The proposals of the Advisory Committee on Administrative Reform:

Lessons Learned from drug-induced hepatitis
Masumi Minaguchi

1 What’s "the Advisory Committee on Administrative Reform :Lessons Learned from Drug-Induced Hepatitis"?
"The Advisory Committee on Administrative Reform：Lessons Learned fromDrug-Induced Hepatitis “was established in May 2008, by the Ministry ofHealth, Labor and Welfare (MHLW), based on "The fundimental agreement”
drawn up between national plaintiffs groups, their lawyers' groups and theMHLW, concerning the drug-induced hepatitis C litigation.
The committee's purpose is to verify the Drug-Induced Hepatitis Scandal
and make practical proposals on administrative reform to prevent a
recurrence of drug-induced disasters.
In April 2010, after two years' deliberations, the committee released areport entitled "Proposals for Administrative Reform in Preventing a
Recurrence of Drug-induced Disasters” (132 pages).
2Historical significanceJapan has witnessed the recurrence of drug-induced disasters such as
Thalidomide, SMON (subacute myelo-optic-neuropathy), dura mater infectedwith Creutzfeldt-Jakob Disease, HIV-tainted blood products, and classactions have been filed repeatedly by victims, not only for compensation, butalso to clarify the government's responsibility, establish permanent measuresfor victims, find the true facts, and develop preventive measures.
In response to each litigation, regulatory systems have been forced tochange little by little.
However, this is the first time that the MHLW has established an advisorycommittee to learn from drug-induced disasters and make practical
proposals for administrative reform in order to prevent further disasters.
The committee is a new and significant development of“Form-Policy-Function” of pharmaceutical class action. .
3

Outline of the proposals for administrative reform

The report consists of two parts. Part one is about the verification ofdrug-induced hepatitis, and Part two covers proposals for administrativereform.
In the administrative reform part, the report presents the following
fundamental view related to the cause of drug induced disasters: "The

problem exists in decision making. True information has not reached doctors
and patients, even though it has reached drug companies and the MHLW."
The report emphasizes that "a precautionary principle" is essential, andproposes drastic reform measures for the entire system, including the way of
Pharmaceutical and Food Safety Bureau, the Pharmaceuticals and Medical
Devices Agency( PMDA), human resource development, and education.
Regarding clinical trials, the report proposes as follows:Clinical trial
registrations be made compulsory. Items for registration and disclosure
should be broad. Examinees' rights should be legally defined. A unified legal
system through clinical trials and other clinical research should be also beestablished.
The fundamental view of the above proposal is that transparency isessential, as is the establishment of a foundation independent from theinfluence of drug companies.
Regarding approval reviews, the report has proposed the following, basedon the view that both rapid approval and drug safety are important: Thequalifications and quality of PMDA reviewers should be enhanced.
Conditions of approval and evaluations of performances and conditions
should be checked thoroughly. Transparency, such as disclosure of thereview process before approval, should also be improved. The MHLW'sresponsibility for the package inserts included with the drugs should be madeclear as well.
Regarding post-marketing safety measures, the report suggests thatapproval reviews and post-marketing measures should be harmonized sothat anything found during the approval process can be further shared in the
post-marketing safety system. Pharmacoepidemiology should be included
more in post-marking safety measures. A new receipt database systemshould be established so that the number of people using the drug users
make clear.
A regulatory system for unapproved drugs and devices should also beestablished. Risk communication should be improved, as should theregulation system on package inserts, and a reporting system to accept ADR
information from patients is also necessary.
.
The report has proposed that doctors and patients become more familiar
with a relief system for suffers of adverse drug reactions, and that the rangeof objects for relief, including anti-cancer drugs, be broadened.
4

A third party organization to inspect and evaluate drug
regulations

More noteworthy is a proposal by the committee to set up a third party
organization to inspect and evaluate drug regulations.
It will first launch as a standing counsel to watch and evaluate the entire
drug regulation process, and recommend that the MHLW take particularaction, in order to prevent drug-induced disasters. The counsel consists often people who are drug-induced victims and specialists in various fields andwill be independent from the MHLW. .
For ten years, the Japan Federation of Bar Associations and Medwatcher
Japan have been demanding the establishment of such an organization.
5Future Issues

Even though the report is imperfect due to the limited deliberation period, it
is essential to work towards achieving them.
We need to take action!