Schwerpunktthema

TA in Biomedicine and Healthcare - from clinical evaluation to policy consulting

In the light of the heavy media coverage of the race for sequencing the entire human genome in the last year and the expectations and promises of a break through in medical treatment and diagnosis connected with the Human Genome Project (HGP), it can not come as a surprise that the European Parliamentary Technology Assessment Network (EPTA) has chosen "TA in Biomedicine and Health Care" as subject for its Annual Conference in Berlin last year. But apart from its topicality the choice was also motivated by the growing importance of Biomedicine and Healthcare issues in the work programmes of the EPTA organisations in recent years. Parliamentary Technology Assessment as carried out by EPTA organisations always included TA on health care issues. This occupation of parliamentary TA with Biomedicine and Health Care has however, remarkably enough, developed in some distance from activities going on in what is internationally known as Health Technology Assessment (HTA). The choice of the conference subject thus also offers an opportunity to bring two perspectives on Health Technology - Parliamentary Technology Assessment (PTA) and Health Technology Assessment (HTA) together and see if (and if so how) these two perspectives can learn from each other. The paper will give a brief overview over the field of TA in Biomedicine and Health Care as carried out by parliamentary TA institutions as well as by HTA institutions in order to identify those features both approaches have in common and some peculiarities of each approach to health care issues.

Looking back into the history of Technology Assessment

Among the huge amount of projects carried out by the Office of Technology Assessment (OTA) of the US Congress during its 17 years of existence health care issues always played a major role. One of the first reports delivered by OTA to the Congress in 1975 was dedicated to the Development of Medical Technologies: Opportunities for Assessment (OTA 1976). This report is considered as the kick off point for their profession by the international community of professional HTA experts. Objectives, subjects and methodology of health technology assessment were outlined for the first time in this report, and the report nowadays still is referred to in debates on issues, objectives and procedures of HTA.

HTA and TA institutions at national parliaments both share the same origin and of course have objectives and some of their methods in common. But during the seventieth and eighties HTA developed into an international, word wide community particularly dedicated to TA on health care issues. Health technology is the only field of technology assessment so far which has gained a distinctive profile in the sense of a particular subject, client, expertise and specialised institutions. HTA like TA in general aims at supporting decision making by providing comprehensive information on the preconditions for, and consequences of the implementation of new technologies. Whereas parliamentary TA units do this for a broad range of technologies and fields of technology policy following the agenda of political discourse, Health Technology Assessment is restricted to a particular field of technology application and a particular set of problems. Generally the explosion of costs in the health care sector caused by expensive new technologies is seen as the reason why HTA continually gained in importance and has gradually been established at hospitals, medical research institutes, and at national health care administration bodies. What is generally called "High Tech Medicine" put the publicly funded health care systems under pressure, and increasingly led to demands to justify costly new medical applications.

As we can learn from the preface of the OTA report from 1976, the motivation of the Senate Committee on Labour and Public Welfare to charge the Office with tackling the issue of HTA was

"to examine Federal policies and existing medical practices to determine whether a reasonable amount of justification should be provided before costly new technologies and procedures are put into general use" (OTA 1976, p. vii).

It was the expensiveness of new technological applications in health care (at that time, e.g. coronary bypass surgery, ultrasound foetal monitoring, computer tomography), which led to initiatives to assess new technologies with regard to their safety, effectiveness and costs before widely introducing them into medical practice.

A definition of Health Technology Assessment published in 1997 in the final report of a project on the role of HTA funded by the European Union underlines the importance of the cost versus medical benefit subject, when stating:

Health Technology Assessment "... includes studies of ethical and social consequences of technology; factors speeding or impeding development and diffusion of health technology; the effects of public policies on diffusion and use of health technology and suggested changes in those policies; and studies of variation in use of technologies."

And then the report continues:

"The most prominent part of HTA is to determine, insofar as possible, the benefits and financial costs of a particular technology or group of technologies. The main goal of such studies is to improve 'value for money' in health care." (Introduction to the EUR-ASSESS Report 1997, p. 135).

Technologies and problems dealt with in Health Technology Assessment

HTA mainly has been and still is occupied with studies focusing on the one hand on the economic evaluation of costs caused by new technologies for the health care system, and on the other hand on the clinical evaluation of the efficacy and safety of new technologies and medical treatment with regard to the patient's health. The perspective taken by HTA studies when dealing with new diagnostic and therapeutic technologies is to a large extent determined by the clinical setting made up by

• the patient (his health, safety, right to know);
• the technology (its performance and costs)
• and by the medical expert, physician (his education, problems of medical decision making, questions of best medical practice).

