title: Challenges to pharmaceutical policymaking: lessons from Australia's national medicines policy.
abstract: OBJECTIVE
  National medicines policies (NMP) provide a means for governments to achieve their objectives in relation to pharmaceuticals and other medicines. This research aimed to identify challenges to implementing the objectives of the Australian NMP from the perspective of key stakeholders.
  
  
  METHODS
  In 2012 and 2103, we conducted 30 semistructured interviews with stakeholders involved in the discovery, clinical testing, regulation and funding of medicines in Australia. We asked participants to describe their careers and to give their opinions on specific issues surrounding drug development, clinical research, regulation and subsidisation in Australia. Data were analysed using Morse's outline of the cognitive basis of qualitative research and Charmaz's outline of data analysis in grounded theory. The initial phase of 'open coding' revealed findings that could be mapped to three of the four objectives of the NMP. We then conducted 'focussed coding' for themes relevant to these objectives.
  
  
  RESULTS
  Participants identified many issues relevant to the ongoing evolution of the NMP, relating primarily to ongoing tensions between the commercial objective of ensuring a viable medicines industry, and the non-commercial objectives of ensuring that medicines are safe, effective and affordable. There were also several other challenges identified to the achievement of both the commercial and non-commercial objectives of the NMP. These included limits to government funding, globalisation, consumer advocacy, changing scientific paradigms and new information technologies.
  
  
  CONCLUSIONS
  There are many issues that need to be addressed if policymakers are to achieve the best outcomes from the NMP. Tensions between the commercial and non-commercial objectives of the NMP suggest the need to ensure that one stakeholder group's imperatives do not stifle those of other groups. At the same time, there are several emerging issues that are likely to concern all stakeholders equally, and these are both challenges and opportunities for new kinds of collaboration. What is known about the topic? We know that stakeholders have several concerns about medicines policy, but little is known about the specific challenges to implementing medicines policy from the perspective of those involved. What does this paper add? We demonstrate that stakeholders have many concerns that could impact the implementation of medicines policies. These relate primarily to ongoing tensions between the objective of ensuring a viable medicines industry, and the objectives of ensuring that medicines are safe, effective and affordable. There are also several issues that potentially pose a challenge to achieving both the commercial and non-commercial objectives of the NMP. These include limits to government funding, globalisation, consumer advocacy, changing scientific paradigms and new information technologies. What are the implications for practitioners? Policymakers need to systematically address the barriers to the ongoing implementation of the NMP. Policymakers should also ensure that one imperative (such as the commercial imperative) does not stifle other objectives. Other emerging issues are likely to concern all stakeholders, and these provide opportunities for new kinds of collaboration among stakeholders.
authors.affiliation: Australian Institute of Health Innovation, AGSM Building, Level 1, University of New South Wales, NSW 2052, Australia.
authors.forename: Wendy
authors.initials: W
authors.lastname: Lipworth
authors.affiliation: Centre for Values, Ethics and the Law in Medicine, Medical Foundation Building (K25), University of Sydney, NSW 2006, Australia.
authors.forename: Evan
authors.initials: E
authors.lastname: Doran
authors.affiliation: Centre for Values, Ethics and the Law in Medicine, Medical Foundation Building (K25), University of Sydney, NSW 2006, Australia.
authors.forename: Ian
authors.initials: I
authors.lastname: Kerridge
authors.affiliation: Department of Clinical Pharmacology, St Vincent's Hospital Sydney and Faculty of Medicine, University of New South Wales, Victoria St, Darlinghurst, NSW 2010, Australia.
authors.forename: Richard
authors.initials: R
authors.lastname: Day
mesh_terms: D001315:Australia; D035843:Biomedical Research / Q000191:economics / Q000592:standards*; D002986:Clinical Trials as Topic / Q000191:economics / Q000592:standards*; D055808:Drug Discovery / Q000191:economics / Q000592:standards; D004345:Drug Industry / Q000191:economics / Q000592:standards*; D005380:Financing, Government; D005653:Fund Raising / Q000379:methods; D006291:Health Policy; D006801:Humans; D007407:Interviews as Topic; D011050:Policy Making; D055553:Prescription Drugs / Q000191:economics / Q000592:standards*
chemical_list: D055553:Prescription Drugs