Building Capacity for Tobacco Dependence Treatment in Japan. Request for Proposals (RFP) - Background and Rationale

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Building Capacity for Tobacco Dependence Treatment in Japan Request for Proposals (RFP) - Background and Rationale Geographic Scope Japan Application process This application process has two steps: Letters of Intent (LOIs) and Full Proposals. The application process and format for LOIs is described below. Based on an expert panel review of LOIs, a number of applicants will be asked to submit Full Proposals. Funding and Administration of Projects Selected projects will be funded by Pfizer Inc. Operational and technical support will be provided by Global Bridges/Mayo Clinic and the Japan Cancer Society. Applicant Eligibility Applications are invited from institutions, organizations or associations, e.g. professional schools, universities, professional associations, government agencies Grants can only be awarded to organizations, not individuals. Individuals named in the project proposal are NOT eligible if they have accepted any funds from the tobacco industry or its affiliates in the past five years. Clinical Area Tobacco cessation Purpose of this RFP The World Health Organization (WHO) regards the treatment of tobacco dependence as one of the six pillars of global tobacco control, as outlined in its original MPOWER Report in 2008 i. Along with the other five pillars Monitor the tobacco epidemic, Protect from secondhand smoke, Warn about the dangers of tobacco use, Enforce bans on tobacco advertising, promotion, and sponsorship, and Raise tobacco taxes Offering help to quit tobacco use is considered by the WHO to be an essential element in the reduction of the wide-ranging and serious health effects caused by tobacco use. The treatment of tobacco use is also a key provision of the WHO s global public health treaty on tobacco use, the Framework Convention on Tobacco Control (FCTC) ii. Article 14 of the FCTC states that: Each Party shall develop and disseminate appropriate, comprehensive and integrated guidelines based on scientific evidence and best practices, taking into account national circumstances and priorities, and shall take effective measures to promote cessation of tobacco use and adequate treatment for tobacco dependence. iii While the WHO s MPOWER Report and FCTC are now integral parts of global tobacco control efforts, most countries who are Parties to the FCTC, including Japan, which ratified the treaty in 2004, have not widely adopted the tobacco dependence treatment

elements of either MPOWER or FCTC Article 14. Therefore this RFP seeks to accelerate the adoption of evidence-based tobacco dependence treatment in Japan, by offering health-related organizations in Japan e.g. universities, foundations, health care facilities and systems the opportunity to propose and undertake activities that can lead to increases in the provision of tobacco dependence treatment and subsequent decreases in death and disease due to tobacco use. Background Tobacco use in Japan, which consists almost entirely of combusted cigarettes, kills more than 140,000 people annually and tens of millions more are exposed to death- and disease-causing second-hand smoke. Fortunately, cigarette smoking now appears to be in a period of transition in Japan ivv. A recent meeting of Japanese and international tobacco control experts convened to provide guidance to this program concluded the following: The prevalence of cigarette smoking among men has almost been halved in the past two decades, while smoking among women has not increased; The number of cigarettes smoked per capita has also been halved, meaning that not only are there fewer smokers in Japan, but those who do smoke are smoking less; There is increasing awareness of the health benefits of providing completely smoke-free indoor environments; The Japanese government has reduced its ownership stake in Japan Tobacco over the past decade from a majority, to one-third; The average price of a pack of cigarettes has been slowly increasing, primarily due to rises in the excise tax on cigarettes; The Japanese government has committed itself to hosting a tobacco-free Olympics and Paralympics in Tokyo in 2020; Novel nicotine delivery systems, including so-called heat-not-burn products, are increasingly available in Japan; and The Japanese government ratified the WHO s tobacco treaty, the Framework Convention on Tobacco Control (FCTC), in 2004 and has recently accelerated efforts to comply with the provisions of the FCTC, including Article 14, which, as noted above, requires Parties to the treaty to make affordable tobacco dependence treatment widely available to all smokers. The net effect of these transitional events and policy changes will be to increase the number of cigarette smokers who seek help to end their dependence. While Japan has made progress in providing tobacco dependence treatment in recent years beginning with a paradigm-shifting smoking cessation guideline in 2005 vi, which made cigarette smoking a medical issue by declaring it a disease and the smoker a patient who needs medical intervention the health care system is unprepared to address the coming treatment demands and a great deal more will need to be done in order to meet these demands. Some progress has been made in such areas as insurance coverage for some tobacco dependence treatment, but other insufficiencies remain to be addressed. These include:

