Qare Pharmaceuticals

Formerly Paedpharm Pty Ltd.

Transparency Review Secretariat Therapeutic Goods Administration PO Box 100 Woden ACT 2606

10th February 2011

Dear Sir / Madam

Suite 302, Level 3, 75 Grafton Street Bondi Junction NSW 2022, Australia

PO Box 1674, Bondi Junction NSW 1355 T: 02 9300 1900 F: 02 9387 6654

www.carepharmaceuticals.com.au ABN 30 009 200 604 • ACN 009 200 604

We wish to comment on the transparency ofTGA processes and decision-making in relation to the way in which the TGA determines the classification of borderline therapeutic goods (medicine or medical device) and therefore determines the regulatory path to be followed and hence the data required to be submitted.

We recently had an initial meeting with the TGA regarding a vaginal gel which was proposed to be indicated (amongst other things) to assist in the prevention of bacterial vaginosis. The product works by reducing the pH of the vagina which inhibits the growth of objectionable bacteria and promotes the growth of desirable bacteria.

This product has been classified and approved as a medical device in Europe, with millions of tubes having been sold over a number of years. This product also meets the Australian definition of medical device. Our initial enquiry with the TGA's Office of Devices Blood and Tissues was regarding the animal origin requirements for one of the ingredients. We provided details of the product name, formulation and labels including directions for use.

The TGA alluded to the fact that the product may be considered a medicine, in response to which we prepared a justification for why the product was a medical device. A meeting was arranged to discuss the animal origin matter and the classification issue.

However it turned out that, after we had gone to the trouble and expense of arranging a meeting at the TGA with two senior Care staff and a consultant, including flights and accommodation, that the TGA had reviewed this exact same product about 11'2 years previously at the request of another prospective sponsor. It had already determined that, because, in its view the product had a chemical action, it was to be classified as a medicine not a medical device. The TGA did not dispute that the product met the Australian definition of medical device, it merely stated that the product met the definition of a medicine and their legal advice was that it should be classified as a medicine.

The issues we have regarding the transparency of the TGA processes and decision making are:

For the best of health

FESS· Painstop· Parachoc • Paedamin • Maybe Baby· Nasalate· Rectogesic

1. The TGA personnel involved were clearly aware that this product had been looked at in the past and the outcome of that process. Yet at no stage prior to our meeting did they mention to us either that it had previously been reviewed, or the outcome of that process. Such advice could have been provided much earlier either by phone call or e-mail. If we had known about this determination at an early stage our company could have been saved considerable time and expense in terms of the preparation for and costs associated with meeting the TGA in Canberra.

2. No proper reasoning was ever provided for the decision to classify this product as a medicine. The product may meet the definition of a medicine if it does in fact act by chemical means (which in itself could be disputed). However it still meets the definition of a medical device (this definition does not exclude products that act by chemical means). In this situation, there is no guidance as to why the TGA chose to insist that the product be regulated as a medicine. Surely if two pathways are available, the applicant should be able to select the one for which they have the better data package available.

3. Because the meeting was preliminary in nature and there was no application on foot, there is no appeal mechanism available to us as prospective applicants when we disagree with a fundamental decision such as this.

The only option available to us would be to submit a medical device application anyway, allow it to be rejected and appeal that decision. In this case that could only occur after a preceding step was achieved (obtaining a TGA Conformity Assessment Certificate for the manufacturer). Each of these steps would cost our company tens of thousands of dollars (at least) and months or years in time. The risk would be that even if we were successful in having this point of view recognised as correct, the TGA could choose to change the legislation to undo this outcome. As a small­medium sized company, we cannot afford to outlay money of this nature unless the outcome is likely to be favourable.

Therefore these fundamental decisions are able to be made in a way that is not transparent and not subject to challenge except via the very risky and expensive process outlined above.

4. In addition to the above, we note that there are two products included in the ARTG as medical devices which make claims on their labels and package inserts about bacterial vaginosis and appear (from the information provided with the products) to work by lowering vaginal pH. In other words they appear to have the same characteristics that, according to the TGA's advice, made our product a medicine, and yet they have been allowed to be included in the ARTG as medical devices.

