What is Happening with the Provisional Approval Pathway?

^{Posted on January 25, 2018}

We’ve come a long way

When the independent review of medicines and medical devices regulation was announced in October 2014, the pharmaceutical sector immediately saw the opportunity for an expediated approval pathway for certain prescription medicines.

A provisional approval pathway would allow certain promising new medicines to reach patients with unmet clinical needs earlier than might otherwise be the case, while ensuring appropriate measures are in place to manage the risks inherent in the fact that additional data are still required. The pathway could allow medicines to reach Australian patients up to two years earlier than under the current framework¹. This is similar to pathways now being utilised by the European Medicines Agency (EMA), US Food and Drug Administration (FDA) and Health Canada.

Fast forward to late 2017, and the review has been conducted and reported on, the government has responded to the many recommendations and the Therapeutic Goods Administration (TGA) has managed a huge volume of changes as a result. New or update regulatory processes have been implemented across all product categories and further reform continues.

But where is the much-anticipated Provisional Approval pathway?

Much work has been done by both the regulators and industry to prepare for the introduction of the Provisional Approval pathway to the point where draft guidance has been developed and undergone targeted consultation with relevant industry groups (November 2017).  Advice was that TGA planned for implementation this month (January 2018), or at least in first quarter this year, pending critical legislative changes passing through parliament.

The Therapeutic Goods Amendment (2017 Measures No. 1) 2017 incorporates the necessary legislative changes including creation of a new class of therapeutic goods (‘provisionally registered goods’) on the Australian Register of Therapeutic Goods (ARTG) and new provisions under which medicines eligible for the ‘Provisional Approval’ pathway may then be evaluated for provisional registration.

Also included in the Bill are amendments to the Therapeutic Goods Act facilitating, among other things:

• Reforms to the regulatory framework for complementary medicines, (including establishing a list of permitted indications and a new assessment pathway for listed complementary medicines);
• A more comprehensive post-market monitoring scheme;
• Broadening investigation and enforcement powers;
• Advertising requirement amendments; and
• Greater use of assessments of comparable overseas regulators;

It is the slow transition of this Bill through parliament that will push implementation of the provisional Approval pathway out beyond January 2018. On 30 November 2017 the Bill was referred to Senate Community Affairs Legislation Committee for enquiry and report, with the report being due on 2 February 2018.  It is understood that the impetus for referral of the Bill to the Senate Committee came from Greens Senator Richard Di Natale in response to consumer advocate objections to the proposed advertising provisions.

Submissions to the Senate Committee from Medicines Australia and other organisations have urged the Committee to support the proposed reforms including, if required, the separation of the relevant provisional approval provisions into a stand-alone Bill to ensure earliest possible access to promising treatments for Australian patients.  These submissions are consistent with the overall balance of responses which support the majority of the proposed Bill and highlight the advertising reforms as requiring further consideration by the parliament.

What happens next?

For now, we wait with bated breath until the Senate Community Affairs Legislation Committee releases its report on 2 February. It will be the content of that report that determines the immediate fate of the Bill and thus, the Provisional Approval pathway. Possible recommendations include the current Bill is to be passed without amendment or the Bill should be amended (including possible division into two separate Bills).

When the report is available, the Bill will be received by the Senate and continue to follow the standard progress of legislation.  The time taken for the Senate to consider a Bill can vary greatly from a single day, to many months.  Therefore, while the TGA may have established themselves in a good position to launch the new pathway, legislative hurdles still need to be overcome before implementation.