Pharmaceuticals and Healthcare

As a response to the growth of Iran pharmaceutical market, including the advance of Iranian companies as well as international players, Farama & Co has set up a practice dedicated to the legal support of pharmaceutical companies. The pharma industry is attracting an increasing

amount of attention from the state, which is evident from the growing number of statutory acts regulating the industry, as well as more elaborate strategies to stimulate national production of pharmaceuticals.
Our experience of working with major Iranian and foreign pharmaceutical companies allows us to utilize the unique skill-set of our specialists to form teams capable of executing assignments of the broadest nature and complexity.
As part of an integrated service for companies in the pharmaceutical and healthcare sectors, Farama & Co provides, inter alia, the following services:
• due diligence of companies to identify existing and potential legal risks, as well as recommendations on minimizing risks following the due diligence results
• drafting documents required for the operation of pharmaceutical companies
• development and implementation of required internal policies, including anti-corruption and compliance procedures, as well as compliance with the regulator and prevention of conflicts of interest when doing business in the Iran;
• extensive support in dealing with intellectual property issues arising out of doing business in Iran in the pharmaceutical sphere
• extensive support in relation to antitrust regulation, including the representation of the interests of pharmaceutical companies in investigations and examinations of cases of violation of the antimonopoly legislation
• extensive support in issues related to public procurement of drugs
• consultation and preparation of legal opinions on specific to pharma sector legislation
• legal support of pharmaceutical companies in court proceedings and representation in disputes related to the conduct of the pharmaceutical business.
One of the key capabilities of the practice is the legal assistance in conducting internal investigations to identify risks of violations of Iranian legislation.

Please contact us: Mr. Alireza Kamkar
[email protected]

FAQ

Does Iran have a plan to open insurance sector for foreign investors and what is maximum ownership percent in the mother land (Iran)?

A) Based on the Central Insurance of I.R. of Iran Document of Strategic Goals, “Absorbing foreign persons in the state insurance market” and “promoting collaboration and cooperation with foreign insurance companies” are among the strategic goals.

B) In view of article 113 of Fifth Development Plan Act of the country passed in 2010, foreign investors by observing general policies of principle 44 of I.R. of Iran constitution and relevant affairs can be engaged in insurance sector in following forms:

1- Participation of foreign insurance companies with local trading insurance companies by giving priority to non-governmental sector for establishing a joint commerce insurance company in Iran.

2- Absorption of foreign capital by local insurance companies (including transfer of stocks to foreign persons).

3- Establishment and activities of foreign commerce insurance companies’ branches and brokers

1-C) In view of article 35 of Iran Central Insurance Act and Insurance Practice, passed on June 20, 1971, transfer of stocks of non-governmental Iranian insurance companies to foreign national persons or legal entities, up to twenty percent of the stocks, is possible by receiving the agreement of I.R. of Iran Central Insurance, and more than this number (up to 49%) depends on the proposal of I.R. of Iran Central Insurance and approval of High Council of Insurance as well as approval of council of ministers.

By virtue of the note to the same article, transfer of stocks of Iranian insurance firms to foreign governments or transferring more than 49 percent of their shares to foreign natural persons or legal entities is strictly prohibited.

Are foreign insurance companies allowed to receive activity permits in the mainland? What are the possible alternatives and options for arrival and participation? (For example, in undeveloped insurance sectors, joint investmen?

A) By virtue of article 45 of Central Insurance Establishment Act of Iran and Insurance practice, foreign insurance companies can receive activity permit in main land by observing the relevant regulations and having the necessary qualifications. The requirements for starting activities by foreign insurance institutes in the country have been stipulated in chapter four of section two of the mentioned Law. In addition, by virtue of article 50 of the same law, foreign insurance companies, in addition to being subject of the regulations of Central Insurance Establishment Act of Iran and Insurance practice and its executive by-laws, will be also subject of general rules of foreign companies and institutes in the country [Iran] as well.

B) Based on relevant laws and regulations, the options for foreign insurance companies’ presence and participation are as follows:

1- Participation with local trade insurance companies by giving non-governmental sectors to establish joint commerce insurance in Iran

2- Establishment and activity of branches and representatives/brokers

3- Establishment and activities of communication office

What is the process of receiving insurance permit for the foreign insurance company inside the main land?

