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Today, Medwatcher Japan submitted a “Request to reconsider the rules on conflict of interest (COI) for Ministry of Health, Labour and Welfare councils - In light of the COI issues with council members regarding HPV vaccines” to the Minister of Health Labour and Welfare.

On April 25th, 2014, the MHLW revealed inaccuracies in disclosed information on COIs by its council members; the council concluded the side effects of HPV vaccines (“cervical cancer vaccines”) as “psychogenic responses, not caused by ingredients of vaccines” last January.

Considering the newly revealed information and previously publicized minutes of council meetings, 11 out of total 15 council members (73%) had received unrestricted grants and/or lecture fees from HPV vaccine manufacturers, GlaxoSmithKline and/or MSD (a subsidiary of Merck). Especially, three members (20%) had received financial benefits that make them ineligible to exercise their voting rights.

It also became apparent that 6 members, or 40% of the overall members, did not disclose their COIs correctly as they should have.

Furthermore, both of the two members who chair the council in turn have COIs but neither of them had disclosed the information correctly. One of the two chairs was found to be ineligible to exercise his/her voting right.

The rules on COI for MHLW councils were put in place when a survey group leader on Tamiflu side effects was found to have received a substantial amount of financial benefits including unrestricted grants from a pharma company which imports and sells Tamiflu.

The rules are set according to the amount received by an individual: when the annual amount received from a specific company exceeds 5 million yen, the person is ineligible for participating in council’s deliberations; when the amount is 5 million yen or less but exceeds 500,000 yen, the person is eligible for council’s deliberations but not for exercising his/her voting right. The rules, however, do not define specifics of disclosure and the deliberation eligibility criteria are not sufficiently rigorous. Furthermore, as far as a quorum is constituted, council deliberations can be implemented regardless of the number of members who have COIs.

Another example of problems with the current rules is they do not prohibit receiving financial benefits from the relevant company during the deliberation; it is not disclosed whether or not an individual member received during the deliberation if the disclosure category (there are three categories: 500,000 yen or less; over 500,000 yen but 5 million yen or less; and over 5 million yen) does not change.

Therefore, Medwatcher Japan submitted to the Minister of Health, Labourt and Welfare a request to reconsider the current members of abovementioned council and the current COI rules, as well as to legally mandate disclosure of COI relationships modeling the US Sunshine Act.

<Gist of the request>
Following items were requested:

1. To reconsider the joint council members of “Side Effects Review Group on HPV Vaccines (Cervical Cancer Vaccines), Immunization and Vaccine Sub-Committee, Health Sciences Council” and “Safety Investigation, Pharmaceutical Safety Measurement Group, Pharmaceutical Affairs and Food Sanitation Council.”

2. To reconsider the rules on participating in council deliberations by setting up an evaluation committee based on the Article 19 of Rules on Participating in Deliberations at Pharmaceutical Affairs Sub-Committees and surveying how the Rules are being exercised at Pharmaceutical Affairs Sub-Committees and Side Effects Review Group on HPV Vaccines (Cervical Cancer Vaccines), Immunization and Vaccine Sub-Committee, Health Sciences Council.

3. To mandate pharmaceutical and medical devices companies to disclose provisions of financial and other benefits to doctors and other healthcare professionals by legislation.

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