Declaration of the G7 Health Ministers:: 8 – 9 October 2015 in Berlin
G7 Germany
October 2015
1. In continuation of the G7 Summit in Elmau on 7 and 8 June 2015, we, the G7 Health Ministers, discussed the health topics Antimicrobial Resistance (AMR) and Ebola during our G7-Meeting in Berlin on 8 and 9 October 2015.
2. The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being. We are therefore strongly committed to continuing our engagement in this field with a specific focus on strengthening health systems through bilateral programmes and multilateral structures.
3. The G7 Health Ministers agreed on the following actions for the implementation of the G7 Leaders’ Declaration as outlined in the “Berlin Declaration on AMR” and “G7 Health Ministers’ Commitment – Lessons learned from Ebola”…
Berlin Declaration on Antimicrobial Resistance –
Global Union for Antibiotics Research and Development (GUARD)
Agreed by G7 Health Ministers in Berlin 2015
[Excerpt from 22 paragraphs]
…17. We will work, in collaboration with WHO, building on existing networks, to promote a global network of researchers; experts from academia, industry, healthcare, veterinary care, regulatory agencies, food safety and agriculture; philanthropic organizations; and international organizations to provide opportunities to exchange information on ongoing research activities, access to expertise for funded projects, and retention of accumulated knowledge. We welcome the initiative by Germany to organise the first expert meeting in 2016/2017.
18. Given the global nature of drug research, development and commercialisation and the global challenge antimicrobial resistance poses, we call for greater interaction and synergies between research initiatives. We see the need for global access to – and availability, affordability and rational use of – safe, effective and quality-assured antimicrobials. We will therefore explore the feasibility and need of setting up a global antibiotic product development partnership for new and urgently needed antibiotics, vaccine development, alternative therapies and rapid point of care diagnostics and seek collaboration with others such as WHO and Drugs for Neglected Disease Initiative (DNDi).
19. We encourage international cooperation on antimicrobial stewardship and regulatory dialogue on the approval and regulation for antibiotics. Convergence and harmonisation on technical requirements including for clinical trials and for the approvals for new antibiotics can help to bring new antibiotics faster to the market. In this perspective, we support the ongoing efforts in the wider context of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and its veterinary equivalent VICH and emphasise to take the special needs for antibiotics into account. We will take into account the recommendations and action areas of antibiotics of the Transatlantic Taskforce on Antimicrobial Resistance (TATFAR) as it enters the next five year implementation period.
20. We are committed to explore innovative economic incentives to enhance the research and development of new antibiotics, other therapeutic options, and diagnostics. We will investigate various instruments, such as a global antibiotic research fund and a market entry reward mechanism for truly new antibiotics targeting the most important pathogens and most needed for global public health. We recognise and commend the work of various reviews on AMR, such as the OECD, and other independent Reviews on AMR, tackling the lack of new antibiotics internationally and the initial proposals on how governments around the world could act collectively to stimulate innovation from a range of organisations, private or public, big or small.
21. We will continue close collaboration with our science ministers to advance these goals related to research and development, and invite other countries, international and philanthropic organizations to join this initiative.
22. We call for a High Level Meeting on AMR in 2016 at the United Nations General Assembly to promote increased political awareness, engagement and leadership on antimicrobial resistance among Heads of States, Ministers and global leaders.
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G7 Health Ministers’ Commitment – Lessons Learned from Ebola
Agreed by G7 Health Ministers in Berlin 2015
[Excerpt from 20 paragraphs]
…10. We support the ongoing work of the IHR Review Committee and look forward to the Committee’s findings on effectiveness and functioning of the International Health Regulations, as well as its recommendations for improvement, for instance, related to training, for innovative ways forward for standardized, transparent, and reliable instruments for effective monitoring and reporting under IHR. In this regard, we support a clear role for the WHO to assist countries in IHR implementation.
11. In order to prevent future outbreaks from becoming large-scale public health emergencies, the G7 Leaders have agreed to offer to assist at least 60 countries, including the countries of West Africa, over the next five years to implement the IHR, including through the Global Health Security Agenda (GHSA) and its common targets and other multilateral initiatives. By the end of 2015 we will, in collaboration with WHO, announce the countries that the G7 are collectively supporting or have consulted with or agreed plans to support to fulfill the Leaders’ commitment. This work is responding to country needs and entails building on existing in-country expertise and partnerships, programmes and projects. It is an integral part of an overall health systems strengthening agenda, which includes the development of basic health care systems as well as water, sanitation and hygiene programs. The initiative will be conducted in close cooperation and coordination with the WHO. We will continue also to work closely with other relevant institutions including the World Bank, the Global Fund to fight AIDS, Tuberculosis and Malaria, and Gavi, the Vaccine Alliance.
