ETHICAL AND LEGAL

PROBLEMS OF TRANSPLANTATION

Organ donation

• Organ donation is the donation of biological tissue or an organ of the human body, from a living or dead person to a living recipient in need of a transplantation.

Deontological issues

• Certain groups oppose organ donation on religious grounds, but most of the world's religions support donation as a charitable act of great benefit to the community. Issues surrounding patient autonomy, living wills, and guardianship make it nearly impossible for involuntary organ donation to occur.

Deontological issues

• From the standpoint of deontological ethics, the debate over the definitions of life, death, human, and body is ongoing.

• For example, whether or not a brain-deadpatient ought to be kept artificially animate in order to preserve organs for procurement is an ongoing problem in clinical bioethics.

The use of cloning to produce organs

The use of cloning to produce organs with an identical genotype to the recipient has issues all its own. Cloning is still a controversial topic, especially considering the possibility for an entire person to be brought into being with the express purpose of being destroyed for organ procurement.

While the benefit of such a cloned organ would be a zero-percent chance of transplant rejection, the ethical issues involved with creating and killing a clone may outweigh these benefits.

The use of cloning to produce organs

However, it may be possible in the future to use cloned stem-cells to grow a new organ without creating a new human being.

Ethics In Xenotransplantation

Transplantation represents a highly successful means of treating a variety of human illnesses.

Xenotransplantation, the transplantation of organs, tissues or cells from one species to another, if applied to man, would offer the possibility of a huge supply of organs, tissues and cells for transplantation thereby relieving the “chronic” shortage of human donor.

There is the need to minimize the likelihood of the introduction of new infectious agents into the human population via the transplant.

The Health Risk

Risk – understood as an unwanted or damaging future event, the actual occurrence of which is not certain but possible – is defined by means of two characteristics: the level of probability and the extent of damage.

The probability of the occurrence of a certain damaging event in particular circumstances can be expressed as a risk percentage or as a statistical frequency.

Acceptability of the risk

Probability and extent of damage – define the acceptability of the risk, as reflected by the risk/benefit ratio.

Only when a risk can be concretely assessed it is possible to apply criteria for evaluating its acceptability.

Informed consent for xenotransplantation

Given the animal source of the organs which will be transplanted, this issues concerns only the recipient and, secondly, his relatives.

At the outset the recipient should be given every information regarding his pathology and its prognosis, the xenotransplant operation and subsequent therapy, and the probability of success and the risks of rejection.

Principle of heart transplantation

Patentability and xenotransplantation

Research on xenotransplantation in large measure is

being carried out largely by private pharmaceutical companies which have committed substantial economic resources to this endeavour; they have also been providing financing to public institutions for the purpose of obtaining better therapeutic results.

It is therefore reasonable for them to expect an economic return on the investment made; one of the possible ways to do this is by acquiring patents.

Possibility of patenting living beings

There is a difference between a “discovery” (which cannot be patented) and an “invention” (which can be patented).

Although it is our view that the transgenic animal as such – and all the more when they are used for transplantation into man – should be considered “nonpatentable

Donation after death

The laws of different countries allow potential donors to permit or refuse donation, or give this choice to relatives. The frequency of donations varies among countries.

There are two main methods for determining

voluntary consent: "opt in" (only those who

have given explicit consent are donors) and

"opt out" (anyone who has not refused is a donor).

Donation rates and legislation

Register of Organ Donation and Transplantation shows Spain, Belgium, France, and Italy — which all have "presumed consent" laws on organ donation, where everyone is considered a donor unless they specify otherwise — in the top in the top five.

In contrast the USA — which practices an "opt in" consent law where their citizens provide express and informed agreement to donate organs and tissues in the event of their death — is also in the top five ahead of many other countries that are "opt in".

The ethics of blood management

Blood transfusion practices have evolved empirically, with few or no research data supporting them. In the past several decades, fuelled by fears of infection and reports of mistakes, patients have increasingly demanded their rights to choice, both in the components given to them as well as to refuse to receive these therapies based on religious convictions.

In parallel, episodic blood unavailability and growing awareness of the need to apply evidence-based methods have caused physicians to begin re-evaluating traditional practices and to focus on minimizing or eliminating unnecessary transfusions while learning and applying methods that permit reuse of the patient's autologous blood or rely on pharmacologic agents.

THANK YOU