Therapeutic Products Bill HEALTH PRACTITIONERS FORUM 22 March 2019

Today’s team Sheila Swan – Chief Advisor, Regulatory Policy, MoH Hannah Adams – Senior Analyst, Regulatory Policy, MoH Susan Martindale – Principal Policy Analyst, MoH Pamela Randell – Project Coordinator, MoH

Agenda Item 1 Overview of the intended therapeutic products scheme: Regulatory instruments, product coverage, key controls, types of authorisations 2 Approach for authorising prescribers 3 Approach for unapproved medicines 4 Health practitioner prescriber authorisations 5 Health practitioner authorisations Tea and coffee 6 Other authorisations 8 Personal imports 9 Use or supply-restricted devices 10 Advertising controls 11 Next steps te

Overview of the intended therapeutic products regulatory scheme

Purpose & Design Purpose: The purpose of this Act is to protect personal and community health by- (a) ensuring acceptable safety, quality, and efficacy or performance of therapeutic products across their lifecycle; and (b) regulating the manufacture, import, promotion, supply, and administration or use of therapeutic products. Design Principles-based framework with three subordinate tiers.

Guiding principles The Regulator and any other person exercising a power under this Act must be guided by the purpose of this Act and the following principles: (a) the likely benefits of therapeutic products should outweigh the likely risks associated with them: (b) regulation of therapeutic products should- (i) be proportionate to the risks posed by the products; and (ii) support the timely availability of therapeutic products: (c) the administration of this Act should be carried on in an open and transparent manner: (d) there should be co-operation with overseas regulators, compliance with international obligations, and, if appropriate, alignment with international standards and practice.

There will be less detail in legislation and more in the regulations and regulator-made instruments Content Process Therapeutic Products Act Primary legislation sets out: the purpose of the Act provides a set of principles and criteria to set the parameters of the regulatory regime sets boundaries for the scope and development of subordinate legislative instruments contains the primary elements of the regulatory regime provides enforcement powers sets out accountability arrangements Legislative instrument, made by Parliament  Regulations Regulations will contain further detail on: matters not appropriately dealt with in regulator-made instruments (such as fee setting) matters to do with accountability key elements of the regulatory regime that will remain relatively stable and which are significant to the design of the regulatory requirements Schedule 3 lists the matters that can be specified in regulations Legislative instrument, made by the Governor-General by Order and Council Regulations will be subject to review by the Regulations Review Committee Rules Contain the detail of the regulatory requirements Schedule 3 lists the matters that can be specified in rules Legislative instrument, made by the regulator Subject to review by the Regulations Review Committee Notices Contain administrative detail of the scheme Schedule 3 lists the matters that can be specified in notices Non-legislative instrument, made by the regulator The regulator must not issue a notice unless satisfied that doing so if necessary or desirable to promote the purposes of the Act; and it is no broader than is reasonable necessary to address matter that gave rise to it

A wider range of products would be covered The new system would regulate: Medicines This includes cell and tissue products and radiopharmaceuticals Medicines will continue to be classified: category 1 (prescription), category 2 (pharmacist), category 3 (pharmacy), category 4 (general sale) Active Medicinal Ingredients Defined separately from medicines, so a smaller set of controls can be applied to them Medical devices Type-4 products This is a catch all category for future therapeutic products that we don’t know about yet It will ensure the Regulator has the ability to apply regulatory requirements, as appropriate, when these products start coming to market The Government will be considering regulation of natural health products as a separate process.

The scheme would consist of two broad components Product approval requirements Generally a TP can’t be imported or supplied unless it is approved. Exceptions are: the Regulator can declare some classes of product to be approval-exempt the import &/or supply of an unapproved product for a specific patient via a ‘special clinical needs supply authority’ a licence or permit or regulation can authorise the import &/or supply of an unapproved product (eg for a clinical trial) There will be different approval pathways possible Controlled activity restrictions The Bill regulates who is allowed to carry out certain activities involving therapeutic products (called controlled activities) and how those activities are carried out In addition, the Bill also: Enables obligations to be imposed on people who in the course of business: import, supply, administer, use, or have possession of, any TPs Imposes restrictions on advertising Prohibits things such as tampering with, or misrepresenting, a TP.

