Session B4 – Medical Devices · Presentation Outline • Relevant Legislation & TGA Processes –...

Session B4 – Medical Devices Decision Making & Reviews

Presenters: Marlene Keese (TGA) Gary Burgess (MTAA)

Presentation Outline

• Relevant Legislation & TGA Processes – An overview of decision making principles and

legislative provisions for requesting a review of decisions

• A Sponsor’s Perspective – Practical issues to consider before requesting

a review of a TGA decision

Marlene Keese Principal Legal Officer Office of Legal Services

Session B4 – Medical Devices Making Regulatory Decisions

Sponsor Information & Training Day – 9 September 2014

OUTLINE

• What is a regulatory decision • Making a regulatory decision • Review of regulatory decisions

Session B3: Medical Devices - Decision Making and Reviews

What is a regulatory decision?

• The legislation confers a wide range of powers on the Secretary for the purposes of regulating therapeutic goods.

• “Regulation” includes exercising the range of powers conferred upon the Secretary under the legislation, and this often involves the exercise of discretions and making decisions.

Making Decisions under the Acts and Regulations


What is not a regulatory decision? • Where,

– there is no exercise of any power or discretion conferred upon any particular person, and

– there is merely a statement of a consequence or statement of fact,

then any finding of that fact or consequence is not a “decision”, but an application of the law.


Making regulatory decisions When making regulatory decisions, the following matters are relevant and must be considered: • what power is being exercised to make the regulatory decision • what preconditions, if any, are required to be met before a decision

can be made • what limitations there may be for making a particular decision • any rules that may apply to the making of that decision, such as the

rules of administrative law


Making regulatory decisions

• There are “Rules” for how decisions should be made when a decision maker is exercising a statutory power – are referred to as ‘the principles of administrative law’, and are

relevantly set out under section 5 of the Administrative Decisions (Judicial Review) Act 1977

What are the principles of administrative law?


Making regulatory decisions

• These principles are designed to ensure that decisions made under enactments are lawfully made, and require decision makers to observe, among other things, the following rules: to make the decision;

– natural justice – procedures that were required by law to be observed in connection with the making

of the decision are observed; – the person making the decision has the authority to do so; – the decision is authorized by the enactment; – there is no improper exercise of the power conferred by the enactment ; – the decision is not induced or affected by fraud; – there is evidence or other material available to justify the making of the decision; – the decision did not involve an error of law.

(d) that the decision was not authorized by the enactment in pursuance of which it

What are the principles of administrative law?


Review of Decisions • If a person is dissatisfied with a decision of the Secretary,

there are certain appeal routes to challenge that decision, which are: – Internal review by the TGA; – External merits review by the Administrative Appeals Tribunal; or – Judicial review by a court


Review of Decisions

• Most of the administrative decisions made by the Secretary under the therapeutic goods legislation may be the subject of internal review by the Minister or the Minister’s delegates.

• To establish which decisions are subject to internal appeal, check the following provisions: – For decisions made by the Secretary under the Therapeutic Goods Act, see

s.60(1) of that Act; – For decisions made by the Secretary under the Therapeutic Goods

Regulations, check regulations 5M and 48(1) of those regulations; – For decisions by the Secretary under the Therapeutic Goods (Medical

Devices) Regulations, see regulation 10.7 of those regulations

Internal Review


Internal Review

• The applicant (a person whose interests are affected by a decision of the Secretary that is amenable to internal review) has 90 days to lodge a request seeking reconsideration of that decision;

• Under section 60, the 90 days starts from either: – from the day the person receives notification of that decision, or; – if no notification is required, then from the date the decision is either published in the

Commonwealth Gazette or the TGA website, or the day the decision first comes to that person’s notice, whichever is earlier

• Generally speaking, the Ministerial delegate has 60 days in which to undertake an internal review

• In lodging a request for internal review under the Act, the applicant must lodge with the application, any information it wishes the Ministerial delegate to consider – otherwise the Minister is not obliged to consider that information, unless either the

Minister should ask for further information or the applicant lodges late information disclosing a problem with the therapeutic goods in question

Lodging Applications for Internal Review


Internal Review

• On reconsideration of the initial decision the Minister (through her delegate) may: – confirm initial decision – revoke initial decision or – revoke and make substitute decision

