Whose Biobank? Should Biobanks Serve Research Interests or the Needs for Personalized Medicine? Analysis of the Hungarian Law

Introduction

The Hungarian law that regulates the use of genetic data and biobanks will soon be 10 years old (Parliament of Hungary, 2008). Collections of biological samples have, of course, a longer history, in Hungary and elsewhere. When the first biobanks began to operate about 20 years ago, they were regarded as innovative research tools that could maximize the researchers' access to (mainly) genetic data. At that time, it was not clear what kind of data protection issues biobanks would raise or how benefit sharing could be achieved in a fair way. Also, the principle of noncommodification was not yet fully discussed. As regulation on biobanks followed the model of biomedical research, participants' future therapeutic interests were not adequately taken into account or were simply regarded as a technical issue within the data protection frame. Given that patients have a general right to healthcare information, it would be difficult to argue that biobank participants should not share the same rights.

International Framework

In Article 2, the Oviedo Convention explicitly states that “the interests and welfare of the human being shall prevail over the sole interest of society or science” (The Council of Europe, 1997). Consequently, disclosure of individual research results is almost an inevitable development in the field of biobanking. If genetic data are a type of personal data, then persons should have the right to control their data. Despite the conceptual and legal heterogeneity of biobanks, some countries (e.g., Estonia adopted the Estonian Human Genes Research Act 2000, Finland has the Biobank Law No. 688/2012) have regulated biobanks, tissue banks, and the protection of genetic data in a special law. Still, many European countries (e.g., Italy, Czech Republic) apply a kind of patchwork regulation, not specific to research biobanks (Lenk et al., 2011). Originally, the main aim of the biobank laws was to facilitate research, and research participants were considered as generous donors rather than future patients.

Therefore, instead of a law specifically designed for biobanks, several types of health law (focusing on transplantation, data protection, etc.) may be applicable in the field of biobanks. The aim of this article was to examine the relevant legal frameworks and the obstacles to returning data to donors in genetic biobanks.

Over the past 50 years, medical research and the rules and regulations that govern research have significantly changed. A participatory model seems to offer more benefits for those who have given their samples to biobanks. We need to ask ourselves the question: how should individuals or groups of individuals benefit from biobanks-based research? In addition to this, does biobanking require a new regulatory model? Personalized medicine promises to ensure that the most effective treatment is applied to the most appropriate patients (Bombard et al., 2013). Still, the regulatory model did not change into this direction as it did not provide new tools in the hands of the patients to acquire personalized care. Even in cases when patients seek genetic tests by themselves, they often have the impression that individualized information and interpretation are missing—not to mention the lack of subsequent personalized care.

The main relevant European legal norm, the Directive 95/46/EC of October 24, 1995, on the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data stipulates that national laws should protect personal data and the right to privacy as recognized both in Article 8 of the European Convention on Human Rights and in the general principles of Community law.

As the new General Data Protection Regulation was adopted on April 27, 2016, and will enter into force on May 25, 2018, there is a strong message from Brussels to further harmonize different kinds of data protection regimens and to strengthen the protection of personal data (The Eurpean Union, 2016). But, at the time of writing this article, the Directive is still the main source of data protection norms.

The Directive sets out a number of principles to give substance to and amplify those contained in the Data Protection Convention of the Council of Europe. It allows Member States to adopt legislative measures to restrict the scope of certain obligations and rights provided for in the Directive when such a restriction constitutes, notably, a necessary measure for the prevention, investigation, detection, and prosecution of criminal offences (Article 13).

The European data protection laws are relevant both with respect to the genetic data and to the genetic sample. This latter aspect has become relevant with the obiter dicta of the S. and Marper v. the United Kingdom case (The European Court of Human Rights (ECtHR), 2008). In paragraph 5, the Court observed “that the genetic profiles contain substantial amounts of unique personal data….” The Court also noted that the Government accepted that DNA profiles could be, and indeed had in some cases been, used for familial searching with a view to identifying a possible genetic relationship between individuals. Furthermore, according to paragraph 75, “in the Court's view, the DNA profiles' capacity to provide a means of identifying genetic relationships between individuals above is, in itself, sufficient to conclude that their retention interferes with the right to the private life of the individuals concerned” (ECtHR, 2008: 22).

