New Law to Boost EU-level Cooperation on Health Tech Assessments

Regulatory NewsRegulatory News
| 15 October 2018 | By Ana Mulero 

In a boost for health technology assessments (HTA), the European Parliament recently adopted a new law that allows for greater cooperation among EU member states.
The law on HTAs specifically seeks to minimize duplicate assessments on new medicines and medical devices with the goal of removing unnecessary barriers to patient access and reducing administrative burden on industry. Following its 3 October adoption, the law was well-received by MedTech Europe as it “builds the foundation for further negotiations with the [EU] Council.”
The move is further intended to aid health care professionals and patients in decision-making processes on new medicines or medical devices. This is because HTA can help identify the added value by making comparisons of existing products, the European Parliament said on the new law, pointing to “rules for sharing data, setting up coordination groups, avoiding conflicts of interest among experts and publishing the results of the joint work” as areas provisions cover.
“At the moment each member state does its own assessment of each new medicine or medical device to assess if it's better than existing products,” said Soledad Cabezón Ruiz, the European Parliament member leading the HTA plans. “Not only is this inefficient and duplicates efforts, it also means opportunities to improve the quality of healthcare technology are being missed.”
MedTech Europe touted certain considerations applied to make the proposal submitted by the European Commission (EC) earlier this year “more relevant and appropriate for medical technologies,” especially in light of the EU medical device and in vitro diagnostics regulations.
There are three “key areas must be well addressed” for the increased collaboration in the HTA space to serve its intended purposes, the trade association argued. These areas relate to the defined scope of technologies that will undergo HTAs, the distinction between CE marking and HTA and the introduction of a transition period for the participation of EU member states.
On the distinction between CE marking and HTA, the trade association further argued that the European Parliament has “rightly introduced the appropriate point in time” to assess medical devices after the entry of a new product into the EU market. “The appropriate time point shall be identified in cooperation with relevant stakeholders,” according to the adopted law. HTAs rely more on the use of real world evidence from data registries compared to CE marking.
Under the adopted law, a new regulation must be drafted in the upcoming months by national HTA authorities designed by member states to define the methodologies and the content that will be used to ensure consistency in conducting joint clinical assessments and consultations.
The vast majority of respondents (87%) to a 2017 EC questionnaire showed support for continued HTA cooperation at the EU level post-2020, which is when the last joint action in the space was set to expire with a budget of EUR 20 million (US $23.15 million).


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