Tilburg University. Organ donation, policy and legislation Coppen, R. Publication date: Link to publication

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1 Tilburg University Organ donation, policy and legislation Coppen, R. Publication date: 2010 Link to publication Citation for published version (APA): Coppen, R. (2010). Organ donation, policy and legislation: With special reference to the Dutch organ Donation Act Utrecht: Labor Grafimedia BV General rights Copyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright owners and it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights. Users may download and print one copy of any publication from the public portal for the purpose of private study or research You may not further distribute the material or use it for any profit-making activity or commercial gain You may freely distribute the URL identifying the publication in the public portal 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. Download date: 03. nov. 2015

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4 Organ Donation, policy and legislation With special reference to the Dutch Organ Donation Act Remco Coppen

5 Cover design: Cover photo: Donor form: Word processing: Printing: Richard van Kruysdijk Louis Janssen Herma van den Brink LABOR Grafimedia BV, Utrecht ISBN Phone: Fax: NIVEL, PO Box 1568, 3500 BN UTRECHT All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior written permission of NIVEL. Exceptions are allowed in respect of any fair dealing for the purpose of research, private study or review.

6 Organ Donation, policy and legislation With special reference to the Dutch Organ Donation Act PROEFSCHRIFT ter verkrijging van de graad van doctor aan de Universiteit van Tilburg op gezag van de rector magnificus, prof.dr. Ph. Eijlander, in het openbaar te verdedigen ten overstaan van een door het college voor promoties aangewezen commissie in de aula van de Universiteit op vrijdag 3 september 2010 om uur door Remco Coppen geboren op 20 december 1976 te Rotterdam

7 Promotores: Prof.dr.ir. R.D. Friele Prof.mr.dr. J.K.M. Gevers Prof.dr. J. van der Zee This thesis was conducted at NIVEL, Netherlands Institute for Health Services Research, Utrecht, The Netherlands. The studies described in this book were carried out with financial support from ZonMw (the Netherlands organisation for health research and development), the Ministry of Health, Welfare and Sports, the Ministry of Education, Culture and Science, and the Kidney Foundation.

8 Contents Chapter 1 General introduction 7 Part I Chapter 2 The potential of legislation on organ donation to 33 increase the supply of donor organs Part II Chapter 3 The impact of donor policies in Europe: a steady 53 increase, but not everywhere Chapter 4 Donor education campaigns since the introduction 71 of the Dutch Organ Donation Act: increased cohesion between campaigns has paid off Chapter 5 Explaining differences between hospitals in numbers 87 of organ donors Part III Chapter 6 Opting out systems: no guarantee for higher donation 101 rates Chapter 7 Imagining the impact of different consent systems 113 on organ donation: the decisions of next of kin Chapter 8 General discussion and conclusions 127 References 153 Samenvatting (Summary in Dutch) 179 Dankwoord 197 Curriculum Vitae 203 List of publications 207 5

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12 General introduction 1.1 Introduction In the second half of the twentieth century it became medically possible to transplant organs from one person into another. Over the years transplantation medicine has undergone enormous development. Currently, the transplantation of organs is a regular medical procedure for people with failing organs. However, organ transplantation requires the availability of donor organs from other (mostly deceased) persons. Since the 1980 s there is a shortage of donor organs in the Netherlands (Gezondheidsraad, 2003). The number of people waiting for an organ has increased, while the number of available post mortem donor organs has remained fairly stable. This shortage resulted in waiting lists for patients to receive an organ, with increasing waiting times building up to several years (Gezondheidsraad, 1987). The problem of organ shortage is not unique to the Netherlands; all developed countries have a severe shortage of donor organs (Council of Europe, 2008). Nowadays, with a population of 16 million, there are 1288 people waiting for a donor organ in the Netherlands (Nederlandse Transplantatie Stichting, 2010), 1 while there are around 200 post mortem donors 2 each year (Nederlandse Transplantatie Stichting, 2009). It is, therefore, important to maximise the number of post mortem donor organs. In doing so one should take account of fundamental principles pertaining to the right to physical integrity, equitable access to and equal availability of care, and the noncommerciality principle. The shortage of donor organs in the Netherlands persists. This leads to a lot of pressure on the Dutch government to take measures directed at increasing the supply of donor organs. This thesis focuses on the Dutch policy to increase the supply of post mortem donor organs, with special reference to the Organ Donation Act s 1 The number of people waiting for an organ on 31 December In this thesis donation rates are the number of post mortem organ donors of whom at least one solid organ had been successfully transplanted per year. Some countries (e.g. France and Sweden) use a deviating definition for their number of effectuated donors: the number of post mortem organ donors of whom at least one solid organ had been recovered for the purpose of organ transplantation per year. 9

