By biopolitics the French usually mean the politics of life. Indeed this is a reflection of the gift of life. In bioethics, this term has taken a rather different meaning; it reflects that at the end of the day, whatever discussions we have in the field of advancing medical technology and their moral impact, and whatever position we take, we must at some point come to valid and workable solutions which can only be reflected in the law. The field of bioethics is therefore full with persons coming from diverse fields, such as medicine, religion, law and indeed lay.
European countries have made considerable progress in this area. Biotechnology laws range from those specific to patient rights, to those on more specific areas, such as genetics, reproductive technology, biobanks etc. Of course laws arise when their need arises too. In our case, unfortunately, this has not been the case. It is true that the country had (and still has) more urgent matters to attend to. But certainly there are enough people around, and much ground work has been done to start implementing laws in this area. It is true that there are EU directives which guide us. But these are only directives, which the government must either adopt or work a formula which fits our needs.
Indeed it is about needs. To take an analogy, general practitioners cater for the needs of the population. By population one does not necessarily mean the population of the whole country, but the population of the area in which one works. There are certainly areas which are underserved in various respects, and others which are over served. While one area may have a health centre, another area makes use of a health centre which is several villages away – like Safi and Zurrieq people must travel to Floriana. Quite unlikely! Therefore general practitioners find themselves filling niches which are quite different. In one area people all come with a health insurance to cover all their tests, in another area you get a high percentage of people who refuse a normal prescription and ask that they get their medications through their free-medication card.
Countries therefore have different bioethical needs. While some countries are liberal, others are more conservative. If Malta does not put its act together in the field of bioethics, it will continue to miss out on opportunities to participate in important meetings which either make or influence changes in the directives. It will then be more difficult to take a stand on various issues.
A stumbling block which we have experienced is the moral controversy which arises with every technology introduced. The obvious example is the use of artificial means of reproduction, which have been used in our country for decades now. Yet we have managed somehow to shy away from legislating. When I was secretary to the Bioethics Consultative Committee we worked for several years to produce a document which reflected the general Maltese normative value towards this field. This was followed by several years in which the document was shelved.
A few years ago, the parliamentary committee for social affairs took up the issue under the chairmanship of Clyde Puli. But the report was not taken up by parliament and enacted into law due to statements made by the Curia and followed up by the President. Evidently, the work was not enough. There now seems however to be a general agreement that what is taken to be immoral on one side need not be imposed to be illegal upon society. Yet the government has to find the courage to move in one direction or the other. The change in personalities which has occurred may facilitate this process.
It is always painful for a conservative society to accept that trends in human rights go beyond what is generally considered to be moral or immoral. This is what has occurred with reproductive technology. Yet Maltese infertile couples seem to have no problem with accepting this technology, and they seem to be getting enough pastoral support to make the ethical choice of going forward with their decisions. It is also evident that the ecclesiastical authorities look upon these couples with great charity, as none so far has been condemned in any way or given any form of prohibitions, as is given, for example, to couples who choose to separate.
But reproductive technology is not only what biotechnological laws are about. They are indeed about patients’ rights. The only one we have so far, which is not in and of itself, a law on biotechnology, is the Data Protection Act. We certainly however take full advantage of this law and personally have worked on several EU-funded, so-called Framework Projects, which have the objective of making proposals to the EU directive on data protection, making it more amenable to health care and patient rights, especially when it comes to medical data and genetic biobanks.
But the EU directive on data protection is not about protecting fundamental rights and freedoms of the individuals, which is left to local legislation. It is rather, to facilitate transfer (legitimate transfer) of data between EU states. Therefore when it comes to Health Care, having a law to protect rights and freedoms where it comes to information is not enough. We must have laws which go beyond simply protecting data, but reinforce patients’ rights. These must be reinforced in areas especially where patients may be treated as a commodity, such as insurance, employment, and genetic services. While we had a Charter, which applied only to St Luke’s hospital, and not the other hospitals, we have no laws which govern specific areas, such as the use of genetic information.
Patients must have a law which gives them not only rights to medical secrecy and confidentiality, but rights to clearly delineate whose property the medical file is – whether it is the patient’s, or, as has been expressed by the local union, the hospital’s. When it comes to accessing information, a third party, such as an insurance or a research worker, may have easier access, perhaps due to know-how, than patients themselves.
Conversely, a law on biobanks would, for example, govern the methods used to obtain samples for genetic experimentation, and explain what rights patients have. May I, for instance, at any time, decide that I want my sample to be taken away from the biobank, or insist, that I want a process of information before every experiment it is to be used on. Anonymising information is not enough, for I may have a moral objection to the experiment itself, and although I would not be identified, I may not wish my sample to participate in that experiment. Certainly some form of broad consent must be obtained, but having no formal measures which govern the use of population samples may render them to be too vulnerable.
When it comes to genetics, the nightmare is the abuse of genetic information by employers or lawyers. Of course their ends are legitimate as they both want to assess risk. But the means for them to obtain information are so easy that there has to be a law which disallows them to make use of this material, which is mainly a research tool. UNESCO and EU guidelines both prohibit or limit the use of genetic information, for example, to have an insurance policy. A genetic test is predictive and can also tell me something about relatives. This information, when used to assess risk, becomes unfair, because it simply does not balance against the general population. Moreover if insurance companies and employers, etc, may use such information, which can easily be misinterpreted, it would discourage people from coming forward to donate samples to be used exclusively for research.
If there is no law to protect my sample from use other than for research, I may even be liable to fraud if I do not hand over that information to someone who can be seen to be legitimately requesting it.
We need to develop a culture of bioethics and biopolitics in order to protect people not merely from advancing technologies, but from the side effects which these technologies may have, as described in the example above. Health care has moved forward from simply treating a condition. We speak about health promotion and health prevention, and holistic approaches. We must cater therefore for patient rights in all its forms, starting from giving people the right to express wishes in advance (vide article on Advance Directives), to protecting them from that which even they do not know about, but which scholars have conceived.
For many patients, it is a fact that many things which we know we know, or things which we know that we don’t know, are, for them, things which they don’t know that they don’t know. This is the extreme form of vulnerability which only a law on biotechnology can partially remedy. It should be the duty of every health care professional thus to explain the rights of the clients or patients.
Pierre Mallia is Associate Professor in Family Medicine, Patients’ Rights and Bioethics at the University of Malta; he is also Ethics Advisor to the Medical Council of Malta.