People's attitudes differed. Many citizens expressed dissatisfaction with the grey economy and with difficult accession to modern health services. But there were many patients who did not bribe physicians and did not show any dissatisfaction. Some of them believed that the Czech health care is excellent, because they did not see any other possibility. Some people considered health care to be a component of human fate. When one was in the right time at the right place, he/she was lucky and could survive. If not, it was a matter of bad luck as many other fatal situations. In paternalistic society physicians were powerful agents and the best way how to get their favour was a bribe. The bribe could be financial or in the form of some scarce service. Some goods and services were hardly available. People who could offer something to mutual exchange had a much better life than others. Physicians belonged to this privileged group and so their social status was quite high. In spite of this, the majority of physicians was not satisfied. The permanent search for scarce technology was exhausting, and the grey economy was obviously in conflict with Hippocratic tradition. It is no wonder that the decision of the Czech government to move to insurance system was almost consensually accepted.

In 1992 a public health insurance system was introduced. Very soon it appeared that the modern health care system is rooted in democratic negotiations. Many problems began to be addressed publicly and public negotiation about possibilities to solve indentified problems began. All beliefs in other possibility to solve problems gradually appeared to be false. Initially, Czech political leaders believed in market forces and state interventions were not popular. The insurance system has many market elements; therefore, the Czech political leaders believed that the system will work well without any regulatory interventions. Only a strike of physicians in 1994 forced the Czech politicians to take the risk of breaking down the Czech health care seriously. (Šimek, 1996) Negotiations between health care providers, insurance companies, and state officials began, and have lasted until now under the heading of "tripartite."

In the early phases after the introduction of the insurance system in financing health care in the Czech Republic, Czech physicians exhibited quite high moral standards. As we mentioned earlier, in the first several years after the implementation of the system in Czech health care, an enormous amount of money was spent in the system without any efficient

Czech people experienced two opposite systems of financing health care. First, a seriously underfinanced and paternalistic communist state system hiding all troubles connected with lack of resources. Political propaganda promised free health care for everybody and high scientific quality. In everyday experiences people very soon realised that all these promises are impossible to fulfil. In the eighties a joke circulated rewording a classical fairytale. The joke well illustrates the experiences of Czech people with state health care regardless of state propaganda. "Socialist health care was born and a big christening party was held. Three strange sisters were invited, the fourth was forgotten. The first strange sister declared "you will be free" the second "you will be for everybody" and the third declared "you will be of highest scientific quality". Then the forgotten strange sister arrived. She could not change the previous prophecies, so she declared: "it never will be that all three prophecies will be in force simultaneously. At least one will always be missing." The Czech experiences correspond with this joke. Health care, which was free for everybody, was not of the highest quality; new expensive technology was not for everybody and many patients were obliged

People's attitudes differed. Many citizens expressed dissatisfaction with the grey economy and with difficult accession to modern health services. But there were many patients who did not bribe physicians and did not show any dissatisfaction. Some of them believed that the Czech health care is excellent, because they did not see any other possibility. Some people considered health care to be a component of human fate. When one was in the right time at the right place, he/she was lucky and could survive. If not, it was a matter of bad luck as many other fatal situations. In paternalistic society physicians were powerful agents and the best way how to get their favour was a bribe. The bribe could be financial or in the form of some scarce service. Some goods and services were hardly available. People who could offer something to mutual exchange had a much better life than others. Physicians belonged to this privileged group and so their social status was quite high. In spite of this, the majority of physicians was not satisfied. The permanent search for scarce technology was exhausting, and the grey economy was obviously in conflict with Hippocratic tradition. It is no wonder that the decision of the Czech government to move to insurance system was

In 1992 a public health insurance system was introduced. Very soon it appeared that the modern health care system is rooted in democratic negotiations. Many problems began to be addressed publicly and public negotiation about possibilities to solve indentified problems began. All beliefs in other possibility to solve problems gradually appeared to be false. Initially, Czech political leaders believed in market forces and state interventions were not popular. The insurance system has many market elements; therefore, the Czech political leaders believed that the system will work well without any regulatory interventions. Only a strike of physicians in 1994 forced the Czech politicians to take the risk of breaking down the Czech health care seriously. (Šimek, 1996) Negotiations between health care providers, insurance companies, and state officials began, and have lasted until now under the heading

In the early phases after the introduction of the insurance system in financing health care in the Czech Republic, Czech physicians exhibited quite high moral standards. As we mentioned earlier, in the first several years after the implementation of the system in Czech health care, an enormous amount of money was spent in the system without any efficient

to pay for it. Grey economy became a stable part of health care.

almost consensually accepted.

of "tripartite."

control. Czech physicians did not misuse relative free available resources for private profits. New modern technology and scarce drugs were purchased without notable regard on the physician's incomes. The physicians' strike in 1994 was not so much a demand for a raise of wages; much more important stimulus was the need to rationalise the flow of money in health care. In that time "salus aegroti" was really the "suprema lex".

An increasing gap between the financial resources (collected by public health insurance) and skyrocketing health care costs have required some urgent regulatory measures. Finally, some restrictions in the supply of health services were implemented. In 1997, ambulatory specialists were given an upper limit of incomes and general practitioners shifted to capitation fee (complemented by fees for special services). In hospitals, fixed budgets have been re-established according to the sum and structure of health care services provided in the previous period (called"historic limits from 1996-1997"). (Krizova & Simek, 2002)

While the first transformation period was accompanied with the boom of Western hi-tech medical care, the shift to prospective payments with upper limits has frozen the escalation of volume of care, and even led to a decrease in provided services in some hospitals. According to data provided by The General Health Insurance Company (GHIC), the volume of hospital services fell immediately to 80% on average while the minimum rate being set by the payer (GHIC) was 75% of the entire volume. Physicians warned the public that it would be no longer possible to achieve the same quality and accessibility of care. Rationing has become a matter of broad mass media campaign. Hospital departments, hospitals, or individual physicians have tried to compensate for their losses by "non-profit charity foundations". Patients, citizens, or corporate donors can subsidise the clinical care by contributions to these charities. It is not unlikely that this sponsoring had influenced access to services that were restricted by waiting time or denial – especially hip replacement, cardio surgery, eye treatment etc. Some physicians admitted that they had somehow taken the fact of sponsoring into account in course of their clinical decision-making. Nevertheless, in their opinion, "they always try to balance the health needs of different patients and not to harm patients in acute need". According to the official statement of the Czech Medical Chamber, sponsoring must not have any influence on the provision of health care services and must not be negotiated at the moment of acute health need.

A special form of sponsoring was organised by private providers who had asked their patients to pay an extra annual registration fee. They pointed out higher investments to their medical practice and better equipment. The fact that some patients do pay these fees may have an impact on medical decisions about referrals to specialists, spa treatment, rehabilitation, psychotherapy or prescription of expensive drugs. The patients may be differentiated by the fact that they showed their loyalty to their physician by registration fees. The way the doctor assesses their medical need becomes influenced by financial incentives and it is not excluded, that the economic motivation of the physician may slightly change his/her clinical view.

