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					                                                                                     EUROPÄISCHE AKADEMIE DER WISSENSCHAFTEN UND KÜNSTE
                                                                                                  EUROPEAN ACADEMY OF SCIENCES AND ARTS
                                                                                                 ACADEMIA SCIENTIARUM ET ARTIUM EUROPAEA

                                           CONGRESS HIGHLIGHTS
                                                                                                         Ausgabe 11 / September 2007

                                      Health is Wealth: Step II
                          Toward to a European Lead Market in Healthcare
                           Principles of Classification in Healthcare based on Innovation

                                  Summary of the discussion in Salzburg on June 6th 2007

      The Goal for Classifying Medical
      Provisions is to bring all medical
      practice to the highest possible
      State of the Art and to find a
      common European basis for the
      medical arts. Medical progress
      is inextricably linked to innova-
      tion; and both innovation and
      medical progress are a source of
      improved public health out-
      comes and a dynamic lead mar-
      ket development. Classification
      should be a guiding framework
      to systematically (re-) evaluate
      treatment provisions of modern
      medicine. This should also sup-
      port decisions in investment and
      reimbursement of health care.           which met on June 6th to formu-           improvement in small, but mul-
      With constant reevaluation out-         late a draft on the principles for        tiple steps, both of which are
      dated concepts are removed              rational classification of medical        important to improve our health-
      freeing up resource for the finan-      provisions.                               care system over time. Such pro-
      cing of new and improved                                                          gress improves not only the qua-
      concepts.                               Any classification of medical             lity of provision but ultimately the
                                              practices and technologies                quality of life.
      The report “Health is Wealth” to        should appropriately address the
      the European Parliament recom-          specific characteristics of medi-
      mends in the Cluster Medical            cal innovation. Innovation in
      Arts a classification of all Medi-      medical processes and techno-
      cal Provisions. In the meeting          logy is the single most important
      with the Health Council on              driver of improvement in Health
      October 10, 2005 the wish was           Care. New and better tech-
      expressed to develop principles         niques and methods are appear-
      for classifying Medical Provi-          ing every day to help practitio-
      sions.                                  ners in their efforts both in fight-
                                              ing and preventing diseases.
      The Academy formed an interdi-          Innovation is a result of a conti-
      sciplinary group composed of            nuous effort which needs to be
      medical experts in their field,         sustained in order to fully sup-
      representatives from industry,          port the improvement of a popu-
      the European Commission and             lation’s health. Medical progress
      the Council, health administra-         can occur as radical innovation
      tion and insurance providers,           or as a constant “evolutionary”                        Andreas Penk                                                                                                                1
Medicine and its practice have a
broad reach across every cultural
endeavour, from prevention to
intervention by way of prediction
and prognosis, diagnosis, thera-
py, rehabilitation and long term
care. Innovation is incremental
knowledge based on experience
and scientific investigation which
meets a hitherto unmet medical
need and thereby creates a new
market. The transformation from
bench to clinic requires an exact
scientific process according to
high scientific standards, exten-
sive clinical testing and a huge
upfront investment of the innova-
tor. The transformation steps
                                                                        Felix Unger
depend on the nature and severi-
ty of the disease, the invasiveness    stimulate a European market                    -   The Information tech-
of the intervention and the accep-     in all areas of medicine and gives                 nology (IT) gives a further
tability of risk or possible harm to   quick access to information.                       stimulus in propelling
the patient.                           There is a quick local know-how                    modern medicine, es-
                                       translated in the European area                    pecially in research and
New evolving areas that can be         on a large scale for the benefits of               patient care and is a
expected to find a new market          patients. E-Health is complemen-                   prerequisite for e-Health
focus include                          tary to medical information and                    and e-Medicine.
   - e-Health and e-Medicine           innovation. The created network is
       E-Health is a powerful          a facilitator for common quality in      Molecular medicine and Gene
   tool to improve the quality         Health Care in all Europe.               technology are expanding fields
   of care, ensure free a c c e s s                                             in understanding diseases and
   across borders to informa-          -   Other fields in the innovative       finding key elements for therapy.
   tion for professionals and              area are all the new                 Prediction might be influenced by
   patients; similarly mobility            upcoming developments in             gene technology. Moreover mole-
   of the patients will become             Nanotechnology for better            cular medicine and gene techno-
   easier     as     a     result.         understanding of diseases            logy open new doors to a better
   E-Health is a tool to                   and fighting them.                   understanding of individual
                                                                                patients’ diseases and to engage
                                                                                in personalized medicine.
                                                                                Truly innovative technologies
                                                                                must be given the market freedom
                                                                                to demonstrate their clinical value
                                                                                by collecting clinical data from
                                                                                real world use to supplement the
                                                                                limited data of clinical studies
                                                                                submitted for initial regulatory
                                                                                approval. Therefore, innovative
                                                                                technology is to be considered in
                                                                                the Classifications as Class I
                                                                                (classification described below)
                                                                                for a period of five years with sub-
                                                                                sequent reevaluation and re- clas-
                                                                                sification if appropriate.

