Codes of Practice
This article was originally published in SRA
Executive Summary
New code covers industry links with patient organisations in Europe
New code covers industry links with patient organisations in Europe
A new code of practice covering relationships between the pharmaceutical industry and patient organisations in Europe has come into force1.
The code, agreed by the European Federation of Pharmaceutical Industries and Associations in October 2007, took effect on 1 July. EFPIA notes that this is the first time that its pharmaceutical industry members have committed to follow similar ethical rules in working with patient organisations.
Under the code, drug companies must, among other things, make publicly available by March 2009 a list of patient organisations to which they provide financial support and/or significant indirect or non-financial support. The information, which should be updated once a year, should include a description of the nature of the support.
The code requires companies to have written agreements defining their support and encourages multiple sources of funding for patient organisations. It also requires companies: to obtain written permission for the use of patient groups' logos; not to seek to influence the content of sponsored patient organisation material to favour commercial interests; and to limit hospitality to a reasonable level.
The code reflects EU law by prohibiting the advertising of prescription-only medicines to the public. EFPIA notes that it builds upon principles that the federation, together with pan-European patient organisations, last updated in September 2006.
Also on 1 July, EFPIA's revised code of marketing practice on the promotion of prescription-only medicines to, and interactions with, healthcare professionals took effect3.
Spain
National industry associations are responsible for the implementation of EFPIA codes. In Spain, for example, Farmaindustria, the Spanish pharmaceutical industry association, has announced that it has updated its code of marketing practice and, at the same time, has launched a new code governing relationships with patient organisations4. Both are in line with the relevant EFPIA codes.
UK trade body suspends Roche after code breach
Meanwhile in the UK, Roche has been suspended from the trade association, the ABPI, for a minimum of six months for having seriously breached the industry's code of marketing practice. Between 2003 and 2005, Roche supplied large quantities of its obesity drug Xenical (orlistat) to an individual who was not a healthcare professional. In doing so, the company breached Clause 2 of the ABPI code of marketing practice, which deals with action likely to bring discredit upon, or reduce confidence in, the pharmaceutical industry, as well as breaching a number of other clauses. Roche's re-entry into the ABPI is conditional upon an audit, which is due to take place in September.
References
1. EFPIA Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations, http://212.3.246.100/Objects/2/Files/Code%20with%20Patients%20final%20Oct%202007.pdf
2. EFPIA press release, 30 June 20008, www.efpia.org/content/default.asp?PageID=559&DocID=4959
3. EFPIA Code of Practice on the Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals, www.efpia.org/Objects/2/Files/code%20medicines%202007.pdf
4. Farmaindustria press release, 23 July 2008, http://prensa.farmaindustria.es/comunicado.html?id=48362
5. ABPI press release, 14 July 2008, www.abpi.org.uk/press/press_releases_08/140708.asp