical Manufacturers Association of Japan (PMAJ) Charter of Corporate Behavior, PMAJ Compliance Program Guidelines, PMAJ Code of Practice, Fair Competition Code for Ethical Drug Manufacturers and Distributors, and other voluntary industry codes. We have made efforts to increase transparency based on the industry's voluntary codes. However, as these collaborative activities become more and more active, situations may arise in which medical institutions and healthcare professionals become deeply involved with a particular company or product, and it is undeniable that there may be concerns that this may have some influence on the decisions of medical institutions and healthcare professionals. We have established these guidelines in light of the fact that, as a life-related industry, the pharmaceutical industry in Japan is greatly involved in the lives and health of patients and the public, and that transparency of its activities is even more important than in other industries in Japan, where the national health insurance system is based on universal coverage.