How to achieve ‘free movement of tissue’ in the EU research area 1
How to achieve ‘free movement of tissue’ in the EU research area 1
Abstract and Keywords
In accordance with Garwood-Gowers' observation of governments' interests in human tissue research, this chapter explores the shipment of tissue samples and data between countries as it is promoted by the establishment of the European Research Area (ERA). Whilst biobank-related research brings new opportunities for Europe and the world, at the same time it raises the question of Europe's ability to sustain a competitive edge in knowledge and innovation. One factor affecting Europe's ability to sustain its edge in biomedical research are the legal and regulatory challenges to the shipment of biological samples across the borders of its member states. While sample shipment has become an industry of its own, the legality of sending a sample of human origin from, let's say, the Dutch pathology archives, to a (public) research institute in Sevilla, Spain, is fraught with uncertainty for EU scientists and their institutions. This chapter addresses the legal challenges of tissue transfer by taking into account the different concerns of stakeholders and donors, but also concerns couched at institutional or national levels. It suggests a way to overcome these concerns. In particular, it suggests meeting the donors' concerns by informed consent procedures and institutional concerns by a special sample transfer policy. In response to national concerns, export controls are recommended.
In one sense, Antoni van Leeuwenhoek (1632–1723) can be considered the founding father of cross-border tissue banking. The Dutch autodidact scientist not only invented and manufactured his own microscopes, but also collected and analysed, among many other specimen, his own tissue, including the plaque on his teeth, his own blood, and his own sperm. He annotated his observations in great detail, arranged for their proper imaging, and shipped the results from Delft, The Netherlands, to the Royal Society in London. There his work was discussed, replicated, and subsequently published in the Society’s Philosophical Transactions. Some of the samples he sent were so perfectly preserved that they can still be analysed today, almost 400 years after their submission to the Society’s collection.
At the time, van Leeuwenhoek’s ‘data and sample sharing’ with the international scientific community did not raise any concerns or anxieties and did not met encounter any regulatory hurdles. Today, the widespread availability of annotated samples to the international scientific community seems just as pivotal to scientific progress as the availability of Van Leeuwenhoek’s groundbreaking contributions. Yet while scientific research on human tissue is international by definition and human tissue samples have been shipped across European borders for centuries, these shipments are now a cause for anxiety and restrained by uncertainty over their legality. After a brief discussion of the root causes of this concern, this chapter will explore practical and legal pathways to overcome these concerns and uncertainty. In the absence of pertinent European Union regulation of the use of human tissue for research, I will draw an analogy between the international transfer of human tissue and the international transmission of personal data. This analogy suggests that cross-border shipments are permitted, provided that adequate safeguards are in place to address stakeholder concerns. Notably, analysis of the EU framework for cross-border transfers of personal data reveals a pragmatic public–private law approach to providing donors with adequate safeguards for cross-border shipments of their tissue in the form of an EU-approved set of standard contractual clauses. The analogous use of these clauses not only safeguards the interests of the institutions that are the parties to such contracts, but also provides enforceable civil remedies which empower individual donors whose tissue is being transferred to (p.128) secure their own interests, and thus allow free movement of human tissue for research in the EU research area.
13.3 Anxiety over tissue flows results from concerns over abuse
The root cause of the current anxiety and uncertainty surrounding the flow of human tissue across national (European) borders can be traced back to the interests of the stakeholders in cross-border sample flows. The stakeholders and their individual concerns can be roughly divided into three groups (Table 13.1).
