Bioethics UNESCO Round Table - enska
Round Table on Bioethics
UNESCO
Paris
22-23 October 2001
Introduction
For the past decade, we have witnessed a quantum leap in several fields of science and technology of importance to the health sciences. The rapid development in information technology, and in a number of fields of the bio sciences makes it necessary for us to take a moment to reflect on the ethical implications these changes bring with them. We have to secure the ethical conduct of science and technology and be sure that the rapid pace of scientific progress does not leave our views and practices of ethics behind. I therefore welcome this opportunity to share with you some of our experience and reflections.
In Iceland we have followed the international discourse on these issues very carefully and we have conducted extensive and nation wide debates on important issues relating to the application of new knowledge and technology within the health sector. It is our experience that the previous mode of addressing single issues is no longer applicable. It has turned out that when reflecting on e.g. patient’s rights, we are without further notice thrown into serious debates on the introduction of new technologies, such as information technology, progress in biomedical and biological research, with repercussions on the development of our legislation, and our religious and cultural basics. We do also have to address the role of public authorities, societal responsibility and fundamental questions pertaining to the freedom of inquiry.
These are among the perspectives that have guided us in revising existing and introducing new legislation in the field of biomedical sciences. In some cases, we have taken the lead, in other cases we have been able to build on the development in other countries. Besides taking into account international conventions, declarations, practice and experience, including the work under the auspices of UNESCO Bioethics Committee, the guiding principles have been respect for human dignity, for personal privacy, while safeguarding the principles of scientific freedom and striving for the public good.
On stemcells and cloning
The relevant legal framework concerning research on stemcells and cloning is the Act of law on Artificial Fertilisation from 1996, which also covers in vitro fertilisation and artificial insemination.
As a general rule, all research, experiments and operations on embryos is prohibited in Iceland The only exception where research on embryos is allowed is if the research is part of an in vitro fertilisation treatment, concerns diagnosis of hereditary diseases in the embryos themselves, has the purpose of advancing treatment of infertility, or improving the understanding of the causes of congenital diseases and miscarriages.
In general, the provisions in the Icelandic legislation are considered restrictive. Up to now no research on human embryos or embryonic stem cells is carried out in Iceland and cloning is strictly prohibited.
Genetic research
The Icelandic population has lived in isolation for centuries. Iceland was settled 1100 years ago by a small group people from Norway, Ireland and the British islands. Thus the Icelandic population is rather homogeneous in genetic terms. The origin of genetic mutations can be traced to a limited number of individuals. There is a genuine countrywide interest in genealogy. This interest owes probably most to the Icelandic name system where family names hardly exist. Genealogical information is available on all Icelandic citizens centuries back and this has recently proved to be a great asset for biomedical research.
The Icelandic Health Sector Database
The most difficult task in recent Icelandic legislation concerning the health sector relates to the establishment and the operation of a centralised Icelandic Health Sector Database.
Few years ago a company, DeCODE Genetics, launched the idea of building and operating a population-wide health sector database. Similar ideas of co-ordinating and linking health information had been discussed for years, but it was completely new to think of such a database run by a private company. This required a new type of legislation. The result is a probably a unique legal framework for handling sensitive data, protecting the integrity and privacy of individuals while opening up an extremely important field of research. The Act provides for the operation of a centralised database containing non-identifiable health information, which will be entered from medical records.
The Bill was passed by the Parliament in 1998 with an almost two-third majority of votes after an unprecedented extensive public debate in Iceland. The arguments raised in this debate were of scientific, ethical and legal nature. The legal issues concerned compliance with international legal instruments related to data protection and medical research, questions on the harmony with basic principles of the doctor-patient relationship and if the exclusive right to operate such a database impinged upon scientific freedom in the country.
The principle for the Health Sector Database is that health information will be entered with presumed consent. This has been debated eagerly in Iceland. People can change their minds at any time and “opt out” meaning that the collection of data on him/her will immediately cease. The population is well informed and individuals who want to “opt out” report their decision to the Director of Health. The Act does not provide for already entered information to be removed, which has been criticised. Recently, however, DeCODE Genetics and The Icelandic Medical Association have made an agreement that if an individual requests his information to be withdrawn from the Health Sector Database, this will be done.
All the studies need prior approval by the National Bioethics Committee and are overseen by the Data Protection Authority, which has approved the security of the working procedures. A representative of the Data Protection Authority encodes all information and samples before transfer to DeCODE or other companies or laboratories. It is a unique rule of precaution, that the key to the code, which can link the code with the donor, is in the possession of the Data Protection Authority and not of the investigator, as is the common international practice.
