MINISTRY OF HEALTH OF UKRAINE
Central Commission on Ethics
State Pharmacological Centre
APPROVED
Deputy Minister of Health of Ukraine
_______________ AP Gudzenko
Insurance clinical trials of medicinal
products in Ukraine (responsibility of the customer in case of damage to life and health of patient)
(Guidelines)
“APPROVED”
Chairman of the Central Commission
Ethics Health Ministry of Ukraine
_______d.m.n. Sci. VM Kornatskyy “APPROVED”
Deputy Director of State Enterprise “State Pharmacological Center” Health Ministry of Ukraine
_______d.m.n. Sci. AM Morozov
Kyiv 2010
MINISTRY OF HEALTH OF UKRAINE
Central Commission on Ethics
State Pharmacological Centre
APPROVED
Deputy Minister of Health of Ukraine
_______________ AP Gudzenko
Insurance clinical trials of medicinal
products in Ukraine (responsibility of the customer in case of damage to life and health of patient)
(Guidelines)
“Agreed”
Chairman of the Central Commission
Ethics Health Ministry of Ukraine
MD, Professor. VM Kornatskyy
«____» ___________ 2010 “Agreed”
Deputy Director of State Enterprise “State Pharmacological Center” Health Ministry of Ukraine
MD, Professor. AM Morozov
«____» ___________ 2010
Kyiv 2010
OF THE DEVELOPERS:
The Central Commission for Ethics Health Ministry of Ukraine
State Enterprise “State Pharmacological Center” Health Ministry of Ukraine
Compiled by
MD, Professor. Talayeva Tatiana, Deputy Chairman of the Central Ethics Committee of the Ministry of Health of Ukraine;
PhD Olga V. Silantyev, executive secretary of the Central Ethics Committee of the Ministry of Health of Ukraine;
Skaryna Olga, head of legal department of the Ukrainian Council of protecting the rights and patient safety;
Tit Marina Alexandrovna, head of legal department of the Ukrainian Council for patients rights and security;
PhD Kovtun, Ludmila Ivanovna, Head of the Department of clinical trials and preclinical testing of SE “State Pharmacological Center” Health of Ukraine;
Moskalenko Darya Petrovna, a head of monitoring adverse reactions to the Department of Clinical and preclinical testing of SE “State Pharmacological Center” Health of Ukraine.
Reviewer:
Kundiyev Yuri Ilich, NAS and AMS of Ukraine, Vice-President of the Academy of Medical Sciences of Ukraine, MD, professor, director of the Institute of Occupational Medicine AMS of Ukraine, Chairman of the Commission of Bioethics at the National Academy of Sciences of Ukraine;
Grevtsova Radmila Yuriyevna affairs specialist, director of the Institute of Medical and Pharmaceutical Law and Bioethics of the Academy of Advocacy of Ukraine, president of the Ukrainian medical and legal associations.
The compilers express their sincere gratitude to the Ukrainian Medical Law Association (President – k.yu.n. R. J. Grevtsova) personally and first vice-president of the Association, MD, Professor Alla Stepanenko V., research projects and publications which were widely used in compilers developing data guidelines.
Recommended Fourth National Congress on Bioethics (September 2010).
CONTENTS
List of Acronyms
Interpretation of key terms used in the methodological recommendations … … … … … .. … … … … … … … … … … … .. … … … … … … ..
Introduction … … … … … … … … … … … … … … … … … … … … … … … … … …. …
1. Legislature of order and security of clinical trials in Ukraine … … … … … … … … …
2. Ethical aspects of insurance patient (healthy volunteer), participating in a clinical trial … …
3. Requirements for the insurance company that participates in the insurance liability of the customer trials … … … … … … … … … … … … … … … … … … … … … … … …
4. General and specific requirements for a contract of liability insurance customer trials … … … … … … … … … … … … … … … … … … … … … … … …
4.1. Certification by the fact the contract was signed … … … … … … … … … … … … … … … … … … … … … … … … ..
4.2. Requirements for liability insurance contract customer trials to third parties (patients, healthy volunteers) … … … … … … … … … … … ..
5. Terms of the insurance payments … … … … … … … … … … ..
6. Reasons for refusal of insurance benefits … … … … … … … … … …
Sources … … … … … … … … … … … … … … … … … … … … ..
