Petition to Enable Treatment of Cystic Fibrosis in Japan

Created by the Committee to Enable Cystic Fibrosis Treatment in Japan

A Plea for Assistance

To The Minister of Health, Labour and Welfare:

Cystic Fibrosis (CF) is a chronic incurable genetic disease of children whose exocrine glands throughout the body do not work normally. Blockage of the lungs and the pancreas by abnormally thickened mucus severely impairs the breathing and digestion. Thus, CF is a life-threatening, incurable disease.

In Europe and the United States of America, one out of 2500 Caucasian babies is born with cystic fibrosis. In Japan, approximately one out of 350,000 babies is born with cystic fibrosis. CF is exceedingly rare in Japanese.

In Europe and the United States of America, the median life expectancy for children with CF used to be 8 years in the 1960's. However, due to medical progress and an improvement in treatment options, the median life expectancy in 2009 has reached nearly 38 years. CF is now considered both a pediatric and an adult disease.

However, in Japan, due to tight control of pharmaceutical laws, it is difficult to receive the treatments which are standardized internationally for CF (for example, by the World Health Organization). The current median life expectancy in Japan is only about 15 years. There are less than 30 CF patients living in Japan. Moreover, Japanese CF pediatric patients can receive a government subsidy to pay for medications through a special program for those with pediatric chronic illnesses, only until the age of 20. This government subsidy is cut off when the CF patient reaches 20 years of age, resulting in extreme financial burdens on CF adult families.

Japan must narrow the gap of CF treatment, in comparison to Europe and the U.S. We request that the Japanese government amend the treatment situation for CF patients in Japan in a timely manner.

We, families, friends, health care professionals and interested parties in Japan formally request the following from the Japanese government:

1) In order to change the treatment of CF disease in Japan, we wish to request that cystic fibrosis be included in the special medical expense assistance program for general incurable diseases. Currently, CF treatment in Japan is offered only as a restricted clinical research trial until the age of 20. CF medication and treatment are highly expensive and must be used throughout the lifespan. Including CF in the medical expense assistance program for incurable diseases is the only way to offer equal treatment to all CF patients regardless of income or access to foreign CF specialists.

2) The basic medications which are used in Europe and the United States of America, such as pancreatic enzymes for digestion (for example, enteric-coated pancrelipase- Creon or Ultrase), inhaled antibiotic medication ( for example, TOBI and Colistin), and inhaled mucolytic enzymes (Dornase alfa-Pulmozyme) should be approved in Japan and covered by the national health insurance.

We appeal to you to understand the difficult situation for cystic fibrosis patients in Japan who lack adequate medication and treatments. The Committee to Enable Cystic Fibrosis Treatment in Japan would like your support through your signature. Through our efforts, we hope to convey our wish for better CF treatment to the Japanese government.

Addendum from the United States of America
Cystic Fibrosis Community and Supporters:

We, the citizens of the United States of America, and members of the American cystic fibrosis community, hereby support Japanese cystic fibrosis families in their appeal to the Japanese government for attention, pharmaceutical law amendments and funding for lifelong health insurance coverage. We urge the Japanese government to relax the restrictions on the importation of CF medications that have been thorough investigated for safety and approved by federal drug agencies in both Europe and the United States of America. We ask that the Japanese government understand that the small population of CF patients in Japan makes clinical trials scientifically insignificant and financially impractical.

In addition, non-Japanese CF patients, especially Americans with CF, have been denied access to CF medications while living in Japan for business and education purposes. This has forced American families to pay enormous shipping costs from America, leave Japan or choose not to live in Japan due to a lack of access to CF medications.

We recognize the devastation this disease causes for families, but improved medication and treatment offers increased length of life in CF patients, and hope and quality of life for both CF patients and their families. We believe that to deny access to available medication to people with diseases like CF, where medications are readily available in other developed countries, can be perceived as a potential violation of basic human rights.

We sign the attached petition to encourage the Japanese government to hear the pleas of Japanese CF patients and respond in a compassionate and expeditious manner.

In summary, there are two primary aims for petitioning the Japanese Government:

1) Include CF in the medical expense assistance program for incurable diseases
2) Expedite approval of medications available in Europe and the USA in Japan, and allow national health insurance to cover the cost of these medications.

This information will not be used for any other purposes except for this petition. When signing, please sign for yourself. Persons of any age can sign this form, but they must understand what they are signing.