DeCODE has already made contracts with several health institutions to deliver health information to the database, but the operating licence provided by The Ministry of Health will not come into force until the Data Protection Authority has defined the security procedures and approved that they meet the security targets defined by the law and regulations.
The emphasis on confidentiality and anonymity of data in the Act on the Icelandic Health Sector Database has made it necessary to define in a new way how the principles of individual integrity are to be understood. The general conception in the international debate on integrity refers to the individual. In the case of the Health Sector Database, the minimum unit of reference consists of anonymous, triple-coded data on ten or more individuals. This is a new unit of reference in the legal context.
The Database will create a powerful tool for epidemiological studies on a nation-wide scale, but according to the Act, no information on individuals can be given. It has been criticised that DeCODE will have the possibility to link information in the Health Sector Database with genealogical and genetic information. However, this linking is only temporary and will be done according to procedures approved and overseen by the Data Protection Authority, and importantly, no genetic or genealogical information is allowed to enter the Centralised Health Sector Database. I ask you also to bear in mind that the genealogical information in DeCODE´s genealogical database, “The Book of Icelanders” is constructed from publicly available information and importantly the genetic information that DeCODE has in their genetic database originates from biological samples obtained with written informed consent given by the donor.
The last issue heavily debated is the exclusive right of a private company to operate the Health Sector Database. Here it is important to point out that although the operation is exclusive, the access to the Health Sector Database is open to everyone on equal terms, provided that the queries to be asked have been approved by a multidisciplinary ethics committee.
Tissue Banks
In Iceland we have extensive tissue banks, including one covering more that 50 years collection of specimens from autopsies and biopsies, including samples from cancer patients. The increasing interest to access such samples for research purposes along with the rapidly expanding genetic research involving large collections of blood samples, prompted a bill on biobanks. To my knowledge, Iceland has taken the lead in establishing a regulatory framework for tissue banks serving disease diagnosis and scientific research. In many countries, legislation in this field is limited to grafting and transplantation of organs and tissues between individuals. This new legislation came into force last year and reflects the ongoing discussions on relevant issues in Europe and elsewhere.
The main objectives defined in the Act are (i) to authorise keeping and utilisation of biological samples, (ii) ensure confidentiality and (iii) safeguard the interests of the donor (iv) while serving purposes of science, medicine and public good.
The essential topics of the debates on the bill in Iceland concerned: property rights over tissue samples, arrangements for consent of tissue donors and protection of personal data.
The Act on Biobanks strongly emphases the protection of personal data.
Research on Cancer
A new research company Icelandic Genomics Corporation has in collaboration with physicians at the Landspitali University Hospital and other health institutions and The Cancer Society launched a huge project called the Icelandic Cancer Project. The available cancer tissue specimens from hospital collections along with blood samples and information obtained with informed consent from the participants provide the basis for this Icelandic Cancer Project as well as for other research on cancer in Iceland.
The National Bioethics Committee
The National Bioethics Committee of Iceland - was established in 1997. The members and deputy members of the Committee represent the biomedical professions, law, theology, education and the general public. All members are selected with reference to their capacity and record of knowledge in the field of health sciences, scientific ethics and human rights. The reference to international declarations, directives, regulations and guidelines on bioethics underlines that international practice and conventions are the basis for the Committee’ work.
The regulations on scientific research in the health sector are based on the Act on patients’ rights. According to the Act, it is not allowed to perform any research projects in health sciences involving humans without a prior evaluation and approval by the ethics committee concerned. The National Bioethics Committee evaluates and approves collaborative and multinational studies, whereas studies performed solely within the major hospitals or within the health care services are evaluated by institutional interdisciplinary ethics committees. A number of issues have been on the agenda of the National Bioethics Committee. First, the Committee has evaluated scientific studies, after their approval monitored the subsequent work and performance of the studies, as provided by the Act. Secondly, the Committee established guidelines and given advice on the performance of research within the health sector, including genetic research and research on cancer, use of registries and tissue specimens, and on informed consent of participants. At last, the Committee has been instrumental as a source of reference in the development of legislation in the biomedical field.
Concluding remarks
In my remarks I have tried to outline the main issues we are debating in Iceland with regard to bio ethics. I thank you for this opportunity to exchange views on this vital matter which has repercussions on all realms of society, science and technology. In order to ensure the progress of our societies where bio sciences and research are becoming more prominent in the current international debate with a view to formulate a global framework of great importance.