title: How innovative are new drugs launched in the UK? A retrospective study of new drugs listed in the British National Formulary (BNF) 2001-2012.
abstract: OBJECTIVE
  Innovative new drugs offer potential benefits to patients, healthcare systems, governments and the pharmaceutical industry. Recent data suggest annual numbers of new drugs launched in the UK have increased in recent years, and we sought to understand whether this represents increasing numbers of highly innovative drugs being made available or the introduction of increasing numbers of drugs with limited additional therapeutic value.
  
  
  METHODS
  Retrospective observational study of new drug entries in the British National Formulary (BNF).
  
  
  METHODS
  Number of new drugs launched in the UK each year (based on first appearance in the BNF) from 2001 to 2012, including new chemical entities and new biological drugs, categorised by degree of innovativeness according to published criteria that incorporate both clinical usefulness and the nature of the innovation.
  
  
  RESULTS
  Highly innovative, moderately innovative and slightly innovative drugs made up 26%, 18% and 56% of all newly launched drugs, respectively, for the study period (n=290). There was an upward trend in annual numbers of slightly innovative drugs from 2004 onwards (R(2)=0.44), which aligned closely with the recovery in total numbers of new drugs launched each year since that time. There were no discernible time trends in the highly or moderately innovative categories. New drugs for malignancy and skin disease were most likely to be characterised as highly innovative (44% and 57%, respectively).
  
  
  CONCLUSIONS
  Highly innovative new drugs comprise only around a quarter of all new drug launches in the UK. In contrast, drugs categorised as only slightly innovative comprised well over half of all new drugs and annual numbers in this category are increasing. Current policy initiatives that seek to increase the supply of innovative new drugs have long-lead times to impact, and will need careful assessment to ensure they deliver their aims without unintended consequences.
authors.affiliation: NIHR Horizon Scanning Centre, School of Health and Population Sciences, University of Birmingham, Birmingham, UK.
authors.forename: Derek J
authors.initials: DJ
authors.lastname: Ward
authors.affiliation: NIHR Horizon Scanning Centre, School of Health and Population Sciences, University of Birmingham, Birmingham, UK.
authors.forename: Angharad
authors.initials: A
authors.lastname: Slade
authors.affiliation: NIHR Horizon Scanning Centre, School of Health and Population Sciences, University of Birmingham, Birmingham, UK.
authors.forename: Tracey
authors.initials: T
authors.lastname: Genus
authors.affiliation: Coventry City Council, Council House, Coventry, UK.
authors.forename: Orsolina I
authors.initials: OI
authors.lastname: Martino
authors.affiliation: Department of Public Health, Epidemiology and Biostatistics, School of Health and Population Sciences, University of Birmingham, Edgbaston, Birmingham, UK.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Stevens
mesh_terms: D017277:Drug Approval; D055808:Drug Discovery; D004345:Drug Industry / Q000639:trends*; D006801:Humans; D062069:Inventions; D010602:Pharmacopoeias as Topic; D012189:Retrospective Studies; D006113:United Kingdom
keywords: Innovation; New drug launches; Pharmaceuticals; United Kingdom; time trends