1. Therapeutic Products Bill
Information Session
11 February 2019

2. Today’s presenters Sheila Swan – Chief Advisor, Regulatory Policy
Susan Martindale – Principal Analyst, Regulatory Policy
Hannah Adams – Senior Analyst, Regulatory Policy

3. Agenda Item Time Presentation on the Therapeutic Products Bill
9.30 – 10.30
Tea and coffee
10.30 – 10.45
Questions for the panel
10.45 – 11.50
Next steps
11.50 – 12.00

4. Overview of the intended therapeutic products regulatory scheme

5. Bringing therapeutic products regulation into the 21st century
A new look Bill drafted using the modern drafting style
Much of the scheme detail will be in the regulations, rules and notices
Definitions and meaning are covered in sections 14 – 50, then the controls, authorisations and powers relating to these are set by the subsequent sections

6. There will be less detail in legislation and more in the regulations and regulator-made instruments
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
enforcement
powers
out accountability
arrangements
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
will be subject to review by the Regulations Review Committee
Rules & Regulator
Notices
Rules and Regulator Notices with the force of law
will
contain
the detail of the regulatory requirements and
should be made by the
Regulator R
ules will be subject
to review by the Regulations Review
Committee

7. A wider range of products would be covered
The new system would regulate:
Medicines
Including cell and tissue products and radiopharmaceuticals
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.

8. 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).
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

9. 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 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-3 products, on a patient

10. The bill would enable flexibility in how controlled activities are authorised
Provision in Act or Regulations
The Act would provide the authority for certain controlled activities; eg prescribing, the ability for pharmacists etc to compound and dispense
It will also be possible to authorise controlled activities via regulations. These will be used to authorise more specific situations, eg. maritime re-fitters
Licence
There would be criteria for who can obtain a licence, eg ‘fit & proper’ person test
The Regulator would be able to add licence conditions
Licences would require appropriate Responsible Persons to be nominated
There would be obligations for the Licensee and Responsible Persons
Permit
These would have similar requirements / obligations to licences, but are intended to be used for more short-term or exceptional situations, e.g. a pharmacy in a shipping container following an earthquake

11. But activities would generally be authorised using the same types of authorisations as now
The draft Bill does not specify which type of authorisation should be used for particular controlled activities
Generally, if an authorisation needs to apply to:
a class of persons or all persons in a specific circumstance - this would occur via the Bill or regulations (eg, activities conducted by health practitioners)
a particular person /or company on an on-going basis - a licence would be used (eg, manufacturing, wholesale supply, pharmacy business)
a short-term or exceptional circumstance - a permit would be used.

12. The regulator would also be able to issue a range of regulatory orders
The Regulator would be able to issue:
recall orders
premises restriction orders
advertising remediation orders
directive orders
product prohibition orders
medicines access limitation orders (akin to a restriction notice under current legislation)
The Regulator would also be able to make public safety announcements.

13. There would be a better calibrated set of compliance and enforcement tools
The Regulator would continue to have the power to:
add conditions, amend, or revoke product approvals, licences and permits
suspend licences and permits
The regulator would have a wider range of enforcement options that include:
criminal offences – with higher potential penalties
infringement fees
enforceable undertakings (an alternative to prosecution where the applicant enters into a voluntary agreement with Regulator to do certain things to improve compliance & quality)
The Bill links to the Search and Surveillance Act 2012 to provide the regulator with investigative powers. The regulator would have the following powers of entry:
entry and search without a warrant (for routine monitoring & where there are concerns of non-compliance)
entry and search with a search warrant (including dwelling houses & Marae)
the right to inspect therapeutic products being imported.

14. The Bill enables more flexibility to ensure the required expertise can be accessed
Expert Committees
The draft Bill allows the regulator to seek expert advice (from an individual or committee)
Committee structures are not specified in the draft Bill to allow more flexibility
Review of regulator's decisions
The review process would be via a specially convened review panel, made up of at least 3 relevant experts with no conflicts of interest, one of whom must be a lawyer with at least 7 years experience
Decisions made by the review panel could be appealed to the District Court.

