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An important ulterior goal is to give at least a preliminary evaluation of the contention that both the number and the cost of claims have been driven to record levels. If the figures bear this out, it

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

would lend support to those who consider the UK to be gripped by a compensation culture, and undermine the Government’s view that, although the compensation culture is a myth, the public’s erroneous bel

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

Examples of combination products may in

ef that it exists results in real and costly burdens.

Compensation Recovery Unit statistics say that the number of claims has increased only by three per cent in the last five years. The more detailed

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

igures reveal that not all types of injury have reflected in this small increase. In particular, it is notable that accident claims have actually declined, and it is the substantial rise in claims for d

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

sease that accounts for the overall increase.

The Insurers’ Bodily Injury Awards Studies. Throughout the period studied, legal costs, including both claimant and defendant costs, averaged 30 per cent o

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

Combination pro

the total motor personal injury claims. This means that legal costs continued to increase by more than double the rate of the rise of national average earnings.

National Health Service statistics prov

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

de that there has undoubtedly been a very great increase in clinical negligence claims in the last 30 or so years. The Pearson Commission reported in 1978 that the number of claims of malpractice agains

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

t doctors and dentists (including those in private practice) had been running at about 500 a year. By 1990-1991, the estimated number of new medical claims made against the NHS in England had risen to b

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

tween 5419 and 6979 for the year. The Oxfordshire study reported a “steady growth” in new claims in the period 1974-1998. In answers to Parliamentary questions in 2005, the number of claims made from 19

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

6-2004 was broken down, using information supplied by the NHSLA. These figures confirmed the “continuation of the downward trend” in claims numbers that has been evident in recent years. They now are cl

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

se to the lowest estimate for the year 1990-1991, coming down from a peak in the period 1997-2002. Cost of claims A complete picture of the NHS’s annual expenditure on clinical negligence compensation

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

Following aspects would a

in England is available from 1996. This reveals a general upwards trend up to and including the year 2004-2005. The figures are startlingly higher than those available for the start of the 1990’s, when

dd to the challenges in developing combination products:

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

he annual cost of clinical negligence compensation was reported to have been ?53.2 and ?51.3m in 1990-1991 and 1991-1992 respectively. Even these are very much higher than the estimated figure for 1974-

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

5 of ?1m. In claims for clinical negligence that were closed by the NHSLA in 2004-2005, defence and claimant costs were equal to, respectively, 13.76 per cent and 19.81 per cent of damages.

Outstanding

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

liabilities for clinical negligence One of the most frequently misapplied statistics in the current compensation culture debate is the annual estimate of the NHS’s outstanding liabilities for clinical

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

negligence (including both known and unknown but expected claims, and taking into account the likelihood of settlement). This has risen from ?3.2 billion in 1999 to ?5.9 billion in 2003 and ?7.8 billion

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

Professional from academic institutions, pharmaceutical industries, health care indust

in 2004. The figures refer to liabilities that the NHS claims will arise over a longer period of time, and are very much greater than the sums that are actually paid out on an annual basis. Estimating t

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

e cost of outstanding liabilities is an exercise that is fraught with difficulties and the resulting figure representing a “worst case” scenario has been heavily criticised. Although the estimate of out

.

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

tanding liabilities is frequently cited in the press and media, it must be handled with care. It would be quite wrong, for example, to use it to calculate the percentage of the annual NHS budget that is

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

Companies that provide selfless information through particip

currently spent on clinical negligence compensation. These figures provide the basis for an initial examination of the claim that a damaging compensation culture has developed in the UK in recent years

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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