Document1 FA3STNet (Federated Advanced/Adaptive/Anticipatory S&T Networks) – Pilot Proposal Name of Pilot Proposal: Antimicrobial Resistance (AMR): Development of a Collaborative Science and Research AMR Network 1. Business Need 1.1 Issue Statement Antimicrobial resistance is a serious and growing global public health threat with profound impacts on our healthcare system, global trade, agriculture, environment, and health and food sectors. Resistance is largely due to the impacts of antimicrobial treatments, improper prescribing practices, patient compliance, own use importation and extra-label use, and use in livestock as growth promoters. Each year in Canada, more than 18,000 hospitalized patients acquire infections resistant to antimicrobials. It is estimated, from an extrapolation of US economic impact data that the current annual direct medical health cost of AMR could exceed two billion dollars. It is projected that if no concerted, coordinated multi-sector action is taken, that this cost will rise exponentially over the next decades as Canada and the world enters a post-antibiotic era where infections can no longer be combatted effectively with antibiotics and other antimicrobials. The scale and complexity of AMR, which cannot be resolves by a single organization or government, requires a FASTNet approach for certain of its elements (e.g. R&D activities) that would: - Provide appropriate flexibility in entering and exiting partnering arrangements with respect to human and financial resources, especially beyond the federal government; - Empower by having financial and management tools in place that enable the desired fluidity in the composition of the partnership; - Diversify the approaches to partnerships to include a variety of organizations beyond the Federal government (provinces and territories, other governments, industry, NGOs and academia); and, - Leverage knowledge, ideas and resources across institutional, jurisdictional and international borders. 1.2 Alignment with GoC Priority The federal government recognizes addressing the growing threat of AMR in Canada is a shared responsibility among federal departments, and recently released its Antimicrobial Resistance and Use in Canada: A Federal Framework for Action on AMR (November 2014), which serves as a starting point for a collaborative response. 1 Document1 The goal of the AMR Framework is to protect Canadians from the health risks and economic impacts related to antimicrobial resistance. It includes three pillars: Surveillance, Stewardship, and Innovation. The federal role for AMR is included in the mandate of several departments. A clear federal S&T role is outlined in the Framework on AMR. The federal approach cites federal responsibility for promoting health, preventing and controlling disease, brokering knowledge and facilitating innovation, tracking and monitoring disease threats, and ensuring the safety of antimicrobial products and all foods sold and prepared in Canada. It specifically identifies PHAC, EC, HC, CFIA, and AAFC as having a role to play. PHAC has been identified as having a federal coordinating lead to address the issue. It is noteworthy that AMR has recently been identified by the Genomics Research and Development Initiative (GRDI) as one of two top priorities for Phase VI interdepartmental Shared priority research. 1.3 Rationale for a FA3STNet Approach and Expected Outcome of the Pilot The AMR challenge is large and complex, and multiple public and private sectors have a contributory role in each of the three pillars of the Framework. While the Framework is an initial attempt to organize the federal response in Canada, it is recognized that effectively and timely solutions to AMR will require close collaboration among sectors. In the context of testing the FA3STNet approach on a pilot scale, it is proposed to limit the scope of the pilot to science and research, with a specific focus on collaboration in research and development (R&D), thereby addressing the ‘innovation’ pillar of the Framework. It is proposed to establish a functional collaborative network for R&D targeting AMR that would engage the GoC, other governmental jurisdictions, academia and private sector in areas of mutual interest. It is anticipated that outputs from the FA3STNet would directly support the federal Framework and its implementation in Canada. 2. Partners It is proposed that the partners in the AMR science and research/R&D pilot would include organizations that fund and/or execute R&D relevant to AMR. 2.1 Lead Department AMR is primarily a public health issue from an impact perspective. In that context the Public Health Agency of Canada has been identified as the federal lead, with a mandate to provide guidance to physicians and the general public on the wise use of antimicrobials, as well as carrying out active surveillance of AMR and targeted research. PHAC also represents Canada’s 2 Document1 interests in several international fora that are addressing the issue, engaging both bilaterally with other countries (e.g. US and UK), as well as internationally, such as through WHO initiatives. 2.2 GoC Partners Although AMR is seen as primarily a public health risk, the complexity of the issue requires that it be addressed through a ‘one health’ approach, that is, integrating animal health and environmental domains with the human, as well as considerations of broad economic factors. The integrated one health approach extends to R&D activities targeting AMR. The GoC partners identified in the Framework are PHAC, CFIA, AAFC, HC and EC. It is expected, however, that this list of directly contributing partners would be extended for the AMR science and research/R&D pilot to include CIHR, DNDD, IC, Justice, NRC and others. 