13 Chapter 1 objective in this matter. The impact of the Act, and the effects of the additional policy measures will be assessed. In this chapter we will first explain some relevant aspects of organ donation and transplantation (section 1.2). Next, we will focus on the reasons for introducing legislation on organ donation in the Netherlands (section 1.3), the Dutch Organ Donation Act and additional policy measures (section 1.4), and the development of organ donation post mortem since the enactment of a legal system in the Netherlands (section 1.5). In section 1.6 we will examine the Dutch shortage of donor organs in an international context. Furthermore, this chapter contains the research questions of this thesis and elaborates on the strategy for studying the impact of the legal system on the shortage of donor organs (section 1.7). The final section (1.8) provides an overview of the structure of this book. 1.2 Organ donation and transplantation Organ donation is the removal of tissues of the human body from a person who has recently died (post mortem organ donation), or from a living donor, for the purpose of transplantation into another person with a failing organ. For a medically successful transplantation it is necessary to take account of (1) high quality standards for donor organs and (2) the fact that the human body experiences an implanted donor organ as foreign and will reject such organs. Donor organs have to meet high quality standards because an organ of low quality may cause the death of the recipient. The quality of an organ is influenced by age, sepsis, malignancies (with some exceptions for brain tumours), and active viral infections (e.g. HIV, herpes) (Nederlandse Transplantatie Stichting, 2006). Because of these factors, only a limited number of deceased people are eligible for post mortem organ donation. In the Netherlands, approximately 80% of post mortem donors died from a cerebral vascular accident (CVA 59% in 2008) or (traffic) accident (21% in 2008) (Nederlandse Transplantatie Stichting, 2009). These rates are consistent with other Western European countries (Coppen, Marquet, & Friele, 2003). To suppress the body s reaction of rejecting donor organs it is important to find the best medical match between the donor and recipient. For this 10

14 General introduction reason, the allocation of donor organs requires at least blood group matching; kidneys are also allocated by tissue matching (also called Human Leukocyte Antigen matching or HLA matching). Nevertheless, a transplant patient has to take immunosuppressive drugs to suppress the rejection of the donor organ for the rest of his or her life (Frohn, Fricke, Puchta J.C., & Kirchner, 2001). The world s first cadaveric donor kidney transplant ever was performed in 1963 in Belgium. 3 In the Netherlands, the first transplantation of a kidney took place in 1966 (Akveld, 1987; Polak, 1980). Since then, transplantation medicine has undergone enormous development. Over the years, transplant techniques improved and rejection symptoms became more manageable by means of (combinations of) drugs and better HLA matching (Kootstra, 1988; Cohen et al., 2005) (see Box 1.1 for a historical overview of milestones in transplantation). Transplantation of organs has evolved from being a medical procedure with an experimental character to a regular medical treatment for several diseases. The development of transplantation medicine contributes to the quality of life of many people (Kontodimopoulos & Niakas, 2008), and transplantation is often the only therapy for certain patients to live a relatively normal life, without severe disabilities. 3 ( ). 11

15 Chapter 1 Box 1.1 A historical overview: milestones in transplantation Year First transplantation worldwide of 1963 Kidney (Belgium) First transplantation in the Netherlands of * 1966 Kidney (Leiden) 1966 Pancreas/kidney/ (USA) 1967 Heart (South Africa) 1967 Liver (USA) 1979 Liver (Groningen) 1981 Heart/lung (USA) 1984 Pancreas (Leiden/Maastricht) 1984 Heart (Rotterdam) 1987 Intestine (USA) 1990 Lung (Groningen) 2001 Intestine (Groningen) Source: : ( ) *: ( ) Nowadays, organs which can be donated post mortem include lungs, liver, pancreas, intestines, heart, and kidneys (see Box 1.2 for information on heart beating and non heart beating donors). Some organs (kidneys and liver parts) can also be procured during life (living organ donation) (Gezondheidsraad, 2003). As surgery on a healthy body may have serious consequences for a person (Hou, 2000), in general post mortem donation is 12

16 General introduction preferred to living donation. Nevertheless, the number of living donations has increased over the years (Nederlandse Transplantatie Stichting, 2009). Box 1.2 Post mortem donation: heart beating vs. non heart beating donors For post mortem organ donation it is important that organs can be preserved from the moment the donor is declared dead until the moment that the organs are actually transplanted. The preservation of most organs, therefore, requires a supply of oxygenated blood, and the presence of blood circulation is necessary (Gezondheidsraad, 2003). This is only possible when the donor is declared brain dead and is mechanically ventilated (Op de Coul, 1998). Such donors are called heart beating donors. Even if blood circulation is absent, the donation of some organs (kidney, liver, lungs and pancreas) is still possible. After death by cardiac arrest the blood circulation stops and organs are no longer supplied with oxygenated blood. It is then important to artificially perfuse these organs (Kievit, Nederstigt, & Kootstra, 1998). Such donors are called non heart beating donors. 1.3 Issues in organ donation in the Netherlands The development of transplantation during the eighties and early nineties confronted the Dutch government with two main issues. A first issue was that from a legal point of view the procurement of a donor organ is a potential infringement of someone s basic right to the integrity of his/her body. A second issue in organ donation was the scarcity of donor organs. Organ donation and physical integrity of the donor The right to physical integrity of one s body is laid down in art. 11 of the Dutch Constitution and reads: Everyone shall have the right to inviolability of his person, without prejudice to restrictions laid down by or pursuant to Act of Parliament. Art. 11 also applies after one s death. Removing organs from one s body is a violation of the right to physical integrity. This right is not 13

