1
Hawaiian Islands (USA) G u l f O f A d e n R e d S e a T h e G u l f Caribbean Sea North Sea Timor Sea Tasman Sea East Siberian Sea Bering Sea Sea Of Japan East China Sea South China Sea Pacific Ocean M e d i t e r r a n e a n S e a C a s p i a n S e a Bay Of Bengal Arabian Sea Black Sea Gulf Of Mexico Pacific Ocean Atlantic Ocean Indian Ocean Arctic Ocean Sea Of Okhotsk Barents Sea Kara Sea Laptev Sea Norwegian Sea Beaufort Sea Hudson Bay Baffin Bay Davis Strait Atlantic Ocean Southern Ocean Scotia Sea Ascension Island (Uk) St. Helena (Uk) Netherlands Antilles (Nl) Falkland Islands (Uk) Reunion Islands (Fr) Cayman Islands (UK) New Caledonia (Fr) Sao Tome & Principe Tahiti United Arab Emirates Latvia Ghana French Guiana (Fr) Cabinda (Angola) Melilla (Spain) Gibraltar (UK) Ceuta (Spain) Canada United States Of America Mexico Belize Honduras Nicaragua El Salvador Guatemala Costa Rica Panama Bahamas Haiti Dominican Rep Jamaica St. Kitts & Nevis Antigua & Barbuda Anguilla Virgin Islands (US) Dominica St. Lucia Barbados Grenada Trinidad & Tobago Guyana Suriname Venezuela Colombia Ecuador Peru Bolivia Brazil Paraguay Uruguay Argentina Chile Greenland Iceland United Kingdom Ireland Northern Ireland France Spain Germany Italy Norway Sweden Denmark Netherlands Belgium Guernsey Isle of Man Luxembourg Liechtenstein Monaco San Marino Vatican Andorra Portugal Austria Hungary Poland Ukraine Belarus Estonia Finland Romania Montenegro Moldova Bulgaria Bosnia Albania Serbia F.Y.R. Macedonia Greece Malta Cyprus Lebanon Palestine Israel Syria Jordan Turkey Egypt Libya Algeria Tunisia Mali Western Sahara (Morocco) Niger Chad Sudan Mauritania Morocco Cape Verde Guinea Burkina Faso Benin Cameroon Gabon Central African Republic Nigeria Uganda Zambia Namibia Botswana Zimbabwe South Africa Tanzania Madagascar Mozambique Ethiopia Kenya Eritrea Yemen Oman Bahrain Qatar Saudi Arabia India Bhutan Burma (Myanmar) Sri Lanka Maldives Seychelles Comoros Mauritius Thailand Cambodia Vietnam Macau Hong Kong Singapore Brunei Russia Kazakhstan Mongolia China Uzbekistan Turkmenistan Tajikistan Afghanistan Kyrgyzstan Azerbaijan Georgia Armenia Pakistan Iran Iraq Malaysia Indonesia Japan North Korea South Korea Taiwan Philippines Micronesia Palau Guam Papua New Guinea Timor Leste Solomon Islands Vanuatu Fiji New Zealand Tasmania Samoa Niue (Nz) French Polynesia Tonga Australia South Australia St. Vincent Aruba Kiribati Tuvalu Nauru Marshall Islands (Usa) Alaska (US) Togo Cote D'ivoire Congo Angola Cuba Djibouti Laos Nepal Bangladesh Somalia Eq Guinea Gambia Guinea Bissau Lesotho Liberia Burundi Rwanda Malawi Senegal Sierra Leone Swaziland Slovakia Czech Rep Lithuania Slovenia Switzerland Puerto Rico (US) Bermuda (UK) Croatia Guadeloupe (Fr) Democratic Republic Of Congo Kuwait Aon Life Sciences Clinical Trials Risk Map Aon Risk Solutions Life Sciences Group 6 th Edition Aon Life Sciences Group One Liberty Place 1650 Market Street, Suite 1000 Philadelphia, PA 19103 t: 1+215.255.1857 e: [email protected] About Aon Aon plc (NYSE:AON) is a leading global professional services firm providing a broad range of risk, retirement and health solutions. Our 50,000 colleagues in 120 countries empower results for clients by using proprietary data and analytics to deliver insights that reduce volatility and improve performance. © Aon plc 2018. All rights reserved. The information contained herein and the statements expressed are of a general nature and are not intended to address the circumstances of any particular individual or entity. Although we endeavor to provide accurate and timely information and use sources we consider reliable, there can be no guarantee that such information is accurate as of the date it is received or that it will continue to be accurate in the future. No one should act on such information without appropriate professional advice after a thorough examination of the particular situation. www.aon.com GDM05431 Aon Life Sciences Clinical Trials Risk Map The globalization of clinical trials continues to be on the rise, leading to a plethora of regulatory and operational challenges for the Life Sciences industry. Aon’s 6th edition Clinical Trials Risk Map highlights clinical trials insurance