The following would be controlled activities (which require an authorisation) Manufacturing a TP (which for medicines includes compounding and dispensing) Wholesale supply of most TPs -includes exports Non-wholesale supply of: Category 1 (Prescription) medicines Category 2 and 3 (Pharmacist- & pharmacy-only) medicines in the course of business Supply-restricted devices contrary to supply restrictions Type-4 products Carrying on a pharmacy business Conducting a clinical trial of a TP Prescribing a medicine or issuing a standing order (enabled via HPCA) Issuing a special clinical needs supply authority (for unapproved products) Administering prescription medicines Possessing prescription medicines and prescription medicine AMIs Taking medicines (except general sale) and prescription medicine AMIs overseas in the course of business Using use-restricted devices contrary to use restrictions, or type-4 products, on a patient.

The bill would enable flexibility in how controlled activities are authorised The draft Bill does not specify which type of authorisation should be used for particular controlled activities, but the general approach would be to use a: Bill or Regulations – when authorising a class of persons or all persons in a specific circumstance (eg, activities conducted by health practitioners) Licence – when authorising a particular person / or company on an on-going basis (eg. manufacturing, wholesale supply, pharmacy business) Permits – when authorising short-term or exceptional circumstance.

Regulator Form In providing advice to Cabinet on the Regulator Forum, the Ministry will be considering: Independence: decision-making and operations Accountability Sustaining capability and capacity Positive regulatory culture Efficiency and effectiveness (includes cost of establishment and ongoing operations) Flexibility

Health Practitioner Authorisations

The Bill retains the current medicine categories Prescription medicines - Category 1 Pharmacist - Category 2 Pharmacy - Category 3 General-sale medicines - Category 4.

The Bill is clearer that ensuring the competence of prescribers is the responsibility of the relevant RA The legal basis for a Health Profession’s authority to prescribe would be linked to its scope of practice, rather than set out in the Bill or Regulations The Responsible Authorities for professions that can currently prescribe will need to update their scopes of practice to explicitly state this and include any limitations on that authority The Minister of Health’s approval would be required before a new health profession could include prescribing in its scope of practice, or before changes could be made to an existing prescribing authority Where the medicines able to be prescribed are listed, approval of any changes to those lists would be delegated to the Regulator Whether a health profession has the authority to issue a standing order would also need to be explicitly stated in the scope of practice.

The requirements would tighten access to unapproved medicines The supply of an unapproved therapeutic product would require a ‘special clinical needs supply authority’ (SCNSA) to ensure there is an active & recorded consideration of why an approved medicine is not appropriate As the ‘off-label’ use of a medicine is outside of its approval, a SCNSA would be required. However, there would be minimal requirements (eg, it could be a tick box on the prescription) Who can issue a SCNSA will be set via a mix of the Bill and Regulations. It is intended that: health practitioners could issue a SCNSA for unapproved medical devices health practitioner prescribers could issue a SCNSA for the off-label use of approved medicines only medical Practitioners could issue a SCNSA for medicines that have not been approved in New Zealand (as is the case currently). But once a SCNSA had been issued for a particular patient for a particular medicine, another prescriber could prescribe that patient’s ongoing supply.

Authorisations for health practitioner prescribers: Approved products Health practitioner prescribers would continue to be able to: supply approved and approval-exempt medicines to patients (s61(1) and 61(2)) dispense an approved or approval-exempt medicine (s61(5)) prescribe an approved or approval-exempt medicine (s61(3)) administer an approved or approval-exempt category 1 (prescription) medicine (s61(4)) issue a standing order for an approved or approval-exempt medicine - if this is specifically included in their professions prescribing authority (s61(6)).

