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Insurance Law In the Clinical Trials Arena
Submitted By
Dr. Doaa Abotaleb
Teaching Assistant at Faculty of Law – Ain Shams University
“Insurance is a mean to live secure”, it was said previously, but actually it
explains the insurance in a very little words, a mean to feel safeguarded and
protected against any risk or danger in the future. The range of insurance
protection includes many and different types of dangers and risk, its scope
increased according to the developments and improvements in human life.
One of the most important developments in human life is the drugs,
medicines and medical sciences. Every day, there are new techniques for
medication and new drugs invented to insure better life for all humans. All these
new techniques and drugs need a very complicated scientific process for a long
time to be used safely among people. This process called “clinical trials” or
“medical research”. The most difficult point in this process is the necessity to
experiment the new technique or the new drug over humans to observe its safety
and medical effect.
Accordingly, the clinical trial process or medical research may constitute one
of the risks that endanger our life. For that legal scholars suggest to recourse to the
insurance law to insure the necessary protection for both; medical staff and
research subjects.
In this paper, the writer will deal with the insurance law within the clinical
trials process and how it may insure better degree of protection and security
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during and after this process. This paper will be divided into the following main
points:
1.
2.
3.
a.
b.
4.
Clinical Trials: broad lines
Insurance Law: broad lines
Insurance Law in Clinical Trials
For the Investigator’s responsibility
For the Research Subjects’ health care
Recommendations
The objective of this paper is to point out the advantages and disadvantages of
the legal system dealing with the medical research process in the United Arab
Emirates, and how to recover its disadvantages. The methodology used in this
paper is to compare between the UAE’s legal system with the established systems
of other countries such as the United Kingdoms and the United States. A focus
will be made over the international standards and principles governing the medical
research process.
1. Clinical Trials: Broad lines:
We can’t imagine life without clinical trials nor our future. To be clearer, all
medicines and drug inventions were found as a result of clinical trials. Clinical
trial is a process used in scientific fields to test, to experiment or to try-out a new
method of the treatment for certain illness or a new drug by experimenting it on
human beings as a subject of this research. The aim of the clinical trial is to test
the safety and the efficiency of the new method of treatment or the new drug, its
advantages and disadvantages, its side-effects and its cases of use.
In this regard, the European Union Council defines clinical trials as “any
investigation in human subjects intended to discover or verify the clinical,
pharmacology and/or pharmacodynamics effects of one or more investigational
medicinal products, and/or to identify any adverse reactions to one or more
investigational medicinal products and/or to study absorption, distribution,
metabolism and excretion of one or more investigational medicinal products with
the object of ascertaining its (their) safety and/or efficacy”(1).
Also, the Medicine for Human Use Regulations 2004 (UK) defines clinical
trials as “any investigation in human subjects, other than a non-interventional
trial, intended: (1) to discover or verify the clinical, pharmacological or other
pharmacodynamic effects of one or more medicinal products, (2) to identify any
(1)
European Union Directive 2001\20\EC, Part 2 – Definitions – (a)
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adverse reactions to one or more such products, or (3) to study absorption,
distribution, metabolism and excretion of one or more such products, with the
object of ascertaining the safety or efficacy of those products”(2).
In the international community level, there are large number of the legal
documents which deal expressly with the clinical trials process. The most
important one of these documents and the oldest one is the Nuremberg Code,
which appeared after the crisis of the Nazi Physicians and researchers – during the
World War II – who did medical experiments over prisoners and hostages without
their consent nor providing them with any means of compensation or recovery.
This code contains the principles mentioned in the judgement of the court
governed this case in August 1947, and approved by the United Nations in 1948(3).
In addition, the Declaration of Helsinki has been enacted in June 1964 by
the World Medical Association, to highlight the ethical principles for medical
research involving human subjects, which must be adopted in every clinical
research involved human beings as research subjects(4).
Also, in the continental level, the European Union Council has enacted
directives for member states to govern clinical trials with all its aspects, such as
Directive 2001\20\EC(5) and Directive 2005/28/EC(6).
In the national level, not all countries adopt laws or regulations to organize
and govern the clinical trials process. In fact, some countries don’t have any legal
instruments to govern matters related to clinical trial except very broad articles in
the constitution or in the civil code(7). Other states had a well-organized legal
system to deal with clinical trials problems from A-Z, such as the United States of
America(8) and the United Kingdom(9).
