28.02.2018 | Brussels Background Health Technology Assessment at European Level - One man’s joy, another man’s sorrow

More cooperation between the Member States when it comes to Health Technology Assessment (HTA) has long been part of the European Union (EU) policy agenda. A topic that is more present than ever now that the Commission has published its proposal for a new HTA regulation at the end of January. The aim of the proposal: Joint clinical assessments at EU level. Sounds good? – Well, not for everyone.

But let’s first clarify what HTA actually is and why it so important for everyone involved. HTA describes the systematic evaluation of effects, properties and impacts of health technologies. It is an evidence-based method, which assesses a health technology, i.e. medicines and compares it to other technologies or current standards. During the process of HTA economic, organisational and social issues of the health technology or intervention are evaluated. The outcomes of the assessment do often serve as a basis for informed policy decision making and price negotiations. Currently, there are more than 50 different regional and national HTA authorities in the EU, which are operating independently from one another. This diversity leads to enormous differences between the countries resulting in fragmentation and also duplications of work, which does also affect the EU internal Market. The removal of such barriers to the free trade of goods (Article 26 TFEU) is also the legal basis for the proposal in contrast to the protection of public health  (Article 168 TFEU) as one might think. The EU already tried to take action for many years. Part of this action was the Directive 2011/24/EU on cross-border healthcare, which has not been as fruitful as hoped. In addition, the EU has been funding joint actions, HTA networks and the EUnetHTA  project for many years now, with limited success and only slight alignment on methodological issues. As funding for these initiatives will run dry in 2020, the Commission proposed a way to secure cooperation on HTA beyond 2020 with a legislative proposal, which has not been well received by everyone. Especially the EU-5 do not welcome the proposal at all. 
In brief, the proposal is based on four principles, being joint clinical assessment, joint scientific consultations, horizon scanning, and elements of voluntary cooperation. At the core of the proposal stands the mandatory uptake of clinical assessments by Member States, which effectively deprives Member States from their competence to assess the added value of medicines for their specific country. In Germany e.g. the German Federal Joint Committee (Gemeinsamer Bundesausschuss [G-BA]) fears that a mandatory harmonisation at EU level would destroy Member States’ procedures and would transfer the control of medicine supply to the EU level. A similar statement was made by one of Germany’s largest statutory insurers, the AOK Federal Association. In their opinion, the HTA proposal does intervene with national competences and might lead to lower standards in the HTA process when compared with the current procedure. France also expressed concerns and wants to take an active part in the negotiations from the very beginning. Smaller Member States actively welcome the approach of the European Commission as a European process means shared burden and shared expertise. Especially interesting for those who are lacking formal HTA-processes. 
The pharmaceutical sector has welcomed the planned HTA proposal. It would bring more predictability, consistency and a reduction of duplication, which of course is in the industry’s favour. Interestingly enough, for once the pharma and public health stakeholder’s opinions are in line, as the public health advocates like the idea of a shared cooperation on HTA as well. In their opinion this would be an effective tool for the reduction of inequalities and disparities in access within the EU. 
However, what shall be the price for a reduction of duplication of work? Not everyone in the pharmaceutical sector will be happy with this proposal.  Not all companies are aiming for a centralised authorisation – which would lead to the mandatory European HTA process - especially not for niche products. Big Pharma might have a different approach than smaller or Mid-Cap pharmaceutical companies. Bigger companies can compensate a bad HTA appraisal with a huge portfolio whereas smaller companies cannot. 
In addition the proposal foresees voluntary cooperation on issues that go beyond a pure clinical assessment e.g. cost-benefit analysis, which are even at national level highly sensible. BeNeLuxA and other projects have been heavily criticised by the industry. The proposal would give such cooperation an institutional framework. Thinking ahead you might wonder, whether the proposal indicates a trend towards a further-reaching harmonisation of health policies at European level? And where would a further harmonisation of health systems bring us? Are the countries willing to continuously give up their mandate to health as well as national systems and values? Well, that we cannot answer but we will see what the future brings.