Seanad Éireann debate -
Wednesday, 27 Jun 2001

Vol. 167 No. 8

Genetic Information: Motion.

Dr. Henry

I move:

That Seanad Éireann calls on the Minister for Enterprise, Trade and Employment to introduce, as a matter of urgency, legislation banning the use of genetic information by insurance companies or employers particularly in view of the fact that the Government has signed the European Committees (Legal Protection of Bio-Technological Inventions) Regulations, 2000; and in view of the importance of the bio-technology industry in Ireland to outline the Government's policy on the patenting of genes.

I am delighted to welcome the Minister of State at the Department of Enterprise, Trade and Employment, Deputy Kitt, to the House as he witnessed some of my anger about this topic when he addressed a meeting of the Oireachtas Joint Committee on Enterprise and Small Business yesterday. I am very impressed at the size of the team which accompanies him as it must indicate this matter is being taken very seriously.

I was extremely pleased to be sent last week by the Oireachtas Joint Committee on Enterprise and Small Business to a meeting in Brussels of the temporary committee on human genetics established by the European Parliament. However, I was rather depressed to discover that round table discussions in this area have been ongoing for almost six months although we have had little input into them. Senator Avril Doyle attended part of the meeting although she was also obliged to attend another committee meeting on the issue of water. Many of the meetings held within the European Parliament are not simply for the benefit of MEPs; members of national parliaments are also encouraged to attend these meetings.

I sympathise with the Minister who was recently obliged to travel to Madrid where Ireland became the 51st country to sign up to a very important trademark directive to which other EU countries signed up years ago. We must take EU directives more seriously in this country at the time of their introduction rather than moaning and groaning about their provisions at a later date. It is a great pity that we do not enthusiastically engage in debate on EU directives. If sufficient staff are not currently available in various Departments to deal with these directives and to facilitate people travelling to Europe, additional staff must be appointed. The civil servants present will be delighted to hear that I cannot wait for the introduction of benchmarking which will confer a real sense of importance and value on some Civil Service and public service positions.

The temporary committee on human genetics was established as a result of the perception that directives on bio-ethics are becoming outdated at a rapid rate. The committee members asked whether a public debate had occurred in Ireland on this topic to which I was obliged to answer in the negative. Would we find ourselves in our current predicament about genetically modified organisms in plants if the matter had been properly debated when it first came to light?

I am particularly concerned about the manner in which the insurance industry may use genetic testing. A 1995 paper published in America, the land of the free market, states:

To the extent that insurance is a business, insurance companies will be duty bound to use genetic screening to exclude affected families from the insurance pool but, in so far as insurance is a communal, moral enterprise, the exclusion of the ill from the insurance pool is unacceptable.

All of us are used to being asked various questions about illness in our family and so forth when we take out insurance and we are able to reply to them, but when we are asked about genetic testing, it is a different matter. The fact that a person's mother or father died of heart disease may not mean that a person has a genetic predisposition to it. It may mean that person's parents smoked, drank, stayed up all night and did not go to bed early like that person does. The implications of having to ask someone for a test might mean that the person concerned will not take it if he or she has a genetic disposition to cardiac disease. Because that person does not want an insurance company to know that is definitely what happened to his or her parents, that person may not make the lifestyle changes which could affect his or her life in a proper manner.

We have a large number of diseases with a genetic base because we were pushed to the edge of Europe and until recently there was not much immigration. We all come from very much the same genetic pool. There is a problem in that there is a basic consanguinity among a very large number of us.

The insurance business is entitled to have a basic level of knowledge about us, but for it to provide a basic level of cover, it is not entitled to look for our genetic make-up. There must be solidarity between those whose genes may not be as glamorous as others. We need rapidly to develop a debate on this subject.

The Government is one of the only governments in Europe that does not have legislation regarding the use of genetic tests and the insurance industry. Even the United States introduced legislation on genetics and the ethics of genetic counselling and I have the debate on that US Senate Bill. The United Kingdom does not have legislation banning genetic testing. It has had a voluntary code on genetic testing in place for some years, but that has not proved to be satisfactory. This is important to us because the parent companies of most of our insurance companies are United Kingdom companies. We should introduce our own legislation on this area immediately. The British will introduce legislation, but that will only affect the companies in Britain.

If people take out expensive insurance to insure themselves for £1 million or £2 million rather than, say, a life assurance policy one must take out to buy a house, the position must be fair to the insured and the insurer and we can consider that in a different manner.

We must remember that genetics is in its infancy. We do not even have standards regarding laboratories that might be set up to carry out genetic testing. This reminds me very much of a Bill I tried to bring in setting up a register of institutes that were giving in vitro fertilisation advice or therapy. We do not even have that. That was a Bill I introduced four years ago, an area on which we were told legislation was to was to be enacted shortly. “Shortly” can mean four years.

Home kits are being produced which people can use to do gene testing on themselves. I could not vouch for the accuracy of them. If people feel they will be driven to do this regarding genetic testing, one can imagine the great worry that could be caused and the many mistakes that could be made. Insurance staff may also have a great deal of trouble interpreting the test results they are given. This is particularly important in America where sickle-cell anaemia is quite common. Sickle-cell anaemia only develops if one inherits the gene from one's father and mother. Insurance company staff were loading people who had only a sickle-cell trait. In other words, they only had one parent with the trait, and not necessarily the disease. There is also not widespread availability of testing here. It would be a grave imposition to allow this to progress.

It is important to remember that genetic information is not totally about one person alone. If it is discovered that a person has one gene that is considered unacceptable to an insurance provider, it may also ask about the person's parents, siblings and children. That data could be used to spread loading on other members of the person's family.