regulations and complexities for over 80 countries throughout the world leveraging Aon’s global network and clinical trials expertise. Our global network is positioned to help life sciences companies efficiently and effectively secure international clinical trials coverage that complies with the regulatory requirements of individual countries, ultimately minimizing the risk of financial volatility. Aon Life Sciences Group The Aon Life Sciences Group has been assisting life sciences companies with securing international clinical trials insurance for over 30 years. We have the largest equity-owned global network in the world, housing clinical trials specialists who provide our life sciences clients with industry-leading expertise and accountability. Our experts constantly review country-by-country clinical trials regulations in order to provide our clients with industry-leading risk management advisory and brokerage services. Symbols Illustrating Clinical Trials Insurance Characteristics Compulsory Clinical Trials Insurance Requirements Key to Symbols Medical Malpractice is a Standard Policy Extension Foreign Entity may be Listed as Named on a Local Policy High Compulsory Limit of Liability = >$5MM Compulsory Aggregate Limit of Liability = <$5MM Admitted Insurance Laws May Apply No Compulsory Clinical Trials Requirements Compulsory by Law Compulsory by Law with high ERP or/and LoT No Data Available Coverage is Available on a No Fault Basis Standard Clinical Trials Insurance Coverage may not include Trial Participant Pre-Enrollment Screening Clinical Trials Insurance Policies allow Direct Reimbursements to Trial Participants Required as per local guidelines and/or standard practice Symbol Definitions: Compulsory Clinical Trials Insurance Requirements: Government-mandated clinical trial liability insurance, evidence of which must be provided by sponsors to regulators before regulatory authorities will grant approval to commence the trial. Extended Reporting or Life-of-Trial Requirements: Government-mandated insurance regulations requiring that clinical trials insurance include extended reporting or “tail” liability for a period of time following the completion of a clinical trialor Life-of-Trial coverage. Compulsory Limit of Liability: Government-regulated clinical trial insurance with limit of liability requirements (in some countries limit requirements vary by trial size/number of human subjects). High Compulsory Limit of Liability: Government-regulated clinical trial insurance with limit of liability requirements in excess of $5 million (in some countries limit requirements vary by trial size/number of human subjects). Medical Malpractice is a Standard Policy Extension: Professional liability coverage for trial investigators as part of their participation in the study is a standard coverage under thelocal clinical trials liability policy. Coverage is Available on a No Fault Basis: A type of clinical trial liability policy under which insureds areindemnified for losses regardless of fault. Foreign Entity may be Listed as a Named Insured on a Local Policy: A foreign sponsor can be listed as the named insured under the localclinical trial liability policy without the need of a local legal representative. Admitted Insurance Requirements May Apply: Local country law requires that insurance be purchased from an admitted or locally licensed insurance company in the country in which the clinical trial is being conducted. Aon Office: Countries where Aon has a physical presence (in one or multiple cities) and can assist life sciences clients in obtaining local clinical trial insurance and can provide input on local customs and regulations. The information contained in this map is based on Aon experience as of the publishing date (04/18). The environment (both regulatory and practical) for clinical trials is constantly changing and this map should not be solely relied upon without further consultation from an Aon Life Sciences professional. In addition, ethics committees, regulatory authorities and published guidelines within individual countries can differ depending upon individual study requirements and the views of individual regulators and ethics committees.

