Regeneratieve geneeskunde verzekerd?

Kugako Sugimoto, NOST Tokyo

Origineel gepubliceerd op de site van Agentschap NL.

De Japanse overheid is een discussie gestart rond de ziektekostenvergoeding voor regeneratieve geneeskunde. De discussie gaat niet alleen over welke kosten van behandelingen in publieke of private praktijken gedekt worden, maar ook over de aansprakelijkheidsverzekering voor medisch personeel en bedrijven die (stam)cellen produceren. In Japan is er een duidelijk besef dat een goede regeling van de vergoeding en de aansprakelijkheid een belangrijke voorwaarde is voor het slagen van de toepassing en commercialisering van de regeneratieve geneeskunde.


Medical Insurance for Regenerative Medicine


 

Summary

The Japanese government has started a discussion on policies regarding private medical insurances for regenerative medicine. The discussion includes insurance coverage for regenerative medicine as a private practice, highly advanced medical treatment, and liability insurance for medical practitioners and cell processing companies. Preparation of private medical insurance for regenerative medicine is an essential part of successful application and industrialization of regenerative medicine and cellular therapy in Japan.

Details

The Council for regenerative medicine set up by the Ministry of Health, Labour and Welfare, Ministry Education, Culture, Sports, Science and Technology and the Ministry of Economy, Trade and Industry will form a sub group focusing on insurances and schedule its first meeting in early December, 2013. One of the goals of the meeting is to provide insurance companies information about exemption[P1]  from payment of premium and to encourage them to prepare insurance plans for regenerative medicine.

Liability

Doctors and medical institutes have been responsible for medical mistakes [P2] when it happens. In the fall of 2014, cell processing companies can become responsible for the damage to the patient’s health because cell processing companies get orders from the doctors and prepare processed cells outside the medical institution. Currently, in place are a medical professional liability insurance, a liability insurance for the medical institute, and a product liability insurance. All of them  might be applicable for regenerative medicine. It is still technically difficult to produce cells with the identical quality for regenerative medicine. Risk and effects of the regenerative medicine depend on cases, skills and various other factors. The standard to determine cause and effect in the case of adverse effects will be discussed as well as the issues of sharing liability between medical professionals and cell processing industries.

For Patients

Examples of insurance for the patients would also be discussed at the meeting. Some regenerative medicine might fall into the category of private practice and combination therapies beyond insurance coverage. Basically in Japan, medical expenses of patients will be covered by the public medical healthcare system and copayment by the patients. Private insurance with a contract supplement for highly advanced medical treatment covers the expenses that the public medical care does not cover. The definition of highly advanced medical treatment and the medical institutes that perform the treatment are prescribed by the Minister of Health, Labour and Welfare and are updated regularly.

One example of currently approved highly advanced medical treatment at the National Cerebral and Cardiovascular Center is an injection of stem cells effective for angiogenesis to the patients of peripheral arterial obstruction. Stem cells are collected from the patient’s bone marrow and injected into the legs of this patient. Surgery and drug treatments are considered to be conventional treatment for this disease. Therefore, treatment using stem cells is not covered by public medical healthcare system.

A new insurance for regenerative medicine might be similar to current cancer insurance plans that support copayments and associated expenses such as transportation and loss of absence from work.

Conclusion

To implement and industrialize regenerative medicine including the use of iPS cells, financial support for doctors, cell processing companies, and patients is needed. Private insurance would back them up. Since regenerative medicine is expected to be a huge industry in the near future, insurance companies also consider this a business chance/opportunity.


Source

  1. National Cerebral and Cardiovascular Center
  2. The Nikkan Kogyo Shimbun, Ltd. (Nov. 27, 2013)

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