Division on European HTA

There have been aspirations for closer collaboration between European Union (EU) Member States (MS) on Health Technology Assessment (HTA) for at least two decades. In January 2018 the European Commission (EC) put forward it’s most ambitious proposals yet for MS to work together. Leela Barham takes a look at the progress of the Commission’s proposals.

Ambitions for European HTA

The EC has set out a number of ambitions for how a more – but not fully centralised – collaborative approach to HTA could help MS. They have a vision where there will be more HTAs done, for less, making better decisions, making business easier for industry, better informing patients, and ultimately getting patients faster access to new medicines. Such a prize is therefore something that the Commission believes is worth pursuing, despite a plethora of approaches across MS.

A MS co-ordination group on HTA

The EC proposals are for a MS co-ordination group who can collectively work out who does what where, when it comes to HTA in Europe.

The proposals are for joint clinical assessment and joint scientific consultations, as well as a horizon scanning function. Other areas of work within HTA can be done jointly, where MS volunteer to work together on hot topics such as the use of real world evidence (RWE). That also means that the more controversial elements of some countries HTA – value for money– are still for the MS to do, and decide upon.

MS should respect the findings of HTAs done by others in the Union. Eventually MS will have to take into account joint clinical assessments when doing their own work and not duplicate the work: in this way, the intention is that EU HTA will become mandatory for MS.

Industry support

There’s support for the proposals from within the Commission and from industry, with the European Federation of Pharmaceutical Industry Associations (EFPIA) backing the ideas in principle.

MS reactions

The idea of working together on HTA in Europe is by no means new. Differences in opinion over a host of issues with HTA is part of the reason it has taken so long to get to even draft legislation at the European level. Responses to the EC proposals continue the controversy.

The Czech Republic has set out its concerns in a reasoned opinion. A key concern is that the proposals go against subsidiarity. The Czech position highlights the need for reimbursement, economic and social benefits and implications of technologies to potentially remain at the member state level, with voluntary European co-operation.

France has also set out its concerns in a reasoned opinion. Similarly there is a concern about going against subsidiarity.

Poland and Germany too have set out their views in reasoned opinions but they are not – at the time of writing – available in English. Both are also reportedly against the proposals. Germany’s Federal Joint Committee (G-BA) has also sent out a warning shot: they’re concerned about a one-size-fits all approach.

Collectively the Czech Republic, France, Germany and Poland could block the proposals.

Other countries have contributed their views too. Ireland is broadly supportive but emphasizes the need for quality in the work. Poland has raised questions about the legality of the proposal, which given the complexities of European law, is difficult for a lay person to judge. Portugal has also given a view but this is not – at the time of writing – available in English.

Progress of the Regulation

The draft Regulation set out by the Commission is going through the process within the European Parliament. This means that it gets looked at by a number of Committees and changes are suggested.

The Environment, Public Health and Food Safety Committee (ENVI) is the responsible committee within the Commission: essentially the one that will be in charge of the drafting as the Regulation is debated. It laid out a draft report in May 2018, setting out 171 Amendments. In essence there is support from the Committee, but it wants a lot of changes. As it goes through further committees, more Amendments have been tabled, in two further reports of Committee discussions, reaching 404 Amendments in one report, and 598 Amendments in another. Just what will be in the final draft is very much subject to change.

Continuing push for European HTA

The Commission continues to discuss the ambitions for European HTA. The Commission ran a whole day discussion of the proposals on 9 July 2018. In their commitment to transparency, they web streamed the day. Debates included discussion on transparency and affordability of drugs. The latter cannot be dealt with just by working on HTA together at the European level, but it signals just how hot a topic money is when it comes to new drugs and other tech.

The Commission has highlighted how 300 policy makers, healthcare providers, patient representatives and other experts discussed the proposals. They’ve emphasized stakeholder support for stronger EU cooperation on HTA.

Next steps

The legislative process is in early stages within the European Parliament: with a number of steps still to be carried out, particularly a ENVI vote, expected in September. Even with a positive vote, there are still more stages before formal adoption and even then it will be years before the Regulation will be implemented, in whatever shape it finally takes.