Life Sciences Group Aon Life Sciences Clinical Trials Risk Map

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Page 1: Life Sciences Group Aon Life Sciences Clinical Trials Risk Map

HawaiianIslands (USA)

Gulf Of A

den

Red Sea

The Gul f

Car ibbean Sea

Nor thSea

T imorSea

TasmanSea

East S iber ian Sea

Ber ing Sea

Sea OfJapan

EastChina

Sea

SouthChina

Sea

Pacific Ocean

Mediter raneanSea

Caspian Sea

Bay Of Bengal

Arabian Sea

BlackSea

Gulf Of Mexico

Pacific Ocean

At lant ic Ocean

Indian Ocean

Arct ic Ocean

Sea OfOkhotsk

Barents Sea

Kara SeaLaptev Sea

Nor wegian Sea

Beaufor t Sea

Hudson Bay

Ba�n Bay

Davis St rait

At lant ic Ocean

Southern OceanScot ia Sea

Ascension Island (Uk)

St. Helena (Uk)

NetherlandsAntilles (Nl)

FalklandIslands (Uk)

Reunion Islands (Fr)

CaymanIslands (UK)

New Caledonia (Fr)

Sao Tome & Principe

Tahiti

United Arab Emirates

Latvia

Ghana

French Guiana (Fr)

Cabinda (Angola)

Melilla (Spain)

Gibraltar (UK)Ceuta (Spain)

Canada

United StatesOf America

Mexico

Belize

Honduras

NicaraguaEl Salvador

Guatemala

Costa Rica

Panama

Bahamas

HaitiDominican Rep

Jamaica

St. Kitts&

Nevis

Antigua & Barbuda

Anguilla

Virgin Islands (US)

DominicaSt. Lucia

Barbados

Grenada

Trinidad & Tobago

Guyana

Suriname

Venezuela

Colombia

Ecuador

Peru

Bolivia

Brazil

Paraguay

Uruguay

ArgentinaChi

le

Greenland

Iceland

UnitedKingdom

Ireland

NorthernIreland

France

Spain

Germany

Italy

Norway

Swed

en

Denmark

Netherlands

Belgium

Guernsey

Isle of Man

Luxembourg

Liechtenstein

MonacoSan Marino

VaticanAndorra

Port

ugal

Austria Hungary

Poland

Ukraine

Belarus

Estonia

Finland

Romania

Montenegro

Moldova

Bulgaria

Bosnia

Albania

Serbia

F.Y.R. Macedonia

Greece

Malta

CyprusLebanon

Palestine

Israel

Syria

Jordan

Turkey

EgyptLibya

Algeria

Tunisia

Mali

Western Sahara(Morocco)

Niger

Chad

Sudan

Mauritania

Morocco

Cape Verde

Guinea

BurkinaFaso

Benin

Cameroon

Gabon

CentralAfrican Republic

Nigeria

Uganda

Zambia

Namibia

Botswana

Zimbabwe

SouthAfrica

Tanzania

Madagascar

Mozambique

Ethiopia

Kenya

EritreaYemen

Oman

Bahrain

Qatar

SaudiArabia India

Bhutan

Burma(Myanmar)

Sri Lanka

Maldives

Seychelles

Comoros

Mauritius

Thailand

Cambodia

Vietnam

MacauHong Kong

Singapore

Brunei

Russia

Kazakhstan

Mongolia

China

Uzbekistan

TurkmenistanTajikistan

Afghanistan

KyrgyzstanAzerbaijan

Georgia

Armenia

Pakistan

IranIraq

Malaysia

Indonesia

Japan

North Korea

South Korea

Taiwan

Philippines Micronesia

Palau

Guam

Papua NewGuinea

Timor Leste

Solomon Islands

VanuatuFiji

New Zealand

Tasmania

Samoa

Niue (Nz)French

Polynesia

Tonga

Australia

South Australia

St. VincentAruba

Kiribati

Tuvalu

Nauru

Marshall Islands(Usa)

Alaska (US)

Togo

Cote D'ivoire

Congo

Angola

Cuba

Djibouti

Laos

Nepal

Bangladesh

Somalia

Eq Guinea

Gambia

Guinea Bissau

Lesotho

Liberia

Burundi

Rwanda

Malawi

Senegal

Sierra Leone

Swaziland

Slovakia

Czech Rep

Lithuania

Slovenia

Switzerland

Puerto Rico (US)

Bermuda (UK)

Croatia

Guadeloupe (Fr)

Democratic RepublicOf Congo

Kuwait

Aon Life Sciences Clinical Trials Risk Map Aon Risk Solutions | Life Sciences Group1+215.255.1857

[email protected]

© Copyright Aon plc 2018. All rights reserved. Published by Aon Global Corporate Marketing and Communications.

The information contained in this map is based on Aon experience as of the publishing date (04/18). The environment (both regulatory and practical) for clinical trials is constantly changing and this map should not be solely relied upon without further consultation from an Aon Life Sciences professional.In addition, ethics committees, regulatory authorities and published guidelines within individual countries can di�er depending upon individual study requirements and the views of individual regulators and ethics committees.

