26 October, 2014
Lauranne De Lathauwer
Skills: Legal Research and Reasoning
European Law School Maastricht
Exam Assignment I
Number of words: 1917
Tutor: A. Parise
EGG CELL DONATION ON THE EUROPEAN CONTINENT
The need for uniformity
1 Table of Contents
Introduction
1. Background
1.1 Egg Cell Donation and its Risks
1.2 Legislations in European Countries Concering Egg Cell Donation
1.3 Reproductive Tourism
2. The Beneficial Aspects of a Regulation
2.1 More Integration
2.2 Safety
2.3 Fairness
3. How Can The EU Implement a Regulation
3.1 Tissue and Cell Directive 2004
3.2 The Process of Making a Regulation
3.3 Germany: a Possible Roadblock
Conclusion
2 Introduction
“Donation: Helping others to happiness” is the slogan of the website for the Center of
Reproductive Medicine in Brussels1. Almost every Fertility Clinic website plays on
the solidarity and altruism we are supposed to have for each other by displaying
pictures of happy model families and smiling pregnant women. The question of
whether this approach is ethical arises when in reality, egg donation and everything
that comes with it, is not always so rosy. Unfortunately, donors are not always well
informed and often not aware of the possible serious health risks that occur when
donating. Couples who are facing an infertility problem in countries with less
advanced fertility treatments often travel to other countries to make their dream of
becoming a parent come true. This is called “Reproductive Tourism” and is a
consequence of the many different laws in the European countries. Such travels often
conflict with the laws of their home country. Hence, there are a lot of reasons why the
European Union should establish a regulation concerning this topic. This paper will
only cover one of the Assisted Reproduction Technologies in Europe: Egg cell
donation. The question why the European Union (EU) should implement a regulation
concerning egg cell donation will be addressed in this paper. The first part will focus
on the background of egg cell donation and the risks that materialize, the different
legislations in European countries and Reproductive Tourism. The second part, will
cover the beneficial aspects that come with establishing a regulation, keeping
uniformity, safety and fairness in mind. Finally, the third part will mention the already
established Tissue and Cell Directive, explain how the European Union can
implement such a regulation and the possible problem it might face.
1. Background
1.1 Egg Cell Donation and its Risks
Egg cell donation is the process of extracting egg cells from one woman’s body and
implanting them in another woman’s body.2 In this light, the “acquisition” of egg cells
1 (Centrum
voor Reproductieve Geneeskunde) <http://www.brusselsivf.be/egg-donation> accessed 22
October 2014
2 'Ethical
Considerations of Egg Cell Donation' (Stemcellbioethics)
<http://stemcellbioethics.wikischolars.columbia.edu/Ethical+Considerations+of+Egg+Donation>
accessed 24 October 2014
3 is a more correct and descriptive term because not all women are “donating” their
eggs. Most of the donors ask for compensation. When someone gets remuneration in
exchange for human tissue, it is no longer a donation since the definition of a
donation is giving something to someone without charge. 3 Therefore, egg cell
donation can be seen as a commercial act rather than an act of pure altruism and
solidarity.
One of the biggest problems in this field of scientific advance is the fact that
many of the donors are not aware of the risks involved with the acquisition of their
egg cells. Not only will the donor deal with the usual effects that come with taking
hormones such as nausea, increase in bodyweight, and mood swings.4 There are also
long-term risks, specifically an increased risk of developing cancer later in life.5
1.2 Legislations in European Countries Concerning Egg Cell Donation
Every country has its own national legislation adapted to their culture,
religion, economy, history and political views. The EU published “A report on The
Regulation of Reproductive Cell Donation in the EU” in 2006 containing results of a
survey taken by the Member States.6 In 25% of the European Union countries, egg
cell donation is prohibited. These countries are Austria, Germany, Italy, Norway, and
Portugal. The countries that allow egg cell donation are Belgium, Denmark, France,
Great Britain, Greece, Ireland, Spain, the Netherlands, the Czech Republic and
Sweden. However, just because egg cell donation is legal in these countries, does not
3 Advisory Committee for Bioethics, 'Opinion no. 43 of 10 December 2007 on the problem of
