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Therapeutic Products Bill. Christchurch Session. 27 March 2019. Today’s team. Sheila Swan – Chief Advisor, Regulatory Policy, MoH Susan Martindale – Principal Analyst, Regulatory Policy, MoH Hannah Adams – Senior Analyst, Regulatory Policy, MoH
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Therapeutic Products Bill Christchurch Session 27 March 2019
Today’s team • Sheila Swan – Chief Advisor, Regulatory Policy, MoH • Susan Martindale – Principal Analyst, Regulatory Policy, MoH • Hannah Adams – Senior Analyst, Regulatory Policy, MoH • Andi Shirtcliffe – Chief Advisory Pharmacy, Chief Medical Officer, MoH
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
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 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 and/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.
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-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.
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.
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 • Category 1 – Prescription • Category 2 – Pharmacist • Category 3 – Pharmacy • Category 4 – General Sales. • There would be protection of confidential supporting information for pharmaceuticals • There would be alignment with international standards and practice • A licencewould 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 – minor and major • 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 • Obligated to comply with the approval, ensure the product complies with the approval & any specified standards, ensure another person complies with any requirements placed on them by the approval, and comply with any requirements set in regulations (eg, for packaging and consumer information) • 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
The new scheme would adopt the global model for device regulation • Two broad categories – in-vitro diagnostic (IVDs) and non-IVDs • 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. for emergency scenarios). The Bill would enable different product approval pathways, including: • 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. 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.
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
Pharmacy licences will continue to regulate product-related activities not clinical advice • Pharmacies are licensed under the Medicines Act, and would continue to be licensed under the Therapeutic Products Bill, to conduct activities that involve medicines. In particular: • compounding • dispensing • non-wholesale supply of prescription, pharmacist and pharmacy medicines (category 1, 2 & 3 medicines) • Pharmacists activities that do not involve these activities (eg, provision of medicines-related clinical advice ) are not regulated under this legislation, but are covered by the Health Practitioners Competence Assurance Act • Where a controlled activity involving a medicine needs to include clinical advice to occur safely, the draft Bill achieves this by linking the authorisation to particular health practitioner profession(s).
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 authorisepharmacy 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).
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 licencerequirements 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 • day-to-day implementation of those systems • Potential benefits: Regulator efforts focused on pharmacy systems and practice, potential for greater investment in pharmacies.
The key differences for clinical trials would be: • A licence would be required for all clinical trials of TPs • There would be a risk-appropriate approach for licensing and for trial requirements that was reflective of international norms. This would mean that “first use in humans” studies would receive more scrutiny than trials using only approved products • We would expect the regulator to set performance times for processing applications that at least matched those achieved currently and to report its performance results publicly. • Ethics approval explicitly required • Not mandatory to seek Health Research Council (HRC) advice on applications to approve a clinical trial • We would expect the regulatory & ethics approval processes to run in parallel and be facilitated by on-line application tools.
The authorisations for health practitioners are largely the same • 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 • Part 3, subpart 3 of the draft Bill provides the authorisations for health practitioners to perform particular controlled activities. • These generally reflect the status quo. The key changes are: • where the authorisation for a profession to prescribe sits • a different requirement in relation to unapproved products (noting, there is now a concept of unapproved medical devices) • health practitioners would be able to supply category 3 (pharmacy) medicines to their patients. • The Bill continues to authorisepeople working under standing orders to supply and administer medicines (s71); and caregivers to supply and administer medicines that have been lawfully prescribed and supplied (s72).
Where the authorisation for a profession to prescribe would sit • 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.
Requirements for 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.
Health practitioners would be able to supply category 3 (pharmacy) medicines to their patients • Currently pharmacy medicines can only be provided from a 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).
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 pharmacyonce 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.
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.
There would be a transition period, which begins after the scheme has commenced • Existing product approvals – would become a new approval that can be dealt with as if it had been granted under the new scheme and subject to any new obligations (including sponsor obligations) or requirements set • Existing licences – would carry on until their expiry date or replacement by a licence under the new scheme. In addition, they would be subject to any new obligations or conditions set under the new scheme • Pending product approval or licence applications – are dealt with under the new scheme • Products / activities that would require an approval or licence for the first time - the Bill would provide a temporary licence to those lawfully supplying a product, or conducting a controlled activity, before commencement. They would then be required to apply for an appropriate approval (ie, a product approval and/or licence) within a specified time period. Once they have applied, their temporary licence continues until the regulator has determined their application • Others aspects – Schedule 1 also includes transition provisions for existing authorisations (eg, issued prescriptionsand standing orders).
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.
