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With levels of consumer debt having recently surpassed ?1 trillion in the UK, more and more people have found themselves in the unfortunate position of having insufficient funds availa

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

ble to cover their outgoings. As many consumers look for an escape out of debt, they are sometimes advised to consider bankruptcy if they have large levels of debt. However, there is

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

Examples of combination products may in

another option that may help people who find themselves in financial difficulty reclaim a firm financial grounding: an Individual Voluntary Arrangement, or IVA.

An IVA is a

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

legal contract between you and your creditors, and it is a legally binding arrangement. It is supervised by a licensed Insolvency Practitioner, the purpose of which is to enable you t

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

reach an agreement with your creditors and avoid the consequences of bankruptcy. If you can’t afford to repay all your debts, an IVA can be used to repay as much of the debt as possi

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

Combination pro

le in the most appropriate way. Creditors - such as credit card companies, banks and even debt buying companies such as Capquest - are more likely to accept proposals made through an

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

VA as they are likely to receive a greater monthly payment than they would if a debtor were made bankrupt.

An IVA works in several ways: it reduces the amount of debt that i

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

repaid, freezes interest charges and reduces monthly payments – meaning more money is available at the end of the month. An IVA is a totally private arrangement – nobody needs to know

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

about it apart from the debtor, the supervisor of the IVA and the creditors concerned.

IVAs normally involve the ceasing of interest payments and charges by creditors, as we

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

l as a percentage of the outstanding debt being written off. They are prepared to consider this because the alternative may be a bankruptcy where they would receive far less. Generally

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

an IVA will involve a monthly payment plan which lasts for no longer than 5 years. However, this period could be reduced if a lump sum is available, perhaps from the release of equity

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

Following aspects would a

from property.

IVAs are available to all individuals, Sole Traders and Partners who have encountered financial difficulty. However, IVAs are most commonly used by those who

dd to the challenges in developing combination products:

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

own their own property and wish to avoid the possibility of losing their home or business in the event they are made bankrupt. To set up an IVA, a proposal is submitted to court with

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

view to obtaining an Interim Order, which is used to stop creditors from taking any further action against the debtor, whilst a meeting of creditors takes place to decide whether or n

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

t the proposals for the IVA are acceptable.

Acceptance of the proposals requires 75 per cent in value of those creditors who vote. This 75 per cent relates only to those w

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

o actually vote, all will be bound by the terms of the arrangement whether they voted or not. Upon approval of the IVA, a Supervisor is appointed to ensure the proposals are adhered to

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

Professional from academic institutions, pharmaceutical industries, health care indust

and to distribute the dividends to creditors. Assuming the debtor complies with the terms of the arrangement, upon completion of the IVA he will be fully discharged from all liabilit

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

es included within it.

There are many companies available who are able to arrange an IVA for those encountering financial difficulty. In most cases, however, these companie

.

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

will charge a fee for their services, although there are also some charities who can arrange IVAs free of charge. The Citizens Advice Bureau can also advise on setting up an IVA. How

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

Companies that provide selfless information through particip

ver, in all cases anyone considering setting up an Individual Voluntary Arrangement should speak to a qualified debt counsellor about the best way forward prior to making any decisions

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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