Instructions for Insurance against Civil Liability Arising from Conducting Pharmaceutical Studies for the year 2013

The Official Gazette of the Hashemite Kingdom of Jordan Amman: Thursday 18 Rabi' al-Thani 1434 AH. Corresponding to 28 February 2013 AD Issue No.: 5209 Issued by the Prime Ministry - Directorate of the Official Gazette Website: www.Pm.gov.jo

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Instructions for Insurance against Civil Liability Arising from Conducting Pharmaceutical Studies for the year 2013 Issued pursuant to the provisions of item (2) of paragraph (b) of Article (5) of the Pharmaceutical Studies Law No. (2) of 2011

Article (1): These instructions shall be called (Instructions for Insurance against Civil Liability Arising from Conducting Pharmaceutical Studies for the year 2013) and shall come into effect thirty days after the date of their publication in the Official Gazette.

Article (2): a- The words and phrases below shall have the meanings assigned to them in the effective Pharmaceutical Studies Law, wherever they appear in these instructions, unless the context indicates otherwise. b- For the purposes of these instructions, the words and phrases listed below shall mean the following: Insured: The entity requesting the conduct of pharmaceutical studies for its benefit in accordance with the provisions of the effective Pharmaceutical Studies Law. Injured Party: Any person who has suffered harm due to the conduct of pharmaceutical studies on them. Harm: Death or total permanent disability or partial permanent disability and the moral damages resulting from any of them, temporary disability, medical treatment costs incurred by the injured party, the period of incapacitation, and the losses and damages caused by the injured party to third-party property as a result of conducting pharmaceutical studies on the injured party. Deductible Amount: The part that the insured is obligated to bear from the value of the payable claim.

Article (3): The insured is obligated to conclude a valid insurance contract with one of the insurance companies operating and licensed in the Kingdom to insure against their civil liability arising from harm caused to the injured party in the following pharmaceutical studies: a- All bioequivalence and bioavailability studies. b- All studies conducted on humans that involve intervention, whether in the patient's treatment method or the medications they take. c- Cases not mentioned shall be considered, and a decision shall be issued by the Director General based on a recommendation from the Pharmaceutical Studies Committee.

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Article (4): a- It is stipulated that the limits of the insurance company's liability for compensation for harm under the insurance contract concluded between the insured and the insurance company shall not be less than the limits stated in the table attached to these instructions, which forms an integral part thereof. b- The insurance company and the insured are prohibited from agreeing to reduce the limits of the insurance company's liability below the limits stated in the table attached to these instructions, but they may agree to increase them. c- 1- The value of local insurance within the Kingdom for participants in therapeutic pharmaceutical studies must not be less than the global insurance value as duly stated in the global insurance policy submitted for the same study, provided that it is detailed according to the items listed in the table attached to these instructions and shall in no case be less than the limits stated in this table. 2- The limits of the insurance company's liability for compensation for a single case must not be less than the limits stipulated in the global insurance. 3- The local insurance company is obligated to provide the institution with proof of the application of items (1) and (2) of paragraph (c) of this Article.

Article (5): It is required to obtain prior approval from the Insurance Commission for the insurance contract form, and to provide proof of this to the institution, and that it contains the following: a- Insurance policy number. b- The pharmaceutical study subject to insurance, including its title and the institutional committee's approval thereof. c- Study phase. d- Study location and address. e- Number and date of the study plan approved by the Pharmaceutical Studies Committee. f- Number of persons subject to the pharmaceutical study at its location. g- Expected study start date. h- Expected study end date. i- Deductible amount, which must not exceed (2%) of the value of each claim. j- Limits of the insurance company's liability for compensation for each injured party, which must not be less than the limits stipulated in the table attached to these instructions. k- The insurance company's commitment to compensate the injured party for temporary disability allowance regardless of the injured party's age or whether the injured party is employed or not.

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l- The insurance contract may not be canceled by the insurance company or the insured as long as the pharmaceutical studies are ongoing, unless another insurance contract replaces it with the prior approval of the Pharmaceutical Studies Committee. m- In the event of conducting therapeutic pharmaceutical studies, the insurance company is obligated to provide the institution with an undertaking stating that the insurance coverages for patients participating in these studies in Jordan are in no case less than the highest insurance coverage for patients participating in the same study in other parts of the world.

Article (6): The Director General shall issue the necessary decisions to implement the provisions of these instructions.

Article (7): The Instructions for Insurance against Civil Liability Arising from Conducting Pharmaceutical Studies for the year 2010 are hereby repealed.

Director General of the Jordan Food and Drug Administration Dr. Hayel Mohammad Obaidat

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Table of Insurance Company Liability Limits

Type of Harm	Nature of Harm	Liability Limits
Death/Bodily Injuries	1. Death	(17,000) Dinars per person paid to legal heirs
	2. Total Permanent Disability	(17,000) Dinars per person
	3. Partial Permanent Disability	(17,000) Dinars multiplied by the percentage of disability per person
	4. Temporary Disability	(100) Dinars weekly for a maximum period of (39) weeks - per person
Moral Damages	1. Death	(3,000) Dinars per person paid to legal heirs up to the second degree
	2. Total Permanent Disability	(3,000) Dinars per person
	3. Partial Permanent Disability	(3,000) Dinars multiplied by the percentage of disability - per person
Medical Treatment		(15,000) Dinars
Losses and Damages to Third-Party Property		Determined by the value of the damage, with a maximum of 25,000 Dinars