On January 20, 1997, the JCLU submitted an opinion letter to the Central Pharmaceutical Affairs Council of the Ministry of Health and Welfare, concerning the Ministry's draft amendment to the standards of good clinical practice. The opinion was formulated at the request of the Pharmaceutical Affairs Bureau of the Ministry which came on December 11, 1996.

The JCLU had once submitted the Ministry an opinion letter concerning an amendment to the Mental Health Act, but never been asked by the Ministry for an opinion. Following this request, the Board Meeting of December 17, 1996 asked member attorneys who had handled a pharmaceutical injury case to formulate an opinion letter. Experts' views from medical doctors were also reflected in finalizing the opinion.

The opinion letter gave a positive evaluation to the Council draft as it recognizes the importance of respecting patients' rights and attempts to guarantee it in practice and in substance. The letter also found major improvement in the draft about human rights. Detailed definitions provided in the outset of the draft has a list of those who are socially weak. In order to secure informed consent, the draft specifies in detail the items necessary in the consent and information forms, and makes it mandatory to issue a photocopy of these forms.

Having given a positive evaluation, the JCLU also made the following ten propositions:

1. A public clinical practice review board should be established in each prefecture for review and supervision;



2. A legal expert should be included in a clinical practice review board;



3. Audit should be done by a clinical practice review board as an independent third party;



4. Attention and consideration for the social weak should not be provided abstract but specified as much as possible;



5. In accordance with the 1988 UN Body of Principles for the Protection of All Persons under Any Form of Detention or Imprisonment, it should be stated clearly that pharmaceutics cannot be used experimentally on all detainees, including involuntarily hospitalized mentally ill patients;



6. Medical institutions that use pharmaceutics experimentally are mandated to disclose and notify the patients concerned information regarding the use, including the result;



7. Patients should be entitled to file a question, consultation, and complaint with a clinical practice review board;



8. Patients should be entitled to plain explanation of what the "experimental use of pharmaceutics" is about, and to be accompanied by a person they wished when explained;



9. In the case where a consent of a patient is hard to obtain, approval should be needed not only from the proxy but also from a clinical practice review board as an independent third party;



10. In the case where a patient was damaged by the experimental use of pharmaceutics, those who requested the practice are liable to compensation even when there was no negligence. In addition, cause and effect are to be presumed between the use and damage.

Supposedly, inquiry from the Ministry was based on a reputation of the JCLU member attorneys who had handled pharmaceutical injury cases. Opinion writing upon request from a public entity has added another dimension to JCLU activities.

Further vigilance would be necessary to see how this JCLU opinion will be incorporated into future actual practice.