List of Acronyms
Medicinal drugs
HF clinical trial
Civil Code Civil Code ofUkraine
GCP Good Clinical Practice
Interpretation of key terms used in the methodological recommendations
Insurance – This type of civil legal relations to protect the property interests of citizens and legal persons in case of occurrence of certain events (insurance claims), defined by the insurance contract or applicable law, at the expense of funds that are formed by paying citizens and legal entities of insurance premiums (insurance contributions, insurance premiums) and proceeds from the placement of these funds.
Insurers are recognized financial institutions, which are created in the form of stock, full, limited partnerships or additional liability under the Law of Ukraine “On Business Associations” taking into account the specifics envisaged by this Law, and received in the prescribed manner a license for insurance activities. Members of the insurer shall be not less than three. Insurance activity inUkraineis administered exclusively by insurers – residents ofUkraine.
Insurers recognized legal entity and capable citizens who have entered into contracts with insurers or insurance are insured under the legislation ofUkraine.
Voluntary insurance – is insurance that is based on agreement between the insured and insurer. General conditions and procedures for voluntary insurance are determined by insurance regulations that are set independently by the insurer pursuant to this Act. Specific terms of insurance shall be determined at the conclusion of the contract under the law.
Insurance risk – an event, the event which is held insurance and having features and the probability of chance occurrence.
Insured event – an event, provided the insurance contract or law, which took place with the onset of which occurs insurer’s obligation to pay the sum insured (insurance) to the insured, the insured or other third party.
Insurance amount – the amount of money within which the insurer under the terms of insurance shall make compensation in the insurance case.
Insurance payments – the amount of money paid by the insurer under the insurance contract when the insured event.
Indemnification – insurance payment, which is an insurer within the sum insured under the contracts of property insurance and liability insurance in the insurance case.
Insurance premium (premium, premium) – charges for insurance, which the insurer is obliged to make the insurer under the insurance contract.
Insurance rate – rate premium per unit of sum insured for a certain period of insurance.
Limit of liability – stipulated by the contract of insurance limit (maximum) amount of money payments for each insured event or series of cases due to one reason.
Insurance – a written agreement between the insurer and the insurer under which the insurer undertakes in the insurance case to an insurance payment to a third party specified in the contract of insurance the insured to whom a contract of insurance (to provide assistance, to perform service etc.), and the insurer undertakes to pay insurance payments in due time, and other conditions of the contract.
Close relatives – individuals, the natural relationship between them based on the origin of each other or from common ancestors and have legal significance in the cases provided by law. Close relatives are the husband / wife, parents, children, brothers and sisters;
Investigational drug – pharmaceutical form of the active substance or placebo being studied or used for comparison in clinical trials, including drugs that are already issued a registration certificate, but they are used or produced (made or packaged) in a different way compared with the registered dosage form, or used for unregistered indications or uses for more information on the registered form of the product;
Legal representatives – parents, adoptive parents, foster parents, guardians, trustees and representatives of acting as guardians and trustees;
Applicant for clinical trials – an individual or legal entity (eg, sponsor, contract research organization) that submits an application for a clinical trial to Health or its authorized body. The applicant may apply for a clinical trial only if orders issued by the sponsor, with clearly defined delegated powers;
Informed consent – the decision to participate in a clinical trial, which must be made in writing, dated and signed, made voluntarily after proper informed of the nature of the clinical trial, its importance, impact and risk, duly executed documents shall be made by a person who is able to give agreement or its legal representative, in exceptional cases where the person can not write, it may give oral consent in the presence of at least one witness who testifies consent of the subject in the study written informed consent;
Clinical trials (research) product – a research work aimed at any research involving human subjects as intended to identify or confirm the clinical, pharmacological and / or other pharmacodynamic effects of one or more investigational medicinal products, and / or detection of adverse reactions to one or more investigational medicinal products, and / or to study absorption, distribution, metabolism and excretion of one or more drugs in order to verify its (their) safety and / or efficacy;
Contract research organization – natural or legal person under an agreement with the sponsor with one or more of its functions (powers) in a clinical trial, and acting under orders issued by the sponsor with clearly defined delegated powers;
The patient (healthy volunteer) – a person who may be involved as studied in clinical trial;
Primary medical records – original documents, data and records (eg, medical history, hospital cards, laboratory notes, memos, diaries or questionnaires, dispensing medicines, printing devices, verified and certified copies or transcripts of phonograms, microfiches, photographic negatives , microfilm or magnetic media, x-rays, administrative documents, records stored in the pharmacy, laboratory and instrumental diagnostics department of participating in a clinical trial, etc.);
Adverse reaction – within the PRE trial new drug or study for a new use, especially if the therapeutic dose of the product is installed, the adverse reactions to the drug have to attribute all the negative and unintended response to the product of any the dose. The term “response to the medicinal product” means that there is at least permissible probability of a causal relationship between use of medicinal ZASO ¬ bu and adverse reaction, ie the relationship can not be excluded.