12. The serious domestic and international consequences of the Ebola virus disease outbreak have highlighted the need for a more effective global system of disease surveillance, allowing early event detection, in part through the development of rapid diagnostic tests and the
development of better risk modelling, prevention, and surveillance to trigger timely national and global responses. In the future, countries should be encouraged to immediately notify health risks to the WHO in accordance with the IHR, in addition to removing bureaucratic barriers to escalating early notifications at the local, country and global levels. We commend ongoing efforts of the African Union and its regional organizations to build up a surveillance system that will, in cooperation with WHO, be instrumental in the struggle against future disease.
13. In the research and development (R&D) response to the Ebola crisis, we identified a number of gaps and inefficiencies where actions are needed to prevent and manage future outbreaks. We stress that progress should be made as a matter of preparedness on lead candidate products (vaccines, treatments, diagnostics, and personal protective equipment) pre-established protocols, and capacity to ensure the ability to quickly move to advanced phase clinical trials, product development, and scaled-up product manufacturing, which may only be performed when the outbreak occurs. We highlight the need for a more comprehensive applied and translational research in partnership with at-risk countries. We underline the importance of direct collaboration between countries and health research funders, and we call for continued financing, collaboration and coordination on their collective response to emerging epidemics of global concern, including through initiatives such as the proposed WHO blueprint for research and development preparedness and rapid research response during future public health emergencies and the Global Research Collaboration for Infectious Disease Preparedness (GloPID-R).
14. We are convinced that it is essential to ensure that country-owned research is enhanced, including non-medical research such as social, behavioural, medical anthropology, and communication research. We consider that a broad range of capacity-building is needed in developing countries afflicted by or at risk of serious infectious disease outbreaks. It also requires training of research workers and of health staff extending down to the local level. It is important to ensure that epidemiological and, wherever possible, relevant trial information data is shared openly and transparently and shared early in the event of a public health emergency. It is also important to ensure good coordination and prioritisation of timely access to biological materials and clinical samples for research in accordance with national and international legal frameworks.
15. We recognise global gaps in medical facility infection control and related occupational health and safety frameworks designed to protect and train healthcare workers. Healthcare workers are critical national assets at the front line of initial epidemic detection and containment. Enhanced, national occupational health and safety administrations play a key role in the development of resilient, sustainable, and ready health systems.
16. The Ebola crisis has demonstrated a critical lack of safe and effective systems for deployment of medical experts to public health emergencies of this nature, in particular around insurance, medical evacuation and safe return to work post-deployment. It has also highlighted a lack of standard procedures and protocols across deployable teams which limits their inter-operability. Therefore, we will support national and international efforts, including the WHO’s global health emergency workforce, to provide a sustainable multi-disciplinary pool of experts. WHO should play a central role in coordination and facilitating the deployment of these experts. We welcome the process of developing one such initiative within the European Union (EU) (European Medical Corps), which will provide certain capacities to the global health emergency workforce.
17. We recognize the valuable recommendations of the WHO Ebola Interim Assessment Panel and the reform measures adopted by the 68th World Health Assembly in May 2015 – including the establishment of a contingency fund and the decision to establish a global health emergency workforce, making use of existing and strengthened partner mechanisms. We share the assessment that the WHO needs to be strengthened, and we support the reform process to make WHO fit for purpose to effectively fulfil its core functions in health emergencies.
18. We commit ourselves to strengthening WHO in order to better perform its leadership coordination roles on global health issues, and particularly in the face of epidemic threats, global health security, and the necessary support to countries in their efforts to be better prepared for global health crises. We share the view that the WHO must re-establish itself as the authoritative body, providing leadership, and coordinating the international preparedness for and response to health emergencies. This includes informing governments and the public around the world about the extent and severity of an outbreak as rapidly and as comprehensively as possible.
19. It is important that financial resources and mechanisms be strengthened, both within the WHO and elsewhere, to ensure timely, effective and coordinated response to disease outbreaks. Therefore, along with WHO’s Contingency Fund, we support the initiative by the World Bank to develop a Pandemic Emergency Facility…
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