This is necessary to ensure that       Classifying medical provisions          Class III:
new technologies are reimbursed        has been established in the area        no effect: disturbances in general
fully thus providing a viable incen-   of medical interventions, mainly        feeling
tive for innovation. As older tech-    the basic classification foresees
niques are shown to be inferior        three classes:                          Class I and IIa are items to be
they will be eliminated from the                                               reimbursed totally.
medical offer.                         Class I: based on a rich and            Class IIb and III are covered by
                                       robust data base comprising ran-        the patient.
Classification is based on evi-        domized studies and clinically-
dence which can be gained by           based experience and evidence.          For diagnosing a triple classifica-
experience, consensus and stu-                                                 tion seems to be feasible, as well
dies in various forms.                 Class IIa: mostly based to consen-      for prevention as
The gold standard of evidence is       sus studies
the randomized clinical trial. Well    Class IIb mostly based to expe-         Effective
designed, observational and            rience                                  Less effective
population-based clinical trials                                               Non effective
without randomization can also         Class III: based to the clinical
provide valuable data especially       experience.                             which can be adapted to Class I,
when assessing parameters like                                                 IIa, IIb, III too.
quality of life, treatment satisfac-   Classification  linkingevi-
tion, compliance or dramatic ef-       dence and long term out-                In drug therapy:
fects.                                 come to disease severity
Evidence from respected authori-                                               Class I:     safe and effective
ties based on clinical experience,     Class I:
descriptive studies, reports from      highly effective: life threatening      Class IIa: effective
experts or consensus studies are       and acute situation (e.g. fracture,
sources of evidence too.               myocardial infarction)                  Class IIb: safe
Similarly, clinical outcomes over
periods longer than characteristi-     Class IIa:
                                       effective: chronic and long term        Class III: neither safe nor effective
cally observed in RCTs are also an
important measure.                     conditions
                                                                               The classification gives the basis
                                       Class IIb:                              for reimbursement of medical pro-
The strength of recommendations                                                visions: Class I and Class IIa are
                                       less effective: (e.g. homeopathy,
can be graded:                                                                 items to be reimbursed via the
                                       natural medicine, but cosmetic
                                       surgery too)                            Solidarity in Taxes and insurances,
   • strongly      recommended
     with strong evidence of
     efficacy and substantial
     clinical benefit,
   • generally recommended
     when there is strong or
     moderate evidence for
     efficacy, but limited clinical
   • not recommendable owing
     to moderate evidence
     against efficacy and ad-
     verse outcome, unless bene-
     fit outweighs risk in the ab-
     sence of other treatments
   • never recommendable in
     strong evidence against
     efficacy or adverse out-
     come (CDC-Grading).                                         José Rubia, Jack Watters

Class IIb and Class III are those
items, where the costs are
covered by the patients.

The final goal in classifying is a
constant re-evaluation of the
medical provisions to maintain a
relevant and state of the art
assessment status. This is a con-
tribution for a constant quality
control and insurance. This is a
tool for adequate reimbursement.

Classification means a constant
re-evaluation of medical practice
and is the basis for quality
management. Furthermore classi-                wide medical care of the highest                report should design a European
fication provides an indispensa-               international standard is given.                concept for a Lead Market and
ble and common basis for a Euro-               This is the vision of a European                how to implement this Lead Mar-
pean Market and supports the                   Lead Market in Health.                          ket according the Lisbon and
concept of a European Lead Mar-                                                                Maastricht Criteria.
ket.                                           As next step the Academy should
                                               launch a report on: Creating an
With a constant quality control a              Innovate Europe: toward the Euro-
basis for a homogenous Europe-                 pean Lead Market in Health. This                Salzburg, July 7th, 2007

    Felix Unger (Chairman), Praeses Acad.
    Karl Bornschein, Thesaurarius Acad.
    Thomas Brandtner, Councillor of Europe
    Frans de Bruïne, European Commission
    Manfred Deutsch, Soc. Acad.
    Gilbert Fayl, Soc. Acad.
    Günther Grabner, Soc. Acad.
    Richard Greil, Soc. Acad.
    Markus Homann, AXA Konzern AG
    Ralf Ihl, European Association of Geriatric Psychiatry
    Stefan Kaltenbacher, Johnson & Johnson Medical Products GmbH
    Gerhard Knorr, Bavarian Ministry of State
    Michel Letort, CVH Division Sorin Group
    Konrad Meßmer, Soc. Acad.
    Dierk Neugebauer, Barmer Ersatzkasse
    Andreas Penk, Pfizer Pharmaceutical Group
    Francisco José Rubia, Propraesides Acad.
    Friedrich Sandhofer, Soc. Acad.
    Michel Taillet, European Society for Therapeutic Radiology and Oncology
    Maurice Wagner, Eucomed
    Jack Watters, Pfizer Pharmaceutical Group

        Impressum: Herausgeber und Medieninhaber: Europäische Akademie der Wissenschaften und Künste, St.-Peter-Bezirk 10,
   5020 Salzburg/Austria, Telefon +43-662-84 13 45, Fax +43-662-84 13 43, e-mail:,
          Die Europäische Akademie der Wissenschaften und Künste wird von der Republik Österreich, dem Herzzentrum Salzburg,
dem European Institute of Health, dem European Heart Institute und der Europäischen Akademie der Wissenschaften und Künste e.V. unterstützt.
                                                        Druck: J. Huttegger, Salzburg

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