Her argument was that the actual exploitation is an ethical failing, a human exploitation; a perception of the poor as organ sources which may be used to extend the lives of the wealthy.Economic drivers leading to increased donation are not limited to areas such as India and Africa, but also are emerging in the United States. Increasing funeral expenses combined with decreasing real value of investments such as homes and retirement savings which took place in the 2000s have purportedly led to an increase in citizens taking advantage of arrangements where funeral costs are reduced or eliminated. Brain death versus cardiac death
Brain death may result in legal death, but still with the heart beating and with mechanical ventilation, keeping all other vital organs alive and functional for a certain period of time. Given long enough, patients who do not fully die in the complete biological sense, but who are declared brain dead, will usually start to build up toxins and wastes in the body. In this way, the organs can eventually dysfunction due to coagulopathy, fluid or electrolyte and nutrient imbalances, or even fail. Thus, the organs will usually only be sustainable and viable for acceptable use up until a certain length of time. This may depend on factors such as how well the patient is maintained, any comorbidities, the skill of the healthcare teams and the quality their facilities.
Indevus had developed intellectual property around the extended release formulation which it licensed to Madaus for most of the world.In 2012 the FDS approved the first generic version of the extended release formulation, granting approval to the ANDA that Watson Pharmaceuticals had filed in 2009. Annual sales in the US at that time were $67M. European patents had expired in 2009.As of 2016, the drug is available worldwide under many brand names and formulations, including oral, extended release, suppositories, and injections. Society and culture
Marketing rights to the drug became subject to parallel import litigation in Europe in the case of Speciality European Pharma Ltd v Doncaster Pharmaceuticals Group Ltd / Madaus GmbH (Case No. A3/2014/0205) which was resolved in March 2015. Madaus had exclusively licensed the right to use the Regurin trademark to Speciality European Pharma Ltd. In 2009, when European patents expired on the drug, Doncaster Pharmaceuticals Group, a well known parallel importer, which had been selling the drug in the UK under another label, Ceris, which was used in France, began to put stickers on their packaging with the Regurin name. Speciality and Madaus sued and initially won based on the argument that 90% of prescriptions were already generic, but Doncaster appealed and won the appeal based on the argument that it could not charge a premium with a generic label. The case has broad implications for trade in the EU.