The Hungarian Law on Genetic Data and Biobanks

In Hungary, there is a unified law (Parliament of Hungary, 2008) that provides general conditions for genetic testing, screening, and research: the Parliamentary Act No. XXI of 2008 on the Protection of Human Genetic Data and on the Regulation of Human Genetic Studies, Research and Biobanks (hereinafter referred to as Genetic Act). An important feature of this law is that it does not make a distinction between the genetic testing, screening, and research conducted in the public or the private sector nor between the different ways subjects are notified (private or public) about the possibility of genetic testing.

The problems that result from the legal focus on genetic examination (testing and screening) that is performed mainly within the traditional clinical framework have become apparent only when private companies appeared in the field. Concerns about commercial genetic testing, directly offered to consumers without a medical intermediary, appeared only after the Genetic Act had been already adopted. These concerns became most salient when in 2012 a scandal on the inappropriate use of genetic examinations emerged: an extreme right wing politician requested to be tested for “racial purity” (Abbot, 2012; MTI, 2012). In response to this event, a joint opinion was issued by the Hungarian Health Science Council (ETT) and its subcommittee, the Human Reproduction Commission (HRB).

In this article, I will first describe the general conditions and legal guarantees within the 2008 Genetic Act and then briefly describe the specific data protection elements that, in my view, support access to genomic information.

After 2002, several attempts were made to draft a law on the protection of genetic data and on the regulation of biobanks in Hungary. The debates on the ethical and legal issues of human genetic data had already started within the circles of the Health Science Council. Moreover, in a number of scientific publications, prominent experts on genetics and molecular biology emphasized the special challenges of genetics and genetic research. Thematic issues were published by two major science and social science journals: Világosság in 1999 (Világosság, 1999) and Magyar Tudomány in 2002 (Venetiáner, 2002). The topic of genetics was new and attractive at that time, and enthusiasm was the dominant mood among scientists. The idea that the law and ethics should reflect upon the potential misuses also appeared in the articles and panel discussions of several conferences.

On the other hand, the popular interpretation of what genetics is all about was and still is quite ambiguous. At the beginning of the legislative process in 2003, the Minister for Health launched an invitation for public consultation and published the proposal on its website. The consultation was based on of the Oviedo Convention. As Article 28 of the Convention states:

György Kosztolányi and the author of this article, together with the members of the Health Science Council, published a Preliminary Expert Concept on the first draft of the law. A Hungarian medical periodical, Lege Artis Medicine (Sándor et al., 2004), published this first draft and various expert organizations—such as the Parliamentary Commissioner on Data Protection, the Health Science Council, the Hungarian Civil Liberties Union, and different medical and other professional organizations—were invited to participate in the debate and to submit their written opinion with proposed amendments.

Due to many years of drafting, it took more than 5 years to complete the text. A major constraining factor was political instability: the Ministry of Health was not stable during the period of drafting the law (between 2002 and 2008), as none of the ministers survived more than 1 year in office in the midst of wrestling with the long overdue healthcare reform.

During these 5 years, the debate did not enrich the preliminary draft with novel thoughts and ideas, and the text did not become more detailed nor did it focus on the new challenges emerging in the field. Instead, problematic issues were simply cut out of the text. As a result, instead of making a comprehensive law on the use and processing of human genetic data in various domains, the law adopted by the Parliament exclusively focused on the diagnostic and therapeutic uses of genetic data and on biomedical research. Commercial testing, paternity testing, or direct-to-consumer testing were not the focus of this Genetic Act; however, genetic consultation and providing adequate and individually tailored information before genetic examination were already prescribed by the law.