The concerns of each stakeholder can be summarized as follows. A major concern for donors relates to the perceived potential of their tissue being cloned by a foreign scientist. Hence they do not want their sample to be shipped to, say, South Korea (Hwang et al. 2005). A second concern for many donors is the potential for their tissue to be used for commercial purposes by a foreign company (see Chapter 5, section 5.3 in this volume). As observed in a report by the Australian Law Reform Commission:
Another thing that clearly emerged at the public forums is the atavistic or primal fear among members of the community about their genetic material being sent ‘overseas’ (again, often expressed as being ‘sent to the US’).…So, at almost every event, someone in the audience expressed concern about volunteering for an experiment at an Australian university research lab or teaching hospital, then finding that the research group had ‘spun off’ into a private biotech company, which then merged with or was taken over by American interests—and ‘the next thing you know, your DNA is overseas’! (Weisbrot 2004)
Briefly, most donors do not want to find their freely donated DNA ‘listed’ overseas on the New York Stock Exchange. Also, donors have expressed serious concerns about the potential for sensitive data to be obtained from their sample and related concerns over the safe storage of their samples. As Nils Hoppe observes, ‘it is inherent in the research methodology of many biobanks that a linkage to a specific individual is required for the research to be conducted and that the identifiability of the data subject hinges on the density of other data and contemporary technological means’.2
With regard to institutional concerns, institutions storing collections of samples must primarily honour any commitments, contractual and statutory, to the donors of these samples. This may force them to retain ownership or intellectual property rights of their collections and to provide adequate safeguards to protect data confidentiality. Also, as these samples are a finite resource, the institutions must take care to preserve the collection and set priorities for their limited use. With regard to national concerns, the investments that some nations have made in collecting
Table 13.1 Stakeholders and individual concerns
Private: cloning, commerce, confidentiality
Institutional: depletion, investment, acknowledgment
National: biosafety, biopiracy, bioterrorism
The above concerns have been addressed in a number of rules and regulations. Paradoxically, this has resulted in a thicket of diverging and often conflicting regulations which have added layers of complexity. This complexity is further compounded by the number of jurisdictions involved, as evidenced in Chapters 8 (the UK framework), 10 (the Swiss framework), 11 (the French framework), 12 (the Italian framework), and 14 (comparing German and European guidelines) of this volume. Evidently, donor, institutional, and national concerns arise every time tissue is collected and used for research, whether at home or abroad. However, these concerns are amplified when the tissue is shipped across borders, as the stakeholders have no assurance that the country of destination provides ‘adequate protection’ of their respective interests. This raises the question of how these concerns can be addressed and how adequate safeguards can be given.
13.4 How to address national concerns
13.4.1 No export
An intuitive and indeed pragmatic solution is to ‘just say no’ to the export of collected tissue to third countries. When the tissue is kept in the country of origin, any concerns over its abuse overseas will be avoided. In addition to outright export bans, some countries have enacted legislation prohibiting tissue collections from their citizens to be shipped abroad. Article 18 (4) of the Estonian Human Genes Research Act provides that ‘all tissue samples (in the GeneBank, JAB) shall be stored in the territory of the Republic of Estonia’. However, the Government of the Republic may, at the request of the chief processor of the collection and if good reasons therefore become evident, grant permission for tissue samples to be stored outside the territory of the republic if it is ensured that the chief processor has effective control over the tissue samples and that the tissue samples cannot be used in a manner prohibited by Estonian law.3 In Iceland, the transport of human tissue other than for diagnosis or quality control is subject to the approval of the National BioEthics Committee and the Data Protection Authority.4
(p.130) 13.4.2 Export control
With respect to national concerns for bioterrorism, EU Council Regulation No 1334/2000 of 22 June 2000 could apply. This regulation sets up a Community Regime for the control of exports of dual-use items and technology.5 Dual-use goods and technologies are products and technologies which are normally used for civilian purposes but which may have military applications. Annex IV of the Regulation details the items that are controlled prior to being transferred within the Community. To that end, the Annex implements internationally agreed dual-use controls including the Wassenaar Arrangement, the Missile Technology Control Regime (MTCR), the Nuclear Suppliers’ Group (NSG), the Australia Group, and the Chemical Weapons Convention (CWC). As of 28 October 2009, human tissue samples were not listed in the Annex.
13.5 How to address institutional concerns
13.5.1 Control through ‘in-house analysis’
Existing biobanks differ in the way that they make their samples accessible. Some, like the UK Biobank, do not release their samples to researchers but instead perform the analyses requested by third-party researchers themselves, unless there is a compelling case for physical release to the researcher. Others encourage third-party requesters, including those from abroad, to use the services of locally designated parties for genotyping rather than genotyping in their own laboratories, for reasons of costs, speed, and creation of added value for the collection.