The situation in the United Kingdom got unpleasant at a certain stage where, for example, people were asked to have tests for hereditary kidney disease, breast cancer and Alzheimer's disease. Is it right to ask people to have a test for something for which there is no known cure, for example, Alzheimer's disease or Huntingdon's disease, both of which result in the early deterioration mentally and physically of the person and for which there is no known cure? Should one be obliged at the age of 30 to take such a test? People should have the right not to know such information as well as the right to know. Our genetic counselling services are also very shaky. There are many ethical issues to be examined in this area. It is far too sensitive to be let into the hands of a commercial concern such as an insurance company.

The progress made in research on the human gene has been fantastic and much more rapid than we expected, thanks in the main to the collaboration of various laboratories on an international scale who disclosed the information as soon as they had it, but if that had been kept to one private laboratory, one does not know whether that information might have been disclosed. A situation could develop where persons would agree to be tested for one disease and a gene chip could be produced, which would allow a person to seek information on a sequence of DNA, and another faulty gene could be discovered that the person did not want to know about or did not agree to let information be known about. That is also a major ethical issue.

All this is of major importance in setting ourselves up properly in the genetic area and the area of genetic patenting. The Environmental Protection Agency looks after everything regarding patenting within laboratories to make sure that is all right. We have not made any effort to set up a central commission or council on genetic patenting, not only human but all genetic patenting. It is important to remember that while the last century might have been the century of physics, the one before that the century of chemistry, without a shadow of a doubt this will the century of biology and bio-technology

I commend the intergovernmental report on modern biotechnology which is superbly written. A great deal of trouble was gone to in the writing of it. It points out the consequences of public hostility to bio-technology. It is most important we try to do something about that. It also refers to the medicinal products of genetically modified medicines.

We have a large pharmaceutical industry, which is very lucrative. Forfás is working on various projects and BioResearch Ireland is helping to translate the university ideas and projects into commercial companies. Elan, Intergen, Genzyme, Schering Plough, Eli Lilly and many others are operating on a smaller scale. All of them are heavily involved in innovations which have been brought forward due to the discovery of different genes and their properties.

A major debate is taking place within the World Trade Organisation regarding whether a gene is a discovery or an invention. One has to come down on the side that the properties of the gene are the invention because the gene is common to our ancestral heritage. We should try to get more involved in that debate at a local level. I have heard very little about it.

The money being put into research here is staggering compared to what it was a few years ago but it it important to remember that the money put into research in Europe by various governments and corporations is only about one-third of the amount of money put into it in the United States. It is suggested that their patent law means they have been able to forge ahead but those involved in the research do not subscribe to that view. They believe what is more important is the fact that more money is being put into it.

Part of the meeting dealt with trying to encourage European Union companies to invest more money in current research in genetics. If novel patents are found for various diseases, it is the various governments who will have to buy back those novel drugs so if they were involved with a good share in the beginning, it might be financially worthwhile.

I asked about the Government's policy on genetic engineering because I could find little documentation on genetics apart from the Fianna Fáil position paper on the genetic engineering of food which was published in 1997. However, I am sure that Fianna Fáil, being a modern political party, has substantially updated its position since then. I look forward to hearing the Government's policy on patenting. I considered using the word "philosophy" but then thought I might be going a bit far, so I used the word "policy". I am sure the Minister will enlighten me this evening.

Mr. Quinn

I am happy to support this motion. It is exactly what Private Members' Business in the Seanad is geared for, to debate topics such as this that are not sufficiently debated. I was impressed by Senator Henry's reference to the age of biotechnology. I am familiar with genetics only in the area of genetically modified foods and genetically modified organisms. The lack of information on the subject is striking. I found the report Senator Henry referred to fascinating.

There has been too much emotion and too little scientific expertise in debate on this subject. Even with regard to the scientific expertise, we are not sure if the scientists are in the pockets of somebody or other, given than so many of them are either working for people who are in the business or they have a background of opposing developments in the area. Therefore, I find a debate such as this fascinating.

In general, I am a champion of competition in business but the insurance industry is one in which unbridled competition can do more harm than good and can sometimes work against the public interest. This topic is, therefore, of particular interest. If there are no restrictions on how insurance companies compete, they will inevitably seek to maximise their profits by excluding bad risks from cover and concentrate their business only on low risk customers. To be truthful, I support that approach up to a point. It makes sense. However, it might be useful to define what that point is because we might arrive at a useful principle as a result. Hopefully, the result of this debate will be that we arrive at some principles in this area.

Insurance companies should have the freedom to refuse risks if the risk is due to an action taken by the customer or arises from a choice made by the customer. Take as an example a person who is such a bad driver that he or she is repeatedly involved in accidents. It is right that such a driver should have to pay more for insurance or even be refused insurance so that those who behave themselves on the roads will get the benefit of a lower rate. While insurance is a way of spreading risk among the community of the insured, it is not a licence to behave as one wishes and have other people pick up the bill for the consequences.

If a person makes a lifestyle decision which makes him or her a better risk from the point of view of insurance, there is nothing wrong with an insurance company targeting that type of person as a customer or giving them financial incentives or benefits to put their business with its company rather than with another. I have in mind somebody who decides not to drink alcohol or to smoke. They could be considered a better insurance risk. It is a decision made by the individual; a lifestyle decision that is within the power of the person to make.

Where we need to draw the line is in allowing insurance companies to discriminate against people for reasons that are outside the control of the customer. This is the argument against allowing insurance companies to use genetic testing in either deciding whether to accept a customer or what they will charge a customer on the basis of their genetic history. One could say that if somebody has a pre-existing medical condition when they apply for insurance, they have no control over it but it is accepted practice for insurance companies to take it into account. That is understandable because if there was no such escape, nobody would apply for insurance until they became ill. There would be no such thing as insurance. One would wait until one was ill to take out insurance because the insurance companies would not be allowed to take it into account. That would be an impossible situation. One could not run an insurance scheme on that basis.

