[5 years after the creation of the Nursing and Paramedical Hospital Research Program of the French Ministry of Health: issues and Challenges]. / Bilan de 5 ans du Programme hospitalier de recherche infirmière et paramédicale (PHRIP): quels enjeux, quels défis ?

INTRODUCTION: since 2010, the French General Directorate for Healthcare Provision (DGOS) has launched an annual call for research projects which aims to promote the development of paramedical research: the Nursing and Paramedical Hospital Research Program (PHRIP). CONTEXT: five years after its creation, the question arises to what extent this program has contributed to reinforce the importance of paramedical research in France. OBJECTIVE: the objective of this study is to conduct a five years review of this program and to identify issues and challenges that it faces. METHOD: all research projects selected in the PHRIP program from 2010 to 2014 were included. The analysis focused on quantitative (number of projects, project budget, overall budget per year, last budget share obtained as an indicator of progress of the project) and qualitative variables (profession of project leaders, themes of research, type of healthcare facility which receives funding for research project). RESULTS: almost €l0M were committed for 104 research projects over a five-year period. Among the strengths of the PHRIP program is the positioning of the patient at the center of its research projects and the increasing diversity in projects leaders' professions. Challenges are to prioritize research on primary care, to involve independent private practice healthcare practitioners as well as strengthened methodological support of paramedical practitioners to build and conduct research projects. DISCUSSION: a review ten years after the program launch would allow to assess, with hindsight, the impact of this program on the importance of paramedical research in France. CONCLUSION: the PHRIP program has generated considerable interest among French paramedical practitioners. These have finally identified a public funding program specifically dedicated to them, which allows them to invest themselves in their own applied research.

Medico-economic evaluation of health products in the context of the Social Security Financing Act for 2012.

The participants in round table 6 of the Giens Workshops 2012 drafted recommendations based on the collective interpretation of important elements of the decree concerning the medico-economic evaluation of health products published a few days earlier (02 October 2012). The medico-economic evaluation (MEE), becomes an additional determinant for fixing the prices of health products by the Health products economic committee (Comité économique des produits de santé, CEPS) via the hierarchisation of treatment strategies, and thus modifies the market access conditions. Limiting the analysis to medicinal products and medical devices for which a major, important or moderate improvement in the medical service rendered (ASMR) or of the expected service (ASA) has been requested and presenting a significant budget impact on the Social Security expenses, excludes health products with ASMR or ASA with a lower level requested which often create complex price fixing problems and often have a major budget impact. This latter concept remains to be defined in detail. The MEE envisaged for the first registration must include the need to confirm or refute the initial hypotheses especially concerning the actual position in the therapeutic strategy at the time of renewal of the registration. For the first registration, the conventional reference to European prices guaranteeing a minimum price to innovative medicinal products, the medico-economic models submitted by the industry to the French Drug Authority (Haute autorité de santé, HAS) must be used to guide the compilation of new data to be requested at the time of the registration renewal and to negotiate the level of the discounts in the framework of a price-volume agreement, if applicable. The MEE will allow comparing the result of the analysis to the model hypothesis at the time of the renewal of the registration, which may contribute to the renegotiation (either up or down) of the price of health goods. The costs related to obtaining new data must be controlled. In order for the MEE to allow confirming the relationship between the price requested and the benefit expected, the group privileges the definition of reference values with an indicative and non-normative value, likely to evolve with time rather than a threshold. Concerning the evaluation procedure: the time to market access must not be lengthened; while the possibility of regular meetings between the industry and the HAS is recommended to avoid methodological divergences. A transitory period should allow the implementation of the entire evaluation procedure which must also take into account the specificities of health products registered before the 3 October 2013.