Answers - Insurance

Medical practitioners are often faced with lawsuits and claims for negligence and malpractice - a

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

n occupational hazard of being a medical practitioner. Hence, medical liability insurance that co

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

Examples of combination products may in

ers practitioners in case of such lawsuits and claims is very important for every kind of medical

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

professional.

There are many insurance companies that offer medical liability insurance. However

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

because of the mounting number of lawsuits and cases against medical practitioners, many of thes

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

Combination pro

companies have either stopped providing medical liability insurance or charge a heavy premium. T

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

is is because most of these companies have had to pay a lot in such claims or for legal expenses.

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

Thus, medical liability insurance in itself seems to have become a liability for most liability c

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

mpanies.

This has led to a kind of crisis within the medical community, more so in specialty are

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

s like orthopedics, with many practitioners choosing to retire early or to close practices becaus

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

of the unavailability of affordable medical liability insurance. This is causing other social pr

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

Following aspects would a

blems because it results in increasing costs of health care, making it harder for everyone.

Howe

dd to the challenges in developing combination products:

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

er there are many insurance companies that offer medical liability insurance, either directly thr

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

ugh their exclusive brokers and agents or through independent agents. Independent agents are thos

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

who are entitled to sell policies from different companies. These agents can help medical practi

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

ioners select the suitable policy from among the available policies.

Most of the insurance compa

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

Professional from academic institutions, pharmaceutical industries, health care indust

ies have compartments and segregations when it comes to charging premiums. For instance, an ortho

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

edic surgeon would be charged a different premium than a general practitioner. Usually these prem

.

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

um rates are fixed and are not negotiable. However, looking and shopping around with different co

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

Companies that provide selfless information through particip

panies will open up different options for someone who is shopping for medical liability insurance

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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Answers - Medical Liability Insurance

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