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Organ Transplant Legislation From Trade to Donation

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					Organ Transplant Legislation:
  From Trade to D onation




          Right to Health Program
    Egyptian Initiative for Personal Rights
                February 2010
Egyptian Initiative for Personal Rights                                              2




        Title:           Organ Transplant Legislation: from Trade to Donation

        Publisher:      Egyptian Initiative for Personal Rights (EIPR)
                        8 Mohamed Ali Jinnah Street Garden City – Cairo
                        Tel/fax: + (202) 27943606 - 27962682

        Website:        www.eipr.org
        Email:          eipr@eipr.org

        Designed By: Kirolos Nagy
        First Edition: February 2010 – Cairo

        National Library Registration no.: 4188/2010




        Acknowledgments

        Dr. Alaa Ghanaam , Right to H ealth Program Director at the EIPR,
        prepared and drafted the analysis, which formed the basis for this position
        p ap er. Dep u ty Director, Soha Abd elaty, review ed and ed ited the rep ort as
        w ell as assisted in the research and d rafting of som e of the sections. Sherif
        Arafa, Research Intern for the Right to H ealth Program , assisted in the
        research and d rafting. Med ia Officer Ahm ed Mahgou b help ed review and
        edit the report.
3                                                                                         Organ Transplant Legislation


                                              Table of Contents


Introduction ...................................................................................................................... 4

I. Organ and Tissue Transplant: The Rights to Health and Life................................ 6

II. International Standards Established by Organizations for Organ and Tissue

Transplantation………………………………………………………………………… 9

III. Organ and Tissue Transfer, Transplantation and Procurement....................... 12

IV. National Legislation to Regulate Organ Transfer, Transplant and Prevent

Organ Trafficking ........................................................................................................... 14

V. Preliminary Observations on the Bill ..................................................................... 19

VI. Basic Steps Needed to Implement the Law .......................................................... 22
Egyptian Initiative for Personal Rights                                              4


                                          Introduction
Organ transp lantation is, w ithou t a d ou bt, one of the m ost significant
achievements in m od ern m ed icine. In m any cases, it is the only treatm ent for the
late stages of organ failu re and chronic heart, liver and kid ney d isease. Organ
transplants continue to give hope to millions of people around the world.

Many cou ntries tod ay engage in organ transp lant su rgeries, bu t su ccessfu l
p rogram s in these cou ntries d o not necessarily offer an organized method for the
p rocu rem ent of organs from d onors of variou s cu ltu ral, religiou s and econom ic
backgrou nd s. Rather, a high level of societal aw areness p articu larly am ong
d octors, law m akers, p otential d onors and organ recip ients is the key to the
success of organ transplantation.

Althou gh it is a basic tenet that d onation
must be the fou nd ation for all organ and             Experience from countries all
tissu e transp lants, the rarity of organs has      over the world demonstrates that
given rise to a grow ing com m ercial m arket       commercial trade in this area has
for organs on the local, regional and               evolved from being a market that
international levels. As a resu lt, abu se and       trades organs to being a market
exp loitation takes p lace, esp ecially of the       that trades people, whereby the
poor for the benefit of the rich, and also for      poor and the most vulnerable are
the benefit of local or cross-border                    being exploited —whether
interm ed iaries, in w hat is know n as             directly or through intermediary
“transp lant tou rism ”. It is consid ered a                   transactions.
flagrant violation of basic hu m an rights,
particularly the right to life and the right to     World Health Assembly, EB124/15,
health.                                             paragraph 5, report on the meeting
                                                          of 20 November 2008
The World H ealth Organization (WHO)
has m onitored the grow ing p henom ena of
transp lant tou rism , w hich started to ap p ear in the m id -1990s. Estim ates show
that it accou nts for 10% of all organ transp lant p ractices w orld w id e.1 Organ
trafficking and transp lant tou rism continu e to exp and on the local, regional and
international levels d esp ite the absence of com p rehensive research and
d ocu m ented statistics su rrou nd ing the p henom enon. This situ ation requ ires
nations and their governm ents to exert greater efforts to lim it this p henom enon
throu gh the issu ance of legislation crim inalizing the organ trad e. Local, regional

1WHO, “WHO Proposes Global Agenda on Transplantation,” 30 March 2007,
<http://www.who.int/mediacentre/news/releases/2007/pr12/en/index.html>.
5                                                            Organ Transplant Legislation


and international bod ies m u st also coord inate efforts to stop the sp read of the
black market in human organs.2

For m any years, Egyp t has been one of the few cou ntries in the w orld w ithou t
legislation crim inalizing the organ trad e and regu lating organ and tissu e
transp lant, p articu larly from the d eceased to the living. N evertheless, the issu e
has been the su bject of a broad d ebate am id rep eated w arnings of “a m afia of
organ traffickers,” w hose victim s are the p oor and m ost vu lnerable. Increasingly
strong d em and s have been heard for clear, strict legislation that w ou ld regu late
the chaos in this critical field in the health sector.

On the other hand , a large p rop ortion of those w ho u rgently need organ
transp lants in Egyp t still have no chance of obtaining the necessary organ
becau se of the high cost of the op eration, p articu larly w hen p erform ed ou tsid e
the fram ew ork of u niversal insu rance (w hich covers not only the cost of the
transp lant itself, bu t p ost-op treatm ent and convalescence as w ell). In ad d ition,
the reliance on living d onors as the sole sou rce of organs, as is the case in Egyp t,
has created a severe shortage of organs d u e to the sm all nu m ber of d onors, w ho
often fear com p lications as a resu lt of the transp lantation. This u ltim ately
d ep rives others of their rights to life and health, thu s encou raging transp lant
tourism and the exploitation of those who are vulnerable.

