SARAH-JANE TASKER | THE AUSTRALIAN | DECEMBER 7, 2017
PHARMACEUTICALS: Australian patients are missing out on potentially life-saving drugs, or spending thousands of dollars to import them, because of an industry rule that forbids pharmaceutical companies promoting drugs available via special access schemes.
Cancer experts are lobbying the Therapeutic Goods Administration and Medicines Australia to create a central database about open access drug programs.
Carlo Montagner, chief executive of Specialised Therapeutics, said both doctors and patients were in the dark about what drugs were available as a result of an industry rule that such programs cannot be proactively communicated to physicians.
Mr Montagner has decided to make clinicians aware of cancer drugs his company will be distributing in Australia from early next year via a special access program.
“It’s technically a breach of the code, but it’s not right. We need to make patients and their carers aware that there is an access program,” he said.
“We are prioritising the patient, rather than the code.”
Before drugs are approved by the TGA in Australia, many become available to patients via access programs. Under the Medicines Australia Code of Conduct, pharmaceutical companies are not allowed to communicate information about access programs, as it is deemed by Medicines Australia, the industry body, to be advertising.
There are stories of patients spending tens of thousands of dollars importing drugs that were available in Australia through an access program that they, and their clinician, were unaware of.
Professor John Zalcberg, who heads the cancer research program at Monash University, said the rules were being misunderstood.
“Clinicians would like to know when these compassionate programs exist and because of interpretations by the TGA and Medicines Australia — which I think are legitimate but they haven’t understood this as a problem — we can’t talk about these things,” he said.
The cancer expert has held talks with the TGA, Medicines Australia and the Medical Oncology Group of Australia and is hoping to find a solution.
Richard Vines, chief executive of Rare Cancers Australia, said: “I understand why there are restrictions but it has to be balanced. You have to be able to tell clinicians and advise patients (about these programs) — otherwise, what is the point?” he said.
A spokeswoman for Medicines Australia said: “The most appropriate way for a person to find out about and seek compassionate access for a breakthrough medicine is through their doctor,” she said.
“If a doctor believes that a particular therapy not available for their patient on the PBS would be the best treatment option then they can seek compassionate access from the relevant pharmaceutical company. This is a common approach that is utilised by many of our members at enormous cost to the individual company.”