However, the future is the point of insurance and the essential quality of the future is that it is unknowable. This is crucial to the question Senator Henry poses this evening. A genetic test cannot forecast with certainty what will happen. All it can do is show that there is a higher likelihood of a particular disease occurring in a person and we are not even sure it can say that without contradiction.

There is a difference of kind and not just of degree between a pre-existing medical condition and the finding of a genetic test. When Senator Henry outlined the motion to me a few days ago I gave it a great deal of thought. If we accept this as the principle for establishing the cut off point, it might also affect existing practices of insurance companies that, so far, have survived without any criticism. It always seemed unfair, when I sought insurance, that the company asked what ages my father and mother were when they died. That is not something I can control. Is the insurance company blaming me or taking it into account? That is the unscientific precursor, as it were, of the genetic test. It is an attempt to draw a conclusion about what will happen to somebody on the assumption that an early death reflects a condition that can be inherited. I believe asking such questions should be banned as well. The debate should at least take account of whether it is a legitimate way of doing business.

I have tried to be brief and put my points clearly. Senator Henry gave the House a vast range of information from around the world but this is a specific issue. If we believe that insurance companies are going to survive and that they serve a purpose, they must take account of existing illnesses. However, can they take into account something that is not under the person's control or even within their knowledge and is not based on good science? If so, are we in a position to open the debate and to consider on what principle legislation should be based? I support the motion.

Mr. Mooney

I move amendment No. 1:

To delete all words after "Seanad Éireann" and substitute the following:

"calls on the Minister for Enterprise, Trade and Employment to continue to monitor closely developments in the field of bio-technology to ensure that the Government reacts appropriately to those developments, having regard to the speed of developments in the area of bio-technology, having regard to the structures at present being put in place for a Bioethics Council under the auspices of the Royal Irish Academy, having regard to the insurance industry's Code of Conduct, which imposes a five year moratorium on use of genetic test results by insurers in respect of life assurance policies up to £300,000.".

I acknowledge the contribution of Senator Henry in initiating this important debate but I take issue with one of her comments. I believe there has been an ongoing debate in this country. In 1998, the Minister for the Environment and Local Government issued a document on genetically modified food. There have been several letters to The Irish Times from a wide variety of sources in the medical and scientific professions. I have them all here and they date back over the past couple of years. The debate may not have been broadened to the extent Senator Henry would wish in that it is not in the public domain in the same way as GM foods, but we are on the cusp of a major debate in this area.

It is rather interesting to go through the various statistics relating to it. For example, one report states that biotechnology is one of the most rapidly developing technologies of our time, with worldwide annual sales estimated to be in excess of $100 billion this year, and it currently employees 300,000 people in Europe alone. Obviously there is a great deal at stake.

Another element of it, in the context of the amendment to this motion about the area of the developments in biotechnology, is that, once again, the disadvantaged in the world seem to be at the mercy of the multinationals. For example, in the context of the report to which Senator Henry referred of the ongoing debate in the European Parliament and of the directive relating to gene line therapy and many others, opponents state that the draft directive fails to make restrictions sufficiently explicit. Third World NGOs and Governments are opposed to this directive because of what they refer to as bio-piracy, the appropriation by multinationals of the genetic inheritance and knowledge of developing communities with no return to them. Oxfam says that therapeutic techniques or new plant varieties developed by biotech companies are often based on old wisdom handed down through generations in a developing country. That knowledge is then privatised and sold back to the same community. It is an area in which Ireland would have a particular interest because of our strong credibility due to Ireland Aid in Third World countries, especially in Africa, where there is already ongoing biotechnological processes being put in place to extract various ingredients out of natural resources in Third World countries for sale on the open market. It seems to me that we could end up in a situation such as that which developed recently in South Africa about the AIDS vaccines, where major multinationals could extract the base ingredient and then sell it back to them at such an exorbitant price that the people who would benefit would be unable to purchase it.

However, the thrust of Senator Henry's motion is about the insurance industry. The insurance industry is testing the water on this and it should not be allowed to get away with it. I have come to that view having studied much of the available evidence and the various reports of committees sitting to address this matter. What they are look ing for are the rights to future genetic test results rather than current practice in this area. The main reason I suggest is that they are defending the current testing procedures without there being any scientific reliability placed on those tests or, indeed, their relevance to insurance certificate applications. How, for example, can insurance companies justify the inclusion of genetic test results which are unreliable? I would suggest that they would have to publish more data. They must be more publicly accountable. They cannot just insert a line and leave it at that. How does the insurance industry take account in its actuarial calculations of such factors as early diagnosis and treatment for genetic disorders? Can they come out and be a little more publicly accountable about how they determine the actuarial figures regarding insurance premiums?

In addition, as I am sure Senator Henry would agree, there is a very small number of cases involving genetic test results and, therefore, I would submit, as the UK House of Commons committee on this matter has suggested, that they should be ignored by the insurance industry until such time as their scientific relevance is established. It will not cost them anything. Financially they are not losing anything by it because of the small numbers involved. In fact, I understand that three insurance companies in the UK which practice in this country are ignoring the tests. Their current policy is also to take account of negative tests only in the calculation of premiums which, I believe, is an important consumer protection. I say this because while Senator Henry correctly says that there are those who may not wish to take the test because they would be afraid they would be prevented by it, those who have taken it – particularly in the case of Huntington's disease which affects over 300 families in this country – and were found to be negative, have found it to be a plus when they then applied for insurance.

