[Transparency in relations between multinational R&D pharmaceutical companies' corporate social responsibility activities and patient organizations in the Europe, Japan, and the United States].

Objectives　Multinational R&D pharmaceutical companies operating in many countries and regions have deep ties with patient groups that are recipients of their corporate social responsibility (CSR). CSR activities are diverse and range from direct funding (including donations and sponsorships) to indirect funding (such as expenses associated with company-sponsored lectures); there are rewards for CSR requests for patient groups (writing, supervision, and surveys), and labor is provided by company employees. In developing pharmaceutical products, R&D companies can provide greater benefits to patients by listening to them. It is therefore important for all stakeholders to ensure transparency regarding the relationship between companies and patient groups. This study aimed to identify trends in information disclosure toward ensuring transparency of relations between CSR activities and patient groups based on industry groups regulations in Japan, the United States, and Europe.Methods　The contents described in regulations by the European Federation of Pharmaceutical Industries and Associations (EFPIA), Pharmaceutical Research and Manufacturers of America (PhRMA), and the Japan Pharmaceutical Manufacturers Association (JPMA) concerning such transparency were qualitatively and inductively analyzed in terms of four concepts: transparency, equal partnership, mutual benefit, and independence.Results　Most of the descriptions relate to transparency. The EFPIA regulation is the most detailed; it states that there should be no influence on patient groups' work or on events and activities organized by companies or patient groups. The rules of the three associations also impose the need to maintain records concerning the purpose and contents of financial support and activity items. However, information disclosure to secure transparency is not required in the PhRMA regulation. The JPMA regulation does not specify a clear update schedule; the EFPIA regulation requires disclosure information to be updated once a year. In terms of equal partnership, such terms as "mutual respect," "equal value," and "establishing a trust relationship" appeared in searches with all three regulations. None of the regulations referred to "mutual benefit." All the regulations either respected or validated the independence of patient groups.Conclusion　Each pharmaceutical association set its own regulations and recommended voluntary information disclosure by member companies; however, the extent of such disclosure differed with each association. The regulations of industry associations form the basis for the policies of member companies; thus, it is desirable that the contents and regulations related to mutual information disclosure be established in great detail worldwide.