Review of Decision by the Minister


Review of Decisions • Decisions made by the Secretary may also be the subject of external

review. • There are two types of external reviews of administrative decisions:

– Merits review by the Administrative Appeals Tribunal; and – Judicial review by a court (generally the Federal Court)


Review of Decisions

The AAT: • is an administrative body, not a court • jurisdiction must be conferred by the Commonwealth legislation. • has been conferred power to undertake reviews of decisions made by the Minister or the

Minister’s delegate on internal review under the therapeutic goods legislation. • with the exception of “new information” described in s.60A of the Act

– the AAT is empowered to take into account any information it considers relevant for the purposes of reviewing a decision, including current or new information not before the Ministerial delegate, and is not bound by the rules of evidence.

• may uphold or revoke the Ministerial delegate’s decision, or substitute its own decision with that of the Ministerial delegate

• is also subject to the rules of administrative law, and a failure to apply these rules allows the TGA or the other party to the AAT proceeding to appeal to the Federal Court on an error of law.

Merits Review by the Administrative Appeals Tribunal (the AAT)


Review of Decisions

• “merits review” means that the AAT may review a decision of the Minister on review, and make a decision as to whether, given all the facts before the AAT, the Minister’s decision was the best decision that could have been made.

• The AAT may substitute its own decision in place of the Ministerial delegate’s decision if the Tribunal believes it can make a better decision based on information before it.

• Sometimes the AAT may arrive at a different decision to that of the Minister because it has new information before it that the Ministerial delegate did not have at the time the delegate made a decision.

• Even though the decision made by the Minister may be correct at law, the AAT may still replace that decision on the basis of a merits review because it believes it can make a better, and still lawful, decision.

What is a Merits Review?


Review of Decisions

• “judicial review” of administrative decisions is conducted by the courts – a court (usually the Federal Court) examines whether the rules of administrative law

were applied in the making of the decision in question • Judicial review may be undertaken in relation to any decision or action taken pursuant to

a provision of any Commonwealth enactment • Judicial review is mainly about process

– the court does not look at the merits of a decision, if a decision is legally sound because the rules of administrative law have been applied, a court will not interfere with that decision

• Should a court find that the rules of administrative law have not been correctly applied, it will refer the decision back to the decision maker for a fresh decision that correctly applies the rules of administrative law

• A court is not able to substitute its own decision with that of the decision maker, it can only support the decision as being legally sound or remit the decision to the decision maker so that the latter can make a fresh decision that is compliant with the rules of administrative law

Judicial Review


A Sponsor’s Perspective

Practical issues to consider before requesting a review of a TGA

decision

Internal Review Figures* • TGA make more than 34,000 decisions a year

• Only 25 requests for internal review in first 6 months of

2014 – 15 (56%) initial decision confirmed – 7 (32%) initial decision revoked and/or substituted

• 4 out of 7 were due to additional info was provided – 3 (12%) review requests withdrawn – Very similar to previous 6 month period – All 25 reviews completed within legislated 60 days

* TGA KPI Report for January to June 2014

TGA Decision Makers • TGA Delegates of Secretary or Minister for major decisions:

– National Manager – Group Heads – Office Heads – Section Directors

• Generally speaking, the following are not Delegates of the

Secretary for making major regulatory decisions: – Device assessors (except for s41JA requests) – QMS inspectors (mostly) – Staff on the Devices information line – Members of the Advisory Committee for Medical Devices

(ACMD)

Non-decisions • Some events are not considered to be ‘decisions’

– Instead they are considered to be ‘operations of law’ – You cannot request an internal review (s60 appeal) of these actions

Common examples include: • Lapsing of an application under s41EG (CA certificates) or s41FK

(Application Audits) of the Act – non-payment of assessment fees by due date – failure to respond to request for info within further 10 work days

• When an ARTG entry application is deemed to be ineffective under

s41FC(2) of the Act – application fee has not been paid – A TGA CA certificate is required but is not in force

What is not an ‘initial decision’? • Some decisions made under the legislation are not considered to be

‘initial decisions’, and therefore you cannot request an internal review (s60 appeal) of these decisions

For example: • s41FH – Deciding which applications to select for auditing

• s41FI(1) – Deciding which aspects are considered for auditing

• Regulation 9.7 – Deciding whether to reduce assessment fees

• Any ‘proposal’ to make a certain decision, e.g. proposal to cancel an

ARTG entry

A decision is made … Someone at the TGA has just made a decision that affects your interests. What should you do?

