‘This new law is a good step towards improving European citizens' access to medicine and health technologies. It will improve the quality of health technologies, inform research priorities and eliminate unnecessary duplication. Also, it has the potential to make the health system more sustainable.’ (MEP Soledad Cabezón Ruiz, S&D.)
In an unusually short time, by Brussels’ standards, the European Parliament has voted on the proposal for a regulation on the European Health Technology Assessment (HTA). Just nine months after the European Commission published its proposal for deeper cooperation between the EU Member States when assessing medicines and medical devices, MEPs have agreed on numerous changes.
Clear majority in the European Parliament
By a clear majority (576 yes: 56 no: 41 abstentions), the plenary of the European Parliament adopted the report by Spanish MEP Soledad Cabezón Ruiz (S&D) on 3 October 2018. ‘We want a European regulation on Health Technologies Assessment (HTA), which allows member states to make the most reasonable choices for the patients and for the public budget, instead of letting commercial interests prevail,’ said the rapporteur.
Dr Peter Liese (EPP) was also satisfied with the agreement. He stressed that it is no longer fitting to have at least 28 procedures in 28 Member States following centralised approval by the European Medicines Agency (EMA) for evidence of added value. Therefore, the scientific work should be done jointly at European level to promote faster access to medicines. However, the rules regarding pricing and reimbursement should continue to be set at national level.
GKV-Spitzenverband welcomes the strengthening of national HTA organisations
The European Parliament’s recommendations take up some of the concerns of the Member States and the GKV-Spitzenverband (National Association of Health Insurance Funds), opening the way to a possible compromise.
For example, the European Parliament has strengthened the role of national HTA organisations by specifying that they should stipulate the methods and processes for the joint assessment in their own coordination group. The GKV-Spitzenverband also welcomes the fact that the amendments proposed by the Parliament make a clear commitment to evidence-based medicine and distinguishing between ‘Assessment’ and ‘Appraisal’ (part of the draft regulation). The latter should and must be reserved for the Member States.
Changes to the majorities required for contentious issues, such as the scientific reports, are also welcome from the perspective of the GKV-Spitzenverband. Whereas the European Commission has proposed a simple majority (one country, one vote), the European Parliament has called for a qualified majority. This means that at least 55% of the Member States must agree to a proposal for a resolution, with each country having one vote. Furthermore, the consenting Member States must represent a total of at least 65% of the EU population.
Nevertheless, the GKV-Spitzenverband refers back to its comments on the proposed regulation and its suggestions to the European Parliament for amendments. The points made by the GKV-Spitzenverband, particularly the possibility of divergent assessments at national level and the need for methodological clarity and transparency of the procedure, are still considered essential if the European HTA is to be a high quality process that takes due account of national processes.
The GKV-Spitzenverband is also critical of the reduction in the number of medical devices eligible for HTA evaluation as compared with the Commission’s proposal. This does not do justice to these products and their importance to healthcare. Soledad Ruiz sees it similarly: ‘In fact, it is in the field of medical devices where more scientific evidence is needed to take decisions. It is an emerging market but it is still very fragmented, so a European evaluation will definitely be an added value.’
Whether or not the legislative proposal can be finalised before the end of the legislative period depends largely on how quickly agreement can be reached in terms of a joint position from the Council before the trialogues between the Council, the European Parliament and the Commission can be started. Presently, however, it is not possible to predict when the Council will be ‘ready to agree’.
The larger and smaller Member States are at odds over fundamentally crucial political provisions, such as the question of the binding nature of a Europe-wide benefit assessment. This makes it difficult to continue with discussions on technical coordination rules, because detailed issues cannot be started before the main debates over competences and the regulatory ideas of both the Commission and the Member States have reached common ground.
The Austrian Presidency intends to submit a progress report by the end of its term of office in December 2018. Romania takes over the EU Presidency on 1 January 2019, but will only have a few months to negotiate prior to the European elections being held from 23 to 26 May 2019. Subsequently, Finland (2nd half of 2019) and Croatia (1st half of 2020) will take over the EU Presidency, before the German Council Presidency starts in the second half of 2020.
Further information is available on the European Parliament website.