The products concerned are ARTG No 143965 and ARTG No 156268 and copies of their ARTG records are attached. The products were included in the ARTG in 2007 and 2008 respectively as Class IIa medical devices. In the case of ARTG No 143965, the intended purpose specifically mentions maintenance of vaginal pH and helps prevent bacterial vaginosis. In our view, the TGA should have reviewed the status of these products as medical devices when our proposed product was first looked at 1 liz years ago. However, this does not appear to have occurred and, despite assurances

provided at our meeting in October 2010 that these products would be reviewed, they remain in the AR TG at the time of this submission.

The TGA's action (or lack of it) in relation to these products gives those products a considerable competitive advantage over several years now as they are able to be sold in circumstances which should be applicable to our product also, but which we have, in practical terms been told we are not able to access. In our view, these products should be treated in the same way as our product - either all are medical devices or all are medicines - so that a level playing field can be achieved.

These fundamental decisions (particularly about borderline products) are critical to whether it is commercially viable to introduce a product to the Australian market. Decision making in relation to the classification of these products should be able to be made in the absence of a full application as often it is this decision that will determine if it is commercially viable to proceed with the preparation of an application at all. Such a process should be .available and handled in a manner that is transparent and readily understood by all parties.

We respectfully request the review to recommend that TGA put in place transparent processes for dealing with fundamental questions such as the classification of a product before an actual product application is made. These processes should include providing proper reasons for the decision as to classification, based on the legislation, and include an appeal mechanism for situations where the applicant disagrees with the decisions made.

Yours sincerely

M~~ner Managing Director

TGA eBS

Public Summary r Summary for ARTG

kEntry:

I 143965 Aurora Pharmaceuticals Pty Ltd • Lubricant, patient, vaginal

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product type:

Status:

Approval area:

Medical Device Included Class lIa

Aurora Pharmaceuticals Pty Ltd Tla Omega Pharma

Level 1 116 Byfiled Street, NORTH RYDE, NSW, 2113 Australia

29/08/2007

Medical Device· Class lIa . Included

Active

Medical Devices

Conditions

The automatic conditions applicable to the inclusion of all kinds of medical devices in the Register are as specified in section 41 FN of the Therapeutic Goods Act 1989.

The standard conditions that are imposed under section 41 FO of the Therapeutic Goods Act 1989 when kinds of medical devices are included in the Register are as set out in the following paragraphs.

For a medical device included in the Register under Chapter 4 and imported into Australia, the Sponsor must ensure that information about the Sponsor is provided in such a way as to allow the sponsor to be identified.

Each sponsor shall retain records of the distribution of all of the sponsor's medical devices included in the Register under Chapter 4. In the case of records relating to a Class AIMD medical device, Class III medical device, or Class lib medical device that is an implantable medical device, the distribution records shall be retained for a minimum period of 10 years. In the case of records relating to any other device, the distribution records shall be retained for a minimum period of 5 years.

The sponsor of a medical device included in the Register under Chapter 4 shall keep an up to date log of information of the kind specified in Regulation 5.8.

It is a condition of inclusion in the ARTG that the sponsor of a medical device that is an AIMD, Class III or implantable Class lib provides three consecutive annual reports to the Head of the Office of Devices, Blood and Tissues, Therapeutic Goods Administration following inclusion of the device in the ARTG. (as specified in 5.8 of the regulations) Annual reports are due on 1 October each year. Reports should be for the period 1 July to 30 June. The first report following the date of inclusion in the ARTG must be for a period of at least six months but no longer than 18 months. Subsequent reports are to be provided on 1 October for a further 2 years. The annual report must include all complaints received by the manufacturer relating to problems with the use of the device that have been received by them over the year.

Where a medical device included in the Register, contains a substance which is included in the Fourth Schedule to the Customs (Prohibited Imports) Regulations or the Eighth Schedule to the Customs (Prohibited Exports) Regulations the Sponsor shall, at the time of importation or exportation of the medical device, be in possession of a licence and a permission for importation or exportation of each consignment of the goods as required by those regulations.