To be more familiar with the clinical trials process, one must notice that it is
passed by certain steps:
(2)
Medicines for Human Use Regulation 2004, Art.2 (1), clinical trials
Code of Nuremberg 1947.
(4) Declaration of Helsinki 1964.
(5) European Union Directives 2001.
(6) European Union Directives 2005.
(7) This is the position of Egypt, where there isn’t any special set of laws to govern clinical trials except a
broad article in the Egyptian constitution. In case of clinical trial problem, the general rules of the civil and
criminal laws will applied.
(8) Mainly, the clinical trials process governed in the United states by the Code of Federal Regulation, Title 21
(Food and Drug) and Title 45 (Public Welfare)
(9) The clinical trials process governed by the Medicines for Human Use regulations 2004 and it amendments.
(3)
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 Preclinical Testing I: in this step, scientists in their labs may found a
predictors that certain chemical component may be used successfully to treat
certain disease. So, scientific experiments done in the labs to understand how that
component may works and what its safety profile looks like. The results in this
step are just information, which may be in the next steps, proved to be useful for
that illness or not.
 Preclinical Testing II: in this step, scientists and researchers test the new
components (which may be useful or not) on animals in the labs. The aim of this
step is to test the effect of these components on the animals which may had some
features similar, with some degrees, to human beings. If the scientists reach to
useful result, they can move to the next step can apply for the “New drug
investigation” process through the competent administrative authority.
 Clinical trial Phase I: this step consider as the first step in the clinical trial
process. In phase I of the clinical trial process, the investigators choose a limited
number of human beings to use them as research subjects. The purpose of this
phase is to test the safety of the new components when used for individuals and
whether or not it may cause severe problems. The number of the subjects of the
research in this phase is a very limited, about 5 to 10, and they usually receive a
small sample of the new drug. In most of clinical trials, subjects of this phase are
healthy volunteers, who agree to participate in this study and provide an informed
consent for this purpose. Due to the dangerous of this step, investigator and
his/her team must collect a detailed and up-to-date description to the subject, in
order to determine whether to continue in this study or not according to the results
of this phase(10).
 Clinical trial phase II: if the investigator/s of the clinical trial was/were
satisfied with the results of the previous phase, they can move to the phase II of
the study. The purpose of the trial in this step is to determine the safety amount of
the drug to be used for treatment and to ascertain its side-effects. The number of
the research subjects in this phase increased to be about 50 to 100 subject, they
usually be a mix of healthy volunteers and patient volunteers. The testing
technique used in this phase is the control group method to find the medical effect
of the new drug. If this step completed successfully, they can proceed for the last
step(11).
(10)
Richard M. Cooper, "Response", (2008), Harvard Law Review Forum, vol.121, p.36. Code of Federal
Regulation, Chapter 1, Subchapter D, Part 312, Subpart B: Investigational New Drugs, Sec. 312\12 phases of
an investigation; Joseph A. DiMasi, Ronald W. Hansen, Henry G. Grabowski, The price of innovation: new
estimates of drug development costs, “Journal of Health Economics”, (2003), Vol.22, P.157.
(11) ibid
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 Clinical trial Phase III: the last step in the clinical trial process is to test the
new drug with a large number of the research subjects which may be at least 200
subjects. That is to be sure about the results of the previous stages of the study and
to precisely determine the safety degree of the drug and its medical effect, as well
as, its side-effects. All these data must be introduced to the competent authorities
to review the study with all its steps and decide whether to approve it, require
revision or refuse it(12).
When dealing with clinical trials process from a legal perspective, one must
say that, there are certain requirements which must be satisfied in the clinical trial
process in order to be approved by the competent authorities. One of these
requirements related to the insurance in its broad meaning from two aspects;
insurance for the medical responsibility of the investigator and his/her
accompanies in the clinical trial process and the medical insurance for the
research subjects against any damages resulted from the trial. All will be
discussed later in details.
 Clinical trials in the United Arab Emirates:
In the United Arab Emirates, the legislator prohibits doing any researches or
medical experiments on human unless it was approved by the competent
authorities and satisfied all the conditions and requirements. Article no. 10 of the
law no. 10 of 2008 in respect of the Medical Liability, in the second paragraph
stated that “Researches or medical experiments on human beings are prohibited
without obtaining the proper approval of the concerned authority as set out in the
executive regulation and in accordance with the conditions provided under the
said regulation”.
In this regard, the cabinet issued the Implementing Regulation of the Law no.
10 of 2008 in respect of Medical Liability by the decision no. 33 of 2009.