It is in this context, that the Egyp tian Initiative for Personal Rights (EIPR)
su bm its this p osition p ap er to offer a rights-based p ersp ective on organ and
tissu e transp lant p olicies as a m eans by w hich the state can m eet its
com m itm ents to the hu m an rights to health and life. In this d ocu m ent, the EIPR
stresses the u rgency of a legislation that w ill p u t a stop to organ trafficking and
ensu re the availability of this typ e of health care for all ind ivid u als as p art of a
system of u niversal insu rance. The EIPR recom m end s that all concerned p arties
p u t asid e the d ebate on the d efinition of d eath and look at the consequ ences of
fu rther d elaying the p rop osed law . Finally, the EIPR u rges p olicym akers to be
m ind fu l of the fact that this law w ill be of no valu e if the state d oes not allocate
the fu nd s need ed to im p lem ent it, m onitor its ap p lication and encou rage society
to adopt a culture of donation.




2   Ibid.
Egyptian Initiative for Personal Rights                                                         6


                       I. Organ and Tissue Transplant:
                         The Rights to Health and Life
International conventions have p reserved the right to health as a basic hu m an
right, stressing the state’s obligation to resp ect and fu lfill this right. The right to
health is not lim ited to the p rovision of p reventive and cu rative health services,
bu t is rather a com m itm ent on the p art of states to the right of every p erson to
enjoy the highest attainable standard of physical and mental health.3

Accord ingly, General Com m ent N o. 14 on the right to health 4 issu ed by the UN
Committee on Economic, Social and Cultural Rights states that “the realization of
the right to health m ay be p u rsu ed throu gh nu m erou s, com p lem entary
ap p roaches, su ch as the form u lation of health p olicies, or the im p lem entation of
health p rogram s d evelop ed by the World H ealth Organization (WH O), or the
adoption of specific legal instruments.”5

The right to health is com p rised of the follow ing elements:6 the availability of
ad equ ate health services and p rogram s, p rovid ed by the state; the accessibility to
health services w ithou t d iscrim ination, w hich com p els the state to ensu re that all
segm ents of society can bear the costs of treatm ent and services; and finally the
health services m u st be of good qu ality that is accep table by the citizens. These
elem ents illu strate the im p ortance of form u lating legislation that allow s the
d onation of organs to the need y as one m eans of gu aranteeing their right to
health. Su ch legislation w ou ld also enable the p oor to obtain organs w hen they
need them w ithou t d iscrim ination, thu s giving them a better chance to recover if
they do require an organ transplant.

Ap p lying the stand ard s set forth by Article 12 of the Convention on Econom ic,
Social and Cu ltu ral Rights to the obligations of signatory states allow s for the

3 Article 12 of the International Convention on Economic, Social and Cultural Rights, 1966.
Several other international and regional conventions have also uphold the right to health,
including the Universal Declaration of Human Rights (1948), Article 25; the Convention on the
Elimination of All Forms of Discrimination Against Women (1979), Articles 11 and 12;
Convention on the Rights of the Child (1989), Article 24; and the African Charter on Human and
Peoples’ Rights (1981), Article 16.
4 The General Comments are documents issued by the UN treaty monitoring bodies, including

the Committee on Economic, Social and Cultural Rights to clarify the articles of the treaties they
are monitoring, particularly the commitments and principles incumbent on signatory nations to
these treaties.
5 General Comment No. 14 (2000), UN Committee on Economic, Social and Cultural Rights,

paragraph 1.
6 Ibid.
7                                                             Organ Transplant Legislation


id entification of violations of the right to health. Violations can occu r “throu gh
the om ission or failu re of States to take necessary m easu res arising from legal
obligations”7 or when states do not guarantee equal access to health services. The
right to health can also be violated throu gh the d irect action of states (i.e., the
failu re to issu e a law regu lating organ transp lant and p rohibiting the trad e in
organs) or the actions of third p arties that are not regu lated by the state (i.e., the
organ-trafficking m afia). In the latter exam p le, the state is failing to p rotect the
poorest and most vulnerable members of society, who are the main victims of the
organ trad e. They are easy targets of exp loitation becau se of their m aterial need s
and their ignorance of the d angers of transp lant op erations. Measu res, su ch as
p assing legislation, are need ed to p rotect those p ersons w hose right to health is
being violated by a third party.

The right to life is a non-derrogable right that the state cannot su sp end even in
tim es of w ar or national em ergency; it cannot be abstained by taking m easu res
that m ay arbitrarily d ep rive a p erson of life. Protecting the right to life also
entails much more than this, as indicated by General Comment No. 6 on the right
to life issu ed by the UN H u m an Rights Com m ittee: “Moreover, the Com m ittee
has noted that the right to life has been narrow ly interp reted too often. The
exp ression ‘inherent right to life’ cannot p rop erly be u nd erstood in a restrictive
m anner, and the p rotection of this right requ ires that States ad op t p ositive
m easu res. In this connection, the Com m ittee consid ers that it w ou ld be d esirable
for States p arties to take all p ossible m easu res…to increase life exp ectancy…” 8
Viewed from this p ersp ective, it is necessary to p ass an organ transp lant law to
give citizens the op p ortu nity to live longer and healthier. It is also im p ortant to
m inim ize the risks the m ost vu lnerable face as a resu lt of exp loitation by organ
traffickers.

