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At one time in the 1920s, international companies wanted to buy land near Gullfoss, in the southwestern quarter of Iceland, and build a hydroelectric plant there. Sigr??ur T?masd?ttir, the daughter of a local farmer, helped lead the opposition to the plant. As a protest she walked a

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

ll the way to Reykjav?k and even threatened to throw herself over the falls if the sale went through. Although the government did not intervene, she and her fellow opponents prevailed, and the land was given over to a nature preserve.

Iceland's scenery has been shaped by fire and i

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

Examples of combination products may in

e: it is a frozen land that is always letting off steam. More than 200 volcanoes, U-shaped valleys, jagged lava fields, hot springs and geysers and the largest icecap in Europe – bigger than all the mainland European glaciers put together – go to create a rugged, bizarre landscape u

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

like anything else on Earth. About 80% of Iceland’s land is lava desert, glaciers or lakes; the only arable areas are on the coast. Of the 300,000 or so Icelanders who sparsely populate this island, some two-thirds live in the capital, Reykjavik.

Until recently, the T?masd?ttir sto

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

y was a one-off. Icelanders have been so used to having clean air, clean water, clean everything that they scarcely noticed when these marvellous assets were threatened.

Things Are Changing – For Worse
The colossal $3 billion K?rahnj?kar dam, due to be completed this year, wil

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

Combination pro

submerge under 150 metres of water a hitherto untouched 57 square km of wilderness, boasting gushing rivers, thundering waterfalls, multi-coloured mountains and mossy highlands ablaze with flowers. The project, designed solely to drive an aluminum smelter further down the valley at

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

Reydalfjordur, has government support and will be paid for by Landsvirkjun, the national power company. The hydroelectricity it generates is contracted for sale for 50 years to the American aluminum giant Alcoa, which is closing two smelters in the US and relocating to Iceland as a

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

ost-cutting measure.

After what it claims were extensive community input and environmental studies, Alcoa is fast completing construction of the Fjar?a?l ("aluminum of the fjords") smelter, which is expected to create hundreds of jobs in Iceland, both in the facility and in support

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

ng industries. Late in March this year, the first ship carrying cargo for the smelter arrived in Reydarfjordur. The Pine Arrow was bringing nearly 40,000 tonnes of alumina from Western Australia, after a voyage of 44 days. It takes almost two tonnes of alumina to produce one tonne o

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

aluminium.

So far so good, it may seem. Four hundred jobs, an addition to the economy and the harnessing of natural power.

Karahnjukar Dam
But a movement called Saving Iceland, a coalition of groups opposing further development, is up in arms. The area of the dam is one of

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

he main breeding grounds for reindeer. It is a protected nesting ground for thousands of pink-footed geese and a favourite haunt of the snowy owl, ptarmigan and the majestic gyrfalcon. The rock formations – red, black and all colours of the rainbow – are a unique record of 10,000 ye

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

Following aspects would a

ars of geological and climatic change, providing clues to scientists worldwide, studying, among other things, global warming. All this is to disappear under water. The environmental impact of the project spreads much wider than this highland wilderness and the fjord below. Other riv

dd to the challenges in developing combination products:

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

rs will be disturbed, the habitat of animals such as seals will be destroyed and an officially protected area, Kringilsarrani, will be damaged. Many geologists fear catastrophic flooding may result from frequent glacial surges and eruptions in K?rahnj?kar's catchment area. They also

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

question the wisdom of building a huge dam on a substructure weakened by geothermal fissures.

“It is a very rare nature that we are the guardians of,” says Olafur Pall Sigurdsson, one of the organisers of Saving Iceland, “and we are squandering it.”

Last September, Omar Ragnarsson

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

one of the country’s most respected television reporters, announced that he could no longer cover the K?rahnj?kar project with impartiality and would campaign against it. Answering his call, more than 8,000 people attended an anti-dam rally in Reykjavik. In 2006 Andri Snaer Magnaso

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

, a poet, playwright and novelist, published Dreamland, an overwhelmingly convincing book that puts Iceland’s environmental issues into a global perspective.

Alcoa acknowledges that any human development cause changes within the environment. It claims to have a team of 60 people, a

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

Professional from academic institutions, pharmaceutical industries, health care indust

l experts in their field, working to design the project in keeping with Alcoa’s long-term goals for sustainable development.

Iceland’s Goals
What about Iceland’s long-term goals? It is hard to reconcile Alcoa’s words with the reality of this monster, which dominates the landsc

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

pe – the main dam 190m high, 730m wide and 53 km of tunnels, the largest structure of its kind in Europe. Nor is it much consolation that Alcoa has launched its “Ten Million Trees” programme, starting with the planting of seedlings in the Reydarfjordur area. True, Iceland’s is a sta

.

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

k landscape, so deforested that the government used to (and perhaps still does) supply tree seeds to residents and ask them to scatter the seeds from their cars wherever they went.

Can Alcoa Forest possibly make up for Alcoa’s forced violation of the land?

Sensitive eco-tourists c

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

Companies that provide selfless information through particip

n contribute to Iceland’s economy and well-being, without doing damage, by travelling lightly, taking only photographs and leaving only footprints. AwimAway’s Iceland Gold tour (www.awimaway.com) takes in all the magical wonders of Iceland in a green and environmentally friendly way

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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