As registered medicines, this term means any negative or unexpected reactions associated with the use of a medicinal product in usual doses for prophylaxis, diagnosis or treatment of diseases, restoration, correction or effects on physiological functions;
Clinical trial protocol – a document that describes the objectives, methodology, procedures, organization and statistical aspects of clinical trial, and usually previously obtained data on the investigational product and justification of a clinical trial;
Sponsor – legal or natural person who is responsible for initiating and organizing clinical trial and / or funding;
The third person – in clinical trials tend to – patient, healthy volunteer.
Good Clinical Practice (GCP) – Standard planning, implementation, execution, monitoring, auditing and documenting clinical trials, as well as processing and presentation of their results, the society serves to guarantee the reliability of data and protection of human health and the anonymity of subjects.
Introduction
Clinical trials of drugs in Ukraine, both international and domestic conducted in accordance with the principles of Good Clinical Practice (Good Clinical Practice), which is specified in the Manual 42-7.0:2005 approved by the Health Ministry of Ukraine of 22.07.2005, the number 373 and in accordance to “Procedure for conducting clinical trials of medicinal products and expertise of clinical trials and Model Regulations Ethics Committee” approved by the Ministry of Health of Ukraine from 23.09.2009r., № 690.
InUkraine, clinical trials of drugs, based on their legal regulation, were conducted with 90 of the last century and from year to year their number increased (in 1996 agreed 79 tests in 2006. – Only322, in2008. – 208 multi- and 67 odnotsetrovyh clinical trials.
Number of patients (healthy volunteers), who spoke as the subjects of drug testing in 2008. totaled 27,961 person representing 5.14% of the total number of patients and healthy volunteers (544,116 people) who participated in CR in all countries.
Harmonisation of procedures for HF inUkrainewith international requirements, according to the principles of GCP – a guarantee that the rights of subjects – patients and healthy volunteers are protected, kept confidential and obtained the study data is reliable information. Following established practice, the standard liability insurance customer kV.
Insurance activity inUkraineis administered exclusively by insurers – residents ofUkraineand regulated general insurance law.
Given the specificity of insurance participants clinical trial drug, which is a biomedical research involving people (patients, healthy volunteers, including children, minors), the need for an objective determination of risk of clinical drug research, which requires appropriate training of experts of the insurance company , moral and ethical aspects of insurance compensation research participants – there was a need for supporting documents methodological orientation of this type of insurance, guidelines for the protection of the rights of the KB.
To insurance companies and their experts that insures risks in clinical trials, drugs, other than general insurance legislation, there are some ethical, legal, qualification requirements, implementation of which is the guarantee of effective insurance protection for participants kV and payments for the possible occurrence.
1. Legislature of order and security of clinical trials inUkraine
InUkraine, the interests of research participants (patients, healthy volunteers) are protected by law for the right to compensation when the insured event (in the case when the harm done to the patient).
Insurance clinical trials of drugs is based on the insurance legislation ofUkraine. Basic principles and concepts referred to in the Law of Ukraine “On Amendments to the Law ofUkraine” On Insurance “(2001). In Article 7 of the Act lists the types of compulsory insurance, but this list is not included liability insurance customer trials to third parties (patients (volunteers) for damage to their life and health during clinical trials of medicinal products.
This provision is implemented in accordance with other laws of Ukraine – “On Medicines” (Article 8) – “Customer trials of the medicinal product must before starting clinical trials to conclude a contract of life insurance and health of the patient (volunteer) in order prescribed by law “, ie insurance KB is not mandatory type of insurance, but is essential to its holding.
