Introduction

Did you know that about half of the medications commonly prescribed at hospitals can actually be purchased without a prescription?

Approximately half of the prescription drugs prescribed by hospitals and clinics can be purchased at pharmacies without a prescription. This system is called "over-the-counter sales," and it applies to many of the drugs that you would normally get prescribed at a hospital. In particular, if you have mild symptoms that are not serious enough to require a visit to the hospital, using over-the-counter sales can help reduce the hassle of going to the hospital and the burden of medical expenses.

It is also a very convenient system for people with drug allergies that cannot be treated with over-the-counter drugs. Many over-the-counter drugs are combination drugs that contain multiple ingredients, so if you are allergic to one of them, you cannot use the combination drug and your options are limited, but with retail sales, you can purchase only the ingredients you need.

However, this system of over-the-counter sales is subject to restrictions on sales and advertising based on notifications from the Ministry of Health, Labor and Welfare that have no legal basis, and a bill to abolish over-the-counter sales by law is expected to be submitted to the Diet this year. If this amendment goes ahead, people will no longer be able to buy medicines that can currently be purchased without a prescription, and will have to go to a hospital to get them. As a result, the burden on hospitals will increase, and it may become more difficult for people who really need treatment to visit hospitals.

To correct this unreasonable situation, we will file a lawsuit and fight the illegality of the notification. We will also respond to the movement to amend the law and continue our activities to protect patients' options. This is not just an issue for pharmacies and medical professionals, but an important issue that concerns all of us. Please take an interest and join the discussion.

Summary of the lawsuit

In order to allow us to continue operating our "overall" pharmacies, we filed an administrative lawsuit (actual party lawsuit) against the government, seeking damages.

Currently, sales and advertising at "over-the-counter" pharmacies are strictly restricted by directives from the Ministry of Health, Labor and Welfare. However, these restrictions have no clear legal basis, and what should be permitted is being unfairly restricted.

In this lawsuit, we are seeking to have this notification declared illegal and invalid, and for it to be recognized that pharmacists have a legitimate right to engage in "over-the-counter" sales under the law. Furthermore, as a result of this notification, "over-the-counter" pharmacies have been unfairly treated, such as being refused purchases from pharmaceutical wholesalers or being forced to purchase at higher than normal prices. Furthermore, advertising expressions such as "You can buy without a prescription," "You can get medicine without going to the hospital," "For people who are too busy to go to the hospital," "You can easily purchase medical drugs," and "It's cheaper than buying at a hospital" are also restricted, resulting in a situation where many people are not even aware of the existence of "over-the-counter" pharmacies.

I am deeply concerned that this unjust regulation not only causes economic losses for over-the-counter pharmacies, but also robs them of the opportunity to provide necessary medicines to those who need them. For this reason, the three over-the-counter pharmacies are seeking compensation from the government.

This is not just an issue for us pharmacists, but an important issue that affects everyone who needs medicines.

What is retail sales?

Do all "medical drugs" require a prescription? Actually, that's not true!

There are about 20,000 types of medicines prescribed at hospitals (medical drugs). Many people may think that "medical drugs = you can't buy them without a prescription," but that's not actually the case.

Under the Act on Ensuring Quality, Efficacy and Safety of Medical Devices, etc. (hereinafter referred to as the "PMD Act"), which regulates pharmaceuticals, approximately 7,000 types of medical drugs are classified as "non-prescription medical drugs" and can be purchased at pharmacies without a prescription, at the discretion of the pharmacist.

However, future changes to the law may restrict this system. If the number of "medicines that cannot be purchased without a prescription" increases, it may become more difficult to obtain medicines that have been easily purchased up until now.

Examples of typical prescription drugs that can be purchased without a prescription under current law

*This refers to pharmacy drugs that have not been designated by the Minister of Health, Labour and Welfare under Article 49, Paragraph 1 of the Pharmaceuticals and Medical Devices Act.

The benefits of retail sales

In our daily lives, when we feel a little unwell, we sometimes think, "It's not serious enough to go to the hospital, but I'd like some medicine."

Our interpretation is that under current law, pharmacies are permitted to sell medications sufficient to suppress symptoms in such cases.

