Health Technology Assessments (HTAs) are carried out on new medicines or medical devices to decide whether the technology offers advantages over current treatment, and whether it should be reimbursed by health insurers or health systems.
Although pharmaceutical and medical device regulation is largely done at European level, HTAs are carried out nationally. There are currently some 50 HTA bodies in the 26 Member States and Norway.
Some use similar assessment methods, some use different ones. This means that the level and speed of patient access to new medicines and devices varies widely across the EU.
Although there has long been cross-border cooperation such as the HTA Network, at strategic and EUnetHTA technical levels, it has become clear that voluntary cooperation is not ideal and that results are rarely implemented.
In order to face the upcoming challenges posed by new, cutting-edge medical diagnostics and devices, we need a sound and proper legal framework. This will strengthen cooperation among Member States and deliver meaningful results.
Currently, there is no guarantee that new health technologies are assessed according to the same criteria. This means that industry spends too much time and money on time-consuming studies carried out multiple times.
Creating a Europe-wide approach to HTA allows us to minimise fragmented, delayed access to therapies within Member States. Almost two years ago, the European Commission published its proposals for sustainable EU cooperation on HTA.
This addressed the shortcomings of the current model for EU HTA cooperation, which is purely voluntary. This leads to a challenging and distorted market access for health technologies due to the various HTA processes and methodologies across the EU, duplication of work for HTA bodies and industry.
This is unsustainable, particularly given that results are often not used, leading to unnecessarily duplications. The proposal requires a joint clinical assessment to be carried out at EU level by Member State experts, which must be used by Member States in their overall HTA.
It is important to underline that the proposal only covers the clinical aspects of technologies. Other aspects, such as pricing and reimbursement and ethical concerns, remain with the Member States.
“Creating a Europewide approach to HTA allows us to minimise fragmented, delayed access to therapies within Member States”
Progress within the Member States is slow, and there are concerns over the proposal over whether more flexibility is required in the assessment or the if there is a need for stricter balance when forming a majority in the Coordination Group.
The European Parliament listened to those concerns and paved the way to a more inclusive approach on the HTA file by the Member States. Nevertheless, Member States still block the way to progress.
Parliament, under the leadership of the Socialist and Democrats, adopted its first reading position on 14 February 2019. For the MEPs, the goal is to improve the quality and efficiency of healthcare interventions and the sustainability of health systems.
A European HTA procedure will help improve access to medicines and medical devices for patients. In addition, greater cooperation on health will reduce bureaucracy and speed up access to innovative treatments.
However, with every negotiation, there also is the possibility of failure. The Parliament will not agree to simply any compromise.
Member States should know that there are red lines that will not be crossed. A mandatory adoption of the evaluation, for example, is essential to ensure the new Regulation is worthwhile.
Parliament also does not want to see a continuation of a permanently financed, project-based approach led only by Member States.
The overall compromise has to have clear European added value, be legally sound and - most importantly - be workable.
What is certain in the debate is that EU cooperation is needed to ensure a constant exchange of information and knowledge between HTA institutions in Europe, thus increasing synergies between Member States, streamlining HTA methodologies, increasing transparency and evidence-based decision-making, improving predictability for the industry.
Finally, we want cooperation at EU level to be strengthened and the competent authorities supported more efficiently in assessing the real added value for patients with new therapeutic options.
We owe it to our citizens, who need to be confident that the newest medicines or the next-generation hip joint will meet the highest standards everywhere, be it in France, the Netherlands or Spain.
The focus of all institutions has to be on the patient’s wellbeing and, above all, rapid access to high quality medicines. In the interest of European patients, the Council should accelerate their work in order to start the inter-institutional negations.