Concerning the results of this legislative process, one may state that the 2008 Genetic Act became shorter and simpler than in the original draft version in a desperate effort to avoid sensitive issues. Thus, the law addresses the use of genetic information only in the very narrow biomedical sector: in the fields of genetic testing, screening, and research. The law restricts the use of genetic data only to this biomedical context. Therefore, even in the lack of regulating broader uses of genetic data based on the Act, genetic data processed for diagnostic or research purposes cannot be disseminated for the purposes of insurance. Despite the intended laconic law, the mere word “genetics” was a calling for a vehement debate by various political actors. Fears of genetic discrimination, exploitation, or trafficking data to foreign countries were the major concerns in the political debate. Perhaps, it is not an exaggeration to say that this law served as a learning exercise for the wider public on contemporary ethical issues in genetics.

In 2012, a case with a private genetic test that had also international repercussions shed a light on direct-to-consumer testing in a private company and provoked a debate on this issue. The infamous case was based on a request by an extreme right wing politician to be tested for “racial purity.” Although the 2008 Act does not provide a possibility to conduct a genetic test for such purposes, the “pedigree study” was conducted and the results were uploaded on a website. Since this case shook the reputation of the entire Hungarian community of geneticists, prohibition of discrimination has been reinforced in the Hungarian Act on Genetic Data. The Genetic Act was amended in 2013 by Parliamentary Act No. CXXVII of 2013 and formulated some general principles on genetic research that aims to study differences between ethnic groups.

In Article 1 of the Act, the purpose of the law states: “to lay down rules on human genetic tests and screening (studies) and human genetic research, the conditions and purposes of the treatment of genetic data and rules on biobanks.” The Act applies to genetic sampling for human genetic study and human genetic research performed under this Act in the territory of the Republic of Hungary, the processing of genetic data irrespective of the place of sampling, and to genetic testing and screening and human genetic research and to biobanks.

For the detailed knowledge of genes and for genetic research on the exploration of the causes of illnesses, examinations are needed that might throw light on the individual realization of the genetic information as well. This, in turn, necessitates the examination of the health status of the individual and the determination of variability among the population. This leads us to conclude that it is of vital importance to involve as many individuals as possible into such studies.

Data Anonymity, Data Coding

One of the basic preconditions to disclose data to biobank participants is that the data are accurate and stored with access to personal data. The original idea behind regulating access to genetic data and biobanks was based on the combination of the scientists' need to create large research data pools while granting rights to patients over their genetic data.

One of the specificities of the Hungarian Parliamentary Act is that it regulates three different levels of coding and anonymity in its Article 3(1):

• the encoded genetic sample or data, which means genetic sample or data where all the personal identification data relating to the person giving the sample are replaced by a code;

These various options correspond with different needs of research participants and play an important role in the access to individual findings. For a long time, it was a common believe that anonymous data could guarantee the highest level of protection of genetic data. However, many problems were identified with regard to the systematic anonymization of genetic samples and data. First of all, anonymous data cannot be matched with other health data and as such these data are less relevant for scientific research. But anonymization is also problematic if one takes into account the participant's interests: with anonymization (i.e., erasing personal data) a further feedback based on the request of the owner of the sample is practically impossible. (In the case of decoding, genetic data of course identification could be done by matching samples, but in the case of anonymization, it would require expensive and time-consuming efforts.)

In the preamble, it is recognized that the natural lifelong genetic qualities of an individual need special and enhanced protection in genetic research on human biological material samples. The goal of these research efforts is to the better understand the background of illnesses and the exploration of treatment possibilities, with a view to the need of the enhanced protection of human dignity during genetic research, having regard to the Oviedo Convention.

In Article 1, the Act lays down rules on human genetic studies and human genetic research, the conditions and purposes of the treatment of genetic data and rules on biobanks.

The Act is applicable to genetic sampling for human genetic study and human genetic research performed under this Act in the territory of the Republic of Hungary, the treatment, and processing of genetic data irrespective of the place of sampling, and to genetic testing and screening and human genetic research and to biobanks.

One difficulty that laws on biotechnologies always face is how to make a balance between legal and scientific definitions of certain terms. While science can be perfectly comfortable without laying down definitions of biobanks and genetic data, in law common references are necessary. But this leads to another problem, namely, once such legal definitions are in place, they cannot be flexibly adopted to the continuous developments in biotechnology. This may explain the numerous problems in the field of cloning and stem cell research.

