The Director of Ethics and Compliance at Medicines Australia, Deborah Monk, says the association is troubled there may be a lack of understanding about the requirements of the Therapeutic Goods Act 1989 (The Act) and the guidance provided in the MA Code of Conduct.
The Medicines Australia Code is a self-regulatory Code, which necessarily must be consistent with all Australian legislative requirements.
However, we can all agree with Carlo Montagner in his recent opinion piece, that we want patients to have access to new treatments that will help them lead longer and healthier lives, and if necessary, this includes medicines that are not yet approved in Australia.
Pharmaceutical companies provide numerous opportunities for patients to gain early access to innovative medicines. That’s something that our industry does extremely well. Not only do they provide access through clinical trials during the development of a medicine, but also through compassionate access or other early access programmes; aimed at providing patients with the treatments they need until the regulatory process concludes and the medicine is registered and more importantly available through the Pharmaceutical Benefits Scheme (PBS). Companies also provide clinicians with early access to medicines through Product Familiarisation Programmes (PFPs), which inform clinicians about how to use new medicines appropriately and manage their patients care when receiving a new medicine.
Nevertheless, the laws are clear. There is a specific section in the Therapeutic Goods Act that prohibits a person from publishing or broadcasting an advertisement about any therapeutic good that is not included on the Australian Register of Therapeutic Goods (ARTG).
The Act also makes it an offence for any person to make a claim, by any means, that they or another person can arrange the supply of therapeutic goods that are not registered or listed goods. These legal requirements should always be carefully considered before communicating with doctors about being able to prescribe an unapproved medicine.
Medicines Australia and our members do not support promotion or advertising of compassionate access that falls outside the laws in Australia. The MA Code of Conduct is intended to apply the Therapeutic Goods legislation to the activities of member companies when they interact with doctors.
If the TGA forms a view that companies can proactively inform doctors about the availability of an unapproved medicine through compassionate access programmes, Medicines Australia – and the innovative medicines industry – would be fully in support of it.
Medicines Australia and the TGA are working with doctors to consider a range of options to enable appropriate information on compassionate access programmes to be more accessible to clinicians who can then inform their patients.
As a result of these discussions, we are examining possibilities such as optionally listing compassionate access programmes on a third-party web site that is only available to doctors. This may represent a workable solution in line with the Therapeutic Goods Act, while still ensuring that the trusted role of the doctor as the primary source of information about a medicine is protected.
So, the question about information, advertising, promotion and the role of medical practitioners in this, is a timely discussion to have, particularly through engaging with the administrator of the legislation, the TGA to understand their perspective.
We would welcome constructive dialogue on this, and the Code of Conduct from members and non-members alike.