commercialisation of human body parts ' (health.belgium, 2007)
<http://www.health.belgium.be/internet2Prd/groups/public/@public/@dg1/@legalmanagement/docum
ents/ie2divers/15532535_en.pdf> accessed 24 October 2014
4 Lisa C. Ikemoto, 'Reproductive Tourism: Equality Concerns in the Global Market for Fertility
Services ' (prochoicealliance, 2009)
<http://www.prochoicealliance.org/files/Ikemoto_Reproductive_Tourism_Equality_Concerns_Book_P
roof_final.pdf> accessed 24 October 2014
5 'Ethical Considerations of Egg Cell Donation' (Stemcellbioethics)
<http://stemcellbioethics.wikischolars.columbia.edu/Ethical+Considerations+of+Egg+Donation>
accessed 24 October 2014 6 European Commission, 'Report on the Regulation of Reproductive Cell Donation in the European
Union' (ec.europa.eu, 2006)
<http://ec.europa.eu/health/ph_threats/human_substance/documents/tissues_frep_en.pdf> accessed 24
October 2014
4 mean that they have similar rules. They all have different policies on the import and
export of reproductive cells, anonymity of the donors, and remuneration.7
1.3 Reproductive Tourism
Guido Pennings, Professor of Ethics and Bioethics at Ghent University
(Belgium), defined reproductive tourism as “the travelling by candidate service
recipients from one institution, jurisdiction, or country where treatment is not
available to another institution, jurisdiction, or country where they can obtain the kind
of medically assisted reproduction they desire.”8 Furthermore, this is a consequence
of the differing laws in Europe. An example of Reproductive Tourism occurs when
private clinics in Spain or Romania sell eggs to couples from countries where they are
unable to get assisted reproductive treatment. Sometimes couples go abroad to receive
services due to long waiting lists in their own country. Consequently, this
commercialism of human tissue is often paired with less high-standing and unsafe
medical practice.9
2. The Beneficial Aspect of a Regulation
2.1 More Integration
A uniform European regulation concerning egg cell donation would mean
more integration and more unity. The individual governing bodies of the European
Member States allow travel from one country to another to receive and provide
services according to the Freedom of Services within the internal market of the EU.
But what if the services provided in one country are illegal in another one? European
7 Corinna Sorenson, 'ART in the European Union' (euro.who, 2006)
<http://www.euro.who.int/__data/assets/pdf_file/0019/80371/EuroObserver8_4.pdf?ua=1> accessed 24
October 2014
8 Guido Pennings, 'Legal harmonization and reproductive tourism in Europe' (oxfordjournals, 2004)
<http://humrep.oxfordjournals.org/content/19/12/2689.full> accessed 24 October 2014
9 Lisa C. Ikemoto, 'Reproductive Tourism: Equality Concerns in the Global Market for Fertility
Services ' (prochoicealliance, 2009)
<http://www.prochoicealliance.org/files/Ikemoto_Reproductive_Tourism_Equality_Concerns_Book_P
roof_final.pdf> accessed 24 October 2014
‘Reproductive Tourism' (ncbio.org, 2013) <http://ncbio.org/nordisk/arkiv/macklin-ppt.pdf> accessed
24 October 2014
Philipa Mladovsky, 'IVF and reproductive tourism ' (euro.who, 2006)
<http://www.euro.who.int/__data/assets/pdf_file/0019/80371/EuroObserver8_4.pdf?ua=1> accessed 23
October 2014
5 harmonization is the ultimate solution to this issue and a regulation that is the same
for every European Union Member State is necessary to create such harmony. The
EU has moved away from being simply an economic organization many years ago,
and has already implemented many regulations in other fields. Thus, creating a
regulation in this field would therefore not be unreasonable. It would only result in
more harmony and integration.
2.2 Safety
Another reason why a single regulation would be beneficial is that it would
decrease Reproductive Tourism. Citizens would no longer be required to travel to
another country if they can get the same service in their own country. Since not all
countries allow reproductive treatment, providers in other countries take advantage by
raising the price of this treatment. Another reason for traveling abroad is the long
waiting lists in some countries.10 The circumstances in public hospitals in developing
countries that offer reproductive treatments are often questionable.11 If there is a
regulation that ensures a safe medical environment, the risks of complications will
diminish as well. A supranational law is a good solution to regulate the safe practice
in this medical field. It is to the utmost advantage of the patients, doctors and
scientists that an intervention of the EU takes place.
