Review of the Therapeutic Goods Administration’s ...

P.O.Box 7219 Duffy ACT 2611 Phone 02-6161 1110 Mobile 0413-432-101 7890 Fax 02-6287 1162

Review of the Therapeutic Goods Administration’s

Consultative Arrangements

“Working Together”

A Report on the review of

TGA’s Consultative Mechanisms

by

Strategic Consulting Services Pty Ltd

Project Principal

Alan H Evans

July 2004

Review of the Therapeutic Goods Administration’s consultative arrangements – July 2004

Table of Contents

(1) Executive Summary....................................... 1

(2) Background..................................................... 4

(3) TGA Consultative Mechanisms ................... 7

(4) The issues- the view from the outside .......... 12

(5) Consultation- The Future.............................. 19

(6) Possible Models of Consultation................... 30

Appendix A- Terms of Reference ...................... 36

Appendix B-Discussion Paper forwarded to participants 37

Appendix C-List of parties interviewed ........... 40

Appendix D-CASA-Aviation Safety Forum..... 42


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Chapter

1 Executive Summary Review of TGA’s consultative arrangements and recommendations for future arrangements.

Executive Summary

1. The TGA has a wide range of consultative mechanisms in place at present which involve the pharmaceutical industry, health professionals and consumers and which provide the basis for extensive consultation.

2. While the present consultative arrangements are extensive, external parties do not consider these have fully met their consultation needs.

3. Stakeholders have indicated that the intent, purpose and/or objectives of TGA’s various consultative processes have not always been clear.

4. Some external parties have expectations as to the possible outcomes of consultation with the TGA that given the TGA’s statutory responsibility are not capable of realisation. This includes for example, a role in decision making on individual applications for marketing approval.

5. Each of the external parties (suppliers, therapeutic intermediaries and consumers) considered that the TGA decision making was more influenced by the others.

6. All parties expressed the view that they would welcome increased communication with the TGA and its officers and that there would be benefit to all, in increased levels of information being provided by the TGA.

7. Therapeutic intermediaries such as health professionals and hospitals are desirous of being more involved in consultation with the TGA.

8. Patient groups have a limited knowledge of TGA functions and many groups have had limited consultation with the TGA to date.

9. The cost of TGA services is such an overwhelming issue of concern to some external parties that it adversely affects their participation in the consultation process.

10. The principles and objectives of any consultation that the TGA undertakes should be identified by the TGA at the outset of consultation and communicated to all parties from the outset to ensure that all those


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involved in consultation understand the basis on which it is taking place and thus properly contribute to the effectiveness of the consultation process.

11. The TGA website should be an effective and a primary source of information on TGA’s policies, functions and processes to industry, health professionals and the community and sufficient resources should be provided to achieve this.

12. There would be substantial benefit in the TGA conducting regular comprehensive information seminars on its functions and operations for industry, therapeutic intermediaries, consumer representatives and the community.

13. The TGA should provide dedicated resource responsible to a single senior executive in the TGA management for the effective communication, liaison and consultation with all parties who interact with the TGA on a frequent or periodic basis.

14. The transparency of the current regulatory system should be increased and the withholding of information based on “commercial in confidence” be the exception and not the rule and such withholding be at the TGA’s discretion after taking into account the views of affected parties.

15. In order for the TGA to meet its statutory responsibilities it should ensure all interested or affected parties from industry, consumers and health professionals are represented in the appropriate consultative forums.

16. Because public health and safety is the primary focus of the TGA’s functions and its regulatory responsibility, an independent chair is not considered an appropriate option for TGA Consultative Forums as such a person does not have the statutory responsibility for outcomes. In order to ensure that there is appropriate responsibility and accountability, any consultative forums established by the TGA should be chaired by a senior officer of the TGA.

17. There are a large number of parties who arguably have valid reasons to be consulted by the TGA on matters relating to the regulation of therapeutic products and devices. If they were included in a single consultative forum this would result in such a forum being too large and unwieldy and thus ineffective. The TGA would be best served by the establishment of an overarching Advisory Committee drawn from nominations put forward by relevant interests to provide the TGA with advice on strategic planning, performance and service standards, benchmarking, cost recovery, quality improvement, resource requirements and options, management initiatives and issues management.


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18. The Advisory Committee would comprise members drawn from nominations made by the relevant stakeholders such as suppliers, industry, health professionals, consumers etc and the organisations representing those groups and selected by the National Manager. The National Manager would select the members of the Advisory Committee taking into account the need to balance stakeholder interests and the needs of the TGA.

19. The National Manager of the TGA should be the chair the Advisory Committee, the function of which would be to provide the management of the TGA with considered advice on matters such as TGA’s strategic plan, performance and service standards, benchmarking, cost recovery, quality improvement, resource requirements and options, proposed management initiatives, issues management etc.

20. The Advisory Committee would meet at least annually but consideration could be given to it meeting six-monthly. The Committee could also be convened on an ‘as needed’ basis.

21. It is recommended that the TGA establish new consultative arrangements as follows:

• A range of consultative forums for each of suppliers, therapeutic intermediaries and consumers. The forums would meet at least annually or additionally as and when the TGA had matters on which it wished to consult the relevant parties.

• The suppliers’ forum could be supplemented by additional forums for each of the industry sectors i.e. prescription medicines, devices, OTC medicines, and complementary medicines. Representation should be broadened to include a cross section of industry as well as the various industry associations. While it is expected that industry associations would take a leading role, it is important that those in industry who are not part of the industry organisation have their voices heard.

• Industry for its part would have to bring to the table information, on a confidential basis, to assist in predicting future demands on TGA’s resources.

• The consumers’ forum should include representatives of patient groups as well as the peak consumer organisations. The forum would provide a vehicle for the consumers to articulate the standards they expect the TGA to apply to its operations. The TGA would invite a range of participants to this forum to ensure broad representation and the TGA would be responsible for the preparation of the agenda for the forum.

• The intermediaries’ forum would be held annually and it may be beneficial to consider combining intermediaries and consumers in some joint sessions, as they would have some issues in common.

• The deliberations of the Consultative Forums be reported to the TGA Advisory Committee


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Chapter 2 Background

The Therapeutic Goods Administration (TGA) is a business unit of a Commonwealth Government agency, the Department of Health and Ageing (DoHA).

The primary role of the Department is to promote and protect the health of all Australians and minimise the incidence of preventable mortality, illness, injury and disability. It does this by undertaking a variety of roles and providing funds to enable the provision of high quality health services, including preventative, curative, rehabilitative maintenance and palliative care.

The Department has a number of policies and programmes in place to achieve its portfolio objectives. One such policy is the National Medicines Policy (NMP), the objectives of which are: 1. Timely access to the medicines that Australians need, at a cost individuals and the

community can afford, 2. Medicines meeting appropriate standards of quality, safety and efficacy, 3. Quality use of medicines and 4. Maintaining a responsible and viable medicines industry.

