Commonwealth of Australia Explanatory Memoranda

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THERAPEUTIC GOODS AMENDMENT (2017 MEASURES NO. 1) BILL 2017

                                           2016-2017



          THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA




                             HOUSE OF REPRESENTATIVES




   THERAPEUTIC GOODS AMENDMENT (2017 MEASURES NO. 1) BILL 2017




                                    ADDENDUM TO THE

                             EXPLANATORY MEMORANDUM




This addendum responds to concerns raised by the Senate Standing Committee for the
Scrutiny of Bills in Scrutiny Digest No. 12 of 2017, dated 18 October 2017.




 (Circulated by authority of the Minister for Health and Minister for Sport, the Hon Greg Hunt MP)
SCHEDULE 1: Provisional registration of medicines

At the end of items 14 to 17 - add:

In seeking a review, consumers would not have access to the same information as the TGA,
given the nature of the evidence available. The Secretary's decision to provisionally register a
medicine requires that he or she be satisfied, on the basis of preliminary clinical data, that the
safety and efficacy of the medicine have been satisfactorily established. This decision will be
based on highly technical data, and will require a high degree of expertise, given that the
safety and effectiveness of the medicine will only be able to be judged in relation to a limited
number of patients and perhaps on surrogate endpoints. TGA has access, through its
Committees, to medical experts who can provide advice to the Secretary to assist in making
these decisions and may consult with other regulators.

Public information available to consumers or consumer groups about the merits of the
medicine will be limited, as information about the product will be confined to the preliminary
data obtained by the applicant, or may be commercial-in-confidence. Consumers may not be
able to access a comparable degree of medical expertise to successfully challenge such a
decision. Further, as applicants will be best placed to advocate in respect of their products,
the targeting of review and appeal rights to applicants is likely to benefit consumers where
the exercise of such rights by applicants is successful. Consumers and consumer groups will
not be prohibited from supporting a sponsor appealing against a decision.

This approach to appeal rights will be balanced by increased transparency of decision-making
in relation to provisional registration, including publication of provisional approval
determinations; rapid publication of TGA decisions relating to provisional registration; and
full details of decisions relating to provisionally registered medicines in the Australian Public
Assessment Reports (AusPARs) for prescription medicines. The criteria for the Secretary's
decisions to grant or refuse to grant a provisional determination are intended to be set out in
amendments to the Therapeutic Goods Regulations 1990, which will also be subject to
Parliamentary scrutiny.

Information is intended to be published on the TGA website in relation to such matters as the
automatic lapsing of provisional registration; the extension, suspension or cancellation of
provisional registration; and the transition from provisional to full registration. It is intended
that health professionals and consumers will have transparency of TGA decision-making
processes to inform their treatment decisions and maintain confidence in the TGA's
regulatory standards. Meetings with sponsors prior to submission of applications are intended
to clearly set out the requirements of the application process, and to minimise the chance that
an application will be refused by the Secretary.

If the Secretary decides that a medicine is not suitable for provisional registration, but
individual patients still wish to access the medicine, there are a number of other methods by
which patients may obtain that medicine. The Special Access Schemes (Categories A and B)
and the Authorised Prescriber Scheme provide ways for patients to access medicines which
are not on the Australian Register of Therapeutic Goods, provided their medical practitioner
believes that they are suitable for the patient. A product at this stage of its development may
also be the subject of continuing clinical trials within Australia.




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Under existing processes for registration, there have not been any AAT appeals by consumers
or consumer groups against decisions not to register medicines in at least the last 10 years.

Introducing a system of provisional registration is intended to enable promising new
medicines to proceed to market more quickly. It is estimated that as a result of these
measures, some new medicines may be able to be provisionally registered up to two years
earlier than under the current framework providing clear benefits to very sick patients.
Limiting appeal rights to applicants is intended to give greater certainty and finality to
applicants, expedite decision-making, and ensure that resources are directed to considering
new applications. A negative decision does not preclude future applications for provisional
determination by the sponsor, nor future applications by the sponsor as further clinical data
becomes available.

SCHEDULE 2 - Indications and ingredients for listed medicines

At the end of item 19, add:

The Bill represents the second stage of the legislative response to the Expert Panel Review of
Medicines and Medical Devices Regulation (the Review). Subsection 60(2B) of the
Therapeutic Goods Act 1989, which was inserted into the Act as part of the first stage of
legislative reform, limits appeal rights to the applicant where the Secretary decides not to
recommend that the Minister amend the determination setting out permitted ingredients for
complementary medicines. This was consistent with the recommendations of the Review, in
which the Expert Panel suggested that uncertainty could be overcome if:
      " ... review and appeal rights are restricted to the person who made the application
      only. This approach would allow for appropriate review of such decisions whilst
      ensuring that the [TGA] was not exposed to review requests from a potentially large
      class of people, tying up [TGA] resources in responding to appeals."

Consistently with the approach taken in relation to applicants for permitted ingredients, and
for the same reasons, review rights for new permitted indications are limited to the applicant
(Schedule 2, Item 19, new subsection 60(2C)). Third parties who might wish to object to a
permitted indication will be able to do so once a product with that indication appears in the
marketplace by lodging a complaint with the TGA. This will provide a means for consumers
to voice their concerns and potentially have a review undertaken.




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