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Over the last 10 years there has been a big clamour for the Euro, with many of our European counterparts having already introduced the

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

currency into their economies. The UK has been a little slow in taking up the Euro, however as the inevitable push towards closer Eu

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

Examples of combination products may in

opean ties continues - with many suspecting the resistance will be ambushed by politicians - the Euro will come to play a larger part

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

n our daily lives.

This has opened up a whole new industry with many financial companies spotting this massive opportunity in the mar

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

ket place. At the moment, the UK has total control of our interest rates, although it looks as though this may change in the future a

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

Combination pro

and when the European Bank become more of an issue. There are regular meeting where Europe Treasury officials meet to discuss the ge

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

eral trend in European interest rates, but the buck currently stays with the home government.

Many people are starting to look at tak

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

ing out Euro mortgages, car loans, home improvement loans, etc and taking advantage of the current difference in interest rates (Europ

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

an Central Bank rates are lower than those in the UK at this moment in time). This is where financial advisers are starting to push c

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

oss currency transactions, whereby the loan is taken out in Euro’s and converted into sterling, then payments are converted from Sterl

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

ng into Euros to make the repayments.

There are a number of issues which people will need to monitor including :-

· The exchange rat

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

Following aspects would a

e between the Euro and Sterling. If the Euro were to gain in strength against Sterling, then your normal monthly payments would rise

dd to the challenges in developing combination products:

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

ecause there would be less Euro’s to the pound. You would benefit if Sterling was stronger. · Interest rates. European Central Bank

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

interest rates have a major impact on the Euro, as they are used to cool down and re-inflate ecomonies. The same can also be said of t

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

he UK currency, and relationship with the Bank of England.

As well as the issue of actual capital repayments, there are also addition

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

l costs associated with exchanging your currency each month. No matter how small the cost, this will have an ongoing impact and basic

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

Professional from academic institutions, pharmaceutical industries, health care indust

lly increasing the cost of your borrowing.

In summary if you are looking to take out a Sterling / Euro Loan then it will only really

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

work for larger amounts like mortgages, business development, etc where the costs are smaller as a percentage of the amount involved.

.

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

The problem is that the larger the loan you take out, the more potential for variation in your repayments.

All in all, not an easy s

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

Companies that provide selfless information through particip

bject to grasp, and one which should probably be left to the professional for now.

Useful Link :-

European Central Bank www.ecb.in

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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