EXPLANATORY STATEMENT
Medicines Advisory Statements Amendment Specification 2015 (No.1)
Subsection 3(5A), Therapeutic Goods Act 1989
The Therapeutic Goods Act 1989 (the Act) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.
The Medicines Advisory Statements Specification 2014 (the Principal Specification) was made by the Minister under subsection 3(5A) of the Act in May 2014, and was registered on the Federal Register of Legislative Instruments on 11 June 2014. It sets out the advisory statements required to be included on the labels of certain medicines, if they contain particular ingredients (in most cases, this relates to active ingredients only).
The purpose of the Medicines Advisory Statements Amendment Specification 2015 (No.1) (the Amendment Specification) is to amend the Principal Specification to correct some minor errors and to make some changes to improve consistency and useability. No new requirements are being introduced by the amendments.
The Amendment Specification commenced on the day after it was registered on the Federal Register of Legislative Instruments.
BACKGROUND
Subsection 3(5) of the Act sets out a number of circumstances in which the presentation of therapeutic goods is considered to be unacceptable for the purposes of the Act including, for example, where the presentation of a therapeutic good states or suggests that the goods have ingredients, components or characteristics that they do not have, or where the label of the goods does not declare the presence of a therapeutically active ingredient.
One of these circumstances is, at paragraph 3(5)(ca) of the Act, where the therapeutic goods in question are medicines that are included in a class of medicine prescribed by the Regulations for the purposes of that paragraph, and where the medicine’s label does not contain the advisory statements specified under subsection 3(5A) of the Act in relation to the medicine.
Subsection 3(5A) of the Act authorises the Minister to make a legislative instrument specifying advisory statements in relation to medicine for the purposes of paragraph 3(5)(ca) of the Act.
The main kinds of medicines required to comply with the Principal Specification are over the counter medicines and complementary medicines. Prescription medicines and medicines such as radiopharmaceuticals and medical gases (that are not usually supplied directly to consumers), are not within the scope of the instrument.
The advisory statements set out in the Principal Specification are designed to address specific risks related to the use of medicines that have been identified via pharmacovigilance activities, testing, adverse event reports or other scientific or clinical information. Having advisory statements on medicine labels ensures that consumers are informed about these risks.
The Principal Specification is primarily based on the TGA document the Required Advisory Statements for Medicine Labels (the RASML). Schedule 1 of the Principal Specification consists of the current edition of the RASML, dated September 2008, and amendments to that document up to “Update 4”. Schedule 2 consists primarily of the RASML as amended by “Update 5” and “Update 6” of that document, which were provided for public comment in 2009 and 2011, respectively. Schedule 2 also contains some additional advisory statements, including for example statements which the TGA required sponsors of cough and cold medicines to include on their medicine labels as a condition of registration in 2012.
Sponsors of relevant medicines are only required to comply with Schedule 1 of the Principal Specification for the first 18 months after its commencement on 12 June 2014. Only after that initial 18 month period must sponsors comply with Schedule 2. Sponsors may, however, elect to comply with Schedule 2 during that initial 18 months if they wish to do so.
The Amendment Specification mainly corrects a small number of minor errors and inconsistencies in Schedule 2 of the Principal Specification.
Schedule 2 currently requires a number of non-steroidal anti-inflammatory drugs (NSAIDs) - diclofenac, flurbiprofen, ibuprofen, ketoprofen and naproxen – to carry certain advisory statements if they are for oral use in children or if they are for oral use generally including in children. The Amendment Specification would correct this to only require those statements if the products in question are for (or include) oral use in children under 12 years of age.
This qualification was inadvertently not included in Schedule 2 at the time of making the Principal Specification. Its inclusion now is consistent with advice the TGA gave to industry at that time, which was that the requirement for these NSAIDs to carry the new advisory statement “Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and vomiting” would only apply to such medicines that had paediatric doses.
The Amendment Specification also addresses the inadvertent inclusion in Schedule 2 of the Principal Specification of a restrictive advisory statement intended for oral NSAID medicines for indomethacin for external use and ketoprofen for dermal use, replacing it with the correct required statement for such topical preparations. The Amendment Specification also corrects unintended errors in the entries in Schedule 2 for selenium compounds and for hydroxyanthracene derivatives.
The Amendment Specification also removes an inconsistently applied requirement for some statements to be located immediately preceding the directions for use on some medicines (but not on others). No statements will now be subject to the requirement that they “be included immediately preceding the directions for use”.
In addition, the Amendment Specification makes a small number of minor, editorial amendments to the Principal Specification to improve readability.
CONSULTATION
The TGA invited comments on the proposed amendments via the TGA’s website on 16 March 2015. Three submissions were received, and all supported the proposals.
The Specification is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
In relation to compatibility with human rights, it is considered that the Specification is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011, and a Statement of Compatibility setting that out in further detail is below.
SUPPLEMENTARY MATERIAL - STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS FOR A LEGISLATIVE INSTRUMENT THAT DOES NOT RAISE ANY HUMAN RIGHTS ISSUES
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Medicines Advisory Statements Amendment Specification 2015 (No.1)
This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
The Medicines Advisory Statements Amendment Specification 2015 (No.1) (the Amendment Specification) is made by the Minister under s.3(5A) of the Therapeutic Goods Act 1989, and makes minor corrections and editorial changes to the Medicines Advisory Statements Specification 2014 (the Principal Specification).
The Principal Specification sets out advisory statements required to be on labels of prescribed kinds of medicines (mainly, those other than prescription medicines or certain medicines used mostly in hospitals, e.g. radiopharmaceuticals). These advisory statements are intended to help consumers be aware of important safety information, and to assist them to make informed decisions on medicine selection and safe use.
The Amendment Specification corrects a small number of inadvertent errors in the Principal Specification, mainly to do with clarifying that certain requirements relating to the labelling of some non-steroidal anti-inflammatory drugs (NSAIDs) for use in children only apply if those products are for use in children under 12 years of age. A small number of minor, editorial changes are also included, in particular to improve consistency and useability of the Principal Specification.
Human rights implications
This legislative instrument does not engage any of the applicable rights or freedoms.
Conclusion
This legislative instrument is compatible with human rights as it does not raise any human rights issues.
Dr John Skerritt, delegate of the Minister for Health