Limits to the validity of contracts on human tissue in Italy, England and the EU
Santamaría, Enrique
DOI:
10.33612/diss.122733643
IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please check the document version below.
Document Version
Publisher's PDF, also known as Version of record
Publication date: 2020
Link to publication in University of Groningen/UMCG research database
Citation for published version (APA):
Santamaría, E. (2020). Limits to the validity of contracts on human tissue in Italy, England and the EU: a comparative analysis. University of Groningen. https://doi.org/10.33612/diss.122733643
Copyright
Other than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons).
Take-down policy
If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim.
Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons the number of authors shown on this cover page is limited to 10 maximum.
Limits to the validity of contracts on human tissue in
Italy, England and the EU
A comparative analysis
ISBN 978-94-034-2463-7
© O.E. SANTAMARÍA ECHEVERRÍA, 2020
Printed by: Ridderprint, www.ridderprint.nl
Limits to the validity of contracts
on human tissue in Italy, England
and the EU
A comparative analysis
PhD thesis
to obtain the degree of PhD at the University of Groningen
on the authority of the Rector Magnificus Prof. C. Wijmenga
and in accordance with the decision by the College of Deans. This thesis will be defended in public on
Monday 20 April 2020 at 18.00 hours
by
Orlando Enrique Santamaría Echeverría
born on 13 July 1987Supervisors
Prof. A.J. VerheijProf. A.L.B. Colombi Ciacchi
Assessment Committee
Prof. G. Resta Prof. M.H. Wissink Prof. H.N. SchelhaasAcknowledgements
I first of all want to express my gratitude to my supervisors, Professor Aurelia Colombi Ciacchi and Professor Albert Verheij for guiding me during the years of research that culminated in this book. Aurelia, I am grateful for your enduring and patient help in navigating the, often difficult, waters of the PhD life. Your advice and kind support was essential to my development as a researcher. Albert, I am thankful for providing me with the opportunity to embark in this project, for your special attention to details, for encouraging me, and for our refreshing discussions about art and literature.
I also want to thank the members of the assessment committee, Professor Harriët Schelhaas, Professor Mark Wissink, and Professor Giorgio Resta for their time and valuable comments on this work. Your comments not only proved helpful in improving this book, but also provided me with fertile insights for future research. I am also thankful to Professor Martijn Hesselink, Professor Hanoch Dagan, Professor Aditi Bagchi, Assitant Professor Lyn Tjon Soei Len, and all the other participants in the summer schools at the University of Amsterdam for their comments and feedback to preliminary parts of this book. Furthermore, I want to thank Professor Pauline Westerman and Marjolijn Both for their vital support during these years.
In addition, I want to express my appreciation to Professor Paula Giliker and Professor Giorgio Resta for generously allowing me to conduct research and access the library collections at the University of Bristol and Università Roma Tre, respectively. I also want to thank the Max-‐Planck-‐Institut für ausländisches und
internationales Privatrecht in Hamburg for providing me with a workplace and
access to its valuable collections.
I am also immensely thankful to Professor Emilssen González de Cancino for her enduring guidance since my early days as a student at Universidad Externado de
Colombia. To my home university I owe the possibility of financing my L.L.M and
PhD studies at the University of Groningen.
I am also happily indebted to my friends and colleagues Jantina Hiemstra, Lea Diestelmeier and Marnix Wallinga for their friendship and life companionship. Finally, I want to thank my parents, Orlando and Teresa, and my sister Violeta for their unconditional and selfless love and support. I could not have finished this process without you. Last, but not least, my gratitude goes to my love, Stephanie, for becoming the rock upon which everything else is built.