Concern is being expressed at the rapid developments in biotechnology. There may come a time when there will be screening of employees for genetic defects. This may be just around the corner. The state of Iowa in the US has passed legislation to limit the use of such screening.

Dr. Michael Clarke, who is a Member of Parliament and chairman of the Science and Technology Committee in the House of Commons, in publishing the report recently stated that the use of these tests by insurance companies raises significant moral and ethical concerns and will have a significant impact upon all those involved in the field of human genetics, patients, researchers, industry and clinicians, and that they question the predictive significance of positive genetic test results and their actuarial relevance at such an early stage in the development of genetic science.

I also want to acknowledge that a group has been or will be set up to monitor and advise on genetic innovations. This is in response to public concerns over the ethical questions raised by scientific advances. I look forward to the Minister of State, Deputy Tom Kitt, amplifying on the Government's proposal in this regard. I understand that Ireland is one of the last EU member states without a bio-ethics advisory body and I hope this group will bear fruit.

In Ireland a huge number of issues need to be considered, particularly genetic discrimination in gene patenting. It seems that what is going on in the US – Senator Henry alluded to this and to the US Senate legislation – is creating a wake-up call in the EU. The EU is trying to play catch-up on this issue and I hope it will move in that direction. Certainly the committee Senator Henry attended, if it is the same committee, was set up not that long ago in response to concerns in this area.

The great majority of geneticists worldwide are fundamentally opposed to genetic information being used by insurance companies. This has become an issue because many more genetic tests are being developed and, as I said earlier, the people who suffer from Huntington's disease have great concerns that discrimination is practised against the relatives of people with Huntington's disease and other genetic diseases when they go to buy life assurance.

Of course I welcome the code of conduct produced by the Insurance Federation of Ireland which came into effect on 1 May. A cursory reading of it would seem to suggest that anybody applying for insurance cover of up to £300,000 would not be subject to these genetic tests. In the absence of any evidence to the contrary, however, it seems to me that the insurance industry is effectively just responding to public concern. In fact, it suggested that the UK industry's code of conduct, on which, I would say, the Irish one is based, is out of line with practice in 18 US states and with that in many EU countries. In those jurisdictions legislation has already been introduced to exclude the use of genetic information in obtaining insurance. Furthermore, the UK code was introduced against the advice of an expert UK Government commission on genetic testing.

The Government has a unique opportunity to affect the long-term quality of life of its citizens by enacting suitable legislation. In fact, my research indicates that all those who are watching and monitoring the developments in this area wish the Government to take action rather than allow a voluntary code of conduct operate among the insurance companies. There are much wider issues with which the amendment deals in the context of the developments of biotechnology, and I hope the Minister of State might address some of them. As Senator Quinn stated, it is not so much genetic testing in the insurance industry which is exercising the minds of the populus but the GM area and the area of consumer foods and of the food chain in general. They need to be reassured and any other fears in that area need to be allayed.

Mr. D. Cregan

I want to raise a few points generally about the vast difference between life insurance and business insurance. It is worrying to hear what Senator Henry said. There is a vast difference between life and business insurance. Senator Quinn referred to the way in which insurance companies can treat people. Some time ago I was involved in expanding my business. It is a tidy little business but is now expanding well. Given the moneys I was drawing from banks, insurance cover was required. I was subjected to numerous tests to ensure I was healthy and suitable for cover. Fortunately, I passed them and my family will do very well if I pass away. Nothing will be owed because the insurance companies will cover it.

Bad drivers should suffer the consequences of their driving and insurance companies should have the right to make that a condition of cover. However, they should not have the right to impose tests before granting financial cover. Within the past five years I was required to undergo testing for AIDS by the insurance companies on three occasions. It was disturbing but thank God I had no problems. However, I would not like to be told that genetic testing on me indicated I was in the early stages of senile decay. Applicants for insurance should not be subjected to this.

According to a report in The Irish Times of 13 May 1998, life assurance becomes difficult and expensive if an applicant is found to be at risk from a genetic illness. Failure to disclose a family history may result in a policy being invalidated and the dependants left in poverty. That is very serious. Does it mean, for example, that if a person failed to tell an insurance company 40 years ago that a parent had a bad heart his cover could be invalidated? If so, that would mean the insurance company would have the benefit of premium income for 40 years but the family would not benefit if the person died in his 41st year. That needs to be looked at.

I have all my businesses insured through the one broker and last week he told me he no longer considers it worth his while to sell cover to any member of my family because the Central Bank imposes so many controls. Given my standing with him he will deal with my family members for business but what about the ordinary person who seeks cover? If he discloses that his brother is handicapped will his cover cost him an extra £5 per week? If insurance companies can do that it is very serious.

I understand the need for testing to ensure that applicants are healthy but what is under way here is very extreme. Does it mean that fewer people are taking out insurance and that, say, only those under the age of 40 years will seek insurance? If so, the State will then have to take the responsibility to ensure that those without cover are well looked after. Given the condition of the health services that will not be possible.

This is not the way to proceed if the Government wishes to create the incentive for all members of the public to take out personal insurance and pension policies. If the insurance companies are allowed to do this it will cost the taxpayers. I am proud to say I put a lot of money into my pension schemes but others may not be so inclined. For example, there is insufficient promotion of the benefits of AVCs for pension purposes but these will become less attractive if the insurance companies impose tests of the kind outlined by Senator Henry.

I understand why insurance companies are concerned with the cost of motor cover but life assurance is a different matter. There is a danger that they may not cover the less healthy and less well off. Genetic illnesses are very serious but applicants for cover should not suffer for it. Yet they do in the form of premium loadings. Given the profits made by these companies, this practice must be questioned.

