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Albania has come a long way since the dark days of the 1997 crisis. Back then, the future looked bleak, with Ponzi (pyramid) schemes, unemployment climbing, and output collapsing. But since adoption of the currency board arrangement a decade ago, along with co

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

nsistent implementation of supporting fiscal policy and structural reforms, growth has been strong and stable, inflation has been kept low, and unemployment has fallen.

Albania's EU invitation of accession the past June is a landmark, holding the promise of s

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

Examples of combination products may in

ustained growth and rising living standards. EU-financed projects, if properly prioritized, can help boost economic performance through improved and additional infrastructure. Also, full integration into the common EU trading area should boost trade and compet

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

ition. Finally, a reduction in Albania's perceived risk should further encourage private investment, helping to raise productivity growth. But accession alone is no panacea. Satisfactory economic performance will continue to depend on sound macroeconomic poli

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

cies and sustained structural reforms. A key challenge will be to maintain a prudent fiscal policy.

The government remains committed to the currency board arrangement that has served the country well. But the absence of an independent monetary policy leaves f

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

Combination pro

iscal policy as the only macroeconomic policy lever. Albania's strong fiscal stance has cut public debt almost in half of GDP since 2004, to 55 percent of GDP. This performance provides credibility to the fiscal surpluses planned under Albania's Nationa Progre

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

mme for execution of SAA, recently reviewed by the EU. At the same time, however, the budgetary challenge will intensify. With large net EU transfers expected to increase domestic development spending substantially, the government will have to reduce other exp

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

nditures to keep overall spending under the government's chosen ceiling of 45 percent of GDP. Another formidable challenge is reducing the large current account deficit to a sustainable level.

At over 16 percent of GDP in 2006, the current account deficit ha

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

s tripled in three years. Although this external imbalance continues to be largely financed by foreign direct investment, external private debt has also risen substantially. In light of the risks posed by such high debt, Albania should self-insure against unfo

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

reseeable shocks. The government should continue to build readily available reserves as insurance against a sudden disruption of capital flows to Albania. The country's defenses are at comforting levels in case of a moderate and temporary shock. But a deeper a

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

nd more durable stoppage of inflows would be far more consequential for Albania. Latin America's financial crisis almost a decade ago should be a reminder that even countries in generally sound shape are not immune from the impact of crises elsewhere-and the s

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

Following aspects would a

udden reversals of capital inflows that can result. Albania therefore needs to be prepared for such a contingency. Sustained fiscal surpluses will be required to strengthen the government's Fiscal Reserve Account while also saving for additional spending deman

dd to the challenges in developing combination products:

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

ds arising from an aging population.

With demand for imports of both investment and consumption goods expected to remain high, as well as outflows for servicing the sizable accumulated external liabilities, reducing the current account deficit will require a

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

much higher level of exports than in recent years. Research presented at the May 31 meeting suggests that even though various indicators indicate that Albania remains competitive, the margin may be falling. With the exchange rate fixed under the currency board

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

there is no choice but to continually enhance the flexibility of domestic product and labor markets. In this regard, the unfinished structural reform agenda elaborated at the seminar demonstrates the huge challenge ahead.

As required of all candidate EU memb

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

ers, Albania has the responsibility to establish the domestic conditions needed for eventual euro adoption. Albania already is in solid shape on 4 of 5 of the Maastricht criteria for participation. But inflation, currently well above the permissible range, nee

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

Professional from academic institutions, pharmaceutical industries, health care indust

ds to come down. As illustrated at the seminar on May 31, some special aspects of acceding countries-such as very strong domestic demand driven by "EU-phoria"-make reducing inflation to very low levels a serious challenge. With commitments already made to main

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

tain a prudent fiscal stance, and in the absence of independent monetary policy, bringing down inflation will also require many reforms to improve the business climate, eliminate obstacles to competition in product markets, and increase the flexibility of labo

.

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

r markets to enhance mobility and ensure that wage growth stays in line with productivity growth.

While EU invitation for membership offers countless opportunities, reaping the maximum benefits will be an enormous challenge. Given the required efforts, now is

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

Companies that provide selfless information through particip

not the moment for policy complacency. The Albanian government is well aware of this. Policymakers will hopefully be aided by the domestic consensus that the above framework-so effective since 1997-will yield even better results on the road to euro membership

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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