However, the choice of in-house analysis may be dictated not only by considerations of cost, efficiency, or the prospect of raising extra revenue, but also by considerations of data protection and commitments made to sample donors (e.g. the samples will not leave the country or even the repository). Export bans or in-house analysis policies are likely to alleviate donor concerns. In addition, these concerns may be lessened by informing donors about (possible) international shipment of their samples, the transfer policies to which applications for international shipment will be subject, and the conditions attached to such shipment. Based on this information, donor interest could be further protected by stipulating that donors consent to international transfer of their samples.
13.5.2 Institutional control through access policy
Any institutional challenges could be addressed by establishing a policy for sharing and distributing samples. Such a policy should include a clear and transparent procedure for reviewing requests for international transfer of samples. The policy is to make clear exactly what tissue can be transferred as well as define what tissue will not be transferable. Further safeguards can be built in by establishing a separate transfer committee. The elements to be considered by such a committee when reviewing a request for transfer could include, but are not limited to, the following:
1. the nature of proposal;
2. whether the proposal meets the scientific objectives of the bank;
3. the potential impact of the science;
4. whether the proposal concerns a high- or low-impact disease;
5. whether the requesting party is a for-profit or a not-for-profit organization;
6. the credentials and competence of the requesting party and his/her institution;
7. the quality of the proposal;
8. the types of analysis proposed to be performed on the tissue;
9. the amount of tissue requested per analysis;
10. the scope of informed consent;
11. commitments to participants to return results and/or benefits accrued by the proposed research;
12. the willingness of the requesting party to provide reciprocal access on similar terms;
13. the willingness to pay for a return on investment, with the possibility of differentiating fees by type of requester (for-profit or not-for-profit).
13.5.3 Institutional control through transfer agreement
Next to having in place a policy for sharing and distributing samples and a clear and transparent procedure for reviewing requests for transfer of samples, it is considered ‘best practice’ to only allow the transfer of samples on condition that a material transfer agreement (MTA) has been implemented (this contractual agreement practice is used by French biobanks, for example (see Chapter 11, section 11.2). The implementation of an MTA not only serves to allocate intellectual property rights or to secure proper handling of the material, but also serves as a means by which the tissue bank can meet its obligations towards its participants who donated the material and who may continue to donate samples during the lifespan of the biobank. For example, the MTA could contain a representation on the part of the transferring institution that proper informed donor consent for the transfer has been obtained. The MTA also provides a means of defining and limiting the purposes for which the tissue will be used, for example by allowing or prohibiting genetic characterization of the tissue. A condition which must be met before any tissue can be transferred is that the recipient has the approval of the competent medical ethical review board for the proposed research on the tissue, as set out in the Protocol attached to the agreement. Other conditions could pertain to the provision of evidence by either party that they have obtained all appropriate import and export licenses. Typical undertakings in such MTAs are that the recipient may only use the tissue ‘for the common good in scientific research’, that the recipient shall not use the tissue for profit or any other commercial gain, and that the recipient may not use the tissue in human subjects. Other undertakings relate to confidentiality (e.g. the recipient shall refrain from tracing or identifying the donor of the tissue), feedback of findings and data (e.g. recipient shall share all data, results, and analyses generated in the course of its processing of the tissue), and ownership and intellectual property (e.g. title to the tissue is and remains in the ownership of the tissue bank).
13.6 How to address donor concerns
13.6.1 Donor control through consent and/or property
The best way for a donor to control international transfer of tissue is via consent (however, see Chapter 2 for the limits of this concept). It seems to follow from the traditional doctrine of informed consent for participation in research that institutions have a legal obligation to inform donors that their tissue might be transferred for research abroad. Consequently, as part of the consent process, donors could withhold their consent to international transfer. Consent for international shipment of samples is routinely asked for in consent documentation for clinical trials. (p.132) In tissue research involving volunteers donors are also being informed that their tissue may be shipped across borders and asked for explicit consent to such shipment. In addition to the control afforded by the requirement of informed consent, Dutch donors can exercise control over their tissue, after it has been shipped abroad (with their knowledge and consent), on the basis of their property rights in their tissue, provided that they have not waived such rights. Under the Dutch Act on Conflicts of Law regarding chattels, donor property rights in their tissue will not be affected by the transfer of such property to another state. This could include, for example, a civil law action for ‘restitution’ of their tissue.
