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Experts are warning that the number of bankruptcies will continue to rise in the UK. This prediction follows the announcement of figures for the

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

fourth quarter of 2005 which were at an all time high.

According to official statistics 13,501 bankruptcies were filed in the fourth quarter o

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

Examples of combination products may in

2005. This figure represents an increase of 11% up on the previous quarter and even more strikingly it was 38% higher than the same period in 2

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

004.

However, these figures only partly show the rue state of affairs. Britain is facing a personal debt crisis and for every person who is dec

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

ared bankrupt, plenty more are suffering from serious debt which blighting the quality of their lives.

The widespread nature of personal debt i

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

Combination pro

largely a result of how easy it is to obtain credit. Consumers are encouraged to borrow more than they can afford so that they can spend today

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

and worry about how to pay for it tomorrow. In other words, consumers want instant gratification and would rather get into debt and have the pro

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

ucts they want than do without or save money.

The other reason that bankruptcies are on the increase is the changing attitude towards it. Ever

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

ince the Enterprise Act of 2002 reduced the period in which people could be discharged from bankruptcy, it has been seen as an easy way to get o

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

ut of debt.

This perception is very far away from the truth however. There are numerous disqualifications, restrictions and stigmas associated

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

ith bankruptcy. And these disadvantages have long term and far reaching consequences.

Consumers who are considering bankruptcy as a way of sort

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

Following aspects would a

ng out their debt problems would be well advised to consider the alternatives. In 1986, the government introduced IVAs as an alternative to bank

dd to the challenges in developing combination products:

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

ruptcy which would benefit both debtors and creditors.

An IVA is a good alternative to bankruptcy because there are no fees or legal proceeding

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

involved with it, unlike with bankruptcy. Moreover, an IVA offers a greater repayment of the debt than would otherwise be achieved if the debto

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

were made bankrupt. For these reasons an IVA is a good alternative to bankruptcy from a creditors’ perspective.

From the debtor’s perspective,

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

an IVA is a good alternative to bankruptcy because it does not have any stigmas of disqualifications associated with it. Additionally:

• Month

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

Professional from academic institutions, pharmaceutical industries, health care indust

y re-payments are based on what the debtor can actually afford to pay

• In most cases, a debtor can keep his/her car with an IVA

• With an IVA

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

as much as 80% of the debt is written off completely

• An IVA enables debtors to clear their debts within five years

Bankruptcy is on the incr

.

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

ease because of the growing amount of consumer debt and the mistaken belief that it is an easy option. Although the UK’s debt problem is not goi

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

Companies that provide selfless information through particip

g to vanish any time soon, debtors would be well advised to consider alternatives to bankruptcy of which an IVA is possibly one of the best ones

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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