Mission impossible?

Since 2017, the European Union of General Practitioners (UEMO) has participated as “health provider” in the Health Technologies Assessment (HTA) stakeholder pool of the European Commission [1, 2] and in the EUnetHTA annual forum [3]. The project, the European Regulation on HTA, is currently going through the process of trilogue, a meeting between the European Parliament, the European Commission and the European Council. EUnetHTA has produced methodological work on the life cycle of new technologies to be assessed, from their emergence (horizon scanning), through discussion with developers (early dialogue), pre-market assessment, monitoring effects in real life after implementation (post launch evidence generation) and finally product re-assessment. This work is now completed, leading to publication of a White Paper. If negotiations are successful, we will have a European law in effect within 3 years.

I have regularly attended, with some colleagues, meetings in Brussels, Amsterdam or Köln, leaving my “swampy lowlands of general practice”, as Iona Heath said in an excellent article on HTA dating from 2004 [4]. It emphasises the big gap between the daily practice of medicine centred on the patient where decisions are shared, and takes into account multiple dimensions (a practical living HTA) and the rational aim of European HTA, which must produce recommendations shared by politicians, payers, manufacturers, patients and clinicians. Iona Heath wrote: “From the point of view of the clinician, HTA delivers considerably less than it promises. The problems center on the inevitability of judgment by both politicians and clinicians and the conflicting foundations of these judgments. Within political decision making, the needs of the population inevitably outweigh the needs of the individual; within clinical decision making, the opposite is the case. Attempting a scientific rationality, HTA struggles with the impossibility of holding the balance between the two.”

I am in agreement with my colleague, as I think that the ambitions of HTA must be limited to a rationality that can be shared internationally, and this is how the European Commission also understands it, having focused its Project of Regulation on scientific evidence, leaving the social, economic and ethical dimensions to local decision makers. It is true that for the general practitioner (GP) in clinical practice, the social and the ethical aspects “will always overshadow the economic.”

At the end of the HTA network collaboration for the European Regulation Project and before the implementation of the law, we can conclude that the mission is not impossible for us, if we can separate the two levels: “the core of HTA, which strives to maximize scientific rationality” and the shared decision process, the key element of HTA in real life, when GPs who are the main prescribers, discuss with their patients the best choice, including important dimensions such as bio-psycho-social aspects, continuity of care and coordination, multimorbidity and quaternary prevention (first do no harm). For this, GPs need confidence in the HTA scientific process, with its methodology being rooted in evidence-based medicine, while remaining free from conflicts of interest and being transparent in its process. GPs need good information in plain language that is understandable for patients, allowing an honest discussion. We have to recognise that the European work is taking us on this route. GPs have to show at the European level the importance of their profession. ­According a recent study [5] on personalised medicine, 90% of patients would want to discuss these matters with their GPs if such a technology were implemented. The idea that industry can have a link directly to the consumer without any mediation is a commodification Utopia. General medicine will have to maintain this important role in the future and will need sustainable development to be recognised as a speciality.