Ideas of drug reimbursement system changes II

• Abstract
• Characteristics of this policy
• Purpose and process analysis
• Expected outcome
• References

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Abstract

In 2005 the MoH created an expert committee for the elaboration of medicine reimbursement system priorities. The fresh Pharmaceutical Law has been issued on March 30, 2007, and has changed the 2001 Law. The main objective of the Law is to ensure the convergence with the European transparency directive and other EU directives related to the drug issue. The expected outcome is the proper balance between equal access to drugs and the necessary rules of reimbursement (limitation of access).

Neue Entwicklungen

After the introduction of the new Law the medicines and medical products reimbursement costs are still generally paid from the public resources - the health insurance fees (National Health Fund resources). The law sets some new rules for the creation of reimbursement lists as well as rules for the refund of medical products. The Ministry of Health has also created the BIL- the Data Base on Reimbursed Medicines that includes information on drugs reimbursement rules valid from 1st of March 2007. This data base was implemented in order to bring Polish legislation in line with EU directives on transparency. It has to be revised adequately for each new MoH regulation on drug reimbursement (the actual situation is checked every 24 hours). 

The Pharmaceutical Law has been based on the document proposed by the group of experts established by the Ministry of Health in 2005 entitled: "Proposition of changes in the medicines and medical products reimbursement system".  In the mentioned document the diagnosis of the current situation has been presented indicating the main problems in this sphere. On the basis of the assumption that the true diagnosis of the current state is the basic and the most important condition for the introduction of quality changes in the system, the group of experts stated propositions for systemic changes. It included for instance the conditions for the creation of  the reimbursement lists. Taking into account the number of differentiated legal documents on pharmaceuticals, the basic proposition focused on the creation of one legal document - the law on fundamental rules for the reimbursement of drugs and medical products.

After agreements with multiple ministries and on the basis of results from consultations with the public, the Polish Parliament elaborated such rules for drug reimbursement and the Pharmaceutical Law has been issued on 30th of March 2007. The Law intruduces general rules and there have been some new MoH regulations issued (2) as neccessary executive laws. The policy in this field did not change significantly the ideas that have been elaborated in 2005 (cf. previous HPM report). The important change concerns the implementation of EU regulations on this subject into the Polish internal system. It is also obvious that some more executive regulation would be necessary in future.

Innovationsgrad	traditionell		innovativ
Kontroversität	unumstritten		kontrovers
Strukturelle Wirkung	marginal		fundamental
Medienpräsenz	sehr gering		sehr hoch
Übertragbarkeit	sehr systemabhängig		systemneutral
current    previous

The Law itself does not introduce any innovative solutions. It has been discussed for quite a long period of time and the need accomplishment with EU rules was widely accepted. Still, the degree of controversy is quite high: the interests of particular groups - patients, pharmaceutical companies, Ministry of Health, National Health Fund - are often on the opposite sides. The systemic impact is fundamental due to the relation costs-effect that has been adopted as a basic rule for reimbursement. Although it has a rational justification - in some cases it may be potentially dangerous for equity (ie. for health care services access - potential inequalities in health as a result). Public visibility - due to the mentioned BIL system - should improve, but the public influence (patients) still can not be meaningful. The policy depends also on the whole system, mainly on the financial resources. 

Purpose and process analysis

Current Process Stages

	Idee	Pilotprojekt	Strategiepapier	Gesetzgebung	Umsetzung	Evaluation	Veränderung/Richtungswechsel
Implemented in this survey?

Initiators of idea/main actors

• Regierung: The main initiative came from the Minister of Health. The elaboration of the proposed version of the Law was the obligation of the MoH - he has the power to influence the pharmaceutical market rules through the reimbursement lists included into his regulations.

• Kostenträger: The NHF as a payer is strongly interested in cost limitation and strongly supports the idea of rationalization of the reimbursement process of medicines and medical products, especially the replacement of particular drugs with generic products.

