Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Medical tourism: regulatory toxicological aspects of organ donation and transplantation

Dr. Cecilia-Carmen Patrascan (Abschlußjahr: 2022)

Summary
Language: English
The medical use of the word "transplant" refers to the replacement of organs, body parts, tissues and cell types for therapeutic purposes. In 2020 there were 913 organ donors nationwide. Despite the Corona pandemic, today we are about the same as last year, with 932 organ donors. In Germany, the case of post-mortem organ donation is defined and protected by the Transplant Law/ Act ("Gesetz zur Spende, Entnahme und Übertragung von Organen und Geweben" (TPG)). Alternatively, a living donor transplant is a solution that replaces post-mortem donation. According to the TPG, a transplant from a living donor involving a kidney, parts of a liver or any other organ that is irreversibly dysfunctional, is only allowed between close relatives and people with higher biocompatibility. In order to ensure that a donation takes place on a voluntary basis, that the medical risks to the donor are reduced and also to exclude any possibility of abuse or organ trafficking, the case must be investigated in advance by the a committee of experts. From International and European law perspective, the European Union is contractually obliged to lay down the standards of quality and safety of organ transplantations. This follows from Article 168 IV lit. A) of the Treaty on the Functioning of the European Union (Vertrag über die Arbeitsweise der Europäischen Union, AEUV). Based on these facts, Directive 2010/45/EU on standards of quality and safety of human organs intended for transplantation was adopted on July, 7th 2010. As the European directives are binding on all Member States, the directive was implemented in German National Law on August, 1st 2012 by amending the Transplant Law/ Act. Regulations on organ donation, organ harvesting or organ distribution are not affected by the directive, as they are individually regulated by the countries concerned. But, the most challenging alternative remains xenotransplantation, defined in the literature as "a transplantation of organs, organ systems, tissues, specific cell types from animals to humans for therapeutic purposes". Although certain animal species have been used for centuries as in vivo experimental models for the development and detection of various pathological or regenerative mechanisms (e.g., different types of cancer, autoimmune diseases, etc.) and drug development therapies for humans, xenotransplantation still involves biocompatibility risks. Regarding, the TPG on transplantation does not cover xenotransplantation because, according to § 1 "...the TPG regulates only the collection and donation of human organs, parts of organs and tissues". In its 1999 opinion on xenotransplantation, the German Medical Association (Bundesärztekammer, BÄK) decided that the preconditions for performing xenotransplants in a reasonably low risk manner were not yet met. In the absence of individual regulation, the provisions of the German Drug Law (Arzneimittelgesetz, AMG) are relevant when it comes to xenotransplantation. According to § 2 para. 1 no. 1 AMG "...medicines are substances and preparations made from substances which, by application to or from the human body, are intended to cure, alleviate, prevent or identify medical diseases, suffering, wounds or ailments." The prevailing view is that a "xenograft" is a drug according to AMG. Pursuant to § 5 para. 1 "medicine must not be placed on the market or made available if they are unsafe".
In conclusion, the risks of a possible infection and a rejection of animal organs due to genetic differences between animals and humans are and remain much higher. The problem involves not only the possibility of transmitting already known human pathogenic infections, but also the risk that infections that were not previously human pathogens will evolve into human pathogenic infections. Regarding, the methods of regulating xenotransplant products are still complex. The regulations/directive/guidelines issued by the regulatory authorities were actually designed at a time when the perceived risk, especially that of transmitting infectious pathogens between species, has been high.
Scientific studies and the large amount of research data from the last two decades indicated that the real risk seems already lower and manageable, therefore the regulatory framework is "acceptable" until a revised interpretation.
Text/ Pages: 87