The rep ort by the UN Sp ecial Rap p orteu r on the sale of child ren, child
p rostitu tion and child p ornograp hy, su bm itted to the H u m an Rights Cou ncil in
March 2006, ad d ressed the issu e of the sale of child ren’s organs, since child ren
are amongst the m ost vu lnerable to exp loitation. The Rap p orteu r noted that
states that have signed the op tional p rotocol of the Convention on the Rights of
the Child on the sale and exp loitation of child ren, as w ell as the p rotocol to
p rohibit hu m an trafficking (w hich is a p rotocol to the Convention Against




7   Ibid., paragraph 49.
8   UN Human Rights Committee, General Comment No. 6 (1982), paragraph 5.
Egyptian Initiative for Personal Rights                                                   8


Transnational Organized Crim e) are obligated to crim inalize organ trafficking.9
Egypt is a p arty to both p rotocols. The Sp ecial Rap p orteu r recom m end ed that
states p ass legislations regu lating organ transp lant and d onation thu s
crim inalizing and p u nishing those w ho traffic in organs, in accord ance w ith the
gu id elines d evelop ed by the WH O. The aim of the legislation is to p rohibit
“‘transp lant tou rism ,’ in w hich the m ed ical establishm ents op enly take
ad vantage of the d isp arities betw een the situ ation of the d onor and the receiver,
with significant risks for both persons involved in the transplant.”10




9 Report from the Special Rapporteur on the sale of children, child prostitution and child
pornography, presented to the Human Rights Council, no. A/HRC/4/31, issued on 26 Dec. 2006,
<http://www2.ohchr.org/english/bodies/hrcouncil/4session/reports.htm>.
10 Report of the Special Rapporteur, 2006, paragraph 80.
9                                                          Organ Transplant Legislation


II. International Standards Established by Organizations for
              Organ and Tissue Transplantation
Since the transp lant of organs from living or d eceased d onors to p atients
su ffering from organ failu re first began, international m ed ical organizations and
agencies have been carefu l to issu e resolu tions prescribing guidelines for the
regu lation of p rofessional stand ard s and ethics in this field . They have
consistently issu ed recom m end ations to regu late p ractices that violate these
principles.

The WH O has cond em ned organ trafficking on m ore than one occasion, starting
w ith World H ealth Assem bly (WHA) Resolu tion 40.13 in 1987. It also drew
attention to the failu re of efforts to com bat trafficking and called on cou ntries to
com p ou nd their efforts in Resolu tion 42.5/1989. Resolu tion 44.25/1991 ad op ted
the first d raft of the WH O’s gu id elines for the transp lant of hu m an organs and
tissu es, w hich established the stand ard p roced u ral and ethical fram ew ork for
these op erations. WH A Resolu tion 44.25 stip u lated the need to ban the sale of
human organs for the purpose of transplantation.

One of the m ost significant recom m end ations issu ed by the WH A w as in its 57th
session (Resolu tion 57.18) in May 2004, in w hich the organization u rged m em ber
states to exercise effective su p ervision on organ transp lants and seek ou t living
as well as deceased organ donors. It also urged member states to “take measures
to protect the poorest and most vulnerable groups from ‘transplant tourism’...”

In 2008, the WH O gu id elines on organ and tissu e transp lantation w ere revised
and ad op ted by the grou p ’s execu tive cou ncil in the m eeting held in N ovem ber
2008. The gu id elines recom m end ed acqu iring legal consent for the extraction of
cells, tissu e or organs from corp ses and allow ed d onations from the living as
long as p rofessionals p rovid e the necessary care to the d onor and qu ality follow -
u p . Moreover, the d onors shou ld be legally com p etent and able to w eigh the
inform ation effectively. Finally, they shou ld be m otivated by a real d esire to
d onate their organs, w ithou t any coercion. The gu id elines stress the need for a
genetic, legal or em otional relationship betw een living d onors and recip ients.
Also, the d onation shou ld be accep ted know ingly and volu ntarily. Minors and
incap acitated ad u lts m u st be protected from d onating u nd er d u ress, and the
d onation m u st be m ad e w ithou t p rom ise of p aym ent or any other m aterial
rew ard . H ow ever, d onors m ay be com p ensated for reasonable costs incu rred ,
including the loss of income.
Egyptian Initiative for Personal Rights                                                           10


The gu id elines state that d octors involved in d eterm ining d eath cannot be
involved d irectly or ind irectly in organ transp lant, extraction or exchange in any
shap e or form . In ad d ition, they p rohibit d octors, m ed ical p rofessionals and
insu rance com p anies from involvem ent in transp lant p roced u res if the organ
w as obtained by exp loiting the d onor or the relative of a d eceased d onor, via
coercion or p aym ent. In transp lant op erations, all safety and qu ality stand ard s
m u st be observed . Fu rtherm ore, d onation and transp lantation system s m u st be
clear and they must protect the privacy of individuals involved in the process.

Recently, m ore than 150 rep resentatives of m ed ical organizations and
governm ents, as w ell as sociologists and legal researchers from 78 states and 20
international organizations m et for a su m m it in Istanbu l. The m eeting conclu d ed
w ith the Istanbu l Declaration of 2 May 2008. The su m m it w as organized by tw o
international organizations active in the field , the International Transp lantation
Society and the International Society of N ep hrology. The recom m end ations
contained in the Istanbu l Declaration 11 add ed significant asp ects to the system of
international stand ard s. The d eclaration stressed that hu m an d onation of organs
at d eath shou ld be encou raged , by governm ental and non-governmental
institu tions. It em p hasized the im p ortance of health and p sychological care for
living d onors, as w ell as the need to regard their actions as a heroic, life-giving
feat. It also stressed the need for living d onors to u nd ergo m ed ical and
p sychological evalu ations before and after d onation in accord ance w ith
international guidelines.

The d eclaration referred to the im p ortance of non-d iscrim ination in organ
transp lant p roced u res w ith regard s to gend er, ethnicity, religion or financial
statu s in ord er to achieve the valu es of ju stice and equ ity. The d ocu m ent also
p rovid ed a d efinition of organ trafficking,12 noting that the traffic in organs and
transp lant tou rism violate the p rincip les of equ ity, ju stice and resp ect for hu m an
dignity.

The d eclaration noted that the cost of organ transp lantation shou ld not inclu d e
any p aym ent for the organ, tissu e or cells u sed . Moreover, costs shou ld be


11To see the document, refer to <http://www.transplantation-soc.org/istanbul.php>.
12The declaration defines organ trafficking as “the recruitment, transport, transfer, harboring or
receipt of living or deceased persons or their organs by means of the threat or use of force or
other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a
position of vulnerability, or of the giving to, or the receiving by, a third party of payments or
benefits to achieve the transfer of control over the potential donor, for the purpose of exploitation
by the removal of organs for transplantation.”
11                                                          Organ Transplant Legislation


calcu lated to incorp orate legitim ate exp enses as p art of the treatm ent of organ
recipients.