Bogotá, 20 April 2020
Acknowledgements ... 5
List of Abbreviations ... 12
PART 1 INTRODUCTION ... 15
CHAPTER 1 Background, scope and research questions, delimitation and terminology, methodology and structure ... 17
1.1 Background ... 18
1.2 Scope and research question ... 20
1.3 Delimitation and terminology ... 21
1.3.1 International law, supranational law and national legal systems ... 21
1.3.2 Terminology ... 22
1.4 Methodology ... 24
1.5 Structure ... 25
PART 2 IMPACT OF INTERNATIONAL AND EUROPEAN LAW ... 29
CHAPTER 2 Limits to the use of human tissue in Italy and England & Wales under international and European human rights law ... 31
2.1 Overview ... 32
2.2 Incorporation of international law in Italy and England & Wales ... 33
2.2.1 Italy ... 33
2.2.2 England & Wales ... 36
2.3 Vertical and horizontal direct effect of EU law ... 37
2.4 Horizontal effect of the Charter of Fundamental Rights of the EU ... 38
2.4.1 Italy ... 39
2.4.2 England & Wales ... 40
2.5 International and EU law provisions that may impact the validity of contracts on human tissue in Italy and England & Wales ... 41
2.5.1 Preliminary remarks ... 41
2.5.2 Dignity, equality and respect for human rights ... 41
2.5.3 Respect for private life and protection of personal data ... 42
2.5.4 Consent and integrity of the person ... 43
2.5.5 Miscellaneous provisions ... 44
2.6 Concluding remarks on the international and European human rights limits to the use of human tissue ... 44
CHAPTER 3 Limits to the use of human biological samples under the General Data Protection Regulation ... 49
3.1 Overview ... 50
3.2 Human biological samples and sensitive data ... 50
3.3 The European data protection model ... 51
3.4 The General Data Protection Regulation ... 53
3.5 National data protection laws ... 59
3.5.1 Italy ... 59
3.5.2 England & Wales ... 64
3.6 Concluding remarks ... 66
CHAPTER 4 Contracts on human tissue in the multi-‐level system of sources of
law………. ... 75
4.1 Overview of the relevant sources of law ... 76
4.2 Overview of the content of the following chapters ... 77
CHAPTER 5 Contracts on human tissue in the light of general private law norms on the invalidity of contracts ... 79
5.1 Overview ... 80
5.2 Nullity of the contract ... 81
5.2.1 The constitutive elements of the contract: the agreement and the object ... 81
5.2.2 The constitutive elements of the contract: the cause ... 82
5.2.3 The illegality of the contract ... 86
5.3 The annullability of the contract ... 91
5.3.1 Incapacity ... 91
5.3.2 Vices of the will ... 92
5.4 The rescindability of the contract ... 95
5.5 Concluding remarks on the validity of contracts on human tissue under general private law ... 95
CHAPTER 6 The effect of constitutional norms on the validity of contracts on human tissue ... 99
6.1 Overview ... 100
6.2 Fundamental principles and fundamental rights ... 100
6.2.1 Preliminary remarks ... 100
6.2.2 Human dignity and fundamental rights under the Italian Constitution ... 101
6.3 Horizontal effect of fundamental rights and constitutional principles ... 103
6.4 General constitutional framework for the regulation of acts of disposition of the human body ... 104
6.5 Concluding remarks on the effect of constitutional norms on the validity of contracts on human tissue ... 109
CHAPTER 7 Contracts on human tissue and Article 5 of the Italian Civil Code 113 7.1 Overview ... 114
7.2 Legislative history and regulatory aims ... 114
7.2.1 The Vornonoff case ... 114
7.2.2 Article 5 C.C: historical background and regulatory objectives ... 116
7.3 The notion of physical integrity in Article 5 C.C. ... 119
7.4 Law, public order or good morals as limits to the validity of private acts under Article 5 C.C. ... 121
7.5 Concluding remarks on the validity of contracts on human tissue under Article 5 C.C. ... 122
CHAPTER 8 Contracts on human tissue and Article 50 of the Italian Penal Code ... 125
8.1 Overview ... 126
8.2 Article 50 C.P. and the doctrine of consent on interferences in one’s body ... 126
8.3 Relationship between Article 50 C.P. and Article 5 C.C. ... 127
8.4 Concluding remarks ... 129
CHAPTER 9 The debate on the prohibition of financial gain from the human body and its parts ... 131
legal bases ... 132
9.3 First position: Resta and Dell’ Utri ... 135
9.4 Second position: Romboli, Alpa, Ansaldo ... 137
9.5 Scope of application of the prohibition of financial gain ... 138
CHAPTER 10 Validity of non-‐gratuitous contracts on human tissue concluded between the first transferor and the first recipient ... 141
10.1 Preliminary remarks ... 142
10.2 Non-‐gratuitous contracts for the purposes of research and possible commercial uses ... 142
10.2.1 Overview ... 142