Concerning the most expensive technology and treatment, several therapies (e.g. cochlear and pacemaker implants, neuromodulation treatment in epileptic patients, betapherone treatment in sclerosis multiplex) have recently been regulated by a special commission. This care is financed separately from the budgetary scheme. The payment is sent directly from a special fund of the health insurance company to the hospital. The commission is competent

Medical Ethics in the Czech Republic – Experiences in the Post-Totalitarian Country 141

There were dramatic differences in performed PTCAs between regions in the Czech Republic. In Prague patients there were performed 3 678 PTCAs, it is 58.4% of all PTCAs performed. It means 306 PTCAs done on 100 000 inhabitants. In patients from Southern Bohemia only 173 PTCAs were done, it is 2.7% of all PTCAs and 24.7 PTCAs done on

In the second step we made a simple questionnaire survey among Czech physicians. (Final sample was 401 physicians, response rate was 26.7%.) We asked them about the availability of PTCA, about the reasons why some patients do not receive PTCA treatment, and finally,

The majority of responding physicians (71.4% yes and probably yes) considered PTCA available, only 28.6% of physicians answered no and probably no. There were significant differences between physicians from big cities and from other sites. 89.2% of those who answered no and probably no on the question on availability were physicians from other

We offered several reasons why some of their patients did not receive PTCA treatment. Respondents from big cities preferred the response "the patient came to the specialised centre late" while respondents from other sites preferred response "the patient was referred

As to the impact of informal relationships between physicians on referral to specialised centre 14.2% of respondents consider it very strong, 32.8% respondents somehow strong, 30% of respondents think that informal relationships are probably not important and only 10.1% of respondents are sure that informal relationships have no impact on referral of

Results of our research illustrate the process of development of new expensive technology in dependence on available resources. In the first stage new technology is available only at the big centres and there could not be equity in its distribution. In this stage physicians are aware of the lack of equity, and they are searching for ways to do the process more equitably. Chance and informal relationships of the patient and his attending physician often play an important role in the availability of the therapeutic procedure. The length of the first stage depends on the economic condition of the country, and on the pressure from experts and from members of civic society (patients' initiatives, media, etc.). There is a difficult ethical dilemma in the situation. Should physicians actively announce to individual patients and the media that there is a lack of expensive life-saving technology? On one hand it is necessary to move things ahead; on the other hand, many people would get information about treatment that they never could use. In any case, at least the experts and politicians should be aware of existing life saving expensive technology on the basis of serious methods of technology assessment. Explicit health care policy should be developed and priorities openly discussed. According to our experiences here are the weak points of development in

Due to historical reasons the authority of Churches is traditionally weak in the Czech society, and the Czech Republic belongs to one of the most atheistic countries in EU.

how important informal relationships between physicians in charge are.

to a hospital where PTCA is not performed".

patients with myocardial infarction.

post-communist countries.

**4. Institutions of ethics – The case of ethics committees**

100 000 inhabitants.

sites.

to review the professional indication and upon its acceptance it issues a final approval of the health care provision. The commissioners come from health insurance funds, clinical facilities, the Health Ministry, and the public. The major power is given to the professional medical assessment of the patients' health condition. Only those patients who have already been selected in previous steps by medical professionals are submitted for the more or less formal approval by the commission. Social characteristics may play a certain role; nevertheless, no patient is a priority discriminated on grounds of their social or ethnic origin.

From the beginning of 2008 after the amendment of Act No. 48/1997 Sb., "on the public health insurance" some patients' copayments were introduced. It was a small regulatory fee (30 Czech crowns, a little more than 1 Euro) for clinical examination and a larger fee (90 Czech crowns, almost 4 Euro) for examination at emergency units and charge for each day of hospitalisation (60 Czech crowns, 2.5 Euro). This legal provision provoked sharp political discussion with quite common lack of sound arguments on both sides. In an apparent conflict with law some social democratic county representatives even paid charges for patients in district hospitals from other sources. Nevertheless, the fees brought remarkable sum of money in health care institutes.

To sum it up, in the Czech Republic there are two ways how to overcome difficulties in covering health care expenditures. One is slow introduction of co-payments, both by political decisions and by private initiative of health care institutions. The second is rationing (or priority setting). The political part of rationing is mainly realised through setting economic limits for health care institutions. Economic limits result in two restrictions. The well visible restrictions are waiting lists which have become the standard part of medical care. The less observable restriction represents slower introduction of new technology.

A good example of gradual introduction of advanced technology in accordance with available resources is the distribution of Percutaneous Transluminal Coronary Angioplasty (PTCA) in the Czech Republic. Percutaneous Transluminal Coronary Angioplasty (PTCA) is an effective reperfusion strategy in acute myocardial infarction. Its introduction in therapeutic practice was an important achievement, which helped to dramatically decrease in-hospital mortality from acute myocardial infarction in the last two decades of the twentieth century. In the Czech Republic the first PTCA was done in 1981. In 1999 the method was available only in big prominent centres and for many patients it was not available. Then the four angioplasty centres (they routinely used primary coronary angioplasty from 1995) asked the question how to offer the life saving method also to patients from areas where there were no angioplasty centres. The Cardiocenter of University Hospital Vinohrady, Prague, coordinated a well known and frequently cited study assessing the safety of transporting patients to an angioplasty centre. Transferring patients from community hospitals to a tertiary angioplasty centre in the acute phase of myocardial infarction was proved to be feasible and safe. (Widimský et al., 2000)

In 2000 we did research on the equity in availability of PTCA. It was just proved that transport is safe and life saving, so we asked on distribution of performed PTCAs in the Czech Republic and on practices of transports to angioplasty centres. (Not yet published data.)

to review the professional indication and upon its acceptance it issues a final approval of the health care provision. The commissioners come from health insurance funds, clinical facilities, the Health Ministry, and the public. The major power is given to the professional medical assessment of the patients' health condition. Only those patients who have already been selected in previous steps by medical professionals are submitted for the more or less formal approval by the commission. Social characteristics may play a certain role; nevertheless, no patient is a priority discriminated on grounds of their social or ethnic

From the beginning of 2008 after the amendment of Act No. 48/1997 Sb., "on the public health insurance" some patients' copayments were introduced. It was a small regulatory fee (30 Czech crowns, a little more than 1 Euro) for clinical examination and a larger fee (90 Czech crowns, almost 4 Euro) for examination at emergency units and charge for each day of hospitalisation (60 Czech crowns, 2.5 Euro). This legal provision provoked sharp political discussion with quite common lack of sound arguments on both sides. In an apparent conflict with law some social democratic county representatives even paid charges for patients in district hospitals from other sources. Nevertheless, the fees brought remarkable

