26 October 2012

Pharma Payola

The Australian Competition and Consumer Commission (ACCC) has announced that it proposes to grant authorisation for the 17th edition  of Medicines Australia’s Code of Conduct for three years. Membership of Medicines Australia - which covers major pharmaceutical companies such as GSK - is voluntary. Members must adhere to the Code.

That ACCC indicates that
Authorisation provides statutory protection from court action for conduct that might otherwise raise concerns under the competition provisions of the Competition and Consumer Act 2010. Broadly, the ACCC may grant an authorisation when it is satisfied that the public benefit from the conduct outweighs any public detriment.
Authorisation does not represent ACCC endorsement of a code. Rather, it provides statutory protection from court action for conduct that might otherwise raise concerns under the competition provisions of the Act.
The Code "regulates interactions between Medicines Australia’s pharmaceutical member companies and healthcare professionals such as doctors and pharmacists". The new edition provides a low level of disclosure regarding what I have elsewhere characterised as pharma payola, ie the drug companies providing a range of sweeteners to medical practitioners who might prescribe their products. Those sweeteners can have a substantial financial benefit. It is unclear whether they do induce prescribing of a particular product. However the sweeteners - and their non-disclosure - raise concerns. There is little reason to believe that the behaviour of GSK that attracted a significant penalty in the US is exceptional.

The ACCC indicates that it
considers that the Code results in public benefits by providing greater transparency around the relationships between pharmaceutical companies and healthcare professionals ...
However, the ACCC notes that community expectations of disclosure by the pharmaceutical industry have increased and continue to increase. In light of this, the ACCC considers Medicines Australia could go further in ensuring the Code meets these expectations now and in the future.
The ACCC encourages Medicines Australia to look for ways to address the concerns that have been raised during the ACCC’s consultation process. These include improving the accessibility of reports and the complaints process and considering disclosure of payments made to individual healthcare professionals.
Reluctance by Medicines Australia and some practitioners to embrace true transparency has resulted in criticism by health advocates, consumers and analysts. The ACCC notes that
In order to ensure that the Code continues to meet current community expectations the ACCC’s draft determination proposes to grant authorisation for three years, rather than the five years sought by Medicines Australia. During this authorisation period, Medicines Australia will be able to complete work it has already commenced on reviewing the Code and make any resulting changes.
The authorisation features the statement that -
Edition 17 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.
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).
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. The ACCC notes that Medicines Australia has since convened a transparency working group, inviting participation from consumer, healthcare professional and pharmaceutical industry groups, which will look into ways that payments at an individual level can be disclosed appropriately. Medicines Australia advises that this working group will report by December 2013.
The ACCC also notes that the ability for the public to make complaints and access and utilise the reporting tables is an important feature of increasing the transparency around the relationship of the industry with healthcare professionals.
Medicines Australia, in response to criticisms, had argued -
• it is not necessary to increase the quantum of fines. Medicines Australia submits that fines under the Code remain substantially higher than those in similar industry codes, that the effectiveness of the Code's sanctions in providing a deterrent effect is demonstrated by the increased level of compliance with the Code and that the TG Act provides for additional penalties (including fines and imprisonment) that can be imposed on pharmaceutical companies and individuals who contravene the provisions of the TG Act;
• it is not appropriate to require member companies to report on the sponsorship of individual doctors by name. Medicines Australia submits that it has already taken considerable steps to increase transparency, that it is committed to increasing transparency further and that there has been implementation issues in other jurisdictions which have required individual disclosure;
• there is already consumer and healthcare professional representation on the three Code committees;
• prohibiting brand name reminders will not reduce the level of competition between pharmaceutical companies since there are other avenues available to members to promote their products;
• an effective voluntary code that complements and extends beyond the reach of statutory regulation is of significant public benefit; and
• the proposed patient support program section of the Code does not require amendment, aside from the minor wording amendment suggested by the DHA. Medicines Australia has provided an amended version of the Code to incorporate this change.
What, we might ask, is so wrong about full disclosure of what Medicines Australia characterises as "sponsorship". We should be able to tell - and tell easily - what benefits practitioners are receiving from their 'sponsors'. If sweeteners - or signs of appreciation, love, care, devotion or a commitment to education practitioners - pose no concerns there is no reason why both the practitioners and pharma companies shouldn't be open. Given the past behaviour of GSK - a leading drug company -  we might appropriately be just a tad skeptical about assurances that all is well and all will be even better in future.