Actual - Finance

This time we’ll talk about European Union (EU) that involves a market with a single currency, a single Central Bank and a single monetary policy. There’ll be discussed European single currency, Monetary, and Fiscal policies, and effect of EU innovations on European countries f

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

rom the economic perspective. The current situation in Europe and that affecting the members of the EU is one of unbalance. The Maastricht Treaty envisaged the creation of a European Central Bank, ECB. It also laid down set criteria for countries to fulfil before they could j

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

Examples of combination products may in

oin the single currency. There were four key points that the main players of the treaty stressed were the vital characteristics that potential candidates must to be considered for entry.

Price stability in effect this means controlled inflation. The perspective country must f

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

or at least one year have had an inflation rate no more than 1.5% above the average of a most the three best performers already existing within the Union. This is because a union such as the EU would require its members to be of similar economic importance. If a candidates inf

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

lation rate exceeded the 1.5% precedent set it would harm the way that the EU functions by putting pressure on the top performers to lower their rates to create an equal set rate. Fiscal Convergence, or more simply a budget deficit. The treaty requires that the deficit should

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

Combination pro

ot be more than 3% of the GDP [Gross Domestic Product]. The accumulative debts should not exceed more than 60% of the GDP. Another demand is that there is stability within the currency for two years in the normal ERM bands without having devalued. This is as well as the specif

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

ication that there are requests that the Interest Rate for a year long term shall not have exceeded by more than 2% of the average of at most the best inflation performer that already exists in the EU. The second phase is to start the Monetary union. On the 1st of January 199,

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

states will start to use the Euro as an acceptable currency in the eleven states. National currencies will continue to circulate for a number of years. The ECB will take control over the monetary policy. National currencies will have parity against the Euro and not for instan

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

ce against the French Franc or the German Deutschmarks.

The National Central Banks can no longer conduct their own Monetary policy. They will merely act as agents of the ECB. The exchange rate risk will be eliminated and there will be a single monetary policy throughout the E

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

uropean Union. The third stage will see the emergence of Euro bank notes and coins. These will circulate along with national currencies. In January 2002, the Euro notes and coins will b withdrawn from circulation as the Euro notes and coins start to circulate more widely. Ther

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

will be co-ordinated switch to the Euro for transaction with the public. It is expected that the final changeover will be completed by 1st July 2002 when all national notes and coins will be withdrawn. There are several key points that the introduction of the Euro will bring.

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

Following aspects would a

These factors will eliminate additional costs associated with national currencies, enhance price stability and transparency. It will also simplify travel across Europe, with prices stability and transparency. It will also simplify travel across Europe, with prices becoming fi

dd to the challenges in developing combination products:

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

xed and travel more frequent. Another advantage would be the revenue saved in the transferring of one currency to the other, such a saving to the average person could mean a better holiday. If the single currency is embraced by Britain it may stimulate employment and will be a

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

ble to compete with the dollar which has not been possible with regard to the national currencies of European countries, this would lead to both low inflation, and a stable monetary economy. However there would be some disadvantages of Britain scrapping the pound in favour of

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

the European single currency. Some of these problems would be that the member states will lose their monetary policy freedom; governments will affect the employee’s contract in money terms. To even change all the machines, i.e. Cash machines, tills in be a long and costly proc

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

ss, not only will these be affected but so will all the business who have to change their computer systems. In a counter argument the structural weakness of the Euro, greatly effecting Britain decision. In my conclusion I have highlighted five specific Tests for Britain’s Entr

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

Professional from academic institutions, pharmaceutical industries, health care indust

y to Europe.

Would entry be good for jobs, Investment will continue to come to Britain. Financial Services Industry will continue to dominate. Whether Business Cycles are compatible, whether there is sufficient flexibility to deal with problems. None of these factors have bee

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

n met yet and it is unlikely that they will be clearly met. It has been argued that the European Central Bank’s decisions will have an impact on Britain.

Close attention will be required on the interest rates. Currently the interest rates will decline. There are several facto

.

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

rs that may work against Britain. There could be a high degree of sterling volatility against the Euro. London may lose its position as the international financial centre. The government and central business will study the success of the Euro and see when the time is right.

A

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

Companies that provide selfless information through particip

lthough there’re many facts about the pros and cons of joining the European single currency, ultimately it will be up to the British public in a referendum. It will be interesting to see how the media uses its influence as to whether the public will favour entry into Euro Land

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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