In July 2016, the Belgian Agency for Medicines and Healthcare Products (“FAMHP”) took steps to establish a National Innovation Office as part of the European Union (“EU”) Innovation Network. The National Innovation Office is currently being established by the FAMHP. It is expected to become functional in the first quarter of 2017.

The National Innovation Office is intended to help accelerate the availability of innovative medicinal products to patients, especially in therapeutic areas where an unmet medical need exists.

Background

The establishment of National Innovation Offices in the EU Member States forms part of the objectives set out and agreed on by the EU Innovation Network. This Network was developed in parallel to the European Medicines Agency (“EMA”) Innovation Taskforce.

The EMA Innovation Taskforce, developed in 2014, provides a forum for early dialogue with applicants. During free-of-charge briefings, developers of innovative medicinal products can discuss their initial research findings with the EMA’s experts and proactively identify any scientific, legal and regulatory issues and opportunities.

The EU Innovation Network, initially developed informally, seeks to achieve the same aims at the level of the National Competent Authorities in the individual EU Member States. It is coordinated by the European Medicines Agency (“EMA”) and the Heads of Medicines Agencies (“HMA”). HMA is composed of the National Competent Authorities of the EU Member States.

The aims of the EU Innovation Network include:

  • the provision of an effective and supportive regulatory framework to patient-focused innovation;
  • the exchange of best practices to establish innovation contacts points/offices in more regulatory agencies; and
  • the consolidation of EU expert views on emerging and challenging topics relevant to innovative therapies and technologies.

Stakeholders’ consultation

In July 2016, the FAMHP consulted small and medium-sized enterprises (“SMEs”), academic research centres and affiliated partners concerning the National Innovation Office project. This consultation was conducted with the intention of fine-tuning the project and aligning the objectives of the National Innovation Office with the current and future needs of SMEs and academia.

The results of this public consultation were presented at a workshop held in Brussels on 1 December 2016. At the workshop, the FAMHP also introduced its draft action plan for implementation of the National Innovation Office in 2017.

The key activities of the National Innovation Office

The National Innovation Office is being established with the intention of serving as an easy and central access point for sponsors of medicinal products who seek regulatory advice in Belgium.

The FAMHP intends to offer a wide range of services through the National Innovation Office. These services will be defined by the FAMHP over the coming years and implemented in several stages. So far, the FAMHP has determined that the key activities of the National Innovation Office will include:

  • the provision of national scientific and/or technical regulatory advice;
  • the provision of support to SMEs and academia that are involved in the research and development of new innovative medicinal products and medical therapies; and
  • the provision of pre-submission guidance and early-phase regulatory advice to sponsors of medicinal products.

The National Innovation Office will be established as a separate entity under the FAMHP’s Directorate General Pre-Authorisation. It will be staffed by personnel currently working at the FAMHP’s Scientific Technical Advice and Knowledge Management (“STA-KM”) unit.

Details concerning the funding of the National Innovation Office will be decided at a later stage. The FAMHP has declared that the financing model will be inspired by the zero-based budgeting model, in which every function within the Innovation Office will be subject to an assessment of its needs and costs for each new period.