Sandra Gallina, Director General at Directorate-General Sante (DG SANTE) European Commission, tells us how the Health Technology Assessment bridges the gaps to build a strong European Health Union
Health technology, such as medicines and medical devices, is fast evolving. This calls us to keep up with this trend in order to fully take advantage of the opportunities it affords in improving public health, delivering better patient care and benefiting society as a whole.
As Europe’s population ages, healthcare costs are likely to increase in the coming years. This will bring more chronic diseases, along with complex and expensive new technologies. At the same time, European countries face mounting budgetary constraints, which heightens the need to make their healthcare systems all the more efficient to adequately care for patients.
To address such challenges, health technology assessment (HTA) has become an ever-more important tool used by national authorities for sound evidence- based decision making, for stimulating innovation and for maintaining sustainable healthcare systems.
HTA independently and objectively assesses how new or existing technology benefits health systems compared to other existing ones. Whilst clinical assessments performed by national or regional HTA bodies are often based on global evidence, full HTA assessments delve deeper, take in the whole picture by including economic, ethical, social and organisational factors, making them far more relevant to those that need them.
More than a decade of EU cooperation on HTA under the EUnetHTA Joint Actions has shown how it has paid off.
The Regulation on HTA focuses on the clinical aspects, allowing Member States to pool their resources and expertise and carry out one clinical assessment at the EU level, instead of 27 individual ones. This will enable all Member States to access high quality and timely clinical assessments to inform and support their decisions.
Other non-clinical aspects like economic, ethical and social, as well as country-specific clinical elements such as data on national disease epidemiology, will continue to be addressed by each country, followed by appropriate national decisions on pricing and reimbursement.
Industry will also become even more efficient when submitting clinical evidence for HTA, as it will only need to go through a single EU-level process.
More importantly, patients and clinicians will be better informed by having access to quality and transparent Joint Clinical Assessment reports. They will also have their say by providing their view about living with a certain disease, expressing their needs and expectations from a new treatment. Health stakeholders will also benefit from a platform to have their say and provide input on guidance documents and other relevant joint activities.
After four years of negotiations, the Regulation on HTA entered into force in January 2022 marking an important step as the first deliverable of the Pharmaceutical Strategy. The Regulation will become applicable in January 2025 when the first joint clinical assessments on cancer medicines and advanced therapies will start.
The COVID-19 pandemic has shown the precious gift that is our health and the strength of European cooperation. In response to the crisis, the Joint Action EUnetHTA 3 developed a series of COVID-19-related actions such as collaborative reviews, monitoring of ongoing clinical trials of potential COVID-19 treatments (e.g. antivirals and monoclonal antibodies).
Such contributions showed that HTA can help bridge the gaps existing in public health systems and contribute to the building of a strong European Health Union.
“Health technology, such as medicines and medical devices, is fast evolving. This calls us to keep up with this trend in order to fully take advantage of the opportunities it affords in improving public health, delivering better patient care and benefiting society as a whole.”
Once all the ‘t’s have been crossed and the ‘i’s dotted, will we avail of the full and wide benefits that the Regulation will bring, helping clinicians, technology developers and HTA authorities, and ultimately people across the EU since each citizen has a right to benefit from the most valuable advances in health technology.