Health tech legislation from EU
The European Commission launched a new Health Technology Assessment (HTA) on January 31st 2018 intended to foster pan-EU collaboration on new medical devices and medicines. The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) published their (2017-2020) Joint Action 3 plan.
The three year plan will outline pan-EU collaboration on new medical devices and medicines. The two organisations had successfully implemented collaborative goals in previous work plans for the years (2010-2012) and (2012-2015).
The EUnetHTA is a network of technological and medical organisations. The commission has allocated members with certain tasks. The focus is on competitiveness in the medical industry and catalysing innovation throughout the region. Through close cooperation the commission seeks to foster early identification, adoption and efficiency of emerging health technologies.
Alleviating market access hurdles, by pushing national authorities to legislate accordingly, will bring relief to beleaguered investors and healthcare entrepreneurs. Finally allowing for faster and broader access to information and technologies benefits patients in making their health care decisions. Professor Guido Rasi EMA’s Executive director predicts that, “By working together the, EMA and EUnetHTA help medicine developers to improve clinical research and become more efficient in generating the evidence each of us needs for good decision-making.”
An example of this new collaboration is the report on midostaurin by Ryadapt. A chemotherapy medication studied and reported on by the Finnish Medicine Agency and co-authored by Norwegian Medicine Agency. This type of cross border cooperation is arranged and promoted by the plan and has at its disposal an array of similar tools. Developers and manufacturers of health technology will benefit from such cooperation between member states.
The legislation aims to alleviate the pressures arising from an ageing population and the increase of certain chronic diseases across the EU such as diabetes, cancer and dementia. In addition healthcare accounts for approximately 10% of the EU’s GDP giving the member states a strong economic incentive where such activity is present. Germany is one of a small group of countries which strongly opposes the EU wide HTA. However spokesperson Anca Paduraru reassured the concerned member states “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”.