To sum it up, in the Czech Republic there are two ways how to overcome difficulties in covering health care expenditures. One is slow introduction of co-payments, both by political decisions and by private initiative of health care institutions. The second is rationing (or priority setting). The political part of rationing is mainly realised through setting economic limits for health care institutions. Economic limits result in two restrictions. The well visible restrictions are waiting lists which have become the standard part of medical care. The less observable restriction represents slower introduction of new

A good example of gradual introduction of advanced technology in accordance with available resources is the distribution of Percutaneous Transluminal Coronary Angioplasty (PTCA) in the Czech Republic. Percutaneous Transluminal Coronary Angioplasty (PTCA) is an effective reperfusion strategy in acute myocardial infarction. Its introduction in therapeutic practice was an important achievement, which helped to dramatically decrease in-hospital mortality from acute myocardial infarction in the last two decades of the twentieth century. In the Czech Republic the first PTCA was done in 1981. In 1999 the method was available only in big prominent centres and for many patients it was not available. Then the four angioplasty centres (they routinely used primary coronary angioplasty from 1995) asked the question how to offer the life saving method also to patients from areas where there were no angioplasty centres. The Cardiocenter of University Hospital Vinohrady, Prague, coordinated a well known and frequently cited study assessing the safety of transporting patients to an angioplasty centre. Transferring patients from community hospitals to a tertiary angioplasty centre in the acute phase of myocardial

In 2000 we did research on the equity in availability of PTCA. It was just proved that transport is safe and life saving, so we asked on distribution of performed PTCAs in the Czech Republic and on practices of transports to angioplasty centres. (Not yet published

infarction was proved to be feasible and safe. (Widimský et al., 2000)

origin.

technology.

data.)

sum of money in health care institutes.

There were dramatic differences in performed PTCAs between regions in the Czech Republic. In Prague patients there were performed 3 678 PTCAs, it is 58.4% of all PTCAs performed. It means 306 PTCAs done on 100 000 inhabitants. In patients from Southern Bohemia only 173 PTCAs were done, it is 2.7% of all PTCAs and 24.7 PTCAs done on 100 000 inhabitants.

In the second step we made a simple questionnaire survey among Czech physicians. (Final sample was 401 physicians, response rate was 26.7%.) We asked them about the availability of PTCA, about the reasons why some patients do not receive PTCA treatment, and finally, how important informal relationships between physicians in charge are.

The majority of responding physicians (71.4% yes and probably yes) considered PTCA available, only 28.6% of physicians answered no and probably no. There were significant differences between physicians from big cities and from other sites. 89.2% of those who answered no and probably no on the question on availability were physicians from other sites.

We offered several reasons why some of their patients did not receive PTCA treatment. Respondents from big cities preferred the response "the patient came to the specialised centre late" while respondents from other sites preferred response "the patient was referred to a hospital where PTCA is not performed".

As to the impact of informal relationships between physicians on referral to specialised centre 14.2% of respondents consider it very strong, 32.8% respondents somehow strong, 30% of respondents think that informal relationships are probably not important and only 10.1% of respondents are sure that informal relationships have no impact on referral of patients with myocardial infarction.

Results of our research illustrate the process of development of new expensive technology in dependence on available resources. In the first stage new technology is available only at the big centres and there could not be equity in its distribution. In this stage physicians are aware of the lack of equity, and they are searching for ways to do the process more equitably. Chance and informal relationships of the patient and his attending physician often play an important role in the availability of the therapeutic procedure. The length of the first stage depends on the economic condition of the country, and on the pressure from experts and from members of civic society (patients' initiatives, media, etc.). There is a difficult ethical dilemma in the situation. Should physicians actively announce to individual patients and the media that there is a lack of expensive life-saving technology? On one hand it is necessary to move things ahead; on the other hand, many people would get information about treatment that they never could use. In any case, at least the experts and politicians should be aware of existing life saving expensive technology on the basis of serious methods of technology assessment. Explicit health care policy should be developed and priorities openly discussed. According to our experiences here are the weak points of development in post-communist countries.

#### **4. Institutions of ethics – The case of ethics committees**

Due to historical reasons the authority of Churches is traditionally weak in the Czech society, and the Czech Republic belongs to one of the most atheistic countries in EU.

Medical Ethics in the Czech Republic – Experiences in the Post-Totalitarian Country 143

2007; Hedgecoe et al., 2006), historical works (Glasa, 2000; Hedgecoe, 2009) or detailed analyses of some of the (discursive) practices of the ethics committees (Angell et al., 2006;

In the Czech Republic the ethics committees were only created in 1990. It was the initiative of Martin Bojar, then the Minister of Health. He established the Central Ethics Committee at the Ministry of Health, and recommended to all major health institutions to create their local ethics committees. Within a short period of time 20 local ethics committees were established and their number has gradually grown to the current number of approximately 100. (Simek, 2000) Functions were voluntary and unpaid, and the main qualification was the moral credit of appointed volunteers. Until the adoption of Act No. 79/1997 Coll. on medicines, the Czech ethics committees had been operating without any statutory regulation for many years. (Šimek et al., 2000) In the year 2004 the Directive 2001/20/EC was incorporated into the Czech legislation (current legislation: Act No. 378/2007 Coll. on medicines and Decree No. 226/2008 Coll.). In 2003, under the new legislation, some local ethics committees were recognized by the Ministry of Health as multi-centric ethics committees. Their task is to provide a single national opinion on multi-centric clinical studies. The local ethics committees continue to express their views on mono-centric studies, and give their opinion on the appropriateness of carrying out an authorized multi-centric study in the place under

Our research started by participatory observation at meetings and at the Summer Schools of Medical Ethics, organized by the Forum of Czech Ethics Committees. Furthermore, we carried out half-structured interviews with the members of the ethics committees, with representatives of contracting authorities, with examining doctors (investigators), and 1 interview with a representative of the State Office for Drug Control. Six focus groups were organized with the members of the ethics committees. To get an overview of the distribution of some of the attitudes expressed in the interviews, a simple questionnaire survey was realized among the members of the ethics committees. The response rate was 11 % so it was

If we try to generalize our experience, the members of the Czech ethics committees are people willing to selflessly do something more for the "common good". They are not authoritarian in their role; they prefer agreement over all other possibilities of conflict resolution. Like in other European countries (Klingmann, 2009) only about 1% of studies is rejected. Significantly, more frequent are comments intended to modify a project, about one half of projects are adjusted based on comments from an ethics committee. In the interviews and discussions the members agreed that they feel better in the role of an advisor rather

The chairman of the committee usually has natural authority. The next important person is the secretary. S/he is the guarantee of an error-free bureaucratic part of the work. Discussions of the committee are sometimes more, sometimes less discursive and usually take place in an atmosphere of tolerance; anyone who so desires is given an opportunity to express his/her opinion on the discussed matter. Most often the resolution is adopted by consensus, only rarely is it necessary to vote. Remuneration for the work was never raised

O´Reilly et al., 2009).

their authority. (Šimek et al., 2008)

only of an illustrative nature.

than an arbiter.

as an important issue.