10.2.2 The relation between the general prohibition of financial gain and the legal regime of the acts of disposition of the human body ... 143
10.2.3 The adequate protection of human dignity ... 143
10.2.4 The adequate protection of personal data and privacy ... 144
10.2.5 The risks to the person’s physical integrity and health ... 144
10.2.6 The positive and negative consequences of delegating the collection of human tissue to the market ... 144
CHAPTER 11 Examples from the contract practice ... 147
11.1 Preliminary remarks ... 148
11.2 MTA’s without commercial purposes ... 148
CHAPTER 12 Concluding remarks on the limits to the validity of contracts on human tissue under Italian law ... 153
12.1 Validity of contracts on human tissue under national law ... 154
12.2 Validity of contracts on human tissue in the light of the supranational principle of prohibition of financial gain ... 155
PART 4 ENGLAND & WALES ... 159
CHAPTER 13 Contracts on human tissue in the multi-‐level system of legal sources……… ... 161
13.1 Overview of the relevant sources of law and regulation relevant for contracts on human tissue ... 162
CHAPTER 14 The Human Tissue Act 2004 ... 165
14.1 Overview ... 166
14.2 Legislative history ... 166
14.3 The Act’s rules on the use of human tissue ... 167
14.3.1 Preliminary remarks ... 167
14.3.2 General normative framework of the HTAct ... 168
14.3.3 Consent under the HTAct and the HTA Codes of Practice A and E ... 169
14.3.4 Restrictions of activities in relation to donated material and the prohibition of commercial dealings in human materials for transplantation ... 175
14.4 Concluding remarks on the validity of contracts on human tissue under the HTA ... 178
CHAPTER 15 Consent for the removal of tissue from living persons in England & Wales ... 181
15.1. Overview ... 182
15.3 Concluding remarks on the effect of the doctrine of consent on the validity of
contracts on human tissue ... 185
CHAPTER 16 Common law doctrines on the invalidity of contracts ... 189
16.1 Overview ... 190
16.2 Illegality ... 190
16.3 Public policy ... 191
16.4 Headings of illegality or public policy that possibly limit the validity of contracts on human tissue ... 193
16.5 Concluding remarks on the validity of contracts on human tissue under common law ... 196
CHAPTER 17 Fundamental rights and their effect on private relationships in England & Wales ... 199
17.1 Overview ... 200
17.2 The relationship between private law and fundamental rights under the law of England & Wales ... 200
17.3 Terminological uses of the terms ‘horizontal effect’, ‘direct horizontal effect’ and ‘indirect horizontal effect’ ... 201
17.4 Models of the horizontal effect of Convention rights ... 202
17.5 Human dignity ... 206
17.5.1 Preliminary remarks ... 206
17.5.2 Is the principle of human dignity relevant to contemporary contract law in England & Wales? ... 206
17.6 Concluding remarks on the effect of fundamental rights on the validity of contracts on human tissue ... 209
CHAPTER 18 Examples from the contractual practice ... 211
18.1 Preliminary remarks ... 212
18.2 Material transfer agreements between or within academic institutions ... 212
18.3 Material transfer agreements in which one of the parties is a company ... 216
18.4 SGC OSTA ... 217
18.5 Concluding remarks ... 218
CHAPTER 19 Concluding remarks on contracts on human tissue under the law of England and Wales ... 221
PART 5 COMPARATIVE ANALYSIS ... 227
CHAPTER 20 Comparative analysis ... 229
20.1 Introduction ... 230
20.2 Contracts on human tissue explicitly prohibited or allowed by law ... 230
20.3 General limits to the validity of contracts on human tissue ... 232
20.3.1 Stemming from supranational fundamental rights sources ... 232
20.3.2 Stemming from EU supranational sources: data protection law ... 232
20.3.3 Stemming from the rules and doctrine on the invalidity of the contract ... 234
20.3.4 Stemming from the protection of human dignity and other fundamental rights .. 237
20.3.5 Stemming from the relation between the protection of physical integrity and health, and consent ... 239
20.4 Limits to the validity of non-‐gratuitous contracts on human tissue between the first transferor and the first recipient ... 242
20.5 Limits to the validity of contracts on human tissue between the first recipient and subsequent recipients (e.g. MTA). ... 245
CHAPTER 21 The validity of gratuitous contracts on human tissue concluded
between the first transferor and the first recipient ... 253
21.1 Introduction ... 254
21.2 Consent ... 254
21.3 Identification, codification and anonymization of samples and the protection of fundamental rights ... 258
21.4 Recommendations ... 264
CHAPTER 22 The validity of non-‐gratuitous contracts on human tissue concluded between the first transferor and the first recipient ... 267