The TGA, as part of the DoHA, contributes to some extent in meeting all these objectives but has particular statutory responsibility for ensuring the quality, safety and efficacy of therapeutic products (objective 2). It does this through a range of assessment and monitoring activities consistent with the provisions of the Therapeutic Goods Act 1989 (the Act) and related legislation. It also contributes to the remaining elements of the NMP through, among other activities, its: • regulatory responsibility for advertising and labelling of therapeutic products

(objective 3); • scientific assessments and approvals which are taken into consideration by funding

bodies such as the Pharmaceutical Benefits Advisory Committee (PBAC) and/or the Medical Services Advisory Committee (MSAC) when considering applications for government subsidy thus reducing the direct costs for consumers (objectives 1 and 4);

• active contribution to international standards setting which in turn minimises the need for country-specific regulatory requirements while still meeting the core objective of protecting public health and safety. Through maintaining a world class regulatory system recognised by its international peers, the TGA contributes to Australia’s maintaining a viable and responsible industry (objective 4).

In addition, the TGA advises other regulatory authorities on potential public health risks posed by agricultural, veterinary and industrial chemicals used in the community. This paper, however, focuses on the stakeholder consultative arrangements relevant to therapeutic products only.


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The TGA makes a significant contribution to the health of all Australians. The community as a whole confidently uses the wide variety of therapeutic products available in the market place in the strong belief that they are safe and effective when used for their intended purpose because ‘someone in government’ has ensured that this is the case. Until 2003 when the Pan product recall occurred, that ‘someone’ was not readily identifiable by consumers – a situation that has now changed to some extent but which demonstrated the need for the national regulator to increase its public profile domestically.

The TGA has approximately 400 staff who collectively ensure that the therapeutic products available in the market place meet the appropriate standards of quality, safety and efficacy. These staff provide the major interface between the organisation and the suppliers and users of therapeutic products thus the external perception of the regulator is significantly influenced by the actions of the staff, no matter what other systems are in place to inform and consult with various parties.

The TGA is currently structured around its more traditional functional lines but increasingly, the separations are diminishing and a matrix structure emerging as the interactions between the specialities increases. Consequently, interaction between the TGA and its external stakeholders is also evolving although its present focus is on existing relationships, sometimes to the detriment of improved relationships with newer players in the therapeutic product marketplace. The nature and intent of the consultation is also changing but further work needs to be done to ensure there is a clear understanding among the parties about the objective(s) of the particular consultation being undertaken.

The question of whom should be consulted and when, is a significant challenge. Like most organisations, the TGA cannot and does not have unlimited resources to allocate to satisfy the wishes of all the various external parties concerning consultation. The TGA is required to fully recover the cost of all the activities that fall within the scope of the Act from the fees it charges. It is also a basic tenet that the fees and charges collected from each industry sector fully recover the costs attributable to regulating that sector, that is there is no cross subsidisation between sectors. The TGA needs to balance the competing demands of cost containment and meeting its primary responsibility for ensuring that the therapeutic products it approves for marketing meet the appropriate standards of quality, safety and efficacy and are provided in a timely manner. Consequently, the resources allocated to consultation are determined based on both overall priorities and priorities within the individual industry sectors. Unfortunately this may mean that the resources available for consultation do not match the demand in one or more industry sectors.

In addition to consulting with external stakeholders, the TGA is also the primary source of advice on therapeutic products for the Parliament, the Government, Ministers and the Parliamentary Secretary. It has significant interaction and requirement to consult with other Commonwealth and State Government agencies in relation to the regulation of therapeutic products

The TGA has a number of mechanisms, both formal and informal, to undertake consultation with its stakeholders and partners. One of the formal mechanisms for example is the TGA-Industry Consultative Council (TICC). The role and function of TICC and other bodies are discussed further in Chapter 3.


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The approach adopted for this review of the TGA’s consultative arrangements was to:

1. Identify the parties in the health care continuum who it might reasonably be

assumed are parties that the TGA should consult with because of their supply of, use of, or involvement with, therapeutic products.

2. Where appropriate consult with TGA staff to ascertain their views as to the nature of consultation and the parties with whom the TGA should engage in consultation.

3. Analyse the consultative mechanisms of organisations similar to the TGA to ascertain what contributes to effective consultation in the Australian environment.

4. Consult with a wide range of parties in the health care continuum that had experienced consultation with the TGA and those that had not.

5. Analyse the outcomes of the consultation. 6. Analyse the consultative mechanisms of organisations similar to the TGA. 7. Analyse best practice consultation principles in Australia and elsewhere 8. In light of the outcomes of 2-7 above, review existing TGA consultative

arrangements and provide advice on any changes that could improve TGA’s consultation mechanisms.

Prior to the consultations, relevant parties were sent a discussion paper (Appendix B) which assisted in focusing on some key issues. The length of interviews ranged from one (1) to three (3) hours. The amount of time was often dependent on the extent of previous involvement with the TGA and/or the number of parties or individuals involved in the discussion. Consultation- what is it?

It was important to define at the outset what is meant by consultation. Extensive research by various institutions and bodies who have examined consultative mechanisms and forums indicates that for consultation to be effective it is important that all parties participating in consultations understand and agree on the purpose of, and the outcomes being sought from the consultations.

For the purposes of this project, consultation is defined as an interaction between the TGA and external stakeholders, the purpose of which is to one or more of the following:

1. provide information to participants; 2. exchange views between the external parties; 3. establish a formal process of dialogue between the parties with the aim of

avoiding and/or resolving conflict over issues, 4. negotiate with the aim of reaching agreement about issue; 5. establish cooperative partnerships by bringing the parties together to develop

agreed solutions to common problems.


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Chapter 3 TGA Consultative Mechanisms

The TGA employs a number of mechanisms for consultation with its various external stakeholders. It also regularly seeks advice from Expert Advisory Committees established under the Act to inform its decision-making when giving marketing approval to therapeutic products.

The TGA Industry Consultative Committee (TICC)

The TGA-Industry Consultative Committee (TICC) was established in 1997 to provide a high level forum for industry to provide direct feedback to TGA on broad policy, resource allocation and program performance issues. The TICC is a consultative forum, not a management or advisory committee and comprises representatives from TGA and peak industry groups as follows:

• Medicines Australia (MA) • Australian Self Medication Industry (ASMI) • Complementary Healthcare Council of Australia (CHC) • Medical Industry Association of Australia (MIAA) • National Manager, TGA (Chair) • Director, Business and Services Branch, TGA

Other members of the TGA senior management team routinely attend the meetings to assist in its deliberations and discussions.

A representative of the Consumers' Health Forum (CHF) was added to Committee in 2001, initially as an observer, but who now participates fully in the discussion.

The TICC meets formally a minimum twice each year in May and November. Meetings are also held on a bilateral basis in February/March of each year to discuss fees and charges for the following financial year.

The terms of reference of the TICC are as follows:

(i) To examine and comment on the TGA corporate strategic plan developed within the context of Government policies;

(ii) To examine and comment on TGA performance against the key performance indicators set out in the Corporate Plan and Budget Statements; and

(iii) To examine and comment on the TGA budget, including new initiatives and other budget measures, and on the proposed industry fees and charges.


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The TICC has provided an important mechanism for extensive consultation by TGA with its key stakeholders since its inception. It allowed all industry sectors to appreciate the constraints within which the TGA operates and the many common issues impacting across all the sectors. This enabled industry to make positive contributions to the decisions of the TGA and avoid negative reactions to them. It also provided the TGA with a mechanism to achieve co-operation with industry and consumers in determining the approach to key issues to assist the TGA in meeting the Government’s objectives for therapeutic products.

