Russian Government Decree № 714 "Approval of rules for compulsory insurance of the life and health of patient"

Russian Federation

Government Decree No. 714 of September 13, 2010.

ON APPROVAL OF TYPICAL RULES FOR COMPULSORY INSURANCE OF THE LIFE AND HEALTH OF A PATIENT INVOLVED IN CLINICAL TRIALS OF A MEDICINAL PRODUCT

(as amended by Government Decree of Мау 18, 2011, No.393)

In accordance with Article 44 of Federal law On Circulation of Medicines the Government of Russian Federation states:

To approve the Typical rules for compulsory insurance of the life and health of a Patient involved in Clinical Trials of a medicinal product.

The Chairman of Government of
The Russian Federation
V.PUTIN

Approved
by Russian Federation Government Decree
of September 13, 2010, No. 714

THE TYPICAL RULES FOR COMPULSORY INSURANCE OF THE LIFE AND HEALTH OF A PATIENT INVOLVED IN CLINICAL TRIALS OF A MEDICINAL PRODUCT

I. General Considerations

This Typical rules determines insurance rates for compulsory insurance of the life and health of a Patient involved in Clinical Trials of a medicinal product (hereinafter “Clinical Trials”), the order of establishing of the individual identification code of the Patient by the Insurant, the order of informing of the Insurer by the Insurant on the Patients involved in Clinical Trials the procedure for the payment of the insurance premium, the list of documents required to enable payment of benefits, the procedure for exercising the rights and obligations of the parties to a compulsory life and health insurance of a Patient involved in Clinical Trials, against any harm caused to the Patient’s life or health as a result of the clinical trial and effecting on relations, emerged from the above mentioned agreement.
For the purpose of this Typical rules the following basic concepts are used:
“individual identification code of the Patient” — a sign combination identifying the particular Patient.
“Patient” – natural person who gave a voluntary informed consent to participate in the clinical trial conducted by a medical organization, which shall be confirmed by his/her signature or signature of his/her legal representative on the Patient information sheet.
“Insurant” – organization, arranging the conducting of the clinical trial, which in accordance to the Laws of the Russian Federation is responsible for insurance of the life and health of a Patient involved in Clinical Trials and made the Contract with an Insurer;
“Insurer” – insurance organization engaged in certain Insurance Activities in accordance to the Laws of the Russian Federation and which made the Contract with an Insurant;
“Contract” – a Contract of compulsory insurance of the life and health of a Patient involved in Clinical Trials, against which the Insurer is obligated on the base of stated charge stated in the Contract (insurance premium) when the loss stated in the Contract occurs (insurance event) to pay to Insured Person (beneficiary) in case of harm to the life or health of the Insured Person the benefits under the Contract;
“Insured Person” – a Patient, whose property interest connected with harm caused to the Patient’s life or health as a result of a clinical trial is covered by insurance under the Contract;
“Insurance Act” – a document created by the Insurer, which contains data about Insurer’s reviewing of requirement for benefit payment, including the data about the presence or absence of insurance event, about the Insured Person (beneficiary) and the extent of benefits which are due to him/her and about reasons of rejection of benefits payment.
The Contract is signed by the insurance organization for a Patient participating in the clinical trial in accordance to the Laws of the Russian Federation and on the base of current Typical rules.
When the harm to the life and health of the Insured Person occurs the beneficiaries are the following persons:
a) people entitled to compensation for harm in the event of death of the breadwinner in accordance with the civil legislation:
disabled people, living in dependence on the dead Insured Person or entitled by the day of his/her death to obtain the upkeep from him/her;
a child of the dead Insured Person, who was born after his/her death;
one of the parents, spouse or member of the family irrespectively of his/her ability to work, who does not work and is engaged to care of upkept from the dead Insured Person children, grandchildren, brothers and sisters of the dead Insured Person under 14 years old, but who according to the health state-associated conclusion of medical bodies need in outside care. One of the mentioned persons, who became disabled during care retains the right for compensation of the harm after the termination of the care;
persons lived in dependence on the dead Insured Person and who became disabled within 5 years after his/her death;
b) parents, spouse, children of the dead Insured Person – if there are no people mentioned in subitem 4 of this item;
c) people, on whose upkeep the Insured Person lived – in case of death of the Insured Person who did not have any individual income;
d) the person, who incurred the funeral expenses on the Insured Person – in the aspect of compensation of such expenses.
Claims for compensation of harm caused to the Insured Person’s life or health shall be satisfied within the limitation period established by the civil legislation.

