With a background in health economics, policy and law, I shared the belief throughout my career that legal compliance is intertwined with the commercial strategy of a company and influenced by economical and political factors. The resulting compliance strategy has the potential to ensure trust in patients and potential clients, while taking the quality management of the medical technology to the next level. Through NAALA I can fully deploy this approach. It is therefore time for an update regarding the developments in this interesting intersection of law, politics and economics. 

After more than three years of negotiations, the Council of the European Union agreed to move forward with a mandate to start discussions with the European Parliament on Health Technology Assessment. Health Technology Assessment (hereinafter: “HTA”) is an evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing technologies (recital 2, Regulation on HTA Cooperation). HTA aims to provide decision makers with information to be used in decisions regarding, for example, reimbursement. HTA does not only include technological products only, in fact the name might be misleading. HTA includes medicinal products, medical devices and/or treatments and procedures. How come there is a need for regulation in this field? 

As the European Union is all about free movement of goods and ensuring a smooth functioning of the internal market, this draft regulation, of course, aims to contribute to that. Nowadays, Member States might carry out parallel assessments. In addition, there are divergences between national laws and regulations that have resulted in developers being confronted with multiple and divergent requests for data. This has led to duplications and variations in outcomes, which increased costs and slowed down the market entry of promising and much needed health technologies. 

Despite the European Union co-funded joint actions that have carried out joint assessments within this framework, it remained project-based and there was a need for a more sustainable model of cooperation. 

The regulation on HTA cooperation aims, among others, to streamline disparate national HTA processes and generate a single, joint clinical assessment, with a focus on joint relative effectiveness assessment of pharmaceuticals and certain types of medical devices. Rightfully, the scope of this draft regulation is limited to four out of nine domains by reference to which health technologies are assessed. These four clinical domains concern the identification of a health problem and current technology, the examination of the technical characteristics of the technology under assessment, its relative safety, and its relative clinical effectiveness (Recital 3, Regulation on HTA Cooperation). The five remaining non-clinical assessment domains remains a national competence.  

The regulation wishes to ensure harmonised rules on the clinical aspects of HTA and enable the pooling of expertise and resources of HTA bodies by requiring joint clinical assessment to be carried out for all medicinal products undergoing the central marketing authorisation procedure and certain medical devices which are in the highest risk classes. 

There is however some criticism on the proposal lacking guidance on the inclusion of real world evidence and post-market clinical follow-up. This leaves the European Parliament with some topics to discuss, which we will closely follow.