Patentability and Xenotransplantation

18. Research on xenotransplantation has hitherto in large measure been 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 .

From a formal point of view, there is no technical or legal obstacle standing in the way of the patenting genetically engineered animal organs intended for transplants.(⁷²) It should be emphasised however that the norms drawn up by the European Community to regulate this matter could not, at the time they were being drafted, take into account the use of such organs for transplant from animal to man, since this therapeutic procedure had not yet been accomplished in clinical practice.

We therefore stress that, given the extraordinary financial commitment that has been made, now is the time to reconsider - or rather to be more precise about - the specific norms that apply.

We are aware of the broad debate underway on the basic question of whether the possibility itself of patenting living beings (even though genetically modified) or parts of them, especially when they contain genetic elements derived from humans (as is the case with animal organs genetically engineered for xenotransplantation into man), is ethically acceptable. We are also aware that 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", we nonetheless believe that it is not the purpose of present document to address this complex question directly.

Here, we shall limit ourselves to emphasising that, whatever answer may be given to this basic question, it is always necessary - as a bare minimum - to guarantee respect for the fundamental right of every person to equitable access to the health care they may be needed, without discrimination and without being impeded by excessive costs. This applies above all else to accessibility to treatment. This objective - in the hypothetical case of patents connected with xenotransplantation, a procedure which should be viewed from a therapeutic standpoint - can be reached by making appropriate legal requirements apply (for example, the introduction of compulsory licences), thus allowing "production" at accessible prices(⁷³) which would hopefully be controlled by a supranational body specifically set up for this purpose.