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Tuesday, Oct. 2, 2012
Companies liable for drug trial damages
MJ is considering using an experimental drug that his doctor has offered to treat colitis, but isn't sure who is responsible if anything goes wrong.
"After many unsuccessful treatments, it seems we are getting close to or have arrived at a last-resort stage. He has offered to put me on an experimental drug that works well on mice. I would be one of the guinea pigs for humans.
"I want to know who has the legal responsibility if anything goes wrong. If I used this drug and needed treatment to cure any damage from it, who would be responsible? Who would pay for treatment? Could I get compensation from the doctor or hospital?"
We spoke with attorney Miho Niunoya of Atsumi & Sakai, a Tokyo-based law firm, who explained that, in general, the pharmaceutical company is responsible for any damage caused by either using the drug or the company's negligence.
"When an experimental drug is used by a patient," Ms. Niunoya explained, "it should follow the Good Clinical Practice (GCP) regulation or, in other words, the Ministry of Health, Labor and Welfare's Ordinance on Standards for Implementation of Clinical Studies on Drugs. The ordinance provides that the person or entity that offers an experimental drug, which is usually a pharmaceutical company, has to compensate the patient for any damages that occurred from using the drug.
"The company must pay this compensation regardless of whether negligence occurred or not — however, compensation is not usually paid if damages are caused by the doctor, hospital or any other third party that provided the . . . drug to the patient. In addition, if any damages are caused by the patient, they will not typically receive any compensation."
Ms. Ninuoya said that under the ordinance, health providers are required to provide documentation that explains compensation for damages along with a consent form for the patient to sign.
In the case of negligence by a pharmaceutical company, doctor, hospital or any other party that caused damage to the patient, says Ms. Niunoya, "the patient may make a damages claim under the general rule of Civil Code, or in other words, breach of contract or tort."
For more about Atsumi & Sakai or to contact Ms. Niunoya, visit www.aplaw.jp/en/.
Green fingers in Tokyo
CC writes: "I read the (Light Gist) article from Jul. 31 titled 'Green-fingered gaijin reaps alien harvest in Tokyo' and am wondering, where are the community gardens in Tokyo?"
The Ministry of Agriculture, Forestry and Fisheries' (MAFF) website has a countrywide list of community gardens, which can be found here: www.maff.go.jp/j/nousin/nougyou/simin_noen/s_list/index.html.
The lists are downloadable Excel files and are organized by region and prefecture. They include information such as where the sites are located (city/town/ward), garden name, size, number of plots, rental fees, lease period, whether the plots are available to residents outside of the city or ward, contact phone numbers and, for some listings, a website. MAFF's site and the files are all in Japanese, though, so if you can't read kanji you might need to use a web translation tool or ask a friend to help you.
Two other sites that might also be helpful — although they have most of the same information as the files mentioned above and are also in Japanese only — are qualitylife-net.com/farm/FarmTop.do and www.shimin-nouen.com/toukyou.lst.html.
If anyone can recommend any other community gardens in Tokyo (or resources in English), please let us know.