Executive regulation concerning organ transplants
- Country:
- Polen
- Partner Institute:
- Institute of Public Health, Jagiellonian University Medical College, Krakow
- Survey no:
- (14) 2009
- Author(s):
- Anna Mokrzycka
- Health Policy Issues:
- Public Health, Politischer Kontext, Qualitätsverbesserung, Leistungskatalog, Zugang, Patientenbelange
Current Process Stages
| Idee | Pilotprojekt | Strategiepapier | Gesetzgebung | Umsetzung | Evaluation | Veränderung/Richtungswechsel | ||
|---|---|---|---|---|---|---|---|---|
| Implemented in this survey? |  |
|
|
|
 |
|
|
 |
Abstract
The Ministry of Health realised the competence for the law concerning rules of transplantation procedure implementation and issued the project of executive regulation on the 20th of October. The main goal of the regulation is to establish a set of procedures: mainly the potential donor qualification process. The legal base for the regulation is a Law from the 1st of July on cells, tissues and organ transplantation processes.
Purpose of health policy or idea
The main objective of the policy is to establish transparent and precise rules for transplantation procedures. Art. 1 of the MoH regulation of 20 October 2009 states the two particular spheres of its provisions:
- concerning the rules and methods of functioning of the transplantation qualifying centres
- concerning the rules and methods for the qualification of potential donors
The executive regulation aims to install precise and legally clearly stated procedures for the implementation of the Law on cells, tissues, and organ transplants from 1 July 2009. There was also a clear need to adapt the requirements for transplantation procedures to the changes to the Law from 1 July 2009 on cells, tissues and organs transplantation processes changes and to the Polish penal code introduced on 14 July 2009, which stated that the healthcare unit providing transplantation procedures may establish a qualifying centre for transplantation.
The main consequence of such provisions is to set unified rules for all the centres established. The executive regulation is expected to be a legal instrument for this. Three groups are affected by the described regulation:
- medical doctors (members of the qualifying centres teams),
- patients expecting the transplantation procedure and
- donors (or families of donors).
Main points
Main objectives
The main objective of MoH is to introduce transparent, unified and coherent rules for transplantation procedures in all the transplantation qualifying centres functioning within the healthcare unit structures, based on the Law of 1 July 2009 on cells, tissues and organ transplantation processes and being in accordance with the Polish penal code introduced on 14 July 2009.
The instrument - executive regulation is a proper legal instrument in this sphere (it is not included into the EU notification system concerning the participation of Poland in the information and data exchange procedures stated in the EU regulation from the 22nd of December 2002 concerning the functioning of the national notification system, (Dz. U. Nr 239, poz. 2039 oraz z 2004 r. Nr 65, poz. 597)).
Type of incentives
Non -financial: specific legal instruments included into the executive regulation of MoH precisely defining the procedures (requirements, rules, instruments for references etc.) for organ transplants
Groups affected
Patients: better access to transplantation services - clear rules and procedures allowing for quicker and more transparent access., Teams of the qualifying transplantation centres: more legally defined instruments for the decision-making process, more reliability., Donors (and families): more transparency, better conditions for the observance of their rights.
Suchhilfe
Characteristics of this policy
| Innovationsgrad | traditionell |
|
innovativ |
| Kontroversität | unumstritten |
|
kontrovers |
| Strukturelle Wirkung | marginal |
|
fundamental |
| Medienpräsenz | sehr gering |
|
sehr hoch |
| Übertragbarkeit | sehr systemabhängig |
|
systemneutral |
The MoH executive regulation is proper and adequate and it seems unlikely that it will be criticised as such. It gives quite a wide range of competencies to the transplantation qualifying centres concerning the decision process (additional diagnostic tests, consultations, specific laboratory tests).
The regulation introduces two basic categories of patiens:
- stable cases and
- urgent cases.
The decision is up to the team: the waiting lists are not applicable for the second group. Such simplicity, on the one hand, may help to perform provided procedures easily. On the other hand it may cause problems: it may be a decision on who is going to live and who is going to die (a decision not easy to avoid anyway in the described sphere).
Political and economic background
The regulation described is a consequence of the overall policy changes in the area of organ transplants, concerning among other fundamental problems in this sphere also a question of a great importance - the change of mentality taking place within Polish society concerning transplants, safety and trust.
How to strenghten, control and unify procedures concerning organ transplants is still fundamental in Poland. The role of the Polish Catholic Church is important in this area, specifically in the sphere of dead donors qualification issue. It should be stressed that the church position in this matter has changed significantly during the last years and the general approval for the transplantations must be noticed.
The executive regulation has been derived from the main objectives of the mentioned Law from 1 July 2009. It aims to achieve the overall aims of this law (transparent procedures, clear rules, better observance of the rights of donors and their families, transparent procedures for qualification, professionals rights assurance etc).
