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Submissions received and next steps: Management and communication of medicines shortages

27 June 2018

The TGA would like to thank respondents who provided submissions in response to the public consultation: Management and communication of medicines shortages.

A total of 50 submissions were received. Of the submissions received:

  • 2 were from government bodies
  • 18 were from industry suppliers/sponsors/manufacturers
  • 5 were from industry organisation
  • 16 were from health professionals, medical institutions or health professional bodies
  • 9 were from consumers or consumer organisations.

All submissions that gave permission to be published on the TGA website are now available below in PDF format.

Consultation outcomes summary

The TGA undertook public consultation between 28 March and 30 April 2018 on changes to the management and communication of medicines shortages. The specific matters under consultation were: the definition of a medicine shortage; medicines in scope for mandatory reporting; proposed reporting timeframes and content of notifications; the proposed list of medicines on the 'Medicines Watch List' of critical medicines; and proposed penalties for non-compliance. The TGA also sought feedback on the new Protocol for the management and communication of medicines shortages more generally.

Virtually all stakeholders supported the need for better management and timely communication of medicine shortages.

Consumer stakeholders confirmed the need for timely and accurate information to be communicated to consumers who are affected by a medicine shortage; and supported the proposed definition of a medicine shortage.

Health professional bodies supported the proposed definition of a medicine shortage, the reporting obligations and the proposal that all information on a critical shortage be reported within a 2 day timeframe. They supported the purpose of the 'Medicines Watch List' and, in general, advocated for the stricter (criminal) penalties set out in the consultation paper.

Industry stakeholders raised concerns with some of the consultation paper proposals. Their view was that the definition of a medicine shortage was unclear and unnecessarily broad. Furthermore, whilst they agreed that all medicines shortages should be reported by sponsors as soon as practicable after becoming aware, their view was that there may be instances where it is not possible to report all of the necessary information within 2 business days. Some stakeholders preferred a 5 day reporting period for critical shortages. Furthermore, industry stakeholders were not convinced a penalty scheme was necessary; and unanimously stated that criminal sanctions were too severe.

Next steps

The TGA has considered stakeholder feedback and has made a number of revisions to the proposed mandatory reporting scheme.  The revisions detailed below are designed to strike a balance between the needs of those stakeholders impacted by medicines shortages who need prompt information with which to manage the response to the shortage and making the scheme practical and workable for those stakeholders responsible for reporting shortages.  The amendments proposed to TGA's therapeutic goods legislation to enable implementation of the new scheme reflect these changes.

Medicine Shortage definition

The definition of a medicine shortage has been revised to state that there is a shortage of a medicine in Australia at a particular time if the supply of that medicine in Australia will not, or will not be likely to, meet the demand for the medicine at any time in the next 6 months for all of the patients in Australia who take, or who may need to take, the medicine.

This addresses concerns by some stakeholders that a local shortage, rather than a national one, could have been classed as medicine shortage under the previous definition. It also removes the subjectivity associated with determining if a patient's care needs to be adjusted due to the shortage

Medicines Watch List

There will be a new 'Medicines Watch List' created as a legislative instrument. This will provide transparency and certainty for sponsors and other stakeholders in relation to the reporting obligations for medicines included on the list, while also providing the flexibility to amend the list to ensure it continues to reflect medicines deemed to be of critical importance. Medicines will be included on the basis that if there was any shortage of, or permanent discontinuation of the supply of, the medicine in Australia, that this could result in:

  • significant morbidity in relation to patients in Australia or
  • the death of one or more patients in Australia.

Reporting obligations

Reporting obligations will require sponsors to provide key information only (name of the medicine, reason for the shortage, expected start date of the shortage and an anticipated end date) to the TGA within 2 working days of becoming aware of a medicine shortage.  Sponsors will be requested to provide the remaining information within the following 3 working days for medicines on the 'Medicines Watch List' and for medicines which are deemed to be of critical impact. This will address industry's concerns and will maintain the timeliness sought by health professional groups for reporting of critical medicines shortages. All other shortages must be comprehensively reported to the TGA within 10 working days of the sponsor becoming aware of the medicine shortage.

For discontinuations of medicines that are likely to be of critical impact, sponsors will be required to report the discontinuation at least 12 months before it is proposed to occur. In instances where sponsors are unable to comply with this timeframe, then it must be reported as soon as practicable after the decision to discontinue is made. If the discontinuation is not likely to be of critical impact, sponsors must report the discontinuation at least 6 months before the discontinuation is proposed to occur. In instances sponsors are unable to comply with this timeframe, it must be reported as soon as practicable after the decision is made.

Penalties for non-compliance

Amendments to the legislation are proposed to allow for a new civil penalty provision which applies where a person contravenes the reporting requirements. Contravention of this provision will attract a maximum penalty of 100 penalty units for an individual, and 1,000 penalty units for a body corporate.  Compliance measures in relation to these new reporting obligations will be in accordance with the TGA's Regulatory Compliance Framework. The TGA will continue to take a graduated, risk-management approach to compliance that attempts to identify persons at risk of unintentional or deliberate non-compliance and enable the development of appropriate strategies to prevent non-compliance. A graduated approach in this regard, including activities to raise awareness and understanding of the new scheme, will allow the TGA to respond appropriately to the full range of non-compliant behaviours. Regulatory measures available to the TGA for a breach of these reporting obligations will range from the publishing of the names of sponsors who do not comply with the new requirements, to the issuing of infringement notices and, in the most serious cases or where there is repeated non-compliance, the initiation of civil penalty proceedings.

The Protocol for the management and communication of medicine shortages

The Protocol is also being revised as a result of consultation feedback received. We will undertake further targeted consultation on the Protocol to ensure it clearly articulates the new requirements for those stakeholders responsible for the reporting, communication and management of medicine shortages.

Submissions

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