The d eclaration consid ers the establishm ent of an efficient health system a
strategic goal in ord er to p revent the sp read of organ failu re, w hich lead s to an
increased d em and for organs. In ad d ition, it stressed the im p ortance of
comprehensive insu rance system s that can bear the costs of transp lantation
op erations w ithou t ou t-of-p ocket p aym ent requ irem ents, w hich op ens the d oor
to organ trafficking. The d eclaration also stressed the significance of su p p orting
ed u cation and raising aw areness p rogram s for health sector w orkers and
citizens. Fu rtherm ore, the d ocu m ent also noted the im p ortance of joint regional
action to p rep are a registry of d onors and p otential recip ients w ithou t
undermining the national interest of any country.
Egyptian Initiative for Personal Rights                                                      12


      III. Organ and Tissue Transfer, Transplantation and
                         Procurement
Initially, transp lantations w ere lim ited to the heart, liver and kid ney. H ow ever,
as m ed icine and su rgery have ad vanced , m ore op p ortu nities have em erged for
the transplant of other vital organs, such as the pancreas, lungs and various types
of tissu e transp lants. These tissu e transp lants inclu d e corneas, card iac valves,
and skin and bone, of w hich an estim ated 3-5 m illion take p lace every year
around the world.13

Kid ney transp lantation occu p ies a sp ecial statu s. Althou gh kid ney d iseases can
be treated w ith d ialysis, it is generally agreed u p on that kid ney transp lants are
the m ost op tim al treatm ent for renal failu re, in term s of su rvival rates, im p roved
quality of life and cost efficiency. Both low and high-income countries are similar
in this regard and kid ney transp lants are the m ost com m on typ e of
transplantation, accou nting for 50,000 of the 70,000 kidney transp lants arou nd
the world every year.14

The transfer of organs from d eceased d onors requ ires a strong institu tional
stru ctu re. First of all, it is necessary to id entify those w ho intend to d onate their
organ(s) and to obtain their consent or the consent of their loved ones. This is
follow ed by the extraction of the d onor’s organ and its secu re transfer for
transplant to the medical team performing the surgery.

Althou gh, w orld w id e, there is a greater reliance on d eceased d onors, the
procurement of organs from living donors has become inevitable to save the lives
of thousands of patients on waiting lists. Thus living donation is a possibility, but
it requ ires the form u lation of sp ecial guidelines to avoid harm to the d onor’s
health.15

The p roblem cu rrently facing the w orld is that there is a constant, grow ing need
for a sou rce of alternative organs. Until science find s a w ay to overcom e the
obstacles facing organ transp lant w ith non-hu m an tissu e, hu m ans, p articu larly
the d eceased , w ill rem ain the sole sou rce of organs available for transp lant. This
has m ad e organ transp lant a sensitive, d ifficu lt end eavor, for it is the only


13 Rüdiger von Versen, “Ethics, Access and Safety in Tissue and Organ Transplantation: Issues of
Global Concern,” WHO document WHO/HTP/EHT/T-2003.1.
14 WHO, “Human Organ and Tissue Transplantation: Report by the Secretariat,” WHO document

EB112/5 at http://www.who.int/ethics/topics/human_transplant_report/en/index.html, 2003.
15 Ibid.
13                                                                  Organ Transplant Legislation


m ed ical specialty in w hich the d eath of one p atient is the basic cond ition for
saving the life of another. In tu rn, it has linked the com p licated issu e of the
definition of death to organ transplantation.

How to define death?

Elim inating the traffic in organs is largely d ep end ent on encou raging d onations
and fostering a cu ltu re of contribu tion. One of the biggest obstacles facing the
p assage of a law in Egyp t is the controversy over the d efinition of d eath. Is a
person whose brain stem is dead, considered dead? Or does death entail the total
shut down of all bodily organs?

Official d ocu m ents and rep orts issu ed by international m ed ical grou p s and
agencies, su ch as the WH O and the WH A are free of, or m ore p recisely,
intentionally avoid agreeing on a u nified , international d efinition of d eath.
Rather, each cou ntry has been left to d eterm ine those stand ard s ap p rop riate to,
and consistent with, the thoughts and beliefs of its own citizens.

In fact, the cu rrent d isp u te is alm ost entirely a m ed ical d isp u te; religion settled
the m atter long ago. Many Mu slim clerics and legal scholars, as w ell as nearly all
legislative and religiou s ju risp ru d ential agencies, have issu ed statem ents
d eclaring the p erm issibility of organ d onation and the transfer of organs from
living donors on the cond itions that no harm com e to the d onor and no financial
p aym ent is m ad e for the d onated organ. These institu tions have u p held the
p rincip le of d onation w ithou t com p ensation in ord er to benefit the living, but
they left the clarification of other im p ortant p rincip les, su ch as the d efinition of
d eath, to d octors. Sheikh Mahm u d Ashu r, the form er Dep u ty of al-Azhar and a
m em ber of the Islam ic Research Cou ncil, exp ressed this stance w hen he said ,
“The d ebate over brain d eath is a m ed ical, not religiou s, m atter. Religiou s law
sees death as the spirit’s exit from the body and the end of life in the body. As for
brain d eath, no cleric shou ld give an op inion; this is for d octors.” 16 Sheikh Ashu r
p laced the bu rd en of d efining d eath on d octors, ad d ing that they are the real
cause of the delay in the law since they cannot agree on the definition.17

Many cou ntries have overcom e the d ebates on the d efinition of d eath. Thu s they
m anaged to issu e legislation consistent w ith international stand ard s by referring
the issue to special committees of doctors to decide on the matter.