II. The object of compulsory insurance, insurance event

The object of compulsory insurance shall be the Insured Person’s property interest connected with harm caused to the Patient’s life or health as a result of a Clinical Trial.
The insurance event is the death of the Insured Person or health impairment caused to him, including health impairment entailing disability as a result of participation in Clinical Trials in case of a cause-and-effect relation present between this event and participation of the stated person in the Clinical Trial of the medicinal product.

III. The extent of benefits

The extent of benefits under a compulsory insurance Contract shall be as follows:
a) in case of the death of the Insured Person – RUR 2 million. The benefit in mentioned extent shall be distributed throughout beneficiaries accordingly to theirs quantity share and share alike;
b) in case of the Insured Person’s health impairment with the following sequela:
first class disability – RUR 1.5 million;
second class disability – RUR 1 million;
third class disability – RUR 500 thousand;
c) in case of the Insured Person’s health impairment without any disability – not more than RUR 300 thousand.
The extent of benefits indicated in the item 8 of this Typical rules, may be increased by a court decision.

IV-1. The order of establishing of the individual identification code of the Patient by the Insurant

13-1. The individual identification code of the Patient shall be set by the Insurant after the Insurant obtains the permission to carry out the Clinical Trial from the Ministry of Health and Social Development of the Russian Federation (hereinafter — the “Permission”).
13-2. The individual identification code of the Patient shall have the following structure consisting of successive positions arranged from the left to the right:
positions 1—3 — number of the Permission (from 001 to 999);
positions 4—11 — date of issue of the Permission (DD.MM.YYYY where DD means the date, MM means the month, YYYY means the year);
positions 12—14 — the sequence number of the medicinal organization stated in the Permission and carrying out the Clinical Trial (from 001 to 100);
positions 15—17 — the first letters of the surname, name and patronymic of the Patient;
positions 18—25 — date of birth of the Patient (DD.MM.YYYY);
positions 26—33 — the unique number assigned to the Patient by the researcher responsible for carrying out of the Clinical Trial (hereinafter — the “Permission”) consisting of numbers and (or) letters registered in the minutes of the Clinical Trial.
13-3. The individual identification code of the Patient shall be set by the Insurant on the basis of the data on the Patient participating in the Clinical Trial presented by the Researcher and provided by paragraphs 5—7 of Clause 132 hereof.
13-4. The individual identification code of the Patient shall be reported by the Insurant to the Researcher for its registration in the information sheet of the Patient and his medical records.
13-5. individual identification code assigned to the Patient shall not be changed.

IV-2. The order of informing the Insurer by the Insurant of the Patients involved in Clinical Trials of a medicinal product

13-6. The Insurant shall forward the register (registers) of the individual identification codes of the Patients in paper or electronic form to the Insurer in accordance with the contract.
13-7. The Insurant and the Insurer shall exchange and check the data on the individual identification codes of the Patients within the terms and in the order provided by the agreement concluded between them and shall exchange the necessary information on the basis of the unity of the exchange technology, information confidentiality and ensuring the protection of the information resources from attacks and unauthorized access.