22.1 Introduction ... 268
22.2 Autonomy and paternalism ... 270
22.2.1 Autonomy as self-‐authorship ... 270
22.2.2 Hard paternalism ... 271
22.2.3 Soft paternalism ... 272
22.2.4 Limits to soft paternalism ... 274
22.3 The limits to paternalism: arguments against non-‐gratuitous contracts on human tissue for research ... 276
22.3.1. Coercion and exploitation ... 278
22.3.2 Commodification and human dignity ... 280
22.3.3. Altruism and solidarity ... 289
22.4 Governance, autonomy and paternalism in non-‐gratuitous contracts on human tissue ... 291
22.4.1 First case: Washington University vs William J. Catalona ... 293
22.4.2 Second case: Greenberg vs Miami Children’s Hospital ... 295
22.4.3 Third case: PXE International ... 297
22.4.4 Comparing the three cases: differences and similarities ... 298
22.5 Concluding remarks, recommendations and suggestions for legislative reform. ... 301
PART 7 CONCLUSIONS ... 305
CHAPTER 23 Summary of conclusions ... 307
23.1 On the limits stemming from international and supranational law sources ... 308
23.3.1 On the limits stemming from fundamental and human rights documents ... 308
23.1.2 On the limits stemming from the GDPR ... 309
23.2 On national limits derived from the application of international and supranational law documents ... 310
23.2.1 Italy ... 310
23.2.2 England ... 311
23.3 On national limits derived from the internal system of law sources ... 311
23.3.1 Italy ... 311
23.3.2. England ... 314
23.4 Comparative analysis of the limits to the validity of contracts on human tissue ... 317
23.4.1 On contracts on human tissue explicitly prohibited or allowed by law ... 317
23.4.2 On the general limits to the validity of contracts on human tissue ... 317
23.4.3 On the limits to the validity of non-‐gratuitous contracts between the first transferor and first recipient ... 321
23.4.4 On the limits to the validity of contracts between the first recipient and subsequent
recipient ... 322
23.5 This book’s position ... 324
23.5.1 On consent ... 324
23.5.2 On the protection afforded to the first transferor’s data ... 325
23.5.3 On the validity of non-‐gratuitous contracts between the first transferor and the first recipient ... 327
23.6 Recommendations ... 328
CHAPTER 24 Agenda for further debate ... 331
ANNEXES ... 335 ITALIAN MTAs ... 336 UniFi MTA ... 336 UniTo MTA ... 340 ENGLISH MTAS ... 345 Brunswick MTA ... 345 Bristol MTA ... 349 UCL MTA ... 352 Lambert MTA ... 357 SAMENVATTING ... 369 BIBLIOGRAPHY ... 379
C.C. Codice Civile Italiano
C.P. Codice Penale Italiano
Cass. Corte di Cassazione
CFREU Charter of Fundamental Rights of the European Union CJEU Court of Justice of the European Union
Corte Cost. Corte Costituzionale Cost. Costituzione della Repubblica Italiana
D.P.C. Data Protection Code DPA 1998 Data Protection Act 1998 DPA 2018 Data Protection Act 2018
ECHR European Convention of Human Rights
ECtHR European Court of Human Rights EU European Union
GDPR General Data Protection Regulation
HRA Human Rights Act 1998
HTA Human Tissue Authority
HTAct Human Tissue Act 2004
UDHR Universal Declaration of Human Rights
WHO World Health Organization
Introduction
Part 1
Background, scope and research
questions, delimitation and terminology,
methodology and structure
PART 1 INTRODUCTION
CHAPTER 1 Background, scope and research questions, delimitation and terminology, methodology and structure
1.1 Background
The development of new technologies in genetic research and the increasing understanding of the human genome has led, in the last decades, to an increase in the use of human tissue in the fields of research, diagnosis and medical treatment. In fact, the potential commercial use of genetic information and the findings of research on human tissue have awakened a growing interest of private companies on this kind of bodily materials. The exchange of human tissue that up until the 1970’s happened without the need of any formal agreements is now privately regulated by contracts.1 The use of these contracts runs parallel to an unprecedented growth of the global biotechnology market: by 2017 the market was estimated to be worth 414.5 USD and, by 2025, it is expected to reach a value of 727.1 billion USD.2
The existence and growth of this market is, paradoxically, supported by a large national, supranational and international legislative consensus on the prohibition of making the human body and its parts, as such, a source of financial gain.3 At the European level, just to give an example, Article 3.2.c of the Charter of Fundamental Rights of the European Union,4 –mirroring Article 21 of the Oviedo Convention5– prescribes that “(i)n the fields of medicine and biology, the