16 Mona Abu al-Nasr, “al-Jadal hawl ta’rif al-mawt yu’arqil qanun zira’at al-a’da’ bi-Misr,” BBC
Arabic, 24 Feb. 2008,
<http://news.bbc.co.uk/hi/arabic/world_news/newsid_7261000/7261958.stm>.
17 Ibid.
Egyptian Initiative for Personal Rights                                                            14


       IV. National Legislation to Regulate Organ Transfer,
            Transplant and Prevent Organ Trafficking
Becau se of the lack of national legislation crim inalizing organ trafficking and
regu lating the d onation of organs from the d eceased , there is an alm ost com plete
reliance on living organ donation in Egypt, without strict supervision. As a result
very few transp lants are p erform ed d u e to the shortage of organs. This situ ation
relieves the state of its obligation to p rovid e for su ch op erations on a broad basis
and allocate the basic financial resou rces to su p p ort them w ithin a system of
com p rehensive, u niversal insu rance. Thu s, the m ajor p roblem is that a great
number of people who need transplants are without a solution. At the same time,
the p resent situ ation p erm its organ trafficking becau se of the absence of
deterrent legal statutes.

To take only one exam p le, an organ transp lant law w ill have an enorm ou s
p ositive im p act on the lives of liver p atients in Egyp t, w hich has one of the
highest rates of hep atitis C in the w orld . Accord ing to the m ost recent stu d y, the
first national survey of citizens aged 15-59, 9.8% of the population has the virus.18
Chronic hep atic viru ses bring increased risk of grave com p lications, first and
forem ost, cirrhosis, w hich can lead to liver failu re or cancer. Thu s far, there is no
treatm ent for these cases excep t for liver transp lantation, w hich is only for those
able to survive the operation.19

From 2002 to 2007, official rep orts ind icated that 430 liver transp lants w ere
cond u cted in Egyp t.20 On 20 March 2007, Minister of H ealth H atem al-Gabali
annou nced the first su ccessfu l liver lobe transp lant from a living d onor at a
governm ent hosp ital, the Sahel Teaching H osp ital in Shu bra. Accord ing to a
news report, the patient fully recovered.21

While a liver lobe transp lant costs nearly LE 600,000 in p rivate hosp itals, (an
am ou nt w hich m ost Egyp tian p atients cannot afford ) it costs only LE 250,000 at
the Sahel Teaching H osp ital. For the need y, financial su p p ort of LE 50,000-
200,000 is offered d irectly from the Ministry of H ealth or the Misr bi-Kheir

18 El Zanaty and Associates, Egypt Health and Demographic Survey 2008, Ministry of Health and
Population.
19 Ahmad Shahin, “Zira’at al-a’da’ bayn al-tibb wa-l-qanun wa-l-din,” al-Qahira, Sept. 2007, pp.

37-8 and 60.
20 Faruq ‘Abd al-Majid, “‘Amaliyat zar’ kabid jadida bi-mustashfa al-sahil khilal ayyam,” al-

Ahram, 11 April 2007, p. 8.
21 Egyptian State Information Service, “Minister of Health: Liver Transplant Operations To Be

Performed at Sahel Hospital,” 23 April 2007.
15                                                                   Organ Transplant Legislation


Program in conju nction w ith the m inistry and Dar al-Ifta’, w hich su p p orts the
need iest p atients w ith fu nd s from the alm s. The Sahel H osp ital also has p rivate
funding to supplement the costs of such operations.22

N evertheless, there is a m ajor reliance on charity to fu nd these op erations at the
Sahel H osp ital, w hich greatly lim its them .23 Clearly, am eliorating the situ ation
requires the creation of a national program as well as the political will to pass the
organ transplant bill and guarantee adequate funding for implementation.

It shou ld also be noted that the health consequ ences of organ transp lantation
requ ire lifelong treatm ent, the costs of w hich the p oor have d ifficu lty m eeting.24
The costs of a transplant operation are not limited to the surgery, but also include
post-op treatm ent and follow -u p , as w ell as d ru gs that the p atient m u st u se for a
long tim e (the cost of w hich is nearly LE 2,000 p er m onth).25 The d onor m ight
also su ffer com p lications, w hich is w hy som e cou ntries d o not allow living
d onations and rely on d eceased d onations.26 There are no precise numbers on the
nu m ber of su ccessfu l transp lants carried ou t by the Sahel H osp ital, bu t it is
rumored that 7 out of 19 patients did not survive the transplantation.27

At the sam e tim e, organ trafficking and transp lant tou rism are w id esp read in
Egypt, although there are no accurate figures on the scope of the phenomenon, or
the nu m ber of beneficiaries. Ministry of H ealth officials ad m it to the existence of
trafficking, carried ou t w ith the p articip ation of som e m ed ical p ersonnel and
treatm ent facilities.28 Dr. H am d i al-Sayyid , the p resid ent of the Egyp tian Med ical
Syndicate and the chair of the H ealth and Environm ental Affairs Com m ittee in
the Peop le’s Assem bly, estim ates that one-third of liver transp lants cond u cted in
Egyp t are illegal.29 The Ministry of H ealth has intensified insp ections of facilities
that p erform organ transp lants in recent m onths after heavy m ed ia coverage of
the p henom enon and of a WH O rep ort nam ing Egyp t as a site for the trad e in




22 “Life Is Not a Luxury,” Egypt Today, Feb. 2008, vol. 29, no. 2.
23 Faruq ‘Abd al-Majid, “Markaz jadid li-jirahat al-kabid bi-mustashfa al-sahil,” al-Ahram, 24 June
2008, p. 9.
24 Hiba Farfali, “Marda zira’at al-kabid fi khatar,” Ruz al-Yusuf, 17 Aug. 2008, p. 2.

