Advice You - Finance

In 2005, over 20,000 people in the UK avoided bankruptcy and succeeded in clearing thei

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

r debts. This article discusses how they were able to do so and why the 15,389 people

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

Examples of combination products may in

who filed for bankruptcy at the beginning of this year should have checked out the alte

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

rnatives first.

In 1986, the government introduced a scheme called an Individual Volun

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

ary Arrangement, or IVA for short. IVAs were designed to give people a legitimate alter

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

Combination pro

native to bankruptcy.

The government understood that although bankruptcy had numerous

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

disadvantages attached to it, for many debtors it seemed to be the only option. It ther

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

efore set up IVAs to give people a way to both avoid bankruptcy and clear their debts.

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

An IVA is a formal and private arrangement between a debtor and his/her creditors. As a

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

result, there is no stigma attached to an IVA in the way there is with bankruptcy beca

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

use no-one else needs to know about it.

If an IVA is agreed, interest on the debts fro

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

Following aspects would a

zen. This is very different to a debt management plan which many people set up as a way

dd to the challenges in developing combination products:

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

of trying to avoid bankruptcy. With a debt management plan, interest can continue to ac

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

crue on your debts even when the plan is in place.

An IVA allows debtors to pay off th

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

eir debts via affordable monthly repayments over a five year period. These can be as lo

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

w as ?200 a month. Moreover, it is usual for a certain amount of your debt to be writte

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

Professional from academic institutions, pharmaceutical industries, health care indust

off altogether with an IVA.

After the five years have expired and providing that you

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

have adhered to the terms of your IVA, you are declared debt free.

An IVA offers a ver

.

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

y good way to avoid bankruptcy and its negative repercussions. Once an IVA has been set

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

Companies that provide selfless information through particip

up, your creditors are not allowed to contact you and interest on your debts is frozen

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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Advice You - How to Avoid Bankruptcy and Clear Your Debts

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