As discussed elsewhere in the report the attitude of the industry members of the TICC to their participation now appears to be less positive than in the earlier years of its operation. In large part, this would appear to be due to the issue of increasing TGA fees and charges, which has had an impact on all parties. This has resulted in some negativity that has affected the attitude of industry representatives in their working relations with the TGA. It is clear that, given the cost recovery arrangements, industry believes it should have an increased role in the decisions and day to day management of the TGA. As the regulator, the TGA is accountable to the Parliament for its administration of the Act, particularly for meeting its public health and safety responsibilities. In meeting those responsibilities, the TGA must provide a balance between the competing needs of both industry and consumers through administering a regulatory system that protects public health and safety while minimising the regulatory impost on industry. More effective consultation and increased transparency of decision making will go some way towards improving the current unease.

Other bilateral meetings with the individual industry sector groups are conducted throughout the year as the need arises. The TGA has utilised both informal and ad hoc forums to address issues. These have included for example issues such as the appropriate mechanisms for determining how fees for the evaluation of prescription medicines are established, the fee regime for medical devices and the processes used for the evaluation of medicines. The evidence would indicate that these mechanisms have proved beneficial to both industry and the TGA in addressing particular issues of concern.

Expert Advisory Committees The TGA has a number of expert advisory committees that provide specialist professional and technical advice, expertise and input to its decision-making processes. These committees are an important part of the TGA’s consultation process.

• The Australian Drug Evaluation Committee (ADEC) provides independent, scientific

advice to the TGA on the quality, risk-benefit, effectiveness of and access to medicines referred for its consideration. The TGA uses that advice to guide its decision-making in determining whether to approve an application for marketing approval for a prescription medicine. The Committee has six to seven core members and up to twenty (20) associate members. At least three of the core members must be eminent medical practitioners with at least two who are specialists in clinical medicine; one of the remaining core members must be a pharmacologist or hold a degree in science, specialising in pharmaceutical science. Among the associate members, all of whom must have specialist qualifications and experience in fields of medicine complementary to those of the core members, must be at least one toxicologist, one general practitioner and a pharmaceutical chemist with recent manufacturing experience in therapeutic products.


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The Consumers Health Forum (CHF), using finds provided by the TGA for this purpose, provides consumer input to the ADEC considerations.

The ADEC has a number of sub-committees, the members of which are also highly qualified in their particular fields of expertise.

• The Complementary Medicines Evaluation Committee (CMEC). This committee

provides scientific and policy advice relating to controls on the supply and use of complementary medicines. The CMEC provides this advice with particular reference to the safety and quality of products and, where appropriate, efficacy relating to the claims made for products. The Committee and its Expert Advisory Panel comprises members with backgrounds in the health professions, industry, consumers and practitioners, which enables it to reflect the broad range of views in the community.

• The Medicines Evaluation Committee (MEC) provides advice on matters relating to

the safety, effectiveness and quality of any OTC medicine or ingredient within an OTC medicine. The committee is made up of between eight and twelve members who together have expertise in general medicine practice, specialist medicine practice including geriatric and paediatric medicine, clinical pharmacology and clinical toxicology, pharmaceutical chemistry, pharmacology, microbiology, community pharmacy, medicine manufacture and government regulation. A member with expertise in consumer issues has been recently added to the committee.

• The Medical Device Evaluation Committee (MDEC) provides independent medical

and scientific advice on the safety, quality and performance of medical devices supplied in Australia including issues relating to pre-market conformity assessment and post market monitoring. The Committee is made up of 12 core members and up to 20 associate members. Together, members have expertise in a broad range of disciplines including general medicine practice, gastroenterology, cardiology, anaesthesia, orthopaedics, plastic & reconstructive surgery, neurosurgery, gynaecology/obstetrics, ophthalmology, vascular & transplant surgery, restorative dentistry, biomedical engineering, in vitro diagnostic devices, medical device manufacture and consumer issues.

The core members include at least 3 persons who are medical practitioners eminent in the medical profession and at least 2 of whom are specialists in clinical medicine. The remaining core members have expertise in the areas of consumer issues, industry issues; biomedical engineering and biomaterials. All associate members have specialist qualifications and experience in disciplines complementary to that of the core membership.

There are also a number of other committees providing input and advice to the TGA including: • The National Coordinating Committee on Therapeutic Goods (NCCTG) which is a

Commonwealth, State and Territory committee that provides recommendations on administrative and regulatory controls for therapeutic goods.

• The Therapeutic Goods Committee (TGC) which provides advice on standards for therapeutic goods, including labelling and packaging, and on principles to be served in the manufacture of therapeutic goods for use in humans. It has a number


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of standing subcommittees to address such specific issues as medicines labelling, blood and tissues, packaging and general standards for tablets, pills and capsules.

• The National Drugs and Poisons Schedule Committee (NDPSC) which considers

submissions for additions or alterations to the Standard for the Uniform Scheduling of Drugs and Poisons and other tasks associated with the public health aspects of the scheduling of drugs and poisons. The Committee includes representatives of State and Territory health authorities, specialist medical and/or technical experts and representatives of various sectional interests.

Collectively, these committees make an important contribution to the TGA’s consultative and decision-making processes and it is the general view that they are operating effectively within their clearly defined statutory roles. They have an ongoing role that will continue regardless of any changes to the TGA’s consultative mechanisms arising from this report but are mentioned here for the sake of presenting a complete picture of the existing consultative framework.

Ad Hoc Consultative Arrangements

From time to time and depending on the issue, the TGA will convene ad hoc committees or working groups to exchange ideas on, and/or seek input to proposals for a new regulatory framework or to vary an existing arrangement. Discussion papers are also widely circulated to relevant stakeholders for comment and are published on the TGA Internet site with an invitation for written submissions. Seminars are convened from time to time to provide information on particular topics.

The TGA also regularly consults directly with individuals be they companies, consumers or intermediaries on a wide range of issues relevant to their relationship with TGA.

Recent notable examples include: • The committee established by the TGA that collaborated to produce the

‘Guidelines for Tamper-evident Packaging of Medicines, Complementary Healthcare Products and Medical Devices’ which had the support and acceptance of industry, consumers, health professionals and other affected parties and which formed the basis for regulation. A number of parties interviewed expressed the view that this is a very successful example of consultation and collaboration by the TGA.

• An Expert Advisory Group was established to consider the development of a regulatory framework for tissues and emerging biological therapies. A number of principles were developed and supported through the consultation process in 2003. A second round of stakeholder workshops was conducted by the TGA during February to April 2004, to refine details of the framework. The remaining concerns expressed at these workshops were presented to the Expert Advisory Group (EAG) on Regulation of Cellular and Tissue Based Therapies, for its guidance. The development and consultation process is ongoing with the recent Symposium, NATA Accreditation and TGA's Licensing: What are their roles in manufacture of human cellular and tissue based therapies, a direct result the EAG's


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recommendation to explore options with regard to licensing steps of manufacture performed at pathology laboratories.

• Ongoing consultation between the TGA and industry on the development of regulatory guideline documents for prescription and non-prescription medicines (including complementary medicines) and for medical devices; and

• Stakeholder consultation during the Review of Advertising Therapeutic Products in Australia and New Zealand in 2002 lead, among other things) to the establishment of an Interim Advertising Council (IAC) to further develop the new trans-Tasman Advertising Code and its supporting administrative arrangements. The IAC has broad representation from industry (both therapeutic products and the media), health professionals and consumers. Its work is ongoing at the time of writing this report.