According to article no.8 of this regulation, no medical experiment or a research
may takes place except after obtaining the license from the competent authority.
The later differ according to the nature and the goal of the research or the
experiment, which in any case must be one of the following authorities; Ministry
(12)
ibid
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of Health, Abu Dhabi Health Authority, Dubai Health Authority, Dubai
Healthcare City and Public universities(13).
As article no.9 of the implementation regulation stated, any one of these
competent authorities, when reviewing a request to conduct a medical research or
study (clinical trial), must assures the fulfilment of certain conditions. These
conditions may be categorized in the following points:
 Conditions related to the clinical trials:
- The research shall take place in a proper place, equipped with all the
necessary facilities
- The research must be done according to the rules mentioned in the
international legal documents and applied all over the world
 Conditions related to the researcher (the investigator):
- The investigator/s must be qualified and had excellent knowledge about
the rule of conduction clinical researches
- The investigator/s must be familiar with the medical, scientific, legal
sharia aspects related to the field of the research
 Conditions related to the protection of the research subjects:
- The research subject must agree to subject to the trial, and this acceptance
must be evidenced
- This consent must be provided by the research subject in person or by his
guardian in case of partial in complete incapacity.
- The research subject must be aware of all aspect of the research before
accepting it, and this awareness must be evidenced
- The research subject must be free of any mean of coercion or force to
accept the research whether tangible or intangible
- The rights and dignity of the research subjects must be respected
 Conditions related to the procedures of conducting the research:
- A request to conduct a clinical trial must be introduced to the competent
authority
- This request must be attached with a protocol of the study which explain
all the details of the study (the benefits of the study – the procedures – place
Art.8 of the implementing regulation of the law no.10 of 2008 in respect of medical liability stated that: “It
shall be prohibited to conduct medical research or experiments on humans unless after obtaining the
necessary license from one of the following bodies, as per their jurisdiction:
1) Ministry of Health
2) Health Authority – Abu Dhabi
3) Dubai Health Authority
4) Dubai Healthcare City
5) Public universities”
(13)
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where the research will take place – the duration of the research – the number of
the required research subject in each phase)
- A document contains the names and details of the main investigator and
his/her team
- A detailed description of the qualifications required for research subjects
and the criteria of selection
- The informed consent form which must contains all information about the
research
- Resources to fund the clinical trial
The federal government in the United Arab Emirates adopts a policy to
develop and improve the medical experiments and scientific researches to be
applied in the near future. This plan is clear when reading article 10 of the
implementation regulation of the law no. 10 of 2008 in the respect of medical
liability. In this article, the regulation adopts a strategy for conducting medical
research through the following steps:
1. Establishing a medical research system according to the international
standards
2. Establish a mechanism for conducting medical research and to benefit
from its results
3. Create programs to train the researchers about the techniques of the
clinical trials
4. Create a database to register any clinical trial operated, operating or might
be operate in the state level
5. Establish an administrative system to benefit from the medical research
patents.
2. Insurance Law: broad lines
Insurance law is a branch of the private law which governs all matters related
to the insurance from its creation till its end, such as the insurance contract, rights
and obligations of the parties, insurance companies and agents, insurance services,
etc.
In this regard, spot light must be focussed on the insurance contract, as it
constitutes the legal tool used to provide insurance services. So, the insurance
contract may be defined as the contract by which the Insurer is required to provide
to the Insured person/beneficiary a sum of money, salary or any other type of
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compensation, in case of occurrence of the risk which insured against, in return of
instalments or any other payments made by the Insured person to the Insurer(14).
Accordingly, any insurance contract must satisfy certain elements which are:
a. The Insurer: is the insurance company which must be established and
registered according to the laws and regulations to provide insurance services(15).
b. The Insured person: is the person who signs the insurance contract with
the insurance company (insurer) in order to benefit from its services. He/she may
be contacted for his/her interest or for the interest of another person (beneficiary).
c. The risk insured against: is the event or the accident which may endanger
the insured/beneficiary interest. There are different types of the insured risk such
as death, illness, responsibility, loss, or damage of a property, theft, fire, travel,
profession, etc.
d. Instalments: is a sum of money paid by the Insured person regularly, every
month or every year according to the contract, to the Insurer for a period of time
or until the happening of the risk insured against. The amount of these instalments
determined according to the type of the risk and to the amount of the
compensation.
e. The sum of money (compensation): is the amount paid by the Insurer to
the Insured person or to the beneficiary as a result of the occurrence of the insured
risk. It may be a specified amount of money (determined when since the insurance
contract was signed) or changeable according to the volume of the damage or the
harm.
