Find out about the
following issues.
How is
the genetic testing of minors regulated? At what age is an
individual considered adult, and capable of giving informed
consent?
Under what circumstances can
medical secrecy be broken?
Is it legal for insurance companies
to have access to the results of genetic tests?
Is it legal for insurance companies
to have access to other medical records?
Click on an issue to find out more.
Click here
to view by country
How
is the genetic testing of minors regulated? At what age is
an individual considered adult, and capable of giving in informed
consent?
United Kingdom
Genetic tests
are subject to the In Vitro Diagnostic Medical Devices Directive
(98/79/EC). In Britain, The Advisory Committee on Genetic
Testing (ACGT) (which has now become part of the Human Genetics
Commission) advised the Government on the issue of genetic
testing of minors, and issued a Code of Practice for genetic
testing. AGCT recommended against the pre-symptomatic genetic
testing of children for disorders for which there is currently
no therapy, and where onset is normally in adult life. Genetic
testing of minors is only recommended as part of a clinical
diagnosis when a child is already displaying symptoms.
Testing of minors must not take place unless
written consent has been obtained. In England, Wales and Northern
Ireland, only a person with parental responsibility for a
person under 16 years can give consent for that child to be
tested. A court may waive the requirement for consent where
it is satisfied that this is in the best interests of the
child. Section 8 of the Children Act 1989 provides courts
with the power to make a 'specific issue order' in connection
with any aspect of parental responsibility for a child, such
as consent for a
genetic test.
In Scotland, the law on consent differs.
Although in general children under 16 years do not have legal
capacity, the Age of Legal Capacity (Scotland) Act sets out
exceptions to this general rule. Children can consent themselves
to a medical procedure if, in the opinion of the qualified
medical practitioner attending them, they are capable of understanding
the nature and possible consequences of the procedure.
Denmark
Genetic testing is not
specifically regulated in Denmark. Genetic testing can be
done so long as the law on patient rights (Lov om patienters
retsstilling) from 1998 and the law on practising doctors
work (Lov om udøvelse af lægegerning ) from 2001
are followed.
The law on patient rights states, that a patient, who is 15
years old, can give informed consent for treatment. However,
the parents have to be informed and involved in the decision
of the minor until the patient is 18 years old. In some cases
the parents can give informed consent. That is if the doctor
finds that the 15-17 year old patient has made a decision
without having fully understood the consequences.
Finland
Genetic tests can be done to minors, when
it is necessary for their own health or if the information
is needed to diagnose the existence of a genetic disease in
family members. If the onset of a disease is expected at this
age, or can be prevented through treatment, genetic testing
may also be used. Other genetic tests should be delayed. If
the patient has turned 15 and can be expected to understand
the importance of the test, a written consent from him or
her is sufficient for carrying out the test.
France
In France, minors (under 18 years old) are
protected by a decree related to the gene prints (Public Health
Code) dated 23rd June 2000. Only the parents of minors or
those holding parental authority can authorise testing. To
do so, they must give free, informed written consent (Art.
R. 145-15-4). For their consent to be 'informed', the doctor
must supply them with balanced, accurate information. No consent
is needed from minors themselves, although such agreement
is compulsory for biomedical research.
French law recognises two situations…
If the minor is already ill, genetic testing can only be prescribed
if the results will enable better management of their condition
or allow other members of the family to be helped.
If the minor is asymptomatic, there is another, supplementary
condition: it must be possible for the child or their family
to benefit from curative or preventive measures immediately.
If there is no way of preventing or treating the disease,
the legislator has forbidden testing until the minor reaches
adult age (18 in France).
Germany
In Germany, there
are no specific legal regulations regarding the genetic testing
of minors. In general, the explicit consent of the patient
or his or her legal guardian must be given for any genetic
testing. In cases where minors are concerned parents can give
their consent on behalf of the child.
However the medical guidelines of the
professional associations of doctors advise that any genetic
diagnosis should only be done after counselling in. In the
case of minors, genetic testing should be done only if there
are any therapeutic options. Otherwise the testing should
be postponed.
Italy
In Italy, genetic testing of minors can
only be requested by their legal representative, thus by their
parents. Tests are allowed only to reveal genetic malformations
or hereditary diseases.
Besides, according to Italian laws, each person is considered
adult after 18 years of age. For minors, the consent to therapeutic
and diagnostic treatments must be given by their legal representative.
Therefore, minors have no right to express their opinion and
to decide about health problems.