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Chapter 4 The Issues-The view from the outside

For the purposes of this review, those external to the TGA and Government, who it may be appropriate for the TGA to engage in consultation on a structured basis have been divided into Suppliers (sponsors of therapeutic goods, industry organisations) Therapeutic Intermediaries (medical practitioners, pharmacists, hospitals and organisations representing those groups etc) and Consumers (patients, patient groups and consumer organisations).

What emerged from the interviews undertaken as part of this project was that greater clarity is needed to ensure the participants are clear about the purpose of any discussion or other interactions, for example is the purpose to inform, to seek views or to negotiate an agreed position?

Consultation, the track record

In the following paragraphs, the consultant has sought to reflect the views as expressed by the interviewees. No judgement has been made about whether these views are soundly based in fact or are simply a reflection of individual perception. Either way, the views signal the need to improve both the general levels of knowledge and understanding of the TGA’s functional responsibilities, the processes adopted to fulfil its statutory obligations and its interaction with the various stakeholders at all levels.

All parties

From the interviews and analysis it is clear that the issues affecting the parties who have engaged in consultation with the TGA in the past and those that could be involved in future consultative arrangements are quite diverse and at times contradictory.

The lack of clarity as to what activity was actually taking place at any given time, coupled with the parties’ different expectations about the outcome they were seeking from the interaction, affected their perception as to the benefit or otherwise of the activity that occurred

Stakeholder confidence in TGA’s consultative processes is not as high as would be considered desirable given the importance and critical nature of the goods being supplied and the reliance by the Australian community on the TGA to ensure that therapeutic products marketed in Australia meet appropriate standards. A variety of reasons for this came to the fore during this project. For example

• there were, on occasions, unrealistic expectations surrounding the role of the various parties engaged in the consultation process

• in a number of cases, even though the parties are involved in the supply or use of therapeutic products, they have not been part of the TGA’s consultation processes to date


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• what has essentially been a meeting convened by the TGA to provide or exchange information has been mistaken for a more inclusive consultative process

• because of previous experiences or perceptions, the level of trust between the parties, essential for effective consultation, is not as high as is considered desirable

• the failure of the expected or desired outcomes from previous consultations to be realised, or realised within acceptable timeframes, has had a negative impact

• a belief by some parties that, on occasions, the consultation occurred after the ‘real decision’ had been made and that they were participating in an exercise for ‘appearances’ sake.

Of the over 60 parties who were consulted during this project, there was not a majority who expressed the view that overall they were satisfied or very satisfied with their experience of consultation with the TGA at the present time. In some of these cases, the level of interaction with the TGA was recent and limited. Research demonstrates that a key element that needs to be present for effective consultation is a high level of trust between the parties involved. On a number of occasions, those consulted during this project expressed the view that they did not trust the TGA to deal fairly with them. There is no evidence to support this view but it does, nonetheless, have the potential to adversely influence the effectiveness of the interaction. One of the recurring themes during the project was the need for access to reliable and current information. For consultation to be effective, the parties need to have a reasonable level of information about the issues that are to be discussed. It was clear from the interviews that a number of parties did not have a good level of understanding of the functions, roles and powers of the TGA and how it goes about undertaking them. This was true, even on occasions, for those who have had a significant period of involvement in the therapeutic products industry. Some potential sources of information such as the TGA website, whilst seen as useful, were considered to require a reasonable level of knowledge of the TGA’s activities, functions and personnel to be able to navigate effectively. A number of interviewees, particularly the suppliers of therapeutic products, expressed the view that the information on the website was, on occasions, out of date or not comprehensive enough. A related issue is the lack of transparency in the regulatory processes adopted by the TGA. This is seen to limit the ability of stakeholders to provide meaningful input into the various processes when the opportunity is available. Consumers and therapeutic intermediaries in particular were the most critical of the opaqueness of the system and consequently this affected their attitude towards the TGA. Suppliers, whilst expressing some concerns about the potential effects of greater transparency, recognised that much of the argument for maintaining the existing system has dissipated and they were prepared to consider an opening up of the process.

The ability to access or identify the right area or person in TGA to obtain information on matters of concern to them was identified by many as an issue. They considered it difficult to access the right sources and indeed a number of those interviewed expressed the view that on occasions they believed that some personnel in TGA appeared to want to limit or discourage dialogue between the TGA and external parties.


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There was a general view that the TGA was not as responsive to contacts and queries from interested or affected parties as they would desire. Some expressed the view that on occasions they considered that the TGA had not complied with its Customer Service Charter.

Suppliers

The various industry organisations have a good level of interaction with and access to the TGA. Smaller suppliers, and those suppliers who did not have a significant involvement with the relevant industry association, did not consider that their level of interaction with the TGA was satisfactory to them, nor did they consider that they were effectively consulted. Many of these smaller suppliers engage agents or consultants to undertake regulatory functions on their behalf who, for a number of reasons, are generally not members of industry organisations. Consequently both groups may miss out on opportunities to be involved in TGA’s consultative processes.

During interviews with some suppliers, a view emerged that it was unproductive to question or disagree with the actions of certain areas within the TGA because of the likelihood of retribution such as delaying marketing approval. No one has provided any evidence of such behaviour. Further, it would be serious breach of the Australian Pubic Service (APS) Code of Conduct with potentially serious consequences for the individual if such an allegation is sustained. Nonetheless, this ‘urban myth’ does persist and it contributes to, and to some extent explains the lack of trust between some of the participants. On the other hand, some suppliers quite clearly indicated that they have a good working relationship with the TGA, leading to a higher level of confidence in the relationship and its benefits.

A key concern of suppliers was the time frames in relation to consultation. They felt that unrealistically short time frames were often set and then, after significant involvement in addressing issues or responding within the tight time frames, the TGA did not respond with outcomes in agreed time frames or on occasions did not produce an agreed outcome from the consultation. This is another contributor to negative perceptions of the TGA by suppliers

The TGA fees and charges exercised the minds of many of the interviewees. However, given the Government requires the TGA to fully recover the cost of all the activities that fall within the scope of the Therapeutic Goods Act 1989 (the Act), the scope for consultation is limited essentially to the methodologies adopted to arrive at the required quantum. The level of concern expressed about this subject does not always reflect the quantum of that sector’s contribution to TGA’s revenue. It would appear that for some, the desired focus of TICC Meetings for example should be almost exclusively on financial matters whilst others wanted it to have an even broader charter than it has now. Some suppliers appeared to have difficulty focussing on major policy issues unless they have financial implications.

Suppliers considered that the TGA did not take enough account of the fact that Australia is a small market and was overly conservative and cautious in its approach to issues. They also believed that the TGA did not take enough account of the expertise residing within industry and also had a negative view to some of the advice or information emanating from industry. Given that many from industry consider themselves health


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professionals first and foremost, they felt that such an attitude by TGA officers impugned their professional integrity.

Suppliers considered that consumers and medical practitioners overly influence the TGA.

Suppliers also considered that the TGA was becoming more closed and that there was a growing reluctance in some sections of the TGA to allow communication between suppliers and TGA officers. Some suppliers also indicated that they had difficulty in communicating with or obtaining responses from the TGA.

