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2nd International EBHC Symposium 2007
“How is it done”
The Symposium took place in Krakow of 19-20 November 2007, from the initiative of:
  • Central and Eastern European Society of Technology Assessment in Health Care (CEESTAHC),
  • Leon Kozminski Academy of Entrepreneurship and Management in Warsaw.
The Minister of Health - Professor Zbigniew Religa and the Mayor of the City of Cracow took the volunteer patronage of the Symposium.
1st Symposium focused on the most important issues of the reform of the Polish health care system; a way of modernization leading towards solutions optimal for all interested parties of the health care system was proposed.
In this year we presented experience of countries which have already made this journey. Was the way right? Were there analternatives? Did it prove to be a way to nowhere?
These questions were addressed by worldwide recognized experts, invited to share their reflections, but most of their experience of modern solutions implementation in their countries’ health care systems. Polish experts also presented possibilities of changes in the national system of health services; they also tried to answer the fundamental question: why, in spite of so many years of education in EBHC, the changes are not as dynamic as theoretical visions, simulations, or pre-election promises?
That is why the Symposium received a subtitle: "How is it done?"
We decided it is the time to support theory with practice and prove that changes are not only necessary, but – first of all – possible. If other countries have successfully dealt with problems, with which polish health care system is faced today, then they are manageable. Invited experts will constitute “living proofs” for this thesis.
The form of Symposium assumed longer time for discussion with eminent experts, which allows the participants to benefit from their knowledge to a greater degree than is usual for this kind of meetings. Communication was facilitated by simultaneous translation of all speeches into Polish and English.
On behalf of all the persons and institutions engaged in organization of the Symposium we heartily thank you for taking part in this event, so important for Polish medical environment.

First day - Monday, November 19th, 2007
  • Session: The List of Reimbursed Drugs
  • Session: Therapeutic Programs / Orphan Drugs
  • Session: Register of Services and Health Insurance
Second day - Tuesday, November 20th, 2007
  • Session: HTA Guidelines
  • Session: Pricing
  • Session: Registers
  • Session: Benefit Packages

  • Prof. Silvio Garattini, PhD, MD
    Director of the “Mario Negri” Institute, doctor and freelance professor of chemotherapy and pharmacology.
  • Andrzej Sośnierz, MD
    President of the National Health Fund.
  • Prof. Finn Břrlum Kristensen
    Director of The Danish Centre for Evaluation and Health Technology Assessment (DACEHTA) and Project Leader of the European network for Health Technology Assessment (EUnetHTA).
  • Artur Fałek, MD
    Deputy Director of the Department of Drug Policy and Pharmacy of the Ministry of Health.
  • Waldemar Wierzba, PhD, MD
    Director of the Health Technology Assessment Agency (AOTM).
  • Michael Barry, PhD, MD
    • Senior Lecturer/Consultant Clinical Pharmacologist at the University of Dublin, Trinity College
    • Clinical Director of the National Centre for Pharmacoeconomics
    • Board Member of the interim Health Information and Quality Authority (HIQA)
  • Prof. Saira A. Jan, M.S., Pharm. D.
    • Associate Clinical Professor, Rutgers University
    • Director, Clinical Programs Pharmacy Management; Horizon Blue Cross Blue Shield of New Jersey
  • Prof. Jacek Ruszkowski
    Director of the Public Health Center, Leon Kozminski Academy of Entrepreneurship and Management, Warsaw; a member of the Senate of this Academy, senior researcher, lecturer and consultant.
  • Amanda Burls, PhD, MD
    • Director of West Midlands Health Technology Assessment Collaboration (WMHTAC)
    • Senior Clinical Lecturer in Public Health and Epidemiology in the Department of Public Health and Epidemiology, University of Birmingham
    • Honorary Consultant in Public Health Medicine, West Midlands Region
    • Fellow of the Centre for Evidence-Based Medicine, Oxford
  • Alric Rüther, PhD, MD
    Head of the German Agency for HTA (DAHTA/DIMDI – German Institute for Medical Documentation and Information). Participation in building up the German Cochrane Centre. Assoc. professor of University of Cologne, department of Health Economics and Clinical Epidemiology.
  • Krzysztof Łanda, MD
    Independent consultant and Team Leader of World Bank projects.
  • Leszek Sikorski, PhD, MD
    Director of the Center for IT Systems in Health Care.
  • Brian Godman, M.A.
    Currently a Research Scientist at the Mario Negri Pharmacology Research Institute in Italy, evaluating potential methods used by governments and healthcare organisations across Europe to enhance generic prescribing as well as harness the availability of less expensive generics to drive down brand prices. Alongside this, ongoing reforms to enhance the quality and efficiency of prescribing, their impact, and transferability to other European countries.
