Download clinical trials liability insurance

CLINICAL TRIALS LIABILITY INSURANCE
COVERAGE
The policy provides compensation to clinical trials subjects/participants in the event of these
individuals suffering an injury which is directly attributable to their involvement in the trial. Cover
is provided on a no-fault basis, which means that the policy will be triggered if causation has been
proven.
THE NEED:
Research and Development (R&D) The pursuit of
drug discovery and pharmaceutical development
is inherently complex, time consuming, costly,
and fraught with risk. Increased governmental
regulation, competition and the push for rapid
drug development, combined with today’s litigious
business environment, is driving increased demand
for liability insurance cover.
Patient safety is of utmost importance in
pharmaceutical development but unavoidable
accidents can occur. Strict protocols must be
observed before a new medication can be ethically
approved and internationally regulators require that
the clinical trial sponsors carry clinical trials liability
cover in the event of trial-related injuries
to participants.
South Africa is no different - the National Health
Act No. 61 of 2003 and the SA Guidelines provide
the principles on which clinical trials are to be
conducted. The guidelines are related to the
regulatory requirements of the Medicines Control
Council. Section 4.11 of “The Guidelines for
Good Practice in the conduct of Clinical Trials in
Human Participants in South Africa” issued by the
Department of Health, requires that all participants
in clinical trials are covered by comprehensive
insurance (no-fault insurance) for injury and damage;
without which clinical trials cannot be conducted.
Clearly a high-risk area, clinical trial liability requires
unique coverage to provide the maximum insurance
protection. Considering that there are literally
tens of thousands of trials taking place on a global
scale today, and some predictions suggest a 10%
growth in this sector through to 2018, liability cover
opportunities in this market will expand exponentially
in the years ahead.
CLINICAL TRIALS LIABILITY INSURANCE
REDEFINING THE BOUNDARIES OF RISK MANAGEMENT,
NOW AND INTO THE FUTURE
THE SOLUTION:
Participation in clinical trials always carries some risk, including but not limited to: injuries resulting
from the research procedure, injuries caused by the administration of medication or medical
procedures, or an investigator’s failure to follow the protocol or to perform the procedures correctly.
Having adequate and properly executed coverage will protect not only the sponsor, but investors,
investigators and other parties involved in the management of the trial.
Camargue’s Clinical Trials Liability coverage provides unique protection. It offers the maximum
liability insurance for sponsors and practitioners involved in the trial, demonstrates prudent financial
management, protects the safety of test subjects and ensures the ethical behaviour of those to
whom the subjects have entrusted themselves for medical research.
Research companies, clinical trial service companies, including clinical trial facilitators, medical
device manufacturers, pharmaceutical manufacturers, biotechnology researchers and developers,
and contract research organisations should all ensure that the clinical trial with which they are
involved has this specialised liability coverage – it could ultimately result in protecting the clinical trial
from being halted mid-term due to the financial implications of a liability suit.
RISK MANAGEMENT SERVICES INCLUDED IN THE
POLICY COVER:
VALUE-ADDED SERVICES
Camargue’s unique M3 approach to insurance is
geared towards managing, mitigating and migrating
critical business risks – an outcome achieved
through the provision of value-added risk benefits
to policyholders. Notwithstanding the coverage
provided in terms of the policy, the additional risk
management benefits further enhance the Camargue
product offering and go way beyond simple
insurance. The overall result is a well-rounded and
complete solution to the risks faced by businesses.
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Private Arbitration Service:
Offered through TOKISO Dispute Settlement - this
service works towards fast, equitable resolution of
disputes between the insured and their clients. As far
as possible court proceedings are avoided saving time,
money and more importantly reputation