When satisfying all these requirements, there will be an insurance contract
whatever the type of the risk insured against. In this regard, it is important to
notice that the insurance contract is a temporary contract. It comes to the end
when the risk insured against occurred or according to the date which mentioned
in it.
As mentioned before, the type of the insurance contract determined according
to the risk assured against. Accordingly, in case of insurance contract against
medical liability, the risk insured against is the liability of the physicians or
anyone else who work in the medical field.
The law of Insurance companies and agents in the United Arab Emirates, no.9 of 1984, Art.3: “ ‫التأمين عقد‬
‫يلتزم ال ُم َؤ ِمن بمقتضاه أن يؤدي إلى ال ُمؤ َمن له أو إلى المستفيد الذي يشترط التأمين لصالحه مبلغاً من المال أو ايراداً مرتباً أو أي عوض مالي‬
.‫” آخر في حالة وقوع الحادث أو تحقق الخطر المبين بالعقد وذلك في نظير أقساط أو أية دفعة مالية أخرى يؤديها ال ُمؤ َمن له لل ُمؤ ِمن‬
(15) According to the law of Insurance Companies and Agents no.9/1984 in the United Arab Emirates, no
insurance company can be established to provide insurance services unless it has a license from the Ministry
of Economics and Trade (Art. 8). After its establishment it must be registered in the Insurance Companies
Registry at the Ministry of Economics and Trade (Art. 14).
(14)
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 Medical Liability insurance in the United Arab Emirates:
With regard to the insurance against medical liability, one can say that
although it is vital for persons working in the medical field to be covered by an
insurance contract, it isn’t obligatory to – in most countries – to make an
insurance contract for that purpose.
United Arab Emirates constitutes one of the countries which made it
obligatory for any medical institution to provide an insurance coverage for its staff
of the medical field, whether permanent or visitor, against the medical liability.
Not only the medical institutions, but also anyone who work in the medical field
independently, must be covered against the medical liability. In this regard, art.25
of the law no. 10 of 2008 in respect of medical liability stated that:
“It is prohibited to practice a medical profession without procuring medical
malpractice insurance with any licensed insurance companies.
The health facility which receives a visiting physician shall be responsible to
compensate the damaged party for the medical malpractice of the said physician,
without prejudicing its right to claim damages from the physician who committed
medical malpractice”
In the next article, the legislator mentioned the rules which must be applied
by the owner of the medical institution in his relationship with the medical staff of
the institution regarding the insurance coverage. Each one of the medical staff
must participate in the premium paid regularly to the insurance company by no
more than 20% and the rest must be paid by the owner(16).
The reason of this rule is clear, because the legislator makes the owner of the
medical institution the main responsible for insuring the safety and welfare of all
patients benefits from the medical services in his institution. Insurance against
medical liability will assist the medical staff to work without a fear of legal
responsibility due to medical malpractice actions.
Art.26 of the law no.10 of 2008 in respect of medical liability stated that: “The owner of the facility shall
procure insurance to the practitioners working in the facility for the medical malpractice liability insurance.
The owner of the facility shall bear 80% at least of the annual premium and the practitioner shall bear the
balance of the premium”.
The implementing rules and all details were mentioned in the article no.14 of the Implementing Regulation of
the Law no.10 of 2008 in respect of Medical Liability issued by the Cabinet Decision No. 33 of 2009.
(16)
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In case of violation to the rules of insurance against medical liability, the
disciplinary sanctions will apply, according to article no. 34 of the medical
liability law no. 10 for 2008. This article stipulates that: “The disciplinary
penalties provided under the law shall be applied to violations which no penalty is
provided under this Law”. This means that, in case of no sanction mentioned in
this law, the disciplinary sanctions will replace. In fact this article seems useless,
as it contradict with the general rule of interpretation of the legal rules. It is well
known that, when the legislator put a legal obligation, it must be followed by a
sanction for non-compliance or for those who don’t abide the rule.
3. Insurance Law in Clinical Trials:
As mentioned before, insurance law plays vital role in the clinical trials
process. This role divided into two parts; insurance against the liability of the
investigator and insurance for the research subjects’ medical care. In the following
pages, both types will be discussed.
a. Insurance against investigator’s medical liability:
Civil liability which may arise due to an infringement to any of the civil law
obligations, which – mainly – related to the contract or to the law of tort. In order
to avoid the civil liability in these cases, persons recourse usually to sign an
insurance contract with an insurance company to be covered against the risk of the
civil liability. This considers one of the important types of the risks insured
against, which called “insurance against the risk of the liability”.