I am pleased to note Senator Mooney's comments that states in the US have disallowed these practices by insurance companies. The Government should impose controls. In this respect the amendment to the motion does not go far enough. Legislation is required. If the Central Bank has control over how insurance brokers may go about their business there is no reason they cannot take control of the activities of the insurance companies in this area, especially given how well they are doing.

We must not allow people to be worried that because they have a genetic illness their family may inherit it. If so, they may decide not to apply for life cover or, if they do, they may opt not to disclose the information. That may lead to the invalidation of their insurance, which is very disturbing.

Insurance companies do not impose the same rigorous tests on 30 year old applicants as they do on 50 year olds because they know they will make more money on the 30 year olds. Their premium income is of great benefit to the companies. Another aspect is the necessity to pay premiums through bank accounts because door collectors are no longer used by the insurance companies. This means that financial institutions, such as banks and building societies, also benefit from premium payments. While we should not be afraid of technology we should ensure that those who need cover most get it. I am referring to the basics here, not to the high flyer who wants to enhance his pension with AVCs. It would at least ensure that people could rest easy in the knowledge that there will be enough money to bury them.

My mother always said she would live as long as her mother, which was 86 years of age, but she only lived as long as her father. Even my mother thought she was doing better than she was and I keep that in mind. Insurance companies take everything into account but ordinary people do not have sufficient protection and we should not be afraid to provide it. The Central Bank controls brokers and perhaps that is the route that should be taken in ensuring insurance companies are controlled.

Mr. Norris

This is an important debate and I congratulate my colleague, Senator Henry, for tabling the motion. I am disappointed the Government tabled an amendment to the motion, particularly in light of Senator Mooney's well informed contribution which appeared to be in concert with the views expressed by Senator Henry.

Mr. D. Cregan

That is right.

Mr. Mooney

That is the case.

Mr. Norris

I am not happy with the amendment because it refers to the industry's code of conduct, which is not a legal requirement. I will refer to this aspect later because an expert in this area, Professor Andrew Green, has warned precisely against that type of development. The view of the experts should be taken on board. As they would say in England, the reference to the five year moratorium is "wet". Nothing is being done with regard to this issue.

The insurance companies must be monitored in relation to this area. A few years ago I raised the issue of a distasteful and intrusive questionnaire that was being used to discriminate against gay people, but it is still going on. I received an e-mail from a constituent recently who was asked to fill up a form which asked questions such as "Are you a homosexual male?", "Are you a member of any of the following HIV high risk groups.?" and "Is your partner a member of any of these high risk groups?" The constituent said he took great exception to it. When he inquired about the form, he was told that all single males over the age of 25 years are required to answer such questions. This is discrimination on the basis of sex alone. The constituent continued:

Although I am gay and in a relationship (naturally I did not declare this) it is assumed that I am high risk. I have been with the same partner for 10 years and have never once ‘strayed'.

However, he will be loaded by the insurance companies. If this is what they are doing at present, what will they do in light of the advances in genetic science and understanding?

On 19 October 2000, Dick Ahlstrom had an interesting article in The Irish Times about this matter. He pointed out that a British court ruled that insurers may demand the result of genetic tests from clients. Britain is our nearest neighbour and we often pattern ourselves on it. Various genes have been identified in the comparatively recent history of science, such as those for cystic fibrosis, Huntington's chorea, sickle-cell anaemia, retinitus pigmentosa and Tay-Sachs disease. They could be the type of tests insurance companies may require their clients to reveal.

Insurance companies are open about this matter. The article quotes Ms Jennifer Hoban, life assurance manager with the Irish Insurance Fed eration, as saying that "As things stand there is nothing preventing us looking for the results of genetic tests." This is from a representative of the insurance industry. The article continued that, during October, the genetics and insurance committee, an advisory committee reporting to the UK Department of Health, gave insurers the legal permission to ask new policy holders whether they had taken a gene test for an invariably fatal degenerative disorder, Huntington's chorea, and to acquire the results of the test. Two years ago, another UK advisory body, the Human Genetics Advisory Commission, recommended a moratorium on the use of information from such tests. However, this view was rejected by the British Government. There is very little protection in Britain.

Professor Andrew Green is the director of the National Centre for Medical Genetics at Our Lady's Hospital, Crumlin. He is a substantial authority in this area and he was quoted as saying:

I think the Government should introduce regulations. The insurance companies shouldn't regulate themselves in this matter. I don't think people should be in a position to coerce people into tests.

This is the view of the country's leading expert in this area, but the amendment proposes exactly what he says should not be done.

The issue is more complex because there is a certain legislative context in England. As I noted, despite the fact that we are much vaunted as a Republic, we still tend to behave as if we were part of the British Empire. We look to the United Kingdom for legislative models and much of the insurance in Ireland is underwritten by companies that are based in London or Edinburgh. BUPA is a big company, but Ireland is one of its outposts. Its main policy is directed from London. England takes a much more company based approach than other European Union states. Professor Green said: "I think that some countries have actually taken practical steps and the UK is out of line." Ireland is not only out of line, but we are once again slavishly following the United Kingdom which is out of line with its European partners.

There are tests for a variety of diseases, including Huntington's chorea, sickle-cell anaemia and Tay-Sachs, and there is a parallel with the gay issue because Tay-Sachs disease almost exclusively affects members of the Ashkenazi Jewish community while sickle anaemia only affects American negroes. Therefore, specific groups are targeted. From April 1999, in the United States of America, more than 550 different genetic tests were being used to diagnose disease. This has a direct implication in terms of employment. The Americans are great at using statistics, for example, according to a 1998 survey carried out by the American Management Association, approximately 10% of employers – the number is growing – routinely test employees for genetic predisposition to disease. People in the civil liberties area have warned that these results may be misused to target and fire employees who may run up company health insurance costs because they appear as a negative indicator on the balance sheet.