• Patienten, Verbraucher: Patients are a very influence sensitive and their attitude strongly depends on media information and comments. Patients position due to this is also very changeable and their influence quite weak.

• Privatwirtschaft, privater Sektor: Pharmaceutical companies have a very important position - it is said to be one of the most influential stakeholders in national health policy that is not interested in changes that aim at limiting spending public sources money but on the highest profit.

• Medien: Media show to the public the most serious and drastic cases of patient exclusion from health care services (ie. limited access to drugs and pharmaceutical products due to the exclusion from the reimbursement list.

Stakeholder positions

Basically the positions of the main stakeholders towards the idea and the medicines reimbursement policy as a whole did not change, that is they still hold very different opinions. After a long period of consultations, however, some kind of compromise has been reached: the law includes general rules that have been proposed in the described policy paper. However, it is not probable that such a compromise can be reached in case of placement of particular drugs on the list. Specific rules depend on executive regulations and methods of social and professional control over the list.

Pharmaceutical companies, the main stakeholders, are still opposed to the policy of drug reimbursement limitation (through the introduction of reimbursed drugs lists) but they do not show such attitude openly at the present time.

The media show to the public the most serious and drastic cases of patient exclusion from health care services (limited access to drugs and pharmaceutical products due to the exclusion from the reimbursement list - the latest example: the MoH decision concerning patients with stoma). It consitutes one part of the media campaign against the negative phenomena concerning the health care system (corruption among medical professions, corruption used by pharmaceutical companies, effects of strikes on patients). This constitutes the unfailing source of news and influences patients who, in general, are strongly oposed to any idea of reimbursement limitation but they do not have instruments to influence the situation.

As it was mentioned above the main role in bringing forward the idea plays the MoH but also the NHF supported it very much. The Polish Parliment accepted the proposed Law due to the generally understood problem of health care services financing and due to the still existing need to comply with the EU transparecy directive and other directives.

Providers position is not clear: medical professionals, especially doctors are under the pressure of media (anticorruption "shows" in TV) but they are also influenced by pharmaceutical companies. A very significant behaviour for them could be observed after the introduction of the new rule that obliged doctors to put the patient's ID number on the prescription. After some initial resistance on the grounds that this procedure is very time-consuming, physicians adhered to the new rule.

Actors and positions

Regierung
MoH	sehr unterstützend		stark dagegen
Kostenträger
NHF	sehr unterstützend		stark dagegen
MoH	sehr unterstützend		stark dagegen
Patienten, Verbraucher
Patients	sehr unterstützend		stark dagegen
Privatwirtschaft, privater Sektor
Pharmaceutical companies	sehr unterstützend		stark dagegen
Medien
TV	sehr unterstützend		stark dagegen
current    previous

Influences in policy making and legislation

The policy on medicines reimbursement proposed by the Minister of Health has been issued in a form of a piece of legislation, based on the previously described document entitled: "Proposition of changes in the medicines reimbursement system"  that has been elaborated by the group of experts. The Pharmaceutical Law has been harmonized with EU legislation:

• The EU Parliament Directive 2004/24/EEC from 31 st of March 2004 changing the Directive 2001/83/EEC;
• the Directive 2004/27/EEC from 31st of March 2004 changing the Directive 2001/83/EEC;
• the Directive 200428/EEC from 31st of March 2004 changing the Directive  2001/82/EEC; (all on the common code of medical products); and
• the Directive 2001/20/EEC from 4th of April 2001 on the harmonization of law rules.

The Pharamceutical Law incorporated mentioned EU provisions concerning drug policy and thus fulfilled the obligation for the implementation of these Directives. The new Law, in accordance with the main purpose: rationalising the changes in the reimbursement system aiming at the optimum use of public resources, has been based on the following rules:

1. Creation of reimbursement lists in a form of one legal document - the law on fundamental rules for medical products reimbursement. These lists should be elaborated by the MoH (the old separate lists are still valid until the new lists are elaborated).
2. The National Pharmaceutical Inspection has been established with the Head Inspector and inspectors on the voivodship level. The National Pharmaceutical Inspection is responsible for supervision over all conditions of production of medicinal products as well as over quality and turnover of medical articles and medicinal products .
3. Two basic lists for two basic types of refunded drugs are provided: • the list of refunded medicaments that are generally used, and • the list of refunded medicaments  that are used for specialised use (limited use).

