Consultation on Part 4 of the Disability Act (Genetic Testing) Submission by the Neurological Alliance of Ireland

Transcription

1 Consultation on Part 4 of the Disability Act (Genetic Testing) Submission by the Neurological Alliance of Ireland Summary: Part 4 of the Disability Act Part 4 of the Disability Act provides safeguards for the use of information obtained from genetic testing. The provisions aim to ensure that people who may be affected by genetic disorders will not be subject to any unreasonable requirements from an employer or an insurance or mortgage provider. The protections provided are in addition to substantial safeguards for the use of personal information contained in the Data Protection Acts. The safeguards provide that: genetic testing may only take place with a person s consent, in accordance with the Data Protection Acts the results of a genetic test can t be used in relation to insurance, a mortgage, a personal pension or employment the person being tested must be made aware of the intended use of the test results and must, as far as possible, be informed about the possible outcomes of the test the use of a person s family history for insurance purposes may be regulated by the Minister after consultation with other relevant Ministers, the Data Protection Commissioner and other interested bodies or groups Part 4 came into operation on 31 December, Neurological Alliance of Ireland The Neurological Alliance of Ireland is the national umbrella body for over thirty not for profit organisations working with people with neurological conditions. It aims to promote the development of services and supports for people with neurological conditions and their families throughout Ireland and greater understanding of their needs through policy development, advocacy, research and awareness raising. 1

2 Neurological Conditions and Genetic Information The purpose of the legislation is to ensure that people who may be affected by genetic disorders will not be subject to any unreasonable requirements from an employer or an insurance or mortgage provider. The issue of genetic information and the availability of genetic testing is of growing importance in relation to neurological conditions. The UK Genetic Testing network have highlighted that for neurological conditions which had treatment options available, early genetic testing assisted in the early intervention and management of the condition with better clinical outcomes. However there remain a significant number of conditions for which a treatment is not available despite access to a genetic test for diagnosis. Nevertheless, often early diagnosis of a neurological condition may facilitate management interventions such as accurate genetic counselling. As the role of genes in certain neurological conditions is increasingly understood, and there may be scope for the future identification of treatments based on genetic information, access to and regulation of genetic testing information will become more and more critical for this group of people and their families in Ireland. It is important to note that for some neurological conditions genetic factors have been shown to have a limited role as a determinant or only in relation to a small subset of specific familial subtypes of the condition. Also, the role of genetic factors in neurological conditions is increasingly recognised as complex, requiring interaction with other genes and/or environment in a way that is not yet understood and means that predictive genetic testing is not possible. It is vital to make sure that accurate information is available to all decision makers referred to in Part 4 of the Disability Act in relation to the role of genetic factors in neurological conditions. Specific Feedback on 3.2 Section 42, Genetic testing and processing of genetic data 42. (1) Genetic testing shall not be carried out by a person unless - (a) the testing is not prohibited by law, and (b) the consent of the person to the processing of any genetic data to be derived from the testing has been obtained in accordance with the Acts. (2) A person shall not engage in the processing of genetic data in relation to (a) the employment of a person save in accordance with the provisions of section 12A of the Data Protection Act 1988 (as inserted by the Data Protection (Amendment) Act 2003), (b) a policy of insurance or life assurance, (c) a policy of health insurance or health-related insurance, (d) an occupational pension, a retirement annuity contract or any other pension arrangement, (e) the mortgaging of property. 2