17 Chapter 1 only relevant in the Dutch context, but it is a generally recognized principle. To prevent an infringement of the right to physical integrity, consent for organ donation is necessary. Also in an international context there is general agreement on the necessity to obtain consent for the removal of organs from a corpse. This is for instance reflected in legal documents such as the additional protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin, which stipulates in art. 17 that Organs or tissues shall not be removed from the body of a deceased person unless consent or authorisation required by law has been obtained. The removal shall not be carried out if the deceased person had objected to it. There are several ways to obtain consent for post mortem organ donation. In general, there are two defaults: systems of explicit consent (opting in) or systems of presumed consent (opting out). In explicit consent systems the donor himself has to authorise organ removal after his death (in the form of an advance directive or donor card, or by filling in a form in order to record consent in a national registry). For organ removal in presumed consent systems it is sufficient that the deceased person has not objected to it during his life; consent is presumed (Gevers, Janssen, & Friele, 2004). According to the Explanatory Report on the Additional Protocol (nos ) countries are free to enact systems based on presumed consent or systems based on explicit consent. The Dutch Constitution only permits a deviation from the right to physical integrity when this deviation is allowed by an Act of parliament. Accordingly, the Dutch government took steps to enact a consent system through legislation. The scarcity of donor organs During the nineteen eighties it became clear that transplantable organs were scarce and that the demand for organs was higher than their supply (Akveld, 1988); the number of people on the waiting list for an organ transplant in 1988 was approximately 5 times higher than the annual number of effectuated post mortem organ donors. Because knowledge about HLA matching, surgical techniques and immunosuppressive drugs had improved over the years more patients could be treated for their diseases by means of the transplantation of an organ (Kootstra, 1998). At the same time, the number of procured donor organs had been more or less stable for years. 14

18 General introduction This led to a persistent shortage of donor organs and consequently to a considerable waiting time to receive an organ (Gezondheidsraad, 1987). In 1991 the Dutch government considered that there were two underlying causes for this shortage of donor organs: (1) there seemed to be a lack of trust among the population in organ donation, and (2) there seemed to be inefficiencies in the organisation of the process of organ donation in hospitals. 4 Although approximately 76% of the population supported organ donation (Tijmstra, Slooff, Heyink, & Pruim, 1989), only a limited segment actually gave consent to the removal of one s own organ or the organs of a close relative (Akveld, 1987). In 1987 approximately 10 15% of the Dutch population gave consent to organ donation by signing a donor codicil (a written declaration of will). The Dutch government assumed that the limited willingness to consent was caused by a lack of trust among the Dutch population in organ donation procedures. This was considered to be a major reason for the scarcity of organs. The organisation of the process of organ donation in hospitals was considered to be another cause of the shortage of donor organs. There was a limited capacity in hospitals to remove organs, and the medical staff were insufficiently aware of the relevance of organ donation. They were poorly trained in donor recognition and had limited competence in asking for consent from next of kin of deceased potential donors. The government assumed that these inefficiencies in the organisation were to blame for the loss of a considerable number of organs. The government felt responsible for the organ shortage and considered that the shortage could be solved by increasing public trust in donation procedures and providing legal certainty with the enactment of a legal system for organ donation. Additionally, the incorporation of several organisational provisions (e.g. the hospital donor protocol, in which a hospital describes the procedures in the case of a potential organ donation) into a statutory regime for organ donation was intended to increase the 4 House of Representatives II, 1991/92, , nr. 3, p.2 3 (Explanatory Memorandum). 15

19 Chapter 1 efficiency of the donation procedure and to address the importance of increasing the efficiency of organ donation procedures in hospitals. When drafting the legislation on organ donation, the government was aware of the fact that enacting legislation alone would not be enough to solve the problem. 5 Additional policy measures were needed to resolve the lack of trust issues and the inefficiencies in the organisation of the donation process. The government considered that the population should be informed about the possibility to donate organs and about the legal safeguards concerning organ donation to increase trust in the procedures. 6 Furthermore, the government concluded that additional policy measures should focus on increasing the efficiency of the organisation of the organ procurement process The policy on organ donation in the Netherlands Because of these issues, the Netherlands enacted the Dutch Organ Donation Act in 1998, which provides for a consent system based on explicit consent, and it implemented additional policy measures. The Dutch Organ Donation Act is considered to be part of Public Law (Engberts et al., 2006). Public law regulates matters of public interest (Haan, Drupsteen, & Fernhout, 2001); the government supervises compliance with its provisions (Wijk, Konijnenbelt, & Male, 1997). If the Act should be infringed, there are legal instruments (sanctions) designed to enforce compliance (Engberts et al., 2006). Furthermore, the Dutch Organ Donation Act constitutes a closed legal system, which means that organs can only be donated under the conditions provided by the Act. In this system it is, for example, not possible to donate organs only on condition that they go to a non smoker. 5 House of Representatives II, 1991/92, , nr. 3, p.4, (Explanatory Memorandum). 6 House of Representatives II, 1991/92, , nr. 3, p.4 (Explanatory Memorandum). 7 House of Representatives II, 1991/92, , nr. 3, p.4, (Explanatory Memorandum). 16