In special cases, civil liability may arise in the medical sector due to a breach
to a contractual obligation or to a general obligation not to harm the patients. Civil
liability in this case called “the medical liability” which related to the
responsibility raised as a result of a committing a civil law violation in the
medical sector. In this regard, professionals working in the medical sector may
make insurance contracts to cover their responsibilities which may arise in
relation to their works. This type of the insurance called “insurance against the
medical liability” which will be discussed in the following lines.
Accordingly, insurance against the medical liability may be defined as “a
contract signed by the representative of a medical institution with an insurance
company (the insurer) to cover the staff working in that institution (the insured
person) against any damages result from their work in front of a third party”(17).
‫ بحث منشور على شبكة المعلومات ومقدم لندوة المسئولية الطبية‬،‫ دراسة تحليلية مقارنة‬،‫ التأمين من المسئولية الطبية‬،‫اسامة أحمد بدر‬/‫( د‬17)
.813‫ ص‬،‫ بدولة اإلمارات العربية المتحدة‬8112 ‫ لسنة‬01 ‫في ظل القانون االتحادي رقم‬
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In this regard, one must be noticed that insurance contract for medical
liability do not differ – generally – from insurance against civil liability, in fact it
is just a way to limit the nature of the risk to suit the medical sector
responsibilities which arise against the patients.
Also, it is important to notice that, the medical liability insurance – as a type
of the liability insurance – is completely differ from the condition of the
exemption from the liability from more than one aspect. Firstly, the former is a
contract while the later is a condition may be mentioned in some contracts.
Secondly, in the former, the debtor still liable to pay the compensation to the
injured person but this compensation will be paid by the insurer entirely or partly,
whereas the later becomes free of any liability by such condition(18).
When applying the rules of the medical liability insurance upon the cases of
clinical trials, one can say that, the investigator/s may benefit from this type of the
insurance against any responsibility arising from that trial. In fact the clinical
trial’s investigator may become responsible in case of any damages happened to
the research subjects. This happens in case of injuries exceed the limits of the
harms agreed upon in the informed consent form(19), and the research subject
asked for the compensation.
Accordingly, the sponsor of the clinical trial may sign a contract with an
insurance company to cover the medical responsibility of the investigator against
the compensation claimed by the research subject due to any injuries occurred as a
(18)
ibid
The informed consent form is a document signed by the research subject in order to declare his/her
acceptance to participate and take part in the clinical trial. The informed consent must contain certain
elements about the trial, object, time and duration, importance of the trial, degree of the dangers, security
measures, ways to compensate the research subjects, name of the main investigator and his/her team, sponsor
of the trial, sources of fund and contact details. This document must be signed by the research subject
his/herself or by his/her legal representative when the research subject being a child, disabled or mental
disable. If the trial takes place without such document or it lacks any of the abovementioned information, the
trial will be illegal and legal procedures might be taken against the investigator and the sponsor. For more
details about the informed consent and its requirements; L. Doyal & J.S. Tobias, Informed Consent in
Medical Research (MJ Books); Benjamin Mason Meier, ‘International Protection of Persons Undergoing
Medical Experimentation: Protecting the Right of Informed Consent’ (2002) 20 Berkeley Journal of
International Law; J.K. Mason and G.T. Laurie, Law and Medical Ethics (8th edition, Mason & McCall
Smith’s), P.629; Ian Kennedy and Andrew Grubb, Medical Law (3rd Edition, Butterworth 2002), P.1665;
Jonathan Herring, Medical Law and Ethics (2nd edition, Oxford University Press 2008), P.565; Jean McHale
and Marie Fox, Health Care Law (2nd edition, Sweet & Maxwell), P.682; Jonathan Montgomery, Health
Care Law (Oxford University Press), P.361.
(19)
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result of the trial. In this case the insurance company will pay the due
compensation to the claimant (research subject) instead of the investigator(20).
As stated before, although clinical trials are very important for the scientific
purposes, not all countries provide a legal organization for this process(21). So, in
the following lines the writer will focus on the insurance against medical liability
in the clinical trial process in the laws of the United Kingdom, United States and
the United Arab Emirates.
In the United Kingdom, the clinical trials process organized – mainly – by
the Medicines for Human Use Regulations 2004. This regulation was the tool used
in the United Kingdom to enforce the directives of the European Union regarding
clinical trials.
