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Capital gains tax taper relief is an extremely powerful form of relief and can result in significant tax savings.Taper relief wa

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

s introduced from 5 April 1998. It applies only to individuals not companies. This article concerns individuals only, taxation of corpo

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

Examples of combination products may in

ate bodies is dealt with elsewhere.

There are two types of relief, business asset and non business asset.

Capital gains are calculate

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

by deducting the cost of an asset from the net sale proceeds. Cost can include the original cost of the asset, improvement expenditure

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

and an allowance for inflation known as indexation allowance could be added. Indexation allowance only applies up to 1998 when it was r

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

Combination pro

placed by taper relief.

If the asset was owned on or before 31 March 1982 generally the market value at that date can be substituted f

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

or original cost.

Thus the gain to be charged to tax comprises net sale proceeds less the indexed amount of the original cost and ind

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

xed cost of improvements. There are special rules when assets are transferred between connected persons. Any resulting gain is subject

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

to taper relief.

As a general principle the longer the asset has been held the greater relief available. Business assets attract more

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

elief and accrue faster than non business assets. It is possible to achieve a reduction in the gain up to a maximum of 75% after only 2

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

years in respect of a business asset. Generally non business assets, once held for more than 2 years attract relief at the rate of 5%

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

Following aspects would a

for each year held up to a maximum of 40%. If the asset was held on 17 March 1998 a bonus year is added.

As business assets attract mo

dd to the challenges in developing combination products:

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

e tax relief holding them achieves a greater reduction in liability over a shorter period. Business assets consist of assets used for

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

he purposes of a trade carried on by the taxpayer (alone or in partnership) or by a qualifying company or unconnected unincorporated tr

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

der. They also include shares held in a qualifying company.

One important area to look at in achieving tax savings is property let for

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

commercial use. Don’t forget that the annual exemption is deducted after taper relief is given. Taper relief seems simple but in reali

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

Professional from academic institutions, pharmaceutical industries, health care indust

ty it is a minefield. The definitions of business assets have changed several times under the various Finance Acts. It is necessary to

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

consider the complete period of ownership to determine which rates apply.

Although taper relief can provide significant tax savings i

.

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

needs to be used with extreme care to make sure relief is not under claimed but also to enable maximum advantage to be taken. Like so

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

Companies that provide selfless information through particip

much of our tax system it is certainly an area worth seeking qualified professional advice in respect of capital gains tax taper relief

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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