3 (3) A person shall not process genetic data unless all reasonable steps have been taken to provide the data subject with all appropriate information concerning (a) the purpose and possible outcomes of the proposed processing, and (b) any potential implications for the health of the data subject which may become known as a result of the processing. (4) A person who contravenes subsection (2) or (3) shall be guilty of an offence; an offence under this subsection shall be deemed to be an offence to which section 31 of the Data Protection Act 1998 applies. The NAI is concerned about anecdotal reports that disclosure of genetic testing and of the results is frequently made on proposal forms to insurance companies, even though individuals are explicitly instructed not to disclose this information. The NAI is concerned that this issue be explored, is it arising from a concern among individuals that they must disclose this information (i.e. are they unaware of their rights in this area) or are they under the mistaken belief that a negative result of a genetic test will be weighted in their favour. The NAI is concerned that public awareness of this aspect of the legislation and its implications is not widely understood, particularly among those on whom it directly impacts. There should be an effort to promote awareness and understanding of legal and other issues associated with genetic information among individuals and family members affected by these conditions. The NAI is concerned that steps need to be taken, perhaps through a public awareness campaign in relation to the protections accorded to them under legislation. The NAI is concerned that the issue of disclosure of genetic testing may be being made by current or potential employees to their employers, or to financial institutions, as has been the experience of anecdotal reports from some individuals working in the insurance industry. Little or no information appears to be available on the experiences of employers and other decision makers in relation to this issue, and that this was not addressed in the National Disability Authority information briefing on the proposed review. The NAI would like to see engagement with employer representative bodies and financial institutions in relation to their experience of disclosure of genetic testing among job applicants and current employees. Specific Feedback on 3.3 Section 43, Family History Information 43. (1) Information about the family history of an applicant for insurance may be processed in accordance with such regulations (if any) as may be made by the Minister under section 2B(1)(b)(xi) of the Data Protection Act 1988 (as inserted by the Data Protection (Amendment) Act 2003). (2) Before making regulations referred to in subsection (1) the Minister shall consult (a) in relation to processing connected with health or health-related insurance (other than health or health-related insurance provided for under the Health Insurance Acts 1994 and 2003) with the Minister for Health and Children and the Data Protection Commissioner, (b) in relation to processing connected with an occupational pension, a retirement annuity contract or any other pension arrangement, with the Minister for Social and Family Affairs and the Data Protection Commissioner, 3

4 (c) in relation to processing connected with policies of insurance, or life assurance (other than those specified in paragraph (a)), or a mortgage, with the Irish Financial Services Regulatory Authority and the Data Protection Commissioner. (3) Before making regulations referred to in subsection (1) the Minister may consult with such other bodies or persons as he or she thinks fit. In an Irish context, the results of genetic tests cannot be used but information about the family history of an applicant can be gathered and used and there is currently no regulation in this area. There is a gap in protection regarding family medical history in the current Irish legislation. This means that there is a protection accorded to the individual and family for the results of genetic tests that is not accorded currently to the gathering and use of family history information. It is of note that the US legislation in this area (Genetic Information Nondiscrimination Act GINA) in relation to use of genetic information for employment and health insurance purposes uses a definition of genetic information which includes family history as well genetic tests. The NAI is concerned that the ongoing lack of regulation on the gathering and use of family history has the potential for ongoing difficulty in the following areas: 1. The NAI has concerns in relation to the use of family history information in the area of neurological disease and the transparency in relation to actuarial modelling which uses this information. A number of patient organisations under the NAI umbrella have expressed concerns in relation to the depth and understanding of the role of genetic factors as determinants in the onset of neurological conditions and that there may be an undue weight given to the role of family history as a predictor of risk in this regard. 2. The lack of definitive information and transparency for people with neurological conditions about the use of family history information leads to concerns around disclosure, particularly in small communities. Steps must be taken to reassure people with neurological conditions and their families around access to and use of this information. 3. Anecdotal evidence highlighted to the NAI suggests that some people with genetic neurological conditions are avoiding a diagnosis in order to protect their children from genetic discrimination. This has serious consequences for their own health Ireland is not a signatory to the Convention on Human Rights and Biomedicine which states that Any form of discrimination against a person on grounds of his or her genetic heritage is prohibited. The EU Charter of Fundamental Rights (Article 21) states that Any discrimination based on any ground such as sex, race, colour, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation shall be prohibited It should be remembered that the problem of genetic discrimination cannot be addressed purely by reference the right to privacy of genetic data. Unjustified disadvantage based on unalterable genetic characteristics should also be prohibited. Genetic Testing and Research 4