This is not an abstract fear because the Americans have produced surveys in this area. It is an indicator of what the future could hold for people in employment in Ireland. According to a 1996 Georgetown University poll of 332 families with perceived genetic risks, 22% reported that they had been refused health insurance while 13% had been fired from their jobs based on their perceived risks. This information is being used in America at present to dismiss people from employment. About half the states now have laws that either protect against genetic discrimination or prohibit testing in employment or insurance decisions. More Bills are pending in other states, but we are doing exactly what Professor Green said should not be done.

The amendment states that the insurance industry should be allowed to regulate itself. I remind the House of the trouble we had with the industry before. When Senator Henry and I raised the Insurance Ombudsman's report and the valiant woman involved was put to the pin of her collar to defend the individual against the might of the corporation, it got rid of her. Citizens look to us as legislators to protect their rights.

Insurance companies operate in the market and they must survive in commercial terms. Products are developed to provide the individual with financial protection against unanticipated loss, illness, early death, which people do not anticipate, and disablement of various kinds. Standard premia are calculated on the expected outcome for large numbers of individuals – a control group. There is community based insurance rather than cherry-picking. I recall dealing with these aspects when we considered the legislation to liberate the insurance environment.

The ideal situation is where the companies spread the risks over a large community while still allowing the industry to earn a profit. When insurance policies rely more on risks of only a few individuals or small groups – this is cherry-picking – this social function is lost. The ability to identify and exclude high risk individuals can result in the paradoxical situation of insurance being most easily available to those who are least at risk. With regard to health insurance, this problem is accentuated when the cost of insurance is borne primarily by employers and it is particularly so in small businesses whose profits and even survival may be threatened by the serious illness of employees.

Senator Henry is far more well versed and better able to give an opinion on the problem of scientific definition than I. However, even I can take a brief and I read that even scientists realise there is a grey area in terms of what constitutes a genetic test. Definitions can become important when insurance policies and laws distinguish genetic conditions and genetic tests from other medical conditions and tests. While some conditions, for example the Tay-Sachs syndrome which I have mentioned, have a virtually purely genetic basis, most genetic disorders involve an interaction between a genetic predisposition and environmental factors. Even single gene disorders, for example sickle-cell anaemia and cystic fibrosis, have variable expression, depending in part on such environmental factors as oxygen tension in the former and nutritional factors in the latter. In other words, there is no clear boundary between strict genetic testing and other medical tests.

In America, where genetic testing is carried out, there is provision for counselling before and after the test. This is paid for by the insurance companies. There is no provision for this in this country although, in human terms, it is very necessary.

An Cathaoirleach

The Senator has exceeded his time.

Mr. Norris

I have a couple more comments, if I might be allowed.

An Cathaoirleach

Briefly, Senator.

Mr. Norris

I will be very brief. There is a considerable ambiguity in characterising an individual who has been found, for example, to have the allele, which is the symptomatic cluster for Huntington's chorea. Some people argue that he or she only has a predisposition to develop the condition at a later time. Insurers, however, might argue that the condition is present, albeit in latent form, as soon as the individual acquires the abnormal gene. A person could be penalised for having a predisposition rather than the disease. Distinguishing and classifying individuals with different risks is at the heart of commercial insurance, particularly when individual and small group policies are involved. Insurers do not believe that genetic tests which predict illness, death and disability should be excluded from this traditional practice. Differentiation of applicants on the basis of health risk is legal and should be distinguished from discrimination which is illegal if based on race, gender or sexual orientation. Insurance companies have not called for genetic testing but in the light of what I have said, it is only a matter of time before they do so.

An Cathaoirleach

The Senator should conclude.

Mr. Norris

This is my last comment.

Mr. Mooney

I had a great deal of extra material too.

Mr. Norris

Well, there you are. Senator Mooney talks too slowly—

An Cathaoirleach

Senator Norris must conclude.

Mr. Norris

—and I am being interrupted. The phenomenon of multiplexing could result in a marked reduction in the cost of testing and while insurers have not called for testing they may do so in the future.

Minister of State at the Department of Enterprise, Trade and Employment (Mr. T. Kitt)

I welcome this debate and I thank Senator Henry for placing the issue of the agenda of the House. I thank Senators Quinn, Mooney, Cregan and Norris for their contributions. There has been much talk since the Nice treaty referendum about the need for more transparency regarding the many issues being discussed at EU level and this is one of those issues. There have been major advances in this area and I will try to deal with the points raised by Senators. We must address these issues and, if they are being discussed at EU level, we should bring them back home and sift through them in the Oireachtas.

My colleague, the Minister of State, Deputy Noel Treacy, is responsible for the area of insurance but our Department is also responsible for issues relating to biotechnology and patents. Senator Mooney raised the international dimension and I will refer to that briefly because I have an interest in that area as Minister of State with responsibility for international trade.

I commend the Government's counter motion calling on the Minister for Enterprise, Trade and Employment to continue to monitor closely developments in the field of biotechnology to ensure that the Government reacts appropriately to those developments, having regard to the speed of developments in the area of biotechnology, having regard to the structures at present being put in place for a bio-ethics council under the auspices of the Royal Irish Academy and having regard to the insurance industry's code of conduct, which imposes a five year moratorium on the use of genetic test results by insurers in respect of life assurance policies up to £300,000.

It is obvious to us all that the area of genetic testing is one in which developments are taking place at a very rapid rate. There are many broad issues involved, including public health, protection of personal data, insurance solvency and consumer protection.

I am aware that many people are concerned about genetic test results and how they might impact on the availability to them of life insurance cover in general. I also understand the concerns of insurance companies, particularly in relation to cover provided by them for critical or serious illness and for permanent health insurance.