2.3 Fairness
Another issue that arises is the unfairness of the commercialization of egg cell
donation. According to Petra De Sutter, Professor and Head of the Department for
Reproductive Medicine of the University Hospital in Ghent (Belgium)12, not all
governments see fertility treatments as necessary medical aid. In these countries,
insurance does not cover the costs of the reproductive treatment. This makes egg cell
10 Corinna Sorenson, 'ART in the European Union' (euro.who, 2006)
<http://www.euro.who.int/__data/assets/pdf_file/0019/80371/EuroObserver8_4.pdf?ua=1> accessed 24
October 2014 11 Lisa C. Ikemoto, 'Reproductive Tourism: Equality Concerns in the Global Market for Fertility
Services ' (prochoicealliance, 2009)
<http://www.prochoicealliance.org/files/Ikemoto_Reproductive_Tourism_Equality_Concerns_Book_P
roof_final.pdf> accessed 24 October 2014
‘Reproductive Tourism' (ncbio.org, 2013) <http://ncbio.org/nordisk/arkiv/macklin-ppt.pdf> accessed
24 October 2014
12 Petra De Sutter, (petradesutter.be, 2014) <http://petradesutter.be/over_petra> accessed 24 October
2014
6 donation only an option for the ‘happy few’, the people who can afford fertility
treatments.13 Assisted Reproductive Technology is, therefore, a ‘luxury’ sector in
medical care. A uniform regulation might change governments’ views and lead to
changes in insurance so fertility treatment will be accessible for everyone.14
3. How Can the EU Implement a Regulation
3.1 Tissue and Cell Directive
On March 31, 2004, the EU adopted a directive “on setting standards of
quality and safety for the donation, procurement, testing, processing, preservation,
storage and distribution of human tissues and cells”.15 Although this is already a step
in the right direction, it is not very relevant for egg donation. This directive is more
concerned about the practice of safety and quality standards mentioned above. It does
not cover the real issue that is at stake: the variety of the different national legislations
causing Reproductive Tourism.
In the 12th point of its introduction, the directive mentions that it should not
interfere with national decisions on the use or non-use of any specific type of human
cells. This is exactly what the EU needs and is proof of why the directive is not
effective enough at preventing reproductive tourism. Another reason why the
directive is not effective enough is the poor controls of some of the Member States
covered by the directive and this may lead to unsafe practices.
3.2 The Process of Making a Regulation
A regulation is a binding legislative act that applies directly to the Member
States because they have given the EU the competence to do so by giving up part of
their sovereignty. In order for a regulation to be adopted, it has to follow the
13 'Interview met Petra De Sutter' (accodonline.be 2014) <http://www.acodonline.be/artikels/publiekartikel.aspx?nr=4159> accessed 23 October 2014
C. Ikemoto, 'Reproductive Tourism: Equality Concerns in the Global Market for Fertility
Services ' (prochoicealliance, 2009)
<http://www.prochoicealliance.org/files/Ikemoto_Reproductive_Tourism_Equality_Concerns_Book_P
roof_final.pdf> accessed 24 October 2014 15 Council Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on
setting standards of quality and safety for the donation, procurement, testing, processing, preservation,
storage and distribution of human tissues and cells [2004] OJ L 102
14 Lisa
7 “Ordinary Legislative Procedure”.
16
This procedure works as follows: The
Commission makes a proposal which is sent to the European Parliament and the
European Council; The Parliament adopts its position on the proposal; and, the
Council approves the position of the Parliament on the proposal. When the Council
approves the position of the Parliament, the proposal is adopted as an act.
According to the principle of subsidiarity, the EU should only take action
when it is more effective than the action taken on national, regional or local level.17
The variety of different legislations of the Member States are the basis of
Reproductive Tourism which means that the nationals are not really abiding by their
national law; if they are not able to get what they want in their own country, they are
obtaining it in another country. The principle of proportionality requires that the
action should not go beyond what is necessary to obtain the objectives of the
Treaties.18 By implementing a regulation that will result in more uniformity and
integration, the EU achieves one of its main goals.
3.3 Germany: A Possible Roadblock
When it comes to reproductive treatment, Germany is quite apprehensive
about egg cell donation. The reason behind their apprehension dates back to the
genetic experiments that took place under Hitler’s leadership during the Second
World War. One of the main goals of the Nazis was to achieve the Aryan Race by
manipulating genetics.19 Hence, Genetic Research is still a sensitive topic for the
Germans. In 1990 Germany adopted the “Embryo Protection Act”.