5 Protection of genetic data provides a vital reassurance to people who wish to be involved in genetic research into neurological conditions. The guidelines developed for ethical genetic research in the area of dementia (Alzheimer Europe) outline concerns appropriate to other neurological conditions: Research affecting an individual s genome shall be undertaken only after rigorous and prior assessment of the potential risk and benefits pertaining thereto. Genetic researchers should abide by laws pertaining to this type of research. Researchers should try to avoid contributing towards the coercion of relatives to take part in certain forms of genetic research. No genetic samples should be taken or genetic information recorded without the awareness and informed consent of the participant (or his/her legal representative). As genetic testing may have implications for family members, potential participants should be encouraged to involve relatives in the consent process. Researchers should ensure that participants fully understand explanations about genetics and genetic research, starting with the terms they use. No prior knowledge, even of the most basic aspects of genetics, should be assumed. Researchers should be careful that explanations of their findings do not mislead the general public, and lead to panic or false hopes. The insurance industry should be dissuaded from the inappropriate use of information about the genetics of dementia until cause and effect relationships have been scientifically established. The insurance industry should, in the event of emerging but inconclusive evidence of genetic or other factors affecting the development of dementia, respect a moratorium. An important guide in terms of the ethical concerns and issues around genetic research in an Irish context is Genetic Research and Human Biological Samples Health Research Board 2002 which provides guidance in the area of informed consent. It is important that the protections accorded to genetic data in Ireland are extended to include potential other uses of the information, e.g for private commercial purposes without the expressed consent of the donor. Resourcing of Genetic Services In Ireland The NAI cannot make a submission on the issue of genetic information without highlighting the continued lack of resourcing of genetic testing and genetic counselling services in Ireland. Neurological disease is an area where the potential for treatments based on genetic testing (including individual profiling) is growing. Waiting lists for Genetics services are unacceptably long. Delays in diagnosis or misdiagnosis may result in multiple avoidable appointments with doctors and consultants, incorrect treatments and diagnostic tests, and significant distress. Waiting times for predictive testing, supportive counselling and information services are unacceptably long for individuals and their families who face life changing decisions based on the outcome of this information.. 5

6 In the UK, the Department of Health has an entire division to manage genetic services. The failure to prioritise genetics services at Department of Health and HSE level has resulted in a policy vacuum, a complete lack of planning and a gradual deterioration of the genetics services available to patients and their families. The National Centre for Medical Genetics (NCMG) is the only centre in Ireland providing an integrated clinical and laboratory genetics service. Without appropriate governance and dedicated funding commitments NCMG cannot be expected to maintain a national, accredited, accessible service for patients impacted by genetic conditions. Ireland has one of the lowest levels of clinical genetic consultants and genetic counsellors in Europe. There are only four consultants, or 1 per 1,150,000 people, compared to 1 consultant per 400,000 in France, 1 per 300,000 in Northern Ireland, and 1 per 200,000 in Finland. There are 5.6 WTE genetic counsellors, or 1 per 820,000 compared to 1 per 283,000 in Northern Ireland. All genetic testing services and laboratories used for Irish patients should meet internationally agreed quality standards and have appropriate accreditation systems in place. There are significant risks involved in using random commercial laboratories for certain genetic testing including: Poor quality testing Fragmentation of a family s genetic information Risks to patients getting inadequate inappropriate testing Failure to provide essential key information, individualised counselling and medical advice where appropriate, to patients undergoing highly predictive genetic tests for serious disorders. Summary Points 1. The role of genetic testing in relation to many neurological conditions is likely to assume increasing importance into the future. 2. It is vital to have accurate information available to all decision makers in relation to the role of family history in neurological conditions in order to counter some common misperceptions of the role of genetic factors in some of these conditions. 3. People appear to be making disclosures of genetic testing and results to insurance companies and this may indicate a lack of awareness and understanding of their rights and protections in this area and the need for a specific information campaign. The issue of this disclosure to employers also needs to be explored. 4. The continued lack of regulation and transparency in relation to the gathering and use of family history information has led to continued concerns in relation to this area among people with neurological conditions and organisations working with them. 5. The NAI is concerned at the unacceptable delays for people with neurological conditions and their families in relation to genetic testing and counselling services when people require this information to make important life changing decisions. Consultation The NAI would be happy to engage in further consultation with the National Disability Authority in relation to the current review. 6

7 Please feel free to contact our Development Manager, Magdalen Rogers at or List of NAI Member Organisations Acquired Brain injury Ireland Aphasia Ireland Alzheimer Society of ireland Aware Bloomfield Health Services Epilepsy Ireland Cheshire Ireland Chronic Pain Ireland Dystonia Ireland Enable Ireland Epilepsy Care Foundation Headway Huntington s Disease Association of Ireland Irish Heart Foundation Irish Hospice Foundation Irish Motor Neurone Disease Association Meningitis Research Foundation Migraine Association of Ireland Move4Parkinsons Multiple Sclerosis Society of Ireland Muscular Dystrophy Ireland Neurofibromatosis Association of Ireland North West MS Therapy Centre Parkinson s Association of Ireland Post Polio Support group Syringomyelia Support group of Ireland Spinal Injuries Ireland Spina Bifida Hydrocephalus Ireland The Rehab Group Associate Members Brain Tumour Ireland PSPA Ireland Irish Association of Speech and Language Therapists Irish Institute of Clinical Neurosciences Myasthenia Gravis Association of Ireland Irish Society of Physicians in Geriatric Medicine 7

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