The Irish Insurance Federation has recently introduced a code of practice on genetic testing for its members. The code sets out the conduct to be followed by the industry in Ireland regarding the use of genetic tests. It seeks to balance the legitimate interests of insurers and of the totality of policy holders with the concerns of individual consumers.

The IIF engaged in consultations on the code, prior to its formal introduction, with our Department. The IIF also participated in discussions organised by the Department of Justice, Equality and Law Reform, with representatives of that Department, the Department of Health and Children, the National Centre for Medical Genetics at Our Lady's Hospital, Crumlin, the Huntington's Disease Association of Ireland and the Inherited Disorders Organisation. I understand that those consultations were regarded by the IIF as very productive and influenced the content of the code which was subsequently introduced.

The code is a reasonable attempt by the industry to introduce a large measure of control in an area that is relatively new to everyone. Effectively, there is a moratorium on the use of genetic test results, except in a small number of specified cases. There is no intention that anyone will be required by an insurance company to undergo a genetic test. The most important aspect of the code is that, for life assurance policies, genetic test results will be irrelevant for cover up to £300,000. This limit can be used for life cover in connection with a mortgage or otherwise – or both – and should ensure that most people seeking life cover, including cover for mortgage protection, need not disclose the results of genetic tests. I regard this as a very welcome inclusion in the code.

For cover in excess of £300,000 genetic test results may only be sought in restricted circumstances, that is, companies may only seek the results of tests which have been specifically approved as being reliable and relevant to the underwriting process and even then, only where they have been taken prior to the policy being sought. Results of tests taken after a policy is in place will not be requested by companies.

Decisions on whether insurance companies should be allowed make use of genetic test results could have a bearing on how the insurance market develops. For example, critical illness cover is relatively new and companies have been very prudent in their approach to this type of product. Companies might be reluctant to continue to offer this product if underwriting is restricted.

In addition, companies at present tend to look at the market in terms of largely similar segments, each with a different risk factor and with product prices being set according to the risk. If they became unable to assess the risk for segments with reasonable accuracy they might begin to consider the market as a single unit, thereby necessitating the setting of an average premium which each consumer would have to pay. While this average premium would be lower than what would be normally applicable to certain segments of the market, it would be higher for other seg ments and could result in an individual whose risk would normally justify a lower premium deciding not to buy cover. Thus, the best risks would leave the pool, almost certainly resulting in higher premiums for everyone.

With regard to the possible use of genetic results by employers, the use of all personal data is covered by the provisions of the Data Protection Act and I understand that in the employer/employee relationship, personal data may only be used in so far as it is relevant to the particular employment. A recent EU directive imposes restrictions on the legitimacy of holding sensitive personal data. I assure the House that the views of the Members present will be conveyed to the Minister of State, Deputy Treacy.

I will now turn to the biotechnology area. In March 1999, the Government noted the range of concerns raised by genetic modification and established an interdepartmental group – IDG. The group is chaired at assistant secretary level by my Department and comprises senior officials of five other Departments, as well as representatives from the Food Safety Authority, the Food Safety Promotion Board, the Environmental Protection Agency, Teagasc, Enterprise Ireland and Forfás. The group has examined a wide range of biotechnology related issues and developments, including particularly those raised by the genetic modification of crops and foods. It issued a report in October of last year.

The group concluded that public policy should reflect a positive acceptance of the potential benefits of biotechnology, tempered with a precautionary approach to the potential risks. The recommendations contained in the report are intended to ensure that, as far as possible, the benefits of biotechnology are maximised and the risks minimised without compromising on safety for people and the environment. What was needed were provisions in areas such as regulation, research and public communication and consultation that would be responsive and adaptable to changing conditions. A balance needed to be struck between benefits and risks, long and short-term needs and the varying interests of different groups such as producers and consumers. In doing so, it was necessary to take four main considerations into account, an appreciation of the long-term strategic importance of biotechnology, acceptance of the need for a precautionary approach, a commitment to an independent, well resourced regulatory system and acknowledgement of the need for more effective mechanisms of public information, communication and consultation on biotechnology.

The Government has approved a recommendation of the interdepartmental group on modern biotechnology that the Royal Irish Academy be invited to establish a forum to consider the ethical issues raised by biotechnology in an informed, dispassionate and independent way. Discussions between my Department and the academy on the matter are nearing completion and I hope shortly to be in a position to announce the establishment of a national bio-ethics council. The proposed council will be a broadly-based forum which will include representatives of all the main relevant disciplines. It will have two main, related functions, to identify, consider, interpret and elucidate the ethical questions and issues raised by biological and medical research and to promote public awareness and debate of these issues.

The council will determine its own work programme, but the interdepartmental group will be entitled to refer issues to it for consideration. Though I do not wish to pre-empt consideration of the council's work programme, the use of genetic data for insurance purposes is certainly an issue which a body with its remit could at some point beneficially examine.

The European Communities (Legal Protection of Biotechnological Inventions) Regulations, 2000, have no relevance to the possible use of genetic information by insurance companies or employers. They transpose into Irish law the provisions of an EU directive which was approved by the Council of Ministers and by the European Parliament in July 1998. The directive concerned patent issues only. As Senators will appreciate, patents provide an incentive to innovation. Without the safeguard provided by patents, inventors and industry would be unwilling to invest their time and money in research and development. A fundamental requirement of the patent system is that the invention must be new, must involve an inventive step and must be capable of industrial application.

A discovery of an element of the human body cannot be patented, while an invention relating to an element of the human body may be considered patentable. Under conventional principles of patent law, only inventions, not discoveries, are patentable. The term "invention" applies to something that is artificial in the sense that it is a technical solution provided by man to a technical problem; on the other hand, a discovery concerns something natural.