13.6.2 Adequate safeguards
Currently, there is no EU legislation with direct application to the use of human tissue for research. Of course, there is an EU Regulation for the Quality and Safety of Human Tissue for Therapeutic Use in Humans (Transplants), but this Regulation does not apply to the issue at hand; its scope is limited to human tissue that is used as a transplant or implant for therapeutic use in another human. Although European law is silent on the issue, the European Union is bound by the fundamental human rights and freedoms which are laid down in the European Convention for the Protection of Human Rights and Fundamental Freedoms (ECHR) and in the protocols attached to this Convention. Examination of the various protocols of the Council of Europe revealed Recommendation Rec(2006)4 on research on biological materials of human origin. Article 16 of this Recommendation provides that transport of human tissue to third countries is allowed, provided that ‘adequate safeguards are in place’.6 This raises the question of what safeguards can be considered’adequate’ and how such safeguards can be put in place. The answer can be found in the Explanatory Notes to the Recommendation, according to which the adequacy of the level of protection afforded by the importing state must be assessed in light of all the circumstances surrounding the transfer. The assessment must consider the nature of the biological materials, the purpose and duration of the proposed research, the state of origin, and the security measures complied with in that state.
13.6.3 Contractual clauses
Notably, the Explanatory Notes to the Recommendation specifically provide that adequate safeguards may result from contractual clauses. However, while this Council of Europe Recommendation provides a legal instrument for the legitimate transfer of human tissue from one country to another (i.e. a contract), it stops short of providing both the specifics and the enforcement mechanisms for such a contract. What clauses should such a contract contain in order to satisfy the requirement of ‘adequate safeguards’? Who should be the parties to such a contract? And, as contracts only bind those who are privy to them, how could a third party benefit from the safeguards it contains? For the answers to these questions, we could revisit the laws of the European Union, if draw an analogy between the transfer of human tissue and the international transfer of personal data. As we will show, the concept of using contractual clauses to ensure ‘adequate safeguards’ for cross-border transmission is already deeply rooted in EU data protection law.
(p.133) 13.7 EU law on international transfer of personal data
13.7.1 The principle of adequacy
In the 1990s, the European Union harmonized the various national laws of its member states on the protection of personal data by adopting Directive 95/46/EC (henceforth ‘the Directive’) on the protection of individuals with regard to the processing of personal data and on the free movement of such data (European Parliament and the Council of Europe 1995). The objective of the Directive is to authorize the free flow of personal data between EU member states by imposing a harmonized set of minimum standards protecting the fundamental right of the citizens of member states to privacy with respect to the processing of personal data (Directive, Article 2, Poullet 2006). In addition to establishing the free flow of personal data within the EU, the Directive also provides a mechanism for the transfer of personal data from an EU member state to a non-EU state. The Directive provides that personal data can only be transferred from an EU member state to a third country if the third country has an adequate level of data protection (Directive, Article 25(1)). The adequacy of protection is to be ‘assessed in the light of all the circumstances surrounding a data transfer operation or set of data transfer operations’ (Directive, Article 25(2)). The principle of adequacy is not concerned with the general provisions of law in a third country with regard to data protection, but with the actual level of protection which will be afforded in a particular situation (Aldhouse 1999; Kuner 2001). As a result, the determination of an adequate level of protection is based on a case-by-case scenario instead of evaluating the country overall.
13.7.2 Adequacy by contract
Even transfers of personal data to a third country not offering an adequate level of control may still be authorized using various possibilities under the Directive. One such possibility is the condition that the data exporter adduces adequate safeguards (Directive, Articles 26(1) and 26(2)). Specifically, such safeguards may result from appropriate contractual clauses (Directive, Article 26(2)). In other words, under the Directive, transfers of personal data to third countries, which have not yet been determined by the Commission as offering an adequate level of protection, may be authorized through the use of a contract to be agreed to by the data exporter and the data importer. To establish what contractual clauses offer an adequate level of protection, the Directive provides that the European Commission decides that certain standard contractual clauses offer sufficient safeguards. The member states must comply with the Commission decision (Directive, Art. 26 (4)).