According to international requirements that regulated Guidance on Good Clinical Practice of the International Conference on Harmonization of technical requirements for registration of medicines (ICH GCP): “Standard Procedures sponsor should consider compensation for the cost of treatment of clinical trial participants in the event of injury due to research procedures in accordance with regulatory requirements) (§ 5.8.2 ICH E6).
Directive 2001/20/ES (st.3.2.f) stated that “clinical studies can be conducted, provided … provided insurance or compensation provided by the responsibility of the sponsor.”
In accordance with Articles 7, 8 of the Law of Ukraine “On Medicines”, European Parliament and Council 2001/20/EC “On the approximation of laws, regulations and administrative provisions of Member States regarding the implementation of good clinical practice in clinical trials of medicinal products for human consumption man “of 4 April 2001, and to further harmonization of international rules for clinical trials of medicines in Ukraine approved” The procedure for conducting clinical trials of medicinal products and expertise of clinical trials and the Model Regulations of the Commission on Ethics “(Ministry of Health Ukraine from 23.09.2009r., № 690). Particular requirements for the conditions and principles of insurance participants in clinical research set out in IY, YII, YIII, IX sections hereof.
2. Ethical aspects of insurance patient (healthy volunteer), participating in a clinical trial
Participation in clinical trials of drugs may be accompanied by risk to the health and well-being of patients (healthy volunteers). Therefore, a CR with rights as a subject to be regulated by legal and ethical norms.
One of the remedies is to ensure participant KO his voluntary participation, timely informing patients of all risks associated with study drug (informed consent procedure). The second important factor is to ensure the protection of a possible loss compensation for damage to life and health participants KV through a mechanism of insurance.
Currently, insurance risks of the clinical trial through voluntary contract of liability insurance customer trial to third parties (patients, healthy volunteers) for damage to their life and health during clinical trials of medicinal products.
Therefore, to obtain approval of the Central Ethics Committee of Ukraine and Ministry of Health reportUkrainecompetent authority to conduct clinical trials of medicinal products the applicant clinical research (sponsor, contract research organization) along with other documents, must submit to each structure and a copy of the said contract and copy of the certificate to him.
3. Requirements for the insurance company that participates in the insurance liability of the customer trials
Insurance activity is regulated by legislation of Ukraine, together with the high social importance, medical and ethical aspects of the insurance risks of clinical studies involving people, impose additional requirements and recommended provisions for this type of insurance.
Required, regulated by law, the provisions of:
1.Strahovyk (insurance organization, insurance company) must be registered as a financial institution and be licensed to conduct insurance business under this type of insurance issued in accordance with current legislation of Ukraine the State Commission on Regulation of Financial Services.
2. For insurance liability to third parties (other than provided in paragraphs 12-14 of Article 6 of the Law of Ukraine “On insurance” insurance company should have developed it and registered in the State Commission for Regulation of Financial Services Markets of Ukraine (an authorized agency) of insurance.
3. According to Article 17 of the Law of Ukraine “On insurance” insurance regulations prescribed Special insurance conditions that are also registered with the competent authority.
Recommended position: In order to ensure an appropriate level of insurance organizations, professional approach to insurance contracts and consideration of possible insurance claims – the person responsible insurance company, insurance risk assessment and examination of the insured event of damage to the put the life and health participants KB should have higher medical education and should be familiar with the requirements of GCP, which should be provided with appropriate certificates.
4. The general requirements and specific recommendations for contract liability insurance customer trials
4.1. Certification by the fact the contract was signed.
The insurance contract in writing (Article 16 of the Law of Ukraine “On Insurance”).
The fact that a contract of insurance may be certified by an insurance certificate (policy, certificate), which is a form of insurance contract “(Article 18 of the Law of Ukraine” On Insurance).
Some legal ambiguity of interpretation of the contract due to lack of a single title under the form of this document in the law. However, whatever the name, these requirements mean that the required document (a contract or an insurance certificate or insurance policy or certificate – all synonyms) must be submitted in writing and must meet the form and content prescribed by law .
The insurance company must provide additional documents to complete the contract, usually with the name of the certificate (it does not apply the requirements for form and content of the contract in accordance with the Law). He has an arbitrary meaning indicating the main items of the contract can be manufactured with a certain design registration.
It should be noted that this document can only be a supplement to the contract and does not replace it. The legislation provided for the existence of this document as a single, confirming the contract.
