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Regulatory / Ethical Update Skeptics Groups of Victoria, La Notte, Sept 1, 2013 Health professions & therapeutic goods industry: Regulatory / ethical update Dr Ken Harvey MB BS, FRCPA http://www.medreach.com.au Skeptics Groups of Victoria, La Notte, Sept 1, 2013 Talk outline • Medicines Australia Transparency Code revision. • TGA Consultation Regulation Impact Statement: Regulating the advertising of therapeutic goods to the general public. • Natural Therapy Review Advisory A fundamental change in the relationship Committee. between industry and medical professionals is needed. • Single national Code of Conduct for unregistered health practitioners. 2 Dr Ken Harvey Page 1 Skeptics Groups of Victoria, La Notte, Sept 1, 2013 U.S. Justice Department Fines 3 Unethical conduct • Trials manipulated; negative results suppressed. • Journal articles “ghost‐written”. • Off‐label promotion. • Well paid, but undeclared, medical opinion leaders used to promote company products (educational mercenaries). • Excessive hospitality, kickbacks, bribery. • Consumer groups manipulated. • Spurious patents and legal challenges to delay the4 entry of generics. 4 Dr Ken Harvey Page 2 Skeptics Groups of Victoria, La Notte, Sept 1, 2013 It takes two to tango 5 The need for disclosure • A recent editorial in the British Medical Journal reported that a US Senate Finance Committee investigation has found the medical device company Medtronic was “heavily involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants,” who were paid hundreds of millions of dollars by the company through royalties and consulting fees. • The Committee Chairman, Senator Max Baucus, said Medtronic’s actions had “violated” patients’ trust. • The president of the North American Spine Society, said, “If surgeons had known that the lead authors of the 13 original studies on InFuse (the Medtronic product) had received payments ranging from $1.7m to $64m from Medtronic and that its marketing employees were co‐authors and co‐editors, would they have been as eager to use this product on their patients?” http://www.bmj.com/content/345/bmj.e7299 6 Dr Ken Harvey Page 3 Skeptics Groups of Victoria, La Notte, Sept 1, 2013 In the USA • The Physician Payment Sunshine Act becomes operational this year. • It requires pharmaceutical and device companies to report to the Centers for Medicare and Medicaid Services (CMS) all payments, or other transfers of value, made to individual doctors and teaching hospitals that total more than US$100 per year. • Companies must begin to collect the information by August 1, 2013 and report it to the CMS by March 31, 2014. • The information will be posted on a public website on 30 September 2014. 7 In Australia • Many consumer and health professional groups argued for full disclosure of payments made to individual healthcare professionals in the 16th Edition (2009) Code revision and again in the 17th Edition (2012) Code revision. • The 17th Code Edition incorporated aggregate disclosure of payments, not individual. • MA set up a Transparency Working Group to advise how individual disclosure might be implemented. • A report has now been produced but there was no agreement on the amount of money that would trigger individual disclosure. • Consultation with MA members and other stakeholders will continue with (hopefully) the adoption of individual payment disclosure in new Code revision in late 2014 with possibly payments being recorded from Jan 1, 2015 and public reporting in 2016 (compared to 2014 in the U.S.). 8 Dr Ken Harvey Page 4 Skeptics Groups of Victoria, La Notte, Sept 1, 2013 In Australia •This bill proposed by Senator R Di Natale would have replaced Medicines Australia Code with legislation that set stringent restrictions on the interactions between pharmaceutical companies and physicians. •In June 2013, the Finance and Public Administration Legislation Committee recommended that the bill not be passed. Unlike the U.S., self‐regulation was thought to be more appropriate in Australia. 9 A Code of Conduct for Doctors in Australia 8.11.4 Recognising that pharmaceutical and other medical marketing influences doctors, and being aware of ways in which your practice may be being influenced. 8.11.5 Recognising potential conflicts of interest in relation to medical devices and appropriately managing any conflict that arises in your practice. 8.11.6 Not asking for or accepting any inducement, gift or hospitality of more than trivial value, from companies that sell or market drugs or appliances that may affect, or be seen to affect, the way you prescribe for, treat or refer patients. 8.11.8 Not offering inducements to colleagues, or entering into arrangements that could be perceived to provide inducements. 