About the Council

The Healthcare Biotechnology Council works to highlight the potential of new biotechnology solutions, the pipeline of their applications and defines the implications these new tools will have on the European regulatory and legislative framework.

New advances in biological sciences combined with the acceleration of technological applications are transforming how healthcare is delivered to patients.

The Healthcare Council develops proposals related to the value of innovation and the role of biotechnology, intellectual property protection, regulatory competitiveness, and access to medicines. The working groups provide technical expertise to deliver our long-term priorities.

The Council delivers the Patient BioForum as the platform of exchange of views between patient organisations, healthcare biotechnology members and policymakers.

The Council also engages with the EMA through annual bilateral meetings and regular participation to activities to ensure regulatory framework is fit for biotechnology innovation.

The Council meets three times per year to issue strategic advice and overall vision. It is supported by Working Groups across priority topics.

Healthcare Biotechnology in Action

  • Sartorius
  • Syneos
  • Bronkhorst
  • Vintura
  • BIBRT
  • Kintiga
  • OM Pharma
  • Cytiva
  • Disc Medicine
  • SwiftPharma
  • The Union of Biotechnological Companies BioForum
  • Freget Glaser & Associes
  • Olon Group
  • ASSOBIOTEC
  • Finnish BioIndustries
  • Alexion AstraZeneca Rare Disease
  • SFL
 

Priorities

The Healthcare Biotechnology Council priorities are delivered through a five-year strategy and annual workplans tailored for each working group to maximize the impact of healthcare biotechnology discussions.

Biopharmaceutical Strategy Group

The working group is tasked with advocacy delivery on behalf of the Council on immediate legislative priorities to ensure the specific needs of healthcare biotechnology are duly considered by European policymakers.

OMP-ATMP Group

The working group is tasked with developing policies and narratives relevant for orphan medicines and advanced therapies to ensure patients can fully access and benefit from novel biotechnology treatments and therapeutics in the EU. 

Regulatory Affairs Group

The working group is tasked with developing policies and recommendation to enable a progressive regulatory framework for efficient uptake of new healthcare biotechnologies in the EU. The group actively engages with European regulators, including the European Medicines Agency.

Access & Value Group

The expert group is tasked with developing policies and recommendations relevant to market access and EU resilience, including on shortages, procurement, and supply-chains.