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There is a compelling political development in Sweden you should know about. The outcome could very well impact the world’s anti-nuclear movement and open the doors to a wave of more aggressive nuclear energy build up. Sweden ha

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 long been a bellwether for social progress and change. Shortly after Three Mile Island, the Swedes held a referendum on expanding nuclear energy in their country. Sweden voted it down. But, political climates change. What hap

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

Examples of combination products may in

ens in Sweden could help change attitudes toward nuclear energy in Australia, Germany and elsewhere.

A country’s election can have a widespread ripple effect on an industry. Sweden’s four-party opposition bloc, known as the All

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

ance, is challenging the Social Democrat-led government for control of the Riksdag, the country’s parliament. One of the Alliance’s main objectives is to cut the country’s property tax, and eventually remove it. Each year, Swede

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

must pay a tax equivalent to one percent of a single family home’s tax value. The other item on the Alliance’s agenda is moving forward with the country’s nuclear energy policy.

Exactly two months from now, on September 17th,

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

Combination pro

e predict Swedish voters will choose the center-right alliance, comprised of the Moderates, Liberals, Christian Democrats and the Centre party. Amid other reforms, Sweden’s nuclear energy and uranium policies may be revived. The

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

Centre party, which had supported phasing out nuclear power, has now thrown in its lot with the Alliance, realizing there isn’t an alternative to nuclear for the time being.

Sweden’s Dependency on Nuclear Energy

At first glan

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

e, we bought the same anti-nuclear propaganda the rest of the world’s media swallowed. In other words, we were misled into believing Sweden was phasing out its nuclear power plants. Perhaps, you had also concluded Sweden was shu

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

ting down its nuclear fleet. The reality is quite the opposite. Only two reactors have been shut down – one in November 1999 and another in June 2005. The country’s ten nuclear reactors produce about 75 billion kWh. This has acc

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

unted for as much as 51 percent of Sweden’s electricity production! In 2005, about four percent of Sweden’s electricity was exported.

The major media would have us believe Swedes are anti-nuclear. This conclusion was reached af

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

er Sweden’s 1980 referendum on the country’s nuclear power program. But, Swedish voters were offered three very limited choices about continuing the build up on Sweden’s nuclear energy program, to which the answers could only ha

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

Following aspects would a

ve been: NO, No and no, depending upon the loudness with which a voter voiced his “no.” Few were surprised at the outcome. Yet, no reactors were phased out until nearly two decades later. What was never publicized was that a cle

dd to the challenges in developing combination products:

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

r majority of the Swedish voters believed the existing reactors should continue running until new energy sources replaced nuclear.

A 1996 survey conducted by the Confederation of Swedish Industries appalled the anti-nuclear mov

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

ment – about 80 percent of those surveyed were in favor of nuclear power. Subsequent Swedish polls showed as few as 10 percent of those surveyed wanted nuclear energy phased out. About the same percentage wants to protect Sweden

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

s four remaining rivers from future hydro construction. By contrast, three-quarters of Swedes polled gave “restraining greenhouse gas emissions” the highest environmental priority.

Sweden depends upon fossil fuels for less than

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

ten percent of its electricity generation. You do the math. For future electricity generation, Swedes must face a choice between increasing their nuclear power capacity and escalating their meager dependence upon fossil fuels. A

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

Professional from academic institutions, pharmaceutical industries, health care indust

March 2005 poll revealed an astounding 83 percent of those surveyed would support the country’s plans to maintain, or even increase, its nuclear power program.

The choice may already exist in Swedish laws. A spokesman for the

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

erman Atomic Forum, Christian Woessner, pointed out in a recent media interview, “Under Swedish law the (nuclear) plants can not be closed until there is a viable alternative.” Because Sweden is about 47-percent dependent on nuc

.

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

ear power, Swedish parliament has repeatedly delayed plans to shut down it stations. What once were target dates of 2010 have been reportedly moved back as far away as the year 2050. A recent Swedish article discussed a summary

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

Companies that provide selfless information through particip

f investments in the country’s energy sector through the end of the decade. More than 25 percent will be invested in modernizing and upgrading Swedish nuclear plants.

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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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