Proposals for New Systems to Prevent "Harmful Effects" from
Pharmaceutical and Bio-Chemical Products
The Study Group on Systems for Preventing Harmful Effects from Pharmaceuticaland Bio-Chemical Products
Summary
In Japan, harmful effects are repeatedly being caused by pharmaceutical and bio-chemical products. Major past cases include the thalidomide case, the SMON case, chloroquine addict case, and the case of AIDS caused by HIV- contaminated unheated AHF products which occurred among hemophiliac patients (hereinafter referred to as AIDS caused by unheated AHF products). Consequently, these cases have created a large number of victims among Japanese citizens.
This study is not being conducted from a legal standpoint in which the penal responsibilities of individuals are investigated. Rather, this study aims to clarify the organizational factors that continue to cause harmful effects from pharmaceutical and bio-chemical products, and to present measures to ensure that such cases never occur again by proposing the adoption of necessary systems.
In the study's interim report, special focus was placed on the case of AIDS caused by unheated AHF products and the organizational factors which have led to this crisis. The analysis of these issues identified that "a patient-oriented medical treatment" was absent, and problems existed in how the relationships among industry, bureaucracy, academia and medical care professionals were structured. These structural problems are considered to be the root cause of a medical treatment in which patients are not respected. Moreover, said structural problems contributed to the distorted interpretation of information and application of knowledges in the health care field which consequently led to inappropriate decisions by the administration. This series of multi-layered problems spread across four professional fields is believed to have induced harmful effects from pharmaceutical and bio-chemical products.
In the final report of this research project, major past cases of harmful effects caused by pharmaceutical and bio-chemical products are analyzed. Based on this analysis, the report also suggests that the closed relationship among industry, bureaucracy, academia and medical care professionals needs to be dissolved, and "patient-oriented medical care" should be implemented. In addition, it proposes that a "collaborative system for discovering new information" involving industry, bureaucracy, academia and medical care professionals should be established. This system is aimed at promoting the kind of interrelationship among these four parties which benefits the citizens; generating and disseminating the information necessary for maintaining health and preserving life. Issues including the dissemination of necessary information, establishment of clear-cut rules and the mechanism under which these rules should be followed, as well as the principle of personal responsibility, are considered the basis of this system. Under this framework, professionals from industry, bureaucracy, academia and the medical care field are expected to use their best efforts in generating the necessary information. In particular, the Ministry of Health and Welfare should take a leadership role in this collaborative system and become a policy ministry which undertakes the management and administration of the information generated.
From a standpoint of safety science, the report also suggests that a risk management system for medical products is urgently needed in order to prevent the occurrence and expansion of harmful effects from pharmaceutical and bio-chemical products. In order to properly monitor medical products which are inevitably accompanied by harmful effects until their remedy becomes apparent, it is necessary to conduct quality inspections and to adopt various and reliable protection measures. Furthermore, it is essential to operate this system as an established organization based on the concept that risks need to be managed.
Based on the above analysis, a wide range of policies have been examined in this research project. In conclusion, we suggest the following nine proposals as actual measures to permanently prevent harmful effects from pharmaceutical and bio-chemical products. These proposals also identify areas which our study group believes require improvement over the next five to ten years.
Proposal 1: Promptly Establish a Risk Management System Designed to Prevent Harmful Effects from Pharmaceutical and Bio-chemical Products
In order to promote the health and to protect the lives of the citizenry, it is essential to prevent harmful effects from pharmaceutical and bio-chemical products from occurring. The responsibilities and duties which need to be respectively borne by industry, bureaucracy, academia, and medical care professionals, namely the parties involved in the medical service field, should be clarified, so that the patients' interests will be protected and promoted. Furthermore, these parties should collaborate - while maintaining an objective professional distance from each other - in order to establish a risk management system for medical products at the earliest date possible. In addition, it is imperative to create an environment in which such a system will function effectively. For example, the diagnosis and treatment fees paid to doctors which are currently calculated based on the quantity and quality of the medical products dispensed, should be revised so that such fees are calculated based on the doctors' skills.
Proposal 2: Establishing a Patient-Oriented Medical Care System
To establish a medical care system where patients are the top priority, the Ministry of Health and Welfare should play a central role in establishing a "Patient's Rights Act" (tentative title), which clarifies the doctors' responsibilities and duties by law, and calls for system reforms so that patients' awareness and decision-making ability will be fully reflected in medical policies. In the "Patient's Right Act," "informed consent" will be included as a core concept, and it will be deemed that medical records belong to patients and are always available. In addition, a system of "one chart per patient" should be put into practice immediately.
Proposal 3: Revising the Relationship among Industry, Bureaucracy, Academia and Medical Care Professionals
To prevent future cases where people are adversely affected by pharmaceutical and bio-chemical products and to provide effective and safe medical treatment for everyone, it is necessary to break away from the existing closed relationship among industry, bureaucracy, academia, and medical care professionals. This relationship should be replaced by a new type of collaboration, the prime objective of which is the preservation of life and health of the citizenry. In order to establish this new relationship, information should be disseminated, the responsibilities of the respective parties should be clarified, and the principle of personal responsibility should be strictly followed.
