Classification of policy instruments

This section presents the classification of policy instruments by which governments attempt to put policies into effect. Within the genetic information policy discourse, these must be the regulatory instruments suitable for achieving the aim of adequate protection of individual and community interests without overly affecting other relevant interests, such as valid industry and business interests.

A policy instrument is often defined as a technique or a set of techniques by which governments effect a change of behaviour in a certain direction (Salamon and Lund, Reference Salamon, Lund and M Salamon1989; Howlett, Reference Howlett1991; Daugbjerg, Reference Daugbjerg and Marsh1998; Vedung, Reference Vedung, Bemelmans-Videc, Rist and Vedung1998). In political science, the concept of a policy instrument has been used to explain the choice within a national political context based on the distinction between public or state and private or voluntary provision of goods and services (Howlett, Reference Howlett1991; Howlett and Ramesh, Reference Howlett and Ramesh1993; Daugbjerg, Reference Daugbjerg and Marsh1998; Bemelmans-Videc, Reference Bemelmans-Videc, Bemelmans-Videc, Rist and Vedung1998). This contrasts with the economic stream of literature in which the choice of policy instrument is a technical exercise, where the most effective and efficient instrument for the correction of market failures is identified (Stavins, Reference Stavins1990; Stavins and Grumbly, Reference Stavins, Grumbly, Marshall and Schram1993; Sterner, Reference Sterner2003).

The central assumption of the political science approach to policy instrument choice is that the decision process and its outcomes are shaped by political factors related to the capacity of the state to keep a primary, overarching role in governing processes. The maintenance of state capacity, despite the rapid changes associated with globalisation pressures, according to Pierre and Guy, is ‘because the state, despite persistent rumours to the contrary, remains the key political actor in society and the predominant expression of collective interests’ (Reference Pierre and Guy2000: 25).

Scholars have made numerous attempts to identify the variety of policy instruments used by policy-makers and to classify them into meaningful categories (Kirschen et al., Reference Kirschen1964; Hood, Reference Hood1986; McDonnell and Elmore, Reference McDonnell and Elmore1987; Schneider and Ingram, Reference Schneider and Ingram1997; Doern and Phidd, Reference Doern and Phidd1992; Salamon, Reference Salamon, Salamon and Elliott2002). Howlett and Ramesh (Reference Howlett and Ramesh1993) developed a classification of policy instruments by arranging them along the level of state involvement. They offered a voluntary–compulsory continuum along which policy instruments can be ordered. At one extreme of the spectrum are instruments totally devoid of state involvement and at the other extreme are compulsory instruments totally devoid of private discretion. Between the two extremes lies a range of instruments involving varying levels of state and private provisions.

Within the wide variety of policy instruments, four instruments are usually proposed for different degrees of government intervention with respect to genetic information policy making. These include: constitutional provisions that contain fundamental privacy protection rights and basic principles of the institutional system; statutory legislation, where individual states enact legislation in an attempt to restrict the use of genetic information by private actors; industry self-regulation, which occurs where a collective group, industry or profession is required to formulate and enforce norms within a government framework without any active intervention from the state; and moratoria, which is identified as a voluntary practice affording the industry time to formulate an alternative policy strategy while studying the consequences of the use of genetic information and testing on health and medical research.

Having defined the concept of a policy instrument in a general way, it is necessary to distinguish a number of dimensions that can explain policy instrument choice in order to make the concept fruitful as a tool for comparative policy analysis (Bemelmans-Videc, Reference Bemelmans-Videc, Bemelmans-Videc, Rist and Vedung1998; Rist, Reference Rist, Bemelmans-Videc, Rist and Vedung1998; Howlett, Reference Howlett, Eliadis, Hill and Howlett2005; Howlett et al., Reference Howlett2005). Major dimensions of policy instrument choice include degree of coercion, targeting, past experiences, political support/opposition and ideological preferences (Linder and Peters, Reference Linder and Peters1989; Howlett, Reference Howlett1991; Howlett and Ramesh, Reference Howlett and Ramesh1993). The operational definitions of these dimensions are as follows:

1. 1 Coercion refers to the dominant role of the state in decision making, consciously working to exclude organised interests from policy making; in other words, the extent of organisational ability to affect societal actors.