Therapeutic Intermediaries

This category consisted of medical practitioners, pharmacists, hospitals, professional and industry organisations. The level of interaction with the TGA has to date been less than with for example, suppliers. In some cases, it has been non-existent even though they are significant users of therapeutic products, or intermediaries in the use of therapeutic products by patients. They consider that they can be and have been significantly affected by the decisions or actions of the TGA in relation to therapeutic products and therefore wish to be involved in consultations with the TGA.

Intermediaries see the TGA’s actions and decisions as being strongly influenced by suppliers and those actions and decisions being determined by the need to maintain the income derived from suppliers.

This view in part may occur as the result of the non-involvement of intermediaries in consultation on many issues and thus they are not aware of the views of the suppliers or the TGA.

Intermediaries overall considered that they were not involved in the consultation processes enough and indeed as noted earlier a number had never interacted with the TGA (some were even unaware of the TGA’s location.)

The level of knowledge about the TGA’s functions and its processes is not as high amongst intermediaries as one would expect given their level of professional knowledge. In fact, there is a surprising level of misunderstanding about the TGA’s role, function and powers.

They also in some cases had a firm view that the TGA by having to depend on fees from industry for their income was automatically compromised and believed that the TGA should be funded out of consolidated funds. As a minimum, they believed that the TGA should have a significant portion of its funds provided by Government for its public benefit activities.

A recurring theme from some intermediaries was the cost to them of being involved in consultation and the view that the TGA should meet these costs. Even though most organisations representing intermediaries have offices in Canberra, they considered that the TGA should meet the travel costs of them having personnel travel interstate for meetings. Some intermediaries even suggested they should be funded by the TGA for the cost of staff required to be involved in consultation to enable them to participate effectively in consultation.


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Intermediaries, more so than suppliers, expressed concern about information provision by TGA, including the website and the difficulty in identifying and accessing the appropriate contacts within the TGA to obtain information or advice. This is due in large part to their limited interaction with the TGA and that at times they did not have a complete understanding of the TGA’s role, powers and functions

Consumers

A key feature of this group was the lack of knowledge about the TGA, its role, powers and functions particularly by patient groups. Whilst the TGA has regularly consulted the peak consumer organisations it does not appear that these consultations have been effectively communicated to patient groups. This in part can be explained by the fact that there are a number of patient groups who are not members of CHF for example or that in fact they cannot become members of the Australian Consumers Association (ACA) as the membership of ACA is limited to selected individuals.

A number of patient groups who represent significant patient cohorts that are extensive users of therapeutic products were unable to determine from their records any instance where they interacted with the TGA either directly or through intermediaries. Indeed the consultation process about consultation alerted them to the role and importance of the TGA to their members and interests. The level of understanding of the TGA’s role, power and functions and how the TGA carried them out, was limited.

A small number of consumer organisations indicated that they had resource difficulties, which constrained their capacity to participate effectively in consultation with the TGA and considered that they should be funded by the Government to carry out this function.

Consumers more so than other groups, expressed difficulty in identifying or communicating with the appropriate officers in TGA to obtain advice and information and navigating the website. Some were not even aware of the site or the material it contained.

Consumers consider that suppliers and/or the medical profession significantly influence the TGA’s decisions and/or actions.

Analysing the issues

• The extent of the lack of knowledge of the TGA‘s activities is concerning and is a

contributor to the attitude, held by some of the external parties, which is not always positive towards the TGA. While there are multiple sources of information on TGA’s role and functions, given the critical importance of TGA to the community the public awareness and promotion activities of TGA are less than by similar Government agencies. It is important in order to maintain confidence in TGA’s activities that the community is fully informed about TGA’s role and functions. The cost of this activity would have to be met from TGA’s fees and charges revenue. While this could impose some short-term costs, it could reasonably be argued that the long-term benefits to suppliers of increased public confidence in regulation of therapeutic products would provide commercial benefits.

• The term ‘consultation’ is interpreted differently by different people. This affects the perception as to the value of the consultation and can, on occasions, result in a


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negative perception that is at odds with that of other parties involved who consider the consultation was effective. It would appear from the interviews that it is not the practice by parties to seek to define the precise nature of the consultation being undertaken. This is not the fault of any party but rather a function of long standing practices in which all assume that they are doing the same thing when in fact they are often pursuing different agendas.

• The diversity of views and specific sectoral interests often means that although the TGA may have consulted widely on an issue, the final outcome may not be wholly acceptable to one group or another. The TGA takes account of all the views expressed and seeks to find a balance consistent with its statutory responsibilities.

• There are occasions on which the TGA will be required to implement a decision by Government about which there may have been little prior consultation with stakeholders. In these circumstances, the consultation will usually be about how best to implement the decision rather than the decision itself.

• The process of legislative change can be very lengthy and on occasions, the associated consultative processes can seem to not produce a result within a reasonable time. It may be useful for the TGA to provide some indicative timeframes when undertaking consultation that is a forerunner to changes in legislation.

• The TGA website has a comprehensive range of information available. It is constantly being updated and improved to reduce the need for specific knowledge of TGA’s activities to navigate successfully. A lack of understanding of TGA’s role and activities may increase the difficulty of navigating the site, however this is not uncommon on websites that have significant scientific or technical content.

• It is important that information provided to stakeholders is complete, factually correct, relevant and timely. For this reason, the TGA prefers to channel requests for information through employees with responsibility for providing such information rather than rely on a more random approach.

• Given the impact of fees on suppliers’ balance sheets, it is not unexpected that the level of fees is a significant focus of many of them. Unfortunately the TGA is the primary focus of their concern although it has significant constraints in addressing these concerns. The TGA must comply with Government policy to effect full cost recovery for its regulatory activities. At the same time, it has to fulfil its statutory responsibility to ensure the quality, safety and efficacy of medicines and medical devices in the market place. To do this, it has to ensure that it has adequate resources through applying a appropriate level of fees and charges.

• While the majority of sponsors are members of industry organisations a significant number are not and present consultative mechanisms do not effectively capture them. This can have adverse consequence on TGA achieving it objectives.

• The opaqueness of the regulatory processes that is an issue of concern to a number of parties, is a consequence of industry’s desire to protect commercial interests. While there is an argument that competitors could obtain information as to a company’s intended products, market and commercial advantages if the registration process is fully transparent, the reality is that much information is already obtained from the activities of companies in overseas markets and other sources. Indeed, most companies seem to have a good understanding, gained from a variety of sources, of what their competitors are planning to market in the near future, including what products are currently under evaluation by the TGA. While the TGA goes to significant lengths to protect confidentiality, no one interviewed expressed any lack of confidence or doubt about TGA’s ability to maintain


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security in relation to applications. The requirement for the level of opaqueness is not as relevant as it was in the past, Australia is very rarely the first country to which companies apply for marketing approval for a product and this is unlikely to change in the future. A more transparent process would give many of the parties more confidence in the system and could result in the TGA not being held responsible for a situation not of its making, thereby removing one source of negativity towards the TGA.

• While there may be no substantive basis for the lack of trust between some of industry and some in the TGA, perception can sometimes appear to become the reality. There is enough concern being expressed to consider that this could severely prejudice any initiatives or actions undertaken by TGA to increase or improve consultation with all parties. Therefore it would be important that steps be taken to identify the cause of the problem, whether real or perceived, and to remedy the situation.

