Health Technology Assessment Network Stakeholder Pool meeting – patients involvement

On January 2019, the annual meeting of the Health Technology Assessment Network Stakeholder Pool was hosted by the European Commission. During the meeting, participants discussed how to involve stakeholders such as patient representatives into the processes at a European level. The meeting touched upon recurrent issues such as how to involve two divisions on Health Technology Assessment: patient and their representatives, and payers and insurances. The involvement of patients was particularly discussed.

Background note:
Up until now, Health Technology Assessment has been carried out across Europe at national and local levels, through the national process and methodologies. The process is important, as it is applied to any health technology (broad concept including medicines, medical devices, health protocol, continuity of care). Therefore it helps to determine the ultimately political decision on access and availability of those technologies at national or local level.

The variety of national processes has implied that the same medical technologies are assessed several times leading to different results. To avoid duplication and unequal scientific approaches, the European Union is discussing a regulation proposal on Health Technology Assessment, to strengthen cooperation and ultimately increase the quality and transparency of the results for patients.

The discussions are of outmost importance, as healthcare is not a competence of the EU and Member States are reluctant to submit their health evaluations through other process that might not be theirs only, but shared, even if they do exactly that when it comes to medicines, at the European Medicines Agency.

While the Council of the European Union is currently negotiating and amending the European Commission proposal for a regulation on Health Technology Assessment and the European Parliament resolution driven by the Environment and Health Committee, the European Commission advances building a framework through the EU-funded project EUnetHTA, a project by the EU member states.

The annual meeting of the Stakeholder pool touched upon recurrent issues such as how to define conflict of interest, and how to involve two divisions on Health Technology Assessment: patient and their representatives, and payers and insurances.

The involvement of patients was particularly discussed, in view of the low results obtained to date. EUnetHTA reported having many kind of difficulties reaching out to patients, and very few had been participating ad-hoc to the processes that have been organised to date.

During the meeting, patient representatives called for a more systematic involvement into the joint assessments, as well as for solutions to make patients become actively participating decision-makers.

Under the current scheme, there are many obstacles to involve patients. Some are bureaucratic: how conflict of interest is defined and proofed, with some forms that are far from the reality of ordinary patients and can be eliminatory for patient advocates, unless the participation is supported or channelled through patient organisations. Other are operational: limited detail on the Health Technology Assessment call needing patients makes it difficult to actually find the right patients, language barriers when different patient nationalities are mixed, or even lack of satisfaction evaluation for patients involved in the process.

The existence of different procedures of patients’ involvement among Member States illustrates the need for the development of standard criteria also at European level. To upgrade the patients’ role within the legislative process, the need for training was also discussed as an important factor, all requirements that are in successful longstanding implementation at the European Medicines Agency level. It was pointed out that there is risk of only limiting Health Technology Assessment participation to those trained, which are a minority, and suggested to also improve the details of the assessment call to know in advance if they need and individual patient, patient representing their community or patient representing their organization. For that, communication materials and simplified selection processes, that address the volunteer nature of patients, need to be agreed.

In the concluding comments, the Commission representative underlined the importance of meetings that foster dialogue among stakeholders on Health Technology Assessment, expressing the hope that there will be more such occasions in the future.