20 General introduction The preamble to the Act states that Whereas we have considered that, partly in view of the provisions of Article 11 of the Constitution, it is desirable, given the need to protect the legal interests of the parties involved, to regulate the donation of organs for use in the special medical treatment of others, this with a view to increasing the availability of organs, securing the equitable distribution of suitable donated organs and preventing trade in organs. Accordingly, the Act has to safeguard the rights of donors and other directly involved persons (safeguarding function of the Act objective 1, 3, 4) and has to increase the supply of donor organs (instrumental function of the Act objective 2) (see Box 1.3). Box 1.3 The objectives of the Dutch Organ Donation Act 1 to codify the law and to provide legal certainty, also with regard to the consent system 2 to increase the supply of donor organs and tissues 3 to ensure the fair allocation of donor organs and tissues 4 to prevent commercialisation and organ trade In conclusion, the Dutch policy on organ donation contains three elements: - Safeguarding the rights of donors and other persons through legislation - Increasing the supply of organs through legislation (instrumental function of the Act) - Increasing the supply of organs by implementing additional policy measures The next three sections will examine these elements separately in more depth The safeguarding function of the Dutch Organ Donation Act The safeguarding function is an important aspect of legislation in general and especially of the Dutch Organ Donation Act. In a society the interests of people and governments vary and may conflict with each other. To prevent such conflicts and to acknowledge different interests legislation defines what 17

21 Chapter 1 people may expect from each other and their governments. The safeguarding function of legislation refers to its role to ensure that rights will be respected in accordance with what citizens may expect on the basis of the law in force and in line with the fundamental principles underlying that law. When drafting legislation it is important to take into account universal basic (legal) principles. For example, in our society we agreed that violence to a person s body is not allowed. This is reflected in the right to physical integrity. Other principles are for instance, the principle of nondiscrimination, the principle of the freedom of speech, or the principle of nulla poena sine lege (Latin: ʺno penalty without a lawʺ). Since the second World War such fundamental principles have increasingly been incorporated into international human rights documents (Malanczuk, 1997). There is a traditional distinction between individual freedoms and social rights in the sense of rights that give access to basic social goods (e.g. the right to health care) (Leenen, 2000). Individual freedoms are inalienable and legally enforceable rights protecting the individual (Malanczuk, 1997). The enforcement of social rights is less stringent, as the scope of these rights is limited to national resources and there is room for national interpretation; countries have some freedom in how they codify these principles in their national legislation. However, social rights (e.g. the right to health care) have become more important over the years. Two basic principles that are relevant for health care are the right to physical integrity and the right to equitable access to health care. Draft legislation in health care can be tested against these international principles. As citizens may refer to these principles, countries have to ensure that their legislation is in accordance with them, and that legislation safeguards the interests enshrined in them. Hence, the safeguarding function of legislation contributes to certainty on what people may expect in terms of their rights and duties, given these basic principles. One of the most important interests to be protected in organ donation is the physical integrity of the donor. It is not permitted to retrieve an organ if the donor made an objection to organ donation. Consent systems for post mortem organ donation contain different mechanisms (based on opting in or opting out) to guarantee that organs will not be retrieved against a person s wishes (the first objective of the Act). The Dutch government had to 18