• The TGA has a comprehensive range and number of bodies that it has established to ensure consultation on matters of concern. Many interviewed were not aware of these forums or their functions or indeed that the TGA website contained information on them. Indeed some did not realise that their area of interest was represented on a forum. There are clearly communication issues that need to be addressed. A number of organisations did not see it as their responsibility to communicate information they received from TGA to their members. There is obvious benefit in reviewing these bodies, their purpose, membership and how their deliberations are communicated.

• Therapeutic intermediaries do play a vital role in achieving the objectives of the National Medicines Policy for example and thus are a key player in assisting the TGA in achieving its objectives. A number do not recognise the importance of a strong relationship with the TGA therefore have not devoted sufficient or indeed in some cases any resources to the relationship. While the TGA has a responsibility to ensure it devotes appropriate resources to providing information and effective consultation, it is incumbent on those who benefit either directly or indirectly from the activities of the TGA to also devote appropriate resources to ensure effective interaction.

• The low level of awareness and understanding amongst health consumer organisations of TGA role and functions is concerning. In the past the TGA has relied on peak bodies such as the Consumers Health Forum and the Australian Consumers Association to disseminate information and to represent the views of consumers. This strategy appears not to have been as effective as is desirable and also indicates that these organisations may not have the means or the resources to carry out these functions effectively.


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Chapter 5 Consultation-The Future

Consultation-the future

The terms of reference of the project focussed on the TICC and specifically required the consultant to

• Identify stakeholder interests/interest groups who should be involved as part of the formal consultative process and define possible eligibility criteria for membership;

• Consider the extent to which current membership meets these contemporary needs and identify the gaps;

• Make recommendations on the membership of TICC; and • Define the roles and responsibilities for industry and consumer representatives on

TICC and review the adequacy of the current terms of reference.

The role of a body such as the TICC is to enable the TGA to consult with key stakeholders in an organised manner on matters regarding TGA’s operations. In addressing the TOR, a view has been formed as to what should be the functions of any consultative body established by the TGA. A consultative body established by the TGA should be based on the following principles of consultation,

• To provide a forum to enable an exchange of views between the TGA and external

parties on matters relevant to the operation of the TGA and which affects them directly or indirectly;

• To enable a formal process of dialogue between the parties involved in the provision, regulation and use of therapeutic products with the aim of avoiding and/or resolving conflict over issues;

• To provide a mechanism to enable negotiations aimed at reaching agreement about issues;

• To provide a forum as a means of enabling cooperative partnerships and thus bringing the parties together to develop agreed solutions to common problems.

During the course of the project it became apparent that a re-organised or restructured TGA Industry Consultative Committee (TICC) would not, in the current environment, readily enable the achievement of such principles. There are many contributing factors including

• the negative attitude of some of the parties to the relationship, albeit that such an attitude may not be justified, which has built up over time arising from matters relating to costs;

• some perceived negative experiences in relation to matters of process and procedures;

• the significant pressure on industry representatives to ensure that the actions of the TGA do not negatively impact on commercial outcomes; and

• some stakeholders, often for good reason, still keeping their “team jerseys” on and thus not taking the broader view.

These factors would make it difficult to provide the outcomes necessary for a body such as TICC to be fully effective and thus to play a meaningful or beneficial role in the TGA’s operations.


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There are also many groups not presently represented on the TICC who could legitimately claim that they should be consulted because they are significantly affected by TGA’s decisions and operations. If they were included in TICC, it would become a very large and possibly unworkable group representing a range of sectoral interests, thus reducing its effectiveness and its ability to provide the TGA with beneficial advice.

In considering a way forward, it was important to take account of the most appropriate mechanism to meet the principles of consultation outlined in Chapter 3.

A consultative forum is just that and should not be perceived as part of the day to day management of the TGA. The responsibility and accountability for TGA’s actions and decisions resides with the executives and staff of the TGA. Therefore, it was deemed appropriate to consider both an expanded TICC and alternatives to the present models of consultation that could achieve the best outcomes for the Government, the TGA, industry, therapeutic intermediaries, consumers and the community.

In considering how to ensure that any future consultative arrangements are robust enough to meet changing circumstances and demands, it is necessary to have regard a number of factors. These include things like past experience, examples of best practice consultation in Australia and internationally especially involving organisations similar to the TGA (a regulator of products or services that can have a significantly adverse impact on the health, welfare and safety of the community). It is also appropriate to make sure that any new arrangements address the issues raised by the parties that are or should be involved in any future TGA consultation processes. Other factors to consider are

• ensuring that there is not over consultation and thus the inappropriate diversion of scarce resources,

• avoiding unnecessary duplication; and • avoiding the creation of a forum that is ineffective because it is not valued by

participants.

There were also other issues raised during the consultations which did not readily fall within the TOR but which nonetheless, if not addressed would adversely affect any consultative arrangements. Issues such as the provision of information on the TGA’s role, responsibilities, functions and powers now and in the future, which if not addressed would result in some parties having an information deficit and thus diminishing their ability to meaningfully contribute to any consultative forums that are established.

The present consultative arrangements have served a very beneficial purpose to date, however as the TGA moves forward, there would be benefit in developing mechanisms which will meet the future needs of the TGA and its successor agency and those it has to interact with. This paper therefore takes account of the imminent establishment in the near future of the Trans Tasman Therapeutic Goods Regulatory Agency. Future consultative mechanisms should also reflect contemporary Government practices and thinking and be ones that will require minimal adjustment to adapt to meet the needs of all parties when the Trans Tasman Agency is established. Whatever mechanisms are put in place, they will also have to ensure that they obtain beneficial participation from suppliers, therapeutic intermediaries, consumers and the community and address the issues that the TGA has to deal with and assist the TGA to be the primary regulator in the Asia-Pacific Region.


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Any consultative arrangements will have to ensure that all parties have appropriate input and that consultation does not just involve a select group to the exclusion of those who have a valid argument that they should be consulted.

The issues to be taken into account in devising appropriate consultation mechanisms can be broken down in to the following;

• information provision and access • the nature of consultation, • the objectives of consultation, • the parties to be consulted, • the mechanisms of consultation

If one examines other organisations similar to the TGA as to how they approach consultation, the approaches are quite varied and require different levels of resources.

The USA Food and Drug Administration for example devotes significant resources to both providing information to and consulting with relevant parties. For the TGA to replicate the FDA’s activities would require substantially more resources than the TGA has available, or indeed, that the market could bear given the need to recover costs. It would also be the case that the various parties involved in consultation would not be able to devote the resources that their counterparts in the USA do, nor would it be fair to say could they match them in terms of capacity or capabilities.

Suppliers in the USA consider the FDA to ‘over’ consult and to involve too many parties. They do however consider that the FDA provides an extensive range of information both through its website and by its electronic information services. Consumers consider that the transparency of the FDA processes greatly assists them in ensuring that the FDA takes account of their views. The extent to which the FDA consults them on therapeutic products, which are being sought to be introduced to the market, is considered appropriate.