However, if minors' parents and the physician disagree on
an urgent medical treatment, the latter can apply to a judge
and obtain the authorization to start it.
In case minors' parents disagree with each other, they both
can apply to the tutelary judge, who will make a decision
after considering minors' will (if they are not under 14 years
old). However, even though minors have no legal right to make
decision about their health, the physician must inform them
and consider their will.
Portugal
In Portugal, genetic testing of minors is
subject to the strictest control. The need for genetic testing
has to be thoroughly justified and authorised by more than
one doctor. Any type of molecular biological examinations
can only be done in cases where a medical intervention to
reduce, delay or prevent clinical consequences is possible.
The only exception is when the individual wants to have children.
The parents' informed written consent is compulsory until
the patient is 18 years old.
Spain
There is no specific
regulation about testing minors. The general rules about medical
tests and for the protection of minors, the Minors' Law (state)
and the Family Code (Catalonia) apply. Both adopt the general
principle of granting maximum protection to the 'higher interest
of the minor' as defined in the legal code.
General capacity is linked
to legal majority, which in Spain is set at 18. But in health,
there is a legal and deontological obligation to inform and,
if possible, also obtain the consent of minors who have the
capacity to understand what affects them. From the age of
16 for some issues and 12-13 for others, they are considered
to be 'mature minors'.
European Union
The EU has not
produced any legislation. The subject is considered by the
different national laws.
[Return to list
of Issues]
Under
what circumstances can medical secrecy be broken?
United Kingdom
In Britain, the
Data Protection Act 1998 implements the EU Data Protection
Directive and provides a system of general protection and
security for personal data which covers, amongst other things,
medical data. Patients have a right to expect that their doctors
will hold information about them in confidence. Express consent
is needed from an individual before a doctor can disclose
any information about them.
The General Medical Council
(GMC) advises medical practitioners on how to protect patient
confidentiality. GMC guidelines state that consent is not
usually needed where patients have already consented to treatment,
and where sharing of information will enable that treatment
to be provided.
Other than this, medical
secrecy can only be broken if it is deemed to be in the public
interest. If a patient withholds consent for medical information
about them to be passed on to an outside source, such as the
police or an insurance company, doctors can disclose information
only where it is essential to protect the patient, or someone
else, from risk of death or serious harm.
Denmark
In special cases, a patient's
medical information of a patient can be passed on to authorities,
organisations, private persons etc. without the patient's
consent. That could be in the case of consideration by the
social authorities. The medical information is restricted
by specific rules.That is stated in the national Danish law
on patients rights (Lov om patienters retsstilling) from 1998.
Finland
Breaking medical secrecy is a criminal offence
in Finland, the maximum penalty being a six-month prison sentence.
Medical secrecy can only be broken through a court decision.
France
In France, courts can order the surrender
of medical records, but only in criminal cases with a warrant
from a judge and in the presence of a representative of the
Conseil de l'Ordre des Médecins (French Medical Association).
Germany
Doctors in Germany
are legally bound to medical secrecy by law and by the medical
associations' professional code of conduct. Medical secrecy
can be broken by personal agreement of the patient or by a
court decision in cases where a right of higher value is concerned.
If the patient is under 18
but not a child anymore, the doctor might be bound to medical
secrecy even towards the parents. In such a case, the doctor
has to carefully balance the interest of the patient and the
parents.
Italy
Italian privacy law (31 December 1996) states
that "it is forbidden to disclose medical records, unless
there is an obvious need to prevent, assess or avoid a criminal
act".
Therefore, physicians are obliged to keep secret all the information
acquired, included their visits done or programmed. However,
some exceptions apply to this general rule. Physician can
reveal private information if it is necessary to saveguard
somebody's life or health, even if the person concerned denies
the permission to disclose such information.
Portugal
Confidentiality of any medical
record is covered by Constitutional and Civil law because
doctors are obliged to maintain medical secrecy. This secrecy
can only be broken by a court decision.
Spain
Professional secrecy
is protected by the Penal Code, as well as deontological rules.
A medical secret can only be revealed in the event of danger
to the public health or certain danger for a third party in
certain circumstances.
European Union
The EU has not produced any legislation.
The subject is considered by the different national laws.
However, in all European
countries medical secrecy can only be broken by a court decision.
[Return to list
of Issues]
Is
it legal for insurance companies to have access to the results
of genetic tests?
United Kingdom
Unlike many European
countries, there are currently no laws banning insurance companies
from accessing the results of genetic tests in the UK. Ever
since genetic diagnostic tests for certain conditions began
to be used in the 1990's, insurers have been considering these
results when assessing premiums.
