21 December 2012

Payola and the Code

Posts in this blog over the past year have featured expressions of disquiet about the lack of transparency in relationships between pharmaceutical companies (and more broadly service providers) and medical practitioners ... what in several op eds I've irreverently tagged pharma payola.

Medicines Australia, the nongovernment body responsible for a pharma industry Code of Conductthat is recognised by the Australian Competition & Consumer Commission (ACCC) under Australian trade practices law, has been slow to move towards appropriate transparency regarding service contracts and gifts, despite criticism from consumer advocates and health practitioners and the embarrassment of GSK over a US$3 billion settlement for misbehaviour in the US. In a submission to the ACCC and a meeting with the ACCC last month as part of that regulator's consideration of an updated version of the Code I commented that Medicines Australia appeared to be emulating St Augustine's stance on chastity - give me chastity (or transparency) o Lord, but not quite yet.

The ACCC yesterday announced that it given authorisation to Medicines Australia for edition 17 of the Code of Conduct.

The  Code sets the standards for the marketing and promotion of prescription pharmaceutical products in Australia, including appropriate advertising, the behaviour of medical representatives and relationships with healthcare professionals. All member companies of Medicines Australia must adhere to the Code. Membership of Medicines Australia is voluntary.

The 17th edition of the Code  incorporates amendments that are intended to:
  •  increase transparency around the interactions between pharmaceutical companies and healthcare professionals, third parties and patients – including requiring member companies to report on the sponsorship of healthcare professionals to attend or speak at educational meetings, and on any payments made to healthcare professionals to act on advisory boards or to provide consultancy services; 
  • increase the level of restriction on member companies regarding their interactions with healthcare professionals – including absolutely banning brand name reminders and the provision of prizes to healthcare professionals following competitions; and 
  • increase clarity regarding the application of the Code – for example, by removing separate Explanatory Notes to the Code and including those notes in the body of the Code’s text. 
The ACCC drily notes that
A significant number of interested parties have identified areas where the Code could be further improved. These include: a proposal that pharmaceutical companies disclose on an individual level payments made to healthcare professionals (consistent with developments in the US); improving the accessibility of the complaints process; and providing the educational event reporting tables in a more accessible format (such as Microsoft Excel). 
It comments that
The ACCC accepts that the Code provides a framework for interactions between pharmaceutical companies and healthcare professionals and that the Code is likely to result in public benefits including protecting the general public from inappropriate advertising, setting consistent standards for medical and promotional material and providing for greater transparency around the relationships between pharmaceutical companies and healthcare professionals. However, the ACCC considers that it is important that the Code continue to reflect community expectations about the level of transparency of relationships between the pharmaceutical industry and healthcare professionals. In this regard, the ACCC raised the issue of disclosing payments to individual healthcare professionals in its consideration of edition 16 of the Code in 2009. 
Indeed, Medicines Australia  made it clear that the organisation should hasten slowly. Thanks to raised eyebrows at the ACCC (presumably reflecting, in part, submissions by consumer advocates) the 17th Edition of the Code is recognised for two years rather than the five years sought by Medicines Australia. The ACCC notes that Medicines Australia convened a' transparency working group' following the submissions. The group will "look into ways that payments at an individual level can be disclosed appropriately", eg so that people can see what money is being received by individual practitioners and practices. The group is to report by December 2013.

While the ACCC is encouraged by this, it is concerned that, if the Code is not amended in a timely manner to reflect current community expectations, the public benefits resulting from the Code could be undermined. The ACCC notes that there is general agreement amongst stakeholders that the relationship between healthcare professionals and pharmaceutical companies is an important one and that the payment of fees and sponsorship in appropriate circumstances is legitimate. The ACCC does not consider that moving to individual disclosure would deter the provision of these benefits but instead considers it would assist to maintain community confidence in these transactions. The ACCC recognises the need for Medicines Australia to consult widely with stakeholders to ensure that the framework for individual disclosure can be implemented in a meaningful and workable way and that there are issues that need to be resolved to ensure its success. However the ACCC is conscious that the issue of individual disclosure is not new, noting that it was discussed in relation to the authorisation of edition 16 of the Code and that some of Medicines Australia’s members are already reporting on individual payments in the US. 
 The ACCC goes on to note that it
expects Medicines Australia to complete the work it has already commenced on increasing the level of transparency provided by the Code and to incorporate new provisions into the next edition of the Code that will facilitate greater disclosure around sponsorship and fees paid to individual doctors. The issue of transparency and the steps taken to implement it will be relevant to the ACCC’s assessment of any future application for authorisation of a new edition of the Code. The ACCC is of the view that remaining issues associated with a framework for individual disclosure can be substantially addressed in the next 12 to 18 months, with implementation of an amended Code by early 2015. This would enable Medicines Australia to commence public reporting in 2015.