IV. Insurance rates, the procedure for the payment of the insurance premium

The size of the insurance rate is defined by multiplication of the basic insurance rate, specified on the base of the purposes of the clinical trial of the medicinal product, on the quantity of Patients and factor of the insurance rate.
The basic insurance rate for 1 Patient is as follows:
9811 roubles- for conducting of a clinical trial to assess the safety profile of the medicinal product in Patients from the number of healthy volunteers and(or) tolerability of the medicinal product by they;
3804 roubles- for conducting of a clinical trial to select optimal dosages of medicinal product and course of treatment for Patients with specific disease, optimal dosages and vaccination schemes of immunobiological medicinal products for healthy volunteers;
1941 roubles- for conducting of a clinical trial to establish safety and efficacy of a medicinal product for Patients with specific disease, prophylactic efficacy for immunobiological medicinal products for healthy volunteers;
1445 roubles- for conducting of a clinical trial to to study the possibility to widen the indication for medical use and identify earlier unknown side effects of registered medicinal products, as well to study the bioequivalence and/or therapeutic equivalence for generic medicinal products.
The factor of the insurance rate depends on the quantity of Patients and includes the following:
1 – in insurance of not more than 50 Patients;
0.95 – in insurance of 50 to 100 Patients;
0.9 – in insurance of 101 to 200 Patients;
0.85 – in insurance of 201 to 400 Patients;
0.8 – in insurance of 401 to 600 Patients;
0.75 – in insurance of 601 to 800 Patients;
0.7 – in insurance of more than 800 Patients.
The insurance premium under the Contract depends on the insurance rate.
The insurance premium shall be payed flat by the Insurant within the period prescribed by the Contract.

V. The procedure of signing of the Contract and its expiration time.

For the purpose of the contract conclusion the Insurant shall forward to the Insurer the written application on the contract conclusion with indication of the maximum number of Patients taking part in the Clinical Trial, the name of the medicinal product undergoing the Clinical Trial, the purposes of the Clinical Trial, the names of the minutes of the Clinical Trial.
The contract shall be deemed to have been concluded from the date of its signing and shall become effective from the date of receipt of the register of the individual identification codes of the Patients by the Insurer (if there are several registers — from the date of receipt of the first of them) provided that the insurance premium has been paid before the effective date of the contract.
The register (registers) of the individual identification codes of the Patients shall form the integral part of the contract and shall be attached thereto.
The term of the Contract shall not be less than the term of the Clinical Trials.
In case of extension of the term of a clinical trial the expiration term of the Contract signed for the term of the clinical trial shall be extended on the base of Insurant’s request for the needed term in the prescribed procedure.
The document certifying the performing the compulsory insurance of the Patient is the Policy of Compulsory Insurance of the life and health of a Patient involved in the Clinical Trials (hereinafter “the Policy of Compulsory Insurance”), which shall be issued to every Insured Person.
The documenting of the Policy of Compulsory Insuranceshall be performed by the Insurer using the corresponding form in accordance to the Appendix. The Policy of Compulsory Insuranceshall be uniform on the territory of Russian Federation and after the documenting shall be passed by the Insurer to the Insurant, who issue it to the Insured Person.
In case of changes in Policy of Compulsory Insurance are needed the Insurer shall document the new policy within 2 business days from the day of returning by the Insurant of the requested from the Insured Person of the policy of compulsory insurance.

