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The European Commission has issued a legislative proposal to the European Council and European Parliament on further integration of health technology assessment (HTA) in the EU.

The legislative proposal focuses on the process of HTA, outlining clauses for greater cooperation at a European level on horizon-scanning for new medicines and medical technologies; joint scientific consultations with pharmaceutical industry in the lead up to HTA and on joint clinical assessments for innovative medicines.

If implemented, these proposals would increase cooperation on the more scientific and advisory elements of HTA. However, the legislative proposals would not impact on national considerations in medicines assessment (e.g. societal factors and value judgements) or national reimbursement and pricing decisions, as these are powers reserved to Member States.

The legislative proposal will now be taken forward to the European Parliament for consideration. You can see further information on the proposals here.

What is health technology assessment (HTA)?

HTA is a technical process which assesses the clinical and cost-effectiveness of new medicines and can be used to assess their benefit compared to medicines that are already used in clinical practice. Bortezomib (Velcade®) and lenalidomide (Revlimid®) in myeloma have both been assessed through national processes of HTA.

Across Europe there are national HTA bodies which perform this function (although not every country has one). An example of an HTA body is the National Institute for Health and Care Excellence (NICE) in England and Haute Autorité de Santé (HAS) in France.

HTA is becoming a process which EU member states are increasingly keen to have in place. This is because performing HTA can help health systems decide how to allocate their funding on the most valuable medicines and medical technologies.

What do the proposals mean?

If the proposals are taken forward, they will ensure greater collaboration in coming years on the more scientific elements of HTA. The legislative proposals stop short of recommending that full HTA should take place at a European level (e.g. taking account of additional factors such as economic/social considerations).

The most important announcements are on the joint scientific consultation and clinical assessments.

  • Joint scientific consultation will mean that national HTA bodies and other stakeholders will collaborate to engage with the pharmaceutical industry in the lead up to HTA. They will jointly provide advice to companies on the types of information required to bring a new medicine to market, which can help to ensure that companies make the best possible case for their medicine to decision-makers.
  • Joint clinical assessment will mean that there will be collaboration on performing an assessment of the scientific evidence submitted by a company (e.g. the clinical trial information) on the most innovative medicines. This will then feed into the national HTA bodies full process for consideration alongside other factors such as economic and social factors.

The proposals will not replace the role of the national HTA bodies in conducting full HTA of new medicines. They will also not replace the authority of member states in making decisions on the reimbursement or pricing of medicines.

The central aim of the legislative proposal is to ensure greater consistency in decision-making and HTA processes and to ensure predictability for pharmaceutical companies bringing new medicines to market.

Why has the European Commission taken this action?

The European Commission in 2016 launched an initiative to strengthen EU cooperation on HTA. The aim was to ensure the sustainability of EU cooperation on HTA beyond the third joint action of EUnetHTA which ends in 2020  (see question below for further information on EUnetHTA). In addition, they wanted to address an identified gap between EU joint action on HTA and implementation at a national level.

As part of the initiative, they consulted widely to gather feedback on HTA in Europe and how it should be taken forward. It also proposed different options on how further cooperation might look after 2020 – ranging from maintaining the status quo through to implementing full HTA at the European level. The legislative proposal is a result of this European Commission work and takes account of a wide-range of stakeholder opinion. You can see the full details of the consultation here.

How does the EU currently collaborate on health technology assessment?

There are a range of different policies and initiatives at the EU level that address the issue of HTA, with a central focus on coordinating and harmonising efforts across Member States.

The main work programme is through EUnetHTA, a network of over 70 institutions interested in HTA (including national HTA bodies), established to build a platform for collaboration and information-sharing on health technology across Europe. You can visit the website here.

The work programme of EUnetHTA is set out through Joint Actions. The current Joint Action 3 runs from 2016 and will end in 2020 (the total budget for this is 20 million euros). The primary objective is scientific and technical cooperation, such as developing common methodologies and piloting joint scientific assessments. There is currently no definitive plan in place to take this work forward after 2020, which is why the European Commission is issuing a legislative proposal to secure the longer-term cooperation on this issue.

Where can I find further information?

You can see the European Commission press release and Q&A here.

If you have any questions or comments on the legislative proposals, please email morgan@mpeurope.org



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