Building a more robust medicine supply: proposals to help prevent, mitigate and manage medicine shortages

We asked for feedback on proposals to help ensure the ongoing, reliable supply of important medicines in Australia. Four proposals were consulted on which sought feedback on medicine shortage mitigation or management strategies that would:

• prioritise the evaluation and registration process for certain important generic prescription medicines, to reduce the risk of shortages
• encourage registration of more generic versions of medicines known to be affected by shortages, to mitigate the impact of those shortages
• support a more reliable supply of overseas-registered medicines imported into Australia as substitutes through an annual charge waiver when the Australian-registered medicine is in longstanding or repeated shortage.

We received 47 submissions in response to consultation from industry organisations and peak bodies, health professionals or heath professional organisations, consumer groups and individuals. Respondents provided a range of views and suggestions.

There was general support to enable import of overseas substitutes for discontinued medicines by granting annual charge waivers (proposal 4). Concerns were raised that the charge waiver may negatively impact fairness and sustainability of the TGA cost recovery system by shifting the waived annual charge cost onto other medicine sponsors. A concern was raised that this proposal will increase confusion for patients and healthcare professionals since more discontinued products would be included on the Australian Register of Therapeutic Goods (ARTG), in order to allow the import of overseas substitutes.

Views were mixed on incentivising registration of medicines known to be in repeat or longstanding shortage (proposals 2 and 3). Some stakeholders raised that incentivising registration is unlikely to address the larger issue of shortages. Once registered, there is no guarantee of medicine supply, nor will the proposals overcome other barriers to supply, such as manufacturing issues. Concerns were raised that long term stability of supply is driven by commercial viability, and that TGA fees are not the major factor driving commercial viability. Waiving the fees would therefore have limited impact on supply of medicines. Some stakeholders identified evidence requirements as a barrier to registration, whereas others raised that changes should not result in reduced TGA submission standards.

Overall support for prioritising the registration of new generic medicines was poor (proposal 1). Stakeholders raised that prioritisation of new generics might displace existing products from the market thus failing to address the aim to create a more robust medicine supply. In addition, the TGA evaluation time was not seen as an impediment to the availability of generic products in Australia.

Since public consultation commenced in March 2021 two complementary strategies have been introduced that directly address the issue of medicine shortages.

• The Medicine Supply Guarantee was announced by the Health Minister late in 2021 to better protect patients against supply chain volatility. Medicine companies have committed to hold additional onshore stock of certain medicines, for at least four to six months’ supply.
• The Serious Scarcity Substitution Instruments (SSSIs) were introduced in 2021 and are a powerful tool to help patients receive their medicines from their pharmacist without delay, and also provide better treatment continuity during a medicine shortage. Additionally it relieves workload pressure on prescribers and pharmacists. The instruments allow community pharmacists to substitute specific medicines without prior approval from the prescriber.

In response to the consultation feedback, and the changed regulatory environment we have decided:

• We will initiate amendments to the Therapeutic Goods Act 1989 which, subject to policy approval and passage of legislation, would support import of overseas substitute medicines if the Australian medicine has been discontinued and cancelled from the ARTG. Currently the Australian medicine must be registered to allow the import of a substitute from overseas. This change would ensure continued supply of substitutes for discontinued medicines without the additional regulatory burden of requiring registration or an annual charge waiver for a medicine that has been discontinued.

• We will address barriers to registration by creating a web-based information hub to assist sponsors, including those less experienced in registration of prescription medicines that are subject to, or vulnerable to shortage. The hub will feature access to individual pre-submission advice such as early scientific advice. Existing requirements and standards for applications continue to apply.
   
• In certain circumstances prioritising evaluation of prescription medicine registration applications vulnerable to shortage can prevent or reduce the period of shortage. We will prioritise the start of evaluation for registration applications that are identified to prevent or address a medicine shortage if it is in the interest of public health. Prioritisation will occur following application lodgement on a case-by-case basis, within constraints of existing processes and resources. Existing legislated time frames for evaluation continue to apply to all registration applications.