15. The form and details of the cost recovery approach are still to be decided
The previous Government agreed that the new regulatory system could be funded through either cost recovery, Crown revenue, or a mix of both
The details of the split have not been decided
Regulator form
The form of the regulator is still to be decided
As a placeholder the Bill currently provides for the Chief Executive of the Ministry of Health (ie, the Director-General of Health) to administer the scheme

16. Medicines and AMIs

17. There would be a change in what is covered by the definition of ‘Medicine’
AMIs would be defined separately from Medicines. Controls on AMIs would cover:
manufacturing and conducting a clinical trial for all AMIs
wholesale supply, possessing, and taking overseas in the course of business prescription-type AMIs
Cell and tissue products would be regulated as a type of medicine. The controls would differ depending on the level of manipulation:
Tissue establishments would require a licence
Engineered cells and tissues would require a product approval
C&T not changed from its naturally occurring state would not be regulated:
Organs removed and transplanted without any further processing or banking
Tissue and cells retrieved and used as autologous graft within same surgical procedure

18. A lot would stay the same, but may be expressed differently in the Bill
Products would continue to require an approval (unless an exception applies)
There would still be four classification categories of medicines, but in the Bill they are referred to as category numbers rather than by their current names
There would be protection of confidential supporting information for pharmaceuticals
There would be alignment with international standards and practice
A licence would continue to be required for manufacturing, wholesaling, pharmacy business, and retail sale of pharmacy medicines
Pharmacovigilance activities would continue

19. The key differences for medicines would be:
Greater flexibility to have different pathways to approval, including early access arrangements for truly innovative products
Two-tier system for changes to products
There would be clearer criteria and obligations for sponsors; for example:
Fit and proper person test for sponsor
Contractual relationship required between manufacturer and sponsor
Formal product register of approved products
Explicit ability to recognize another Regulator’s work
Clearer ability to put conditions on approvals
No provisional approval, but can have time-limited approvals
Clearer grounds to cancel an approval, no suspensions
Explicit requirement for the Regulator to have a safety-monitoring system

20. Medical Devices

21. The new scheme would adopt the global model for device regulation
Devices must meet Essential Principles (relating to safety and performance)
Devices are allocated a Risk Classification using international classification rules - this determines the level of regulatory oversight and conformity assessment
Conformity assessment procedures - the required procedures are linked to the risk class for the device
The manufacturer is responsible for maintaining a technical file (STED) demonstrating conformity to the essential principles and for completing a declaration of conformity
Conformity assessments are undertaken by independent Conformity Assessment Bodies (CABs) recognised by the regulator (except for the lowest risk class of devices which can be self-assessed by the manufacturer)

22. Medical devices would require a product approval unless an exemption applies
Exemptions would apply to:
custom-made devices manufactured by, or for, a individual clinician for the sole use of a particular patient
devices used in clinical trials
devices supplied in response to a “special clinical needs supply authority” issued in relation to an individual patient
devices whose supply is permitted by a permit (eg to deal with emergency scenarios)

23. The Bill would enable different product approval pathways
The approval pathways would include:
approval based on scrutiny of evidence of conformity assessment /overseas approval of devices
approval without scrutiny if devices are under a Mutual Recognition Agreement (eg. those that fall under EU MRA)
self-declaration and notification for devices in the lowest risk class
The NZ regulator would need to maintain and publish a list of recognised conformity assessment bodies (probably in a Regulator’s Notice)
These will be a mix of third party conformity assessment bodies and overseas regulators whose conformity assessments will be recognised
The NZ regulator is unlikely to be doing conformity assessments itself

24. Current suppliers of medical devices would need to meet the new requirements
Sponsors must:
be NZ residents or body incorporated in NZ and pass a fit and proper person test
be, or have, a contractual relationship with the manufacturer of the device(s) so they have access to up to date technical dossiers (STEDs) for their devices
have the required conformity assessment documentation for their devices
NZ Manufacturers would require a licence
Wholesalers who supply medical devices in NZ must:
be NZ residents or a body incorporated in NZ
have a licence unless exempt (eg those supplying devices in the lowest risk class)
be the sponsor or have the sponsor’s approval to import
The Regulator would be able to place restrictions on the supply &/or use of certain devices, if required