The lack of coordinated media campaigns to fully inform smokers about both the broad range of negative health effects from cigarette smoke, both direct and second-hand, and the range and availability of tobacco dependence treatment in Japan; The need for all health care providers to deliver, at a minimum, brief advice to stop smoking, and referrals to clinics which can provide treatment; The lack of treatment quit-lines delivered through either telephone or social media channels; and The need for easy, affordable access to tobacco dependence treatment for all smokers, as required by Article 14 of the FCTC. In order to deal with the current period of transition in cigarette smoking in Japan, the current insufficiencies in the health care system s ability to deliver science-based tobacco dependence treatment, the need for health care providers to have the skills needed to deliver such treatment, and the Government s need to comply with the provisions of the FCTC and the commitment to a tobacco-free Olympics and Paralympics in 2020, specific ongoing actions will be needed. About this RFP It is the intent of this RFP to seek, and support, proposals for actions that are designed to accelerate the provision of evidence-based tobacco dependence treatment in Japan, based on the context and needs outlined above. Traditionally, an initiative that seeks to increase the provision of evidence-based medical treatment of any kind will rely on delivering educational programming for physicians. The unique, and evolving, context of tobacco use and control in Japan, suggests that actions in addition to educational programming for physicians will be necessary in order to bring tobacco dependence treatment within reach for all smokers. Therefore, in addition to but not excluding proposing educational programs for physicians in order to accelerate the provision of tobacco dependence treatment for all smokers in Japan, other categories of actions that may be proposed to achieve this goal may include: Building tobacco dependence treatment expertise among any category of health care professional, including physicians, dentists, nurses, pharmacists, clinical social workers, psychologists, etc.; Developing and delivering evidence-based tobacco dependence treatment via internet, mobile health, social media, or other highly-scalable platforms; Creating new tobacco dependence treatment opportunities within existing, or newly created, settings such as clinics, hospitals, or hospital systems; Developing tobacco dependence treatment training curricula including distance learning for any category of health care professional, whether currently in practice or in graduate training; Advocacy and advocacy training aimed at increasing tobacco dependence treatment capacity, availability, and/or accessibility, such as efforts to increase insurance coverage for tobacco dependence treatment at the national level, or providing incentives at the local or prefectural level for smokers to seek treatment for their dependence;

Developing train-the-trainer tobacco dependence treatment educational programs for any/all categories of health care professionals, in order to broaden the number and range of such professionals who are qualified to deliver such treatment; Focusing on tobacco dependence treatment for special and/or underserved populations such as those smokers with co-occurring mental illness or substance use disorder, youth, women, and the poor and/or under-insured; and Raising awareness on the part of the public, policymakers, and health professionals regarding the importance of making tobacco dependence treatment available for all smokers in Japan. Responses to this RFP should not be limited to the categories suggested above and may include any evidence-based initiatives which applicants believe may contribute to the goal of the RFP, i.e. accelerating the adoption of evidence-based tobacco dependence treatment in Japan. Characteristics of a Successful Proposal In order to increase the capacity of the health care system to provide evidence-based treatment to tobacco users, we are interested in receiving proposals that: Improve the ability of health care professionals to provide counselling and support to tobacco users; AND Build on evidence and international best practice; AND Include a robust and well-defined plan for evaluation and dissemination; AND Build the network of health care professionals in Japan providing evidencebased treatment of tobacco dependence, AND/OR Enable health care professional advocates to effect tobacco policy change in Japan, AND Include a plan to sustain the project beyond the period of funding. Out of Scope of this Call Non-interventional studies, such as epidemiology studies Independent research on tobacco-caused disease, including novel diagnostic screening tools and surveys Communication programs for the general public to raise awareness about the harms of tobacco use Maximum Award Levels Competitive Level 1 - Small Scale Projects: up to US $50,000 Competitive Level 2 - Large Scale Projects: up to US $250,000 For international collaborations, at least 80% of budget must support work in Japan. Total funding available for this RFP is US $2,000,000 Timing LOIs must be uploaded to the CyberGrants system no later than 5:00 pm Tokyo time on Friday, 16 June 2017. How to Submit 1. Please go to www.cybergrants.com/pfizer/loi and sign in. First-time users should click REGISTER NOW. 2. Select the following Area of Interest: Japan 2017 Tobacco Cessation

3. Complete all required sections of the online application and upload your completed LOI template (provided below). LOIs will be accepted in Japanese. Please note, however, that the Pfizer website, including navigational prompts, is only in English. Grant review and Notification LOIs will be reviewed by a panel of independent experts. All applicants will be notified of the outcome of their grant application by email in early August. Successful applicants will be invited to submit a Full Proposal for further review. Applicants may also be contacted to provide further clarification in order to support the review of any applications. Terms and Conditions 1. This RFP does not commit Pfizer or its partners to award a grant or a grant of any particular size if one is awarded, nor to pay any costs incurred in the preparation of a response to this request. 2. Pfizer reserves the right to accept or reject any or all applications received as a result of this request, or to cancel this RFP in part or in its entirety, if it determines it is in the best interest of Pfizer to do so. 3. For compliance reasons and in fairness to all applicants, all communications about the RFP must come exclusively to Pfizer at the email address IGLC@Pfizer.com. Applicants should not contact other departments within Pfizer regarding this RFP. Failure to comply will disqualify applicants. 4. Complete RFP Terms and Conditions are available for review at www.pfizer.com/files/pfizeriglc_rfp_termsandconditions_2017apr.pdf i WHO Report on the Global Tobacco Epidemic, 2008 : The MPOWER Package (http://www.who.int/tobacco/mpower/2009/en/ - Retrieved March 18, 2017) ii WHO - Framework Convention on Tobacco Control. Geneva, Switzerland, 2003 (http://www.who.int/fctc/text_download/en/ - Retrieved, March 18, 2017) iii ibid, page 13. iv Levin, Mark, Tobacco Control Lessons from the Higgs Boson: Observing a Hidden Field Behind Changing Tobacco Norms in Japan. American Journal of Law and Medicine, 39 (2013): 471-489. v Tobacco Control Laws, Country Details for Japan. Campaign for Tobacco Free Kids, Washington, DC. Retrieved March 18, 2017 vi Fujiwara H, Abe T, Iida M, Kaji M, Kinoshita K, Takano T, et al. Smoking Cessation Guidelines. Circ J 2005; 69(Suppl IV): 1039 1041