However, due to a "notice" from the Ministry of Health, Labor and Welfare, over-the-counter sales are significantly restricted, making it difficult for patients to obtain the medicines they need, which is their right, even though they are actually able to purchase them.

Furthermore, future changes to the law may result in prescription-only medicines that can currently be purchased without a prescription becoming prescription-required . If this happens, we will be forced to go to the hospital even for minor illnesses, which will increase our time and financial burden, lead to hospital congestion, and increase medical costs .

This lawsuit aims to eliminate these unreasonable restrictions and protect an environment in which everyone can appropriately obtain the medications they need .

The benefits of being able to buy medical drugs without a prescription

① You can get medicine without going to the hospital

Normally, to get medicine from a hospital, you have to go through a medical examination, get a prescription, and then pick it up at a pharmacy. However, if there are medicines that can be purchased without a prescription, you can quickly purchase the right medicine for minor symptoms such as a cold, stomach upset, or hay fever without going to the hospital.

This not only saves on medical consultation and prescription fees , but is also a great benefit for people who are too busy to have time to go to the hospital.

② Reduce hospital congestion and lower the risk of infection

At hospitals, waiting times to be seen are long, and the risk of infection in waiting rooms is higher, especially during epidemics of infectious diseases such as influenza.

For example, long wait times can be a huge burden for people with small children or the elderly. If there were medicines that could be purchased without a prescription, people with mild symptoms could avoid going to the hospital and avoid the risk of infection .

Additionally, for foreigners and people who do not have health insurance cards, being able to purchase medicine without going to the hospital is a great convenience.

3) It will lead to reduced medical costs

Medical expenses in Japan are increasing year by year, placing a heavy burden on the national finances. In particular, if the number of people visiting hospitals for minor symptoms increases, the burden on health insurance will also increase, which could result in an increase in the insurance premiums we pay.

If retail sales are maintained, patients will be able to save on consultation fees and prescription costs, contributing to reducing medical costs across the country.

In addition, by reducing the burden on hospitals, medical resources can be allocated appropriately to seriously ill patients who truly need treatment.

4. You can buy medicines even on holidays and at night

Many hospitals and clinics are only open during the day on weekdays, but for people who are too busy at work to make time to go to the hospital, or who suddenly need medicine at night or on weekends, having options for over-the-counter medications is important.

If there are medications available under current law, you can go about your daily life with peace of mind, knowing that you will be able to get them even when hospitals are closed .

5. People with drug allergies can safely choose their medicine

Many over-the-counter drugs are sold as "combination drugs" that contain multiple active ingredients. However, for people who are allergic to certain ingredients, this can pose a life-threatening risk.

If there were options for prescription drugs that could be purchased without a prescription, it would be possible to avoid ingredients that cause allergies and choose only the ingredients you need . However, restrictions imposed by notifications from the Ministry of Health, Labor and Welfare have limited these options.

Issues at issue

The two main issues in this lawsuit are whether to confirm that the Ministry of Health, Labour and Welfare's notification is illegal and invalid, and whether to seek compensation for damages caused by it.

① The Ministry of Health, Labor and Welfare's notification violates the law

Restrictions on the rights of citizens must be based on laws enacted by the Diet. However, the Pharmaceuticals and Medical Devices Act, which sets out rules for the sale of pharmaceuticals, does not contain any provisions restricting the sale of medical drugs other than those designated as prescription drugs (so-called "over-the-counter" drugs).

Despite this, the Ministry of Health, Labour and Welfare issued two notices restricting sales at pharmacies, without any legal basis.

These notices included the following restrictions:

✅ "In principle, medications are dispensed by pharmacists based on prescriptions" → Although there is no legal restriction on this, the content states that sales without a prescription are not permitted in principle.

✅ Making it mandatory to "recommend necessary medical examinations" → This means that pharmacists must recommend a visit to a hospital before selling medicines that they could otherwise sell at their discretion.

✅ Significant restrictions on advertising → Expressions such as "You can buy it without a prescription" or "You can buy it without going to the hospital" are prohibited.

These notices impose restrictions that do not exist in law, effectively making it harder to sell medical drugs without a prescription.

For this reason, this lawsuit seeks to declare that these notices are invalid as they violate the Pharmaceutical and Medical Device Act, and to confirm that pharmacists have the right to engage in "over-the-counter sales."

