EuropaBio is delighted by the publication of the forward looking report by the US Food and Drug Administration (FDA), called ‘Driving Biomedical innovation: initiatives to improve products for patients’, published on 5 October. It outlines the FDA’s role in facilitating the development of new, innovative products to meet the needs of Americans.  The report details new initiatives the FDA is taking to promote innovation, including enhanced support for Small and Medium Size Enterprises (SMEs).

In particular, it proposes a concrete reflection process for industry, patient groups and university researchers to work together to define an expedited approval pathway for potential breakthrough therapies. The new pathway is intended to reduce the time it takes to develop highly effective therapies by minimising trials that expose patients to less effective treatments and speeding market access for breakthrough therapies. The FDA will aim to publish draft guidance on the topic and to "achieve a common understanding of steps that can be taken when an investigational drug being studied for a serious disease with no acceptable treatment option shows exceptional promise."

Recent regulatory approvals on both sides of the Atlantic, particularly in the field of oncology, have demonstrated that breakthrough innovation is still possible.  Nevertheless, as stressed in the European Medicines Agency (EMA) Road Map to 2015, “an important public-health challenge currently faced is the lack of medicines for unmet medical needs”. For example, today in Europe, despite the evident need, there is still a dramatic lack of treatments for the 30 million Europeans affected by one of the 5,000 to 7,000 rare diseases. Society’s demand for more effective, safer and high quality medicines is high and modern healthcare biotechnology methods and tools have the potential to respond to this demand.

Commenting on the publication of the report, Thomas Bols, EuropaBio’s Healthcare Council Chair said: “As key European stakeholders we ought to ask ourselves whether our existing pathway for developing and approving increasingly complex and innovative therapies is adapted to the current state of science. The emergence of personalised medicine and the shift toward medical treatments tailored to individual characteristics of patients push us – industry, policy-makers and regulators – to rethink how we develop, approve and value medicines. An inclusive, holistic and honest reflection process is needed.”

Nathalie Moll, EuropaBio Secretary General stated: “This FDA report gives us an example of best practice for open dialogue.  We feel it should be replicated in Europe. Over the last two years, the European Commission, led by Vice President Tajani, has launched a number of multi-stakeholder initiatives looking at specific issues of access and healthcare innovation to which we are contributing. Today, we need a forum where issues intrinsically linked such as unmet medical needs, significant benefits of medicines, incentives for responsible healthcare innovation, faster medicine development and early access can be discussed in a comprehensive way.”

Tim Kievits, Chair of EuropaBio’s Personalised Medicines Task Force added: “EuropaBio calls on the European Commission – uniquely placed to bring all stakeholders around the table – to develop such a forum. The healthcare biotech industry stands ready to commit to an in-depth and constructive dialogue with the EU institutions and all relevant partners“.

~ENDS~

Useful links:

Driving biomedical innovation: initiatives to improve products for patients

Road map to 2015: The European Medicines Agency’s contribution to science, medicines and health

EuropaBio Healthcare Manifesto 2011-2012

About EuropaBio: EuropaBio's mission is to promote an innovative and dynamic biotechnology based industry in Europe. EuropaBio, (the European Association for Bioindustries), has 62 corporate and 7 associate members operating worldwide, 2 Bioregions and 19 national biotechnology associations representing some 1800 small and medium sized enterprises.

About Healthcare Biotech: Healthcare biotechnology refers to a medicinal or diagnostic product or a vaccine that consists of, or has been produced by the use of, living organisms.  Often recombinant DNA (a form of DNA that does not exist naturally and which combines DNA sequences that would not normally occur together in order to establish new functions) forms the basis for such biotechnologically manufactured products.  EuropaBio’s healthcare biotech companies are working in areas as diverse as: Orphan Medicinal Products (OMPs), Health Technology Assessment (HTAs), personalised medicine and rare diseases.

For further information, or quotes please contact:

Rosalind Travers

Communications and Associations Liaison Officer

Tel: +32 2 739 1173

Mobile: +32 478 680 301

Email: r.travers@europabio.org

Or

Ludovic Lacaine

Director, Healthcare Biotechnology

Tel: +32 739 1183

Email: l.lacaine@europabio.org

www.europabio.org