Draft Therapeutic Products Bill

Therapeutic Products Bill Information Session

11 February 2019

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

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

Overview of the intended therapeutic products regulatory scheme

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

There will be less detail in legislation and more in the regulations and regulator-made instruments Therapeutic Products Act

Regulations

Rules & Regulator Notices

Primary legislation: •

sets out the purpose of the Act

•

provides a set of principles and criteria to set the parameters of the regulatory regime

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sets boundaries for the scope and development of subordinate legislative instruments

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contains the primary elements of the regulatory regime

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provides enforcement powers

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sets out accountability arrangements

Regulations will contain further detail on: •

matters not appropriately dealt with in regulator-made instruments (such as fee setting)

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matters to do with accountability

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key elements of the regulatory regime that will remain relatively stable and which are significant to the design of the regulatory requirements

Regulations will be subject to review by the Regulations Review Committee Rules and Regulator Notices with the force of law will contain the detail of the regulatory requirements and should be made by the Regulator Rules will be subject to review by the Regulations Review Committee

A wider range of products would be covered The new system would regulate: • Medicines o Including cell and tissue products and radiopharmaceuticals • Active Medicinal Ingredients o defined separately from medicines, so a smaller set of controls can be applied to them • Medical devices • Type-4 products o This is a catch all category for future therapeutic products that we don’t know about yet o 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 1. 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).

2. 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 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

The bill would enable flexibility in how controlled activities are authorised Provision in Act or Regulations

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The Act would provide the authority for certain controlled activities; eg prescribing, the ability for pharmacists etc to compound and dispense

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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

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There would be criteria for who can obtain a licence, eg ‘fit & proper’ person test

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The Regulator would be able to add licence conditions

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Licences would require appropriate Responsible Persons to be nominated

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There would be obligations for the Licensee and Responsible Persons

Permit

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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

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: o 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) o a particular person /or company on an on-going basis - a licence would be used (eg, manufacturing, wholesale supply, pharmacy business) o a short-term or exceptional circumstance - a permit would be used.

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.

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.

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.

The form and details of the cost recovery approach are still to be decided Cost recovery approach • 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

Medicines and AMIs

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: o Organs removed and transplanted without any further processing or banking o Tissue and cells retrieved and used as autologous graft within same surgical procedure

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

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

Medical Devices

The new scheme would adopt the global model for device regulation • • • •

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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)

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)

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

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

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)

Licensing

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

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?

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

Health Practitioner Authorisations

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

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)

The Bill is clearer that ensuring the competency of prescribers is the responsibility of the relevant Responsible Authority • •

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• •

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

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.

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

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

Next steps

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

Questions?

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