The government may argue that these notifications are interpretations of the Pharmaceuticals and Medical Devices Act and are therefore valid. However, the Pharmaceuticals and Medical Devices Act does not contain any provisions imposing such restrictions in the first place, and it is completely unacceptable to enforce rules that have not even been decided by the Diet through notifications.

② Claims for damages caused by unreasonable restrictions due to notification

The notification from the Ministry of Health, Labor and Welfare has caused major disadvantages to pharmacies that sell over the counter drugs. In particular, it is a serious problem that they are no longer able to do business with the four major pharmaceutical wholesale companies.

Currently, the four major companies, which account for approximately 90% of Japan's pharmaceutical wholesale market, refuse to do business with "over-the-counter" pharmacies simply because they are "over-the-counter" pharmacies. As a result, "over-the-counter" pharmacies are unable to purchase medicines directly from the four major companies, and are forced to purchase medicines at inflated prices only through secondary wholesalers.

This problem is caused by the fact that the notification from the Ministry of Health, Labor and Welfare is considered to be "legally binding." In fact, the Director-General of the Ministry of Health, Labor and Welfare stated through media aimed at the pharmaceutical industry that "the notification is legally binding," which has forced the big four companies to refrain from doing business with "over-the-counter" pharmacies.

In addition, a notice from the Ministry of Health, Labor and Welfare prohibits advertising phrases such as "You can buy it without a prescription." This significantly limits the advertising of "over-the-counter" pharmacies, and patients who would otherwise visit the stores are unable to learn about this system, leading to a decrease in sales.

In this lawsuit,

1. Compensation for damages incurred due to price hikes caused by four major wholesalers refusing to do business with us
2. Compensation for damages for loss of sales due to advertising restrictions

We are asking the government to do the following.

▲The scene at the time of filing the lawsuit

social significance

This lawsuit has public significance as it aims to improve patient convenience, reduce medical costs, optimize medical resources, and build a sustainable medical system. It also raises the issue of notification administration with unclear legal grounds and excessive tightening of regulations.

Current status and issues of the medical system

Japan's healthcare system is facing a serious sustainability crisis due to a declining birthrate, an aging population, and stagnant economic growth. With social security benefits expected to exceed 190 trillion yen by 2040, efficient use of healthcare resources is an urgent task.

On the other hand, there are issues such as a declining occupancy rate of hospital beds, the aging of clinic doctors, and difficulties in securing medical personnel, and there are concerns that it will be difficult to maintain the medical care system in the future.

The significance of selling at a loss

To address these issues, "over-the-counter" sales, which allow patients to purchase appropriate medicines for mild symptoms at pharmacies without seeing a doctor, can help reduce the burden on medical institutions and curb medical costs.

In addition, utilizing the expertise of pharmacists will also help improve patients' health literacy, so we believe that the spread of over-the-counter medicines is an important means of contributing to the sustainability of the healthcare system.

The irrationality of notification administration and resistance to legal reform

However, current regulations restrict the implementation of over-the-counter sales. The Ministry of Health, Labor and Welfare has issued a notice stating that, in principle, medical drugs should be sold only with a prescription, but it has been pointed out that this notice does not have a clear legal basis. Furthermore, regulations based on the notice impede flexibility in the sale of medical drugs, resulting in the undermining of public interests such as patient convenience and reduced medical costs.

In addition, the proposed amendments to the Pharmaceuticals and Medical Devices Act, currently under deliberation, are considering significantly strengthening regulations on over-the-counter sales. If these amendments are enacted, over-the-counter sales may be legally prohibited, and there are concerns that patient options will be further restricted. I filed this lawsuit to demonstrate my intention to resist these unreasonable administrative notifications and amendments to the law.

Background and purpose of the lawsuit

The Ministry of Labor's notification unfairly restricts the practice of over-the-counter sales, but the legal basis for this is unclear. Furthermore, the amendment to the law currently under consideration is being considered to strengthen regulations that would effectively ban over-the-counter sales, raising concerns that this would take away patients' choices.

We are challenging these unreasonable notification administrations and legal reforms through litigation and calling for improvements to the system.