Thus, the Central Ethics Committee of Ukraine and Ministry of Health of the State Pharmacological Center MoH Ukraine has submitted a full insurance contract in writing (an insurance certificate policy, certificate), which in form and content meet the Law of Ukraine “On Insurance”.
4.2. Requirements for liability insurance contract customer trials to third parties (patients, healthy volunteers)
According to Art. 980 Civil Code of Ukraine is the subject of the contract – property interests are not inconsistent with law and related to: compensation for damage caused to the insured (liability insurance), that is the responsibility of the insured for damages caused to life or health of a third party (the patient , healthy volunteers), as a result of clinical trials that was caused by an event that falls within the description of how unintentional, accidental, unforeseen, probably so.
The insurance contract must contain:
(According to the Law “On Insurance” (Article 16))
• title of the document;
Comment. The name of the insurance contract, its number, date of signing.
• the name and address of the insurer;
Comment. For the insurance contract liability customer trials must be registered with reference to the insurance company rules and special conditions of liability insurance customer trials to third parties (patients, healthy volunteers) for damage to their life and health during clinical trials of medicinal products (with indicating the registration number and its date with the competent authority).
• surname, name or title insurer and the insured person, their address and date of birth;
Comment. In the insurance contract liability customer trials indicate full name of the insured (sponsored research or contract research organization (if appropriate delegation of authority), or other authorized agency sponsor.
Mandatory is the presence of an individual’s name on whose behalf the paper is concluded and shall include the authority (reason) that entitles a contract (through statutory documents such as statutes, power of attorney, or other acts of civil law).
When insuring “liability” insurer enters into a contract with the insurer in favor of a third party to whom the insurer is required to make an insurance payment when an insured event that is defined
law (Civil Code Art. 985). At the conclusion of the contract, “third person” (patient, healthy volunteer) does not require identification (specifying name, address, etc.). This is due to the established procedures of coordination and conduct of clinical research, which – set of patients (healthy volunteers) performed after the conclusion of the contract and obtain a permit for a KO.
So, in the insurance contract liability of the customer trials to third parties (patients, healthy volunteers) for damage to their life and health during clinical trials of drugs to the insured insures his liability to third parties that do not require identification at the conclusion of the contract shall indicate only the number of third parties.
The third person is identified when an insurer’s obligation to make an insurance payment for damage by means of documents that provides the insurer under the insurance contract. An important document with a written informed consent of the patient (healthy volunteer).
Also in the insurance contract may not indicate the place of clinical research, because at the time of signing the contract they have not agreed competent authority ofUkraine. If necessary, this information may be submitted to the insurance company separately (as a project), and the final list for a clinical trial – upon approval by a regulator.
• surname, name, date of birth or name and address of beneficiary;
Comment. Beneficiary under the contract established a third party, with faceless; as in connection with the foregoing, during the contract it can not be determined exactly. Typically, under such agreement, the beneficiary (third party) may also represent the right to receive compensation – legal representative (parents, adoptive parents, foster parents, guardians, trustees and representatives of acting as guardians and trustees) or successor under the law.
• sum insured under a contract of insurance other than life insurance contract;
Comment. Individual insurance is determined by one person – the patient (healthy volunteer), ie the limit of liability for one person – the limit set by the insurance contract (maximum) amount of money payments for each insured event.
For this type of insurance, given the individual sums insured, legally defined in the Ukraine for compulsory insurance, the decision of the Central Ethics Committee of the Ministry of Health of Ukraine № 18 from 09.12.2009, the Section 5 (with the consent of the State Pharmacological Center MoH Ukraine ) recommended the following: “the minimum amount of insurance can not be less than the sum of the minimum wage for 10 years, ie approximately not less than 10 thousand dollars,” which corresponds to regulations, since the order MZ of Ukraine from 23.09.2009r., № 690 provided “in setting the amount of compensation per person is taken into account best international practices and possible real costs for study.”
Total insured amount is the amount of money to all persons – patients (healthy volunteers), within which the insurer under the terms of insurance shall make compensation.
In this type of insurance is available a limited liability aggregate limit – set by the insurance contract limit (maximum) amount of money to pay all insurance claims for the period of the contract. Because this amount of money calculated on a number of insurance claims (eg, 10 for participation in CR 100) is in contradiction with the Law of Ukraine “On Medicines” (Article 8) and the Order of the Ministry of Health of Ukraine from 23.09.2009r., № 690, which regulate what insurance protection subject to all patients (healthy volunteers) who intend to participate in clinical trials and that in due course signed informed consent.