Article 3 defines genetic sample and genetic data differently. Genetic sample means every human biological sample taken for the purposes of human genetic studies or human genetic research under this Act or to be used for such purposes within the framework of this Act otherwise (including samples of tissue, cells, body fluids, transformed cell line or DNA or RNA extracted from cells). Genetic data are defined in a very broad sense and not just as information that may be derived from the physical genetic samples. Under the Act, genetic data are information on the inherited features of a given person concerned, which arises from the processing of a genetic sample or health documentation and which refers to risks, inherited tendencies, physical or behavioral features of the individual, and is appropriate for identifying the individual.

Basic Terms and Definitions Under the Law

Another essential element of disclosing and communicating relevant health information to biobank participants is the provision of accurate and multilevel information. Characteristic of the Hungarian Act is that biobanks are understood exclusively in the context of genetic research and genetic examination (testing and screening). Under the Act in Article 3[1]7, biobank means a collection of samples containing genetic samples and related genetic and personal identification data for the purposes of a human genetic study or human genetic research.

In the Section on definitions, the law differentiates between biobanks and the so-called archived collections, a term that refers to collections containing genetic samples and data stored separately in a biobank in respect of which the original purpose of the sampling has already been fulfilled.

The Hungarian law focuses on two major fields of the use of the human genetic data: human genetic research and genetic examination (including genetic testing and genetic screening for health purposes). Human genetic research is interpreted as research concerning the structure of genetic material (genes and chromosomes), determining the genetic identity of individuals, their disorders and appearance in physical, intellectual, and behavioral features of the genetically encoded program and the regular features of the transmission from the parents to the offspring of the genetically encoded program and the exploration of disorders to these processes.

Genetic testing means diagnostic, predictive, heterozygotic, prenatal, preimplantational, and pharmacogenetic laboratory studies that are directed to trace DNA and chromosome variants originating from germ cells, RNA, and the specific protein products, which are associated with influences affecting human health harmfully or predicting these. Under the law, genetic screening is understood as a wide range programmed genetic examination of a population or a group within it with the purpose of identifying certain genetic features among persons without symptoms.

As there was no law on genetic counseling before the Act on Genetic Data, the Act also includes brief references to genetic counseling. Under the Hungarian law, genetic counseling means a consultation procedure during which a person authorized thereto by special legislation provides information on the advantages or risks of human genetic studies, explores possible consequences of the results of genetic studies, and helps understand the nature of the illness. Genetic counseling plays a paramount role in communicating both foreseeable and unforeseeable or incidental test results.

One of the most important parts of the Act is Article 6 in which basic rights of the persons are laid down. The person concerned has a right to know their genetic data created during the human genetic study (Article 6[1]).

A further guarantee in the act is that before sampling the person concerned has to be informed, as a part of the genetic counseling, on: the purpose of the sampling, advantages and risks of participating or not participating in the study, possible consequences to the person concerned and their close relatives of any outcome, methods of the storage of the genetic sample and data, and possible identification of genetic samples and data stored in different formats.

When the genetic sample is used for research, the person concerned shall be informed on the provisions of Article 159(3) of the Healthcare Act before signing the declaration of consent on methods of the storage of the genetic sample and data, possible identification methods of genetic samples and data stored in different formats, the inclusion into an archived collection of the genetic sample in the absence of another declaration by the person concerned, and the possible forwarding of stored genetic samples.

One of the most important aspects of the Hungarian law in terms of communicating the findings is that the Act prescribes that the person concerned shall be entitled to learn about the results of the human genetic examination in a consultation that is specifically tailored to his/her needs. This element already points toward the needs of personalized medicine. During the consultation, the person concerned shall be assisted in the long-term processing of the possible consequences of the results and the choice of optimum treatment opportunities. One can of course argue that personalized information does not necessarily mean personalized medicine. Personalized medicine would include the offer of a special treatment or care subsequent to the test.