According to the Eurobarometer from June 2005 only 19% of Czech citizens agree with the statement "I believe there is a God". In the EU this percentage is only smaller in Estonia (16%) than in the Czech Republic. 30% of Czech citizens agree that "I don' t believe there is any sort of spirit, God or life force". In EU only in France more citizens (33%) agree with that statement. (Eurobarometer, 2005) In the Czech history Catholic Church was the pillar of unwanted Habsburg monarchy, Protestantism was the religion of traditional national rivals of Czech people, and so the national Renaissance in the 19th century was based on secular education and science. This tendency was to strengthen by a communist regime. Moreover, communist ideology based on Marxist philosophy did not elaborate ethics as a special discipline. For these two reasons ethics as a discipline is undervalued in the Czech Republic. Common Czech people have no ethical language to use in everyday communication, and moral arguments are used rarely.

We could be worried about human relations in a society where there are no recognized experts in ethics, and people do not use the language of ethics. Our experiences are not fatal, ethical behaviour survives even under such conditions. On the contrary, in an ascribed situation natural moral processes are more visible. We can watch the emergence of moral rules in natural groups and the free choice as the key element in acceptance of moral attitudes in Tugendhat sense. (Tugendhat, 1993) We experience an important role of the nuclear family in moral development. Discursive nature of contemporary ethics is also well observable, as well as troubles arising from breakdowns of the discursive process. Common people usually live in their own moral space and if asked, they most often reason their moral behaviour in terms of the golden rule. ("One should not treat others in a way that he would not like to be treated.") By using the golden rule they are also able to exhibit basic levels of abstraction.

As a result of the situation, political and scientific interest in ethics is also very low. For example there are no chairs for ethics at Czech schools of philosophy and people from religious groups in a new generation of health care ethics teachers prevail. Paradoxically, in the most atheistic country of the EU, in majority of (a few) leading positions in health care ethics are theologists and catholic priests. So the only really secular institutions which are explicitly working in the area of ethics are ethics committees. Ethics committees constitute a special new version of ethical community. They represent a rare social group in the Czech Republic, where the language of ethics is used, and ethics is the matter of concern. Members of ethics committees intuitively use basic tools of contemporary ethics – plurality of attitudes, discourse, and search for consensus. For this reason ethics committees attracted our attention and we did some research on their functioning in the Czech Republic. (Šimek et al., 2008)

The ethics committees are currently remarkable institutions. They function as an authority – without their approval it is not possible to do any clinical research study. On the contrary to common authorities they do not arrive at their decisions on the basis of application of definite general rules, but through methods of ethical discourse. (Whittaker, 2005) They are relatively new institutions; the first recommendation to establish ethics committees at research institutes comes from the first revision of the Declaration of Helsinki in 1975. Therefore, there are many uncertainties in understanding their role and function and we can find some studies concerning a comparison of formal aspects of work of the ethics committees in various states of the EU (Davies et al., 2009; EFGCP Ethics Working Party,

According to the Eurobarometer from June 2005 only 19% of Czech citizens agree with the statement "I believe there is a God". In the EU this percentage is only smaller in Estonia (16%) than in the Czech Republic. 30% of Czech citizens agree that "I don' t believe there is any sort of spirit, God or life force". In EU only in France more citizens (33%) agree with that statement. (Eurobarometer, 2005) In the Czech history Catholic Church was the pillar of unwanted Habsburg monarchy, Protestantism was the religion of traditional national rivals of Czech people, and so the national Renaissance in the 19th century was based on secular education and science. This tendency was to strengthen by a communist regime. Moreover, communist ideology based on Marxist philosophy did not elaborate ethics as a special discipline. For these two reasons ethics as a discipline is undervalued in the Czech Republic. Common Czech people have no ethical language to use in everyday communication, and

We could be worried about human relations in a society where there are no recognized experts in ethics, and people do not use the language of ethics. Our experiences are not fatal, ethical behaviour survives even under such conditions. On the contrary, in an ascribed situation natural moral processes are more visible. We can watch the emergence of moral rules in natural groups and the free choice as the key element in acceptance of moral attitudes in Tugendhat sense. (Tugendhat, 1993) We experience an important role of the nuclear family in moral development. Discursive nature of contemporary ethics is also well observable, as well as troubles arising from breakdowns of the discursive process. Common people usually live in their own moral space and if asked, they most often reason their moral behaviour in terms of the golden rule. ("One should not treat others in a way that he would not like to be treated.") By using the golden rule they are also able to exhibit basic

As a result of the situation, political and scientific interest in ethics is also very low. For example there are no chairs for ethics at Czech schools of philosophy and people from religious groups in a new generation of health care ethics teachers prevail. Paradoxically, in the most atheistic country of the EU, in majority of (a few) leading positions in health care ethics are theologists and catholic priests. So the only really secular institutions which are explicitly working in the area of ethics are ethics committees. Ethics committees constitute a special new version of ethical community. They represent a rare social group in the Czech Republic, where the language of ethics is used, and ethics is the matter of concern. Members of ethics committees intuitively use basic tools of contemporary ethics – plurality of attitudes, discourse, and search for consensus. For this reason ethics committees attracted our attention and we did some research on their functioning in the Czech Republic. (Šimek

The ethics committees are currently remarkable institutions. They function as an authority – without their approval it is not possible to do any clinical research study. On the contrary to common authorities they do not arrive at their decisions on the basis of application of definite general rules, but through methods of ethical discourse. (Whittaker, 2005) They are relatively new institutions; the first recommendation to establish ethics committees at research institutes comes from the first revision of the Declaration of Helsinki in 1975. Therefore, there are many uncertainties in understanding their role and function and we can find some studies concerning a comparison of formal aspects of work of the ethics committees in various states of the EU (Davies et al., 2009; EFGCP Ethics Working Party,

moral arguments are used rarely.

levels of abstraction.

et al., 2008)

In the Czech Republic the ethics committees were only created in 1990. It was the initiative of Martin Bojar, then the Minister of Health. He established the Central Ethics Committee at the Ministry of Health, and recommended to all major health institutions to create their local ethics committees. Within a short period of time 20 local ethics committees were established and their number has gradually grown to the current number of approximately 100. (Simek, 2000) Functions were voluntary and unpaid, and the main qualification was the moral credit of appointed volunteers. Until the adoption of Act No. 79/1997 Coll. on medicines, the Czech ethics committees had been operating without any statutory regulation for many years. (Šimek et al., 2000) In the year 2004 the Directive 2001/20/EC was incorporated into the Czech legislation (current legislation: Act No. 378/2007 Coll. on medicines and Decree No. 226/2008 Coll.). In 2003, under the new legislation, some local ethics committees were recognized by the Ministry of Health as multi-centric ethics committees. Their task is to provide a single national opinion on multi-centric clinical studies. The local ethics committees continue to express their views on mono-centric studies, and give their opinion on the appropriateness of carrying out an authorized multi-centric study in the place under their authority. (Šimek et al., 2008)

Our research started by participatory observation at meetings and at the Summer Schools of Medical Ethics, organized by the Forum of Czech Ethics Committees. Furthermore, we carried out half-structured interviews with the members of the ethics committees, with representatives of contracting authorities, with examining doctors (investigators), and 1 interview with a representative of the State Office for Drug Control. Six focus groups were organized with the members of the ethics committees. To get an overview of the distribution of some of the attitudes expressed in the interviews, a simple questionnaire survey was realized among the members of the ethics committees. The response rate was 11 % so it was only of an illustrative nature.