1 Rodriguez, 2005, p. 489; Streitz and Bennett, 2003, p. 10.
2 Data obtained from the following reports: 1) Global Biotechnology Market by Application
(Biopharmacy, Bioservices, Bioagri, Bioindustrial), by Technology (Fermentation, Tissue Regeneration, PCR, Nanobiotechnology, DNA Sequencing & Others) -‐ Industry Analysis, Size, Share, Growth, Trends and Forecast, 2010 -‐ 2017 Report at <http://www.transparencymarketresearch.com/biotechnology-‐market.html> last consulted, 2 November 2019; 2) Grand View Research, Inc. Biotechnology market
<https://www.grandviewresearch.com/press-‐release/global-‐biotechnology-‐market> last
consulted, 2 November 2019.
3 See Chapter 9 on the prohibition of financial gain.
4 Charter of Fundamental Rights of the European Union (2012/C 326/02) Published in the
Official Journal of the European Union C 326/391 the 26th of October 2012. The Charter of
Fundamental Rights of the European Union was proclaimed the 7th of December 2000, and
entered into force the 1st of December 2009 with the Treaty of Lisbon.
5 Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human
Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine Oviedo, 4.IV.1997, CETS 164 (thereafter: ‘Oviedo Convention on Human Rights and
Biomedicine 1997’). For full text see: <http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm> last accessed 2 November 2019.
For an overview of the literature on the Oviedo convention see for example: Lawson, 2010; Andorno, 2009; McCrudden, 2008; Den Exter, 2010; Beyleveld and Brownsword, 1998.
following must be respected in particular: (…) –the prohibition on making the human body and its parts as such a source of financial gain.”
Precisely because of the aforementioned prohibition on making the human body and its parts, as such, a source of financial gain, the market on human tissue is divided between downstream and upstream players. The upstream players, represented by the initial tissue ‘donors’, are, at first, not allowed to obtain direct economic befits arising from the transfer of their tissue.6 The downstream players, which include hospital, brokers, pharmaceutical companies and universities, can obtain direct economic benefits and, in some cases, are able to appropriate and restrict the access to genetic resources (and their products) via patenting technics.7
Downstream players (with academic or commercial purposes) looking for human tissue to develop their studies have two possible ways of obtaining them. On the one hand, they can obtain them from the original source of the materials, i.e. a person (alive or dead). On the other hand, they can obtain them from other institutions (hospitals, universities, etc.) by making use of contracts denominated Material Transfer Agreements (MTAs).8 A Material Transfer Agreement has been defined as “a contract that governs the transfer of tangible research materials between two organizations, a provider and a recipient, when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives. Biological materials such as specimens, reagents, cell lines, plasmids and vectors, are the most frequently transferred materials, but MTAs may also be used for other types of materials, such as chemical compounds and even types of software.”9
However, contracting via MTAs is only the second step of a chain that starts when the upstream players, i.e. the donors transfer for the first time their tissue to one of the downstream players.
In both steps of the chain the use of human tissue for research raises an innumerable amount of other ethical and legal issues e.g. the protection of human dignity, privacy, autonomy, health and other fundamental rights of the
6 I use the term donor to refer to the first transferor of the tissue, independently of whether or
not the title of the transfer is a donation contract.
7 On gene patents see, for example, Koepsell, 2009.
8 For the notion of material transfer agreement see Rodriguez, 2005.
9 International Society for Biological and Environmental Repositories (ISBER), Best Practices for
repositories: Collection, Storage, Retrieval and Distribution of Biological Materials for Research,
2001 (Third Edition) p. 88.
<http://c.ymcdn.com/sites/www.isber.org/resource/resmgr/Files/ISBER_Best_Practices_3rd_E
di.pdf?hhSearchTerms=%22contract+and+governs+and+transfer+and+tangible+and+research+ and+materials+and+between+and+two+and+organizations%2c+and+pro%22> last accessed 2 November 2019. See also the Guiding Notes for Academic Staff on Material Transfer Agreements by the Imperial College of London <https://www.imperial.ac.uk/media/imperial-‐ college/research-‐and-‐innovation/research-‐office/public/MTA-‐Guidance-‐Notes-‐Academic-‐Staff-‐ [pdf].pdf> last accessed 2 November 2019.
following must be respected in particular: (…) –the prohibition on making the human body and its parts as such a source of financial gain.”