VI. Rights and obligation of the parties to the Contract and insured
persons (beneficiaries)

The Insurant has a right to:
a) review the documents supporting the validity and paying capacity of the Insurer;
b) participate in the research of the facts of the insurance events.
The Insurant is obliged to:
a) insure the life and health of the Patients at its own expense;
b) pass to the Insurer the data needed to sign the Contract and calculate the insurance premium, notify the Insurer with all changes in data provided throughout the Contract expiry term;
c) pay the insurance premium within the period prescribed by the Contract;
d) assist the Insurer to perform the assessment of insurance risks during signing of the Contract;
e) inform the Insured Persons with the Contract terms and conditions and arrange the dispensing to them the policies of compulsory insurance;
f) in case of harm to the life or health of the Insured Person:
within 5 business days from the day of accident during the conducting of the clinical trial to document the act of the accident and pass the copy of it to the Insurer;
within 5 business days from the day of the Insured Person’s informing (beneficiary) about the harm to the life and health of Insured Person to notify the Insurer about the applicants.
The Insurer has a right to:
a) during signing of the Contract request from the Insurant for needed information about specifics of the scheduled clinical trial in order to assess the insurance risks and specifying of the insurance premium;
b) request from the Insurant for additional information throughout the expiry term of the Contract in order to ensure the potential changes of the Contract;
c) participate in the research of the facts of the insurance events, including involvement of its representatives;
d) until the extent of harm to be indemnified is determined in full, the Insurer may, on request of the Patient involved in Clinical Trials (beneficiary), pay part of the insurance benefits corresponding to the actually determined part of the harm caused;
e) pass to the Insurant the requests to provide the corresponding documents and information disclosuring the specifics of conducting of the clinical trial.
The Insurer is obliged to:
a) pursue the Insurant’s statement of signing of the Contract, assess the insurance risks, specify the extent of insurance premium and prepare the Contract for signing;
b) provide to the Insurant 1 copy of the Contract after the signing and other documents concerning the insurance performed;
c) document the Policies of Compulsory Insurance;
d) issue the duplicates of Policies of Compulsory Insurance or the Contract in case of its loss by the Insurant of the Insured Person;
e) register the statement of the Insured Person (beneficiary) of the compensation of harm to the life or health of Insured Person including the specifying the date of the receipt of the statement and information contained in it;
f) inform the Insurant within 5 business days from the day of the receipt of the statement from the Insured Person (beneficiary) of of the compensation of harm to the life or health of Insured Person including the specifying the date of the receipt of the statement and information contained in it;
g) document the Insurance Act which shall be the base of the benefit;
h) perform the payment of benefits in accordance with the procedure, terms and extent, specified by this Typical rules and the Contract, to pass the information about the payment of benefits (the copy of the Insurance Act) to the Insurant. In case of rejection of considering of the event as insurance event to pass to the Insured Person (beneficiary) the reasoned rejection of payment of benefits and notify the Insurant about it;
i) compensate the Insured Person’s (beneficiary’s) expenses related to conducting of expert studies in order to find the cause-and-effect relationship between the death or health impairment of Insured Person and administration of medicinal product.
Insured Person (beneficiary) is entitled to:
a) make a demand of compensation of harm to the life or health of Insured Person directly to the Insurer by means of submitting of corresponding statement;
b) make a demand of increasing of benefits judicially.
Insured Person (beneficiary) is obligated to inform the Insurer with the personal details specified by this Typical rules and needed to pay the benefits.

VII. The procedure of payment of benefits
and the list of documents provided by insured
persons (beneficiaries) to obtain
the benefits