If we try to generalize our experience, the members of the Czech ethics committees are people willing to selflessly do something more for the "common good". They are not authoritarian in their role; they prefer agreement over all other possibilities of conflict resolution. Like in other European countries (Klingmann, 2009) only about 1% of studies is rejected. Significantly, more frequent are comments intended to modify a project, about one half of projects are adjusted based on comments from an ethics committee. In the interviews and discussions the members agreed that they feel better in the role of an advisor rather than an arbiter.

The chairman of the committee usually has natural authority. The next important person is the secretary. S/he is the guarantee of an error-free bureaucratic part of the work. Discussions of the committee are sometimes more, sometimes less discursive and usually take place in an atmosphere of tolerance; anyone who so desires is given an opportunity to express his/her opinion on the discussed matter. Most often the resolution is adopted by consensus, only rarely is it necessary to vote. Remuneration for the work was never raised as an important issue.

Medical Ethics in the Czech Republic – Experiences in the Post-Totalitarian Country 145

Contemporary sociology offers some concepts that could help us better understand what is

Ethics committees could be understood as an ethical community. An ethical community is originally the concept of I. Kant. (Kant, 1996) (Wood, 2000) We cannot fully apply the whole concept; instead, it could be an inspiration for us. The term could be used only in a weak

In the current world of secularization and globalization, religious communities lose their strong influence. People who share the same values rather create informal groups or communities. The members of the ethics committees form a community of people willing to devote a bit of their time and effort to the common good. Their participation comes from free decision, and their motivation is largely moral. In their effort they do not seek prestige or material benefit. In this sense, the members of the ethics committees fulfil some of the characteristics of Kant's "ethical community". There are also substantial differences. Kantian ethics is based on duty, to be a member of an ethics committee is a free choice. Religious position is not the unifying element. A community of ethics committees' members is not and will not be universalistic; it will be bound to a particular common task and to a particular common area. The unifying element of this community is a common specific work task – the

Another concept that could be applied is the concept of epistemic community. Peter M. Haas defines an epistemic community as "a network of professionals with recognized expertise in a particular domain and an authoritative claim to policy-relevant knowledge within that domain". (Haas, 1992) There are four elements in his definition and the Czech

They have a shared set of normative and principled beliefs which provide a value-base rationale for the social actions of community members (principles of the Good Clinical Practice and related codes and legislation). In the ethics committees one can observe a common policy enterprise – that is, a common set of practices associated with a set of problems to which their professional competence is directed, presumably out of the

The other two points of the definition – shared causal beliefs and shared notions of validity – are fulfilled by scientists and experts in the ethics, who, on an all-European scale, work together to define principles of the current research ethics. These experts meet and discuss at preparation of documents, as well as at various conferences, and they publish in professional journals. In this way they create an epistemic basis for addressing the problems of security and preservation of human dignity of the research subjects. (Salter & Jones, 2005) The Czech ethics committees can be considered a local embodiment of the international epistemic community of investigators and bioethicists, who on the supranational level of European directives and international harmonization efforts defined the framework and

The last inspiration we can find in the concept of communities of practice. (Wenger & Snyder, 2000) The communities of practice are characterized by three main features: 1)

going on (or could be) in the development of ethics committees. (Simek et al., 2010)

sense.

protection of subjects of clinical trials.

ethics committees fulfil two of them.

rules of their operation.

conviction that as a result, human welfare will be enhanced.

Most members of the ethics committees are health professionals. Laymen (most often theologists, lawyers, civil servants) are members of a committee mainly because the law requires it. The relationship of the health professionals towards the laymen is friendly, but it is possible to see some reluctance of the ethics committees to accept a larger number of lay members. This is not unusual for the Czech Republic. A similar situation was noted in a Dutch study (Caron-Flinterman et al., 2009) and it is possible to notice a call for greater involvement of patients and their organizations that are already in the preparation of clinical trials. (Wrobel, 2009)

There are certainly many reasons for this hesitation. The common basis we see in uncertainties and tensions faced by the ethics committees. (Barke, 2009) A good clinical trial proves common laws valid for everybody, a good care wants to improve the health and quality of life of an individual patient. (Mol, 2006) The ECs members might feel that there is too much that they are not able to control when they assess the ethical legitimacy of a clinical trial application. (DeMets et al., 2006; Tailor et al. 2008) Given the absence of pregiven answers, the ECs have to actively construct what counts as (an) ethical (issue). The legitimacy of their arguments and decisions is built on heterogeneous sources and performs various functions. (O´Reilly et al., 2009)

The health professionals usually see the benefit of the ill in maintaining or improving their biological health. It is true that preservation of biological life and health is the most crucial task of contemporary health care systems, but the benefit of the ill can be viewed from many different perspectives. (Mol, 2002) We can understand that the health professionals' hesitation to accept the laymen among themselves could also be caused by their fear that other views on the benefit of the ill could prevail in the discussion.

Another common characteristic of the members of the ethics committees is their problem to explain in detail, why they do their work, and what it brings them. When asked questions on their motivation for being members of an EC, respondents felt uncertain and uneasy. Answers were usually very poor and largely formal. The members of the ethics committees most frequently named the necessity and usefulness of their work, without specifying in what exactly they see this necessity and usefulness. Education is not recognized as an important aid. In the interviews the need for education was never mentioned spontaneously. Maybe the controversial role of the ethics committees is reflected here. It is very difficult to be an ethical body and an office at the same time. Underscoring the importance of education shows that members of the Czech ECs do not get the message from the outside world that the controversy of their role can be resolved through education.

In 2005 the civil association, the Forum of Czech Ethics Committees, was established. Twice a year the Forum organizes discussion meetings, and in the summer, the School of Medical Ethics. About fifty people take part in these activities. Participation in the discussion meetings is not formal; the members of the ethics committees come with a visible interest in the matter, and they vividly discuss topics of their interest. Even at these discussions there is an atmosphere of an unusual tolerance. Although opinions sometimes largely differ, serious disputes do not arise.

