Guest Blog by Robert Stringer
In late June, the Federal Government released the Stage 1 report on the Review of Medicines and Medical Devices Regulations, conducted by Emeritus Professor Lloyd Sansom AO, Mr Will Delaat AM and Professor John Horvath AO. This, being the first of 2 reports, focusses specifically on prescription and over-the-counter medicines and medical devices, with Stage 2 addressing complimentary medicines and the advertising framework for therapeutic goods.
The TGA is Here to Stay
First and foremost, the report recommends that Australia retain its capability to assess medicines and that the Federal Government retains the responsibility of determining what products are acceptable for inclusion on the Australian Register of Therapeutic Goods. The spectre of Australia simply adopting approvals from other countries or outsourcing evaluation to a non-government organisation, possibly in line with the Federal Government’s “red tape buster” approach, appears to have disappeared.
Changes to Prescription Medicines Evaluation
Does anyone remember the Baume Report?
The current report makes a number of recommendations to streamline the evaluation processes for New Chemical Entities (NCEs) and new generic and biosimilar products. One of the key recommendations is the creation of a truncated evaluation pathway for applications that have been previously approved by other regulatory agencies and involves sponsors submitting the international evaluation reports with their application. For those whose memories stretch back to 1991 when the last major review of the regulatory framework was undertaken, this is clearly a resuscitation of the Category 2 registration pathway. The devil will be in the detail here as to whether the new approach will meet with more success than the pathway not really trodden. Of course, the fundamental problem of actually obtaining full un-redacted overseas evaluation reports has not been addressed. Furthermore, this approach relies on the proposed products having been already approved internationally, an approach that is not in alignment with rapid patient access to new medicines in Australia.
Priority Review for Breakthrough Medicines – would you like conditions with that?
Common to many of the submissions to the review was a request for the TGA to create a formal priority review process for breakthrough medicines. The report recommends such a pathway, which is suggested to be “provisional and time-limited”, with specific conditions placed on the approval covering subsequent data requirements. It also calls for stakeholders to work on criteria by which to determine breakthrough status, with a view to harmonisation with those of other comparable agencies. Will this actually result in faster access to patients? Hard to say, as how the PBAC views these approvals, presumably based on a more limited data set, remains to be seen…
Back to the Future for Variation Applications
The report recommends that the risk-based regulatory framework continue to be adopted for regulatory change applications, with the concept of self-assessment versus prior approval requirements being based on the level of potential risk. Interestingly, this actually was the approach until around 2012 when the TGA (apparently after a second look at the enabling legislation) decided that self-assessable notification may be unlawful. This recommendation to go back to the future will surely be received well by the regulatory and supply teams across the country!
Non-prescription Medicines – Nothing to see here, folks
While non-prescription regulation was within the scope of the review, the report is silent on any changes, with the exception of recommendations to clarify the re-scheduling process and move the scheduling committee to become a sub-committee of an “Advisory Committee on Medicines” (akin to the current ACPM). Sponsors of OTC products received little joy in reducing the barriers to direct to consumer advertising for Schedule 3 medicines but hope remains since advertising therapeutic goods (and also review of listable OTC medicines) form the basis of the Stage 2 report so further recommendations on this may be forthcoming.
Overarching Regulatory Framework and TGA Structure
In addition to recommending that all products on the ARTG be examined to determine whether they really should be regulated by the TGA, and a recommending a wholesale rewrite of the enabling legislation by the Australian Law Reform commission to improve clarity, the report also proposes some significant changes to the TGA structure, as follows:
Enabling Improved Dialogue – Talk the talk
The report identifies that direct dialogue between sponsors and the TGA is at times challenging (for various reasons) and suggests that removing the actual decision making away from the evaluators and assigning it to the Chief Medical Officer will help improve this situation. While this could work, the separation of review and decision may create more fundamental challenges in terms of the clarity of decision making. It will be interesting to see how this new approach is defined.
Other Stakeholders on the Advisory Committees – Handbags at 20 paces?
The report recommends that the new peak advisory committee (i.e. to replace ACPM) should include consideration of input from “interested parties” (i.e. not just the TGA and the sponsor). This is an intriguing proposition. Could a competitor be considered an interested party? If so, how would their input be obtained?
Funding Models – is 100% cost-recovery on the outer?
The report draws attention to the unusual nature of the TGA being 100% industry funded (a model that is at odds with international practice) and suggests that other approaches may be more appropriate. “Add GST to medicines” do we hear…
The Federal government has been relatively quiet on the report recommendations (apart from a couple of pot-shots at NCE sponsors blaming them for Australian patients having delayed access to new medicines). Perhaps they are waiting for the Stage 2 report which is due out in the next few months. Should the Minister for Health wish to accept the proposed changes, there will be a lot of work to do in Canberra so things are unlikely to happen quickly.
This article was written by Robert Stringer. Robert is a pharmacist with more than 20 years’ experience in the Australian and New Zealand pharmaceutical industries, having held leadership roles in regulatory affairs, clinical research and strategic development functions in a number of international companies. He is the managing director at Brandwood Biomedical’s partner Capital K Consulting Pty Ltd (www.capitalk.com.au), a boutique regulatory affairs and lifecycle management company based in Sydney Australia, which provides strategic and operational services to ethical, consumer and generic pharmaceutical organisations.