Developing a quality management system for the European Network for Health Technology Assessment (EUnetHTA): toward European HTA collaboration.

OBJECTIVES: The European Network for Health Technology Assessment (EUnetHTA) was established in 2006 and comprises over eighty organizations from thirty European countries. In its fifth project phase (Joint Action 3), EUnetHTA set up a quality management system (QMS) to improve the efficiency and standardization of joint work. This article presents EUnetHTA's new QMS and outlines experiences and challenges during its implementation. METHODS: Several working groups defined processes and methods to support assessment teams in creating high-quality assessment reports. Existing guidelines, templates, and tools were refined and missing parts were newly created and integrated into the new QMS framework. EUnetHTA has contributed to Health Technology Assessment (HTA) capacity building through training and knowledge sharing. Continuous evaluation helped to identify gaps and shortcomings in processes and structures. RESULTS: Based on a common quality management concept and defined development and revision procedures, twenty-seven partner organizations jointly developed and maintained around forty standard operating procedures and other components of the QMS. All outputs were incorporated into a web-based platform, the EUnetHTA Companion Guide, which was launched in May 2018. Concerted efforts of working groups were required to ensure consistency and avoid duplication. CONCLUSIONS: With the establishment of a QMS for jointly produced assessment reports, EUnetHTA has taken a significant step toward a sustainable model for scientific and technical collaboration within European HTA. However, the definition of processes and methods meeting the numerous requirements of healthcare systems across Europe remains an ongoing and challenging task.

Information specialist collaboration in Europe: collaborative methods, processes, and infrastructure through EUnetHTA.

The history of European health technology assessment (HTA) goes back more than 30 years. Almost as old as HTA agencies themselves is the desire to achieve European collaboration. This gained further impetus with the establishment of the European Network of Health Technology Assessment (EUnetHTA) in 2006. In this context, the field of information management faced specific challenges. Although these services are an integral part of HTA and information specialists play a key role here, this field is often not adequately represented in the HTA agencies within EUnetHTA. Furthermore, the organization of HTA production, including the types of HTAs produced, as well as funding, varies considerably. In order to meet these different conditions, information specialists have created various products and defined processes. With the EUnetHTA guideline, a common methodological understanding for the production of rapid Relative Effectiveness Assessments now exists. Furthermore, the Standard Operating Procedures map the complex information retrieval processes within EUnetHTA in a hands-on manner. The newly established Information Specialist Network (ISN) will in future ensure that information specialists are involved in all EUnetHTA assessments and that the methods are applied consistently in all assessments. In addition, the steering committee of the ISN manages enquiries and can be contacted to discuss methodological issues. Major barriers such as heterogeneity in the daily work of the EUnetHTA members can only be overcome through more collaboration and training.