• a list of insurance claims;
Comment. In this type of insurance is an insurance company, established the fact of damage to life and health of others because of the emergence during the clinical trial adverse reactions to investigational medicinal product, which caused complications or death – events that fall within the description of how unintentional, random.
The presence of adverse reactions due investigational drugs and personal injury patient (healthy volunteer) establishes Sponsor Research, which provides this information to the insurance organization, which must be specified in the contract of insurance.
Insurance, except for damage due to adverse reactions to investigational medicinal product should include other negative impacts that are directly related to clinical trials and research protocol.
According to international practice, the regulatory body for the HF approvingly refer to a comprehensive insurance clinical trial participants (ie not only to the insurance risks associated with investigational drugs, but also risks associated with researchers and places clinical trials), because the patient can and suffer from errors or omissions medical personnel, medical equipment failure, etc..
• The insurance contributions (payments, bonuses) and terms of payment;
Comment. Is carried out in accordance with legislation.
In accordance with ICC St.983 insurance contract shall become effective on the date of the insured first insurance payment, unless otherwise stipulated by the contract. The moment when the insurance takes effect is important and, together with informing the start of clinical trials for the competent authority of Ukraine and the Central Ethics Committee sponsor or its authorized representative must submit proof that a contract of liability insurance in case of causing injury subjects entered into force and in effect at the start of clinical research (Ministry of Health of Ukraine from 23.09.2009r., № 690).
Insureds resident, in accordance with applicable law, have the right to make payments only in the currency ofUkraine, and non-resident insurer – in foreign convertible currency or monetary unit ofUkrainein the cases stipulated by legislation ofUkraine.
• insurance rate (insurance rate is determined for insurance claims for which no set amount insured);
Comment. Legislatively determined that insurance rates for this type of insurance the insurer calculated actuarially (mathematically) on the basis of the statistical occurrence of insurance claims and approved as part of the Special Terms and conditions of insurance regulator.
The specific amount of insurance rate is determined in the insurance contract by agreement.
It should be noted that to determine the tariff expert insurance company is qualified to determine the risks of clinical research and investigational drugs, which can lead to negative consequences for the patient. Risk assessment is carried out using the protocol of a clinical study, investigator’s brochure, etc.. According to this expert should have higher medical education (see rozd.3, p.11), as well as appropriate training for a KO.
• term of the contract;
Comment. Sure must not be less than the duration of a clinical trial.
In the Ministry of Health of 23.09.2009r., № 690 indicates that this protocol takes into account the peculiarities of the clinical trial and pharmacological characteristics of the investigational product.
In this regard, in some cases, by agreement, the term of the contract period and may include observation of the patient (usually 1-3 years) after the expiration of a clinical trial.
It should be noted that the Civil Code of Ukraine defined this concept as statute of limitations – “is a period within which a person may
go to court to demand protection of their civil rights or
interest “. The general statute of limitations established by law, is three years. However, the “statute of limitations does not apply to the request of the insured (insured) to the insurer of the insurance payments (insurance)” that the patient (healthy volunteer), regardless of the passage of time conducting clinical research, may apply to court for compensation caused during the clinical trial (ICC, Art. 268).
• change the order and the contract;
Comment. Is carried out in accordance with legislation, which states: “the intention to prematurely terminate the contract either party shall notify the other no later than 30 calendar days before the date of termination of the contract, unless otherwise provided for him” (the Law “On Insurance “Article 28).
In case of early termination of the contract, an additional condition for this type of insurance is in advance, the official informed the applicant KV Central Ethics Committee of Ukraine and Ministry of Health of Ukraine competent authority to terminate the contract.
When concluding an agreement on early termination of the contract the insurer has the right to request supporting documents in the insured that KO really stops (this may be a copy of the letter of the insured to the regulatory (authorized) body of notice of termination of the clinical trial in Ukraine).
Change certain provisions of the contract, additions to the contract, and breach of contract is in accordance with legislation, namely Art. 654 Civil Code provides that “Change or cancellation of the contract committed in the same form as the agreement that varies or is terminated, unless otherwise provided by contract or by law or implied in customs business turnover,” ie, an additional agreement as a contract termination must be made in writing signed by authorized persons and stamped as required by law.
