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Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017

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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.

 

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.