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CHHS-MARCE Public Health Preparedness Conference Laboratory Safety, Security and Preparedness in the Evolving Era of Dual Use Research of Concern (DURC) February 10, 2014 Universities at Shady Grove Conference Center Towards a Global Governance Structure for Infectious Diseases Harvey Rubin, MD, PhD University of Pennsylvania Philadelphia, Pennsylvania
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Page 1: CHHS-MARCE Public Health Preparedness Conference Laboratory Safety, Security and Preparedness in the Evolving Era of Dual Use Research of Concern (DURC)

CHHS-MARCE Public Health Preparedness Conference Laboratory Safety, Security and Preparedness in the

Evolving Era of Dual Use Research of Concern (DURC) February 10, 2014

Universities at Shady Grove Conference Center

Towards a Global Governance Structure for Infectious Diseases

Harvey Rubin, MD, PhDUniversity of PennsylvaniaPhiladelphia, Pennsylvania

Page 2: CHHS-MARCE Public Health Preparedness Conference Laboratory Safety, Security and Preparedness in the Evolving Era of Dual Use Research of Concern (DURC)

H5N1? No Official Governing Body…

“Most of us are unequivocal about the value of the research. But deciding what to do with these types of studies is complicated. At the moment, there are no official governing bodies to regulate such decisions. They rely on the good will of the researcher”

Anthony S. Fauci, Chief, Institute of Allergy and Infectious Disease, NIH.Quoted in The Deadliest Virus by Michael Specter. The New Yorker. March 12,

2012

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The Big Question: Is there a crisis?

UK House of Lords

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The Global Burden of Disease Study

infectious diseases accounts for 22% of all deaths and 27% of disability adjusted life years (DALYs)

disproportionate impact on the developing world where

infectious diseases account for 52% of deaths and 50% DALYs in sub-Saharan Africa and only 11% of deaths and 5% of DALYs in established market economies

(Globalization and Infectious Diseases: A review of the linkages. found at http://www.who.int/tdr/cd_publications/pdf/seb_topic3.pdf).

Page 5: CHHS-MARCE Public Health Preparedness Conference Laboratory Safety, Security and Preparedness in the Evolving Era of Dual Use Research of Concern (DURC)

The overall situation in controlling infectious diseases has deteriorated for a number of interrelated reasons: 1

Biological: 1) increase in antibiotic resistant bacterial infections, 2) increase in zoonotic and foodborne infections

Preventing the Spread of Multidrug-Resistant Gram-Negative Pathogens: Recommendations of an Expert Panel of the German Society for Hygiene and MicrobiologyDtsch Arztebl Int 2012; 109(3): 39-45; DOI: 10.3238/arztebl.2012.0039

H. Rubin House of Lords testimony May 2008

Page 6: CHHS-MARCE Public Health Preparedness Conference Laboratory Safety, Security and Preparedness in the Evolving Era of Dual Use Research of Concern (DURC)

Governmental/policy/infrastructure: 1)absence of harmonized regulatory processes hinders rapid development of anti-infective agents

2) disparities in distribution of anti-infective agents to clinics and to patients

3) inadequate rapid and accurate diagnostic testing in the developing world

4) insufficient number of well-trained medical workers

5) unsafe/poorly secured containment and storage facilities

The overall situation in controlling infectious diseases has deteriorated for a number of interrelated reasons: 2

Page 7: CHHS-MARCE Public Health Preparedness Conference Laboratory Safety, Security and Preparedness in the Evolving Era of Dual Use Research of Concern (DURC)

Governmental/policy/infrastructure:

5) national insurgencies and failed states worsen the global communicable disease situation

6) globalization and environmental/climate changes alter patterns of communicable diseases

8) agencies that work for increased access to anti-infective agents must coordinate goals and policies with agencies that work to limit the emergence of resistance to anti-infective agents

The overall situation in controlling infectious diseases has deteriorated for a number of interrelated reasons: 3

Page 8: CHHS-MARCE Public Health Preparedness Conference Laboratory Safety, Security and Preparedness in the Evolving Era of Dual Use Research of Concern (DURC)

Corporate/financial: 1) sparse pipeline of new molecular entities that lead to effective anti-infective agents

2) global financial crises divert scarce resources from health related issues

Research/information: 1) underfunded research to develop antibacterial, anti-fungal and anti-parasitic

agents 2) global infectious disease surveillance and reporting are generally incomplete,

not shared, not interoperable, and not real-time 3) new research in synthetic biology forms an entirely new threat space--

creation of new infectious agents reintroduction of infectious agents that no longer exist in nature generation of infectious agents that exist in nature but are hard to isolate

The overall situation in controlling infectious diseases has deteriorated for a number of interrelated reasons: 4

Page 9: CHHS-MARCE Public Health Preparedness Conference Laboratory Safety, Security and Preparedness in the Evolving Era of Dual Use Research of Concern (DURC)

Illegal activities: 1) Increase in counterfeit drugs contribute substantially to the spread and emergence

of drug resistance of communicable diseases

Social unrest: 1) social disruptions hinder or completely prevent adequate response and mitigation

of an an infectious disease outbreak

The overall situation in controlling infectious diseases has deteriorated for a number of interrelated reasons: 5

Page 10: CHHS-MARCE Public Health Preparedness Conference Laboratory Safety, Security and Preparedness in the Evolving Era of Dual Use Research of Concern (DURC)
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“Therefore it is not an exaggeration to speak of a crisis; on the contrary it is a moral, medical, economic and political imperative to raise these issues at the highest level of government.”