2.3 Non-GoC Partners Resolution of the AMR issue is globally recognized as requiring close integration and sharing of objectives of multiple sectors. In the context of this AMR science and research/R&D pilot, this would include: Academic sector – Several of the U15 Universities have identified AMR as a strategic target for academic research, and have already expressed their interest in working collaboratively with federal scientists and laboratories (e.g. among others, McMaster University, University of Guelph, University of Alberta, University of Manitoba). Private industry – Large pharmaceutical companies have expressed their interest in targeted collaboration with government (e.g. PHAC) in the development of new classes of and alternatives to antibiotics. Similarly, Canadian biotech SME’s are looking for government and others, as well as seeking targeted funding, to partner in research and development activities to address AMR. Other private sector interest parties that could contribute to a science and research/R&D AMR FA3STNet include animal production companies, animal health and welfare companies, and livestock producer associations. International partners - PHAC has bilateral collaboration agreements in place with the US CDC and the European CDC for strategic collaboration in areas of mutual interest. AMR has been identified as one of those areas of joint interest. Canada co-leads, through the Canadian Institutes of Health Research, the European Union's Joint Programming Initiative on Antimicrobial Resistance, which supports research on novel 3 Document1 strategies for overcoming antimicrobial resistance and the sustainable use of antimicrobials to treat infectious diseases. 3. Proposed Scope The proposed AMR FA3STNet has the potential to form a science and research foundation that will support collaborative R&D work to develop further the science base that variously supports the surveillance, stewardship and innovation pillars in the federal Framework. In the context of the pilot, it is intended to develop the multi-sector network and its terms of reference that would undertake such R&D work collaboratively. 3.1 Outline of Proposed Work Addressing AMR will require innovative thinking across research and policy disciplines, and would benefit from an integrated federal approach. The AMR FA3STNet pilot focus on a collaborative R&D network to support and enhance development of: - surveillance methods and systems, - impact models, - interventions that support stewardship of antimicrobials, - new diagnostic methods, - new antibiotics, and - alternatives to current antimicrobials. The proposed pilot for the AMR science and research/R&D FA3STNet will proceed in several interrelated phases of activity over twelve months of work: a) Identification of potential partners in the AMR FA3STNet and confirmation of partner interest in collaboration network, including: o Federal departments and agencies o Provincial and territorial government organizations o Academic sector, as university associations (e.g U15) and individual universities and colleges o Private sector companies – pharma, biotech, animal health, animal producers, etc. o Non-governmental organizations – e.g. CMA, NAHWFC, CAHI, etc. o Non-Canadian governmental organizations – e.g. USCDC, ECDC b) Identification of GoC R&D gaps and priorities in targeting AMR c) Survey of current AMR R&D activities, and of projected strategic targets, of potential partners. 4 Document1 d) Identification of agreements and other tools partners in the AMR science and research/R&D FA3STNet would find useful to allow collaboration e) Identification of impediments to effective collaboration among partners in the AMR science and research/R&D FA3STNet 3.2 Size, Duration and Cost of Pilot Estimated, pending further input, discussion and definition of scope of the AMR pilot among proposed federal partners: - Size - 3 FTE’s (sum of multiple contributors from federal partners). Duration - 12 months from decision to start pilot project. Cost - $150k, in support of travel and meetings with AMR science and research/R&D FA3STNet partners. 4. Risk AAFC, CFIA, EC, HC and PHAC have a mandate to deal with the AMR issue and have internal resources working on the AMR Framework. It is anticipated but needs confirmation that other federal organizations such as CIHR, DND, IC and NRC, as well as ourganizations outside of the federal government, would be willing to join in an AMR science and research/R&D FA3STNet, including this pilot project. 5. Governance and Oversight The AMR science and research/R&D FA3STNet pilot project would be an ADM S&T Integration Board, approved by the federal DM S&T Committee (or Board). Oversight for the pilot project will be by the CSO of PHAC, who acts also as Integration Board ADM champion for the project. The projects will be supported through a dedicated IB working group and a chair, drawn from relevant federal departments. Performance will be tracked by scheduled reporting to the Integration board, reporting up to the DM S&T Committee. _________________________________________________ Contact: Dr. R. Engelhardt, ADM and Chief Science Officer Public Health Agency of Canada rainer.engelhardt@phac-aspc.gc.ca 5 Document1 6