Proposal 4: Roles to be Played by the Ministry of Health and Welfare
In order to ensure the safety and health of the citizenry, the Ministry of Health and Welfare, a regulating ministry focusing on regulations and protection, should be reformed into a policy ministry. The Ministry should completely disclose information to the public, and revise the current overall medical systems to enable citizens to use their own judgment to make the best decisions regarding their health.
At the same time, the Ministry should strengthen its original administrative functions and should develop into a creative and highly informed group capable of proposing resolutions for national issues including a nationwide risk management system.
Proposal 5: Reinforcement of Information Systems Concerning Life and Health and Complete Dissemination of Information
To appropriately respond to the people's "right to know," the Ministry of Health and Welfare should strengthen its system of information gathering and analysis not only on policy decisions and standards related to medical administration, but also on issues regarding the life and health of the citizenry. The Ministry should disseminate such information including uncertain information, expediently and widely so that people can freely utilize it.
Although information concerning the side effects of pharmaceutical products are in principle controlled by the corporations which developed and marketed these products, an information system concerning side effects which can be accessed by the citizens whenever they want should be established by the Ministry of Health and Welfare. Further, it should be clearly designated by law that doctors shall have an obligation to provide a thorough account of potential side effects to patients.
Proposal 6: Implementation of a Strict Inspection System for Medical and Pharmaceutical Products
The Ministry of Health and Welfare has endeavored to improve the inspection system for medical and pharmaceutical products by encouraging the participation of experts, and increasing the number of staff involved. However, the Ministry should recognize that these measures have limits, and therefore, it is necessary to consider radical reforms based on a long-term view. By the year 2000, the present system should be reorganized into a new inspection system which is based on international inspection standards (ICH: International Conference on Harmonization) bringing Japanese inspection standards into conformity with global standards.
To be more concrete, inspections currently conducted by the Ministry of Health and Welfare should be gradually transferred to private inspection institutions. In addition, it should be clarified that the party ultimately responsible for the quality of medical products is the pharmaceutical product corporation. At the same time, oversight inspections by impartial third party experts should be introduced at all stages from development to sales. Concerning sales, a trial use period system should be introduced, and each pharmaceutical and bio-chemical product will be required to carry insurance against the harmful effects of each product. In addition, it is necessary to clarify by law the responsibility of the top management of pharmaceutical companies.
Proposal 7: Proper Medical Treatment, Prescriptions and Doctors
To correct the situation of over dispensation of medicine to patients, the Ministry of Health and Welfare should actively seek the cooperation of those in the medical care field to make efforts to reduce the profit margin from product prices, and promote a proper division of labor between the medical and pharmaceutical fields.
In addition, it is necessary to increase the awareness of doctors and patients towards medical treatment by establishing a widespread policy of "informed consent." Furthermore, in order to clarify doctors' responsibilities, standards for proper application of medical and pharmaceutical products should be established. Under a strict responsibility system, if a patient suffers from harmful side effects resulting from medical treatment applied without following a specified standard, then the doctor in charge should bear responsibility. In addition, medical associations should endeavor to instill higher professional standards in doctors, and to disseminate information concerning standard medical treatments. As a group of specialists in charge of evaluating medical and pharmaceutical products, medical associations should generate, as well as accumulate, the necessary information.
Proposal 8: Required Revisions of Current Blood Product Policies
The Ministry of Health and Welfare should take leadership and establish a risk management system in close cooperation with concerned organizations in order to ensure the safety of blood and its products. For example, organizations such as the "Committee Concerning the Safety of Blood and Organs" (tentative name) may be established. The Ministry should also promote precautionary measures against blood-related infectious diseases, the collection and analysis of foreign and domestic information, risk evaluation, and technological development. In addition, the Ministry should reduce the profit margin from product prices, promote proper use of pharmaceutical and bio-chemical products, heighten doctors' awareness, and realize a sufficient domestic supply of blood including blood products. Furthermore, the significance of blood donation should be emphasized, and the activities of blood-related organizations including the Japanese Red Cross Society should be disseminated. In addition, these organizations should promote efficient utilization of blood from the perspective that blood donation is important for the whole of society. A drastic revision of the Japanese "Bleeding and Blood Donor Supply Service Control Law" dating back to 1956 pertains to the "Act for Regulating Blood-Gathering and Supply of Donated Blood" (tentative title) should be examined in order to clarify issues including the roles to be played by the government and the Japanese Red Cross Society.
Proposal 9: Early Implementation of Relief Measures for Victims
The Ministry of Health and Welfare should specify by law a system where people suffering from the harmful effects of pharmaceutical and bio-medical products would be immediately and properly taken care of. The Ministry should also learn from past experiences in order to prevent a recurrence of medical-related damages by continuously collecting and analyzing cases of medical-related sufferings and immediately provide this information to medical care professionals. In particular, "The Organization for Pharmaceutical Safety and Research" should revise their current relief and payment systems and make them more efficient, so that these measures will become more convenient for the victims to use.
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