Benefit Assessment of Medicinal Products

Manufacturers who want to place innovative medicines on the market must provide evidence for their therapeutic benefit. In the EU, this assessment is performed by national organisations via socalled ‘HTA-procedures’ (Health Technology Assessment). The designs of the studies, which are necessary for the assessment, cannot always fulfil the different national requirements. It is the task of the ‘European Network for Health Technology Assessment’ (EUnetHTA) to establish standards which serve as the basis for the national decision of each Member State – following the slogan ‘Evidence is global, decision is local’.

ʻHTA’ is defined as the systematic, evidence-based assessment of medical procedures and technologies, relating to their impact on the health of the individual, the system and society. Until now this assessment has been performed nationally or even regionally. This is supposed to change: The objective of HTA cooperation is development of uniform European rules for the assessment of the additional therapeutic benefit of medicines – similar to the approach of the European marketing authorization system and pharmacovigilance. This shall be implemented via the common platform ʻEUnetHTA’. EUnetHTA is an independent scien- tific network of the different European HTA organisations, which is promoted by the European Commission. The aim is to elaborate efficient HTA practices as well as common rules and methods, and by this provide a benefit to the different national health systems. In the end, EUnetHTA will produce ‘joint reports’ which may serve as a basis for the decision of each EU Member State.

Diverging national rules as obstacles

Due to the continuing existence of diverging national and regional requirements, it is not an easy task for pharmaceutical manufacturers to prove the benefit of new medicinal products according to rules everywhere. For example, the starting point and duration of the HTA process, as well as the clinical requirements, differ among the Member States. These diverse national approaches lead to different results of the HTA process, and last but not least to increased workload and costs for pharmaceutical manufacturers. Therefore, they would gain an immense benefit from a uniform European HTA process.

Pursue European objectives

Not only pharmaceutical manufacturers, but also national organisations performing the assessments, profit from consequent implementation of the European HTA process: the first mentioned via uniform rules for efficient proof of the therapeutic benefit of new medicinal products, the latter via uniform assessment criteria and efficient use of resources. This is what BAH together with the ‘Association of the European Self-Medication Industry’ (AESGP) are struggling for. It is deemed important to pursue the objectives of the European HTA cooperation past the expiry of the final funding period of the European Commission in 2020. Until then, BAH together with its member companies and all involved organisations will contribute to further development of EUnetHTA.

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