SECOND EURO HEALTH FORUM

In a context of resource rationalization, the creation of agencies responsible for the assessment of healthcare technologies has been encouraged by the European public authorities who consider those agencies to constitute a solution to the challenges they are facing. The set-up of the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom, the Institute for Quality and Efficiency in Healthcare (IQWiG) in Germany, and the French National Authority for Health (HAS) in France clearly reflect each country’s need for an independent body formulating authoritative opinions with the goal of ensuring that patients have access to new therapies.

The Governments of the various member States are the sources of the questions put to those agencies. The responses of the agencies for the evaluation of healthcare technologies are based on the strongest known arguments :

  What constitutes evidence ? Should the various types of studies be classified exclusively on the basis of their ability to minimize bias in the experimental design or on their ability to detect effectiveness differentials in everyday medical practice ? Moreover, is not such an opposition between randomized trials and observational studies obsolete, providing that all the information available is exploited in order to inform political decision making. Are we to continue reasoning in two stages, distinguishing the inferential approach from the final decisions, or would it be preferable to promote an instrument for integrated decisional meta-analyses directly linking the information a priori and its uncertainties, data processing and the decision to be made ?

  What assessment criteria are to be used in an evaluation ? Should we resort to classic biomedical criteria or should we take into account the patient’s preferences in the evaluation of the impact of the disease and its treatment ? Can we continue to let it be believed that the choices are made on the basis of exclusively scientific grounds when the scarcity of the resources available implies that it is necessary to address the magnitude of the returns, in clinical, human and budgetary terms, per thousand euros invested ? In this matter, budget impact model versus medical care cost is a crucial issue. How can we incorporate the uncertainties that govern the rules of the game played by purchasers and producers in the analysis when the social value of innovation is determined contractually or unilaterally by the public purchaser ?

  Who are to judge ? What are the positions of the other partners in the healthcare system : healthcare professionals, patient associations, manufacturers ? Who is to decide what is socially acceptable : the authorities, professionals or informed citizens ? In an open pluralistic democracy, debating the issues is perfectly normal. But it is also necessary for the principal interested parties to be able to contribute.

  How are the agencies responsible for evaluating healthcare technologies to organize themselves at European level ? At what level should they interact between each other and with the other institutional players ? Should they develop a common strategy ?

We will not produce the final answers to all those questions but we will be able to reflect on those themes together, in Paris, on November 25.

For more information : http://www.eurohealthforum.com/

Looking forward to meeting you,

Prof. Robert Launois.