Workshops at our Summit

Workshop Programme 2-3 June 2015

2 June:

• Workshop A: Access not excess
• Workshop B: New economic models addressing antibiotic resistance
• Workshop C: The environmental dimension of antibiotic resistance

3 June:

• Workshop D: Research and innovation for new therapies – collaborative models
• Workshop E: Improved diagnostics for patient safety and surveillance
• Workshop F: Antibiotics in animal production

Workshop A: Access not Excess

Practical steps to find distribution models that increase access to effective antibiotics while reducing excess use in low- and middle-income countries.

A majority of the world’s population live in low or middle-income countries, where health expenditure per capita is of a substantially smaller magnitude than in high income countries. In addition, the infrastructure to enforce regulation is still under development. The private sector is strong and often the first care provider.

In many of these settings, it is the access to effective antibiotics that is the problem, which explains why childhood pneumonia the world’s no 1 cause of death in children under the age of five. At the same time excess, and irrational use of antibiotics is widespread.

How can Access not Excess be simultaneously addressed, where health resources are 1 % (low income countries) or 10% (middle income countries) of those in high-income countries? What should strategies for “controlled distribution and use” look like to have some effect?

This workshop will involve the participants in suggesting feasible strategies for a fictive middle-income and low-income country, taking the perspective of different stakeholders in the change processes. What can be done in the present situation to address access and excess use? How acceptable are such measures to different stakeholders such as Regulators and Ministries of Health, Medical Practitioners, Private Sector, Consumers, NGOs/activists? When a new, effective antibiotic enters the scene some years from now, which distribution mechanism can be used to achieve controlled distribution and use while giving access to those in need? What are differences in approach in a low- vs a middle-income setting?

Experienced policy makers low and a middle-income country will comment on the discussion, before presenting the main ideas in plenum.

Workshop speakers

• Suwit Wibulpolprasert, M.D., Vice Chair, International Health Policy Program Foundation and Health Intervention and Technology Assessment Foundation, International Health Policy Program, Ministry of Public Health, Thailand
• Martha Gyansa Lutterodt, BSc, MA HMPP, MGL, Director, Pharmaceutical Services, Ghana Ministry of Health

Team preparing workshop

• Stefan Peterson, Professor in Global Health, Uppsala University
• Göran Tomson, Senior Professor of International Health Systems Research, Karolinska Institutet
• Karin Abbor Svensson, Programme Administrator, Dag Hammarskjöld Foundation

Workshop B: New Economic Models Addressing Antibiotic Resistance

Antibiotic resistance does not only challenge public health need worldwide, but is also a huge economic burden, for society at large and for the health care setting.

While considerably reducing the efficacy of existing antibiotics, antibiotic resistance also reduces the economic value and profitability of antibiotics, which also contributed to the progressive disengagement of the pharmaceutical industry from developing this type of drugs.

Hence, the established business model for antibiotics based on maximizing sales and use is no longer viable in the face of antibiotic resistance, which requires instead stewardship, conservation and responsible use of these very precious and increasingly scarce resources. This workshop is dedicated to the needs for new economic models, in the private as well as the public sector, which can facilitate the transformations necessary to attack the resistance problem, in terms of both responsible use and development of antibiotics.

The workshop will focus on the economic forces that create barriers or possibilities in three different but related settings:

1. the research and development of new antibiotics,
2. the production and provision of established and new antibiotics, and
3. the use of antibiotics in high, medium and low income countries, considering also that in the latter countries equitable access to antibiotics still needs to be achieved.

Workshop speakers

• John-Arne Røttingen, Division Director, Norwegian Institute of Public Health; Adjunct Professor, Harvard School of Public Health
• Kevin Outterson, Visiting Fellow, Centre for Global Health Security, Royal Institute for International Affairs; Professor, Boston University School of Law and Boston University School of Public Health

Team preparing the workshop

• Alexandra Waluszewski, Professor of Business Studies, Uppsala University
• Enrico Baraldi, Professor of Industrial Engineering and Management, Uppsala University
• Francesco Ciabuschi, Professor of International Business, Uppsala University

Workshop C: The Environmental Dimension of Antibiotic Resistance

The environment plays two important roles with regards to antibiotic resistance; The first is as a route for transmission of several pathogens. The second role is in the emergence of resistance in pathogens, as harmless bacteria in and around us provide a source or reservoir for novel resistance factors that under a selection pressure can be recruited into pathogens through horizontal gene transfer.