The prohibition of egg cell donation is a part of this act. The first section of
the German Embryo Protection Law states “Anyone will be punished with up to three
years imprisonment or a fine, who transfers into a woman an unfertilised egg cell
16 Consolidated versions of the Treaty on European Union and the Treaty on the Functioning of the
European Union [2007] OJ C 326 17 Consolidated versions of the Treaty on European Union and the Treaty on the Functioning of the
European Union [2007] OJ C 326 18 Consolidated versions of the Treaty on European Union and the Treaty on the Functioning of the
European Union [2007] OJ C 326 19 Katrin Weigmann, 'The role of biologists in Nazi atrocities: lessons for today’s scientists'
(ncbi.nlm.nih.gov, 2001) <http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1084095/?tool=pubmed>
accessed 24 October 2014
8 produced by another woman”.20 It is, therefore, safe to say that Germany will most
likely vote against a European regulation concerning egg cell donation.
Conclusion
In conclusion, the risks of egg cell donation and Reproductive Tourism are
two main reasons why the EU should implement a regulation concerning egg cell
donation. The EU has the jurisdiction to create regulations based on ethical and legal
grounds but it will more than likely face some roadblocks along the way. Perhaps the
biggest being Germany’s position on this issue. The EU has proven with its directive
that it is concerned about this topic, however the argument that this is not a main
concern of the EU is a pretty strong one.
This can be countered with the principle of subsidiarity. The different
legislations of the EU member states have created the existence of an unsafe, unfair,
and unethical commercialization of egg cell donation. The directive is not correctly
controlled by the Member States, which is one of the main reasons why Reproductive
Tourism occurs. It is the job of the EU to create a regulation that is both ethical and
effective, if the Member States are not able to do it themselves. Humanity should be
protected from unfair medical practice since money and ethics do not always go
together. A unifying regulation concerning this topic will bring more integration,
safety, and even new revelations in the world of reproductive science.
20 Gesetz zum Schutz von Embryonen1990 s 1(1)
9 Bibliography
Primary sources
Council Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on
setting standards of quality and safety for the donation, procurement, testing, processing, preservation,
storage and distribution of human tissues and cells [2004] OJ L 102
Consolidated versions of the Treaty on European Union and the Treaty on the Functioning of the
European Union [2007] OJ C 326
Gesetz zum Schutz von Embryonen1990, Embryonenschutzgesetz. [English]
Secondary sources
Advisory Committee for Bioethics 2007
Advisory Committee for Bioethics; 'Opinion no. 43 of 10 December 2007 on the problem of
commercialisation of human body parts '. Health.belgium, 2007. Retrieved from
http://www.health.belgium.be/internet2Prd/groups/public/@public/@dg1/@legalmanagement/docume
nts/ie2divers/15532535_en.pdf last visited on 24 October 2014
Ikemoto 2009
Lisa Ikemoto; 'Reproductive Tourism: Equality Concerns in the Global Market for Fertility Services'.
prochoicealliance, 2009. Retrieved from
http://www.prochoicealliance.org/files/Ikemoto_Reproductive_Tourism_Equality_Concerns_Book_Pr
oof_final.pdf; last visited on 24 October 2014
Mladovsky 2006
Philipa Mladovsky; 'IVF and reproductive tourism'. Euro Observer, 2006. Retrieved from
http://www.euro.who.int/__data/assets/pdf_file/0019/80371/EuroObserver8_4.pdf?ua=1; last visited on
23 October 2014
Pennings 2004
Guido Pennings; 'Legal harmonization and reproductive tourism in Europe'. Oxfordjournals, 2004.
Retrieved from http://humrep.oxfordjournals.org/content/19/12/2689.full; last visited on 24 October
2014
Reproductive Cell Donation 2006
The Regulation of Reproductive Cell Donation in the European Union [Report]. Brussels: European
Commission, Directorate-General for Health and consumer protection. 2006
10 Sorenson 2006
Corinna Sorenson; 'ART in the European Union'. Euro Observer, 2006. Retrieved from
http://www.euro.who.int/__data/assets/pdf_file/0019/80371/EuroObserver8_4.pdf?ua=1; last visited on
24 October 2014
Weigmann 2001
Katrin Weigmann; 'The role of biologists in Nazi atrocities: lessons for today’s scientists’. National
Center for Biotechnology, 2001. Retrieved from
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1084095/?tool=pubmed; last visited on 24 October
2014
Centrum voor Reproductieve Geneeskunde
http://www.brusselsivf.be/egg-donation
Ethical Considerations of Egg Cell Donation
http://stemcellbioethics.wikischolars.columbia.edu/Ethical+Considerations+of+Egg+Donation
Interview met Petra De Sutter
http://www.acodonline.be/artikels/publiek-artikel.aspx?nr=4159
Reproductive Tourism
http://ncbio.org/nordisk/arkiv/macklin-ppt.pdf
Petra De Sutter
http://petradesutter.be/over_petra
11