The review process so far:
Sunshine, but no lollipops
The Physician Payments Sunshine Act, which constitutes part of the United States' 2010 healthcare reform, requires the reporting and publication of payments from the manufacturers of drugs, devices, biological and medical supplies covered by Medicare, Medicaid or the Children's Health Insurance Program to physicians and teaching hospitals. Failure to report could involve costly penalties.
The Centers for Medicare and Medicade Services (CMS), the US government department responsible for implementing the Act, issued draft rules in December 2011. The rules were recently finalised.
Both the extent of the proposed penalties and the possibility of identifying individual physicians in public reports go beyond what is proposed in the 17th edition of the Medicines Australia Code of Conduct (MA Code). In authorising the 17th edition for a period of three years, the Australian Competition and Consumer Commission (ACCC) Chairman Rod Sims noted, "...community expectations of disclosure by the pharmaceutical industry have increased and continue to increase. In light of this, the Australian Competition and Consumer Commission (ACCC) considers Medicines Australia could go further in ensuring the Code meets these expectations now and in the future."
The implementation of the US rules will be of interest to the Australian industry as it may indicate the future direction for disclosure here.
The Green machine
On the eve of the Medicines Australia members formally adopting the 17th Edition of the MA Code and sending it to the ACCC for approval, the Greens spokesperson for health, Senator Di Natale, announced that a private members bill had been prepared to ban inducements to doctors "if Medicines Australia fails to take adequate steps." The Senator further stated that "the public find it totally unacceptable that doctors are treated to lavish accommodation and overseas trips, in the name of education."
The 16th edition of the MA Code already prevented "lavish" accommodation, although reasonable levels of accommodation expenses for health care professionals attending a company education meeting, or sponsoring attendance at Australasian or international educational events are permissible. In determining whether accommodation is reasonable, thought is to be given to the amount of medical information being delivered and the distance the delegate lived from the venue.
It seems that Senator Di Natale was not satisfied with the 17th Edition, introducing a private members bill, the Therapeutic Goods Amendment (Pharmaceutical Transparency) Bill, to the Senate on 28 February 2013.
The MA Code is binding on member companies, the majority of which are research based prescription pharmaceutical companies. While 86% of the medicines available to Australians through the Pharmaceutical Benefits Scheme are produced by companies who are members of Medicines Australia, there remains a number of pharmaceutical companies operating in Australia who are not members. Despite this, the Therapeutic Goods Administration normally makes compliance with the MA Code provisions regarding promotion of prescription only products a condition of marketing approval.
The MA Code sets out a number of standards for member companies regarding the promotion and ethical marketing of prescription pharmaceuticals. These obligations operate in addition to the legislative requirements of the Therapeutic Goods Act 1989 (Cth) and associated regulations. Introduced in 1960, the MA Code is regularly reviewed. Most recently, Medicines Australia released its anticipated 17th Edition, which the ACCC has to authorise for a period of two years from January 2013.
While on first glance it may appear as though the 17th Edition contains significant changes, a large proportion of these edits have resulted from the Explanatory Notes contained in the 16th Edition being fully incorporated into the body of the 17th Edition provisions.
The most significant change in the 17th Edition of the MA Code is the introduction of mandatory reporting in relation to:
- Sponsorship of healthcare professionals to attend educational events, whether organised by a member company or a third party;
- Payments to speakers to attend and present at educational events;
- Payments to healthcare professionals as consultants and as members of advisory boards; and
- Payments to health consumer organisations.
While aggregate financial and other information must be reported, the names of individual healthcare professionals who received sponsorship do not need to be disclosed to Medicines Australia.
In an attempt to lighten the reporting burden, the 17th Edition of the MA Code provides examples of tables where the details of such sponsorship and payments made from 1 January 2013 may be detailed. This information must be submitted to Medicines Australia and will be published on the Medicines Australia website in a bid to increase the transparency of the relationship between pharmaceutical companies, healthcare professionals and health consumer organisations.
The new edition of the MA Code also:
- Bans prizes for competitions or quizzes entered into by healthcare professionals; and
- Requires that suspected adverse drug reactions noted during the monitoring of Social Media sites be reported to the TGA in accordance with the Australian Guideline for Pharmacovigilance Responsibilities of Sponsors of Registered Medicines Regulated by the Drug Safety and Evaluation Branch.
Brand name reminders have also been banned and may no longer be given to healthcare professionals. However, some medical education items may still be provided, as long as the item complies with the 'gifts and offers' provisions of the 17th Edition.
Scientific meetings, however, will not be bereft of company branded merchandise, as companies may still provide inexpensive pens, notebooks, lanyards or tote bags at these meetings. These items may only bear the name of the company however, and not the name of any medicine or product.
In addition to the progress made by the 17th Edition, Medicines Australia has also indicated that it intends to oversee the establishment of a working group which will develop further mechanisms for ensuring transparency in the industry's interactions with healthcare professionals. It is clear that amendments introduced in the 17th Edition have not signalled the end of the movement towards greater transparency.
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