The current issue of sale of organs

Assessed Coursework

“The creation of a formal market in organs as a means of solving the organs Shortage”

I. Introduction

In this essay the current issue of sale of organs is placed under a microscope.

First the existing problematic of an organ shortage in the UK is evaluated based on actual data. In addition already existing national and European regulations regarding to the sale of organs are demonstrated.

The obvious requirement of an urgent action to increase the organ supply leads to the question of a suitable problem solution.

The theory of successful regulations are analysed and applied to the creation of a regulated living- donor transplant market in organs as a possible solution to increase the number of organs available. This includes especially a balance of possible risks and benefits while standard-setting, finding a way to motivate individuals to increase the organ supply as a means of behaviour modification as well as establishing an appropriate mechanism of information-gathering.

At least the already existing legal organ trade market of Iran is illustrated. Advantages and disadvantages of this market are demonstrated. It is also shown which of the regulating mechanism seem to be useful or alternatively devious to apply to other countries, such as the UK.

II. Organ Shortage

a) Explanation/data

In 1954 the first human organ transplant was successfully performed and thereby organ transplantations became a current medical method worldwide especially during the last 30 years, after minimizing cases of rejection.¹

“With a few exceptions, no country has sufficient organ supply to satisfy its citizens´ needs. Thus a scarcity of human organs now exists.”²

In the following it is determined whether the United Kingdom is such an exception or whether there is an organ shortage as in most countries in the world and if so, the scope of it.

The figure 2.1 shows 10% increase of transplants in 2013-2014. Despite the increases in the number of people benefiting from a transplant, around three people die each day across the UK due to a shortage of organs. Therefore it can be said that 2013/14 was a record year for organ donation and transplantation in the UK³, but nevertheless figure 2.1 states distinctly the gap between the number of donors/transplantations and the number of patients on the active transplant list. There are around 7000 people currently waiting for an organ transplant. It has to be mentioned here that this number is changing constantly due to the fact that people join and leave the transplant waiting list.⁴

Therefore the Uk is not an exception of the statement because an organ shortage is obviously exists.

Number of deceased donors and transplants in the UK, 1 April 2004 - 31 March 2014, and patients on the active transplant list at 31 March

Abbildung in dieser Leseprobe nicht enthalten

Source: Transplant activity in the UK, 2013-2014, NHS Blood and Transplant

b) Existing regulations

First we will outline the existing regulations according to human organ transplantation.

For a better understanding of this regulations it first has to be mentioned the so called “Alder Hey scandal”. The Alder Hey organs scandal involved the removal without consent, retention, and disposal of organs at the Royal Liverpool Children’s Hospital, during the period 1988 to 1995.⁵

According to the so called “The Tombstone Effect”, which is a phenomenon outlining regulations as “organisational and institutional symbols of mourning and reparation, erected to signal the seriousness of events, the respect due to victims, and the determination to prevent a repeat of suffering.”⁶, this scandal caused a heated debate about organ transplantation/donation and shaped the Human Tissue Act 2004 as a response.

This legal framework for donation governs practice in England and Wales. It established The Human Tissue Authority (HTA), as a regulator according to the removal, storage, use and disposal of human tissue. Furthermore the framework outlines that the system is based upon a hard 'opt-in' system of consent. The specific use of the term “consent” was replaced with the term “authorisation” in The Human Tissue (Scotland) Act 2006. ⁷

However both Acts⁸ consider the wishes of the individuals, which are expressed verbally, written, the ownership of a Donor Card or being part of NHS Organ Donor Register and hence state that the individual has given consent/authorisation for organ donation after death.

If the wishes of the individual are not expressed in either of these ways and cannot detected a nominated representative obtains authority for decision making.⁹

According to European regulation of organ procedures, the EU´s authority follows from Article 168 TFEU, which deals with public health. It first has to be mentioned that the European influence of regulations is carried out by the institutions of the EU as well as the Council of Europe.

In Article 168, clause 7 TFEU it is stated that “the measures referred to in paragraph 4(a) shall not affect national provisions on the donation or medical use of organs and blood”. Hence the national supremacy is kept in this area of law.

