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More than 2.5 million people in the UK have accidents each year, and very few claim compensation for their injuries. Seeking compensation for pain and suffering is a civil and legal right. The t

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

ype of accident could be work related, a road traffic accident or a slip in a super market or something more serious like medical negligence. Whatever type of accident, as long as you’re not resp

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

Examples of combination products may in

onsible then you are entitled to compensation. These people that have suffered from injuries due to no fault of their own deserve compensation for their suffering and with UK law the liable party

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

must compensate the injured person for their loss of suffering. The financial loss could be due to loss of earnings or due to damages to their car or any other personal item. In some extreme ca

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

es the loss of a job and whole way of life might be lost. Some people may have to adapt their homes to deal with the injury permanently. Also stress depression and anxiety are all illnesses that

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

Combination pro

may not have occurred in the accident had never happened. This is why it is ethically right that people should have the opportunity to claim compensation for their injuries however mild or sever

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

e they maybe.

Only about 30% of accident victims seek out a personal injury lawyer and sue for compensation. “Conditional fee agreements” or better known as the “no win no fee” was introduced in

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

1995 when legal aid was still available for personal injury case. The reason it was introduced was to give the people with incomes above legal aid eligibility limits the chance to fund personal

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

njury litigation. People whose income was just about the limit were still finding it difficult to pay for a solicitor. This “no win no fee” agreement eventually became available to fund most civ

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

il cases and the consequence of this was that legal aid was abolished 2000. Contrary to popular belief there has not been a compensation boom, in fact the number of claims has dropped since this

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

time.

The term “No win no fee” is misleading and there is widespread misunderstanding of the term. It sounds like there will be no costs if the case is lost. This is not true. The looser pays t

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

Following aspects would a

he winners cost as well as any damages. But there is still a risk of having to pay the other sides cost if the case is lost, also medical reports etc are normally not covered by no win no fee agr

dd to the challenges in developing combination products:

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

ements. This needs to be addressed further and made clear to people before they start proceedings. Many companies are putting to much emphasis on getting cases to work on and selling their lega

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

l and insurance products. Conditional fee agreements are creating incentives for the legal profession for financial gain. Using the popular “no win no fee” to entice people is misleading and wrong

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

. Many companies are only too each and too quick to let their clients sign the “Conditional fee agreements” without the clients truly understanding all the risks and liabilities they may be expos

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

ing themselves too.

There needs to be more emphasis on advising and explaining what the agreement really means. What the real financial risks are and what can be done to prevent these. A system

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

Professional from academic institutions, pharmaceutical industries, health care indust

of regulation should be introduced to protect the people and surely is the only way forward.

Positive outcomes can be the lessons learnt from compensation claims. Unfortunately sometimes it take

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

s an accident for employers and the public to realise the dangers in the first place. It is a shame someone has to suffer, but on the whole a lot of people should benefit from this. We all have

.

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

to take reasonable steps to prevent harm from arising whether we are employers or citizens

Looking for a good personal injury solicitor is a must. A well known company with experience should off

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

Companies that provide selfless information through particip

er you the best consultation. If the solicitor has never delt with your type of accident or injury claim keep looking for one that has. Good legal firms will offer free advice and consultations

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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