Authorisations for health practitioner prescribers: Unapproved products A health practitioner prescriber can conduct the same activities with an unapproved medicine as an approved medicine, if: there is a SCNSA for that patient or the medicine was lawfully compounded (s62(1)) As currently: health practitioner prescribers could authorise the supply for the ‘off-label’ use of an approved medicine and an unapproved medical device (as they could issue a SCNSA for these) (s64(1)) only medical practitioners would be authorised to issue a special clinical needs supply authority for a product not approved in New Zealand (this would be specified by a regulation made under s64(3)) But once a SCNSA has been issued for a particular patient for a particular medicine, a health practitioner prescriber could prescribe that patient’s ongoing supply (s62(1)).

Authorisations for health practitioners A health practitioner means a person who: is a health practitioner as defined in section 5 of the Health Practitioners Competence Assurance Act 2003 and holds a current practising certificate under that Act. Health practitioners would: continue to be able to supply medical devices (including unapproved medical devices) to patients s62(3)) continue to be able to administer a category 2 (pharmacist) or category 3 (pharmacy) approved or approval-exempt medicine [as these are not controlled activities] have a new ability to supply category 3 (pharmacy) medicines to patients of their practice (s61(2) & 62(1)) Regulations could be made that would allow health practitioner to wholesale supply medicines (without a wholesale licence) if considered appropriate (s63).

Authorisations for others involved in giving medicines to a patient The Bill would continue to authorise people involved in health services to supply and administer an approved medicine (without a prescription) under a standing order would continue to authorise caregivers to supply and administer medicines that have been lawfully supplied & prescribed (s72) provide a new ability for health practitioner workers to non-wholesale supply category 3 (pharmacy) medicines to patients of that practice (new).

Regulations would be used to authorise particular controlled activities in specific situations Section 79 allows regulations to be made to grant authorisations For example, the supply of medicines by: Defence Force medics to defence force staff Visiting sports groups, military groups or heads of state delegations to the members of their groups This regulation making power would also be used to authorise the supply of particular category 1 medicines by particular health practitioners instead of the ‘prescription except-when’ classification.

The requirements would tighten access to personal imports of medicines Objective - to balance personal freedom against protecting consumers from substandard, adulterated, or counterfeit medicines The Bill contains an authorisation that would continue to allow: people to bring all categories of medicines with them into the country import via post/courier of non-prescription medicines from other countries There is no authorisation for people to personally import prescription medicines via post/courier. They would need to seek a special clinical needs supply authority and obtain the medicine from their prescriber or a pharmacy once it had been imported for them. We envisage the importer would usually be a wholesaler It would be possible to use permits to authorise the personal import of prescription medicines via post/courier in some situations, if appropriate The Bill contains an authorisation to personally import medical devices.

There would be the ability to restrict the supply and/or use of specified medical devices Medical devices would not be put into categories with different supply restrictions (as Medicines are) The Regulator would be able to place restrictions on the supply &/or use of specified devices, if required, via the Regulations This would allow tailored restrictions to be implemented where required from a safety perspective. For example, by requiring some level of clinical oversight.

What controls are warranted on the advertising of therapeutic products? It would continue to be an offence to advertise an unapproved product or include any false or misleading information in an advertisement for a therapeutic product There would be a wider range of enforcement tools available for non-compliance, including advertising remediation orders Under the draft Bill, direct-to-consumer advertising of therapeutic products, including prescription medicines, would continue to be allowed However, we are seeking feedback on whether direct-to-consumer advertising of prescription medicines should continue to be permitted.

Next steps Sector forums in March Submissions due by 18 April Analysis of submissions & report back to Cabinet Draft Bill amended, as required Draft Bill introduced to Parliament Select Committee process (which usually includes a public submission process) Development of regulations, rules and notices – will involve consultation on detail of the scheme.