In Part 1 of this series (available here), we examined the impact of the proposal by Australia’s Therapeutic Goods Administration (TGA) to provide early confidential notification to innovators of applications under evaluation for generic and biosimilar product registration. In this Part 2, we focus on the TGA’s other proposed reform, the earlier publication of applications for marketing approval relating to major innovator prescription medicines. The TGA is currently seeking feedback on its Prescription Medicines Transparency Measures by 9 June 2020. The proposed reforms relating to publication of major innovator applications are aimed at providing better access to information on new prescription medicines for healthcare professionals and the general public, but will also have important implications for both innovators and the sponsors of generic and biosimilar medicines, including from a patent perspective.
In February 2019, the TGA released its initial consultation paper entitled Whether the TGA should publish that a prescription medicine is under evaluation, seeking feedback from industry and other interested parties on whether, and if so how, the TGA should disclose that an application for marketing approval for a prescription medicine has been accepted for evaluation. The submissions received showed a consensus of support for early publication of all prescription medicines being evaluated for marketing approval in Australia, with many submissions noting that Australia’s current approach is out of step with the practices of overseas regulators including Medsafe New Zealand, Health Canada and the European Medicines Agency (EMA), all of whom publish information on all prescription medicine applications accepted for evaluation.
The longstanding practice of the TGA has been to treat the submission of an application for marketing approval for a prescription medicine as confidential unless and until the product has been approved and entered on the Australian Register of Therapeutic Goods (ARTG). In practice, this has meant that the TGA will only state that it can “neither confirm nor deny” receipt of an application for registration of a new prescription medicine, including for reasons of commercial confidentiality. Efforts to obtain access to information or documents from the TGA under the Freedom of Information Act 1982 (Cth) proved futile for a patent owner in Secretary Department of Health and Ageing v iNova Pharmaceuticals (Australia) Pty Limited  FCA 1442 (21 December 2010). However, some exceptions to this general rule may apply in specific circumstances. For example:
- The meeting agenda for Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) is published 2-3 months ahead of each meeting. The meeting agenda may identify applications for marketing approval that are under evaluation by the TGA.
- The TGA publishes the outcome of the process to designate orphan drug status or to determine a drug’s priority or provisional status, which occurs prior to the acceptance of the drug for evaluation.
- Where the TGA and an overseas regulator are jointly conducting the review of a prescription medicine, the overseas regulator may publish that the drug is under active review.
Additionally, the sponsor of the innovator medicine retains the discretion to make public, at any time, that its application for marketing approval is being considered by the TGA.
The TGA’s proposal
Under the reforms proposed, commencing as early as June 2020, the TGA will publish information on the following application types:
- Type A – new medicines (i.e., new active pharmaceutical ingredient (API));
- Type B – new combinations of medicines (contains at least one new API); and
- Type C – new indications for an existing approved medicine.
It is proposed that, within one month of the date that an application for marketing approval falling within one of the categories above has passed preliminary assessment, the TGA will publish the:
- Sponsor name;
- Product name;
- Proposed indication; and
- Application type.
Implications for the pharmaceutical industry
Advance notice of applications for registration of a new drug or new indication for an approved drug will be valuable to generic and biosimilar sponsors, and competitor innovators, in some circumstances. Earlier notification of these products and indications may inform decision-making and planning by competitors with respect to their own products and timelines to market. This could impact competitors’ research and product development priorities, product identities and dosage forms, and strategies for potentially challenging an innovator’s patents (either proactively or defensively).
Innovators should also be mindful of the potential consequences of earlier publication for their patent portfolios. In particular, it will be increasingly important for innovators to ensure that relevant patent applications for specific indications, second medical uses or specific formulations, dosage forms or production processes are filed prior to the TGA publishing key details early in the process for obtaining regulatory approval. The early publication of key details such as the compound, dosage regimen and indications by foreign regulatory authorities, including the US Food and Drug Administration (FDA), have created novelty and inventive step issues for Australian patents relating to specific indications or second medical uses in several cases in recent years, which could not benefit from Australia’s “grace period” provisions.
If you are a sponsor of therapeutic goods in Australia and have questions on how these reforms may impact your business, please do not hesitate to contact us.