From a theoretical perspective we can see the Czech ethics committees as more or less informal communities of people having similar sets of attitudes, tasks, and practicalities.

Most members of the ethics committees are health professionals. Laymen (most often theologists, lawyers, civil servants) are members of a committee mainly because the law requires it. The relationship of the health professionals towards the laymen is friendly, but it is possible to see some reluctance of the ethics committees to accept a larger number of lay members. This is not unusual for the Czech Republic. A similar situation was noted in a Dutch study (Caron-Flinterman et al., 2009) and it is possible to notice a call for greater involvement of patients and their organizations that are already in the preparation of

There are certainly many reasons for this hesitation. The common basis we see in uncertainties and tensions faced by the ethics committees. (Barke, 2009) A good clinical trial proves common laws valid for everybody, a good care wants to improve the health and quality of life of an individual patient. (Mol, 2006) The ECs members might feel that there is too much that they are not able to control when they assess the ethical legitimacy of a clinical trial application. (DeMets et al., 2006; Tailor et al. 2008) Given the absence of pregiven answers, the ECs have to actively construct what counts as (an) ethical (issue). The legitimacy of their arguments and decisions is built on heterogeneous sources and performs

The health professionals usually see the benefit of the ill in maintaining or improving their biological health. It is true that preservation of biological life and health is the most crucial task of contemporary health care systems, but the benefit of the ill can be viewed from many different perspectives. (Mol, 2002) We can understand that the health professionals' hesitation to accept the laymen among themselves could also be caused by their fear that

Another common characteristic of the members of the ethics committees is their problem to explain in detail, why they do their work, and what it brings them. When asked questions on their motivation for being members of an EC, respondents felt uncertain and uneasy. Answers were usually very poor and largely formal. The members of the ethics committees most frequently named the necessity and usefulness of their work, without specifying in what exactly they see this necessity and usefulness. Education is not recognized as an important aid. In the interviews the need for education was never mentioned spontaneously. Maybe the controversial role of the ethics committees is reflected here. It is very difficult to be an ethical body and an office at the same time. Underscoring the importance of education shows that members of the Czech ECs do not get the message from the outside world that the controversy of their role can be resolved through education.

In 2005 the civil association, the Forum of Czech Ethics Committees, was established. Twice a year the Forum organizes discussion meetings, and in the summer, the School of Medical Ethics. About fifty people take part in these activities. Participation in the discussion meetings is not formal; the members of the ethics committees come with a visible interest in the matter, and they vividly discuss topics of their interest. Even at these discussions there is an atmosphere of an unusual tolerance. Although opinions sometimes largely differ, serious

From a theoretical perspective we can see the Czech ethics committees as more or less informal communities of people having similar sets of attitudes, tasks, and practicalities.

other views on the benefit of the ill could prevail in the discussion.

clinical trials. (Wrobel, 2009)

disputes do not arise.

various functions. (O´Reilly et al., 2009)

Contemporary sociology offers some concepts that could help us better understand what is going on (or could be) in the development of ethics committees. (Simek et al., 2010)

Ethics committees could be understood as an ethical community. An ethical community is originally the concept of I. Kant. (Kant, 1996) (Wood, 2000) We cannot fully apply the whole concept; instead, it could be an inspiration for us. The term could be used only in a weak sense.

In the current world of secularization and globalization, religious communities lose their strong influence. People who share the same values rather create informal groups or communities. The members of the ethics committees form a community of people willing to devote a bit of their time and effort to the common good. Their participation comes from free decision, and their motivation is largely moral. In their effort they do not seek prestige or material benefit. In this sense, the members of the ethics committees fulfil some of the characteristics of Kant's "ethical community". There are also substantial differences. Kantian ethics is based on duty, to be a member of an ethics committee is a free choice. Religious position is not the unifying element. A community of ethics committees' members is not and will not be universalistic; it will be bound to a particular common task and to a particular common area. The unifying element of this community is a common specific work task – the protection of subjects of clinical trials.

Another concept that could be applied is the concept of epistemic community. Peter M. Haas defines an epistemic community as "a network of professionals with recognized expertise in a particular domain and an authoritative claim to policy-relevant knowledge within that domain". (Haas, 1992) There are four elements in his definition and the Czech ethics committees fulfil two of them.

They have a shared set of normative and principled beliefs which provide a value-base rationale for the social actions of community members (principles of the Good Clinical Practice and related codes and legislation). In the ethics committees one can observe a common policy enterprise – that is, a common set of practices associated with a set of problems to which their professional competence is directed, presumably out of the conviction that as a result, human welfare will be enhanced.

The other two points of the definition – shared causal beliefs and shared notions of validity – are fulfilled by scientists and experts in the ethics, who, on an all-European scale, work together to define principles of the current research ethics. These experts meet and discuss at preparation of documents, as well as at various conferences, and they publish in professional journals. In this way they create an epistemic basis for addressing the problems of security and preservation of human dignity of the research subjects. (Salter & Jones, 2005)

The Czech ethics committees can be considered a local embodiment of the international epistemic community of investigators and bioethicists, who on the supranational level of European directives and international harmonization efforts defined the framework and rules of their operation.

The last inspiration we can find in the concept of communities of practice. (Wenger & Snyder, 2000) The communities of practice are characterized by three main features: 1)

Medical Ethics in the Czech Republic – Experiences in the Post-Totalitarian Country 147

part of health care providers' education. Some research was done and interested persons meet at conferences and seminars. In our survey we presented some results of ten years'

Informed consent was in the Czech Republic implemented from above (EU legislation) and without previous discussions among stakeholders. For this reason it is often understood as a mere formal instrument. Due to historical reasons everyday democratic negotiation is not well developed, and therefore, shared decision making is not an issue in discussions about the implementations of informed consent in the Czech health care. In this specific context

Rationing in the Czech Republic has its specific features thanks to a more prominent lack of resources and thanks to the transition from a paternalistic state health care system to democratic insurance based system. It took some time to understand the need for implementation of regulative measures in the system. Only gradually did all the stakeholders learn the need for negotiations. Official co-payments of patients were unusual and their acceptance in public was quite difficult. Public debate was too much emotive and lacked sound arguments. We could also notice how the slowing down of high expensive

Ethics committees in the Czech Republic represent a special institute of secular ethics in the country, where ethics is underscored both in academia and in everyday communication. We propose to use concepts of ethical community, epistemic community, and community of

**Funding:** The research project is supported by the Grant Agency of the Czech Republic (GA

Angell E., Sutton AJ., Windridge K., Dison-Woods M. (2006) Consistency in decision making

Appelbaum PS., Meisel A. (1987): *Informed consent: legal theory and clinical practice.* New York:

Avard D., Stanton-Jean M., Woodgate R.L., Pullman D., Sagimur R. (2009). Research

Barke, R. ( 2009). Balancing uncertain risks and benefits in human subjects research. *Sci*

Caron-Flinterman JL, Broerse JEW, Bunders JFG. (2009): Patient partnership in decision-

Davies H, Wells F, Czarkowski M (2009): Standards for research ethics committees:

by research ethics committees: a controlled comparison *J Med Ethics* 2006;32: pp.