The Association of British
Insurers, a trade association for UK insurers which represents
over 400 companies conducting 96% of UK insurance business,
developed their own code of practice with regards to the use
of genetic tests. Under this code, insurance companies could
only ask for the results of tests already carried out and
no company could insist that applicants undergo a genetic
test.
However, in October 2001,
a deal was agreed between the ABI and the Department of Health
in which there would be a five-year ban on the use of the
results of genetic tests. Under the ban, nobody has to disclose
genetic test results to insurers unless they are buying a
policy which will pay out more than £500,000 on death
or £300,000 on critical illness. During the moratorium,
the ABI hopes that the Government will reach a consensus on
the use of genetic tests in assessing insurance premiums.
The Human Genetics Commission, which advises the government
on how new developments in human genetics will impact on people
and health care, does not believe that legislation banning
the use of all genetic information by insurers is the correct
way forward. They believe an individual with a family history
of a genetic disease should have the right to use a 'good'
test result to lower their insurance premiums.
Denmark
In Denmark, insurance
companies are not allowed to request or use any information
on a person's genes and risk of getting diseases. That is
stated in the 1997 amendment of the national Danish law on
insurance arrangements (Lov om forsikringsaftaler) from 1986.
Finland
Insurance contracts are based on the information
given by the person taking the insurance and it is his or
her duty to be truthful. If the information is later found
to be incorrect, or if crucial information has been withheld,
the terms of the contract are affected.
France
No, not in France. Genetic testing can only
be conducted for medical or scientific purposes (articles
16-10 of the Civil Code and L.145-15 of the Public Health
Code). It is a criminal offence to attempt to obtain or supply
test results for any other purpose. Insurance companies cannot
ask for a test or use information provided by such a test.
In 1994, then in 1999, the French Federation
of Insurance Companies (representing 95% of the sector) gave
a commitment that it would not use the results of genetic
testing even if the insurance applicant provided them voluntarily.
The 1999 moratorium will end in 2004.
Germany
In Germany there
are currently no specific regulations regarding data resulting
from genetic testing. Parliament's discussion of this matter
was postponed and data from genetic testing is currently being
treated in the same way as other medical data.
However, for the time being a voluntary
obligation of all insurance companies exists not to demand
data from genetic testing from applicants. Some experts call
for a general ban on the use of such data.
Italy
In Italy, there is a public health service,
that is the State pays for the most part of hospital, pharmaceutical,
etc. expenses. Italian citizens are bound to pay for a small
amount of money (called "ticket"), with few exceptions.
However, what previously said does not prevent from stipulating
a private health insurance.
Genetic tests are not allowed unless aimed to predict or reveal
malformations or hereditary diseases. Moreover, the person
concerned must express his/her written consent. Physicians
cannot carry out genetic tests for insurance or hiring purposes,
if not explicitly requested by the person concerned.
Portugal
There is no law in Portugal regulating
insurance companies and genetic test results. There is a proposal
of Decree-Law regarding genetic information that will be discussed
soon by Parliament.
In practice, life insurance contracts are based
upon a declaration by the applicant about his or her health
history. Insurance companies take this declaration to be true
and if the amount is considered normal no medical examination
is required.
However, the Portuguese Association of Insurers
guarantees that at the moment, they do not demand, use or
question applicants regarding genetic tests. They acknowledge
they might do so in the future.
In view of conciliating these interests, the
Ombudsman suggested the creation of a 'public fund' that could
guarantee basic needs for those who are considered high risk
by insurance companies (2000). So far, this fund has not been
established.
Spain
Insurance companies
are not allowed to carry out genetic tests on their customers,
nor to make genetic diagnosis a condition for issuing a policy.
To avoid discrimination, the Council of Europe Recommendations
(on genetic testing for health purposes and protection of
medical information) are followed. They assert that it cannot
be legal to demand genetic tests to issue insurance policies.
Likewise, the protection of privacy provided by the Law for
the Protection of Personal Information applies. The Convention
on Human Rights and Biomedicine, which has been ratified by
Spain, prohibits discrimination for genetic reasons, and the
Declaration of the Rights of the Sick, already approved by
the Parliament of Catalonia, says the same.
European Union
The EU has not
produced any legislation. The subject is considered by the
different national laws.
The European Association of Insurers (Comité
Européen des Assurances, CEA) informs us that 'No European
insurer requires a genetic test'. Document dated 18/03/1998
found on their website http://www.cea.assur.org.