Precisely because of the aforementioned prohibition on making the human body and its parts, as such, a source of financial gain, the market on human tissue is divided between downstream and upstream players. The upstream players, represented by the initial tissue ‘donors’, are, at first, not allowed to obtain direct economic befits arising from the transfer of their tissue.6 The downstream players, which include hospital, brokers, pharmaceutical companies and universities, can obtain direct economic benefits and, in some cases, are able to appropriate and restrict the access to genetic resources (and their products) via patenting technics.7
Downstream players (with academic or commercial purposes) looking for human tissue to develop their studies have two possible ways of obtaining them. On the one hand, they can obtain them from the original source of the materials, i.e. a person (alive or dead). On the other hand, they can obtain them from other institutions (hospitals, universities, etc.) by making use of contracts denominated Material Transfer Agreements (MTAs).8 A Material Transfer Agreement has been defined as “a contract that governs the transfer of tangible research materials between two organizations, a provider and a recipient, when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives. Biological materials such as specimens, reagents, cell lines, plasmids and vectors, are the most frequently transferred materials, but MTAs may also be used for other types of materials, such as chemical compounds and even types of software.”9
However, contracting via MTAs is only the second step of a chain that starts when the upstream players, i.e. the donors transfer for the first time their tissue to one of the downstream players.
In both steps of the chain the use of human tissue for research raises an innumerable amount of other ethical and legal issues e.g. the protection of human dignity, privacy, autonomy, health and other fundamental rights of the
6 I use the term donor to refer to the first transferor of the tissue, independently of whether or
not the title of the transfer is a donation contract.
7 On gene patents see, for example, Koepsell, 2009.
8 For the notion of material transfer agreement see Rodriguez, 2005.
9 International Society for Biological and Environmental Repositories (ISBER), Best Practices for
repositories: Collection, Storage, Retrieval and Distribution of Biological Materials for Research,
2001 (Third Edition) p. 88.
<http://c.ymcdn.com/sites/www.isber.org/resource/resmgr/Files/ISBER_Best_Practices_3rd_E
di.pdf?hhSearchTerms=%22contract+and+governs+and+transfer+and+tangible+and+research+ and+materials+and+between+and+two+and+organizations%2c+and+pro%22> last accessed 2 November 2019. See also the Guiding Notes for Academic Staff on Material Transfer Agreements by the Imperial College of London <https://www.imperial.ac.uk/media/imperial-‐ college/research-‐and-‐innovation/research-‐office/public/MTA-‐Guidance-‐Notes-‐Academic-‐Staff-‐ [pdf].pdf> last accessed 2 November 2019.
1
Scope, research questions, and structure | 19first transferor of the tissue; the protection of other rights and interests of all stakeholders involved and; the requirements for the validity of consent for the transfer of tissue. Which legal mechanisms can be implemented for the protection of the rights and interests of the person from whom the tissue has been extracted and other stakeholders?
Several models have been proposed for the protection of the rights of the original source of the tissue and for the circulation and use of this material for research: a. the informed consent model, b. the proprietary model and, c. the contractual model. According to the first model, the legal basis for the extraction, use and circulation of tissue for research is the informed consent of the person from whom the tissue has originated. According to the second model, such basis is the existence of property rights on the human body and its parts, and not necessarily the consent of the original source of the material. This book explores the third possibility. According to the contractual model, the conclusion of contracts could protect better than any other mechanism the rights and interests of the parties involved in the circulation of human tissue for research.10
Although there have been several proposals to implement the contractual model for the use and circulation of human tissue, there is not a systematic comparative study that analyses the various possible legal limits to the conclusion of contracts on human tissue.11
1.2 Scope and research question
Against the previous background, this book investigates the following research question:
• What are the limits to the validity of contracts on human tissue for research purposes in the Italian and English legal system?
In order to establish such limits, this study focuses on the following possible cases of contractual relations for the transfer and use of human tissue: a) Gratuitous contracts between the first transferor and the first recipient; b) Non-‐ gratuitous contracts between the first transferor and the first recipient; c) Contracts between the first and subsequent recipients. The reader will find in the comparative part of this book a systematic answer to the research question in relation to the aforementioned investigated cases.
