Medical Writing Medical Writing in Paediatrics Regulatory Writing

Volume 21, Issue 2 - Medical Writing in Paediatrics

Regulatory Writing


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.

Download the full article


  1. 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:
  2. Country Rankings. U.S. Census Bureau. Available from:
  3. Strong operating performance for Roche in 2009. Roche Media Release. 3 February 2010 Available from:
  4. Niederer A, Aiolfi S. Die Arme jener, die Transparenz verhindern, sind lang. 21 March. Neue Zürcher Zeitung 2012;60.
  5. MacLean D, Smith J. Re: search for evidence goes on. BMJ Rapid Response. 2 February 2012 Available from:
  6. 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.
  7. Effects of Tamiflu still uncertain, warn experts, as Roche continues to withhold key trial data. BMJ Press Release. 17 January 2012. Available from:
  8. 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.
  9. 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.
  10. Cohen D, Godlee F. Responding to Dr Hayden, Dr Treanor and Dr Kaiser. BMJ Rapid Response. 7 February 2012 Available from:
  11. Hayden FG, Treanor J, Kaiser L. Re: Search for evidence goes on. BMJ Rapid Response. 30 January 2012 Available from:



Medical writing in paediatrics: Children and the future
Message from the President
Challenges of paediatric drug development and impact of paediatric legislation
Writing applications for Paediatric Investigation Plans and waivers
Preparing the Paediatric Investigation Plan application
ADHD: A true neurodevelopmental disorder?
Medicines information for patients: Insights into research and practice for medical writers
The MHRA perspective on the new pharmacovigilance legislation
Are stem cells the future of healthcare?
O, safety, quo vadis?
Crowdpower in the era of ‘health 2.0’
Networking effectively: Essential for being successful in business
The moving image and your business
Forgive me for repeating myself: Self-plagiarism in the medical literature
In the Bookstores
Journal Watch
The Webscout
Manuscript Writing
Regulatory Writing
English Grammar and Style
Out On Our Own


The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Editoral Board


Raquel Billiones


Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir


Jennifer Bell


Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer


Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha


Tiziana von Bruchhausen


Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk