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Panama’s economy is set to surge over the coming years, according to economists and US officials, owing in large part to the recent decision to expand 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

canal. US Ambassador William Eaton spoke of the country’s ‘bright future’ during a speech given at a recent meeting with Panama officials, celebrating th

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

Examples of combination products may in

October 22 referendum in which voters overwhelmingly approved the $5.2 billion canal expansion plan.

“Panama has had one of Latin America's fastest growi

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

ng economies and low rates of inflation,” he pointed out, adding the country also held one of the region’s highest per capital levels of GDP.

“It’s no won

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

er that Panama continues to grow as a regional financial center and a hub for civil aviation and global commerce.”

The ambassador is hardly alone in antic

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

Combination pro

pating the economic benefits of the landmark decision.

A study commissioned by the Panama Canal Authority (or ACP - the autonomous government body that ru

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

ns the canal) showed not only would an expansion be beneficial to the country’s economy, but without it, the famous trade route would languish, losing its

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

ey market position in world shipping.

Without the expansion, which will add a third set of wider locks to ease congestion and accommodate the newer, large

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

r vessels for transport, the Panama Canal was expected to hit its maximum capacity by just 2009. This would have stalled further growth, and added to the a

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

ready long waiting lines at the locks ---driving business to other trade routes, such as the Suez Canal in Egypt.

“Without an expansion, the Canal would f

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

ce new competitors as well as permanent and irreversible changes in trade patterns in which Panama would stop being relevant as a global maritime route,” c

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

Following aspects would a

oncluded the ACP.

With the expansion, however, the country’s gross domestic product (GDP) is now expected to more than double by 2025, adding up to 50,000

dd to the challenges in developing combination products:

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

direct and indirect jobs, and increasing business investment in the Canal Zone by 40 per cent.

Erick Campos, an analyst with Fitch Ratings (a leading glob

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

al rating agency) also endorsed the expansion project, which if handled appropriately, he said, should have a ‘long-term, positive impact.”

Work on the ca

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

al is now set to begin in 2008, finishing in 2014.

In addition to the decision to modernize the 92-year-old canal, Ambassador Eaton pointed to a number of

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

other positive indicators that signaled economic growth for the tiny Central American country.

“… I’m even more excited this year about Panama’s prospects

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

Professional from academic institutions, pharmaceutical industries, health care indust

,” enthused the American diplomat to the assembly. “And, it’s not simply because Panamanians have just taken a huge step forward by deciding to modernize t

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

e Panama Canal.”

Continuing low inflation, a stable dollar economy and the potential for a trade agreement with the United States bolster the economic pic

.

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

ture in Panama, he stressed.

Ambassador Eaton also pointed to upcoming projects such as the 14 hydroelectric and thermal energy plants, and the announceme

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

Companies that provide selfless information through particip

t by Occidental earlier this year of a $6 billion regional refinery, which are expected to fuel growth and employment in some of the country’s poorer areas

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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