Volume 21, Issue 2 - Medical Writing in Paediatrics
Regulatory Writing
Authors: Gregory Morley, Stephen Gilliver, Diarmuid De Faoite, Elise Langdon-Neuner
Abstract
In October 2010, the American congress passed the Physicians Payment Sunshine Act, which will force drug and medical device manufacturers to disclose their payments to healthcare professionals (HCPs). Starting this year, drug makers are required to track all payments to HCPs and from September 2013 onwards, details of these payments will be made freely available on the Internet for all and sundry to analyse. In other countries too, for example the UK with the new Association of the British Pharmaceutical Industry (ABPI) code of practice update, drug companies will be forced into disclosure, though the requirements are usually somewhat less stringent. In response, pharmaceutical companies have been scrambling to become compliant. This is no mean feat, given the complexity and extent of the relationship between drug companies and HCPs. In particular, large drug companies operate in many different countries with many different business cultures and attitudes, and under many different legislative frameworks.
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References
- Application for Compulsory Licence under Section 84(1) of the Patents Act, 1970 in Respect of Patent No.215758. Controller General of Patents, Designs & Trade Marks, Government of India. Available from: http://www.ipindia.nic.in/ipoNew/compulsory_License_12032012.pdf
- Country Rankings. U.S. Census Bureau. Available from: http://www.census.gov/population/international/data/idb/rank.php
- Strong operating performance for Roche in 2009. Roche Media Release. 3 February 2010 Available from: http://www.roche.com/media/media_releases/med-cor-2010-02-03.htm
- Niederer A, Aiolfi S. Die Arme jener, die Transparenz verhindern, sind lang. 21 March. Neue Zürcher Zeitung 2012;60.
- MacLean D, Smith J. Re: search for evidence goes on. BMJ Rapid Response. 2 February 2012 Available from: http://www.bmj.com/rapid-response/2012/02/02/re-search-evidence-goes
- Kaiser L, Wat C, Mills T, Mahoney P, Ward P, Hayden F. Impact of oseltamivir treatment on influenza-related lower respiratory tract complications and hospitalizations. Arch Intern Med 2003;163(14):1667–72.
- Effects of Tamiflu still uncertain, warn experts, as Roche continues to withhold key trial data. BMJ Press Release. 17 January 2012. Available from: http://group.bmj.com/group/media/latest-news/effects-of-tamiflu-still-uncertain-warn-experts-as-roche-continues-to-withhold-key-trial-data
- Jefferson T, Jones MA, Doshi P, Del Mar CB, Heneghan CJ, Hama R, et al. Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children. Cochrane Database Syst Rev 2012;(1). Art. No.: CD008965. DOI: 10.1002/14651858.CD008965.pub3.
- Treanor JJ, Hayden FG, Vrooman PS, Barbarash R, Bettis R, Riff D, et al. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating acute influenza. JAMA 2000;283(8):1016–24.
- Cohen D, Godlee F. Responding to Dr Hayden, Dr Treanor and Dr Kaiser. BMJ Rapid Response. 7 February 2012 Available from: http://www.bmj.com/rapid-response/2012/02/07/re-search-evidence-goes
- Hayden FG, Treanor J, Kaiser L. Re: Search for evidence goes on. BMJ Rapid Response. 30 January 2012 Available from: http://www.bmj.com/rapid-response/2012/01/29/re-search-evidence-goes
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