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Filed a complaint against HPV vaccine manufacturers on suspicion of violations of JPMA Promotion Code for Prescription Drugs

2015-02-26

On February 26th, 2015, we filed a complaint with the Japan Pharmaceutical Manufacturers Association (JPMA) against HPV vaccine manufacturers on suspicion of violations of the JPMA Promotion Code for Prescription Drugs (hereinafter called The JPMA Promotion Code).

◆Purpose of the Complaint
　 HPV vaccine manufacturers MSD and GlaxoSmithKline were found to be donating huge sums of money to The Japanese Expert Board for the Eradication of Cervical Cancer, Executive committee (hereinafter called the Expert Board), which promotes the HPV vaccine. Meanwhile, the former head of vaccine marketing at GlaxoSmithKline of Japan was found to have been promoting the HPV vaccine after receiving commissions from the Expert Board. Both of these are considered a violation of the JPMA Promotion Code. Following a thorough investigation we therefore request that measures are taken to address these violations in line with the Rules of Actions against the Breach of the JPMA Promotion Code.

◆Reasons for the Complaint（Outline）
1. Relationship between the HPV vaccine manufacturers and the Expert Board
　Since its establishment in November 2008, one of the aim of the Expert Board's activities has consistently been to spread and promote the HPV vaccine and inoculation in Japan, and to achieve this, it has conducted a wide range of activities targeting a variety of areas such as the government, the Diet, local municipalities, the media, medical institutions, public awareness groups and members of the public. As a result, it has exerted a huge influence on such things as Japan's legislative process for the HPV vaccine, the government, and public opinion.
On the other hand, the Expert Board's promotional activities such as the early approval of the HPV vaccine, making the vaccine free of charge, a higher immunization rate and resuming active recommendation of the vaccine are all directly linked to increased sales of the HPV vaccine.

　The Expert Board also received huge sums of money (general donations) including 35 million yen in 2012 and 38, 500,000 yen in 2013, from companies that make and sell the HPV vaccine (MSD, GlaxoSmithKline and Japan Vaccine Co., Ltd). It can therefore be assumed that, since its establishment, the Expert Board has relied on donations from HPV vaccine manufacturers to fund its activities.

　It has also become apparent that a former employee who was the head of vaccine marketing at GlaxoSmithKline up until April 2009 was involved in promoting the HPV vaccine from January 2011, after receiving commissions from the Expert Board.

On June 29th, 2015, we received a response from the JPMA stating that there has been no violation of the JPMA code. However, this response is based on an insufficient investigation and is therefore unjustified.
　


2.　Violation of the JPMA Promotion Code for Prescription Drugs
(1) The JPMA Promotion Code, which comes under Part 2 of the JPMA Code of Practice, does not contain any stipulation that directly refers to the provision of services or capital to groups like the Expert Board, but despite the lack of such a stipulation, the JPMA Promotion Code requests that member companies make a decision in line with its contents. Therefore, based on this perspective, it can be said that the HPV vaccine manufacturers' huge donations to the Expert Board are a violation of the JPMA Promotion Code, as outlined below:

(2) The Provision of Money to Medical Personnel
This goes against the JPMA Promotion Code's Item 9 "Provision of cash or its equivalents" which states the following: "member companies shall not offer, either directly or indirectly, any cash or its equivalents to health professionals, medical institutions, etc., for the purpose of potentially influencing the appropriate use of drugs."

(3) The Provision of Services
　According to the JPMA Promotion Code's Item 7 "Seminars and Study Meetings," Item 8 "Gifts" and Item 9 "Provision of cash or its equivalents," the Code bans health professionals or medical institutions, etc., from offering any payoffs that could potentially influence the appropriate use of drugs, so the provision of services as seen in the example of the former head of vaccine marketing at GSK is a violation of the JPMA Promotion Code.

(4) Disguised Promotion
　Although the Expert Board received funding and services from HPV vaccine manufacturers to promote the HPV vaccine, this was not made clear. The fact that this was not clearly indicated means that it should be referred to as a form of disguised promotion that goes against the following statement in section 2.2 in the Code of Practice of the IFPMA (International Federation of Pharmaceutical Manufacturers & Associations), of which JPMA is a member: "Transparency of Promotion: materials relating to pharmaceutical products and their uses, whether promotional in nature or not, which is sponsored by a company, should clearly indicate by whom it has been sponsored. Promotion should not be disguised." It is therefore also a violation of the JPMA Promotion Code.

(5) Circumvention of the JPMA Promotion Code
　The Expert Board's activities consist of many that would violate the JPMA Promotion Code if organized and arranged by MSD or GlaxoSmithKline themselves. Examples of such activities include the making and distribution of brochures that aim to raise public awareness or enlighten the public by emphasizing the validity and necessity of the HPV vaccine but lacking sufficient information on the danger of side effects, and tours dispatching people to meetings held abroad where participants' travel expenses are covered by the manufacturers. Any financial support for such activities from HPV vaccine manufacturers is a circumvention of the JPMA Promotion Code and therefore a breach of the said Code.