• rights and obligations of the parties and the responsibility for failure or improper performance of the contract;
Comment. Regulated by the Law of Ukraine “On Insurance” (Article 20, Article 21) and the Rules and special conditions of insurance, approved by the regulator.
According to the Law “On Insurance” the insurer must:
1) inform the insured of the terms and rules of insurance;
2) within two working days, as soon becomes aware of the insured event, to take steps to execute all necessary documents for timely payment of the insurance or insurance compensation insurer;
3) If an insured to an insurance payment or payment of insurance provided in the contract term. The insurer shall bear property liability for late payment of insurance (insurance) by paying the insurer a penalty (fine, penalty) an amount determined by the terms of the contract;
4) to reimburse costs incurred by the insured in the insurance case to prevent or reduce losses, if your contract;
5) at the request of the insured in case of his actions that reduced insurance risk, or increase the value of the property to renew the contract of insurance with him;
6) keep secret information about the insured and its financial status except as provided by legislation of Ukraine.
Insurance contract may also provide for other obligations of the insurer, focused on human participants kV.
Insured must:
1) make timely insurance payments;
2) at the conclusion of the contract to provide information about the insurer all known circumstances that are essential for the assessment of insurance risk, and continue to inform it of any change of insurance risk;
3) inform the insurer of any other applicable insurance contracts on the object of insurance;
4) take measures to prevent and reduce losses caused as a result of occurrence;
5) notify the insurer of the insured event within the period prescribed conditions of insurance.
Insurance contract may also provide for other obligations of the insured to enforce the rights of the HF and simplify the reimbursement of the loss of health.
• other conditions agreed by the parties;
• signatures of the parties;
Comment. Pravochyn who commits a legal entity signed by a person authorized to do its constituent documents, power of attorney,
law or other acts of civil law, and
sealed (CCU, St.207).
Font of the contract shall not be smaller than Times New Roman, 12.
5. Terms of the insurance payments
Insurance payment is in accordance with legislation, “of insurance benefits and payment of insurance held by the insurer under the insurance contract or legislation based on the application of the insured (or its successor entities, defined the terms of insurance) and Insurance Act (emergency certificate), which is the insurer or authorized person in a form determined by the insurer “(Law of Ukraine” On Insurance “, Article 25).
1. Statement from the insured regarding possible insurance event
Statement from the insured regarding possible insurance event shall be submitted within the specified contract period, but this term must match specified in the order MZ of Ukraine from 23.09.2009, № 690, namely the sponsor (contract research organization sponsored by the presence of delegated functions cooperate with the insurance company) for 7 calendar days from the time they become aware of any adverse reaction that can be regarded as an insurance case should send a message to the insurance company. Sponsor also learns about the event over two days (in accordance with the above mentioned order of the Ministry of Health ofUkraine).
Suspicion of the damage may be due to other than the adverse reaction, the reasons (see section 4., P.4.2, stor.14).
Thus, the insurer shall be governed by the general term applying to the insurance company in 9 days with events that can be treated as insurance in case.
In addition to the insured, a statement about the occurrence of adverse reactions to the insurance company can provide and the patient (healthy volunteer) or his legal representative, and in his absence – close relatives, for 9 days.
2. Insurance investigation
On receipt of application by the insurer of a possible case of insurance, the insurance organization began to perform specialized insurance investigation insurance case, from the insured must receive all required documents as stipulated in the contract of insurance, the insurer may make a request for him other documents required under the contract and the laws of Ukraine and international agreements on HF.
Mostly, it documents the medical direction (certificates, extracts from the history of the patient-patient or outpatient card vypysnyy epikryz protocol, anatomical and pathological research, etc.). Provide expertise in these documents upon which the decision about insurance compensation patient (healthy volunteer), is an expert insurance company with higher medical education (see rozd.3, p.11), which is the recommended norm for this type of insurance.
Upon receipt of all necessary documents for some time, caused by the Special Conditions and the contract of insurance, the insurer recognizes this is an insurance event and makes the payment of insurance or does not recognize this is an insurance event, specified in the Insurance Act.
In case of refusal to pay insurance, the insurer shall notify its decision to the insured and the third person in writing the reasons for refusal.
