title: Innovative regenerative medicines in the EU: a better future in evidence?
abstract: BACKGROUND
  Despite a steady stream of headlines suggesting they will transform the future of healthcare, high-tech regenerative medicines have, to date, been quite inaccessible to patients, with only eight having been granted an EU marketing licence in the last 7 years. Here, we outline some of the historical reasons for this paucity of licensed innovative regenerative medicines. We discuss the challenges to be overcome to expedite the development of this complex and rapidly changing area of medicine, together with possible reasons to be more optimistic for the future.
  
  
  CONCLUSIONS
  Several factors have contributed to the scarcity of cutting-edge regenerative medicines in clinical practice. These include the great expense and difficulties involved in planning how individual therapies will be developed, manufactured to commercial levels and ultimately successfully delivered to patients. Specific challenges also exist when evaluating the safety, efficacy and cost-effectiveness of these therapies. Furthermore, many treatments are used without a licence from the European Medicines Agency, under "Hospital Exemption" from the EC legislation. For products which are licensed, alternative financing approaches by healthcare providers may be needed, since many therapies will have significant up-front costs but uncertain benefits and harms in the long-term. However, increasing political interest and more flexible mechanisms for licensing and financing of therapies are now evident; these could be key to the future growth and development of regenerative medicine in clinical practice.
  
  
  CONCLUSIONS
  Recent developments in regulatory processes, coupled with increasing political interest, may offer some hope for improvements to the long and often difficult routes from laboratory to marketplace for leading-edge cell or tissue therapies. Collaboration between publicly-funded researchers and the pharmaceutical industry could be key to the future development of regenerative medicine in clinical practice; such collaborations might also offer a possible antidote to the innovation crisis in the pharmaceutical industry.
authors.affiliation: Centre for Reviews and Dissemination, University of York, Heslington, York, YO10 5DD, UK. mark.corbett@york.ac.uk.
authors.forename: Mark S
authors.initials: MS
authors.lastname: Corbett
authors.affiliation: Science and Technology Studies Unit, Department of Sociology, University of York, Heslington, York, YO10 5DD, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Webster
authors.affiliation: Medical Oncology, The Christie Hospital and University of Manchester, Wilmslow Road, Manchester, M20 4BX, UK.
authors.forename: Robert
authors.initials: R
authors.lastname: Hawkins
authors.affiliation: Centre for Reviews and Dissemination, University of York, Heslington, York, YO10 5DD, UK.
authors.forename: Nerys
authors.initials: N
authors.lastname: Woolacott
mesh_terms: D035843:Biomedical Research; D064987:Cell- and Tissue-Based Therapy / Q000592:standards*; D003365:Costs and Cost Analysis; D004345:Drug Industry; D005062:European Union; D005544:Forecasting; D006801:Humans; D044968:Regenerative Medicine / Q000331:legislation & jurisprudence* / Q000592:standards*; D057170:Translational Research, Biomedical
keywords: Cell therapy; European Medicines Agency; Gene therapy; Regenerative medicine