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The debt crisis that politicians have been agonising about is getting worse, not better. By the end of

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

October 2006, total personal debt in the UK was more than ?1.25 trillion (up by more than 10% on last

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

Examples of combination products may in

year) and average household debt stood at ?8,592.

With economic forecasters predicting these figures

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

o continue to rise, the future looks bleak for debtors. Or does it?

In 1986, the government introduc

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

ed a new debt re-payment scheme called an Individual Voluntary Arrangement, or IVA for short. Conceive

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

Combination pro

as an alternative to bankruptcy, IVAs are becoming an increasingly popular way of clearing debt. This

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 shown by the fact that 50,000 IVAs were completed in 2006 and it is estimated that this figure coul

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

d double by the end of 2007.

So why are IVAs so popular? The answer lies in the range of benefits tha

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

they offer to people in serious debt.

Unlike bankruptcy there is less stigma associated with an IVA

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

ecause it is a private agreement between a debtor and his/her creditors. In other words, no one needs

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

o know that you are paying into an IVA unless you choose to tell them.

With an IVA you propose to rep

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

Following aspects would a

ay a specific amount of your debt each month based on what you can actually afford over, typically, a

dd to the challenges in developing combination products:

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

ive year period. Therefore, although you will be expected to budget carefully, you and your family wil

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

not suffer financially if you sign up to an IVA. Plus monthly repayments can be as little as ?200.

M

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

oreover, with an IVA your debts do not continue to spiral out of control. Interest on them is frozen

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

hilst the IVA is in place. Furthermore it is very common for a large proportion of your debts (normall

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

Professional from academic institutions, pharmaceutical industries, health care indust

well over 50%) to be written off completely.

Another advantage of an IVA is that creditors are prohi

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

bited from contacting you whilst it is in place. In other words, you are legally protected from them h

.

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

rassing you via emails, letters and phone calls.

Most importantly, if you stick to the terms of your

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

Companies that provide selfless information through particip

VA, you will be declared debt free at the end of the IVA and can make a fresh start with a clean slate

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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