2. 2 Targeting is identified by clarification and precision of the problem situation.

3. 3 Political context includes political culture, pattern of social conflicts, the nature of support and opposition, accountability and past experience.

4. 4 Ideological preferences or principles limiting or advancing government intervention in industry. A focus on these factors related to state capacity helps to explain why these national styles of instrument choice exist.

As to empirical analysis of the German and Israeli cases, our approach is based on a comparative analysis of policy instruments. We examine the appropriateness of various policy instrument choices made in Israel and in Germany for securing the rights for privacy, non-discrimination and access to research benefits for individuals and communities. The article is based on a literature study of public documents, such as governmental bills, proposals, statements and consultation responses. The following section presents the current regulatory framework for the use of genetic information in Israel and Germany (summarised in Table 1).

Table 1

Policy regulation of the use of genetic information in Israel and Germany

Genetic information policy making in Germany and Israel

Non-discrimination policy in insurance and employment

A further important factor that may discourage individual and/or community participation in genetic research is the fear of genetic discrimination in employment and insurance. Employers may make selective hiring, placement, promotion or termination decisions based on genetic profiling. Insurance companies may discriminate against asymptomatic or pre-symptomatic individuals when assessing eligibility and setting insurance premiums (Billings et al., Reference Billings, Kohn, de Cuevas, Beckwith, Alper and Natowicz1992; Natowicz et al., Reference Natowicz, Alper and Alper1992; Alper et al., Reference Alper, Geller, Barash, Billings, Laden and Natowica1994; Hall and Rich, Reference Hall and Rich2000; Lemke, Reference Lemke2005).

The central importance of protecting individuals and communities from discrimination is enshrined in sections 29 and 30 of Genetic Information Law 5761–2000 of Israel, which states that: ‘An employer shall not require an employee or a person applying for employment (in this section – an employee) to provide genetic information or to undergo genetic testing . . . An insurer shall not ask an insured or a person applying for insurance (hereinafter – an insured) whether such person has undergone genetic testing and shall not ask for the results of genetic testing from an insured, nor request such person to undergo genetic testing.’ The report of the Israel Academy Bioethics Committee backed the law guidelines with the threat of legal sanctions, emphasising the concern of group genetic discrimination in research: ‘Genetic profiling of a collectivity that can be defined by ethnic or national origins could lead to risks of stigmatisation of all those who belong to the collective. Worse, this could lead to discrimination in various forms – moral, physical or economic.’Footnote ⁶

The government choice to introduce statutory legislation rather than voluntary regulatory measures could be partly explained by the Jewish historical experience of racial discrimination and stigmatisation. The fear of Jewish stigmatisation was recently raised by the Ashkenazi Jewish community in the US over genetic screening programmes. During that time, the American Jews called on the National Human Genome Research Institute (NHGRI) to set ethical guidelines to secure their community (Ashkenazi Jews) from genetic discrimination by health insurance companies. According to Marlene Post, president of Hadassah, the Jewish women's organisation that sponsored the meeting with the Jewish Council for Public Affairs, all participants shared a concern of fear of discrimination and stigmatisation. ‘We need to protect ourselves both from discrimination and ignorance . . . We've got to start breaking down myths that ethnic groups mean genetic groups. They don't’ (Wadman, Reference Wadman1998:851).

In 2005, the German parliament debated a proposed anti-discrimination law put forward by the government. Based on a series of EU directives, the anti-discrimination law would make punishable discrimination based on race, ethnic origin, age, sex, disability or sexual orientation. The primary aim of the law is to prevent discriminatory practices in the workplace, in educational institutions or, for example, by landlords. Until the new law, workers in Germany relied on the country's general dismissal protection. The opposition to the law includes industry and trade groups, who accuse the governing coalition of Social Democrats and Greens of trying to create more bureaucracy and tight regulatory measures that could hinder economic growth. Nevertheless, the new Anti-Discrimination law does not address genetic discrimination by employers or insurance companies.Footnote ⁷ However, the existing law, which is designed to prohibit discrimination in employment based on certain disability characteristics that may be linked to genetic traits, could provide protection against genetic discrimination in some cases. The need for targeting and coercive legislation to address existing problems posed by genetic testing techniques can be demonstrated in the case of a German teacher's genetic discrimination suit in October 2003.Footnote ⁸ A young teacher in Germany was refused a permanent job on the grounds that members of her family had Huntington's disease and she was, therefore, at risk of developing the disease herself (Burgermeister, Reference Burgermeister2003; Darmstadt Administrative Court, 2004; Lemke, Reference Lemke2005). Under German employment law, government authorities can reject candidates for civil service, including teachers, on the grounds of ill health to minimise absenteeism and save money. The applicant lodged an appeal against this decision before the Administrative Court in Darmstadt, which ruled mainly in her favour and instructed the State of Hessen to immediately appoint her to government service. In the court's opinion, the school authorities had wrongly assessed the state of her health as an applicant. The school board declined to contest the decision and has since employed the woman in question under a government service contract. Thus, this case raised concerns that employers could use the current legal vacuum on genetic testing in Germany to discriminate unfairly against employees.