The rules of payment (reimbursement) are still the same (as they were stated in the Law on services financed from public funds):

• hospital patients get drugs for free,
• drugs for free can also be delivered in sudden cases (treated by hospitals),
• in case of ambulatory treatment patients get drugs via prescriptions. The level of payment in the third case may differ due to the drug category: 1. a stated lump sum (flat -rates) for basic and prepared (recipe) drugs and 2. 30% or 50% of the drug price in cases of so called additional drugs (ie. all drugs different from basic drugs and only drugs that were put on the list). The maximum lump sum has also been stated (circa 1 EURO in case of a basic drug and circa 4 EURO in case of the prepared drug).

The Law is also based on the changes in the procedure of medicaments reimbursement introduction (the EMEA solutions: to qualify for reimbursement, medicaments have to be adequate to the health priorities (published by Ministry of Health) and to the finance resourses of the NHF as well as National Health Policy).  The Law divides all medicaments in three categories (and states rules of refund):

• Generics medicaments
• innovative medicaments, and
• the new category: the unique drug (a drug that cannot be substituted and there is only one for the specific treatment).

The Law accepted the rule that generics for the costs reason may be reimbursed only when the bio equivalency tests are passed (it does not include medicaments in the midterm period, accordingly to the Treaty on Accession). The price of the generic drug has to be more that 30% lower than the original one. The new Law states that in case of innovative medicaments the inclusion into the list depends of the cost-effect relation.

All in all, the new law did not introduce any fundamental rule changes; it generally introduces European standards into the pharmaceutical products and drug market at the Law level;  there are still some executive legislations needed.

Legislative outcome

Enactment

Actors and influence

Regierung
MoH	sehr groß		kein
Kostenträger
NHF	sehr groß		kein
MoH	sehr groß		kein
Patienten, Verbraucher
Patients	sehr groß		kein
Privatwirtschaft, privater Sektor
Pharmaceutical companies	sehr groß		kein
Medien
TV	sehr groß		kein
current    previous

Positions and Influences at a glance

Adoption and implementation

In the implementation process the MoH is mostly involved - he is resposible for the new executive regulations that should be issued on the reimbursement lists matter. The MoH list may potentially directly affect patients  - it is a method of limiting patients' access to health services (exclusion from the therapy process due to the defined reimbursement rules change) or even denying access to certain drugs altogether through exclusion of drugs from the reimbursement lists.

The Pharmaceutical Law introduces only the general rules that enable the introduction of some subsequent executive regulations that have not been issued yet. The MoH regulations on reimbursement lists from 2005 and 2006 are still in force and for the implementation process the introduction of new lists is crucial. Until now the two following MoH regulations concerning pharmaceutical policy have been issued:

1. The MoH regulation from 18th of May 2007 changing the regulation on the scope of the necessary information gathered and submitted by pharmacies to the organs resposible for health services financing form public resources (OJ.07.97.647), and
2. the MoH regulation from 17th of May 2007 on the prescription of drugs (OJ. 07.97.646).

In the context of the neceesary changes in pharmaceutical policy, taking into consideration the health care system limitations, the first regulation seems to be important. The basic objective is the limitation of the number of prescribed drugs and better transparency. It is commonly aknowledged in Poland that drugs were prescribed on someone elses name - eg. someone who was eligible to get drugs for free. Therefore, the new rules have been introduced which mandate that on all prescriptions the patient's personal ID number has to be written down by the doctor. The change was widely critisized by the doctors, mostly they criticized the additional time they have to spend writing the number, but after a short time the rule has been implemented. For the evaluation of the implementation process more time is still needed: some more MoH regulations have to be adopted in this field.