25 Amal Ibrahim, “Zira’at al-kabid wa hisad al-hashim,” al-Ahram, 15 Nov. 2007, p. 27.

26 Ibid.

27 Muhammad Hamdi, “Ijabat min mustashfa al-sahil,” Ruz al-Yusuf, 20 June 2008, p. 9.

28 See for example, Hifni Wafi, “Sa’d al-Maghrabi wakil wizarat al-sahha: hunak mafiya

munazzama li-tijarat al-a’da’ al-bashariya fi Misr,” al-Badil, 24 Aug. 2008, p. 13.
29 See the Coalition for Organ-Failure Solutions, <http://www.cofs.org/Where_Egypt.htm>.
Egyptian Initiative for Personal Rights                                                            16


organs.30 This rep ort show s that 78% of com m ercial d onors in Egyp t faced
ad verse health consequ ences as a resu lt of the op eration d u e to several factors,
inclu d ing the lack of a com p rehensive m ed ical exam ination of d onors p rior to
the op eration to assess their health.31 A rep ort issu ed by an international
organization that m onitors and d ocu m ents organ trafficking (the Coalition for
Organ-Failu re Solu tions), ad d s that those w ho agree to these d onations, in retu rn
for m oney, are m otivated largely by p overty. Moreover, 78% of them sp end the
m oney they receive for the op eration in the su bsequ ent five m onths to p ay off
d ebts rather than to im p rove their health.32 Finally, research show s that 94% of
paid donors regret undergoing the operation.33

Legal frameworks regulating donation in the absence of national legislation

Given the inexcu sable lack of legislation, the only legal fram ew ork that exists to
regulate organ transplantation in Egypt was, until last year, the professional code
of ethics and cond u ct of the Egyp tian Med ical Synd icate.34 . In ad d ition, since the
cod e is sim p ly a set of ethical p rincip les end orsed by the synd icate, it natu rally
d oes not ad d ress crim inal liability or civil rights. Moreover, it does not contain
deterrent penalties for those in breach of the code.

The p rofessional cod e of ethics states that the synd icate shou ld be inform ed of
any organ transfer to ensu re the integrity of both the d onation and the
transp lant, in accord ance w ith the ethical gu id elines contained in the cod e. N o
transfer m ay be p erform ed w ithou t the p rior consent of a sp ecial com m ittee.
Articles 49, 50 and 51 of the cod e, established by Minister of H ealth d ecree
238/2003 (5 September 2003), state the following:

Article 49: The human organs and tissues transplant op erations shall be su bject to
the m oral criteria and gu id elines stip u lated in the legislation and regu lations
organizing the foregoing.




30 Yosuke Shimazono, “The State of the International Organ Trade: A Provisional Picture Based
on Integration of Available Information,” Bulletin of the World Health Organization, vol. 85, no. 12,
Dec. 2007, pp. 901-80, <http://www.who.int/bulletin/volumes/85/12/06-039370/en>.
31 D.A. Budiani-Saberi and F.L. Delmonico, “Organ Trafficking and Transplant Tourism: A

Commentary on the Global Realities,” American Journal of Transplantation, 2008, pp. 925-29.
32 Shimazono.

33 Budiani-Saberi and Delmonico.

34 The code is available on the website of the Egyptian Doctors’ Syndicate,

<http://www.ems.org.eg/2_4/2_4_4/2_4_4.htm>.
17                                                                       Organ Transplant Legislation


A rticle 50: It shall be im p erative u p on the p hysician p rior to carrying ou t an
organ transp lant op eration, p u rsu ant to the legislation organizing the foregoing,
to notify the donor of the medical consequences and the risks to which he may be
exp osed to as a resu lt of the transp lant op eration. It is also essential to com p ile
the necessary d ocu m ents w hich confirm the d onor’s know led ge of all the
consequences in this matter prior to carrying out the operation.

A rticle 51: It shall be p rohibited to trad e in the hu m an organs, tissu es and cells
and hu m an em bryos. Und er no circu m stance shall the p hysician be allow ed to
take p art in these op erations. Otherw ise he shall be su bject to d iscip linary
accountability.

The term s “legislation” and “regu lations” ap p ear tw ice in the above-mentioned
articles, although there is no Egyptian law that criminalizes organ trafficking and
regulates donations from the deceased.

The Minister of H ealth has annou nced that u ntil an organ transp lant law is
issu ed , no transp lantation w ill be p erm itted excep t w ith the ap p roval of the
Minister and the Egyp tian Med ical Synd icate. To regu late transp lantations,
Ministerial Decree 70/2009 w as issu ed on 22 Febru ary establishing a central
registry of organ transp lants in the Central Ad m inistration of N on-
Governm ental Treatm ent Facilities and Licenses. The d ecree requ ires m ed ical
facilities that p erform transp lants to su bm it the relevant d ocu m entation on the
p atient and the d onor. It also sets general cond itions, su ch as the need for the
d onor’s inform ed consent. It also requ ires d onors to sign an affid avit to that
effect before a sp ecialized com m ittee established by the d ecree in ord er to obtain
ap p roval for the transp lant. The sp ecialized com m ittee contains an u nsp ecified
number of technical and legal experts. The decree specifies that any facility found
in violation of the d ecree faces a one-year closu re and m ed ical p ersonnel
involved in the violations m ay have their licenses su sp end ed for one year as
w ell. The d ecree states that “all p rivate and p u blic hosp itals shall be d irected to
have no interactions w ith the [facility] d u ring this p eriod , and it shall also be
annou nced in the p ress that there are to be no interactions w ith the m ed ical
p ersonnel. If the violation is rep eated , w hether by the facility or the m ed ical
personnel, both of their licenses will be revoked.”35

There are sp ecific objectives in p assing legislation that regu lates organ
transp lantation and crim inalizes organ trafficking. These inclu d e the follow ing:
p u tting an end to the sp read of hu m an organ trafficking, w hich has flou rished in

35   Minister of Health Decree 70/2009, Official Gazette, no. 56, 8 March 2009.
Egyptian Initiative for Personal Rights                                               18


Egyp t becau se of w id esp read p overty, u nem p loym ent, corru p tion, illiteracy and
the absence of regu lation; establishing a fram ew ork to gu arantee the
intelligibility and integrity of organ p rocu rem ent from those w ho d ecid e, either
before or after their d eath, to d onate their organs; and reform ing as w ell as
integrating the Egyp tian health system to gu arantee the basic rights to life and
health care in the field of organ transfer and transp lant. The Egyp tian health
system m u st p rovid e qu ality health services w ithou t d iscrim ination, in su ch a
way that does not undermine citizens’ ability to access such services.
19                                                                  Organ Transplant Legislation


                 V. Preliminary Observations on the Bill
The d rafting of an organ transp lant bill has p assed throu gh several stages,
p articu larly after it w as confirm ed that illegal organ trafficking exists on a broad
scale in Egypt. The debate over the bill began in the People’s Assembly at the end
of the 1990s, and it w as controversial on the issu e of organ transfer from the
d eceased to the living, the d efinition of d eath and the establishm ent of stand ard s
to define it.