Although the research question investigated in this book can be framed within the much broader debate about the limits to the acts of disposition of the human body, its scope is exclusively limited to the validity of contracts on human tissue
10 Noiville, 2016, p. 145.
11 On the contractual model see, among others, Bellivier & Noiville, 2004; Dick, 2002; Weck, 2005,
for the purposes of research. The reason for this restriction is that the problems that arise from the use of human tissue for research are different from the ones that other purposes, or other parts of the human body (e.g. human organs) give rise to.
Generally speaking, human tissue has a double “nature”. On the one hand, human tissue is a separated part from the human body. On the other hand, human tissue is a source of personal (e.g. health and genetic) data. For this reason, the moral and legal problems derived from the use of human tissue for research have to do with, at least, one of the two “natures” of human tissue. Some of these problems include, but are not limited to, the following questions: a) is the consent of the donor necessary for the extraction, use and contractual transfer of human tissue and the data associated to it? b) If so, what is the scope of such consent? c) Which information should be provided to the donor to consider the consent valid? d) Can the first recipient of the tissue transfer it to other parties without the consent of the first transferor? e) What are the most appropriate legal and technical safeguards that should be put in place to protect the personal data of the donor? f) Could the contractual transfer and use of human tissue threaten the human dignity and other fundamental rights of the donor? g) Can human tissue be the object of non-‐gratuitous contracts? h) Should non-‐gratuitous contracts on human tissue be prohibited on the grounds of an alleged exploitation and coercion of the donor? i) In contracting on human tissue, what is the interplay between individual autonomy and paternalism?
This book intends to give an answer to these questions in terms of limits to the validity of contracts on human tissue.
1.3 Delimitation and terminology
1.3.1 International law, supranational law and national legal systems
This study focuses on the interplay between international and supranational law and the national legal systems of Italy and England.12 In this regard, I identified the possible legal documents that may impact, depending on the effect on each national legal system, the determination of the limits to the validity of contracts on human tissue. Broadly speaking, two types of legal sources are addressed in this book. On the one hand, international and supranational documents on fundamental and human rights, e.g. ECHR,13 the Oviedo Convention and the
12 In this book the references to the English legal system or to English law are to be understood
as the legal sysem and law of England & Wales.
13 Convention for the Protection of Human Rights and Fundamental Freedoms, Nov. 4, 1950,
Europ. T.S. No. 5; 213 U.N.T.S. 221.
1
Scope, research questions, and structure | 21CFREU. On the other hand, international and supranational documents on data protection, e.g. the General Data Protection Regulation.14
The study of this book was limited to countries belonging to the EU. The reason for this choice is that it allowed analysing the differences in the effect of supranational legal sources on the limits to the validity of contracts on human tissue in different national legal systems. Within the EU, the case studies were further restricted to Italy and England. The choice of these two national legal systems answers to different rationales. Firstly, Italy is the only European country that originally included in the national civil code a provision (Article 5 C.C) regarding the acts of disposition of human body.15 This particularity nurtured a long and fertile scholarly literature on the legal status of the human body and its parts. Secondly, unlike many other European countries, England has special legislation regarding the use of human tissue, i.e. the Human Tissue Act 2004.16 These special conditions in each of the national countries investigated allowed for an interesting comparative analysis of the limits to the validity of contracts on human tissue. While in the Italian case, a relatively old (1942) civil code provision set the initial parameters for the determination of such limits, in the English case, a relatively new instrument of statutory law, comprehensively regulates the use of human tissue. Thirdly, both countries were chosen because they belong to different legal families and traditions. This fact enabled the analysis of the question of whether or not the differences in legal technique in both national legal systems could result in different answers to moral and legal questions, i.e. the question of the validity of contracts on human tissue. An initial intuition, later on confirmed during the research period of this study, suggested that the absence of a written constitution in England and the differences in the legal treatment of contracts between the two legal systems could constitute relevant factors for the determination of the limits to the contracts analysed in this book.
1.3.2 Terminology
14 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on
the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation, hereafter: GDPR).
15 The Italian Civil Code of 1942 was the only one, from the old European civil codes, that
incorporated a provision regarding the acts of disposition of the human body and its parts. However, other legal systems, following modern developments, incorporated later on provision on the human body. That is the case of the French Civil Code. This Code, after a reform by the law “n°94-‐653 du 29 juillet 1994 -‐ art. 3 JORF 30 juillet 1994” incorporated Article 16.1 which prescribes that “Chacun a droit au respect de son corps. Le corps humain est inviolable. Le corps
humain, ses éléments et ses produits ne peuvent faire l'objet d'un droit patrimonial.”