The public significance of this case

This lawsuit has the following public implications:

1. Increased convenience for patients : Patients can obtain medicines without visiting a hospital, enabling quicker response.
2. Reduced medical expenses : Fewer outpatient visits by patients with mild symptoms will reduce the burden on medical insurance finances.
3. Optimize healthcare resources : Allow healthcare workers to focus on treating critically ill patients.
4. Legal clarification : The notification administration will be rectified and the legal basis for retail sales will be clarified.
5. Resisting legal change : It is possible to design a system that protects patient choice.

Use of funds

• Litigation costs: These will cover legal fees and procedural costs related to the trial. This lawsuit is important in protecting the retail sales system, so we need specialized legal support.
• Public relations expenses: We will also invest in public relations activities to inform as many people as possible about the importance of the retail sales system. We aim to gain social understanding and support through information dissemination via pamphlets, websites, and social media, as well as media exposure.
• Research costs: We will conduct research to clarify the current state of the over-the-counter system and its impact on patients and pharmacies. This will allow us to prepare to present persuasive data in court.

Your support will be used thoughtfully and effectively to protect patients and the future of pharmacy in this important trial.

Plaintiff’s thoughts

Plaintiff Representative: Ikuhiro Nagasawa

Plaintiff: Yoshihiko Yamashita

Plaintiff Satoshi Hakoishi

Message from the Lawyers

Our legal team is approaching this lawsuit with a strong sense of mission.

Although the law actually allows it, "over-the-counter sales" have been unfairly restricted by a notification from the Ministry of Health, Labor and Welfare, and further amendments to the law are being considered to completely prohibit them. Our society is supposed to be based on the laws established by the Diet. However, the current issue is an extremely unfair situation in which pharmacists are being deprived of their jobs and patients' choices are being narrowed by an administrative notification that is not based on law.

Pharmacists who sell over-the-counter drugs have worked hard every day for their patients. They have supported people who don't have time to go to the hospital for minor symptoms, people who can't use over-the-counter drugs because of allergies, and people who want to avoid crowded hospitals, so that they can properly obtain the medicines they need. Despite this, the government's unilateral restrictions have led to "over-the-counter" pharmacies being denied stock and prohibited from advertising, forcing them into a difficult business situation. And now, if the law is revised, they will be forced to go out of business.

We will never tolerate this absurdity. It is something that should never happen in a democratic society for the state to deprive its citizens of their rights without following the law. This lawsuit is not just to protect "zero-sale," but also a fight to correct the tyranny of the government that ignores the law and protect the legitimate rights of the people .

We, the legal team, will do everything in our power to change this unjust situation.

Introducing our lawyers

Attorney at Law, Yoshihiko Nishiura, registered as an attorney in 2009, affiliated with Nishiura & Nishinakayama Law Office (Toranomon, Minato-ku).
We represent clients in civil and criminal litigation, focusing on corporate law, pharmaceutical and medical device law, and entertainment law.
Member of the Japan Federation of Bar Associations' Committee on Civil Judicial Procedures.
Member of the Judicial System Research Committee of the Tokyo Bar Association No. 2.

Attorney-at-Law Yusuke Taira was registered as an attorney in 2008 and is affiliated with AND Sogo Law Office (Nihonbashi, Chuo-ku).
While he is a researcher in administrative law, he also serves as an attorney in numerous administrative litigation cases.
Defense team for the "From Miyamoto to You" lawsuit, the Kadokawa hostage justice unconstitutionality lawsuit, and the Sunagawa hunting rifle lawsuit | Head of defense team for the "Subsidies for Sex Work" lawsuit, the Communist Party Shochiku case, and the Communist Party Kamiya case

Attorney Yuta Sasaki, registered as an attorney in 2020, is affiliated with Nishiura & Nishinakayama Law Office (Toranomon, Minato-ku).
The firm handles litigation matters, mainly corporate law and labor issues.

Conclusion

Our lawsuits are important efforts to ensure the sustainability of the healthcare system and protect the public interest, such as improving patient convenience and reducing medical costs. They also serve as a means of resisting unreasonable administrative notification and legal reforms.

Please lend us your strength to protect the future of medical care, to protect the pride of pharmacists, and to avoid increasing the burden on society as a whole. Even the smallest support will be a great help in continuing this fight. Together, let's create a better future.