Monitoring and evaluation

Taking into consideration the Pharamceutical Law and the EU standards concerning general rules of pharmaceutical policy - the Polish Law sustains the rules and standards defined in the above mentioned EU directives. For the evaluation of the Law implementation process in the context of  access to health care services more time is still needed: some more MoH regulations have to be adopted in this field.

Expected outcome

The influence of the policy on reimbursement of medicines and medical products can be seen in the whole health care system and it very often dominates the overall health policy - especially in the field of health care services access. It is also well known in Poland that the National Health Fund expenditures on medicines are very high. It has been reported by experts in a so called Green Book for Health Care in Poland and recognized as one of the most important reasons for the system's financial problems. 

At this stage it is difficult to assess the effects of the new Law (and the executive regulations that follow it). The unexpected and undesirable effects are connected to the actual interest of main stakeholders. In the case of the Ministry of Health the actual interest, due to the difficult political context - the new election time, may not be abidance with the transparency rules (decisions excluding some drugs from the lists are showed by Media as decisions excluding particular groups of patients).

The positive change are rules concerning the BIL (the Data Base on Reimbursed Medicines), described above, but the BIL does not include medicines that on the basis of the Law on the health care services financed from the public resources from 27th of August 2004 (art.38.5) can be reimbursed under some specific conditions (eg. so called substitute drugs).

Impact of this policy

Qualität	kaum Einfluss		starker Einfluss
Gerechtigkeit	System weniger gerecht		System gerechter
Kosteneffizienz	sehr gering		sehr hoch
current    previous

The quality of health care services strongly depends on medicines and medical products used during the therapy as well as on access to the medicaments. The access depends on the drug prices. So far the new Law itself did not change the policy of reimbursement (the levels of reimbursement remained the same) but it created conditions for the introduction of new regulations. The important change concerns the accomplishment of EU regulations (the transparency rule). The rational policy in the sphere of reimbursement obviously influences the equity of the system (access to generics, substitute medicines, level of reimbursement, alternative sources of drug financing for poorest people). The decision on including the product into the reimbursement list has been subjected to the cost-efficiency relation in the document that was the base for the policy and it has been accepted as a general rule.

References

Sources of Information

• The Pharmaceutical Law from 31st of March 2007 (OJ.07.75.492)
• The MoH regulation from 18th of May 2007 changing the regulation on the scope of necessary information gathered and submitted by pharmacies to the organs resposible for health services financing form public resources (OJ.07.97.647)      
• The MoH regulation from 17th of May 2007 on the drugs prescriptions (OJ. 07.97.646)
• The EU Parliament Directive 2004/24/EEC from 31 st of March 2004 changing the Directive 2001/83/EEC
• The Directive  2004/27/EEC from 31st of March 2004 changing the Directive 2001/83/EEC
• The Directive 200428/EEC from 31st of March 2004 changing the Directive  2001/82/EEC
• The Directive 2001/20/EEC from 4th of April 2001 on the law rules harmonization.
• The Directive 89/105/EEC from 21st of December 1988

Reform formerly reported in

Ideas of drugs reimbursement system changes. Process Stages: Strategiepapier, Idee

Author/s and/or contributors to this survey

Mokrzycka, Anna

Author works as a Lecturer in:

Health Policy and Management Department
Institute of Public Health
Medical College, Jagiellonian University
31-531 Kraków
Grzegórzecka street 20

Tel: (12) 424-13-74, (12) 424-13-61
Fax: (12) 421-74-47
E-mail: amokrzycka@poczta.onet.pl

Empfohlene Zitierweise für diesen Online-Artikel:

Mokrzycka, Anna. "Ideas of drug reimbursement system changes II". Health Policy Monitor, October 2007. Available at http://www.hpm.org/survey/pl/a10/3