  • Prof. Jacek Spławiński, PhD, MD
    Director of the Department of Pharmacology, National Institute of Public Health, Warsaw, Poland.
  • Ass. Prof.Rafał Niżankowski, PhD, MD
    Head of the AHTAPol Committee on Development of Guidelines on Conduction of Health Technology Assessment (since 2005). Head of the Unit of Angiology, 2nd Department of Internal Medicine, CM UJ.
  • Magdalena Władysiuk, MD
    Vice-president of HTA Consulting. An experienced practitioner of EBM, HTA and PhE; author of numerous training programs and research analyses in HTA.
  • Anna Klim, M.A.
    Senior Specialist in the Department of Drug Policy and Pharmacy of the Ministry of Health.
  • Grzegorz Mączyński, M.A.
    Senior Specialist in the Department of Drug Policy and Pharmacy of the Ministry of Health.
  • Miroslav Palát, MD, MBA
    Strategic and Communication Affairs Director, Johnson & Johnson.

1. The List of Reimbursed Drugs
Silvio Garattini, Michael Barry
Imperfection of the health services market and continuously increasing health care-related expenditures make some degree of regulation mandatory. One of the regulatory tools is reimbursement. Its aim is to ensure availability of drugs of proven efficacy and safety, being the most cost-effective options among alternatives and affordable within available means. Reimbursement has been used since the 1960s and the first list of reimbursed drugs was introduced in order to rationalize the costs of management of asthma. Rules concerning creation of lists of reimbursed drugs should be transparent and based on credible and reproducible pharmacoeconomic analyses.
During this session role and importance of transparent rules concerning the reimbursement system will be discussed in the context of demographic and epidemiologic changes, as well as tendencies on the drug market. Different means of regulation at the national level (positive and negative lists or mixed systems) will be compared; other included topics: alternative methods of calculation of the limit of reimbursement, degree of reimbursement, legal acts influencing competition on the Polish pharmaceutical market, criteria of reimbursement, limits and rules concerning their creation in the context of EBHC.
2. Therapeutic programs / Orphan Drugs
Amanda Burls, Krzysztof Łanda
Increasing availability of medical information makes more patients aware of new, more efficacious treatments for majority of known diseases. This, in turn, increases demand on health care services related to the most advanced health technologies. Therapeutic programs are one of the tools making these new, usually very expensive treatments available for patients. Today in Poland 37 programs annually are carried out by selected hospitals; the list of therapeutic programs is published as an annex to a NHF President’s regulation. Full availability of innovative drug therapies in such diseases as malignancies, multiple sclerosis or viral hepatitis becomes more and more difficult to achieve due to increasing prevalence, limited budget resources and continuous introduction of new drugs and indications.
Issues concerning future financing of expensive therapeutic programs as well as related expectations of patients and health care professionals will be addressed in this part of session. Problems related to introduction of transparent criteria of financing of therapeutic programs as well as role of HTA analyses in decision-making will also be discussed.
Orphan drugs are those used in treatment of rare diseases, prevalence of which does not exceed 5/10 000 (5 cases in 10 000 individuals). There are about 5 000 known ultra-rare diseases, usually of genetic etiology. Orphan drugs require special legal solutions concerning research, approval, market authorization and reimbursement. High costs of treatment using these drugs cause economic (low cost-effectiveness in terms related to general population) as well as ethical dilemmas, since these drugs are sometimes the only chance for patients affected by ultra-rare diseases. Legal solutions are introduced to encourage manufacturers to further research (in the USA since 1983, in the EU since 1999) – tax privileges, research grants, facilitated approval or guaranteed market exclusiveness. These regulations are urgently required in Poland, taking into account demand on these drugs and limited means of the public health care system.
The issues of definition and origin of orphan drugs as well as importance of the problem in Poland and worldwide will be discussed in this part of session; ethical and economic questions will be addressed. Solutions based on evidence from other areas of health care, applied in European countries, will also be proposed.
3. Register of Services and Health Insurance
Andrzej Sośnierz, Jacek Ruszkowski, Miroslav Palát
In countries with well developed market of health care services complementary and supplementary insurances are an important factor limiting excessive consumption of the services and making patients co-responsible for the health care system. In Poland, however, supplementary insurances constitute only a small part of health care-related expenditures, mainly within supplementary insurance programs for employees. The market of voluntary supplementary insurances in Poland is estimated today at 1.5 billion PLN annually, as compared to 42 billion PLN in the NHF and 60 billion PLN in the whole health care system. It is assessed that a properly designed supplementary benefit package would substantially increase this amount – even to 10-15 billion PLN annually. It may be supposed that such insurances will soon become an important segment of the Polish market of health care services. Development of supplementary insurances makes it necessary to introduce an efficient system for accumulation and processing of data concerning health care services – a Register of Health Care Services. This kind of system makes it possible not only to account health care services, but also to define goals and formulate tasks related to health politics. It also allows for recognition of actual health-related needs and prediction of demand for health care services. The Register has been introduced in Poland as a pilot program in 1993; its complete introduction is expected in 2008. Main arguments for the system are rationalization of expenditures and possibility to control whether services are justified and performed on purpose. The prevention may also be important, since awareness of control usually decreases likelihood of undue practices.