Ethics Boards and challenges for public participation. *Health Law Rev ;17,2-3* , pp.

making on biomedical research: Changing the network. *Sci Technol Human*

purpose, problems and the possibilities of other approaches. *J Med Ethics; 35,6*,

the call for a reliable and trustworthy physician is better visible.

technology development could help to overcome deficiencies in resources.

practice, to better understand the role and mission of ethics committees.

CR), contract No. P407/11/0380

Oxford Univ. Press.

*Values*;32: pp. 339-368.

pp. 382-383.

*Technol Human Values;34* , pp. 337-364.

**6. References**

662-664

66-73.

research.

interest and even passion for a particular area, 2) community – they engage in joint meetings and discussions, help each other, and share information, build mutual relationships, meet both in person and "online", and 3) experience and practices – they are united not only by the interest in the same thing, but also by sharing sets of conduct, by the way they deal with things and situations, by the effort to learn to do things differently, to learn things they care about, to do better.

The ethics committees basically operate on these principles. Within the framework of the regular meetings organized by the Forum of Ethics Committees as well as email conferences and website administering, there is an exchange of views, a mutual enrichment, and learning from the experience of others. Discussions are often vivid, and the ethics committees do not agree on many things. However, they share the effort to change something, to learn from each other, and to improve. They also enter into discussions with those from the "other side", with the contracting authorities, and these discussions are interesting and beneficial for both parties.

The ethics committees are new institutions and their roles and functioning are not yet fully stabilized. The basic existential dilemma is their dual role. It is not easy to keep balance between the role of the ethical agents and the role of officials and experts. Moreover, the role of an ethical agent is difficult. Ethics committees assist at keeping ethical standards in the field of continually developing clinical research. For this they need a certain range of knowledge, but also ethical creativity. By ethical creativity we mean an ability to apply, in a creative way, recognized principles of good clinical practice in new unexpected situations. It must be rooted in ethical honesty; creativity can have different meanings.

The ethics committees are, and will increasingly be, under pressure for transparency and accountability of their work, and they will have to open to a greater number of laymen. (Avard et al., 2009; Kelly, 2003) This represents a challenge for the future. The members of ethics committees will need to better elaborate the discursive part of their work. They should better understand what they are doing and why they do it. They should learn to use arguments to justify their standpoints and decisions.

Here are reasons why they will need a good education even if they underscore it. We attempted to apply the concepts of the epistemic community, the ethical community, and the community of practice to the phenomenon of ethics committees. It offers certain concepts, perhaps visions, which could become a functional basis for a discussion about the role of the ethics committees in the near future.

#### **5. Conclusions**

Medical ethics is a Cinderella among other medical disciplines, but in a synergy with other forces (EU legislation, international contacts, development of components of civic society) it has some impact on the development in the Czech Republic. As a discipline, medical ethics suffers from lack of experts, insufficient amount of research projects, public presentation, periodicals, and publications. Medical ethicists are not considered to be relevant stakeholders in health policy making or in discussions on the shape of the Czech health care system. Positively, it has been established at each medical faculty and now it is an obligatory part of health care providers' education. Some research was done and interested persons meet at conferences and seminars. In our survey we presented some results of ten years' research.

Informed consent was in the Czech Republic implemented from above (EU legislation) and without previous discussions among stakeholders. For this reason it is often understood as a mere formal instrument. Due to historical reasons everyday democratic negotiation is not well developed, and therefore, shared decision making is not an issue in discussions about the implementations of informed consent in the Czech health care. In this specific context the call for a reliable and trustworthy physician is better visible.

Rationing in the Czech Republic has its specific features thanks to a more prominent lack of resources and thanks to the transition from a paternalistic state health care system to democratic insurance based system. It took some time to understand the need for implementation of regulative measures in the system. Only gradually did all the stakeholders learn the need for negotiations. Official co-payments of patients were unusual and their acceptance in public was quite difficult. Public debate was too much emotive and lacked sound arguments. We could also notice how the slowing down of high expensive technology development could help to overcome deficiencies in resources.

Ethics committees in the Czech Republic represent a special institute of secular ethics in the country, where ethics is underscored both in academia and in everyday communication. We propose to use concepts of ethical community, epistemic community, and community of practice, to better understand the role and mission of ethics committees.

**Funding:** The research project is supported by the Grant Agency of the Czech Republic (GA CR), contract No. P407/11/0380

#### **6. References**

146 Contemporary Issues in Bioethics

interest and even passion for a particular area, 2) community – they engage in joint meetings and discussions, help each other, and share information, build mutual relationships, meet both in person and "online", and 3) experience and practices – they are united not only by the interest in the same thing, but also by sharing sets of conduct, by the way they deal with things and situations, by the effort to learn to do things differently, to learn things they care

The ethics committees basically operate on these principles. Within the framework of the regular meetings organized by the Forum of Ethics Committees as well as email conferences and website administering, there is an exchange of views, a mutual enrichment, and learning from the experience of others. Discussions are often vivid, and the ethics committees do not agree on many things. However, they share the effort to change something, to learn from each other, and to improve. They also enter into discussions with those from the "other side", with the contracting authorities, and these discussions are

The ethics committees are new institutions and their roles and functioning are not yet fully stabilized. The basic existential dilemma is their dual role. It is not easy to keep balance between the role of the ethical agents and the role of officials and experts. Moreover, the role of an ethical agent is difficult. Ethics committees assist at keeping ethical standards in the field of continually developing clinical research. For this they need a certain range of knowledge, but also ethical creativity. By ethical creativity we mean an ability to apply, in a creative way, recognized principles of good clinical practice in new unexpected situations. It

The ethics committees are, and will increasingly be, under pressure for transparency and accountability of their work, and they will have to open to a greater number of laymen. (Avard et al., 2009; Kelly, 2003) This represents a challenge for the future. The members of ethics committees will need to better elaborate the discursive part of their work. They should better understand what they are doing and why they do it. They should learn to use

Here are reasons why they will need a good education even if they underscore it. We attempted to apply the concepts of the epistemic community, the ethical community, and the community of practice to the phenomenon of ethics committees. It offers certain concepts, perhaps visions, which could become a functional basis for a discussion about the

Medical ethics is a Cinderella among other medical disciplines, but in a synergy with other forces (EU legislation, international contacts, development of components of civic society) it has some impact on the development in the Czech Republic. As a discipline, medical ethics suffers from lack of experts, insufficient amount of research projects, public presentation, periodicals, and publications. Medical ethicists are not considered to be relevant stakeholders in health policy making or in discussions on the shape of the Czech health care system. Positively, it has been established at each medical faculty and now it is an obligatory

must be rooted in ethical honesty; creativity can have different meanings.

arguments to justify their standpoints and decisions.

role of the ethics committees in the near future.