In the Medicines for Human Use Regulations 2004, it was mentioned
expressly that there must be an insurance contract to cover the medical
responsibility of the investigator(22). To be clearer, the legislator in this law
required that, a statement for the medical responsibility insurance of the
investigator must be mentioned in the clinical trial’s protocol(23), in order to be
approved by the Ethics Committee(24). The approval of the Ethics Committee is
very important in the licensing the clinical trial by the competent authority, i.e.
The Medicines and Healthcare Products Regulatory Agency (MHRA)(25). This
(20)
Insurance and Compensation in the Event of injury in Phase I Clinical Trials, Guidance developed by the
Association for the British Pharmaceutical Industry, June 2012, Para. 6.1-6.2; Frank Goudsmit, ‘Global
Clinical Trials Liability Insurance’ (2013) 9 Journal of Clinical Research Best Practice, P. 1-2; R.Qaiser,
Clinical Trial Liability Insurance, P.5, available at:
http://www.niapune.com/pdfs/Research/CLINICAL%20TRIAL%20LIABILITY%20INSURANCE.pdf
(21) Egypt is one of the countries which didn’t organize the clinical trials process yet.
(22) Insurance and Compensation in the Event of injury in Phase I Clinical Trials, Guidance developed by the
Association for the British Pharmaceutical Industry, June 2012, Para. 4.1.
(23) Clinical trial’s protocol: a file filled by the team achieving the clinical trial, containing all details about the
trial, its design and implementation method. This file must be delivered to the competent Ethics Committee to
decide whether to approve the trial or not.
(24) Ethics Committee: a board of professionals established and registered by the United Kingdom Ethical
Committees Authority, according to the Medicines for Human Use Regulations’ requirements. The main
function of the ethics committee is to review the protocols of the clinical trials and decide whether to approve
it or not. In any clinical trial, an affirmative opinion of the Ethics Committee must be rendered in order to be
approved by the licensing authority (The Medicines and Healthcare Products Regulatory Agency MHRA).
For more details about ethics committees; See Medicines for Human Use Regulation, Part2\Art.6; J.K.Mason
and G.T.Laurie, Law and Medical Ethics (8th edition, Mason & McCall Smith’s), P.617. J. Neuberger,
‘Ethics and Health Care: The Role of Research Ethics Committees in the United Kingdom’ [1992] King’s
Fund Institute; Jonathan Herring, Medical Law and Ethics (2nd edition, Oxford University Press 2008),
P.570-572.
(25) The Medicines and Healthcare Products Regulatory Agency (MHRA): the responsible body for regulating
all matters related to medicines, medical products, medical devices and healthcare products. With regard to
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idea is clear when recourse to Para.5 of Art.15 of the Medicines for Human Use
Regulations 2004 which states the necessity of the medical liability insurance for
the investigator in the clinical trials process(26). In fact this article is just an
implementation to was mentioned in the European Union Directives 2001\20\EC
regarding the clinical trial process (27).
On the other hand, the United States organizes the clinical trials process by
the Code of Federal Regulation (CFR). Under the CFR, there is no obligation for
the clinical trial’s sponsor neither to compensate the injured research subjects nor
to insure against medical liability of the investigators. But in case of clinical trials
involving more than minimal risks, a statement about any available compensation
or medical treatment must be mentioned in the informed consent document(28).
This means that, in case of a research or study did not exceed the minimal risks,
there is not any compensation or medical treatment presented to the injured
subject. In both cases, it must be stated in the informed consent document whether
there is compensation or not(29).
In fact, until present, the United States still lacks national standards to
compensate research subjects against any injury resulted from the research. This
led some scholars to recommend that, any institution sponsoring clinical trials to
compensate research participants without regard to fault. According to their
the clinical trials, MHRA is responsible for licensing clinical trials by granting a Clinical Trial Certificate to
the sponsor of the clinical trial, when satisfying all the necessary requirements. For more details about
MHRA, visit http://www.mhra.gov.uk/Aboutus/index.htm
(26) Medicines for Human Use Regulation, Part.3, Art.15, Para.5: In preparing its opinion, the committee shall
consider, in particular, the following matters: (a) ………; (b) …….; (c) …….; (d) …….; (e) …….; (f) ……..;
(g) …….; (h) ……, (i) ………;
(j) any insurance or indemnity to cover the liability of the investigator or sponsor;
(k) the amounts, and, where appropriate, the arrangements, for rewarding or compensating investigators and
subjects, and (l) ……. For more details about the interpretation of the Medicines for Human Use Regulations
2004, review the articles no. 4, 14, 20, 21, 23 of the interpretation document, available at:
http://www.mhra.gov.uk/home/groups/l-unit1/documents/websiteresources/con009387.pdf
(27) European Directives (dir_2001_20), Art.3, Para.2: A clinical trial may be undertaken only if, in particular:
a)...…, b)………, c)……., d)…….., e)………,
f) Provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor.
