Are we one step closer to an EU Health Technology Assessment body?
The EESC publish its positive opinion.
After the first trilogue discussion with the European Parliament, the European Economic and Social Committee (EESC) has published their opinion on the Amended proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU, a legal initiative aimed to set the basis for a streamlined and harmonised joint HTA in the EU. The EESC opinion has been mostly positive, stating that this initiative will effectively address the access barriers generated by the fragmented HTA landscape across Europe. However, some major limitations that could bring even more administrative burden to the industry have not been mentioned by the EESC.
Background
As one of the measures to improve access to medicines across Europe, the European Commission adopted the proposal for EU HTA regulation in 2018, aiming to strengthen Member States’ cooperation on the assessment of health technologies. The main driver of the initiative has been the low business predictability and increased cost to the industry generated by the high level of variability of national HTA procedures, methodologies, and evidence requirements for health technologies in Europe. Consequently, the fragmented HTA landscape in Europe has been acknowledged to be one of the factors responsible for delayed patient access to innovative treatments.
The regulation proposal covers both new medicines and medical devices and, as shown in the figure below, focuses on jointly assessing the clinical aspects of HTA, such as:
- Description of the health problem addressed by the health technology
- Treatment alternatives or “comparators” available
- Description and technical characterisation of the health technology
- Relative clinical effectiveness and safety of the health technology
This way, clinical assessments should be submitted only once at Union level and Member States should take account of the EU HTA results and not duplicate them at national level. Non-clinical aspects of the HTA as well as price and funding will then be independently assessed by the EU Member States to make their final pricing and reimbursement decisions.
Other areas of joint work covered by this initiative include early joint scientific consultations, joint horizon scanning, and continuing voluntary cooperation on other aspects of HTA.
EESC conclusions and recommendations
The EESC has supported the European Commission’s decision of using a regulation for stablishing the joint-HTA process, as a regulation will ensure more direct and more effective cooperation between EU Member States. The EESC agrees with the initiative of submitting one dossier and consider this option to be cost-efficient, as the costs are significantly outweighed by savings for the Member States and industry, because of pooling resources, avoiding duplication, and improving business predictability.
One relevant aspect suggested by the EESC is to include a common EU pricing policy into the joint assessment. Although Member States will continue to be responsible for assessing non-clinical domains of health technology (e.g. economic, social or ethical) and for making decisions about pricing and reimbursement, having a EU-level pricing analysis as reference would improve transparency and access to new therapies according to the EESC. This is highly controversial as price and funding has always been the remit of the member states
The EESC has pointed out only a few limitations to the regulation proposal, the major being:
- The lack of special provisions for SME’s, which have limited resources and capacity for HTA
- The long 6-year transition period for its full implementation, which according to the EESC could be shortened
Discussion
With a positive EESC recommendation, the EU joint clinical assessment is one step closer to become a reality. However, in contrast to EESC opinion, major European industry representatives such as the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) have expressed a more critical view on the proposed regulation. Their main concern being that, as current regulation is written, there is a lack of binding effect on Member States. The regulation allows Member states to freely draw their own conclusions on the clinical value and use the parts of the reports they consider relevant. Moreover, additional clinical evidence could be asked by Member States, decreasing predictability for health technology developers. Consequently, this new regulation could result in duplication of work and pose an even higher administrative burden, especially for SME’s, that lack the resources to face both the uncertainty and the additional workload that the process might bring. This could lead to additional patient access hurdles and delays, the exact opposite outcome of what the regulation is intended.
The long-term vision is that in the future the EU HTA body can become a global success story, similar to the European regulatory system which has led to the EMA becoming a world-leading agency. However, it will be vital for Member States to further compromise and provide binding effects to the EU level joint clinical assessment. The industry should continue to closely follow this legislative process and raise awareness of the inefficiencies that could be generated and could jeopardise the availability of innovative treatments for European citizens.
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