The German example has shown that introduction of statutory legislation may be favoured over constitutional regulative instruments since the greatest threat of infringements is not caused by private parties, such as employers and private insurers, but by state authorities.

Governing benefit sharing

With the rapid development of high-throughput technologies allowing for the screening of very large numbers of samples, and with growing recognition of the important role genetic variation can play, there has been a tendency to try to generate large national population collections in various countries (Iceland, Estonia, Latvia, Sweden and the UK, for example), or to investigate sub-populations with defined characteristics (in Italy and Finland, for instance). Regulating benefit sharing from genetic information databases needs to provide participants access to the benefits, which might include profit sharing, information, better medicines and treatments, improved access to health care and funding for continued studies, or additional research on concerns identified by the community.

In Israel, one of the challenging regulatory issues was the management of DNA sample collections from Ashkenazi Jews by the Israeli commercial company IDgene Pharmaceuticals Ltd. IDgene is a privately owned population genomics company focused on identifying the genetic basis of common diseases. The commercial interest of IDgene in the use of genetic information raised public concerns over the regulation of large population-based genetic studies.

Genetic information, as explained above, constitutes an important instrument for genetic research. Positive results will bring benefits not only to the donor and his/her family, but also to the entire human community. This ‘advantage for the collective’ is an important concept underlined in two reports. The first was issued by the Bioethics Advisory Committee of the National Academy of Sciences, headed by Prof. Michael Ravel. The second was issued by the Ethics Bureau of the Israel Medical Association, headed by Prof. Avinoam Reches (Reches, Reference Reches2002). Both reports stated that not only should researchers work towards applying their results towards the common good, but whenever research uses samples of biological material it is generally assumed that the donor offers the sample for the benefit of the community rather than for personal profit or for the exclusive profit of a private company. There exists a fundamental communitarian ethics principle that ‘donated’ biological material should not become a good of solely economic concern, but that the return of benefits to the community must be guaranteed. Indeed, Prof. Kasher, one of the committee's members argued that the collective notion of ownership (e.g. of research results or human tissue). needs to be clarified, and that ownership of data should be defined to include the communities providing the data, as well as the researchers studying the data (Reches, Reference Reches2002)

In the case of benefit sharing, the Israeli government seems to prefer to leave some room for interpretation, yet still include communitarian criteria to make clear under what conditions the use of genetic information is allowed. As such interpretation has not yet emerged in statutory regulation, the regulation of benefit sharing in genetic information research tends to be reflexive and less targeting and coercive.

In Germany, the concern for benefit sharing was raised in the German National Ethics Council (Nationaler Ethikrat) in 2004, debating the regulation of biobanks for research.Footnote ⁹ It was suggested that since most genetic databases in Germany are initially used for fundamental research, this does not as a rule generate a financial return. The council then concluded that compulsory measures to gain acceptance from commercial companies regarding financial returns are needed, since this balancing of private gain with public benefit would compete with the taxation system. The fact that the council's recommendations did not emerge as a compulsory regulation reveals that once liberalisation had taken place in this policy sector, we find that the governmental actors remain in a secondary position, while companies such as the pharmaceutical industry effectively gain a certain level of influence in genetic information policy making.

Summing up

The comparative analysis has shown that the regulatory measures of balancing public and private interests in genetic information research may be different in similar health-care systems. In evaluating policy instruments that provide solutions to the problems posed by the use and acquisition of genetic information, it is suggested that Germany and Israel have little consensus on the proper level of regulation.