22 General introduction carefully weigh up their decision to opt for the consent mechanism. According to the Dutch Organ Donation Act citizens have the options of registering (1) explicit consent, (2) refusal, or (3) that next of kin or (4) a specified person may decide upon the donation of organs after they have died. 8 The Dutch consent system is considered to be an explicit consent system because retrieval of organs post mortem is not allowed without explicit consent, if not from the donor him/herself (while still alive) then at least from his/her relatives after he/she died. When drafting the Act, the government considered that the donation of organs greatly depends on the trust people have in the donation system. Another important issue is equitable access to and equal availability of care (Hendriks, 2005), which derives from (1) the more fundamental principle that all individuals in the Netherlands shall be treated equally in equal circumstances (art. 1 of the Dutch Constitution) and (2) the right to public health care 9 (art. 22 of the Dutch Constitution). As a consequence, waiting lists for patients to receive a donor organ on a hospital level are not allowed; there are only national waiting lists for donor organs. All patients waiting for an organ are listed and organs are allocated according to the waiting list information (medical criteria and waiting time). To guarantee a fair allocation of organs, and thus equitable access to and equal availability of care (the third objective of the Act), this allocation is based on medical criteria and waiting time. In addition, the non commerciality principle plays a prominent role in organ donation in the Netherlands. This principle is based on the fundamental concept of human dignity, in particular the idea that the human body has an intrinsic value and cannot be dealt with as a mere object. Furthermore, it 8 Staatsblad (Bulletin of Acts, Orders and Decrees) 1998, nr The Committee on Economic, Social and Cultural Rights (CESCR) explains in its General Comment No. 14 (Document E/C.12/2000/) that the right to health cannot be interpreted as a state of complete physical, mental and social well being. According to the Committee the right to health embraces a wide range of socioeconomic factors that promote conditions in which people can lead a healthy life, and extends to the underlying determinants of health, such as food and nutrition, housing, access to safe and potable water and adequate sanitation, safe and healthy working conditions, and a healthy environment (Hendriks, 2009). 19

23 Chapter 1 was considered that a commercial market for organs that are scarce may lead to organ removal on improper grounds or people donating organs out of financial need. A commercial market might not only raise questions about the origin of organs and on their quality, but also about a fair allocation of organs, thereby putting pressure on the system as a whole and endangering the trust of people in the entire organ donation system. Therefore, it is important to prevent commercialisation in organ donation and organ trade (the fourth objective of the Act) (Caplan, Domínguez Gil, Matesanz, & Prior, 2009) The instrumental function of the Dutch Organ Donation Act The instrumental function of the Act originates from the government s policy to address the organ shortage and to reduce the gap between the donation rates and the number of people waiting for an organ. From this point of view the Act is part of the national policy and is used as an instrument to increase the supply of donor organs (the second objective of the Act). An important provision of the Act, designed to increase the supply of donor organs is its consent system. The mechanism behind this consent system is rather complex. The government assumed that people find it important that they can be sure that organs will only be procured if the donor, or his/her relatives, explicitly consented to organ donation (maximum physical integrity). The choice of an explicit consent system was based on the assumption that the supply of donor organs (the Act s instrumental function) would benefit from providing legal certainty through explicit consent registration. Additionally, legal certainty would also benefit from safeguarding an equitable allocation of organs and the prohibition of organ trade. Thus, the safeguarding function of the Act (providing legal certainty) was considered to be a necessary condition to increase consent rates and to boost the national supply of donor organs. Other provisions of the Act supporting its instrumental function include the obligation for hospitals to implement a donor protocol and a donation committee. These provisions form an important legal basis for further implementation of additional policy measures. 20

24 General introduction Additional policy measures The additional policy measures on organ donation are predominantly aimed at the organ donation process in hospitals and donor education. Organ donation in hospitals With the enforcement of the Dutch Organ Donation Act, the Dutch government founded the Dutch Transplant Foundation (NTS). The objective of this foundation is to support organ and tissue donation in the Netherlands. Accordingly, the NTS performs the following tasks (Nederlandse Transplantatie Stichting, 2001; Nederlandse Transplantatie Stichting, 2009): - Supervising the acquisition, classification and transportation of organs from donors and their allocation to suitable recipients, in its capacity as an organ centre, as stated in Section 24 of the Act; - Establishing a national database with data on donations and transplantations; - Implementing activities to optimise donor procurement in hospitals. - Several tasks that result from the implementation of the Act, such as enabling consultation of the Donor register and acting as an information source for medical questions. To optimise organ procurement and to increase the efficiency of the donation process it is essential to counteract bottlenecks in organ donation procedures in hospitals. Consequently, in its plan for donor procurement the NTS proposed to implement structural adjustments to the donation procedure in hospitals. For example, special teams were set up to retrieve the organs of a donor and to overcome the limited capacity to remove organs (Smit, Berg, & Zeggelt, 2001; Smit & Mathijssen, 2002). Also, special donation officers were introduced in Dutch hospitals to increase the awareness of organ donation among medical professionals and to improve their competence in requesting consent from next of kin of deceased potential donors (Akveld, Cleophas, & Ras, 2002). Furthermore, by implementing several applications and databases to compile unambiguous information on donation procedures in hospitals, the NTS aims to increase insight into (bottlenecks for) organ donation procurement (Nederlandse Transplantatie Stichting, 2009). 21

