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In the UK, when a debtor owes a sum of money in excess of ?750 to a creditor, he can be made bankrupt by the creditor applying to the court for a bankr

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

uptcy order to be granted against him. This sum can comprise of debts that are due to a number of creditors who may petition the court as a group for

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

Examples of combination products may in

bankruptcy order, not necessarily a single creditor.

Bankruptcy is an option that can be considered when a debtor cannot pay their debts

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 they become due and their financial affairs become untenable. Although bankruptcy has a bad stigma and is publicly advertised, it should always be 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

nsidered, even as a last resort and a debtor can apply for a bankruptcy order on his own behalf, even if creditors are not willing to do so. Debtors w

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

Combination pro

o are made bankrupt will usually remain bankrupt for one year, after which any debts relating to the bankruptcy are removed.

Many debtors no

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

enter into ‘Individual Voluntary Agreements’ (or IVAs) as an alternative to bankruptcy. If a debtor’s financial difficulties are temporary and he is l

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

kely in the future to be in receipt of funds which may pay all or most of his debts, he can talk to an insolvency practitioner with a view to obtaining

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

such an agreement.

Through an IVA, proposals of repayment of debts are put forward to creditors, which can include banks, building societi

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, credit card companies and debt collection agencies, such as the CapQuest Group. Mostly these

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

roposals involve either a lower monthly repayment or in some cases, a reduced final settlement amount. In order to succeed, however, the arrangement m

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

Following aspects would a

ust be supported by at least 75% of all creditors affected by the IVA.

Despite the ‘softening’ of bankruptcy laws by the Enterprise Act 200

dd to the challenges in developing combination products:

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

, the popularity of IVAs has grown in recent years. The Enterprise Act 2002 effected changes in bankruptcy law which many experts thought would see th

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

end of IVAs, as it was generally regarded that bankruptcy would be seen as an easy way out for many debtors. However, even after a debtor is discharg

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

d from bankruptcy, many banks and other financial institutions will be aware of the debtor’s financial history and this may affect any borrowing capabi

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

ities in the future.

Personal insolvencies are at record levels across the UK, with just over 26000 bankruptcies and IVAs in the period Apri

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

Professional from academic institutions, pharmaceutical industries, health care indust

to June 2006. These figures represent an increase of 10% on the first quarter of 2006, and 66% over the same quarter in 2005.

However, bef

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

re any decision is made as to which route to follow, it is vitally important that a debtor seeks advice from a solicitor, insolvency practitioner or lo

.

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

al Citizens Advice Bureau. There are also many specialised companies to be found the int

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

Companies that provide selfless information through particip

rnet that are available to the debtor who can help to arrange an IVA or provide advice on how best to proceed in dealing with their financial situation

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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