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Debt levels in the UK are rising alarmingly. The latest Insolvency Statistics confirm this trend, with Individu

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

al insolvencies in Quarter 4 2006 up 44% on the previous year. For an individual, insolvency means a person 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

nable to pay off their debts, and has become bankrupt or has agreed an IVA (Individual Voluntary Arrangement).

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

Many people who contact Clear Start have considered bankruptcy or have concerns about being made bankrupt. It i

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

important to understand the implications that bankruptcy can have, and the alternatives that are available to

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

Combination pro

you. Clear Start, which is a top 10 IVA provider in the UK, provides a free debt advice helpline which offers c

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

nsumers impartial advice on their situation and the debt solution which is right for them.

Bankruptcy is a ser

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

ous option, and is often considered a last resort because of it’s disadvantages. Some elements of bankruptcy wh

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

ch people wish to avoid are:

Loss of assets – house and car must normally be sold
Lack of

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

control – decisions are made by the Official Receiver and Magistrate

Credit Status is ruined – virtua

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

ly impossible to get a mortgage, loan or credit card after bankruptcy

Social stigma – bankruptcies ar

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

Following aspects would a

published in national newspapers

Loss of career – a bankruptcy will prevent you from holding certain

dd to the challenges in developing combination products:

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

jobs and public positions

Many people calling Clear Start have found that an IVA Is a better solut

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

ion to their debt problems than bankruptcy, as it has fewer disadvantages. You can often keep your assets, such

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

as your house and car under an IVA; it is a private arrangement, unlike bankruptcy, which is published, and doe

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

n’t carry the same restrictions on the jobs and positions you can hold.

Most of all, an IVA puts you more in c

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

Professional from academic institutions, pharmaceutical industries, health care indust

ntrol of the outcome, as you agree to the proposed monthly payments. As an IVA is less costly for both creditor

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

and debtor than a bankruptcy, many creditors are also seeing IVAs as a good alternative to bankruptcy.

Clear

.

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

tart prides itself on offering an ethical and professional service that people can rely on. The feedback from h

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

Companies that provide selfless information through particip

ppy clients and messages posted across the internet are testament to the service that the organisation provides

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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