3. Statement of the insured and / or third party for payment of insurance
Insurance paid by the insurer based on the application of the insured and / or statements of a third party (or its legal representative, trustee, heir under the law) to pay compensation.
Note that from this moment the injured third party must be identified. Insured (or principal investigator at the request of the insured) must confirm that a patient with a certain number of HF is affected by a person stating his name, first name and patronymic. In the statement of a third party (or its legal representative, guardian, heir under the law) indicates all the necessary passport data for payment of insurance.
6. Reasons for refusal of insurance benefits
According to the Law of Ukraine “On Insurance” sets out common grounds for refusal of the insurer in the insurance payments or insurance among which are:
– An intentional act by the insured or person to whom a contract of insurance aimed at the insured event;
– The insured knowingly submitting false information about the object of insurance or the fact of occurrence;
– Failure to post the insured on the insurance case without a valid reason for this is that an insurer or obstacles in determining the circumstances and the nature and amount of loss;
In the insurance contract may be referred to other cases, the laws ofUkraine.
According to the order MZ of Ukraine from 23.09.2009 № 690 “at the conclusion of the contract are not allowed to establish artificial barriers and restrictions in insurance reimbursement: definition unrealistic deadlines notice of the insurance company about the damage his previous confirmation and size of damages the court or the findings of health health, establishing franchises, etc.. ”
Comment. Not allowed, in particular, specify as exclusion from insurance claims following:
– Adverse reactions to investigational medicinal product to which the patient has been informed in advance (that is mentioned in informed consent form);
– Malfunction of medical equipment used in a clinical trial of medicinal product;
– Blood poisoning, infection with immunodeficiency virus (HIV) and others. If during the investigation provided to blood sampling;
– Concealment of information concerning the availability of the Insured, a third person or entity that conducts clinical trials, convictions;
– If the clinical trial was contrary to generally accepted standards of treatment;
– Other, independent of party HF, but associated with him and led to the deterioration of his health and caused him damage.
7. REQUIREMENTS FOR INFORMING PATIENT (healthy volunteer) on the terms of insurance
Each patient (the person who gave consent to participate in a clinical trial) should be as fully informed about the conditions of insurance must be stated in the informed consent.
Informed consent form should be prepared concisely, accurately, easily understandable language without the use of special terms.
Informed consent signed by the patient (legal representative) and, among other things, shall contain the following provisions regarding insurance coverage:
1) basic data Treaty liability insurance customer clinical trials of medicinal products (full name and address of the insurer, number and date of the contract, individual sum insured);
2) contact details of the insurance company and authorized persons;
3) order the possible application of proactive notification of the occurrence of adverse effects;
In accordance with § 6 (Section IV «The basic requirements for the protection of subjects,” Chapter 1 “General Provisions on the Protection of subjects’) order MZ of Ukraine from 23.09.2009 № 690:
“Investigated (in its sole discretion) or legal representative, and in his absence – close relatives can also initiative (to be specified in the informed consent) for 9 days, notify the insurance company that guarantees their rights, the fact of occurrence of adverse reactions to assessment of it as insurance case. ”
Sources
1. Constitution ofUkraine.
2.HelsinkiDeclaration (2008).
3. European Parliament and Council 2001/20/EC “On the approximation of laws, regulations and administrative provisions of Member States regarding the implementation of good clinical practice in clinical trials of medicinal products for human consumption” of 4.04. 2001
4. Law of Ukraine ” On Medicines” (1996), as amended.
5. Law of Ukraine ” On Insurance” (1997), as amended.
6. Guidelines “Drugs. Good Clinical Practice. CT-N 42-7.0:2008 Health Ministry of Ukraine “, approved by the MOH on 16.02.2009, № 95.
7. Order MZ ofUkrainefrom 23.09.2009r., № 690 “On approval of the clinical trials of medicinal products and expertise of clinical trials and the Model Regulations on Commission on Ethics.”
8. Standard operating procedures (SOPs), the Central Ethics Committee of the Ministry of Health ofUkraine, approved by Order of the Ministry of Health ofUkrainefrom 22.03.2007 № 142.
9. The Central Ethics Committee of the Ministry of Health of Ukraine № 1337 from 30.12.2009, the “Insurance companies insurance participants in clinical trials in Ukraine.”
