Last week, the Council of Europe gave the green light to a new, harmonised regulation on health technology assessments* across EU member states that will ultimately simplify submission procedures for health technology companies and improve access to medicines and medical devices.
In short, health technology assessment refers to the systematic evaluation of properties, effects and/or impacts of health technology. It is an evidence-based, multidisciplinary process to evaluate the social, economic, organisational and ethical issues of a health intervention or health technology. The main purpose of conducting an assessment is to inform policy decision-making, so that national health bodies can make an informed decision on, for example, the pricing and reimbursement of healthcare technologies.
This new EU regulation will enable joint clinical assessments and joint scientific consultations on health technologies between EU member states and allow for more rapid assessments of healthcare technologies. The regulation still needs to be adopted by the European Parliament, but once it passes this final stage the implications for healthcare technology companies, in particular for startups and smaller SMEs, will be significant. Regulating and harmonising healthcare technology assessment across EU member states will boost the identification and adoption of safe and effective healthcare technologies by patients, healthcare systems and healthcare professionals. In practice, this new legislation should mean more healthcare options for patients and better access to health and care services – a massive win, especially in times of a public health crisis like the COVID-19 pandemic.
The massive administrative burden that currently falls on healthcare technology innovators to submit information, data and other evidence required for the clinical assessment by national healthcare bodies will be significantly reduced by moving the health technology assessment from a national level to the EU level as a joint effort between EU member states. Key information will be shared across member states to national health authorities. This essentially means that only one healthcare technology assessment submission at EU level is needed for a specific product from a healthcare technology company. Not only will this lead to significant cost savings for healthcare technology innovators, but also improve overall productivity by reducing work duplication.
So how will this new regulation work in practice? When health technology assessment bodies across the EU evaluate a new health technology, they will now do it together in order to evaluate whether this technology works better, equally well, or worse than the existing offering. In order to do this assessment, they would need to investigate whether, for example, the therapeutic effect of a drug would impact quality of life, how it is administered and how it would impact the overall care pathway. In addition, the health technology assessment bodies also evaluate health economic aspects related to using the technology with patients as part of a healthcare system. As you can imagine, this entire process is very complex, time-consuming and requires multidisciplinary input throughout the submission process. That is where this new legislation will be groundbreaking – it will enable joint health technology assessments and scientific consultations to take place for the first time on an EU level, rather than a national level, meaning more experts are available for the assessments and consultations. This increase in knowledge capacity will lead to faster outputs of joint health technology assessments for innovators across the EU, resulting in a more rapid introduction of health technology tools in EU healthcare systems and thus improved patient access to medicines and medical devices.
EU regulators just took a major step forward towards the harmonisation of health technology assessments across EU member states with positive implications for healthcare technology innovators and the general public in need of safe and effective health and care services. As we saw throughout the pandemic, collaboration between healthcare regulators, policy makers and healthcare technology innovators across regions is the only way forward towards an accessible, effective and equitable healthcare system.
* Council green lights new rules on health technology assessment, improving access to medicines and simplifying procedures, Press release – 9 November 2021 https://www.consilium.europa.eu/en/press/press-releases/2021/11/09/council-green-lights-new-rules-on-health-technology-assessment-improving-access-to-medicines-and-simplifying-procedures/#