16 Human Tissue Act 2004, <http://www.legislation.gov.uk/ukpga/2004/30/contents> accessed
-‐Human tissue and human biological samples
This book prefers the term ‘human tissue’ over other similar terms for two reasons. Firstly, because the term human tissue gives the reader an immediate clearer idea of the subject matter of the book than other terms like ‘human biological material’ or ‘human biological samples’. Secondly, because human tissue is the term used by the English legal system in the Human Tissue Act 2004. Unless otherwise specified, in this work the term human tissue is to be understood as bodily samples, separated from the human body, that contain the genetic information of an individual.17
However, in the chapters related to data protection law I have preferred to use the term ‘human biological samples’. These chapters use the term ‘human biological samples’18 instead of the term ‘human tissue’ because it is a terminology commonly used by both data protection law scholars and scholars from other disciplines than law dealing with the research on the human body and its parts.19 Furthermore, the same terminology is used by GDPR. In the data protection chapters, the term ‘human biological samples’ refers to tissue of human origin used for research purposes.20
Three further clarifications are necessary in this regard. Firstly, in this book the terms human tissue or human biological sample do not include gametes (sperm and ova), embryos or human organs. Although related, these particular types of bodily materials give raise to different problems in the fields of bioethics and law. It would be far outside the scope of this book to include them in the analysis. Secondly, this book focuses on contracts on human tissue for research purposes. For similar considerations, the use of human tissue for transplant or other therapeutic purposes falls outside the aim of this research. Thirdly, in this book the terms ‘donor’, ‘first transferor of the tissue’ and ‘original source of the tissue’ are used interchangeably and independently of whether or not the title of the transfer is a donation contract.
-‐Horizontal effect of fundamental rights
The definitions of horizontal effect, direct horizontal effect and indirect horizontal effect vary from one scholar to another. This book shares an understanding of these three concepts that seems to be widespread in the European private law literature. Accordingly, the horizontal effect of a fundamental right or constitutional principle is the reference made to this right or principle in order to shape the rights and duties of the parties of a private
17 In this definition I follow the one provided by Jiménez, 2003.
18 The italian term for human biological samples is ‘campioni biologici umani’. Cfr. Novelli &
Pietrangelli, 2011, p. 1028.
19 Wendler & Emanuel, 2002; Wendler, 2006; Cambon-‐Thomsen 2004.
20 Human biological samples can also be used for diagnostic and therapeutic purposes. Cfr.
Novelli and Pietrangelli, 2011, p. 1028.
1
Scope, research questions, and structure | 23relationship. A common way to distinguish between direct and indirect horizontal effect is to identify the term ‘direct horizontal effect’ with the foundation of a private law remedy directly on a fundamental right or constitutional principle, and ‘indirect horizontal effect’ with the interpretation of a private law rule in the light of a fundamental right or constitutional principle. Other views, especially in English scholarly works, seem to use the term ‘horizontal effect’ in a way that resembles the above-‐mentioned understanding of ‘direct horizontal effect’.21
-‐Final terminology remarks
The use of the pronouns ‘she’ or ‘her’ is meant to include the pronouns ‘he’ or ‘his’.
Unless otherwise specified, the expression ‘limits to the validity of contracts’ or similar derivatives means limits to the validity of contracts on human tissue.
1.4 Methodology
This book combines different legal methods to determine the limits to the validity of contracts on human tissue.
As in many other cases in legal science, the determination of the limits to the validity of these contracts not only implied putting a puzzle together, but also, and perhaps more importantly, identifying the correct pieces and setting aside the incorrect ones. In this study, the different pieces correspond to the multi-‐ level sources of law that constitute the legal framework for the analysis. In order to investigate the scope and content of these sources, I used a doctrinal research method. In this regard, I firstly identified the international and supranational legal documents and their interplay with the national legal systems chosen as case studies. Secondly, descending to the national level, this study did a detailed review of the national legislation, case law and corresponding scholarly literature. In this step, the absence of specific case law on the subject matter of this book was notorious. For this reason, only a few cases have been reported. Thirdly, this work assessed whether an analysis of examples from the contractual practice was possible. Although a few examples of contracts between first and subsequent recipients were found, it was conspicuously hard to find non-‐gratuitous contracts of this kind. The reason for this difficulty may possibly be explained by the, otherwise understandable, reluctance of the (pharmaceutical) industry to reveal to the public their contractual practices. The Annexes of this book contain the contracts found and analysed.
