It has been found that the response to the new coronavirus has continued for more than two years, and the revision of the law is also affected.

The revision of the "Intractable Diseases Law," which stipulates support measures for patients with intractable diseases, has been delayed from the original schedule, and the Ministry of Health, Labor and Welfare said, "Manpower is devoted to measures for the new corona, and the system necessary for the revision of the law cannot be taken. ".

The "Intractable Diseases Law" is a law that stipulates subsidies for medical expenses for patients with intractable diseases and promotion of research that leads to treatment methods, and was enforced in January 2015.

There is a provision that it will be reviewed as necessary within 5 years from the enforcement, and the Ministry of Health, Labor and Welfare has started discussions for revision in a committee of experts with the aim of formulating a policy around the end of 2019. rice field.

However, due to the spread of the new coronavirus infection, it was forced to suspend the operation, and in July last year, a year and a half after the original plan, the policy was finalized.

In the revised bill,

▽ the start time of medical expenses subsidy will be set to "the time when it became severe", going back from the previous "time of application", and

▽ a database including mildly ill patients will be prepared, and under certain conditions. It is expected that it will be made available to pharmaceutical companies, etc., but according to the Ministry of Health,

Labor and Welfare, there is no prospect of submitting a revised bill.

In addition, we plan to make some revisions to the Child Welfare Act at the same time, such as strengthening independence support projects for children who need long-term medical treatment such as childhood cancer, but the outlook is not clear.

Tetsuhiro Minohara, Chief of the Intractable Diseases Countermeasures Division, said, "We are devoting manpower to countermeasures for the new corona, and we cannot take the necessary system for law revision. I am very sorry for patients and their families. I cannot promise when I can submit it. To be honest, for the time being, I would like to pursue policies that can be done without amending the law. "

Amendment of "Intractable Diseases Law" and new corona

The "Intractable Diseases Law," which came into effect in January 2015, stipulates that a wide range of diseases should be designated as intractable diseases and should be covered by medical expenses subsidies, and that research on the mechanism of disease onset, diagnosis, and treatment methods should be promoted as a national government. Has been done.

With the enforcement of the law, the number of designated intractable diseases has increased from 56 to 338 now, and the out-of-pocket medical expenses have been reduced to 20% in principle.

In May 2019, five years before its enforcement, the Ministry of Health, Labor and Welfare began discussions on law revisions in a committee of experts.

In the material at that time, it was stated that the compilation would be done by the end of the year, but since it will take time to sort out the issues, the committee meeting held in January 2020 at the beginning of the year will decide the timing of the compilation around the spring of that year. I am reviewing it.

However, the infection of the new coronavirus spread immediately afterwards.

Discussions were suspended, the next committee meeting was in October, and the policy was finalized in July 2021 the following year.

Seven years have passed since the law came into effect, but according to the Ministry of Health, Labor and Welfare, it is "quite strict" to submit an amendment to the ordinary Diet session that is currently being held.

The reason for this is that Tetsuhiro Minohara, chief of the Intractable Diseases Countermeasures Division, said, "When we amend the law, we will discuss the contents, discuss with members of the Diet, and coordinate with related ministries and agencies. It's a lot, but now I can't take the system because I'm devoting manpower to the measures for the new corona. "

In addition, although the local government will carry out practical work such as subsidizing medical expenses, it is difficult to create new work due to the revision of the law because it is busy dealing with the new corona. ..

Key points for the revision of the "Intractable Diseases Law"

One of the points of the amendment is to go back to the time when the subsidy for medical expenses became severe.

At the time of applying for the subsidy, there were voices from patient groups and others saying that there were cases where they had already paid a large amount of money.

According to the Ministry of Health, Labor and Welfare, it is unprecedented in the subsidy system so far to move forward when the diagnosis is made.

In the opinion of the expert committee, in consideration of the balance with other systems, the period of advancement is set to an upper limit such as "one month from the application date".

It was also pointed out that the database of patient information was not sufficiently maintained.

The current database contains the contents of the "Clinical Survey Individual Form" that is created when patients apply for medical expenses subsidies once a year.

It means that about 500,000 to 600,000 cases are registered annually.

The data is available only to some researchers who carry out research projects supported by the government.

The amendment will include a mechanism to register information on mildly ill patients who are not covered by medical expenses subsidies, and to make it possible for private companies such as pharmaceutical companies to utilize the data after setting certain conditions. It is expected that the outlook will lead to research on treatment methods and development of therapeutic drugs.

Professor Osamu Onodera of the University of Niigata Brain Research Institute, who has been conducting research on intractable diseases using databases, said, "It is of great significance that private companies can also use data. We cannot start development unless we can grasp the actual situation of how many patients are in trouble due to the need for a large amount of funds. The delay in the revision of the law is to grasp the whole picture of patients with intractable diseases once a day. It will be a day late, and it is hoped that it will be established as soon as possible. "

Patients with intractable diseases waiting for law revision

Patients with intractable diseases are waiting for the revision of the law.

Keisuke Iwasaki (40), who suffers from one of the designated intractable diseases, "spinocerebellar degeneration," hopes that the revision of the law will improve the database and lead to the development of therapeutic drugs.

"Spinocerebellar degeneration" is an intractable disease in which the body cannot move as expected.

Mr. Iwasaki's hobbies were marathon and mountaineering, but after he was diagnosed at the age of 34, he gradually progressed to his illness.

In particular, I've become dizzy over the past year, and it's hard to walk unless I'm holding onto something.

He used to work as a full-time employee at a staffing agency, but he quit because of his illness and is now working at home as a non-regular employee.

Mr. Iwasaki said, "There are more things that I can't do for sure, such as the difficulty of going up and down the stairs, the increase in falls in the house, and the difficulty of talking. I'm scared. "

He goes to a hospital in Tokyo once every three months to follow up, but he is not prescribed any medicine.

There are only two types of prescription drugs for this disease in Japan, and it costs more than 10,000 yen a month, and none of them cures the disease just by relieving the symptoms.

Mr. Iwasaki said, "It is unavoidable that Corona has an influence on the revision of the law, but patients can only live hard that day. The disease is definitely progressing, so early I want you to revise the law and connect it to a cure. "

One-tenth of the Ministry of Health, Labor and Welfare staff is taking measures against the new corona

Since the spread of the new coronavirus infection, the Ministry of Health, Labor and Welfare has set up a countermeasures headquarters and has continued to respond, and now about 400 people, one tenth of the staff, are assigned to the countermeasures headquarters.

According to the Ministry of Health, Labor and Welfare, there are no other effects such as the delay in the revision of the Intractable Diseases Law, but when I interviewed the staff, "I can not do anything else while I am at the countermeasures headquarters, so I will come up with a new policy. There are voices such as "It is becoming difficult" or "There are cases where the person in charge is absent even if there is an inquiry from the local government or related parties, and we cannot respond politely."

About 30 people belong to the intractable disease control section, which is in charge of the intractable disease law, but about one-third of the staff also work on vaccination, and about three of them are in fact the section. It means that you are not in the state.

Regarding the delay in the revision of the law, the Measures for Intractable Diseases Division wants to work on policies that can be promoted without amending the law, such as making the database online and establishing a consultation system for medical treatment.