Page 47 - Insurance Times June 2021

Compensation payable in case of lapses: General extensions available:
The compensation for death or injury caused to the subject The following extensions are allowed (subject to the terms/
due to clinical trial would be as follows: exceptions and conditions contained in the policy) -
1. In case of injuries occurring in a trial subject, he/she 1) Indemnity to Principal: As far as is necessary to meet
shall be provided with free medical management as the requirements of any contract or agreement
long as required to recover from the injury entered into by the insured with any principal the
insurance company will at the request of the insured
2. In case the injury occurring to trial subjects is due to treat the principal as though they were also the insured
the clinical trial, subjects shall be also entitled to but only in respect of liability(as provided under the
financial compensation, which will be over and above policy) arising out of the performance of such contract
any expenses incurred due to medical management of by the insured in connection with the business provided
the subject that the principal shall observe fulfill and be subject to
3. In case of death occurring in the trial subjects, their the terms of the policy in so far as they apply.
nominees would be entitled to financial compensation, 2) Cross Liabilities: Where there is more than one insured
which will be over and above any expenses incurred due is involved in the policy then this policy shall apply to
to the medical management of the subject. each insured as though a separate policy has been issued
to each provided always that the total liability of the
4. All expenses of medical management and financial
insurer shall not exceed the limits of indemnity.
compensation, in case of trial-related injury or death,
shall be borne by the sponsor of the clinical trial. 3) Discovery: In the event of the insurer:
a) Canceling or refusing to renew this section for any
Critical issues in clinical trial liability reason other than -
i) non-payment of premium;
insurance: ii) any act of fraud or dishonesty;
There are several issues relating to clinical trial insurance
iii) non-disclosure of material fact;
that need to be addressed as below:
or, b) agreeing to the renewal or replacement of this
1. Cover for failure of investigational product to provide
section but requiring to impose exceptions or
therapeutic effect. The insurance policy being offered
conditions that are not contained herein;
specifically excludes cover for "non-efficacy of the
product". or, c) increasing the premium by 300%or more;
2. The revised notification increases the liability The insurer will provide an indemnity to the insured subject
substantially, both in terms of compensation payable
to the terms , conditions and limitations of the policy in
and the medical expenses which need to be incurred
respect of any claim which is first made in writing against the
till the lifetime of the individual. While insurance insured and notified to the insurer during a period of twelve
companies are not averse to granting cover as per the months immediately following the final period of insurance
revised compensation structure, they are reluctant to as if the claim had been made against the insured and notified
extend cover as proposed for the medical expenses. to the insurer during the final period of insurance except
3. There is reluctance of Indian & even for the overseas where otherwise stated in proviso(v) below.
insurance companies to offer "worldwide jurisdiction"
cover. Provided always that:-
i) The indemnity will not apply where indemnity is
4. Obviously various cumbersome procedures are involved
provided by any other insurance or by virtue of
in offering multi-trial policy. extension (4) below.
5. Stem cell therapy aspects are always required to be ii) The total amount payable for all claims made
covered by a separate policy. during the final period of insurance and claims
6. Absence of standard structured premium rates and deemed to have been so made by virtue of the
standardized excess/deductibles that are applicable for terms of this extension shall not exceed the limit
this policy. of indemnity for the final period of insurance.

The Insurance Times, June 2021 47