25 Chapter 1 The NTS has delegated its responsibility for the allocation of organs in the Netherlands to the cross border allocation system of the Eurotransplant International Foundation. Eurotransplant was founded in from an informal academic network which focused on the allocation of kidneys. Eurotransplant was formed by small, mostly neighbouring countries (Austria, Belgium, Luxemburg and the Netherlands) and Germany. Later, Croatia and Slovenia joined Eurotransplant. By participating in cross border organ allocation schemes countries increase their donor pool and ensure optimum allocation of the donor organs. When an organ is procured but cannot be allocated in one country, it is offered to another country that has an eligible recipient. This prevents the loss of procured but not transplanted organs. The exchange of organs between the Eurotransplant countries is more or less balanced. Donor education Donor education in the Netherlands is conducted through a specialised centre. Initially, the SDV Donor Information Foundation (Stichting Donorvoorlichting) took care of donor education in the Netherlands. This foundation was set up in 1976 and represented several vested interest parties (the Dutch Kidney Foundation, the Dutch Heart Foundation, the Dutch Red Cross, Dutch Burns Foundation, Cornea Foundation Netherlands, the Dutch Stomach, Liver and Intestines Foundation, the Dutch Diabetes Funds, the Netherlands Asthma Foundation, the Royal Netherlands Society for the Advancement of Medicine) (Stichting Donorvoorlichting, 2001). The SDV Donor Information Foundation contributed to the introduction of the donor codicil and public debate on organ donation. The SDV Donor Information Foundation was also involved in drafting the Dutch Organ Donation Act. In 2003 the SDV Donor Information Foundation merged with the Netherlands Institute for Health Promotion and Disease Prevention NIGZ and continued its activities as NIGZ Donor Education. The aims of NIGZ Donor Education are (NIGZ donorvoorlichting, 2004): 10 ( ). 22

26 General introduction - to increase the number of (positive) registrations in the Donor Register - to increase the awareness of the role of next of kin - to maintain positive attitudes towards organ donation and support the aims of organ donation policy. NIGZ Donor Education has two main functions: 1) to respond to questions about organ donation, 2) to set up and carry out organ donor campaigns (NIGZ donorvoorlichting, 2007). Besides campaigns which focus on the population in general, there are also campaigns which target special groups. Examples of such groups are: eighteen year olds, next of kin of deceased donors, and various religious groups. Since 1 January 2010 NIGZ Donor Education is embedded in NTS Donor Education. 1.5 Developments since the enactment of the Dutch Organ Donation Act Despite the introduction of the Organ Donation Act and the additional policy measures, the shortage of organs remained. Figure 1.1 shows that the demand for organs is still higher than supply. Because of improved techniques, more patients are eligible for an organ transplant and more patients are put on the waiting list. At the same time, the number of donor organs has been more or less stable during these years. This causes a persistent shortage of donor organs, leading to a considerable waiting time. 23

27 Chapter 1 Figure 1.1 The gap between the supply of donor organs and the demand for donor organs 1600 Introduction of the Dutch Organ Donation Act Number of people on the waiting list Number of post mortal organ donations Year Source: Dutch Transplantation Foundation: Annual Reports Organ donation in an international context The scarcity of donor organs is not unique to the Netherlands. Other countries likewise experience a shortage of donor organs (Barber, Falvey, Hamilton, Collett, & Rudge, 2006; Jansen, Leiden, Sieber Rasch, Hoitsma, & Haase Kromwijk, 2007; Roels, Gachet, & Cohen, 2004; Wesslau et al., 2007; Wight & Cohen, 1997). To put the Dutch shortage of donor organs into perspective, this section discusses similarities and differences between a number of surrounding countries for which information was available. These are countries which have all developed health care systems 11 that enables them to perform transplantation of post mortem donor organs as a 11 ( ). 24

28 General introduction regular medical treatment for several diseases. That transplantation of post mortem donor organs is accepted as a regular treatment is reflected by positive attitudes to organ donation. Several studies point out that more than three quarters of the Dutch population is positively disposed towards organ donation (Zijdenbosch & Lutterveld, 1997; Zijdenbosch & Kamphuis, 1998; Ipso Facto, 2000; Verzijden & Schothorst, 2003; Cox, 2005; Lems, 2005). This is in accordance with the public attitude in other countries, such as Sweden (Sanner, 1998) and Spain (Fernández Luca, Miranda, & Matesanz, 1996). Furthermore, these countries share a similar historical background; they are all Western European. Figure 1.2 provides international figures on organ donation rates and the number of people waiting for an organ. Because this thesis focuses on post mortem organ donation we classified the countries based on their donation rates (post mortem). This figure illustrates the gap between the supply and the demand for donor organs, which dates back to the nineteen eighties (Gezondheidsraad, 1987). As transplantation developed and more diseases could be treated by means of organ transplantation, more people were put on a waiting list in these countries. In the meantime, the supply of donor organs proved to be insufficient to treat all patients waiting for an organ. Since then, the size of the waiting list for organ transplantation of these countries by far exceeds the annual organ donation rates. People even die while waiting for an organ (Council of Europe, 2008; Defever, 1990; Smith, 2009). 25

