Consultation document on Organ Donation and Transplantation Response Form

Transcription

1 Consultation document on Organ Donation and Transplantation Response Form Contact details of person and/or institution submitting comments Name of person Address address Knud Erben Name of Institution European Kidney Patients` Federation (CEAPIR) Address Einingerstr. 10e, Munich, Germany address

2 1. This document describes the situation at European level in the area of organ transplantation, identifying the main problems. Are all the basic problems identified? Are the problems identified correctly described? Organ donation and transplantation is a special mosaic. All components must fit in size, colour and exactness, based on the will to gain success step by step in parallel. A harmonized European marketing and legislation of organ donation and transplantation does not exist. This could help bringing present organ donation and transplantation in a more visible way European Day, European Donor Card, European framework within EU directives. A Schengen in Organ Donation and Transplantation should be targeted. A life time support and backup of donors and donor families via medical, social activity should be put in place. The more positive the person experience with organ donation is, the more positive talks and discussions in private and public will be. Today, a lot of living donors and Donor families believe they do not get enough recognition and feel alone when they need help and support. Unmet needs and frustration have no place. Too many potential donors do not become actual donors. The will of the deceased person may not be respected because the head of unit is against transplantation or the extra costs are not reimbursed. This is unacceptable. An infrastructure with link to organ donation in ICU s and Emergency rooms and full financial compensation for extra costs should be of immense help. The staff involved should be encouraged towards pro organ donation. Life saving treatment for organ retrieval only should also be allowed legally and ethically supported. Transplant laws give a legal frame for organ donation and transplantation. In most cases, the results are no better than before the laws where put in place. The focus often is too much on the laws and regulations and not on education, motivation of the practise of the people involved in Organ Procurement. The decision making consent for Organ Donation should be encouraged to be advanced to life time consent and not delegated to relatives. The donor card consent should be a final binding consent. The progress in medicines and medication and other areas of concern often leads to redefined standards. So far, so good. Somehow the impression is that new standards are basically set to increase the number of available organs via marginal donors with possible higher risks in quality and safety, quality of life and survival rates, or to fulfil certain criteria s for successful transplant. What is often overlooked is importance of post transplant patient care. Too many transplantees loose their graft relatively early (mainly kidney) and then return to be been patients on the waiting list. The reasons: included immunosuppressive medication not been available, poor quality treatment after transplantation, the marginal quality of the organ and the reimbursement system and the type and limits of systems. Who controls the controller? Who controls the editor of e.g. guidelines, rules?

3 2. The document also describes a number of actions oriented to tackle the main problems. Is there any other initiative that you consider useful? The family approach: talks and discussions within a family, with relatives and other persons is not replaceable (personal communication to understand the will of the deceased person, exchange of opinion and experience). Donor registries leads to no-discussion and no-involvement of family members and relatives. The family discussion is essential and should be promoted. The directive approach: The EU should consider a cross border "anti trafficking directive". The EU has a responsibility for the population in poorer countries. Wealthy patients should not be allowed to risk the health of poor citizens who sell, or are forced to sell, with / without their consent, organs and tissue. This directive should bind all involved parties in organ donation and transplantation and should impose a severe punishment when proven offences are committed whether within or outside the territory of the EU. The organisational approach: all the best efforts are of little value if at a lower level negative aspects dominate. E.g. why does it help to hurry retrieving a kidney when at the weekend operations will take place many hours later, maybe on the Monday. Often donor procurement agencies and donor allocation agencies have a monopoly. Monopolies may often lead to reduced efforts for the partners emphasis is often directed to secure and increase internal structures and powers. A certain level of competition could be helpful. A choice for hospital and patients as to where they buy services could increase quality and standards. The life support approach: In many by law and ethical practices a patient may be put on life support just to retrieve organs. The only reason you can put someone on life support if you can see a possibility of saving their life. Also, reimbursement issues may be an obstacle. An earlier approach to the family seeking consent might help increase the donor rates.

4 3. The shortage of organ donors is being described as the main problem in the field. Do you think that EU action would have an added value? Do you think that the initiatives described in the document in this direction are sufficient? Are there any other actions that should be promoted at EU level? The national perspective on organ donation and transplantation has become old fashioned. The EU can take a leadership role. The national developments show that in many countries organ donation and transplantation would benefit from an EU drive. All countries in the same boat makes all more effective than working national or even in a friendly competition. National policies and historic developments often do not allow the needed update for a better outcome. To achieve the required adaptation to the future status quo, EU leadership could help surpass established national obstacles that are not approachable nationally. To avoid monopolies and / or potential conflicts of interests, organ procurement services and transplantation coordination and transplant allocation should be separated and controlled by a neutral and independent authority, in which patient representatives should have voting rights. Operation licences could be issued and revoked by this authority. The traceability of a retrieved organ from its procurement till the death of its caring patient should be established. In addition to this, the traceability of a transplant recipient from the transplantation to their death should also become a standard. Too many patients are lost in the follow up process. A quality report issued by the independent European authority including non-medical aspects (Quality of Life) about the transplanted patient and its transplant should become a standard. The patients have a responsibility here to notify there whereabouts in the world. Transparency of the all involved parties is essential. All relevant data, with focus on quality and safety in organ donation and transplantation, must be published. The information and education given to the patient about e.g. risks, side effects, suboptimal conditions of the procured organ, and exceptional situations in the transplant centre should be standardized.

5 4. Accessibility to transplants varies widely in the EU. Do you think that the Commission should foster the coordination between Member States to improve the situation? Do you think that the initiatives described in the document in this direction are correct? Are there any other actions that should be promoted at EU level? (Max 750 words) The reasons for differences in accessibility to transplants should be analysed in details from an external EU perspective. Areas for improvement should be identified and coordination activities initiated where appropriate. For living donors, a model of social and insurance security is missing. An EU initiative might encourage more living organ donation. Cross border donor pools may be helpful but should not reduce the quality of the organ (cold ischemia time). 5 The document presents the following three options for future EU policy on organ transplantation. (1) Use of existing programmes only (2) Active coordination between Member States on organ quality, safety and availability (3) Minimum harmonisation on quality & safety, plus EU initiative on organ trafficking Which one of these options do you consider the most appropriate? Would you wish to modify / add / remove some of the contents included in the option? Please explain your reasons Option one must continue and develop. Option two and three must be initiated / continued and lead into projects and workshops with a phasing in period. All options have benefits. It might to be considered to shift responsibilities from national level to EU level. The experience shows that only strong legislative instruments may lead to success more and better quality transplantation for more needy patients.