(28) Code of Federal Regulation, Title 45, Part 46, Art. 46.116, (a)/6: “For research involving more than
minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical
treatments are available if injury occurs and, if so, what they consist of, or where further information may be
obtained”.
(29) Sabina Gainotti and Carlo Petrini, ‘Insurance Policies for Clinical Trials in the United States and in Some
European Countries’ (2010) 1 Journal of Clinical Research & Bioethics, P. 2-3,
http://www.omicsonline.org/insurance-policies-for-clinical-trials-in-the-united-states-and-in-some-europeancountries-2155-9627.1000101.pdf
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recommendations, “the compensation in this case should include at least the costs
of medical care and rehabilitation and accrediting bodies should include such
compensation as a requirement of accreditation”(30).
In the United Arab Emirates’ law, as stated before, it is obligatory for
everyone working in the medical field to be covered against the medical liability.
The law no. 10 for 2008 in respect of medical liability requires each medical
institution to provide insurance coverage for all medical staff(31).
Accordingly, in the clinical trials’ process investigators will be covered
directly against medical liability, not due to the clinical trials’ rules but as a result
of applying the medical liability law no 10 for 2008.
Abu-Dhabi Emirate constitutes one of the emirates which organize the
medical researches take place in one of its licensed medical institutions. This
strategy includes both legal and structure aspects of the clinical trials process.
Structurally, the Health Authority – Abu Dhabi (HAAD) is the key body
governing and regulating the medical research over human beings(32). The HAAD
is responsible for licensing the medical institution which satisfies all the medical
research requirements. After being a licenced medical research institution, the
later will be obligated to “maintain appropriate indemnity insurance covering, in
respect of its Human Subjects Research:
(a) all adverse outcomes for individuals who are the subject of the research,
(b) all other potential liabilities of the Institution,
(c) all potential liabilities of individual clinicians and researchers employed
by, or contracted to, the Institution”(33).
Accordingly, it is clear that, any licensed medical institution must insure an
insurance coverage for the medical staff against medical liability in case of any
injuries occurred to a research subject, as a result of the research. This insurance
coverage insures a remedy for the injured research subject even if no fault
attributed to the investigator, as long as, there is a damage caused by the trial. In
case of infringement to the rules of this policy, the HAAD has the authority to
impose sanctions according to its rules(34) (35).
(30)
ibid
Art. 25-27 of the Medical Liability law no. 10 for 2008.
(32) Art.1 of the Licensing Requirements for Institutional Human Subjects Research, External policies of the
HAAD, February 2010.
(33) Art. 9.3.4 of the Licensing Requirements for Institutional Human Subjects Research.
(34) Art. 12 of the Licensing Requirements for Institutional Human Subjects Research.
(31)
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b. Insurance for the research subjects’ medical care:
The second form of the insurance law in the clinical trials process is the
medical insurance for the research subjects. As stated before, clinical trial is a
very dangerous process and may entail huge injuries to the persons who subject to
it. So, the laws and regulations of all states – which organize the clinical trial
process – require an extra medical care for the research subjects. This extra
medical care may be provided through the medical insurance contract which must
be signed for the interest of the research subjects.
Accordingly, the medical care insurance may be defined as a type of the
insurance coverage, provided for individuals (the insured person) seeking extra
medical care by specialised medical agencies through an insurance company (the
insurer). In the medical care insurance, the insured person makes a contract with
an insurance company to provide him/her a special medical care – when needed –
in return of premiums paid regularly. This type of insurance assumes an
agreement between the insurance company and certain medical agencies to
provide the insured persons with the required medical care services, which will be
paid not by the insured persons (patients) but the insurance company(36).
Return back again to clinical trials and medical care insurance, subjects to any
clinical trial must be covered by a medical insurance during the study and for a
reasonable period of time after its termination. This coverage is very important to
insure a wide protection for the research subjects against any harm which may
result from the trial whether throughout it or in the long run.