Complies with
The Polish Law of 1 July 2009 on cells, tissues and organ transplantation processes and the changes introduced to the Polish penal code-Law of 17 July 2009.
Change based on an overall national health policy statement
Law of 1 July 2009 on cells, tissues and organ transplantation processes
Purpose and process analysis
Current Process Stages
| Idee | Pilotprojekt | Strategiepapier | Gesetzgebung | Umsetzung | Evaluation | Veränderung/Richtungswechsel | ||
|---|---|---|---|---|---|---|---|---|
| Implemented in this survey? | |
|
|
|
|
|
|
|
Origins of health policy idea
The idea is directly connected to different actions undertaken by different bodies in the light of increasing the number of organ transplants in Poland. The driving forces behind the idea are obviously medical professionals, especially clinical doctors and medical scientists. The wide public debate with participation of medical professionals enhances public understanding of transplantation issues and the MoH regulation is expected to be the instrument that defines, positively simplifies and clarifies conditions and requirements for procedures in this area.
Following the regulation, it is likely that the transplantation centres, due to more stable conditions in the qualification process, will increase the number of transplantations. However, a lot remains to be done regarding the attitude of the Polish society - the approval for the transplantation of human organs is still not as common in Poland as it is in other European countries.
Initiators of idea/main actors
- Regierung: The MoH plays the main role, the executive regulation is a tool for the implementation of the policy change introduced earlier by legislation.
- Parlament: At this stage the role of Parliament as a whole is not significant, but the support for the overall policy concerning the transplantation issues could be observed during past parliamentary initiatives.
- Leistungserbringer: Widely declared support for the policy idea, including the idea to create transplantation centres at healthcare units.
- Patienten, Verbraucher: This stage of policy implementation does not arouse a lot of public attention. Of course, the attitude of potential donors and patients waiting for transplantation may differ.
- Bürgergesellschaft: Public debate slowly changes the overal attitude towards transplantation issues, but it is still not a common behaviour to sign consent for the donation of organs after death. Different organizations try to change the situation and the society's mentality.
- Wissenschaft: Strong and common support for the idea.
- Medien: The Media certainly influences society's attitude towards the problem but at present they are not egaged into policy implementation and there are few commenting voices to the executive regulation by the MoH.
- Politische Parteien: Conservative parties, even though supporting the main policy idea, are often expressing doubts concerning particular issues in the sphere of transplantology.
Approach of idea
The approach of the idea is described as:
amended: MoH issued the described executive regulation following the legislation changes mentioned above.
Stakeholder positions
As it was indicated before, stakeholders generally approved of the policy idea and supported initiatives regarding the transparency of transplantation rules and actions focusing on increasing the number of transplants.
The described regulation is a consequence of legislation changes that were called for mainly by medical professionals. The leadership role at this stage was with the MoH but with strong support of doctors working as transplantation specialists.
Actors and positions
Description of actors and their positions
| Regierung | |||
| MoH | sehr unterstützend | | stark dagegen |
| Prime Minister | sehr unterstützend | | stark dagegen |
| Parlament | |||
| Parliament | sehr unterstützend | | stark dagegen |
| Leistungserbringer | |||
| Clinicians | sehr unterstützend | | stark dagegen |
| Hospital doctors | sehr unterstützend | | stark dagegen |
| GPs | sehr unterstützend | | stark dagegen |
| Patienten, Verbraucher | |||
| Patients | sehr unterstützend | | stark dagegen |
| Potential donors | sehr unterstützend | | stark dagegen |
| Bürgergesellschaft | |||
| Patient organizations | sehr unterstützend | | stark dagegen |
| Medical associations | sehr unterstützend | | stark dagegen |
| Wissenschaft | |||
| Physicians and researchers | sehr unterstützend | | stark dagegen |
| Other academics (e.g. general lawyers) | sehr unterstützend | | stark dagegen |
| Specialized lawyers (mainly advocats) | sehr unterstützend | | stark dagegen |
| Public health academics | sehr unterstützend | | stark dagegen |
| Medien | |||
| Public TV | sehr unterstützend | | stark dagegen |
| Private TV | sehr unterstützend | | stark dagegen |
| Press | sehr unterstützend | | stark dagegen |
| Medical journals | sehr unterstützend | | stark dagegen |
| Politische Parteien | |||
| Civic Platform | sehr unterstützend | | stark dagegen |
| PIS | sehr unterstützend |  | stark dagegen |
| Social Democrats | sehr unterstützend | | stark dagegen |
| Peasants Party | sehr unterstützend | | stark dagegen |
Influences in policy making and legislation
MoH executive regulation is a legal instrument that starts the process of policy implementation. At this point the legislative process is finished. The legal grounds (formal requirements, methods, procedures used by transplantation centres) for the future development are established and now it depends mostly on other circumstances like the actual number of potential donors.