29 Chapter 1 Figure 1.2 International data on organ donors and waiting lists in 2007 Donation rates (per million inhabitants) Numbers waiting (per million inhabitants) ,3 117,5 28,2 107,5 25,3 121,9 22,3 138,8 20,5 172,5 16,9 79, ,7 14,5 48,7 13,2 165,2 10,7 118,8 Spain* Belgium* France* Austria* Italy* Netherlands * Countries with a presumed consent system Countries with an explicit consent system Source: Council of Europe, 2008 Germany Sweden* United Kingdom* Switzerland Although each country has a shortage of donor organs, there are differences in donation rates and in the number of people waiting for an organ transplant. For example, in 2007 Spain had 34.3 organ donors per million inhabitants (PMI) and Switzerland had 10.7 donors PMI (Figure 1.2), while the size of their waiting lists was equal. In that same year, patients PMI were waiting for an organ transplant in the U.K. and (only) 48.7 patients PMI were waiting in Sweden. Fritsche et al. (2000) found significant practice variations in the evaluation of renal transplant candidates in Europe. This may explain the large differences between countries in the numbers of people waiting for an organ. Whether differences between countries in the organisation of the health care system also contribute to these differences is unknown. Can the differences in post mortem donor rates be explained by differences in national organ procurement policies? For instance, countries differ in the 26

30 General introduction way they have organised their consent systems. Some countries have enacted presumed consent systems, while others have enacted explicit consent systems. Figure 1.2 demonstrates that most of the presumed consent countries have higher donation rates than explicit consent countries. But there are other differences between countries. Firstly, countries differ in their quality standards for donors, which may have an effect on donation rates. For example, countries use different criteria when it comes to the maximum age of donors. To achieve a more efficient use of kidneys from elderly donors and to offer transplantation to elderly patients some countries use organs from donors older than 65 years for transplantation of recipients older than 65, whereas other countries have excluded this option (Chang, Mahanty, Ascher, & Roberts, 2003; Cohen et al., 2005). Secondly, there are large differences in the use of non heart beating donors between countries (Gezondheidsraad, 2003). In 2008, 41% of the total amount of post mortem organ donations in the Netherlands consisted of non heart beating donations (Nederlandse Transplantatie Stichting, 2009). In the meantime, the increase in non heart beating donations has been offset by a decrease in heart beating donors (Friele et al., 2004). Also other countries are performing more and more non heart beating donations. In 2008, 5.7% of Spanish, 13.4% of Belgian, 2.4% of French, 3% of Austrian, and 23,5% of British donors were non heart beating donors (Council of Europe, 2008). In other countries, non heart beating donations are not performed. 12 Apart from legal restrictions no proper explanation for the differences between countries can be given. And, thirdly, there are differences between countries other than their donor procurement policies, which are difficult to influence, but may have an effect on procurement rates. These are, for example, cultural differences between countries, such as the influence of the family on organ donation (Fleischhauer et al., 2000), or the religious majority in a country (Gimbel, Strosberg, Lehrman, Gefenas, & Taft, 2003). Apart from that, for the organ supply, the availability of possible donors is vital. Approximately 80% of all deceased organ donors died from either a CVA or a (traffic) accident (Coppen et al., 2003). This suggests that differences in traffic safety (Baxter, 12 In Germany, non heart beating donation is even prohibited by law (Cohen et al., 2005). 27

31 Chapter ) and CVA treatment (Kompanje.E.J.O., 2002; Kompanje.E.J.O., 2003) may be relevant confounders for differences in procurement rates between countries. 1.7 Research questions Although the Dutch Government introduced the Dutch Organ Donation Act, including an explicit consent system, and several additional policy measures, the gap between the organ supply and the demand for donor organs has remained. This has led to ongoing debate about the ability of Dutch law and policy to increase the donor organ supply. Several people took the position that the consent system as laid down in the law was an obstacle to procuring sufficient donor organs (Wezel, Keizer, & Cohen, 2001; Hessing, 2002). These people refer to presumed consent countries, which reported higher donation rates. They expected that replacing the explicit consent system by a presumed consent system would reduce the gap between donor supply and demand (Koene, 2002; Buijsen, 2003). The aim of this thesis is to study the effects of the Dutch Organ Donation Act s objective to increase the supply of donor organs, with a special focus on the Act s consent system, and the effects of the additional policy measures. The following research question will be addressed: What is the impact of legislation on organ donation and additional policy measures on the supply of post mortem donor organs, with special reference to the Netherlands? From a methodological point of view, studying the impact of an Act and its additional policy measures on effects in society, such as the impact on the supply of donor organs, is complicated. Many factors influence the availability of donor organs, and the impact of policy measures is somewhat indirect. To answer the main research question it is, therefore, necessary to use a strategy that addresses these difficulties. In this thesis we have adopted a strategy that approaches the research question from different perspectives in three consecutive parts. Consistency of the results of the 28