The Canadian Therapeutic Products Directorate(TPD), which is the TGA’s counterpart, has comprehensive mechanisms for consultation with suppliers, intermediaries and consumers. For example, it has an Advisory Committee on Management, the function of which is to be a forum for obtaining advice, and a sounding board for management issues relevant to the Therapeutic Products Directorate. The Committee will be asked for advice on areas such as cost recovery, performance, continuous quality improvement, and other Directorate management initiatives. Decision-making responsibility remains with the management of the Therapeutic Products Directorate. From time to time, the Committee may be consulted by other sections of Health Canada as well. The members of the TPD Advisory Committee are drawn from persons nominated by stakeholder groups, such as industry, health professions, academia, and consumers. Members are selected by the Director General, Therapeutic Products Directorate. The membership of the Committee as a whole is intended to reflect an appropriate blend of gender, regional, ethnic, and language representation.

The TPD also has regular meetings(at least annually) with the various industry sectors, representatives of intermediaries and consumers. With industry the meetings are with quite specific groups such as research based prescription medicine companies and


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organisations, generic medicine companies and organisations, medical device companies wholesalers etc.

Minutes of all these meetings are published on TPD’s website and are publicly available. The European agencies tend not to have as comprehensive arrangements as the Canadians and the FDA but do have to follow the European Commissions prescriptive consultation guidelines that have a strong focus on process.

In Australia AQIS, for example, has 13 Consultative Committees addressing discrete areas such as biologicals, meat, dairy, seafood, horticulture products etc. The record of meetings is not publicly available. The agricultural industry has some concerns about the level and nature of consultations that are not dissimilar to those expressed by the therapeutic products and devices industries.

Another Commonwealth body that has a comprehensive consultation mechanism and that has similar functions to the TGA, in that it is a Commonwealth Government agency which is a regulator with a role in protecting public safety, is the Civil Aviation Safety Authority (CASA), which has the Aviation Safety Forum (ASF) as it principal vehicle for consultation. The function and membership of the ASF is detailed at attachment D.

While on occasions, there has been some public criticism of CASA decisions, industry overall appreciates the level and nature of the consultation and considers that the method of appointing membership to the ASF has ensured that the members have relevant expertise and importantly, can make appropriate contributions. It was acknowledged that that the Director consults widely as to who should be appointed as members of the ASF. CASA considers that it gains valuable advice from the ASF that substantially assists it in its decision making.

The Productivity Commission in its “Report on Cost Recovery by Government Agencies” emphasised the importance of consultation and made the following point,

• “Consultation needs to be supported by open and accountable processes that reduce the risk of conflicts of interests or undue influence. The issue is determining the most appropriate structure to encourage meaningful consultation.”

The Government has made a final response to the Productivity Commission report and specifically in relation to consultation mechanisms has determined as follows:


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Government Response to Productivity Commission Report on Cost Recovery by Government Agencies-Consultation The Government agrees that all significant cost recovery arrangements should have appropriate mechanisms to promote consultation with stakeholders. Where stakeholder consultation mechanisms exist, these could consider cost recovery arrangements. In a devolved governance framework, the Government does not consider it appropriate to mandate that consultative committees be established. However, the characteristics of consultative committees outlined in the Government’s guidelines may be a useful guide for agencies

The Department of Finance and Administration has issued “Commonwealth Cost Recovery Guidelines for Regulatory Agencies”(Finance Circular 2002/02) which outlines the processes regulatory agencies such as TGA should undertake in relation to consultation the Guidelines provide for the following,

Agencies with significant cost recovery arrangements should have adequate mechanisms in place to promote consultation with stakeholders (including relevant departments, industry and small business) where appropriate. The characteristics of a committee if relevant, is a matter for each agency, with the approval of their Minister, however agencies may consider the following where appropriate:

! stakeholder representation;

! ability to monitor agency efficiency;

! access to adequate information on agency processes and costs; and

! transparent reporting processes.

Other Government processes can provide information that assists the agency and the Government in monitoring and improving cost recovery arrangements. These processes include consideration by Government during the Budgetary cycle, Australian National Audit Office performance audits and feedback provided by an agency’s audit committee.

These Guidelines have been beneficial in considering the most appropriate consultative arrangements for the TGA. There is, in developing appropriate consultative arrangements, a need to address specifically the critical issue of the TGA being the regulator responsible to both the Government and the community for the safety and efficacy of therapeutic goods and the importance of all relevant parties making the maximum contribution possible to assist the TGA in meeting its statutory responsibilities.


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Information Provision

In order to address the low level of understanding of the role and functions of the TGA it would be beneficial for the immediate future for the TGA to conduct information seminars on its role, functions and powers on a regular basis. Such seminars should be aimed at suppliers, therapeutic intermediaries and consumers (particularly patient groups). The seminars could be conducted over one (1) day and would provide a comprehensive outline of the functions of role and functions of the TGA and the key personnel involved in its activities. Given the resources required to organise such a seminar, the TGA may wish to consider conducting the seminar in conjunction with an independent organisation such as the Association for Regulatory and Clinical Scientists (ARCS) the professional body representing those involved in determining the safety and efficacy of products for industry. This and other organisations have a significant interest in ensuring the dissemination of information and knowledge on the regulatory process. Utilising the services of an organisation such as ARCS could also reduce the cost and resource burden on the n TGA

The frequency of the seminars could be scaled back as the level of understanding of the TGA’s role and functions reached satisfactory levels.

It may also be useful to have a reference booklet on the regulation of therapeutic goods produced out of such an activity to assist new comers to the activity.

Recommendation 1 That the TGA conduct a number of information seminars on its role and functions for suppliers, intermediaries and consumers. The seminar should be cost neutral to TGA.

Given the use of the internet and particularly websites to provide information to the community the TGA Website should be the primary source of information for suppliers, intermediaries and consumers. Therefore it is critical that it is comprehensive and readily navigated.

It may also be useful that the TGA provide a “members only access” to its site for a modest charge to sponsors and others who believe that they have a high need to interact with the TGA and to obtain information critical for their work. This aspect of a portal could also be used to ensure that those who provide a significant contribution to the TGA’s operations can obtain a non compromising benefit for their contribution. The TGA may wish to draw on the resources and expertise of suppliers, intermediaries and consumers to review the website and assist in upgrading it.

Recommendation 2 That the TGA website be regularly reviewed to ensure it meets the needs of users and that the TGA seeks the input of industry, intermediaries and consumers users to assist in upgrades of the website. The TGA also consider establishing a “members only” component of its web portal to provide access to its key partners to improve between the parties. The cost of such a portal component be met by the imposition of a small fee.


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Given the importance of effective consultation, the importance of good communication with and information provision to stakeholders and also to ensure the maintenance of the highest level of trust between the TGA and stakeholders, the TGA may wish to consider identifying resources within the various units of the TGA whose functions in whole or in part are to ensure effective liaison with, improved responsiveness to, information provision to and effective consultation with stakeholders.

For such resources to be fully effective and to ensure consistency in performance of the their functions, these resources should be responsible to and co-ordinated through one senior executive within the TGA who would in turn be responsible to the National Manager for effective communications and liaison both internal and external, and consultation with external parties. The resources under the direction of the senior executive would also have a role in ensuring a continuing commitment to effective consultation by all TGA officers. The resources would be responsible through the senior executive for TGA’s communication, liaison and consultation with key parties.

All of the TGA’s senior management would still have a responsibility for effective communication, liaison and consultation but by having one senior executive responsible for TGA’s overall performance this would ensure that it has the proper focus and that performance of these critical functions would be consistent and of a the highest standard.

Having regard to the TGA’s present structure, we would propose that the Director, Business and Services would be the senior executive to undertake that function.