13.7.3 EU standard contractual clauses
In its published Decision of 27 December 2001,7 the European Commission adopted a set of standard contractual clauses pursuant to Article 26(2) of the Directive, i.e. clauses that are considered as offering adequate safeguards with respect to the protection of the privacy and the fundamental rights and freedoms of individuals and as regards the exercise of the corresponding rights8. The overall idea of using the EU standard contractual clauses is to ensure that data exporters and data importers are assured that the data transfer will have adequate protection (Zinser 2003). In these clauses, the parties agree to a legally enforceable declaration whereby both parties, (p.134) the data exporter and the data importer, process the data in compliance with basic data protection rules and principles (Sotto et al. 2008).9
13.7.4 Content of the EU standard contractual clauses
The EU standard contractual clauses (SCCs) provide an adequate level of protection in third countries by imposing a list of obligations to be satisfied by both the data exporter and the data importer. In general, the data exporter must comply with the laws of the EU and ensure that the data are adequately protected. The data importer, on the other hand, must guarantee that he/she is not aware of any national legislation that prevents him from fulfilling the obligations under the SCCs and that the data are processed appropriately. The obligations include, but are not limited to, the obligation to process the personal data in accordance with the mandatory data protection principles set out in Appendix 2 and to submit its data processing facilities for audit. The principles set out in Appendix 2 include purpose limitations, data quality and security, and the rights of the data subject to access, rectification, deletion, and objection. Although there is no differentiation among the transfer of general personal data and sensitive data under the Directive and the Commission Decisions, the standard contractual clauses require the data exporter to notify the data subject that such sensitive data may be transferred to a country that does not provide an adequate level of protection.10
13.7.5 Member state control
While the conclusion of a contract containing the SCCs provides a sound legal basis for the international transfer of the data, it does not, by itself, obviate the need to have a legal basis for making the transfer of data in the first place. This follows from the fact that an international transfer of data is a form of processing of personal data and thus requires a legal basis. Although the SCCs are an instrument to satisfy the requirement of adequacy, the data protection authorities in the member states still retain powers to prohibit or suspend data transfer in exceptional circumstances (ibid.). National data protection authorities may also issue ad hoc contractual clauses to be used in agreements for the transfer of data based on national law (ibid.). However, if the data transfers are made under contracts using the SCCs, member states cannot exercise their powers (ibid.).
13.8 Donor as third-party beneficiary
13.8.1 Third-party beneficiary
While SCCs should go a long way towards alleviating concerns over abuse, as a general matter of law, contracts only bind those who are privy to them. This raises the question of how the protection of individual donors could benefit from contracts between institutions and foreign researchers. The answer is provided by the civil law doctrine of the ‘third-party beneficiary’. In fact, this solution has been worked out in the EU regime for SCCs. Analysis of the SCCs reveals another feature which is likely to reinforce the position of the donor. Recital 16 to the Commission Decision11 provides that the SCCs should be enforceable not only by the organizations which are (p.135) parties to the contract, but also by the data subjects whose data is being transferred between the two organizations. In particular, this applies where the data subject suffers damages as a consequence of a breach of the contract. The governing law of the contract should be the law of the member state in which the data exporter is established, enabling a third-party beneficiary to enforce a contract on his ‘home terms and turf’.
13.8.2 Enforcement by (associations of) donors
In Chapter 2, Barilan provides anecdotal evidence to the effect that contracts must be enforceable if they are to avoid violations of human dignity. According to legend, the undertakers who, in consideration of a hefty fee, promised Charles Byrne (the poor Irish Giant) that they would bury him at sea, broke their promise and sold his skeleton to the surgeon John Hunter instead.
