Tony Zappia (Makin, Australian Labor Party, Shadow Assistant Minister for Medicare) Share this | Link to this | Hansard source

The Therapeutic Goods (2018 Measures No. 1) Bill 2018 amends the Therapeutic Goods Administration Act 1989, primarily to introduce a mandatory reporting scheme for medicine shortages and medicines that will be discontinued. The bill also includes a number of minor unrelated amendments to the act to improve regulatory efficiencies.

Presently, there is a voluntary notification scheme known as the Medicine Shortages Information Initiative, or MSII, which, along with its website, was launched in 2014. Whilst this voluntary notification scheme was a positive step, the need for a mandatory reporting scheme for medicine was clearly demonstrated by the recent EpiPen shortage. Indeed, there are still ongoing issues with the supply of EpiPens, with the TGA's latest update on 6 August advising of 'a continued constrained supply'. My understanding is that, although the supplier was aware of a short-term interruption to the supply of EpiPens in November 2017, this was not reported to the TGA until January of this year. I understand that supply interruption was due to manufacturing delays. Fortunately, it appears as though the version of the pen for children was unaffected, with the shortage being confined to EpiPens for adults. EpiPen was the only adrenaline autoinjector available in Australia. Adrenaline is a life-saving medicine for people who are at risk of a serious allergic reaction known as anaphylaxis. Anaphylaxis can be life threatening and, for those who are at risk, the trigger is often an allergy to a food, a medicine or an insect sting.

Right now in this parliament, there is a meeting of the National Allergy Strategy Steering Committee talking about these very matters. I welcome that committee to the parliament and congratulate it on the work that it has been doing over recent years—in particular, Professor Richard Loh, Ms Maria Said and the National Allergy Strategy Coordinator, Sandra Vale—trying to bring to the public attention the issues surrounding anaphylaxis—matters of awareness, education and training, prevention and management. Now, perhaps, creating a national database of people who have suffered an anaphylactic episode would also be a good idea. I understand that there is a database that is now held by the Victorian government. They have started that initiative, but it is perhaps something that could be rolled out across the country. That discussion is taking place right now. As one of the two co-conveners of that group, I'm pleased to be speaking about this legislation at a time that they are here in Parliament House and to lend my support to their discussions that will take place over the next hour or so.

Some users of the autoinjectors that I referred to earlier on are advised to carry them at all times. As with most medicines, EpiPens have an expiry date. That means that those who need them need to obtain new ones every so often, even if they haven't actually used their autoinjector. Shortages are not uncommon. There was a worldwide shortage of meningococcal B vaccine which hit Australia in 2016. I'm not suggesting that this was a failure of voluntary reporting. However, the minister may be able to advise whether that shortage was or was not reported through the voluntary scheme. The meningococcal B vaccine is still on the agenda, with a question in this place only this week about its inclusion on the National Immunisation Program. Prior to the South Australian state election, the former state Labor government had committed to providing that vaccination for free to all South Australian children aged two and under. I acknowledge that the new South Australian government has now also followed state Labor's lead.

Whilst I appreciate there are legal requirements which the Prime Minister, in his answer earlier this week, described, there are also precedents to facilitate faster access. In 2001, the Howard government bypassed the PBAC to subsidise the breast cancer drug Herceptin. In 2006, approval for Gardasil's HPV vaccine was fast-tracked after pressure from then Prime Minister John Howard. Presumably, the federal government could also fund the states to provide the vaccine, if it so wished. This matter of the meningococcal B vaccine is one that needs to be addressed, and I have just cited some examples in previous years where the government acted quickly to address matters of public health concern.

I return to the substance of this bill. In their submissions during the government's consultation on a mandatory scheme, the Pharmaceutical Society of Australia said:

Despite the launch in 2014 of the Medicine Shortages Information Initiative (MSII) to assist with information on prescription medicine shortages, generally pharmacists have not found it to be the most helpful resource in terms of the currency and timeliness of information. It has not adequately supported professional practice for pharmacists who have a core role in assisting with continuity of therapy and care for patients.

Repeatedly pharmacists have reported of a mismatch between information made available through the MSII and the actual medicine stock availability situation they have encountered through wholesalers. Issues pharmacists have raised with PSA included:

As the primary point of contact with patients in the supply … of medicines, information relating to the availability of a prescription medicine and the reasons behind any shortage situation are critical for pharmacists. Patients, carers and families can experience significant stress when they cannot receive their medication in a timely manner. The situation is worsened if the pharmacist is unable to provide accurate information regarding the expected length of shortage period or steps that could be taken to source an alternative medicine. Accurate and timely communication with the prescriber is also critical in such circumstances, particularly where decision-making around change in ongoing therapy may be required.

That sums up why we need to have a compulsory reporting system in place. As the Pharmaceutical Society quite rightly point out, information about medicine availability is critical and medicine shortages can be very stressful to patients.

We live in a world with increasing globalisation, and, in many sectors of the economy, this has led to manufacturing moving overseas. This is also true in the pharmaceutical sector and means that we are now more reliant on events and decisions which occur overseas. Furthermore, a number of different brands of a particular medicine, all of which contain the same active ingredient, are sometimes manufactured in one facility. Where this occurs, if there is a manufacturing disruption, several different brands may all be affected at the same time. We should, therefore, be ready to expect more supply disruptions to medicines than was the case in the past. It is obvious that knowing as soon as possible about medicine shortages or discontinuations of supply will enable patients, health professionals and public health authorities to source alternatives earlier or at least better plan for and manage the shortage. For all of these reasons, and given that the voluntary scheme is unsatisfactory, a mandatory scheme is considered necessary.

Sharon Claydon (Newcastle, Australian Labor Party) Share this | Link to this | Hansard source

The debate is interrupted in accordance with standing order 43. The debate may be resumed at a later hour, and the member for Makin will be given leave to continue speaking when the debate is resumed.