We are living in an exciting era for innovation in health. Precision medicines and cutting-edge medical diagnostics and devices have the potential to revolutionise our healthcare, offering effective solutions for patients, including those with unmet needs.
Independent, transparent and effective evaluation of new health technologies, known as health technology assessment (HTA), helps policymakers separate truly useful innovative technologies from ones that simply look good on paper or are showcased at trade fairs.
The Commission’s proposal on sustainable EU cooperation on HTA, adopted on 31 January 2018, is a triple win - for patients, national authorities and industry. EU cooperation on HTA provides enormous potential value for patients.
As the proposal helps to support and uphold true innovation, more HTA could result in patients benefitting from innovative products and interventions, for example precision medicines, innovative tests that detect viral infections and other medical advances we have heard or read about recently.
The proposal offers greater transparency on therapeutic added value and will also bring real innovation to patients faster through a transparent, high quality and timely process in all EU member states. It will help healthcare systems make the right choices, which will make an enormous difference, sometimes between life and death.
On tabling this proposal, the Commission has set out a framework for joint clinical assessments in two areas: for new medicines and for certain new medical devices including in-vitro diagnostics.
Such joint assessments will focus on the clinical benefits these new technologies offer, compared to existing health technologies.
Based on the results, member states - which are responsible for the uptake of these technologies in national healthcare systems as well as pricing and reimbursement - can decide on the added value in their national context.
The extent to which patients will benefit from accelerated uptake of promising innovative technologies will depend on decisions taken by national policymakers.
However, with Pharmaceutical spending accounting for €220bn and medical devices for €110bn - collectively just over 25 per cent of the EU’s annual health care spending - national authorities have a clear interest in taking heed of assessments that will deliver cost-savings and better patient outcomes.
Cost-effective innovation can also mean more effective and sustainable health delivery for member states, which who spend an average of 10 per cent of their GDP on healthcare.
The aim is to be able to use common HTA tools, methodologies and procedures across the EU, working together on joint clinical assessments, joint scientific consultations, identification of emerging health technologies - ‘horizon-scanning’ - as well as continuing voluntary cooperation in areas outside the scope of the proposal. This joint work will be carried out by a member state coordination group on HTA composed of representatives from national authorities.
By working together at EU level member states will not duplicate their efforts, allowing them to pool expertise and make better use of their resources.
Our proposal takes account of the specific characteristics of the pharmaceutical and medical device sectors. It entails a phase-in approach (three years between entry into force and becoming applicable in member states, plus a further three-year transition period) to give national authorities and industry adequate time to adapt to the new procedures.
Additionally, joint clinical assessments for HTA should foster synergies with regulatory bodies while maintaining separation between different remits and processes. HTA does not add any unnecessary administrative burden for companies. Rather, it offers a number of benefits to industry, including SMEs, such as cost savings, clearer rules and greater predictability for their business planning.
The Commission’s proposal for sustainable EU cooperation on HTA follows more than 20 years of voluntary cooperation in this area, including a voluntary EU-wide network and three consecutive joint actions, which between them provided both strategic and political guidance and a solid knowledge base on methodologies and information exchange.
This next step, of strengthening EU cooperation in this area, is overdue. It is supported by 87 per cent of those that took part in the public consultation.
The proposal is now in the hands of the European Parliament and Council and I urge them to engage constructively to see this important regulation adopted by 2019.