The “right not to know” is respected by the law by saying that the person concerned may withdraw from knowing their genetic data by a declaration. The declaration is subject to withdrawal any time without restriction. The person concerned should be informed about this right.

A special case of returning individual research results can be seen in pediatric genetic research. In this case, it is much more difficult to assess and to distinguish between the interests of physicians, researchers, parents, and care providers. More importantly, also the child's interests need to be taken into consideration as they may vary in both the short and long run. The child may need a medical intervention and then it is beneficial to know his/her genetic information. But when there are no medical treatments available, the disclosed genetic data may infringe the rights of the future adult since the genetic data have been revealed in his/her childhood. Who would be responsible for taking preventive steps when a child's genetic test indicates the necessity of it? (Hens et al., 2011).

Article 7 restricts the access to personal genetic data by providing an exclusive right to the person concerned to his/her data and the persons identified by him/her. In exceptional cases, close relatives who have a special interest because of their own medical treatment may ask for the following information: the knowledge of the nature of their illness, the therapy, or the assessment of the risk of illnesses for their descendants. They are entitled to know the data upon their own initiative and request in the framework of genetic counseling. In case of using genetic data or a sample, a written consent by the persons is necessary for processing the genetic data. This legal provision can be found under the title “self-determination.”

Before genetic sampling, it is necessary to obtain the written consent of the person entitled to disposal based on detailed information, irrespective of the purpose of the treatment of the genetic data (Article 8[1]).

The Hungarian law on human genetic data is built on the respect to self-determination of the individual concerned. Articles 8-11 deal with this right in detail. To be valid, the consent to sampling has to include several elements:

(a) declaration of the person concerned to give their consent to (i) taking a genetic sample from them; (ii) storing the genetic sample and the derived genetic data in a biobank and forwarding it to another biobank under Article 26(5); and (iii) storing the genetic sample and the derived genetic data in an archived collection;

During the storage of the encoded genetic sample or data, the person concerned may be identified only for the interest of the person concerned or their close relatives under this Act.

In the absence of a declaration when the person concerned does not expressly refuse it, the genetic samples and data may be placed in an archived collection in anonymized format. The person concerned may withdraw his/her consent. In case of incapacity, the legal representative of the person incapable to give consent may provide the declaration of consent.

Genetic sampling from a deceased person, the examination of a taken genetic sample stored together with personal identification data or which has been encoded, their use for human genetic research or the use of derived genetic data is possible only when the deceased person did not make a declaration objecting to it in their lifetime.

In the case of verbal consent, the oral declaration with the medical practitioner shall be documented in writing with the signature of two witnesses. Another important guarantee is that the persons concerned may withdraw their consent to the treatment of their genetic data being stored together with their personal identification data, code, or pseudonym at any time. For a declaration of withdrawal, the person concerned may request that the genetic sample and all the derived genetic data are destroyed.

The genetic sample and data shall be destroyed immediately, but within 8 days at the latest, after they have been used for human genetic research purposes.

When necessary for illness prevention, the nature of the illness, the therapy, and the risk assessment for descendants may be disclosed to close relatives as well. For this purpose, the medical practitioner shall call the attention of the close relative to the necessity of knowing genetic data in the framework of a genetic counseling or shall involve the direct relative into genetic counseling with the person concerned.

Genetic Testing and Screening

Chapter III provides basic rules for genetic testing and screening. Under Article 12 of the Act, human genetic examination may be conducted with a health service provider equipped, according to a special legislation, with qualified personnel only. Human genetic examination may be performed for the purposes of prevention, diagnosis, therapy, or rehabilitation. The conduct of human genetic examination (test or screening) requires the consent of the person concerned under Article 8(1).

The Act prescribes that no genetic examination is to be conducted on persons incapable of acting except when, subject to the result of the examination, such a measure can be taken that prevents the occurrence of the illness to the person incapable of acting, limits its seriousness, is able to prevent disability, promotes the restoration of health, or is necessary for the determination of the direction of an examination that is already started.

