Advice You - Business

The advantages of exporting are clear. Increased exports greatly benefit a country’s economy, because they create jobs, stimulate economic growth, bring in tax revenues, and enable domestic industries to compete in international markets. Firms that export can grow faster, because they can

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

utilize idle capacity, reduce dependence on domestic markets, increase product lifecycles, and simply make more money.

Previously, the vast U.S. domestic market usually provided American companies ample opportunities to grow and remain profitable. Now, domestic market saturation and incr

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

Examples of combination products may in

ased international competition are taking their toll, leaving U.S. companies with tighter margins and little room for growth. This forces many businesses to look to international markets for new opportunities.

The U.S. government has recognized the significance of increased exports for th

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

e overall health of our economy and has created a sizable infrastructure of export assistance programs to help U.S. companies to export successfully. One of the highlights of these efforts is the Export Trading Company Act of 1982 (“ETC Act”).

The ETC Act was modeled after the large and p

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

werful Japanese trading intermediaries called Shogo Shosha. These intermediaries helped Japan become one of the top exporting countries in the world, achieving a 58 billion dollar trade surplus with the United States. While using the Japanese trading companies as a model, the ETC Act was

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

Combination pro

designed to eliminate two major impediments that prevented small and mid-size businesses from successfully developing foreign markets. By creating exceptions in U.S. antitrust and banking laws, the ETC Act created significant opportunities for small and medium-sized businesses to cooperate

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

in their efforts to exploit international markets.

Antitrust Immunity

Small and mid-size exporters do not have the resources to create separate export departments and often needed to cooperate with competitors by pooling resources or creating joint ventures. Before the passage of the ETC

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

Act, these cooperative activities created serious antitrust risks, since the U.S. antitrust laws prohibit competitors from sharing information and discussing prices. The threat of antitrust litigation, being one of the costliest, often prevented U.S. companies from developing joint export

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

programs backed by adequate resources.

The ETC Act eliminated this uncertainty by introducing a certificate of review program. The program, administered by the Commerce and Justice departments, offers exporters immunity from federal and state government antitrust prosecution for export ac

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

tivities specified in the Certificate. Although, the Certificate does not prevent private parties from bringing antitrust suits against a certificate holder, it provides significant procedural advantages, including a shorter statute of limitations. The certificate holder enjoys a presumpt

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

on of legality and can collect attorneys’ fees from an unsuccessful antitrust plaintiff. If the private antitrust plaintiff prevails in its suit against the certificate holder, it may obtain only actual damages, and not the treble damages (three times actual damages) available in most anti

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

Following aspects would a

trust cases. The Commerce Department calls the certificate of review an “insurance policy” against dubious and frivolous suits.

Bank Holding Company Participation

The U.S. banking system, one of the most sophisticated in the world, has developed considerable expertise and a wealth of res

dd to the challenges in developing combination products:

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

urces on international trade. To enable U.S. exporters to benefit from this knowledge base and expertise, Title II of the ETC Act authorizes bank holding companies (“BHCs”) to make equity investments in Export Trading Companies (“ETCompanies”). To ensure adequate separation between BHCs’

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

export trade and deposit-taking functions, the ETC Act allows BHCs to invest in ETCompanies that meet the statutory definition and comply with additional regulations issued by the Federal Reserve Board. Equity ownership by BHCs not only provides seed capital or infusion of cash to enable E

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

Companies to get off the ground, but offers other significant advantages. As mentioned earlier, BHCs can act as an invaluable source of international trade expertise. Additionally, many BHCs have branches in various countries and can assist ETCompanies in locating foreign distributors and

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

purchasers.

The Role of Trade Associations

Trade associations can play a significant role in the formation of ETCompanies. The broad membership of associations provides an effective mechanism for creation of large trading houses. Each of these members—export service companies, bank hol

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing companies, law firms, accounting, and consulting firms—can contribute their specialized knowledge and expertise to form an ETCompany that will resist cutthroat international competition and succeed in foreign markets.

A number of trade associations have already taken advantage of the E

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

TC Act to secure antitrust immunity for their members. In 2003, Virginia Apple Growers Association obtained certificates of review for its members, who formed VAGA joint venture for exporting U.S. grown apples to foreign markets. During the first year of operation, VAGA generated export s

.

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

les of over $600,000. Other organizations are beginning to notice the advantages of the ETC Act and form consortia to actively explore how their members could benefit from the Act.

Because American businesses have largely remained unaware of the advantages of the ETC Act, they have not fu

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

Companies that provide selfless information through particip

lly utilized its potential. However, favorable exchange rates, growing interest in exporting, and the increasing awareness of the benefits of the ETC Act are likely to foster formation of many more export trading companies that successfully export U.S. goods and services to foreign markets

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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Several states have small business government grants. These are not offered by the federal government but a number of state-run development agencies provide free government grants.

There are many companies that offer wholesale security cameras and surveillance systems. For the most part, their customers are businesses large and small who have a security need beyond the single household system.

An explanatory article on why Microsoft is what they are: a monopoly. A couple basic points on how they conduct business and some notes on their operating strategies.

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