Indeed, in the areas of privacy protection and non-discrimination policy, the Israeli government preferred to use coercive instruments to respond to concerns about commercial use of genetic information. The Genetic Information Law 5761–2000 of Israel creates legal certainty and clarity based on communitarian interpretation of individual and community genetic information. It is argued that the Israeli state appears to include non-discrimination and privacy protection specific to genetic information mainly because of the Jewish past experience with racial discrimination and stigmatisation, and by the prominent role of ethnic cleavages in Israeli society. These experiences have increased the awareness of the danger of abuse, resulting in a strong call for special protection and coercive regulation. In contrast, the state of genetic regulation in Germany relies on constitutional arrangements encouraging existing self-imposed restrictions by the private actors. The provisions mentioned in the German constitutional law are broad enough to encompass protection of genetic information, but have not yet been interpreted into practicable and enforceable genetic privacy and non-discrimination protection. It seems that the German government is more desirous of introducing constitutional provisions for privacy protection that are formulated in a broad and flexible way so as to have a politically desirable liberal effect, namely to support and advance commercial and economic interests to legitimise the public interests in collecting and using such information for developing German industry.

In the area of benefit sharing policy, both Israel and Germany choose to avoid utilisation of a coercive instrument formulated in well-described standards that might be problematic in a competitive area such as that of genetic research. Thus, the regulation of benefit sharing in collecting and using genetic information has so far exclusively been left to self-regulation by the market. It seems that use of voluntary regulatory measures reflects a liberal view, because the benefit sharing objective has not yet raised any public concerns that would warrant disproportionate state intervention.

Conclusions: the implications for genetic information policy making

The entry of genetic information on to regulatory agendas across the globe calls for engagement with ethical concerns for policy makers who do not generally see ethical debate as their primary interest. This paper illustrates that although policy instrument classification may not be able to predict policy outcomes for scholars, it can be used as a strategic tool for policy makers and civil society organisations that wish to develop a comprehensive understanding of the context in which they work and the options for pursuing their strategic objectives.

The comparative analysis of Israeli and German regulation of genetic information supports the claim that statutory legislation, rather than self-regulation, provides a more appropriate means to reconcile the various conflicting interests in terms of individual and community empowerment. Indeed, self-regulation cannot provide systematic governmental evaluation of how well ethical guidelines or codes of conduct fare in practice, or any substantial evidence of the extent to which they are adopted and implemented. In cases of genetic privacy and discrimination, for example, wrongdoers may not be as effectively sanctioned as they might otherwise be if these ethical norms do not have the force of law behind them. Moreover, in the case of benefit sharing, this paper raises the need to address the issue of ownership (e.g., of research results or human tissues) in statutory legislation in order to prevent the public from losing faith in the promises of genetic information research. Thus, in order to justify voluntary public participation in genetic information databases, this paper suggests treating genetic information as distinct from other types of health information. It suggests educating, informing and seeking the consent of participants at all stages of the genetic information research; sensitising researchers to the risks of stereotyping and stigmatisation based on ethnic origin and recognising and respecting ethnic and cultural sensitivities; requiring researchers to provide research benefits and encouraging multidisciplinary research teams that include both biomedical and social scientists.

It is argued that, in the future, National Bioethics Advisory committees in Israel will take a leading role in shaping genetic information policy making. The fact that these committees’ members are coming from different disciplines – ethics, law, science, religion, etc. – promotes dialogue with the public about the ethical, legal and social implications of genetics research. These committees are instrumental for regulation since they provide a forum favourable to the development of a common view among various actors on genetic information policy making. Hence, statutory legislation based on bioethics committee guidelines will continue to have a relatively strong effect in Israel, justifying individual and community voluntary participation in research on the one hand and commercial investment on the other, for the sake of society's welfare as a whole. Indeed, growing public involvement in the meetings and deliberations of the National Bioethics Advisory Commission and the broad dissemination of the Commission's reports to researchers and the public explain why the government accepts the role of bioethics commissions to set out coercive policy instruments in the area of genetic information. In the German case, it seems that the entry of a coercive counterbalancing power, such as the EU, into the regulation of genetic information in Germany may lead towards tight and coercive regulation of genetic information.