As an exception, a genetic examination may be performed in the interest of a close relative as well on a person incapable of acting within the framework of purposes under paragraph (3) when the examination cannot be replaced by another one, the benefits to be obtained from the examination exceed possible associated risks and disadvantages or the nature of the examination inevitably justifies the conduct of the examination on a person incapable of acting.

Genetic Research

The second topic addressed by the law is the use of genetic samples and data for research. Human genetic research is of huge scientific significance as it involves the structure of genetic material (genes and chromosomes); the appearance of genetically encoded programs in physical, intellectual, and behavioral features; the regular characteristics of transmitting the genetically encoded program from parent to offspring; and the exploration of generic disorders. To ensure achievement of these above-mentioned goals, the bill lays down the framework for the use of samples and data in research; the necessary data protection guarantees; the rules on population genetics research as a special type of genetic research; and the conditions for using samples stored in an archived collection for a new research. If a genetic sample is taken for purposes of genetic testing, but is later used in research, then a repeated consent procedure is required by the law.

Genetic samples and data may be used for human genetic research in accordance with the provisions of this Act only. The general provisions of the Healthcare Act on research conducted on humans apply also in the case of human genetic research. Human genetic studies can be performed only by institutions that meet the legal conditions on the storage of genetic samples and data. Otherwise, the research plan is not authorized.

Larger scale population-based examination (screening) is also mentioned in the Act. Under Article 17 human genetic research on the population may be conducted for the determination of the distribution of genetic variants between individuals within a given group or between individuals belonging to different groups, and to the exploration of the nature and consequences of the latter.

In genetic research on human behavior, an entire personality should be taken into account to ensure widerange information and a procedure respecting the extra-genetic features of the personality. During the research procedure, the whole population involved in the research may be informed on the purpose of the research, the range, and numbers of subjects covered by the research, the duration of the research, and the method of storing samples and data, which shall not replace the individual information and declaration of consent of those concerned.

The genetic sample or data obtained during genetic research should be processed in a way not allowing for personal identification and according to a distinct characteristic of the group covered by the research.

Article 17(4) is concerned with the fear of genetic reductionism. Human genetic research on human behavior should be conducted in such a manner that respects the dignity of the individual by taking into account the extra-genetic features of personality. At the moment, there are no detailed provisions how to ensure this due to the lack of an adequate tool. A social scientist trained in psychology and/or sociology should be involved in the research to avoid stigmatization and to jump too quickly to the conclusion of genetic determinism.

During the research, the person concerned may request the encoding, pseudonymization, or anonymization of the genetic sample intended for research purposes only and of the derived genetic data. The use of non-anonymized genetic sample or data stored in an archived collection for a new research necessitates the declaration of consent of the person concerned under Article 8(1). When the person concerned does not give their consent to use for a given research, the sample and the data may not be used for the given purpose.

Genetic data can only be stored together with personal identification data if the genetic sample upon consent of the person concerned and if the genetic sample is encoded. The genetic sample or data can be used for human genetic research purposes without encoding and a special consent if the declaration of the person concerned under Article 8(1) allows for it.

For the purposes of further processing the genetic sample or data that were collected before this Act entered in force, the persons concerned shall be called on to provide a declaration of consent under Article 8(1) by setting a deadline of 6 months as from the entry into force of the Act. For this purpose, the data processor needs to publish an invitation on the website and in the official gazette of the Ministry managed by the Minister in charge of health affairs (Article 20). When consent cannot be obtained, the genetic sample or data shall be anonymized in accordance with the requirements of this Act. Therefore, anonymization is interpreted as a tool for securing data protection.

Security of Genetic Data

The third element of returning data to gene donors is the security of the genetic data. During the storage of the genetic sample or data, the protection of the genetic sample or data shall be ensured against destruction, termination, change, injury, publication, or access by unauthorized persons (Article 24). Unless provided otherwise by this Act, genetic samples and data shall be stored in an encoded format. Encoded genetic samples, data, and code keys shall be stored separately, both physically and electronically. Access to the code key shall be authorized to a person being responsible under Article 26 within the framework of this Act. During the separate storage of the code key, it shall be ensured that no other person may access it apart from the person entitled thereto.