Legislative outcome
success
Actors and influence
Description of actors and their influence
| Regierung | |||
| MoH | sehr groß | | kein |
| Prime Minister | sehr groß | | kein |
| Parlament | |||
| Parliament | sehr groß | | kein |
| Leistungserbringer | |||
| Clinicians | sehr groß | | kein |
| Hospital doctors | sehr groß | | kein |
| GPs | sehr groß | | kein |
| Patienten, Verbraucher | |||
| Patients | sehr groß | | kein |
| Potential donors | sehr groß | | kein |
| Bürgergesellschaft | |||
| Patient organizations | sehr groß | | kein |
| Medical associations | sehr groß | | kein |
| Wissenschaft | |||
| Physicians and researchers | sehr groß | | kein |
| Other academics (e.g. general lawyers) | sehr groß | | kein |
| Specialized lawyers (mainly advocats) | sehr groß | | kein |
| Public health academics | sehr groß | | kein |
| Medien | |||
| Public TV | sehr groß | | kein |
| Private TV | sehr groß | | kein |
| Press | sehr groß | | kein |
| Medical journals | sehr groß | | kein |
| Politische Parteien | |||
| Civic Platform | sehr groß | | kein |
| PIS | sehr groß | | kein |
| Social Democrats | sehr groß | | kein |
| Peasants Party | sehr groß | | kein |
Positions and Influences at a glance
Adoption and implementation
In the future process of adoption, civil society and medical professionals will play the main role. The most important question in the context of the described issue is the public attitude and change of a common approach. There is still a lot to do in this field but the legal grounds that are expected to foster the development of transplants are set. From the medical doctors perspective the introduced rules will enable healthcare units to undertake necessary actions in a shorter time and will provide them with stable conditions (in a formal context).
Monitoring and evaluation
The executive regulation provides a mechanism for reviewing the implementation process - the qualifying teams will be controlled by national cosultants. At this stage, an evaluation of the policy's future development can not be provided. However, it seems unlikely that the project will not be accepted.
Statistics will show the policy's influence on the number of transplants. However, a future increase in the number of transplants depends not only on the described piece of regulation but also on the social and cultural aspects mentioned above, which are connected to mentality and beliefs among the population.
Review mechanisms
External evaluation of the process - national consultants
Dimensions of evaluation
Prozess
Results of evaluation
Expected outcome
The executive regulation was an expected and necessary step towards implementation of the policy. It will probably change the situation of patients, who will have shorter waiting times for transplants while formal requirements are being clarified. The same can be said for medical doctors. Looking from the expert point of view - not engaged in the difficult process of patient qualification - it should positively influence the issue of access and equity: the more clear and formally defined rules, the better and just conditions for the qualification process.
Impact of this policy
| Qualität | kaum Einfluss |
|
starker Einfluss |
| Gerechtigkeit | System weniger gerecht |
|
System gerechter |
| Kosteneffizienz | sehr gering |
|
sehr hoch |
The policy impacts the problem of transparency in the sphere of transplantations, equal acces and clear rules for decision making for medical professionals. It is expected to be a tool that enables more rational decisions based on precisely stated legal grounds concerning a patient's qualification process. It defines six fundamental criteria but still leaves the necessary room in the decision-making process for medical professionals to judge based on their knowledge and experience. The important mechanism of external evaluation has also been provided: qualified transplantation teams are monitored by national consultants who control decisions taking into account all criteria stated in the executive regulation.
References
Sources of Information
- MoH executive regulation of 20 October 2009, www.mz.gov.pl/wwwmz/index?mr=m491&ms=0&ml=pl&mi=56&mx=6&ma=79.
- Law on cells, tissues and organ transplantation processes of 1 July 2005, OJ 2005, No 169, clause 1411, and 2009 No 141, clause 1149.
- Law amending the Law from 1st July 2009 on cells, tissues and organs transplantation processes changes and to the Polish penal code from14 July 2009,
- EU Regulation of 22 December 2002 concerning the functioning of the national notification system, OJ No 239, clause 2039 and OJ 2004 No 65, clause 597.
- Law on Patients' Rights and Patients' Rights Ombudsman of 6 November 2009, The Official Journal 2009, No 52, clause 417, No 76, clause 641 - www.mz.gov.pl.
- Law introducing the Law of 6 November 2008 on Patients' Rights and Patients' Rights Ombudsman, the Law on Accreditation in Health Care, the Law on Consultants in Health Care of 24 April 2009 , The Official Journal 2009, No 76, clause 641.
Author/s and/or contributors to this survey
Anna Mokrzycka
Lecturer and researcher at the Health Policy and Management Department, Institute of Public Health, Jagiellonian University. Research on social protection system, disability, health insurance. Ph.D. in Social Protection and Labour Law.