The focus of the Council of Europe concentrates on dealing with “organ trafficking” and “transplant tourism”. In 2008 the Council of Europe issued “The Declaration of Istanbul on Organ Trafficking and Transplant Tourism”. The Declaration proposes measures to respond to the need for increased deceased donation, while taking measures to, “ensure the protection and safety of living donors and appropriate recognition for their heroic act while combating transplant tourism, organ trafficking and transplant commercialism”.¹⁰

The EU has set out an Action Plan on Organ Donation and Transplantation (2009-2015), which was enacted in July 2010 as Directive 2010/53/EU¹¹ of the European Parliament and of the Council aiming to ensure a high quality and safe standard for donations, procurements, transportation, traceability and follow-up of human organs.¹² A controlling transplant centre is required which leads to the development of a regulatory mechanism as well as setting standards for the quality and safety of organs for transplantation, through keeping record of living and deceased donors, placing a reporting system and implement an effective and proportionate system of penalties for breaches of the Directive.¹³ In the UK this requirement is met by the Human Tissue Authority, which furthermore has to authorise all organisations involving matters of donation.¹⁴

III. Solution

As stated above there is a current organ shortage whence already a black market occurred. Hence an urgent need of action is required to find an effective and ethically acceptable method to expand the pool of potential donors and therefore to increase the supply.

There are different solution approaches such as an opt-out system where everyone would be assumed to want to donate organs after their death unless, having received information about the system, they had chosen to opt out of donation during their lifetime.¹⁵ As mentioned previously this essay will focus on the approach of creating a regulated living-donor market in organs as a means of solving the organs Shortage.

a) Formal Market in organs

Since it is obviously that the current system and measures did not accomplish the aim of translating the high degree of public support for organ donation into actual donations of organs it is questionable whether and how a formal and regulated market of organs could be a possible solution.

Ascertain whether a regulated market is an appropriate solution, we first have to determine what constitutes a successful regulatory regime.

aa) Theory of a good regulatory regime

In theory “regulation involves three key aspects: One, standard-setting, or the ‘rule’ itself.[…] Second, behaviour-modification, or the way in which rules are complied with and enforced.[…] Third, information-gathering; systems of regulation require elements of ‘detection’, as otherwise regulators would not know whether their standards ‘make sense’ and are being complied with.”¹⁶

Therefore the development of a standard is a key aspect of any regulatory. It has to be mentioned here, that only having a standard is not sufficient. Its setting has a direct impact on behaviour modification as well as information-gathering.¹⁷

[...]

¹ D. Rothman, “The International Organ Traffic”, 10th Annual Conference on “The Individual vs. the State,” Budapest, Central European University, (2002); M. Defever,”The policies of organ transplantation in Europe: Issues and problems” Health Policy, 16 (1990), 95- 103

² Gilman, N., Goldhammer, J., Weber, S., Deviant Globalization, Black Market Economy in the 21st Century, New York, London: The Continuum International Publishing Group, p.73

³ The Organ Donation and Transplantation Activity Report 2013/14

⁴ http://www.nhsbt.nhs.uk/news-and-media/news-articles/news_2014_07_10_2.asp

⁵ http://news.bbc.co.uk/1/hi/1136723.stm

⁶ “The Tombstone Effect: Long Shadows and the Pursuit of Comfort”. In: Explorations in Governance: A Collection of Papers in Honour of Christopher Hood. Ed. by 2012

⁷ http://www.odt.nhs.uk/donation/deceased-donation/consent-authorisation/legislative-framework.asp

⁸ Human Tissue Act 2004, Human Tissue (Scotland) Act 2006

⁹ http://www.odt.nhs.uk/donation/deceased-donation/consent-authorisation/legislative-framework.asp

¹⁰ http://www.declarationofistanbul.org

¹¹ http://europa.eu/legislation_summaries/public_health/threats_to_health/sp0008_en.htm

¹² Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation.

¹³ Department of Health (2011) Public Consultation on Regulations to Transpose Organ Directive 2010/53/EU into UK Legislation. DH, London. Human Tissue Authority (2011) Public consultation on documentary framework for the quality and safety of human organs intended for transplantation. HTA, London.

¹⁴ Department of Health (2011) Tissue authority to set EU transplant standards. Press release, 10 March

¹⁵ http://www.odt.nhs.uk/pdf/the-potential-impact-of-an-opt-out-system-for-organ-donation-in-the-UK.pdf

¹⁶ M. Lodge & K. Wegrich, Managing Regulation; Regulatory Analysis, Politics and Policy, p.21-22

¹⁷ M. Lodge & K. Wegrich, Managing Regulation; Regulatory Analysis, Politics and Policy, p.57