Ministry of Health, Labour and Welfare


Promotion of the Use of Generic Drugs

I. Measures taken for promoting the safe use of generic drugs

1. Meaning of the promotion of the use

Since the universal health insurance system--which entitles every Japanese citizen to necessary medical care service with a fixed amount of co-payments--was founded in 1961, Japan has attained the highest rate of life expectancy in the world and a high level of insured medical care. However, over the half century since, the environment surrounding healthcare has dramatically changed, including the rapid aging of society. The financial condition of healthcare insurance continues to be severe. Our task at hand is to ensure provision of necessary medical care, and at the same time, build a sustainable medical insurance system that would meet the need of such a demographic change as that mentioned above.
The trends of national medical care expenditure in recent years is that it is expanding at a greater rate than the average national income. The national medical care expenditure in 2009 was over 36 trillion yen, which represents a 20% increase as compared to that 10 years ago. The medical costs are expected to continue to rise, due to advances in medical technologies, aging of the population, etc. Against this backdrop, in order to maintain and uphold the present universal healthcare system, it is important to improve the efficiency of provision of medical care, where possible, while at the same time ensuring provision of necessary medical services.
Generic drugs are pharmaceutical products that are approved for manufacture, and are prescribed as drugs with equivalent therapeutic effects to those of the original drugs. While the quality, safety and efficacy of the generic drugs do not differ from those of the original drugs, the drug prices of the former are lower than those of the latter. The generic drugs can thus be considered to be interchangeable with the higher- priced original drugs.


Thus, by promoting the use of the generic drugs, we can accomplish the following:

[1] reduce the copayments by the patients for pharmaceutical expenses; and

[2] improve the efficiency of provision of medical care (reduction of medical costs) without undermining its quality
The Government actively promotes the use of the generic drugs by setting the goal of, “increasing the market share of generic drugs to more than 30%.”


2. Current status of use

As of September 2011, the share of generic drugs in the transaction of volume of all ethical drugs in Japan was estimated to be 22.8% (Figure 1). Because the definition of “generic drugs” differs between western countries and Japan, a simple comparison of the status of use between the two is difficult. Nevertheless, in view of the fact that the market share of generic drugs in volume exceeds 50% in major countries, the prevalence of use of generic drugs in Japan appears to be still limited (Figure 2).
One of the possible reasons for this is that healthcare professionals, such as physicians and pharmacists, do not yet sufficiently trust in the quality, stable supply, or information available on the generic drugs.
Under this circumstance, the MHLW has identified measures to be taken by the state and manufacturers of generic drugs in regard to such issues as stable supply, assurance of quality, and provision of information about the drugs. The Ministry has also reinforced these measures by setting goals based on the “Action Program for the Promotion of the Safe Use of Generic Drugs” formulated in 2007 (see below). Thus, through various measures, the MHLW has been making efforts to create an environment that would allow patients and medical experts to use generic drugs without any worries.


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3. Action Program for Promoting the Safe Use of Generic Drugs

In response to suggestions from healthcare professionals, and in order to promote more confident use of generic drugs by patients and medical personnel, the “Action Program for Promotion of the Safe Use of Generic Drugs,” established in October 2007, lays out the measures to be taken by the Government and concerned parties in regard to [1] stable supply of the drugs, [2] assurance of the quality of the drug, [3] appropriate provision of information by generic manufacturers, [4] creation of the appropriate environment for promotion of the use of these drugs, and [5] matters related to the health insurance system (Figure 3).
The progress in the attainment of the goals of the Action Program is verified by conducting interview surveys of the members of the relevant industry association and the results are checked every fiscal year and published annually.
As it stands now, except for the goal of “zero stock-out”, all objectives set out as part of achieving stable supply of drugs have generally been fulfilled. For example, concerning the issue of securing a stable supply of the generic drugs from the viewpoint of speedy supply, 99% of orders placed by wholesale stores with generic manufacturers with a request for urgent shipment are delivered to the stores on the same day. Moreover, with respect to the assurance of quality, problems raised by medical practitioners, such as the quality of the generic drugs, are scientifically assessed by the “Generic Medicines Quality Information.
Investigation Committee” established at the National Institute of Health Sciences, and the outcomes are published (Figure 4). Furthermore, from the perspective of information provision, the Japan Generic Medicines Association has been established and operates an IT-based information service system that responds swiftly to requests of healthcare professionals for information (Figure 5).
We are thus of the view that confidence in generic drugs has steadily been on the rise in terms of the system and practice of stable supply, assurance of quality, and information provision.


Figure3

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Figure4

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II. For further promotion of use

1. Preparation of the environment in response to revision of remuneration for medical care services in FY2012

In pursuit of providing a health insurance system environment for promoting the use of the generic drugs, the following measures have been implemented to date: change of the prescription form, amendment of ”Rules for Treatment and Reimbursement for Pharmacies and Pharmacists; Medical Institutions and Doctors who are registered with the National Health Insurance”; revision of additional premiums for generic drug dispensing practice in terms of the basic fees charged by pharmacies, additional premiums for practices that actively use generic drugs in medical institutions, etc.
The effectiveness of such measures is checked based on the “Survey on the Status of the Usage of Generic Drugs” conducted by the Working Group to Discuss the Results of the Revision of Remuneration of Medical Services (hereinafter called WGDRRRMS), the Central Social Insurance Medical Council. Specifically, the survey looks into trends in the changes in the status of use and doctors’ prescriptions of the generic drugs at National Health Insurance-registered medical institutions, and in the prescription status of generic drugs at NHI-registered pharmacies (hereinafter called insurance pharmacies), as well as the awareness among physicians, pharmacists and patients about generic medicines.
Based on the results of such a survey, the Central Social Insurance Medical Council has been holding discussions for revision of remuneration for medical services in FY2012. While the ratio of the use of generic drugs is steadily increasing, their use needs to be further promoted in order to achieve the Government’s goals. To this end, further efforts are required to secure the use and disperse information about the reliability of the quality of the generic drugs, as well as measures for actively prescribing and dispensing these drugs.
Against this background, it has been decided to take the following measures in relation to the revision of the medical service fees implemented in April 2012:

[1] revision of additional premiums for generic drug dispensing practice in terms of the basic fees charged by pharmacies;

[2] provision of information regarding the generic drugs by utilizing the Drug Information Provision Sheets;

[3] Additional premiums for practices that actively use generic drugs in medical institutions;

[4] promotion of generic name prescribing;

[5] modification of the prescription form

[1] Revision of additional premiums for generic drug dispensing practice in terms of the basic fees
Up to now, as the ratios of the generic drugs dispensed (volume basis) in the insurance pharmacies exceeded 20%, 25% and 30%, additional premiums for generic drug dispensing practice in terms of the basic fees were raised in a stepwise manner.
However, the survey by WGDRRRMS revealed that while the percentage of prescription fillings of generic drugs at the insurance pharmacies (volume basis) is on the rise, only about a half of them apply the additional premiums, revealing polarized trends in the dispensing practice. In response, it has been decided to revise the requirements for the additional premiums to more than 22%, 30% and 35%, and also give different reimbursement points for each appraisal (Figure 6).


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[2] Provision of information on the generic drugs by utilizing the Drug Information Provision Sheets
According to the survey results of WGDRRRMS, while dispatching the insurers’ notification of the cost reduction by active use of the generic drugs has generated certain effects, the number of patients who have actually received such a notification remains low.
Moreover, the possibility of change to generic drugs is not always easily recognizable. Even when patients want to change to generic drugs at the insurance pharmacies, they may encounter circumstances in which “prescribed drugs are not available in generic form” or “generic drugs have already been prescribed.”
Thus, as a means of improving the content of information regarding the generic drugs, we have decided to promote the provision of information on generic drugs (availability, prices, etc.) by using the “Drug Information Provision Sheets” handed to patients when drugs are dispensed to them at the insurance pharmacies (Figure 7).


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[3] Additional premiums of practices that actively use generic drugs in medical institutions
Until now, aside from improving systems to promote the use of generic drugs by the medicine departments at medical institutions, when the ratio of generic drug items used by them exceeded 20%, they were rewarded by additional remuneration for medical services(Additional premiums for practices that actively use generic drugs in medical institutions). In order to further promote the use of the generic drugs in medical organizations, a new criterion of “over 30%” was added for raising the number of medical institutions using generic drugs (Figure 8).


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[4] Promotion of generic name prescribing
In the WGDRRRMS survey, the most frequent response to the question of what motivates the insurance pharmacies to change to generic drugs was “ dissemination of the practice of generic name prescribing.” We have decided to promote generic name prescribing in order to mitigate the burden of the inventory management of the generic drugs for the insurance pharmacies and to newly set up a system in which the medical institutions and physicians will be rewarded for the prescription charges when they implement generic name prescribing (Figure 9).


Figure9

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[5] Modification of the prescription form
In the present prescription form specified under the revision of remuneration for medical services in FY2010, a space is provided for a “signature in case all ethical drugs cannot be changed to generic drugs.” With the signature of the prescribing physicians, all drugs prescribed cannot be modified. With the present revision of medical service fees, the format is modified so that the possibility of changing to generic drugs can be individually made clear for each pharmaceutical drug (Figure 10). It is expected that this revision of medical service fees will increase the number of prescriptions which can be changed to the generic drugs.


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2. A Draft Plan for Comprehensive Reform of Social Security and Tax

The promotion of the use of the generic drugs is also mentioned in the “Draft Plan for the Comprehensive Reform of Social Security and Tax” decided by the Headquarters of the Government and Ruling Parties for Social Security Reform in January 2012.


A roadmap for promotion of the use of generic drugs is prepared to promote the comprehensive use of generic medicines, by valuation in terms of remuneration for medical services, providing patient information, making changes to the prescription form, ensuring the quality of the drugs in order to enhance confidence in them among medical professionals. In addition, the drug price of the original medicines for which generics also exist shall be lowered while giving consideration to initiatives for innovation.

In order to construct a sustainable medical insurance system for the future, it is important that the quality of the services provided to the people is maintained and enhanced, while working on prioritization and efficiency where possible.
The purpose of promoting the use of generic drugs is, however, not to limit the medical expenses alone. The ultimate aim, from the perspective of medica l care as a whole, is to try to effectively utilize the limited healthcare resources and provide all Japanese citizens with medical services that are inexpensive and of high quality.


3. In Conclusion

For further promotion of the use of the generic drugs, we consider it important to continue to strive for securing faith in the quality, stable supply, provision of information of the generic medicines among patients and the medical professionals, and disseminating the information through the Action Program for the Promotion of the Safe Use of Generic Drugs. Moreover, it is essential that both the healthcare professionals and the Japanese citizens gain confidence in generic drugs and that their willingness to actively use them be fostered, through such measures as valuation in terms of remuneration for medical services and disseminating information on and raising awareness about these drugs from the insurers to the insured.


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