The objective of this workshop is to identify existing and possible contributions from different stakeholders to limit the risks that resistance emerges or is transmitted via the environment. Reducing risk for both these processes are imperative parts to develop new tools, policies and regulations to counter antimicrobial resistance, in line with the WHO action plan and the strategic agenda of the JPI-AMR.

One environmental hot spot for emergence of resistance are discharges from antibiotic manufacturing. To reduce risks here, and to create incentives for improvement, attention is needed from a variety of stakeholders worldwide. Another challenge relates to the spread of antibiotics and resistant pathogens via human sewage and animal manure. Here, we deal with situations ranging from no treatment to highly advanced treatments in different regions. Limiting resistance transmission in one part of the world will likely benefit all at the end of the day. But what are the obstacles for improvement, and how do we get around them?

Workshop speakers

• Anja Leetz, Executive Director, Healthcare Without Harm
• Joakim Larsson, Professor in Environmental Pharmacology, University of Gothenburg
• Ana Maria De Roda Husman, Professor, National Institute for Public Health and the Environment (RIVM) – Centre for Infectious Disease Control, Netherlands

Team preparing the workshop

• Joakim Larsson, Professor in Environmental Pharmacology, University of Gothenburg
• Kia Salin, Environmental strategist, Medical Products Agency
• Linus Sandegren, Associate Professor, Microbiology – Immunology, Uppsala University
• Leif Norrgren, Professor, Swedish University of Agricultural Sciences
• Björn Ingemarsson, Investment Manager, Uppsala University Innovation

Workshop D: Research and Innovation for New Therapies - Collaborative Models

The pipeline of new antimicrobials is today almost dry. Very few antibiotic drugs have been approved by the FDA or EMA during the last decade, and none of these has useful activity against multidrug resistant pathogens. This has serious consequences for modern medicine.

There is a need to boost development and innovation and recently several public and private investments have been made in the area of antimicrobials, vaccines and diagnostics. For example, collaborative research initiatives such as the IMI programme New Drugs for Bad Bugs (ND4BB) and India’s Open Source Drug Discovery programme (OSDD), have recently been launched. But will these efforts be enough?

WHO’s Global action plan on antimicrobial resistance (AMR) urges member states and other stakeholders to invest in basic scientific research as well as in collaborative partnerships for research and innovation. The European Joint Programme Initiative on Antimicrobial Resistance, JPIAMR, also recognizes the importance of involving different stakeholders in addressing this serious problem.

Are cooperative models the best way forward, and if so, how do we build up the necessary competence within academia and industry? How do we construct models to engage the best academic researchers and at the same time attract industry to meet the needs from a public health perspective? Although obtaining funding for such collaborations will be critical we need to ask whether other elements need to be put in place to ensure that we obtain the best outcome.

The aims of this workshop are to propose how to best overcome the obstacles responsible for the current shortage of new antimicrobials, vaccines and diagnostics in the developmental pipeline, and to identify the specific stakeholders that need to act on this problem in both the short term and the long term.

Workshop speakers

• Sarala Balachandran, Professor, Project Director, Open Source Drug Discovery (OSDD); Chief Scientist, Council of Scientific and Industrial Research (CSIR)
• James Anderson, M.Sc., MBA, Head of Corporate Government Affairs, GSK
• Peter Beyer, PhD, Senior Advisory, World Health Organization, WHO Department of Essential Medicines & Health Products

Team preparing the workshop

• Anders Karlén, Professor in Computer-aided drug design, Uppsala University
• Diarmaid Hughes, Professor of Medical Molecular Bacteriology, Uppsala University
• Gunnar Sandberg, PhD, Programme Director, Swedish Agency for Innovation Systems
• Bengt Guss, Professor in Microbiology, Swedish University of Agricultural Sciences
• Cecilia Nilsson, PhD, Project leader SciLifeLab, Uppsala University Innovation

Workshop E: Improved Diagnostics for Public Health and Surveillance

Whenever antibiotic resistance is discussed, access to better diagnostics is often emphasized as an important tool to help manage the problem. The need for new diagnostics is highlighted in most strategic documents on antibiotic resistance such as the draft Global action plan on antimicrobial resistance, the European Commission’s action plan, the Joint Programming Initiative on Antimicrobial Resistance’s strategic research agenda and national action plans.