A different systems used worldwide for monitoring of health care costs and services will be presented in this session; status and perspectives of the Register in Poland will be discussed. The issues will be presented using perspective of different interested parties of the Polish health care system, taking into account requirements of the market of supplementary insurances. Possibilities of using of the Register as a source of data concerning health care system and usefulness of these data in rational decision-making will be presented. Moreover, concepts and possibilities of development of additional and supplementary insurances as well as experience of other countries will be discussed. Apart from issues related to creation of the register of health care services questions of quality monitoring and calculation of costs in health care will be addressed, with special attention paid to DRG and similar system solutions.
4. HTA Guidelines
Finn Břrlum Kristensen, Jacek Spławiński, Rafał Niżankowski
In Poland. HTA analyses are usually commissioned by decision-makers in the Ministry of Health and the National Health Fund. Development of the market of health care services, implementation of standards recognized worldwide and solutions tested in other countries will make more participants of the Polish health care system aware of usefulness and importance of the HTA analyses. This demand will probably be met by increasing number of companies ready to perform such analyses. Increasing demand for HTA reports and use of their results in decision-making in health care make it necessary to agree upon precise and transparent criteria concerning methodology of different types of analysis. In many countries, appropriate guidelines have been used for years. In Poland, some authors as well as commissioners of HTA analyses have expressed such expectations for some time. The answer came in the form of Health Technology Assessment Guidelines prepared by the AHTAPol Expert Team. These guidelines constitute a major advantage for the idea of HTA in Poland, although it must be admitted that they are not perfect (as is the case with every human doing...) and will certainly require further work.
This session will concentrate on detailed problems concerning interpretation of newly developed guidelines and their practical use in context of actual HTA analyses. The most controversial aspects of the Polish guidelines will be discussed in the context of practice and regulations in other countries or international institutions, which have used such documents for many years.
5. Pricing
Brian Godman, Artur Fałek, Magdalena Władysiuk, Anna Klim, Grzegorz Mączyński
Pricing is an important tool of the country’s health politics. In appropriate pricing, differences between interested parties of the health care system are taken into account as well as other factors, such as goals and priorities of health politics, the country’s social and industrial development and historical background. In the developed countries, health care systems seem to evolve towards price control aimed at rationalization of expenditures on one hand, while on the other towards increasing transparency in pricing (EU Council Directive 89/105/EEC from December 21st, 1988).
The systems of pricing of reimbursed medicinal products will be discussed in this session as well as issues concerning effect of the reimbursement criteria on price level and mechanisms of negotiations (including those based on HTA analyses) aimed at agreements with individual manufacturers as well as those concerning whole segments of the market.
6. Registers
Saira A. Jan, Leszek Sikorski
Registers are a widely used type of medical databases. Registers of adverse events, rare diseases, surgical interventions and epidemiological registers constitute an essential part of medical practice. In Poland demand for registers increases along with awareness of the decision-makers and increasing role of HTA analyses in decision-making. Properly managed registers may be an valuable source of information for economic and cost analyses or analyses of actual effectiveness, especially concerning rarely performed procedures. Development of medical registers is based on wide implementation of IT in accumulation, aggregation and processing data. Appropriate IT methods simplify the process of data accumulation and analysis, thus saving resources and shortening the process of research to absolute minimum. Registers of adverse events, rare diseases and epidemiological registers are present in majority of developed countries, while registers of surgical interventions or screening tests are still quite uncommon. Private companies are not interested in the latter – their concern is promotion and development of their products and not comparative, long term observation. Therefore, it seems that such registers should be kept by public institutions in order to accumulate necessary (and, unfortunately, mostly unavailable at present) data for the payer and patients.
This session will be entirely dedicated to experience of developed countries concerning implementation of solutions aimed at development of registers and their use in reimbursement of health care services.
7. Benefit Packages
Alric Rüther, Waldemar Wierzba
Worldwide benefit packages are the key tool in rationalization of health care-related expenditures in many countries. A benefit package is a list of health care services or procedures which may be performed within health insurance of a specific kind (a positive package) or those excluded from health insurance of a specific kind (a negative package). Transparent inclusion and exclusion criteria are based on credible comparative analysis of efficacy and safety as well as cost-effectiveness and financial analyses.
This session will focus on methodology of creation of benefit packages, guidelines and criteria that should be taken into account (according to recommendations of the WHO and governmental HTA agencies).


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