25. There would be a transition period for current suppliers of medical devices
A transition period starts on commencement of the scheme (which would be around 2 years after the Bill has been passed)
As both a product approval and licence for controlled activities would be required, the transition provisions cover both:
For medical devices that are lawfully supplied prior to the new schemes’ commencement date a temporary licence would be created which authorises the continuation of these activities
Within six months:
the supplier must make a valid product approval application
anyone manufacturing or wholesaling the device must make a valid licence application for that activity
These applications would create a temporary licence authorising continuation of those activities which would remain in place until the regulator has made a decision on the application(s)

26. Licensing

27. The key differences for licences would be:
There would be the ability to tailor roles and requirements for Responsible Persons
One licence could authorise multiple activities
One licence could authorise multiple sites, if the Regulator considers that appropriate
Packing and labelling are regulated as aspects of manufacturing
Licences could be issued for up to 3 years

28. The differences for pharmacy licences would be:
The Bill would enable different distribution and supply arrangements through:
Pharmacy premise and equipment requirements being linked to the activities undertaken - rather than requiring all pharmacies to have the equipment and resources to undertake all pharmacy activities
licences not being tied to traditional brick and mortar pharmacies.
We are seeking feedback on two options for ensuring a pharmacist is in control of a pharmacy business:
Option 1: Strengthened accountability though pharmacist ownership and effective control
Option 2: Open ownership with licence requirements targeted at pharmacist control of quality systems and practices within the pharmacy
We are also seeking feedback on whether:
a pharmacist should be able to provide clinical advice and oversight remotely for any pharmacy activities?
restricting prescribers from taking a finance interest in a pharmacy is still required?

29. The key differences for clinical trials would be:
Licence required for all clinical trials of TPs
Ethics approval explicitly required
Not mandatory to seek Health Research Council (HRC) advice on applications to approve a clinical trial

30. Health Practitioner Authorisations

31. The authorisations for health practitioners are largely the same
An authorisation would required to perform controlled activities
This includes a number of activities performed by health practitioners:
compounding and dispensing (defined as part of manufacturing)
non-wholesale supply of prescription, pharmacist, and pharmacy medicines
prescribing and/or administering a prescription medicine
issuing a special clinical needs supply authority,
issuing a standing order.
Part 3, subpart 3 of the draft Bill provides the authorisation for particular health practitioner professions to perform these controlled activities
These are generally reflect the status quo

32. The Bill retains the current medicine categories, but includes a proposal to broaden access to the ‘pharmacy-only’ category
Prescription medicines (category 1 in the Bill)
A prescription will continue to be required for prescription medicines
Pharmacist and pharmacy-only (category 2 and 3)
The draft Bill includes an authorisation for Health Practitioners and Health Practitioner workers to supply category 3 medicines, within the scope of their practice, to their patients
General-sale medicines (category 4)
There would continue to be no restrictions on who can supply these, but we will be able to set minimum standards in Regulation on how they are supplied (eg, display or storage requirements)

33. The Bill is clearer that ensuring the competency of prescribers is the responsibility of the relevant Responsible Authority
A Health Profession’s authority to prescribe would be linked to, and bounded by, 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 can include prescribing in its scope of practice, or changes are 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

34. The requirements would tighten access to 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
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 the Bill and Regulations. It is intended that:
Health practitioners could issue SCNSA for unapproved medical devices
Health practitioner prescribers could issue 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, a health practitioner prescriber could prescribe that patient’s ongoing supply.

35. The requirements would tighten access to personal imports
Objective - to balance personal freedom against protecting consumers from substandard, adulterated, or counterfeit medicines
The Bill contains authorisation that would continue to allow:
people to bring all categories of medicines with them into the country
import via post/courier 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
It would be possible to use permits to authorise the personal import of prescription medicines via post/courier in some situations, if appropriate

36. 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

37. Next steps

38. 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

39. Questions?

40. Project team Q&A panel Sheila Swan – Chief Advisor, Regulatory Policy
Susan Martindale – Principal Analyst, Regulatory Policy
Hannah Adams – Senior Analyst, Regulatory Policy
Chris James – Group Manager, Medsafe
Andi Shirtcliffe – Chief Advisor, Pharmacy