The code of the pseudonym sample or data shall be put at the exclusive disposal of the person providing the sample. Genetic sample or data may be stored together with personal identification data only subject to the consent of the person concerned (Article 25[1]). A register containing genetic samples and data stored together with personal identification data or encoded genetic samples and data may not be linked to a register containing personal identification data (Article 25[2]).

Within the biobank, the person responsible for the protection of genetic samples and genetic data, the registering of genetic samples and data, and the keeping of the register shall be the head of the institution maintaining the biobank and the person designated by the latter for the supervision of the operation of the biobank. Every genetic sample and data stored in the biobank and all related procedures and activities and the forwarding of the genetic sample and data shall be registered for at least 30 years following the recording of the data, except when the person concerned withdraws their consent to the treatment of genetic data. In such a case, every register relating to genetic data shall be destroyed following the information of the person concerned. Subsequent to the mandatory registration period, the data shall be subject to treatment under the Parliamentary Act on healthcare data. The register may be also an electronic one.

Special Rules on Biobanks

The fifth Chapter of the Act provides the rules on the operation of biobanks. A biobank may be established and maintained by a health service provider authorized to conduct genetic studies and certain medical researches by the health service authority (Article 23[1]). A research plan may be authorized only in the event that the institution engaged in human genetic research has a biobank or avails of conditions related to the establishment and maintenance of a biobank under this Act and special legislation. The operation of a health service provider engaged in human genetic research may be authorized only when it has a biobank or avails of conditions related to the establishment and maintenance of a biobank under this Act and special legislation.

A biobank may provide another biobank (or an entity with a proper research authorization for the purposes of the Act) with genetic samples or data. The health authority shall keep a register, separate from that of health service providers, on biobanks and institutions storing genetic samples and data under a valid research authorization, which shall be publicly accessible. Data necessary for keeping the register shall be provided by authorities and persons authorizing the operation and the research plan immediately following the issue of the authorization. The register may not contain genetic data.

Rules on biobanks shall be applied on every collection of cells, tissue samples, or other human biological materials obtained for the purpose of research and treatment. For human genetic studies, only encoded genetic samples may be transmitted to third countries. Genetic sample or data from a third country may enter the Hungarian territory only if the requirements laid down in the Hungarian law are ensured. Certificates need to be obtained from local health authorities. Genetic samples and data that are anonymized in accordance with the requirements of this Act before it entered into force may be processed in line with the Act for human genetic research and examination.

Despite biobanks started to operate in Hungary many years ago, current applications that are submitted to the National Research Ethics Board with the intent to do research and store tissues in biobanks are still hesitant about using the same biobank data for multiple uses. Although the Hungarian law provides strong and explicit rights to biobank participants, active participation and the request for the return of results is rare due to the lack of open consultations with the public.

Conclusions

Early regulations on genetic data and biobanks struggled with the discrepancy between the rights of gene donors and those of researchers to access and transfer data and to conduct research on them. Given that the general public is becoming more literate about genetics, people want to learn more about their own genetic data and, therefore, the paternalistic legal attitude of the past (to protect individuals of learning their genetic test results) does not seem to meet these changing attitudes. In the future, people should be given more options, for example, they should have the possibility to contact a biobank if they wish and ask to return relevant data. Convenience (complications with the contacting the patient) is not a valid argument against the return of research results, and data protection law does not recognize it.

Although the Hungarian law was not made in the first legal “biobank wave” when national biobanks (like in Estonia and in Iceland) were set up, it nevertheless came into force before the commercial usage of biobank research. As a result, the law remains mainly within the classic research paradigm. Still, it already provides protection to the participants in genetic research and genetic examinations, while the rights of the researchers are not as broadly protected as it was the case in the early legislative attempts. However, the legal framework can and should become more flexible in the future to accommodate both those who do not want to know the research results and those who do like to be informed to be able to make choices of lifestyle or future therapy or to take simple precautionary measures. Although the Hungarian law does not provide detailed guidance for such a flexible and participatory model that takes into account the choices of the biosocial citizens of the future, it already offers a sort of legal skeleton.