I will expand on the whole question of patents for the benefit of the House. I will give some examples. It is possible to patent biotechnological inventions concerning biological material, plants or animals in certain circumstances, and a microbiological or other technical process – an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene in an invention. It is not possible to patent biotechnological inventions whose commercial exploitation would be contrary to public order or morality. Examples of such biotechnological inventions are: any process for cloning human beings; any process for modifying the germ line genetic identity of human beings; the use of human embryos for industrial or commercial purposes; any process for modifying the genetic identity of animals which is likely to cause them suffering without substantial medical benefit to man or animal. It is not possible to patent the human body at the various stages of its formation and development or the simple discovery of one of its elements, including the sequence or partial sequence of a gene.

The Government's policy on the patenting of genes is governed by the Patents Act, 1992, and the regulations which I have outlined. A number of important issues in relation to patents, the TRIPs agreement and intellectual property rights in general, have been raised by a range of interested parties in recent times and by Senator Mooney this evening. These include representatives of the developing world and NGOs, and among the issues of concern to them are those relating to international developments in the field of intellectual property rights. As the Minister with specific responsibility for international trade and intellectual property rights, I believe that we must, of course, listen carefully to these concerns and endeavour to address them in the context of our ongoing international discussions and negotiations on these matters.

In the context of my open agenda on the subject of patenting, intellectual property issues and the developing world, I met a large number of people from the NGO community in preparation for the next round of the world trade talks in Qatar in November. The last talks, which were a shambles, took place in Seattle. On behalf of the Government I made it clear that we want a development round. We want the concerns of the developing world to be a priority. I have initiated a series of communications with NGOs and we had a very extensive discussion today. Intellectual property rights is a key issue for them, and Senator Mooney referred to this. If this is to be a development round, we must take on board their concerns about the TRIPs agreement and how developments in the area of patents will impact on the developing world. There is an excellent article in a recent issue of The Economist which deals with this issue in a balanced way. I will ensure that we communicate closely with our own NGOs. They have tremendous expertise and they liaise closely with their sister organisations in other countries, especially in the EU. We will listen to their concerns in preparation for the next round of WTO talks on the question of intellectual property rights. I will keep the House informed and I hope we can have more of this type of debate.

The use of genetic tests by insurance companies is governed by the code of practice recently introduced by the industry. I will convey the concerns of Senators to my colleague, the Minister of State, Deputy Treacy. A national bioethics council is being established to consider the ethical issues raised by biotechnology. I thank Senators for raising these important issues.

Dr. Henry

I thank the Minister and I thank Senator Mooney in particular for his most supportive speech. It is no wonder he had to be reminded to move the amendment. I cannot understand why the Government puts down amendments to motions such as mine because we were ad idem about it. I was pleased with the Minister of State's contribution apart from a few points. He was too kind to the insurance companies. The insurance companies make plenty of profits. I tried to bring forward an amendment to the Health Insurance (Amendment) Bill the other day to deny genetic testing but I did not succeed. We need to start nipping off these areas because £300,000 sounds a lot of money now but maybe they will maintain the £300,000 figure for a while and it will not seem a large amount of money in the not too distant future. Senator Dino Cregan spoke about the importance of insurance in the field of business.

The great and the good are certainly in the Royal Irish Academy. It is a tremendous institution but I am a great believer in humbler folks having an input into this area. Society has to have a great input to this debate, not just scientists. That is important. Senator Quinn talked about people who give us their opinions about how safe such and such a product is and that there will never be a problem with it. We never know with whom they are connected. To get money for research in Ireland, a large number of people have to go to the pharmaceutical companies. There are marvellous employers here but we have to keep our wits about us. I am delighted with the Minister of State's comments about the TRIPs agreement. It was so easy for them to give in on something like the provision of anti-AIDS drugs for South Africa, Brazil, etc., because, for Heaven's sake, they will not have the infrastructure to supply the needs of the people. Companies which are making the drugs are the only ones who will make anything out of that.

I am sorry the amendment was tabled. I presume the Government does not want to amend it. I note the all powerful figure, Senator Fitzgerald, has arrived.

Mr. Mooney

It is all his fault.

Dr. Henry

I cannot accept the amendment. I wish the Minister of State good luck in Qatar. They are brave to have a meeting there. I suppose the regime is a little firmer than Gothenburg and there may not be as many troubles. The lack of information on biotechnology has driven them to taking this type of action when we badly need more discussions. I hold the Minister of State to his promise that he will organise the next discussion on this topic long before he goes to Qatar so that we can give him pointers because this House sometimes has useful information and ideas. Given our large biotechnology industry we should take a serious interest in patenting. Of course, I realise that the convention has nothing to do with insurance. I apologise that the semi-colon got in the wrong place.

Amendment put.

Tá

Bonner, Enda.Callanan, Peter.Cregan, JohnDardis, John.Farrell, Willie.Fitzgerald, Liam.Fitzgerald, Tom.Fitzpatrick, Dermot.Gibbons, Jim.Glennon, Jim.

Glynn, Camillus.Kett, Tony.Kiely, Daniel.Leonard, Ann.Mooney, Paschal.Moylan, Pat.O'Donovan, Denis.Ormonde, Ann.Walsh, Jim.

Níl

Burke, Paddy.Cregan, Denis (Dino).Henry, Mary.Manning, Maurice.

Norris, David.O'Toole, Joe.Ridge, Thérèse.Ross, Shane.

Tellers: Tá, Senators T. Fitzgerald and Gibbons; Níl, Senators Henry and Norris.

Amendment declared carried.

Motion, as amended, put and declared carried.

The Seanad adjourned at 7.30 p.m. until 10.30 a.m. on Thursday, 28 June 2001.