To illustrate the broad range of medical procedures and technologies that have been scrutinised under the lens of HTA, some results of a survey which was carried out in 1995 on behalf of the Office of Technology Assessment at the German Parliament (Petermann, Sauter 1996) will be presented. This survey covered 815 HTA studies published between 1980 and 1995. The studies were classified according to the type of health care technology dealt with and the problems or dimensions of possible impacts examined.

Most of the studies covered by the survey deal with new therapeutic and diagnostic health technologies and medical treatments. Besides this however, HTA covers the whole range of technological innovations relevant for clinical practice as well as for hospital management (see Tab. 1).

A first cluster consists of studies dealing with health risks caused by technology and environmental problems. This of course is a field of investigation which belongs to TA from its beginnings: Environmental pollution has been one of the first issues which caused demands for long term impact assessment of new technologies. The subject here is not health care as such but environmental and health impact assessment as a responsibility of governmental departments for environment and technology policy rather than health care departments. In some studies - as in more general studies on environment and health - problems of the health care system are involved when it comes to questions of prevention and diagnosis of environmentally induced diseases. In general however the studies are not related to the field of health care policy but to environmental policy.

The second cluster is related closer to subjects of classical Health Technology Assessment but with a focus on particular implications with regard to policy making. The perspectives opened up by Information Technology for health care go beyond problems of the clinical setting and relate health care to general problems of the so called Information Society. On the one hand information technologies like the medical electronic card for the storage of medical records of patients are a means to facilitate the exchange of information on the aetiology of a person's disease, on the treatment the patient has had so far, on known susceptibilities towards drugs etc. for the advantage of the patient. On the other hand technologies like the medical card might be a danger to the patient's privacy; it must for example be prepared for the patient's right to know what data are stored on his smart card and misuse by third parties (employers, insurance companies) should be excluded. The rights of a patient as citizen might be afflicted in these cases, so the problem at stake is directly connected with general political debates on data protection and privacy in the Information Society. In the case of the prospects of Tele-medicine the problems at stake go beyond the responsibilities of health care management and administration. Tele-medicine shows the way to a fundamental structural change in the health care system opening up opportunities for reducing costs, on the other hand however it leaves unanswered questions of medical responsibility, quality of information, commercialisation of health care etc..

The studies carried out by EPTA organisations include several studies on general problems of the health care system. Typically these are problems connected with the general demographic change in western societies. The ageing of society and the availability of technologies for home care (in order to take some load from hospitals and improve the quality of life for elderly people) are prominent here. We find as well some projects dealing with particular HTA issues in a more clinical sense. For example, HTA has been a main field of activity of the Institute of Technology Assessment at the Austrian Academy of Sciences from the beginning of the nineties. This might be due to the fact that a specialised institution for HTA is missing so far in Austria. The fact that projects on health technology in a narrower sense have been carried out by EPTA member organisations in recent years (apart from Austria, this includes also the TA unit of the European Parliament, STOA; and POST, the TA unit of the British parliament) indicates that there is no strict separation between PTA and HTA with regard to the issues coming to the attention of the respective institutions.

The divergencies in the development of PTA and HTA but also indications for growing convergence are also illustrated by the fact that some of the PTA institutions recently carried out major studies dedicated to objectives and state of the art of HTA. In the last decade, some of the EPTA organisations have been exploring the field of HTA under the aspect of whether HTA should be more prominently included in their work programmes. This is done by some kind of meta-studies on HTA - the issue is not Health Technology but Health Technology Assessment (its methods, subjects, goals, forms of institutionalisation etc.). The motifs behind these activities is the realization of the growing importance of Health Technology in the social and political discourse. In a report by the Rathenau Institute from 1995/96 e.g., it is stated that the Rathenau institute's interest in the field of HTA is caused by "the specific need for public debate and national political opinion forming on health care issues".

These latter activities together with a growing number of projects on Health Technology in the work programmes of parliamentary TA institutions were initiated by the growing importance of health care and health technology on the political agenda. This is in part due to information technology entering the health care sector, but to a large extent also to budgetary constraints for funding public health care caused by a crisis of the welfare state. Besides this however the new interest in HTA is mainly caused by the fact, that the rapid advance of biotechnology and genetic engineering and its dominating impact in the field of diagnostics and therapy not only raises the problem of increasing costs for health care but also brings ethical issues on the agenda.

Since the beginning of the 90ies Biomedicine has been a field which is at the centre of activities of most European parliamentary TA units. Issues connected with the field of Biomedicine - the application of genetic engineering and in-vitro-fertilisation technology or more generally the application of results of research in human genetics, and molecular and cell biology in the field of medicine - can be regarded as a main field of interest of PTA units not only within the realm of their occupation with health technology issues but as a central part of their general work programmes during the nineties. Whereas we find issues like genetic testing being only scarcely dealt with by HTA institutions almost every organisation belonging to the EPTA network did carry out at least one major study on this subject in the last decade.

Biomedicine as a challenge for policy consulting