EFPIA statement on the establishment of the HTA Coordination Group
22.06.22
EFPIA welcomes the formal establishment of the HTA Coordination Group, as foreseen by the EU HTA Regulation, representing an important first step in the implementation of the future system of joint clinical assessments and joint scientific consultations starting in 2025.
The EU HTA Regulation represents a significant milestone for the European Health Union, in fact, a revolution in the way of working of Member States, by jointly and systematically assessing clinical evidence, reducing fragmentation and duplication. It will allow Europe to remain a relevant voice globally in the development of innovative medicines addressing medical needs.
Europe has a unique opportunity to enact real step change in how it can attract and bring innovation to patients: through the revision of the pharmaceutical legislation, the introduction of a European health data space and concrete initiatives to strengthen investment in Europe. We are seeing for the first time the beginning of a full value chain approach. HTA plays an important role in this continuum; it cannot become a bottleneck for access.
In this respect, EFPIA believes that the following principles should guide the work of the Coordination Group, also leveraging the previous experience of EUnetHTA Joint Actions. Successful future joint clinical assessments require, inter alia:
- a predictable EU framework for Joint Clinical Assessments (JCA) that ensures that EU HTA represents more than the amalgamation of today’s heavily fragmented clinical HTA activity in the Member States and that is workable for both, for companies and assessors during the very limited time available
- a shared European methodological framework that can reflect the specifics to the context of disease/indication and unmet medical needs, as well as evolving medicine development and regulatory pathways
- a purposeful EU HTA interface with EMA that is mindful of the different roles of HTA and regulatory marketing authorization process in order to ensure that the results of the EMA assessments can be reflected in the JCA, without repeating it or calling it into question
- a balanced conflict of interest framework to ensure that EU HTA deliverables can leverage the unique expertise and knowledge of patients, clinicians
- the recognition of the health technology developer as a key contributor throughout the JCA process including the scoping phase
- sufficient capacity to provide joint scientific consultations (JSC) to all technology developers that seek advice from regulators and HTA agencies and to deliver timely joint clinical assessments
Beyond the critical work to be done at European level, the Coordination Group should also act as a catalyst for national implementation. National processes need to create the conditions so that Joint Clinical Assessment can effectively be used in decision making. It is essential that Member States remove inefficient duplicative parallel processes and limit time consuming complementary clinical assessment activities. Members of the EU Coordination Group should be at the forefront of national implementation efforts.
On the occasion, Nathalie Moll, EFPIA’s Director General, mentioned that “the HTA Regulation is one of the first outputs of the EU Pharmaceutical Strategy with the declared objectives to foster patient access to innovative medicines and to support competitiveness and innovative capacities of the European healthcare sector. The implementation of the Regulation, leading towards an efficient and workable system, is a shared responsibility of Member States, the European Commission, HTA agencies and stakeholders, including patient representatives and industry. EFPIA stands ready to play its part towards the achievement of these objectives”.