Aon Life Sciences Clinical Trials Risk Map

Aon Risk Solutions Life Sciences Group

6th Edition

Aon Life Sciences GroupOne Liberty Place1650 Market Street, Suite 1000Philadelphia, PA 19103t: 1+215.255.1857e: [email protected]

About Aon Aon plc (NYSE:AON) is a leading global professional services firm providing a broad range of risk, retirement and health solutions. Our 50,000 colleagues in 120 countries empower results for clients by using proprietary data and analytics to deliver insights that reduce volatility and improve performance.

© Aon plc 2018. All rights reserved.The information contained herein and the statements expressed are of a general nature and are not intended to address the circumstances of any particular individual or entity. Although we endeavor to provide accurate and timely information and use sources we consider reliable, there can be no guarantee that such information is accurate as of the date it is received or that it will continue to be accurate in the future. No one should act on such information without appropriate professional advice after a thorough examination of the particular situation.

www.aon.com

GDM05431

Aon Life Sciences Clinical Trials Risk MapThe globalization of clinical trials continues to be on the rise, leading to a plethora of regulatory and operational challenges for the Life Sciences industry. Aon’s 6th edition Clinical Trials Risk Map highlights clinical trials insurance regulations and complexities for over 80 countries throughout the world leveraging Aon’s global network and clinical trials expertise. Our global network is positioned to help life sciences companies efficiently and effectively secure international clinical trials coverage that complies with the regulatory requirements of individual countries, ultimately minimizing the risk of financial volatility.

Aon Life Sciences GroupThe Aon Life Sciences Group has been assisting life sciences companies with securing international clinical trials insurance for over 30 years. We have the largest equity-owned global network in the world, housing clinical trials specialists who provide our life sciences clients with industry-leading expertise and accountability. Our experts constantly review country-by-country clinical trials regulations in order to provide our clients with industry-leading risk management advisory and brokerage services.

Symbols Illustrating Clinical TrialsInsurance Characteristics

Compulsory Clinical TrialsInsurance Requirements

Key to Symbols

Medical Malpractice is a Standard Policy Extension

Foreign Entity may be Listed as Named on a Local Policy

High Compulsory Limit of Liability = >$5MM

Compulsory AggregateLimit of Liability = <$5MM

Admitted Insurance LawsMay Apply

No CompulsoryClinical Trials Requirements

Compulsory by Law

Compulsory by Law with high ERP or/and LoT

No Data Available Coverage is Available on a No Fault Basis

Standard Clinical Trials Insurance Coverage may not include Trial

Participant Pre-Enrollment Screening

Clinical Trials Insurance Policies allow Direct Reimbursements

to Trial Participants

Required as per local guidelines and/or standard practice

Symbol Definitions:

Compulsory Clinical Trials Insurance Requirements:Government-mandated clinical trial liability insurance, evidenceof which must be provided by sponsors to regulators beforeregulatory authorities will grant approval to commence the trial.

Extended Reporting or Life-of-Trial Requirements:Government-mandated insurance regulations requiring thatclinical trials insurance include extended reporting or “tail” liability for a period of time following the completion of a clinical trial or Life-of-Trial coverage.

Compulsory Limit of Liability:Government-regulated clinical trial insurance with limit of liabilityrequirements (in some countries limit requirements vary bytrial size/number of human subjects).

High Compulsory Limit of Liability:Government-regulated clinical trial insurance with limit of liabilityrequirements in excess of $5 million (in some countries limitrequirements vary by trial size/number of human subjects).

Medical Malpractice is a Standard Policy Extension:Professional liability coverage for trial investigators as part of their participation in the study is a standard coverage under the local clinical trials liability policy.

Coverage is Available on a No Fault Basis:A type of clinical trial liability policy under which insureds are indemnified for losses regardless of fault.

Foreign Entity may be Listed as a Named Insured on a Local Policy:A foreign sponsor can be listed as the named insured under the local clinical trial liability policy without the need of a local legal representative.

Admitted Insurance Requirements May Apply:Local country law requires that insurance be purchased from an admitted or locally licensed insurance company in the country in which the clinical trial is being conducted.

Aon Office:Countries where Aon has a physical presence (in one or multiple cities) and can assist life sciences clients in obtaining local clinical trial insurance and can provide input on local customs and regulations.

The information contained in this map is based on Aon experience as of the publishing date (04/18). The environment (both regulatory and practical) for clinical trials is constantly changing and this map should not be solely relied upon without further consultation from an Aon Life Sciences professional. In addition, ethics committees, regulatory authorities and published guidelines within individual countries can differ depending upon individual study requirements and the views of individual regulators and ethics committees.