To obtain the benefits the Insured Person (his/her legal representative) shall provide the Insurer with the following:
a) the statement of the payment of benefits;
b) the policy of compulsory insurance;
c) the copy of the signed Patient information sheet;
d) the copy of the Insured Person’s identification document;
e) the copies of legal representative’s identification documents and documents certifying his/her authorities;
f) the copy of the reference of state institution of medical and social expert examination certifying the fact of disability assignment to the Insured Person;
g) the copy of conclusion (reference) of the Insured Person’s state of the health issued by a medical institution;
h) the copy of the court decision of compensation of the harm to the life or health of Insured Person as a result of Clinical Trials (if the deal was treated judicially).
To obtain the benefits the beneficiary shall provide the Insurer with the following:
a) the statement of the payment of benefits;
b) the Policy of Compulsory Insurance of the Insured Person;
c) the copy of the signed Patient information sheet;
d) the copy of the Insured Person’s the death certificate;
e) the copy of the beneficiary’s identification document;
f) the copies of marriage certificate, documents certifying that the beneficiary is the father of the mother of the dead Insured Person, birth certificate(s) for the child (children) of the Insured Person and of the documents certifying the authorities of legal representative;
g) documents, certifying the the dependence of the dead Insured Person or right on upkeeping from his/her;
h) the copy of the reference of federal state institution of medical and social expert examination certifying the fact of disability (disabled child) assignment to the beneficiary, who was in dependence from the dead Insured Person on the date of insurance event occurrence;
i) the conclusion (reference) of medical institution, federal state institution of medical and social expert examination certifying the fact of need in outside care of the beneficiary or other persons, who was in dependence from the dead Insured Person on the date of insurance event occurrence;
j) the reference of the body of people social protection (medical institution, body of pension provision, body of local government, body of people placement service), certifying that the beneficiary from the number of persons mentioned in the paragraph of the fourth subitem a of the item 4 of this Typical rules does not work and is engaged to care the respective persons;
k) the documents, certifying the absence of individual income in the dead Insured Person and his/her dependency from the beneficiary (the reference of the educational institution, certifying the studying of the Insured Person in this institution, documents, certifying his/her disability or need in outside care etc.);
l) the copies of the conclusion of the medical organization about the death of the Insured Person, the autopsy study protocol of the Insured Person and the postmortem epicrisis;
m) the copies of the documents, certifying expenses for the funeral of the Insured Person;
n) the copy of the court decision of compensation of the harm to the life of Insured Person as a result of a clinical trials (if the deal was treated judicially).
The copies of the documents mentioned in the items 25 and 26 of this Typical rules shall be duly legalized or provided along to originals.
The payment of benefits shall be performed by the Insurer within 30 days from the day of receipt of Insured Person’s (beneficiary’s) statement with all required documents attached.
The payment of benefits under the Contract shall be performed independently from benefits on other types of insurances, including the compulsory insurance, as well as by social security and compensation for harm.

Appendix

to the Typical rules of the compulsory insurance of the life and health
of a Patient participating in the Clinical Trials of the medicinal product

(form)

___________________________________________________________________________
(name of Insurer)

POLICY
for compulsory insurance of the life and health of a Patient participating
in the Clinical Trials the medicinal product

serial ____________ No. ______________________________________________________

1. Insurant:
full name of legal entity
_____________________________________
location __________________________________________________________
registration number of the certificate of registration of the leagal entity and date
of issue ________________________________________________________________
bank details ______________________________________________________
INN (Taxpayer Identification Number)____________________________________________
phone ______________________________________________________________________
fax_______________________________________________________________________
e-mail _________________________________________________________

2. The Individual identification code of the Patient

3. The object of compulsory insurance: property interest of the Insured Person, associated to the harm to his/her life or health as a result of a Clinical Trial of a medicinal product for medical use
______________________________________________.
(name of the medicinal product)

4. Beneficiaries in case of harm to the life or health of the insured person:
a) people entitled to compensation for harm in the event of death of the breadwinner in accordance with the civil legislation:
b) parents, spouse, children of the dead Insured Person – if there are no people mentioned in subitem a of this item;
c) people, on whose upkeep the Insured Person lived – in case of death of the Insured Person who did not have any individual income;
d) the person, who incurred the funeral expenses on the Insured Person – in the aspect of compensation of funeral expenses.

5. The extent of benefits in insurance event occurs:
a) in case of the death of the Insured Person – 2 million roubles;
b) in case of the Insured Person’s health impairment with the following sequela:
first class disability – 1.5 million roubles;
second class disability – 1 million roubles;
third class disability – 500 thousand roubles;
b) in case of the Insured Person’s health impairment without
disability assignment – not more than RUR 300 thousand.

6. The Policy of Compulsory Insurance is issued under the Contract for compulsory insurance of the life and health of a Patient participating in the Clinical Trials of the medicinal product for medical use, of _____________, 20__ . N ______, made between