A sponsor shall ensure that a medical device within their control is stored and transported in accordance with the instructions and information provided by the manufacturer.

Manufacturers Name

Lil Drug Store Products Inc

Products I.

Address

1201 Continental Place NE Cedar Rapids

,IW,52402 United States Of America

~G

(J

C/l ~

S S

~----------------------------~I ~ ~ 11. Lubricant, patient, vaginal

Product Type Single Device Product

GMDN

Intended purpose

Page 1 of

Effective date 29/08/2007

34131 Lubricant, patient, vaginal

To be applied to the vagina to: help prevent Bacterial Vaginosis, maintain a healthy vaginal pH & reduce the risk of infections, eliminate vaginal odour and relieve itching & irritation.

Produced at 10.02.2011 at 06:03:12 EST This is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

~

Public Summary Summary for ARTG

. Entry:

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product type:

Status:

Approval area:

Conditions

156268 Advantage Health Care Pty Limited - Vaginal flora gel

Medical Device Included Class lIa

Advantage Health Care Pty Limited

PO Box 600, MORDIALLOC, VIC, 3195

Australia

28/10/2008

Medical Device - Class lIa - Included

Active

Medical Devices

;TGA eBS

The automatic conditions applicable to the inclusion of all kinds of medical devices in the Register are as specified in section 41 FN of the Therapeutic Goods Act 1989.

The standard conditions that are imposed under section 41 FO of the Therapeutic Goods Act 1989 when kinds of medical devices are included in the Register are as set out in the following paragraphs.

For a medical device included in the Register under Chapter 4 and imported into Australia, the Sponsor must ensure that information about the Sponsor is provided in such a way as to allow the sponsor to be identified.

Each sponsor shall retain records of the distribution of all of the sponsor's medical devices included in the Register under Chapter 4. In the case of records relating to a Class AIMD medical device, Class III medical device, or Class lib medical device that is an implantable medical device, the distribution records shall be retained for a minimum period of 10 years. In the case of records relating to any other device, the distribution records shall be retained for a minimum period of 5 years.

The sponsor of a medical device included in the Register under Chapter 4 shall keep an up to date log of information of the kind specified in Regulation 5.8.

It is a condition of inclusion in the ARTG that the sponsor of a medical device that is an AIMD, Class III or implantable Class lib provides three consecutive annual reports to the Head of the Office of Devices, Blood and Tissues, Therapeutic Goods Administration following inclusion of the device in the ARTG. (as specified in 5.8 of the regulations) Annual reports are due on 1 October each year. Reports should be for the period 1 July to 30 June. The first report following the date of inclusion in the ARTG must be for a period of at least six months but no longer than 18 months. Subsequent reports are to be provided on 1 October for a further 2 years. The annual report must include all complaints received by the manufacturer relating to problems with the use of the device that have been received by them over the year.

Where a medical device included in the Register, contains a substance which is included in the Fourth Schedule to the Customs (Prohibited Imports) Regulations or the Eighth Schedule to the Customs (Prohibited Exports) Regulations the Sponsor shall , at the time of importation or exportation of the medical device, be in possession of a licence and a permission for importation or exportation of each consignment of the goods as required by those regulations.

A sponsor shall ensure that a medical device within their control is stored and transported in accordance with the instructions and information provided by the manufacturer.

Manufacturers Name BioClin BV

Products

Address

Delftechpark 55

Delft, , 2628 XJ Netherlands

1~1_._v_a_g_in_a_'_f'_o_ra __ ge_' ______________________________________________________________________ 1 ~ ~ ~

Product Type Single Device Product

GMDN

Intended purpose

Page 1 of

Effective date 28/10/2008

47601 Vag inal flora gel

A herbal compound in the form of a gel in a portable container that is applied by the user in and around the vagina to normalize the vaginal environment and maintain a healthy vaginal flora.

Produced at 10.02.2011 at 06:04:28 EST This is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information