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?

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United Kingdom

How is the genetic testing of minors regulated? At what age is an individual considered adult, and capable of giving informed consent?
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.

Under what circumstances can medical secrecy be broken?
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.

Is it legal for insurance companies to have access to the results of genetic tests?
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.

Is it legal for insurance companies to have access to other medical records?
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.

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Denmark

How is the genetic testing of minors regulated? At what age is an individual considered adult, and capable of giving informed consent?
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.

Under what circumstances can medical secrecy be broken?
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.

Is it legal for insurance companies to have access to the results of genetic tests?
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.

Is it legal for insurance companies to have access to other medical records?
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.

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Finland

How is the genetic testing of minors regulated? At what age is an individual considered adult, and capable of giving informed consent?
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.

Under what circumstances can medical secrecy be broken?
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.

Is it legal for insurance companies to have access to the results of genetic tests?
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.

Is it legal for insurance companies to have access to other medical records?
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.

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France

How is the genetic testing of minors regulated? At what age is an individual considered adult, and capable of giving informed consent?
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).

Under what circumstances can medical secrecy be broken?
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).

Is it legal for insurance companies to have access to the results of genetic tests?
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.

Is it legal for insurance companies to have access to other medical records?
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.

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Germany

How is the genetic testing of minors regulated? At what age is an individual considered adult, and capable of giving informed consent?
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.

Under what circumstances can medical secrecy be broken?
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.

Is it legal for insurance companies to have access to the results of genetic tests?
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.

Is it legal for insurance companies to have access to other medical records?
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.

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Italy

How is the genetic testing of minors regulated? At what age is an individual considered adult, and capable of giving informed consent?
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.

Under what circumstances can medical secrecy be broken?
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.

Is it legal for insurance companies to have access to the results of genetic tests?
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.

Is it legal for insurance companies to have access to other medical records?
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.

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Portugal

How is the genetic testing of minors regulated? At what age is an individual considered adult, and capable of giving informed consent?
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.

Under what circumstances can medical secrecy be broken?
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.

Is it legal for insurance companies to have access to the results of genetic tests?
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.

Is it legal for insurance companies to have access to other medical records?
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.

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Spain

How is the genetic testing of minors regulated? At what age is an individual considered adult, and capable of giving informed consent?
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'.

Under what circumstances can medical secrecy be broken?
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.

Is it legal for insurance companies to have access to the results of genetic tests?
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.

Is it legal for insurance companies to have access to other medical records?
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.

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European Union

How is the genetic testing of minors regulated? At what age is an individual considered adult, and capable of giving informed consent?
The EU has not produced any legislation. The subject is considered by the different national laws.

Under what circumstances can medical secrecy be broken?
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.

Is it legal for insurance companies to have access to the results of genetic tests?
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.

Is it legal for insurance companies to have access to other medical records?
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.

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