**5. Conclusions**

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## *Edited by Peter A. Clark*

The main strength of this book is the international exchange of ideas that will not only highlight many of these crucial bioethical issues but will strengthen the discipline of bioethics both nationally and globally. A critical exchange of ideas allows everyone to learn and benefit from the insights gained through others experiences. Analyzing and understanding real medical-ethical issues and cases and how they are resolved is the basis of education in bioethics for those who will have to make these decisions in the future. The more we examine, analyze, and debate these bioethical issues and cases, the more knowledge will be gained and hopefully, we will all gain more practical wisdom.

Contemporary Issues in Bioethics

Contemporary Issues in

Bioethics

*Edited by Peter A. Clark*

Photo by megaflopp / iStock


**1. Introduction**

Saline aquifers hold the largest potential for geological CO2 storage considering total volume, economic and environmental factors [1]. CO2 storage is considered one important measure for the imminent reduction of greenhouse gas emissions and climate change mitigation [2]. Most suitable reservoir candidates, pilot projects, and commercial operations utilize siliciclastic deeply buried sandstones [3,4]. In evaluating the suitability of saline aquifers for CO2 storage, geological characterization is of crucial importance in estimating the reservoir property distribution and reactivity under prevailing reservoir conditions. Sedimentary facies and burial diagenesis control the petrophysical properties and mineralogical composition of the reservoir host rock, and to some extent the chemistry of pore water. These factors must be specified when evaluating the relative effect of various trapping mechanisms for CO2 (i.e., structural, residual, solubility, ionic, and mineral trapping [5]). The physical and chemical immobilization of CO2 are important controls in risk assessments.

Predictions of the CO2 trapping potential of a storage reservoir over hundreds to thousands of years requires a sound understanding of the geochemical reactions that will come about when CO2 is injected and the thermodynamic system is perturbed [6]. Such predictions ideally require detailed knowledge about the mineralogy, formation water chemistry, mineral surface reactivities, and reaction rates. These data are then used as input in the geochemical batch or reactive transport numerical simulations (e.g., [7–12]). This is, however, not trivial for several reasons. First, there is no simple way to accurately estimate reactive surface areas of the various reactive mineral phases without careful sediment analyses and theoretical models to relate reactive and total surface areas [13–16]. This may lead to corresponding orders-of-magnitude uncertainties in the rates of CO2 mineral trapping [17]. Second, the most commonly used rate models, i.e., based on transition state theory (TST), have been suggested to largely overestimate the growth rates of secondary carbonates at low temperatures and in the shorter time scales (<100–1000 years) [10,17,18]. Third, data on the mineralogy may in many cases be available only as crude XRD data, without details on the individual mineral morphologies, grain size, sediment maturity, etc.

The relative importance of the various trapping mechanisms for injected CO2 in aquifers has been discussed ever since Gunther and co-workers published their geochemical simulations on solubility, ionic, and mineral trapping in the early nineties [19,20]. This relates especially to how fast these reactions are, and if they will impose porosity/permeability changes. This has implications if true complex multiphase reactive flow simulations are needed, or if flow and reactions can be partly separated. Most commonly, reservoir simulations of CO2 storage only include the dissolved CO2 in contact with separate phase CO2, and disregard the mineral-formation water reactions due to slow reaction rates. Furthermore, the heterogeneity of reservoirs with respect to mineralogy and grain size has seldom been taken into account (e.g., [7,16,21–23]). However, some mineral phases and occurrences do seem to react and contribute to mineralization in shorter time scales (100's of years) (e.g., [10,24]) and are thus valid for consideration in sensitivity studies of storage reservoir performance.

We show how to more accurately estimate input parameter values for reactive mineral surface areas, as used in the geochemical modelling of long-term mineralization potential for CO2. Reservoir models can be improved by upscaling from pore- and grain-scale to sedimentary facies distributions with the associated reactive mineral characteristics [25]. A general workflow is outlined, which can be applied to improve facies and mineral specific estimates of reactive surface areas and mineralization potential for CO2 in sandstone aquifers.

## *Case Study: The Johansen Formation, North Sea (NORWAY)*

Simulation examples with input from the Johansen Formation are provided. The Johansen Formation is part of the Northern Lights full scale storage prospect offshore Norway (Figure 1), which is highly relevant at this time due to imminent drilling and plans for CO2 injection [26]. The first formal license for injecting and storing CO2 as part of full-value chain carbon capture and storage (CCS) was approved by Norwegian authorities as of 2019 (Exploitation Licence EL001, by the Norwegian Petroleum Directorate) [26].

The Johansen Formation (Dunlin Group) is a sandstone of early Jurassic age [27]. This prospective reservoir is located offshore of the city of Bergen on the western Norwegian coast (Figure 1). It displays thicknesses in the order of 100–180 m and is located at burial depths of 2–3 km. The saline aquifer is in parts underlying the operating Troll Gas Field in the North, and as a premise for storing CO2, there is to be no risk of interference with on-going production [4]. Thus, the potential injection area considered in evaluations of storage potential for CO2 is located approximately 20 km south of Troll, at top formation depths in the order of 3 km. The Cook Formation is likely to be in contact with the Johansen Formation and provide as a secondary reservoir unit. The main sealing unit is the Drake Formation mudstone [4,28,29].

**Figure 1.** The Johansen Formation is a prospective CO2 storage reservoir offshore of Norway, located at burial depths of ca. 2100–3200 m. The operating hydrocarbon field "Troll" (yellow) is located north of the licensed CO2 injection area "EL001". The cored well 31/2-3 is marked in red, and additional wells with wire line data from the Johansen Formation are marked as black dots. There are no well data available from EL001 as of yet, while an appraisal well is planned [26]. Source data are available at factmaps.npd.no, with suggested injection area and depth maps as shown in [29].

The Johansen Formation is interpreted as a progradational to retrogradational sequence of shallow marine sandy deposits sourced from the east [28,29]. The depositional environment in the licenced injection area (Figure 1) has been interpreted to comprise lower to upper shoreface deposits based on seismic data and extrapolation (across distance and depth) of well data from the Troll area [28]. However, an accurate facies description of sandstone in the injection area is not feasible until an appraisal and/or injection well is drilled and sample material becomes available. The shallow marine facies and mineral assemblages of the Johansen Formation appear analogous to several other CO2 reservoir candidates on the Norwegian Shelf, e.g., the Sognefjord, Fensfjord, Krossfjord, Cook, and Gassum formations [29–35].