Advice You - Finance

If you are facing serious debt problems then you might have or be considering filing for bankruptcy. If this is the case you s

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

hould be aware of the disadvantages associated with going bankrupt and only do so as a last resort. In this article we shall

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

Examples of combination products may in

discuss some of the main disadvantages of filing for bankruptcy and some alternatives that you might want to consider.

What i

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

s Bankruptcy

If you file for bankruptcy you are making an official statement that you are not able to repay your debts. The c

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

ourt will intervene to help you pay some of your debts and erase others completely by arranging for a repayment schedule to be

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

Combination pro

set up for you.

The Disadvantages of Bankruptcy

• Bankruptcy carries a social stigma because bankruptcies are reported in th

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

e local press.

• Once the Bankruptcy Order has been finalised, any businesses that you own will be closed down and your emplo

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

yees will be dismissed.

• You may have to hand over your home to your trustee

• Your bank and building society accounts will

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

be closed and you have to relinquish your credit cards

• Any product that you are in the process of leasing or buying on hir

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

e purchase it will be confiscated.

• Your employment prospects will be prejudiced.

• Bankrupts are not allowed to hold certa

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

n public offices.

• Bankrupts are not allowed to obtain credit for ?500 or above without disclosing their bankruptcy history.

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

Following aspects would a

• You are only allowed to conduct business in the name in which you were made bankrupt.

• You are not allowed to be involve

dd to the challenges in developing combination products:

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

d in forming, managing or promoting a company without the court’s permission.

Alternatives to Bankruptcy

There are a number

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

of alternatives to bankruptcy although their suitability will depend on where you live and your financial situation.

IVAs are

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

one of the most popular alternatives to bankruptcy. They were introduced via the Insolvency Act of 1986 to help those in seri

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

us debt who want to avoid bankruptcy and its disadvantages.

There are no stigmas or penalties associated with an IVA which is

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

Professional from academic institutions, pharmaceutical industries, health care indust

partly why they are so popular. In addition:

An IVA enables you to make monthly repayments based on what you can actually af

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

ford

Interest on your debt is frozen whilst an IVA is in place

Your creditors are not allowed to contact you whilst an IVA i

.

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

s in place

A portion of your debt is written off completely

You are deemed to be debt free within 5 years

IVAs are a suitab

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

Companies that provide selfless information through particip

le alternative to bankruptcy for those who can afford to re-pay at least ?200 a month and who have total debts of over ?15,000

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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