In view of provisions of article 45 of the Central Insurance Establishment Act of Iran and Insurance practice, and the regulations of the law in awarding permission for the registry of branches or representative offices/ brokers by foreign insurance companies, passed n November 12, 1997, and the executive by-law of the same law, passed on March 31, 1999, foreign insurance companies that apply for receiving insurance activities permit in Iran, should submit their application to the Central Insurance Company of the Islamic Republic of Iran. Commencement of foreign insurance company is due to the proposal of the central insurance, approval of high council of insurance, approval of council of ministers and the registry of the branch or reprehensive office/ brokers.

According to the Act pertaining to allowing registration of branch or representatives of foreign companies, passed on November 12, 1997 and the executive by-law of this Act, passed on March 31, 1999, foreign companies which are recognized as legal company provided a counter act in their subject company can register their branches or representatives for insurance activities in Iran.

Based on article 2 of the executive by-law of the Act on Foreign Companies Registry of Branches or Representative Offices, the “branch of the foreign company” will be governed by the place of main company which performs the object and duties of the main company in the place directly. The activity of the branch in the place will be under the name and with the responsibility of the main company. In addition, based on article 4 of the mentioned executive by-law, the “representative of foreign company” is the natural person or the legal entity which has undertaken performing a part of the object and duties of the company, as  the party of representative in the place based on the representation contract. The foreign company representative will have the responsibility for the activities which are performed in the place under the representation of the company party to the representation in the place.

The foreign companies that apply for the registration of the branch in Iran are obligated to present following documents and papers to the General Department for the Registration of Corporations and Industrial Ownership alongside with their request in writing:

Article of association of company, notice of establishment and the last changes registered in concerned offices

The last financial report of the company which has been confirmed

The briefing and feasibility report containing the information about the activities of company, defining the reasons and necessity of registering the branch in Iran, determining the type and scope of authorization; and the place of branch activities, estimation of Iranian and foreign human resources which are necessary, and, the method of funding the foreign currency and Rials currency resources to run the branch.

Applicants of foreign company representation registry in Iran should send [legalized] translation of following documents and original documents and information in Persian language to the General Department for the Registration of Corporations and Industrial Ownership with their written request:

. Certified copy of representation contract

. ID. Documents of the applicant

. History of activities of representation registry applicant on the area mentioned in the representation contract.

. Article of association of the foreign company as the party to representation, establishment notice and the most recent changes registered for the company at the relevant legal offices.

. The report on activities of the foreign company as party to the representation and listing the reasons and the necessity of receiving representative offices

. Last financial report of the foreign company as the party to representation with confirmations

. Introduction of the concerned organization (Central Insurance).

Is it possible to have mixed insurance company?

By virtue of the insurance laws and regulations of the Islamic Republic, one of the categories allowed in establishing and activities of insurance institutes in Iran is mixed insurance company (life and other types) and currently, there is no restrictions in establishing such insurance companies.

Is a foreign company allowed to have stocks in the companies already established in main land? Is it possible for the foreign company to own more than 20% stocks? Is the 20% portion limit exercised for the ultimate shareholder?

By virtue of insurance laws and regulations, owning stocks of insurance companies in Iran, directly or via intermediation, is reviewed for any person (natural person or legal entity) and the person can not own more than twenty percent of insurance company stocks directly or indirectly – via intermediately persons.

What is the minimum deposit of foreign insurance company in any insurance field/risk?

By virtue of Article 46 of the Establishment Act of Iran Central Insurance Act and Insurance Broker, “the deposits of foreign insurance institutes” section, foreign insurance companies should deposit a certain amount for any of the two risks- life insurance and other types of insurance- at the Central Insurance of Islamic Republic of Iran. This deposit for each one of the two categories is minimum five hundred thousand USD or its equivalent currency of the types of currencies acceptable by the Central Bank of the Islamic Republic of Iran. In addition, any foreign insurance company should add to this deposit each year proportion to their revenue until the deposit reaches minimum twice the amount passed by High Council of Insurance. Adding to this deposit beyond that is optional. It should be noted that deposit passed by High Council of Insurance is the same minimum amount as stipulated in law (five hundred thousand USD).

