The Commission’s upcoming proposal on Health Technology Assessment (HTA) will focus on clinical aspects and leave member states to decide on economic or ethical issues, a European Commission spokesperson told EURACTIV.com.
The Health Technology Assessment (HTA) measures the added value of a new health technology (i.e. medicinal products, medical equipment, diagnostic and treatment methods) compared to existing ones.
Through this mechanism, the Commission intends to enhance coordination among the member states in measuring the value of innovative drugs or medical devices.
A legislative proposal on strengthening the EU cooperation on HTA is scheduled to be adopted by Commissioners on 31 January.
Spokesperson Anca Paduraru said that it notably aimed at addressing the issue of having multiple national assessments for the same products with sometimes different results for patients and industry.
An ageing population and a parallel rise in chronic diseases, combined with a rapid increase in innovative medicines, medical devices and cutting-edge diagnostic tools have put extreme pressure on healthcare systems.
HTA is a multidisciplinary process to assess the added value and effectiveness of a given health technology – for example medicine, medical devices, diagnostic tools or surgical procedures, over and above existing ones.
The Commission hopes that it will be used by member states as a tool to ensure cost-effective, accessible and sustainable health systems.
Many of the products and therapies are extremely costly, and there is often a high price variation among member states while healthcare expenditure already accounts for about 10% of EU gross domestic product (GDP).
“Even if this figure remains stable, national authorities need to ensure that their health systems are sustainable,” Health Commissioner Vytenis Andriukaitis told EURACTIV in an interview.
Countries responsible for cost-effectiveness
Asked which body would lead the HTA, the EU spokesperson noted that the consultation demonstrated that HTA cooperation at EU level should be a process driven by member states.
“This is why member states will be part of the governance structure and will be authoring HTA reports. This way, the joint work will meet the needs of member states,” she emphasised.
Regarding the concerns voiced by several member states about a strong and centralised HTA, which they said would limit their ability to decide, Paduraru pointed out that the proposal would fully respect the mandate given by the EU Treaty, in particular, the principles of proportionality and subsidiarity.
“This means that the proposal will not affect member states’ competences with regard to the organisation and delivery of health services and the allocation of resources assigned to them. Member states will continue to decide what health technology should be reimbursed and to what price,” she added.
She also underlined that the joint work would focus on clinical aspects of health technology assessment and leave member states to decide on economic (“cost-effectiveness”) or ethical parts, which are more country specific.
Bulgarians expect tough negotiations
Commenting on the issue, an official of the Bulgarian EU Presidency told EURACTIV.com that the negotiations on the Commission’s proposal won’t be easy and that Sofia would prefer to focus on quality and in no way rush.
“We have not seen the text yet, but bearing in mind the sensitivities on the topic, we do not expect easy negotiations in the Council. Our focus is on quality of the legislation at EU level rather than on speed,” the official said.
But not all member states see the centralised approach in a positive light.
“We are well aware of the member states concerns regarding the Commission’s proposal on Health Technology Assessment,” the official said.
The scope and competences of an EU HTA have divided the member states. Sources suggest that the countries that already have an HTA prefer a less centralised role while others want a strong mechanism.
As part of the bailout deal, the Greek government decided to create its own HTA mechanism. EURACTIV has been informed that a relevant Greek bill will include a provision saying that the opinion of the EU HTA will not be obligatory.
There is no common line in northern countries either. EURACTIV has learned that Germany strongly opposes an uptake of full HTA reports.
The Netherlands, on the other hand, is known to be more in favour of more EU-wide coordination on pharmaceutical access and pricing compared to Berlin.
In November 2017, they launched the ‘equal access to medicines’ initiative. A Dutch diplomat was quoted earlier as saying “we need to strike the right balance between private interests and innovation and ensuring equal and easy access to fairly priced medicines throughout the EU.”
The EU presidency believes it is essential that the member states have sufficient time at their disposal to analyse the text, which will apparently require coordination between various authorities in each country.