In this regard, the statement of medical care insurance must be clearly stated
in the informed consent document, which must be signed by the research subject
in person or by his/her legal representative. The importance of such condition lays
in the fact that judicial compensations for the research subject – in case of injury –
not usually accessible, so the insurance coverage may be a reasonable remedy(37).
For more details about the medical research process in Abu Dhabi see; Omar Shafey, ‘Regulation of
Health Research in Abu Dhabi’, available at: https://www.haad.ae/HAAD/LinkClick.aspx?fileticket=V-ptSK2_O4%3D&tabid=739; Healthcare Regulatory Policy Manual, available at:
http://www.haad.ae/HAAD/LinkClick.aspx?fileticket=VyAME-Ojlm8%3D&tabid=1276
(36) Sandra J. Carnahan, Medicare's Coverage with Study Participation Policy: Clinical Trials or Tribulations?,
“Yale Journal of Health Policy, Law, and Ethics”, (2007), Vol. 7, P.234. see also:
http://www.cancerresearchuk.org/cancer-help/trials/taking-part/insurance
(37) To claim for compensation due to injuries suffered from a clinical trial, the claimant (research subject)
must prove that, there is a fault in the investigator (defendant) behavior resulted in a damage for the claimant,
(35)
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Although the medical insurance for research subjects is vital in the clinical
trials process, some scholars refuse granting this right to the research subjects as it
constitute a mean to induce them to accept the trail. According to their point of
view, making the medical insurance as a right in the clinical trials may contradict
with Such as Code of Nuremberg(38), Declaration of Helsinki(39) and Belmont
declaration(40), which prohibits the using of any mean to convince individuals to
engage in clinical trials(41).
4. Recommendations
After exploring the medical research system in the federal laws and
regulations of the United Arab Emirates, and in the internal system of emirate
Abu Dhabi, certain recommendations must put in the end of this paper in order to
be a useful material. These recommendations resulted from dealing with the legal
aspect of the medical research for more than three years as a PhD student in Egypt
and the United Kingdom.
1. United Arab Emirates not far away from the international standards for
protection of research subjects via insurance. In fact, it constitutes one of the little
countries in the MENA region to establish a complete system for medical research
in general and insurance coverage for medical staff in special.
2. According to the federal nature of the United Arab Emirates, unified
treatment of medical researches must be adopted on the federal level. It is
necessary to insure the same degree of protection and support for medical research
in all emirates. This unified treatment may be done through codification of general
rules in the federal laws and left details to be dealt with in each emirate’s laws and
regulations.
in a way to say that without such fault no damage may happen. In fact it isn’t an easy mission any way, as it is
usually difficult to prove the investigator’s fault. Also, in most cases, there may be a fault from the
investigator without any damage to the research subject and vice versa. So, in most cases the research subject
may lose his/her right of a remedy. For that reason, medical care insurance may be a reasonable way to
compensate the research subjects and to provide them with an equitable remedy. See, Insurance and
Compensation in the Event of injury in Phase I Clinical Trials, Guidance developed by the Association for the
British Pharmaceutical Industry, June 2012, Para. 2.1; Sabina Gainotti and Carlo Petrini, ‘Insurance Policies
for Clinical Trials in the United States and in Some European Countries’ (2010) 1 Journal of Clinical
Research & Bioethics, P.2, http://www.omicsonline.org/insurance-policies-for-clinical-trials-in-the-unitedstates-and-in-some-european-countries-2155-9627.1000101.pdf
(38) Article no. 1
(39) Article no. 26
(40) Articles no. 1 & 2, Part B
(41) Sandra J. Carnahan, Medicare's Coverage with Study Participation Policy: Clinical Trials or Tribulations?,
“Yale Journal of Health Policy, Law, and Ethics”, (2007), Vol. 7, P.264.
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[PRÉSIDENT DE CHAMBRE AU TRIBUNAL DE COMMERCE DE NANTES
CHARGE D ENSEIGNEMENT AU CENTRE DE FORMATION DE LA
PROFESSION BANCAIRE]
3. It is recommended to provide extra protection against medical liability in
medical research to cover all injuries to the research subjects, in case of fault or no
fault attributed to the medical staff.
4. It is recommended also to insure extra medical care insurance for
individuals participating in the medical research.
5. On the court level, specialized tribunals must be established by a federal
law to judge any disputes arising from the clinical trial process. At least one of its
members had a medical background to insure a good understanding of the
motivation of the research and its benefits to both the research subject and the
society
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