What is the minimum capital for properties, liabilities and life insurance?

According to the last resolution of the Council of Ministers (July 21, 2012) minimum capital for the establishment and receiving activity permit by direct insurance companies is as follows:
. Property insurance: 1,600,000,000,000 Rials
. Person insurance (life, pension, personal accidents, medical), 1,500,000,000,000 Rials
. Liability insurance: 1,400,000,000,000 Rials
. Vehicle insurance such as third party, body, driver’s accidents: 1,300,000,000,000 Rials
. Life and other insurance: 1,200,000,000,000 Rials
. Mixed insurance (all fields), 2,500,000,000,000 Rials

If it is allowed to establish mixed insurance company in Iran, what are the minimum conditions for its establishment?

Conditions and terms for establishing insurance company in main land and free zones are governed by the regulations of Establishment Act of Iran Central Insurance and Brokers, passed on June 20, 1971; the regulations of establishing non-governmental insurance companies, passed by High Council of Insurance and the regulations on establishing and activities of insurance companies at Islamic Republic of Iran Trade-Industrial Free Zones, passed by the Council of Ministers on August 23, 2000. The regulations are available in the information site of Central Insurance of Islamic Republic of Iran via HYPERLINK "http://www.centinsur.ir" http://www.centinsur.ir .

Are Iranian insurance companies t allowed to conclude reinsurance contracts with foreign insurance companies and are there any restriction in assignment to outside Iran or inside Iran?

Concluding reinsurance contract with the reinsurance brokers/reinsurance brokers outside the country/ in assigning some of the risks and/or concluding contracts directly by insurance companies that work in Iran is allowed by observing the provisions of article 73 of Establishment Act of Iran Central Insurance and Brokers and regulations passed by High Council of Insurance.

Are there any governmental reinsurance companies in Iran with minimum mandatory assignment amount?

Yes, by virtue of article 71 of Establishment Act of Iran Central Insurance and Brokers and the last regulations which have been passed, all insurance companies that work in Iran should reinsure 25 percent of their life insurance and 15 percent of their other fields of direct insurance transactions before Central Insurance of Islamic Republic of Iran.

Is it possible to transfer hard currencies to Iran (for example, to buy stocks, invest....) and receive hard currencies from Iran (for example, as dividends)?

Any foreign currency exchange and trades in Iran is governed by the regulations of Foreign Currency Transactions of Central Bank of Islamic Republic of Iran.

Are insurance companies allowed to have various types of agreement letters with bank-insurance?

Insurance companies and banks have the possibility of working in different areas including insurance services and joint investments in the framework of the regulations and agreements signed between them.

What are the necessary terms for solvency?

The requirements of controlling insurance companies’ solvency are governed through the by-law of “Calculation and Supervision on Solvency of Insurance Companies”, passed by High Council of Insurance in Iran.

What are the supervisory changes (regulations) which might occur in future (for example, on capital, solvency, and process of permit isusance....)?

To save compatibility of regulations to the current needs and to improve the supervisory role of the supervising body, the insurance regulations are undergoing constant review to reach compatibility to the international standards.

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Mr. Behdad Arian

Office Tel: +98 9121023022
Email: [email protected]

Position
Partner
Bar Admissions
Tehran-Iran
Education
Tehran Azad University, Faculty of Law
L.L.B
Professional Associations and Memberships
Member of Iranian Bar Association
Languages
Farsi, English


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Mr. Alireza Kamkar

Office Tel: +98 9121023022
Email: [email protected]

Position
Associate
Bar Admissions
Tehran-Iran
Education
Tehran University, Faculty of Law 
L.L.B
Shahid Beheshti University, Faculty of Law 
LLM, International Trade
Tehran University, Faculty of Law 
P.H.D
Professional Associations and Memberships
Member of Iranian Bar Association 
Languages
Farsi, English

          Tel: +989121023022