In the latest attem p t to ad op t a law , the Ministry of H ealth su bm itted a bill to the
Peop le’s Assem bly in March 2009. The su bm ission of the d raft w as p reced ed by
another d ebate on the d efinition of d eath, w hich coincid ed w ith the 13th
conference of the Islam ic Research Cou ncil, held on 10-11 March 2009. Du ring
the conference Dr. Moham ed Sayyid Tantaw i, the Sheikh of al-Azhar, reiterated
his ap p roval of both living and d eceased d onations on the cond ition that there is
no financial com p ensation involved . Leaving the d efinition of d eath to
sp ecialists, he said , “What has d elayed the bill thu s far is the d isagreem ent
am ong d octors on the d efinition of d eath.” 36 Du ring the conference, Dr. Yu su f al-
Qarad aw i, the Secretary-General of the Fed eration of Mu slim Scholars, objected
to the refu sal of som e to recognize brain d eath, saying, “Tru e d eath, as
recognized by doctors around the world, is the death of the brain, and there is no
p rovision in religiou s law or science that ind icates it is the d eath of the heart.” 37
This op inion w as also su p p orted by Dr. Essam al-Erian d u ring a w orkshop
organized by the Center for Civil Ed u cation in conju nction w ith the Reform and
Development Party (under establishment) on the same day. Dr. al-Erian attended
the workshop as a representative of the Egyptian Medical Syndicate.38

Althou gh the health committees in both the Peop le’s Assem bly and Shu ra
Cou ncil began to d iscu ss the bill before the end of the last p arliam entary session,
the d ebate w as not conclu d ed and the bill w as p ostp oned to the cu rrent session.
Presid ent H osni Mu barak d eclared that the bill w as a p riority in his sp eech
inau gu rating the new session of p arliam ent in N ovem ber 2009. In the sam e
m onth, a joint com m ittee from the Peop le's Assem bly – com p rising m em bers of
the Com m ittee for H ealth and Environm ental Affairs and the Com m ittee on
Legislative and Parliam entary Affairs - w as form ed to d iscu ss the bill. In an

36 ‘Ala’ Mustafa, “al-Imam al-akbar: ta’attul al-tashri’ mas’uliyat al-atibba’,” al-Ahram, 11 March
2009, p. 19.
37 Ibid.

38 Tamir Abu ‘Arab, “Atibba’ wa rijal din: qanun naql al-a’da’ ta’akhkhara kathiran,” al-Dustur, 11

March 2009, p. 4.
Egyptian Initiative for Personal Rights                                                          20


u nu su al tu rn of events, the d iscu ssants strongly agreed on the im p ortance of
p assing the bill and exp ressed a d esire to overcom e p reviou s d isagreem ents that
had obstru cted its p assage in the p ast. Finally, in a m eeting held on 5 Decem ber
2009, head ed by Assem bly Sp eaker Fathi Su ru r and attend ed by Minister of
H ealth H atem al-Gabali, the joint com m ittee ap p roved the final d raft of the bill
and referred it to the Shu ra Cou ncil for its op inion on the m atter.39 Once the
Shu ra Cou ncil ap p roves the bill, it w ill be referred back to the Peop le's Assem bly
w here it w ill be finalized and voted u p on, taking into accou nt the Shu ra
Council's comments. .

The bill submitted by the Ministry of Health in 2009 is an important step towards
a legislative fram ew ork that m eets the aforem entioned objectives. The bill
p rohibits the trafficking of organs and tissu e, regu lates organ transfer and
transplant and p rotects against hu m an rights violations, p articu larly the rights to
life and health care.

The EIPR su p p orts this legislation as consistent w ith the p rincip les of hu m an
rights, w hile reiterating the need to take several fu nd am ental m easu res to m ake
the legislation effective.

The bill consists of 22 articles and creates a legislative fram ew ork that m eets the
general gu id elines established by the WH O and other m ajor conventions in
accordance with internationally recognized standards.

 The text resolves the d isp u te over the d efinition of d eath, leaving the
d eterm ination to a com m ittee of three sp ecialized d octors w orking in accord ance
w ith stand ard s to be established by the law ’s im p lem enting regu lations. This
article offers a w ise exit from the long-standing d ilem m a on the d eterm ination of
death.

The bill also sets seriou s d eterrent p enalties for violations, p articu larly for organ
traffickers. It also ad d resses a set of vital regulations and cond itions need ed to
regu late the transfer and transp lant of organs and to p revent trafficking. For
exam p le, it establishes the licensing p roced u res for centers engaged in organ
transfer and transp lant as w ell as the fou nd ation of care for p atients w ith organ
failu re in ord er to gu arantee they u nd ergo a social and p sychological evalu ation
before they are p laced on the organ w aiting list. Licensing p roced u res w ill also