Enforcing the terms of the SCCs could indeed be problematic for an individual donor. However, under the EU regime, donors are not left to their own devices. The EU regime provides that data subjects are allowed to be represented by associations or other bodies if they so wish and if authorized by national law. This enables donors who participate in a major biobank to unite and have their representative organization act as a watchdog for the use of their tissue overseas, backed up by the power to initiate legal proceedings on behalf of the donors. Instead of setting up their own organization, donors could opt to have themselves represented by an established patient or consumer advocacy group. To further reduce practical enforcement difficulties, the SCCs stipulate that the data exporter and the data importer should be jointly and severally liable for damages resulting from any violation of those provisions which are covered by the third-party beneficiary clause. Therefore, when data subjects have suffered any damage as a result of the breach of SCCs, by either party, they can take action and receive compensation from the data exporter, the data importer, or both.
Notably, the statutorily imposed mechanism of making data subjects third-party beneficiaries of protective measures, backed up by joint liabilities and accessible remedies, provides a powerful and practical means of helping donors realize the ‘key concepts of the ethical debate’ discussed in Part I, specifically human dignity, respect for the person, and trust in scientific research.12 Even more notably, so far the legal–ethical debate of these key concepts has failed to even note the availability of these European safeguards.
13.9 Combining MTA and EU standard contractual clauses
The above analysis shows that both institution and donor concerns over cross-border flows of their tissue could be addressed by having an agreement in place: an MTA to address institutional concerns and a contract containing SCCs to address donor concerns. In order to promote efficiency and avoid duplication of bargaining and paperwork, the two contracts should be combined. The combination of MTAs and the SCCs further fosters ‘individual as well as collective empowerment that would enhance and support public trust and sustainable partnerships in research’ (Kanellopoulou in Chapter 5, section 5.6).
Combining MTAs and SCCs also creates the opportunity to make the necessary additions to the SCCs. While the analogy between tissue transfers and transfer of personal data goes a long way, it is not complete. Tissue is different from mere personal data, so when the SCCs are being used as a legal basis for transfer of tissue, appropriate provisions addressing tissue-specific concerns must be added. Such provisions can be found in the standard MTA discussed above and (p.136) might include restrictions on the use of the tissue, the obligation to return unused parts of the tissue, prohibitions of commercial use, etc.
Concern and uncertainty over the legality and conditions of cross-border tissue flows hampers EU research. It follows from both EU law and the laws of the Council of Europe that cross-border tissue flows are allowed provided that adequate safeguards are in place. The mechanism developed by the EU, i.e. standard contractual clauses, can be used to establish adequate safeguards for the international transmission of personal data. The SCCs further reinforce the position of the donor, as they are enforceable not only by parties to the contract, but also by the data subjects whose data is being transferred between the parties. The clauses also allow the donor to have associations act on his/her behalf and reduce practical enforcement difficulties by holding the data exporter and the data importer jointly and severally liable for damages resulting from any violation of the SCCs. By integrating the SCCs with the terms of the MTA, the rights and obligations of all stakeholders will be established. Last but not least, this solution demonstrates that the alleged lack of European legal certainty and protection can be remedied by making use of the legal mechanisms that the European Union has had in place for over a decade to help its citizens realize key ethical concepts in biomedical research: their human dignity, respect, and trust in research.
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(1) This chapter is based on the author’s presentation at the Tiss. EU First Project Conference on 28 June 2008 in Göttingen, Germany.
(3) Estonian Human Genes Research Act, passed 13 December 2000, RT I 2000, 104, 685, came into force 8 January 2001.
(4) Icelandic Act on Biobanks, No.110/2000, 12 September 2000.
(5) Council Regulation (EC) No 1334/2000 of 22 June 2000 setting up a Community Regime for the control of exports of dual-use items and technology.
(7) Commission Decision 2001/497 of 15 June 2001, on Standard Contractual Clauses for the Transfer of Personal Data to Third Countries under Directive 95/46/EC, 2001 OJ (L 181/19) 1539.
(8) Commission Decision 2001/497, Article1.
(9) In addition to clauses for controller-to-controller transfers, the Commission has also adopted a set of contractual clauses for controller-to-processor transfers of data, Commission Decision 2001/16 of 27 December 2001 under Directive 95/46/EC, 2002 OJ (L 6/52).
(10) Clause 4(b) of Commission Decision 2001/16 of 27 December 2001.
(11) Commission Decision 2001/16 of 27 December 2001.