However, the discussion is often focused on an optimal diagnostic tool that will be able to deliver both identification of species and antimicrobial susceptibility pattern for any disease in around 30 minutes, without advanced technology and at a low cost. While it would certainly be valuable to have such a test, it is not likely that it will be developed in the near future (e.g. Goosens 2013). Nevertheless, there are still many advances to be made in the diagnostics area, in the absence of such an optimal test, although the demands of diagnostic tools will certainly be quite different depending on their intended usage. Improved diagnostics are key both in resource-limited and more well-equipped settings. In this workshop we will highlight three focus areas where diagnostics are critically needed:

1. Diagnosing multi-resistance – focus on patient safety
2. Diagnostic tests to optimize antibiotic therapy – focus on reducing antibiotic use
3. Diagnostic tools for surveillance

Within the focus areas, the challenges of financing, access and uptake and a process for needs assessment will be discussed. The aim of the workshop, for each area, is to have answered two questions.

• Which are the next steps to take?
• Who can and will take responsibility for taking the next step?

Workshop speakers

• Francis Moussy, PhD, Focal Point Diagnostics Innovation, Essential Medicines & Health Products, WHO
• Manica Balasegaram, PhD, Executive Director, Access Campaign, Médécins sans Frontières (MSF)
• Dr Catharina Boehme, Chief Executive Officer, FIND, Switzerland

Team preparing the workshop

• Anna Zorzet, PhD, Coordinator ReAct, Uppsala University
• Jonas Lundkvist, PhD, Senior Lecturer in Pharmacy, Uppsala University
• Martin Sundqvist, MD, PhD, Molecular Diagnostics, Örebro University Hospital
• Johan Struwe, MD, PhD, Expert, Public Health Agency of Sweden
• Madeleine Neil, MSc BA & Econ., Project Manager Uppsala Health Summit, Uppsala University

Workshop F: Antibiotics in Animal Production

Global livestock production is increasing rapidly. Satisfying increasing and changing demands for animal food products, while at the same time sustaining the natural resource base, is a major challenge to agriculture today, particularly in developing countries. Despite measures taken by some countries, antibiotic use in human and animals and agriculture is still increasing, and the projected increase in demand for animal food products may have a consequent impact on antibiotic use.

Antimicrobials are used in livestock production to treat sick animals, to protect healthy animals in contact with sick ones and during periods of transport or similar stresses. They are also used as growth promoters in some countries and production systems in the absence of clinical disease, which is controversial and has led to a number of countries limiting or banning antimicrobials used in this way.

Available data do not allow the quantification of the contribution of the use of antimicrobials in livestock to the development of resistance in human pathogens. However, it clearly affects the prevalence of resistant bacteria in animals.

The WHO Global Action Plan includes a clear strategy regarding the use of antibiotics in animal production: “A reduction in the consumption of antibiotics used in food production (terrestrial and aquatic livestock, and other agricultural practices) and reduction in the use in animals of antibiotics is critically important for human health. Progressive reduction (to zero) in the use of medical and veterinary antimicrobials for applications other than human and animal health.”

This strategy, in combination with the threat of increasing resistance among animal pathogens (rendering currently available antibiotics ineffective) means that there is an urgent need to reduce the need for antibiotics in animal production.

Workshop speakers:

• Henning Steinfeld, Professor, Coordinator Livestock Information, Sector Analysis and Policy Branch (AGAL), Food and Agricultural Organization of the United Nations (FAO); Stanford University
• Dick Heederik, Chair of the Expert Committee of the Netherlands Veterinary Medicines Authority; Professor, Institute for Risk Assessment Sciences, Utrecht University

Team preparing the workshop

• Susanna Sternberg Lewerin, Professor in Epizootiology & Disease Control, Swedish University of Agricultural Sciences
• Ulf Emanuelson, Professor in Veterinary Epidemiology, Swedish University of Agricultural Sciences
• Björn Bengtsson, DVM, PhD, Associate Professor, Swedish National Veterinary Institute
• Jan Erik Lindberg, Professor in Nutrition of Mono-gastric Animals, Swedish University of Agricultural Sciences
• Eva Wredle, PhD, Senior lecturer in Animal Nutrition and Management, Swedish University of Agricultural Sciences
• Niklas Nordquist, PhD, Research Officer, Swedish University of Agricultural Sciences