1. Calm down and take a deep breath!

2. Read the TGA decision letter

3. Check if the decision is considered an ‘initial decision’

4. Consider whether you think the initial decision was

incorrect and whether you wish to request a review

Presenter

Presentation Notes

Calm down and take a deep breath! Read the TGA decision letter Identify who the decision maker was, what legislative provision the decision was made under, understand their reasons Check if the decision is considered an ‘initial decision’ The decision letter should inform you if it is and include details of your review rights (i.e. how to appeal under s60) Consider whether you think the initial decision is unlawful or inherently unfair, and whether you wish to have the decision reviewed You may prefer to simply re-apply instead Don’t take too long, you only have 90 days to lodge an appeal!

Things to know about s60 reviews

• Must lodge request for review in writing within 90 days – Written request can be can be a letter, fax, email

• Can submit additional supporting info at time of appeal

• When requesting a review you are encouraged to:

– Include a copy of the decision to be reconsidered

– Describe with as much detail as possible which parts of the decision you object to and the reasons why

– Identify the parts of your supporting info that address each of those reasons

Things to know about s60 reviews

• Minister is not able to consider supporting info submitted during the review unless it is specifically requested by the Minister – Do not lodge appeal until you have all the supporting

info you need!

• Possible s60 review outcomes: – Confirm initial decision – Revoke the initial decision – Revoke the initial decision & substitute a new decision – Deemed decision – Remit to another Delegate for a fresh decision

Section 60 vs AAT reviews Section 60 AAT

Appeal time Within 90 days of receiving ‘initial decision’.

Within 28 days of receiving ‘reviewable decision’ .

Review costs No application fee. No assessment fees.

Application fee of around $861. Lawyers fees & court costs.

Review time 60 days to conduct review otherwise initial decision is confirmed.

No strict time limits – may take months or years!

Exposure Details of the review usually kept “in-house” by TGA. Treated the same as other initial decisions.

AAT may publically release details about who has applied, what the decision relates to, and outcome of the review.

Decision maker Senior TGA manager, Delegate to Minister, not in same area as initial decision maker

AAT appointed reviewer, not staff member of TGA or Dept of Health

Deciding whether to appeal • Ultimately up to the affected person

• Seek independent legal advice before appealing, particularly

for AAT reviews

• Don’t just appeal because you don’t like the decision – Should believe that an error has been made – You need evidence to back up your claims – TGA cannot review every decision, and large numbers of

unfounded appeals could affect their ability to cope with other work

• May be quicker/cheaper to re-apply instead of appealing!

Deciding whether to appeal Examples of where requesting a review may be warranted:

• Invalid request for information is made under s41JA, e.g.:

– Less than 10 work days is given to submit info – Info does not relate to matters prescribed under 41JA, such as pricing

information

• Application is rejected after auditing, but notice does not include any statement of reasons

• Decision was made without considering relevant information

• Decision is made on the basis of irrelevant information, e.g.:

– Cost effectiveness – Personal beliefs of decision maker

Statutory Timeframe for CA Applications

What if a decision isn’t made within 255 working days for a CA application involving design examination?

1. s41LE – Reduction of CA assessment fee

2. s41EH – Treating applications as having been refused

– If not notified of a decision within 255 work days, request for the application to be considered ‘refused’.

– This has the same effect as if:

• the Secretary had decided not to issue the certificate; and • the Minister had made a decision under s60 confirming that decision. • Can go straight to AAT for review!

Presenter

Presentation Notes

In other words, the applicant can skip the s60 appeal process and apply directly to the AAT for review!

More Information? • MTAA offer a half-day workshop covering

decision making and reviews for medical devices

• Check Training Catalogue on MTAA website

for more details of Module 1.7 and to register

• Open to MTAA members and non-members

Questions & Discussion

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