The European Parliament voted Wednesday in favor of changes to legislation on health technology assessments (HTAs) that remedy some of the medical device industry’s concerns with the original draft.
If passed, the law will mandate joint, European Union-wide clinical assessments of certain medical devices to inform national-level pricing and reimbursement decisions.
In proposing amendments to the text, the Parliament zeroed in on the need to consider the right time to assess devices and sought to restrict the type of technologies that will undergo evaluation.
HTA bodies are another barrier to market access in Europe. Once a product has proven its safety, efficacy and quality, it may need to go through an evaluation of its value compared to existing health interventions before being granted full access to markets. HTAs happen on a national level, meaning companies need to undergo multiple slightly different evaluations to access all key EU markets.
Critics of the current HTA model think it results in the duplication of work and delays the availability of important products. In response to these criticisms, the European Commission proposed running joint clinical assessments and otherwise centralizing core components of the HTA process.
The Parliament has spent 2018 drafting amendments to the proposal the Commission put forward at the start of the year. This week, the Parliament voted in favor of the amendments.
As trade body MedTech Europe noted in a statement, the Parliament’s amendments include changes that will affect the medical device industry. Notably, the Parliament has refined the definition of the types of medical devices and in-vitro diagnostics (IVDs) that may need to undergo joint assessment. The new text states these products must be "a significant innovation and with potential significant impact on public health or health care systems" to be covered by the joint assessment requirement.
The change was one of several amendments welcomed by MedTech Europe. The trade group also praised the addition of a new subsection on the timing of medical device assessments. If featured in the final text, the subsection will ensure assessments "take place at the appropriate point in time after market launch, allowing for the use of clinical effectiveness data, including real-world data."
Having cleared the Parliament, the amended draft legislation will now pass to the European Council for further debate. MedTech Europe wants the Council to defer the phasing in of the HTA legislation until after the new regulations on devices and IVDs "are fully implemented and operational."