[Return to list
of Issues]
Is
it legal for insurance companies to have access to other medical
records?
United Kingdom
When applying
for medical insurance, an individual is usually asked to fill
in a form giving details of their medical history. As this
constitutes a legally binding document, the insurance company
has the right to refuse payment for any claims if the information
provided is incorrect or insufficient.
An insurance company may
write to an individual's doctor to gain more information,
but under the Access to Medical Reports Act 1988, an insurance
company must first obtain consent from the individual to do
so. Also under the act, an individual has the right to see
any medical report about them prepared for insurance purposes.
To supplement the legal framework,
the insurance industry has devised and operates various security
and confidentiality practices.
Denmark
In Denmark, insurance
companies are allowed to have access to information of a persons
present and previous health. They are also allowed to make
enquiries about present and previous health of members of
the family. That is stated in the 1997 amendment of the national
Danish law on insurance arrangements (Lov om forsikringsaftaler)
from 1986.
Finland
As mentioned above, the person taking the
insurance is responsible for giving truthful information.
Medical records can only be accessed with the patient's consent.
France
In France, insurance applicants are protected
by medical privilege.
Only applicants or their
legal representatives can obtain medical information or certificates.
They alone can then decide whether to pass them on to an insurer
or not and they alone (not their doctor) must complete and
sign any 'health questionnaire' required for their insurance
application.
Consulting physicians working
for insurers can only base their recommendations on medical
records supplied by applicants (any acquisition of information
from a third party is a breach of medical privilege) and they
must not answer any request for medical information. In addition,
appointing the consulting physician of an insurance company
as an intermediary physician is a breach of the Public Health
Code (articles 710-2 and 710-2-2). Insurers can protect themselves
from the consequences of intentionally false statements by
cancelling the policy.
Germany
In Germany, insurance
contracts are based on information supplied by the applicant.
The terms of individual contracts vary according to the way
each applicant performs in an extensive inquiry into their
health. The applicant's age affects the type of questions
they are asked and whether an examination by an appointed
doctor is required. As part of the business relationship between
the insyrance company and the person taking out the insurance,
it is the applicant's duty to give truthful information. Misleading
statements might affect the terms of the contract later on.
Insurance companies can't demand access
to any medical records of an applicant or insured person without
his or her explicit consent. However, most insurance contracts
include a paragraph which demands the applicant's consent
and which gives the insurance company the right to sent questionnaires
directly to the applicant's doctors.
Italy
In Italy, insurance companies can access
medical records of their clients only after their consent.
However, there is not a clear law ruling this access.
A person, who wants a private health insurance, can refuse
the company request for genetic tests while stipulating the
contract. This obviously ends with the loss of the private
insurance. However, if the contract provides for it, the signer
must inform the company about his/her health conditions and
undergo a medical check-up.
Portugal
Yes, but only
with the consent of the applicant.
Further to
this, article 20 of Decree-Law Nr. 176 (26 July 1995) states
that "[regarding] insurance contracts that depend on
medical examinations, in the event of an insurance company
refusing a contract, or agreeing to it on payment of a higher
premium, due to the applicant's state of health (…) the
applicant may only be informed of the situation by a doctor,
unless it can be reasonably supposed that such circumstances
were already known to him/her".
On the other hand, since the insurance
contract stands on a declaration of good faith made by the
applicant, Article 429 of the Commercial Code establishes
that the omission of any relevant and known facts by the insured
party renders the insurance contract void. The applicant is
therefore strongly advised to answer all questions truthfully.
Spain
Insurance companies
do not have access to patients' clinical records. However,
they can insist that applicants for a policy submit to an
examination or check up carried out by company doctors. They
may also require a statement from the policy holder with information
about his or her health, which must be true on the basis of
the contractual good faith requirement. There is assumed to
be contractual freedom and equality between both parties,
which is not always the case.
European Union
The EU has not
produced any legislation. The subject is considered by the
different national laws.
The European Association of Insurers (Comité
Européen des Assurances, CEA) informs us that the common
practice across Europe is to ask candidates to fill in a health
questionnaire (http://www.cea.assur.org/).
The questionnaire includes 'a series of questions on the candidate's
health' - or more exactly, on the diseases from which they
have suffered in the past - as well as on medical treatment
or examinations they have undergone. No European insurer requires
a genetic test. Other tests, such as an HIV test, may sometimes
be required in life or disability insurance for important
sums insured.
[Return to list
of Issues]
|
