Advice Pool - Insurance

All insurance contracts are governed by the concept of ‘offer and acceptance’. This requires you to fill the proposal form and send it to the insurance comp

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

any. Sometimes you are also required to attach a check for the premium amount, with the proposal form.

Your filling the proposal form and sending it to the

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

insurance company is the ‘offer’ and when the insurance company accepts your proposal it is the ‘acceptance’ part of the concept. The amount you pay as prem

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ium is considered as the ‘consideration’ part of the contract. The concept of ‘legal capacity’ also applies to insurance contracts. It requires both the par

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ies to be legally capable of entering a contract. Your insurance contract is based on ‘legal purpose’, which means that the contact is not meant for encoura

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ing illegal activities. The other legal principles that govern the contracts are:

Principle of Indemnity:

This principle requires the insurer to pay an am

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ount, not more than the actual loss suffered, in case of loss. The amount paid as claim by the insurance company should not be more than the sum assured in

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

the insurance contract. The aim is to provide a claim amount that will help the claimant to regain the lost financial position. In some indemnity contracts,

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

the amount payable by the insurance company is subject to the amount of actual loss. Some indemnity contracts also have a provision for the claim to be paid

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

only if the actual loss exceeds a certain amount. For example, in an auto insurance contract of 3000 dollars, you would be eligible for the claim amount on

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

y if your actual loss exceeds 3000 dollars. In case, the actual loss amount is below 3000 dollars, you would be liable to bear all the costs.

Insurable Int

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

rest

In this insurance cover, the insurance contract covers only those properties or events specified at the time of investment. For example, if you live i

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

n your uncle’s house and apply for a homeowners’ insurance, the insurance company will reject the claim, since you are not the owner of the property and do

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ot suffer any personal financial loss in case the house gets damaged.

Principle of Subrogation

The principle of subrogation enables the insured to claim t

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

e amount from the third party responsible for the loss. It allows the insurer to pursue legal methods to recover the amount of loss, which the company has p

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

aid the insured via the insurance claim. For example, if you get injured in a road accident, due to reckless driving of a third party, the insurance company

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

will compensate your loss and will also sue the third party to recover the money paid as claim.

Doctrine of utmost good faith

This means that both the par

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ies are expected to disclose any information, important to the contract. For example, when applying for life insurance, it is your duty to disclose any perm

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

anent ailments that you might have. Likewise, your insurer also is expected to be clear on the illnesses that are not covered under the contract.

Once you

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ecome familiar with the principles, you will be able to understand the scope of your insurance contract. This makes you independent of the insurance advisor

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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