1. Draft Therapeutic Products Bill
CONSUMER FORUM
21 March 2019

2. 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

3. Agenda
Item
Welcome 1
Overview of the intended therapeutic products scheme: Regulatory instruments, product coverage, key controls, types of authorisations 2
Unapproved products / personal imports 3
Pharmacy licencing
Tea and coffee 4
Access to pharmacy medicines 5
Advertising and information 6
Medical devices 7
Adverse event monitoring 8
Next steps te
Item
Indicative timing
Welcome pm
Overview of the intended therapeutic products scheme: Regulatory instruments, product coverage, key controls, types of authorisations pm
Unapproved products / personal imports pm
Pharmacy licencing pm
Tea and coffee pm
Access to pharmacy medicines pm
Advertising and information pm
Medical devices pm
Adverse event monitoring pm
Next steps pm
Any other questions – 4.20
Close 4.30 pm

4. Overview of the intended therapeutic products regulatory scheme

5. 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.

6. 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.

7. 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
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
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
Made by the regulator
Subject to review by the Regulations Review Committee
Notices
Covers operational aspects of the scheme
Schedule 3 lists the matters that can be specified in notices
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

8. 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.

9. 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.

10. 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.

11. Proposed changes to either improve access or safety

12. Unapproved medicines
The supply of an unapproved therapeutic product would require a ‘special clinical needs supply authority’ to ensure there is an active & recorded consideration of why an approved medicine is not appropriate
The draft Bill requires a SCNSA for ‘off-label’ use of a medicine – We are considering this further, as it may cause practical issues
As currently, the intention, is that only Medical Practitioners could issue a SCNSA for medicines that have not been approved in New Zealand
However, once a SCNSA had been issued for a particular patient for a particular medicine, a health practitioner prescriber (who may not be a Medical Practitioner) then could prescribe that patient’s ongoing supply.

13. Personal import 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.

14. Pharmacy licensing – Enabling new supply and distribution models
The definition of a ‘pharmacy business’ is based on the pharmacy activities, rather than the pharmacy premise
Pharmacy licences would be able to authorise pharmacy activities involving medicines to occur in different locations. For example:
Mobile pharmacies
A pharmacist could be licensed to visit rest homes and supply particular medicines
A pharmacist could be licensed to provide marae-based services involving medicines
The licence and its requirements would only be focused on what activities are occurring as part of a pharmacy business
We are also seeking feedback on whether the requirement for a pharmacist to be present should enable situations where this is provided virtually (eg, via skype).

15. Pharmacy - Options for ensuring a pharmacist is in control of a pharmacy business
Option 1: Strengthened accountability though pharmacist ownership and effective control
Retain and strengthen the requirement that a pharmacist(s) has majority ownership and effective control of the pharmacy business
Potential benefits: Reduced risk of negative impact of increased commercial interest in, and influence over, pharmacies
Option 2: Open ownership with licence requirements targeted at pharmacist control of quality systems and practices within the pharmacy
The responsible persons for a pharmacy licence would need to be a pharmacist. They would need to be responsible for:
The quality management systems that impact pharmacy and pharmacist practice and the safe provision of therapeutic products
The day-to-day implementation of those systems
Potential benefits: Regulator efforts focused on pharmacy systems and practice, potential for greater investment in pharmacies.

16. Increasing access to pharmacy medicines
Currently pharmacy medicines can only be provided from licensed pharmacy or retail-only (in remote areas lacking a pharmacy) business
The Bill proposes to allow health practitioners, and their staff, to supply their patients with pharmacy medicines
They would only be able to supply medicines within their scope of practice (eg a podiatrist could supply pharmacy medicines for foot or lower limb conditions).

17. Advertising
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
We are seeking feedback on whether direct-to-consumer advertising of prescription medicines should continue to be permitted.

18. Packaging, labelling and consumer medicine information
The Bill enables packaging, labelling and consumer medicine information requirements to be set
What these requirements should be would be set in regulations and rules
We will consult when we are developing these regulations and rules.

19. Increased regulation of medical devices
Currently there are no pre-market controls on medical devices and limited piecemeal post-market regulation
The new scheme, would implement the international regulatory model, with a full suit of pre- and post-market controls for medical devices
These controls would require:
A licence for clinical trials of medical devices
Product development data as part of product approval
A licence for NZ manufacturers
Overseas manufacturers to be audited and checked via the product approval process
A pre-market product approval (with some exceptions)
A register of all approved devices
A licence for NZ wholesalers (unless exempt)
Mandatory adverse event reporting by product sponsors
Full suite of enforcement responses
Where there are concerns, devices could be declared use- or supply-restricted.

20. Medical devices that are not therapeutic products
The draft Bill only applies to therapeutic products
A number of products have similar features and risks to medical devices, but are not intended for a therapeutic purpose
Examples include: plano contact lenses, some facial or other dermal fillers, equipment used for cosmetic purposes that emits high-intensity electromagnetic radiation
Are there products that are not for a therapeutic product that you consider should be regulated as part of this scheme?

21. Adverse event monitoring
Companies importing and manufacturing medicines are required to report any untoward effects occurring in New Zealand or overseas that they are aware of, but are not required to have systems for monitoring their own products in the market
Under the new scheme, it would be mandatory for product sponsors of both medicines and medical devices to have post market monitoring systems in place and to report any adverse events to the therapeutic products regulator
The Bill also places a legal obligation on the regulator to have a system in place to monitor the safety of therapeutic products.

22. What next 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.