10 Dr Ken Harvey Page 5 Skeptics Groups of Victoria, La Notte, Sept 1, 2013 New transparency a huge burden? 19 August 2013 • The number of individual HCP reports that companies will have to gather in order to comply with MA's new transparency regime could far exceed 500,000 a year, research by Pharma in Focus has shown. • The figure comes from a recently finalised analysis of Medicines Australia's complete data set of events staged between October 2012 and March 2013. • The analysis shows that had individual HCP reporting with a trigger point of $10 or above for each benefit been in place during the six months to March 31, companies would have recorded more than 269,000 occurrences in total, covering 9685 events. • The higher trigger point of $25, which was favoured by companies that presented to the MA transparency working group, would have cut the recording of individual benefits required for the most recent reporting period from 269,000 to 133,000 and the number of events requiring such recording from 9684 to 4100. http://www.pharmainfocus.com.au/news.asp?newsid=7067 MA Code review • Comment of discussion paper requested; • Consumer Workshop, Melbourne, Friday 18th October 2013 12 Dr Ken Harvey Page 6 Skeptics Groups of Victoria, La Notte, Sept 1, 2013 Rules under review? A decade of procrastination Date Initiative 2002 Report of a Review of Advertising Therapeutic Products in Australia and New Zealand 2003 Report of Expert Committee on Complementary Medicines in the Health System 2005 Description of the joint (Trans‐Tasman) regulatory scheme for the advertising of therapeutic products Consultation (Draft) Regulation Impact Statement on the proposed amendments to the current 2006 regulatory system for herbal and homoeopathic medicines in Australia 2007 Consultation ‐ draft (Trans‐Tasman) advertising rule 2008 Regulation of homoeopathic and anthroposophic medicines in Australia Draft Guideline for Levels and Kinds of Evidence for Listed Medicines with Indications and Claims for 2009 Weight Loss 2010 TGA Consultation: Improving advertising arrangements for therapeutic goods Consultation and Report of the Working Group on Promotion of Therapeutic Products Report of the Review to improve the transparency of the Therapeutic Goods Administration 2011 ANAO Report. Therapeutic Goods Regulation: Complementary Medicines TGA reforms: A blueprint for TGA's future Delivering reforms ‐ Implementation plan for TGA Reforms 2012 TGA Advertising regulatory framework: Options for reform TGA Consultation Regulation Impact Statement: Regulating the advertising of therapeutic goods to 2013 the general public 13 Culminating in the latest RIS 1. Alternatives to the pre‐approval scheme 2. The complaints handling process 3. Provision of advice in relation to advertising matters 4. Investigation and enforcement powers 5. Advertising of higher risk medical device 6. Advertising directed to health professionals 7. Advertising of Pharmacist‐Only medicines 8. The Price Information Code of Practice 14 Dr Ken Harvey Page 7 Skeptics Groups of Victoria, La Notte, Sept 1, 2013 Comments on the RIS proposals • Alternatives to the pre‐approval scheme – We support option 4 (c), modified by option 2. This would mean that the TGA, not delegates from two industry associations, would undertake pre‐approval for an extended range of media (adding pay‐tv) and types of advertisements (adding medical devices that are promoted to the public). • The complaints handling process – We support option 2 (a), all complaints to be handled by the TGA. This eliminates concerns expressed about the CRP, removes duplication in the current system and would allow earlier identification of repeat and major offenders and advertisements posing a high risk to public health and safety. – However, the TGA’s current performance on Regulation 9 referrals causes great concern. 15 Comments on the RIS proposals • Investigation and enforcement powers – We support option 2, enhanced investigative and enforcement powers. – These have been long needed and long awaited. Progressing this reform is urgent. • Advertising of higher risk medical device – We support option 2, prohibit the advertising of higher risk medical devices including Class 4 in vitro diagnostic devices (those with a high public health risk). – Naturopaths have expressed concern that this measure will reduce access to their tools of the trade because they will not be able to advertise various diagnostic and therapeutic techniques. – However, many of the dubious devices used by naturopaths are Class I (low risk) devices, or they are not included on the ARTG such as the Hemaview® live blood analysis and QXCI machines. 16 Dr Ken Harvey Page 8 Skeptics Groups of Victoria, La Notte, Sept 1, 2013 Live blood analysis “Another gimmick to sell
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