32 General introduction consecutive parts contributes to the reliability of the answer to the research question. The first part of the thesis contains an analysis of the proposals to change the Dutch Organ Donation Act in order to increase the supply of donor organs. The provisions of the Dutch Organ Donation Act, and the scope to increase the supply of organ donors without compromising the other objectives of the Dutch Organ Donation Act will be studied. The main emphasis of this thesis, however, will be on the empirical analysis in part 2 and part 3. Part 2 will give insight into the impact of the Dutch Organ Donation Act and its additional policy measures on the supply of donor organs. In this part both the impact of the implementation of the Dutch Organ Donation Act s consent system as well as the impact of additional policy measures will be assessed. Part 3 will give insight into the impact which can be expected from changing or adjusting the current consent system. Countries with different consent systems will be compared on their procurement efficiency. Because next of kin play an important role in obtaining consent for an organ donation procedure, part 3 will also focus on next of kin decisions for different imaginary consent systems. This approach leads to three research questions, which will be answered in the consecutive parts: Q1 To what extent is it possible to adapt the Dutch Organ Donation Act with a view to increasing the supply of donor organs? Q2 What is the impact of the implementation of the Dutch Organ Donation Act and its additional policy measures? Q3 Will changing or adjusting the current consent system influence the donor organ supply? 29

33 Chapter Structure of the thesis Part 1: The Dutch Organ Donation Act and the scope to adapt the Act The Act aims at safeguarding the rights of individuals and important legal principles 13, but also at increasing the supply of donor organs (see Box 1.3). The first part of this thesis (chapter 2) focuses on the Dutch Organ Donation Act itself and the legal instruments designed to increase the supply of donor organs. Chapter 2 describes the objectives of organ donation legislation in general, and the provisions of the Dutch Organ Donation Act to increase the donor organ supply in particular. This chapter also pays attention to proposals which were made to amend the Act with a view to increasing the supply of donor organs. We will analyse whether proposed legal instruments are in accordance with the right to physical integrity, equitable access to and equal availability of care, as well as the non commerciality principle. Moreover, we will assess whether it is likely that these instruments will lead to an increased supply of donor organs. Part 2: The impact of the Act and additional policy measures In this part of the thesis we look back on the impact of the Act and 10 years of policy making. In chapter 3 longitudinal data is used to assess the general impact of donor policies on donor procurement in 10 Western European countries during the course of a decade. Special attention is given to the question whether differences in donor rates between countries can be explained by differences in legal systems or whether differences between countries can be explained otherwise. To assess the true impact of the Act and additional policy measures confounding factors will be considered and the data will be adjusted for the impact of these confounding factors. This part of the thesis will also take into account of the fact that policies need time to have an effect. Therefore, we will describe the impact of policies over a longer period of time. A bottleneck in the donation process is the high refusal rate. For this reason, the government has developed a strategy to increase the consent rate for 13 E.g. the right to physical integrity, equitable access to and equal availability of care, and the non commerciality principle. 30

34 General introduction organ donation and to improve the efficiency of the process of organ donation. One element of this strategy is to provide donor education to the Dutch population. This is designed on the one hand, to point out the possibility of becoming an organ donor, and on the other hand to increase the number of registrations. The fourth chapter focuses on the combined impact of several policy measures in the field of donor education in the Netherlands over time. We will assess the impact of the additional policy measures on donor education by using trends in donor registration and donor procurement. Another part of the strategy to increase the consent rates is to optimize the organ donation process in hospitals. There are differences between hospitals with regard to the implementation of policy measures and their numbers of organ donors. These differences lead us to infer that some hospitals are more efficient in donor procurement than others. In chapter 5 these differences are studied and the scope for hospitals to increase their supply of donor organs is assessed. Part 3: Possible impact of changing the consent system The third part of this thesis focuses on what may be expected from changing the current consent system. The consent system is an important instrument of the Act. Many people expect that presumed consent systems lead to higher donation rates than explicit consent systems. The Netherlands implemented a system which is based on explicit consent because it was expected that the safeguarding power of the explicit consent system would contribute to increasing the supply of donor organs. Since the introduction of the Act there has been a lot of debate about changing to a presumed consent system in order to solve the shortage of donor organs. This part refers to the expected effects of a system change. Because other countries have implemented various consent systems, their results may shed some light on the possible effects of changing the current Dutch system (chapter 6). As next of kin seem to play an important role in providing consent for an organ donation procedure, chapter 7 models several imaginary consent systems, which were proposed to an internet panel. This chapter reveals whether the degree to which consent is explicit or presumed influences next of kin in their decisions and how this may have an effect on the supply of donor organs. 31

35 Chapter 1 Chapter 8 is the final chapter of this thesis and summarizes the answers to the research questions, based on the findings of the previous chapters. In this chapter we also reflect on our findings and their relevance for donor procurement in the Netherlands. Finally, pointers are given for future research and policy making. 32

36 2 The potential of legislation on organ donation to increase the supply of donor organs A shortened version of this chapter has been accepted for publication as: Coppen, R., Friele, R.D., Zee, J. van der, Gevers, J.K.M. The potential of legislation on organ donation to increase the supply of donor organs, Health Policy. 33