H. Rubin: House of Lords testimony May 2008

The Answer to The Big Question: Is there a crisis?

Page 15: CHHS-MARCE Public Health Preparedness Conference Laboratory Safety, Security and Preparedness in the Evolving Era of Dual Use Research of Concern (DURC)

How Should the International Community Respond to the Crisis?

Current Science. 96, 658-663, 2009.

Think BIG Specific Implementation Plans

Page 16: CHHS-MARCE Public Health Preparedness Conference Laboratory Safety, Security and Preparedness in the Evolving Era of Dual Use Research of Concern (DURC)

International Compact for Infectious Diseases: Four Interconnected Components

Page 17: CHHS-MARCE Public Health Preparedness Conference Laboratory Safety, Security and Preparedness in the Evolving Era of Dual Use Research of Concern (DURC)

Big Problems Can Be Solved in Small Bits:The Specific Problem of Vaccine Distribution in the Context of

Global Preparedness

Page 18: CHHS-MARCE Public Health Preparedness Conference Laboratory Safety, Security and Preparedness in the Evolving Era of Dual Use Research of Concern (DURC)

The Problem

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• Save 9 million deaths each year

• Reduce disease, disability, death and inequality worldwide

• Improve public health & productivity (GDP per capita)

• Eradicate century old diseases like Polio

Vaccines are the single most cost-effective global health program (WHO)

Yet…2-4 million people STILL die each year from

vaccine-preventable diseases19

Page 20: CHHS-MARCE Public Health Preparedness Conference Laboratory Safety, Security and Preparedness in the Evolving Era of Dual Use Research of Concern (DURC)

Cold Chain

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No power to keep vaccines cold?---WRONG!

Page 22: CHHS-MARCE Public Health Preparedness Conference Laboratory Safety, Security and Preparedness in the Evolving Era of Dual Use Research of Concern (DURC)

• Background– Mobiles cover over 75% of the world– 2/3 by developing countries– Cell towers are the only type of

infastructure in many rural areas– Research shows these towers may

generate up to 10 kWh of excess electricity daily

• Application– Harness electricity from rural cell towers

to provide stable power for co-located vaccine refrigerators and freezers

Our Solution

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http://www.energizethechain.org/

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Energy Accessibility• The International Energy Agency

estimated in 2011 that 1.3 billion people lack access to electricity.– More than 95% of these people are in sub-

Saharan African or developing Asia and 84% are in rural areas

Power Stability in Rural India (Samant, 2007):

90% of local health centers suffered frequent power failures45% of local centers had back-up generators50% of sub-centers 71-90 km away are compliant

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Using Remote Monitoring System (RMS) to track site location, usage, the number/times fridge door opens, and open durations

Page 29: CHHS-MARCE Public Health Preparedness Conference Laboratory Safety, Security and Preparedness in the Evolving Era of Dual Use Research of Concern (DURC)

Energize the Chain - Rerouting power, Reshaping lives

http://vimeo.com/65549347

Page 30: CHHS-MARCE Public Health Preparedness Conference Laboratory Safety, Security and Preparedness in the Evolving Era of Dual Use Research of Concern (DURC)

ETC + UNICEF: Energy & Connectivity for Health

New York, 12 June 2013“UNICEF is intensifying all our efforts, in every country, to reach the hardest to reach, most isolated communities. This approach, in turn, is not only consistent with, but a vital element in our immunization efforts… We cannot rest until we reach these children – in time to prevent the deaths of the nearly two million children who die every year for simple want of a simple vaccine.”                                                                                                                                                                Tony Lake, Executive Director, UNICEF

Strategies for Success:Health worker motivationCommunity participation and ownershipPublic-private partnershipsGovernment ownership and commitmentGovernment Energy policies and operations (e.g., resource mapping)Corporate social responsibilityTechnologies must be user-focused and locally manageable

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ETC has working partnerships with nonprofits & private

telecom companies

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http://www.istar.upenn.edu

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International staff

Established on solid base of research and

practice Promote knowledge of

justice/law peace, security, social and

economic developmentSynthesize national and international knowledge

Convene across disciplines: science,

policy, law

Cultivate inclusive vision of issues

Located amid treaty organisations devoted to international law

Endorse the need for a Global Governance

Structure for Infectious Diseases

GLOBAL GOVERNANCE STRUCTURE FOR INFECTIOUS DISEASES Implementation Matrix

OTHER

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Example 2 The UN

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Special Consultative Status

1) provide expert analysis on issues directly from our experience in the field 2) monitor and implement international agreements 3) play a major role in advancing United Nations' goals and objectives4) attend and participate in UN meetings and conferences 5) submit written and oral statements relevant to the work of the Economic and Social Council (ECOSOC) and its subsidiary bodies 6) organize our own events at UN locations7) maintain five annual grounds passes for our staff to United Nations' premises in New York, Geneva, Vienna, and Nairobi


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