39Nur ‘Ali, “al-Sha’b y uwafiq ‘ala qanun naql wa zira’at al-a’da’,” al-Yawm al-sabi’ online, 5 Dec.
2009; ‘Imad Fu’ad and Muhammad ‘Abd al-Qadir, “Lajnat al-sahha bi-majlis al-sha’b tuwafiq ‘ala
qanun zar’ al-a’da’,” al-Masry al-yom, 6 Dec. 1009, p. 1.
21                                                           Organ Transplant Legislation


gu arantee follow -u p and treatm ent for p atients w ho u nd ergo transp lants. It
upholds the principle of the fair distribution of organs obtained from the recently
d eceased and sets stand ard s for the selection of living d onors that are consistent
w ith p rofessional ethics. It also requ ires w ritten consent from d onors w ith fu ll
know led ge of all d etails of the d onation d u ring and after the op eration. In short,
these p rovisions p rovid e safegu ard s and set gu id elines consistent w ith
international standards.
Egyptian Initiative for Personal Rights                                                22


            VI. Basic Steps Needed to Implement the Law
Desp ite the p ositive asp ects of the bill, the EIPR believes that the state m u st take
d ecisive m easu res to im p lem ent the law after its ad op tion by the Peop le’s
Assem bly. If the real intent of the law is to end organ trafficking and p rovid e an
ad equ ate legal fram ew ork for organ d onation, the EIPR recom m end s that these
m easu res be established by the im p lem enting regu lations. Moreover, these
m easu res m u st be ad op ted w hen execu ting p olicies, p rogram s and p lans
connected to the law, after its passage.

A. Definition of death

There is a d efinite (or an u rgent) need for a p recise, w ell-w ritten d efinition of
d eath to be follow ed by state institu tions and facilities that p erform organ
transp lants. H ow ever, w e believe that d rafting this d efinition is not the
legislatu re’s job. Rather, the law m u st lay the fou nd ation and set safegu ard s that
gu arantee the com p etence, integrity and transp arency of the p rocess.
N evertheless, the d efinition itself requ ires a com m ittee of sp ecialists,
com m issioned by the state, which w ill fu lly research the issu e and agree on a
definition to apply to all facilities.

We shou ld not forget that citizens in ou r cou ntry d ie every d ay and no one asks
w hether it is brain d eath. Each cou ntry m u st establish a technical d efinition of
death and isolate the issue from that of organ transplant.

B. Systems for the transfer and transplant of organs and tissue

The bill establishes a higher com m ittee, form ed by the Minister of H ealth, to
oversee the ad m inistration and organization of organ and tissu e transp lantation.
The com m ittee shall classify d onated organs and tissu e and register p otential
recip ients by tissu e, immunity, blood typ e etc. The com m ittee shall su p ervise
and inspect hosp itals and m ed ical centers that p erform organ transfers and
transplants as well as issue the requisite licenses.

Clear standards that specify the committee’s role and how it shall discharge all of
its m and ates, as stip u lated by the law , m u st be established in ord er to gu arantee
impartiality and precision, and to enable the committee to fulfill its duties. This is
im p ortant since the com m ittee w ill oversee the selection of those hosp itals that
are p erm itted to p erform transp lants. Fu rtherm ore, it should have its ow n
bu d get and ad equ ate financial resou rces, p rop ortionate to the sensitivity and
difficulty of its tasks.
23                                                            Organ Transplant Legislation


The existence of an ind ep end ent com m ittee that offers quality m ed ical services
and su p ervision w ill p ave the w ay for broad p u blic su p p ort. Moreover, the
ind ep end ence of the com m ittee w ill encou rage citizens to ad op t a cu ltu re of
d onation and p rop agate it throu ghou t society. Over the years, the lack of tru st in
the health system has had a d etrim ental effect on com m u nity contribu tion and
on those who have a sincere desire to donate.

The governm ent has issu ed several statem ents recently regard ing the su bm ission
of a new health insu rance bill in the cu rrent p arliam entary session. Organ
transfer and transp lant m u st be inclu d ed in any new health insu rance system .
Otherwise, it will remain a luxury available only to the wealthy.

C. Conditions for the transfer and transplant of organs and tissue

The bill lays out conditions for the transfer of organs from the living to the living,
stressing the need to p reserve the life of the recip ient w ithou t u nd erm ining the
d onor’s right to life. It also em p hasizes the necessity for treatm ent from seriou s
illness w hen there are no other ad equ ate op tions, as long as this d oes not risk the
life of the donor.

This, in p articu lar, requ ires the establishm ent of d etailed m ed ical gu id elines
w hich sp ecify the risks to the d onor, the sp ecific clinical cond itions that m u st be
m et for d onation and the p hysical and p sychological follow -u p care, to be
administered based on internationally recognized standards.

As for d onations from the d eceased , there m u st be safegu ard s to ensu re that the
higher com m ittee, w hich oversees transp lant and transfer, w ill act w ithout
d iscrim inating am ong p otential recip ients. A strong system m u st be established
for m onitoring and su p ervising all asp ects of the w aiting list for p atients
requ iring transp lants. Moreover, if any m alp ractice is p roven, existing p enalties
for frau d and falsification of official d ocu m ents shou ld be ap p lied to all those
involved.

D. Raising awareness

The law establishes cond itions for transferring organs from the d eceased to the
living. For exam p le, consent before d eath is an im p ortant p recond ition for
transferring organs. The ru les and p roced u res of this law w ill be established by
the im p lem enting regu lations. In any case, it is stip u lated that no p aym ent m ay
be involved , that d onations from Egyp tians to Egyp tians m u st take p riority, and
that human dignity must be protected when transferring organs.
Egyptian Initiative for Personal Rights                                              24


Although the culture of organ donation is not prevalent in our society, this article
d id not consid er encou raging p ost-m ortem d onation or d rafting p olicies to foster
a cu ltu re of d onation at d eath. Thu s, the state m u st initiate a broad aw areness
cam p aign to change attitu d es tow ard d eath and organ d onation. The Sp ecial
Rap p orteu r on the sale of child ren, child p rostitu tion and child p ornograp hy has
also recom m end ed “ed u cational p rogram s as w ell as aw areness-raising
activities” as “essential in the fight against traffic of organs.”40




40   Report by the Special Rapporteur, 2006, paragraph 86.

				
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