Useful Advices - Business

10. Pay no income taxes on profits your company does not remit to the U.S. You should pay taxes in your country on money your Panamanian corporation pays you, whether in salary or tax-advantaged dividends or capital gains. However, 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

corporation can pay many of your expenses as legitimate business expenses.

9. Pay no income taxes in Panama. A non-resident Panamanian International Business Corporation or Private Interest Foundation does not pay any kind of tax on a

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

Examples of combination products may in

ny of its income or assets, and does not even have any reporting requirements to the Panamanian government.

8. No Panamanian requirement to collect sales taxes from your customers. (Yea!)

7. No capital gains tax, no tax on inter

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

est income, no stock sale or transfer tax, no property tax, and no gift tax.

6. Panama has the most stable government in Latin America, no army (it was abolished by constitutional amendment in 1994; security is provided by the U.S.) and

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

70 years of the same offshore corporation law. Panama is the registered domicile for nearly 500,000 corporations and foundations, making it the second most popular jurisdiction to incorporate in the world, following Hong Kong. It has the sec

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

Combination pro

ond-largest free trade zone in the world, again following Hong Kong, with almost 2,000 import/export businesses operating inside it and well over 250,000 visitors a year. Products can be imported, warehoused, and sent to customers in any count

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

ry in the world without paying import or export duties.

There is no requirement for paid-in capital. Directors, officers and shareholders can be of any nationality and reside in any country. Meetings of directors, officers, and shareholders

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

may be held in any country (travel and entertainment expenses are 100% deductible), and accounting books may be kept in any country. Corporations conducting business outside of Panama do not require a commercial license for offshore business a

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

ctivities.

There is no need to travel to Panama to establish a corporation or Private Interest Foundation, conduct any form of business, move funds around, or dissolve the entity.

5. But you will want to travel there! Panama is a beau

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

tiful country with world-class beaches on each ocean. If you like to sail, scuba or fish, it is paradise – and still a cheap place to retire. There is excellent medical care and a rich cultural life. Panama has the lowest crime rate in all o

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

f Central and South America.

The economy is generally regarded as one of the most stable, prosperous, and advanced in Latin America. Panama’s legal tender is the U.S. dollar, and there are no currency exchange controls or restrictions. Infla

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

Following aspects would a

tion has been under 2% for the last 40 years. During the Asian currency crisis, Panama was untouched.

Panama is a major node on the Global Crossing optical fiber backbone, so web pages load remarkably fast for Internet surfers around the worl

dd to the challenges in developing combination products:

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

d.

4. Bulletproof asset protection. Panama does not allow piercing the corporate veil. The Panama Private Interest Foundation is one of the most useful asset protection and estate planning vehicles available anywhere in the world. I

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

t allows for Private Protectorate Documents and Private Letters of Wishes, enabling the controllers (called Protectors) and beneficiaries of the Foundation to keep their transactions private and remain 100% anonymous.

3. Entirely avoid

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

state and Federal estate taxes, and there is no gift tax. Panama corporation share certificates can be issued as Bearer shares, an anonymous form of ownership.

2. Even after 9/11, Panama’s bank secrecy laws, which are in its constitu

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

tion, are the best in the world. Revealing banking information to a third party is a serious crime, punishable by a fine and jail term. Panama has no mutual legal assistance treaties to share banking information with any other country, and do

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

Professional from academic institutions, pharmaceutical industries, health care indust

es not recognize court rulings from other countries. The only exceptions are for drug money laundering or drug smuggling, as the government wants to keep that element out of the country.

1. There are reliable, honest people in Panama to

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

handle all your business affairs and Internet hosting, in sharp contrast to some other offshore jurisdictions. The biggest hurdle to going offshore is not language, expense, time or the learning curve. It is not knowing the right peopl

.

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

e. There are too many "offshore opportunities" where they put your money in their pocket and leave. They know you won't sue - it's too expensive, and in many jurisdictions the bad guys have the judges in their collective pockets.

You

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

Companies that provide selfless information through particip

must go into Panama or any other offshore jurisdiction with referrals to honest, experienced people who can get you established quickly, inexpensively and, most important, legally under U.S. or your country’s laws as well as local laws.

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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