The cost of such resources may necessitate a modest increase in fees but sponsors indicated that if it were a modest additional fee, guaranteed to be dedicated to the provision of the functions outlines above they would consider it a worthwhile cost.

The resources could reduce the demand across line areas in dealing with issues. It would also enable the TGA to detect earlier, any developing issues that may adversely affect or impact on the TGA.

The resource could also be useful in enabling the TGA to engage with non-industry stakeholders and assist them in understanding TGA actions and decisions.

Recommendation 3 (i)That the TGA identify resources in the organisation, whose function in whole or in part are to ensure effective communication, liaison and consultation between the TGA and all relevant external parties. (ii) Such resources should be responsible to and co-ordinated through one senior executive of the TGA who would in turn be responsible to the National Manager for the effectiveness of TGA’s communications and liaison both internal and external, and consultation with external parties. (iii)All of the TGA’s senior management should have as part of their duties responsibility for effective communication, liaison and consultation.


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A key issue that arose from the consultations was the matter of transparency, at present the TGA is precluded from providing information in relation to applications for marketing approval of therapeutic products. This in part contributes to misconceptions held by suppliers, intermediaries and consumers as to the TGA actions and attitudes.

In contrast, the FDA has a very open system and processes that appear to contribute to the level of trust as to the FDA’s efficacy in dealing with applications.

Much of the argument for maintaining the level of confidentiality is not considered to be valid in the current environment by most of the relevant parties and given that it is only in very limited instances that Australia would be the first country of registration for a therapeutic product then the commercial impact of the information as to applications being public is limited.

If the TGA were able to increase the transparency of its processes, it would add substantially to confidence in the system and the TGA. This would also be assisted if outcomes of meeting or consultations it has with relevant parties such as suppliers, intermediaries and consumers were publicly available. This occurs in other countries and contributes to increased confidence in the regulator.

The TGA should however have the discretion to not make such outcomes public if it considers that there would be adverse consequences such as for example commercial prejudice or the possibility of public mischief.

Recommendation 4 That the TGA increase the transparency of its system, make more information as to its activities, applications for registration, policies, and processes available to the public and that it make publicly available the outcomes of meetings undertaken as part of the consultation processes that it has with external parties unless the TGA is persuaded that there would be adverse consequences for the community if it did so.

Forms of Consultation

The TGA should determine what activities it considers are appropriate for consultation and what forms of consultation it proposes to undertake and discuss that with suppliers, intermediaries and consumers. It should clearly indicate when it is only providing information to the parties and not consulting to eliminate any potential misunderstandings.

It is also important that all recognise that consultation is a two way process and that suppliers, intermediaries and consumers have a role to play in consulting the TGA on their proposed activities and actions.

Some suppliers for example do not appear to accept fully that they have a major role to play in assisting the TGA to “smooth out” the workflow in order to ensure optimal use of resources and contain costs. In some instances they could, albeit with some difficulty, provide advance information to the TGA of intending applications for marketing approval


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to enable the TGA to better plan the utilisation of staff and resources, thus being able to make the appropriate adjustments in the areas affected in a more timely and cost efficient manner.

Recommendation 5 The TGA at the commencement of any consultations it undertakes, identify the parameters it is operating within. It should for example indicate if the consultation is a negotiation aimed at reaching agreement, a dialogue to provide views and understanding on key issues or a partnership aimed at finding agreed solutions to common problems. Suppliers, intermediaries and consumers should also be prepared to consult with the TGA on their activities.

Who should be consulted?

Industry

The TGA relies to a significant extent on industry associations to be the main point of contact to convey the views of suppliers and while it may be argued that they represent the majority of the industry, the TGA should not rely on them being the only channel of communication both up and down the line with industry. It became apparent during this project that a number of suppliers or their agents were not included in communication loops. This could adversely affect the TGA in meeting its statutory responsibilities and therefore the TGA must include all suppliers or their representatives in the consultation processes. Indeed, it could be argued that because of the TGA’s overall responsibilities it has to take all necessary steps to ensure that all are given an opportunity to hear and be heard and whilst industry organisations provide a useful mechanism for collective consultations this does not relieve the TGA of the responsibility to ensure it fully consults and that it draws all relevant parties into its consultative processes. Therapeutic Intermediaries Again, during the course of the project it became apparent that there were a number of key parties who were significantly affected by the TGA’s actions and who had not been engaged in previous TGA consultations. They do have views and information, which would be of benefit to the TGA as it considers how to fulfil its statutory functions. Because of their expertise and professional capabilities, they also in many instances could offer a much more informed view about therapeutic products than those for example representing consumers and one that is not affected by a real or perceived conflict of interest that suppliers may have.

Consumers

One aspect that became apparent during the course of the project was that it cannot be assumed that the CHF or the ACA represent all consumers. There are many patient


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groups who are not members of the CHF and whilst the Australian Consumers Association maintains the position that it is a major voice representing health consumers it does not have mechanisms to obtain a comprehensive and balanced view of the breadth of patients and consumers.

There are many patient groups who have or should have a serious interest in the TGA’s activities and there would be considerable benefit to all if they were consulted on relevant matters.

Recommendation 6 That in determining whom it should consult with, the TGA should ensure that representation of suppliers, intermediaries and consumers is drawn from a sufficiently broad base and not just organisations. This is required to ensure that the TGA is receiving the full range of views and if necessary it should actively recruit others to its consultative forums.

The forms of consultation

The TGA needs to engage in a variety of forms of consultation and at various levels to ensure that in determining key issues it has had input from the appropriate stakeholders. In reviewing the existing mechanism for industry consultation such as the TICC, it was apparent that no party or organisation considered that it was an effective forum for consultation. This is because for some they were not members even though on any basis of consideration there would be good argument that they should be. Sectors such as the generic prescription medicines industry quite reasonably believe that they should be members. As well it could be argued that intermediaries such as medical practitioners and pharmacists(community and hospital) have as much reason to be included in the consultation as say a consumer organisation. Other health professionals could also argue for inclusion as could therapeutic wholesalers and direct sellers

However if the TICC was expanded to include these groups it would rapidly become unwieldy and ineffective. This problem would be compounded in the near future if it were the model for consultation in the new Trans Tasman Regulatory Agency when the counterpart New Zealand organisations would quite naturally want to be represented. In discussions with the various parties, it was apparent that whilst they all wanted to be consulted, many did not want to be part of consultation mechanisms that had all relevant parties involved at the one time. They would prefer to be part of a discrete group, which reflected their interests. However, a key constraint is to make sure that the TGA is not so burdened down with consultative mechanisms that given its limited resources it is unable to effectively meet its statutory functions.

This suggests that there would be benefit in having an overarching consultative forum that could draw representatives from various organisations bodies and areas and which could


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assist the TGA in meeting the Government Guidelines for consultation mechanisms for cost recovery agencies which are, • stakeholder representation;

• ability to monitor agency efficiency;

• access to adequate information on agency processes and costs and

• transparent reporting processes.

Given the number and extent of the various parties who could legitimately claim to have a serious interest in the TGA’s activities and therefore to be considered for inclusion in any consultative bodies that are established by the TGA, including them all in a consultative forum would result in the forum being too large and thus ineffective. Unless there is rationalisation of representation as higher level committees are established, then there is little benefit in establishing them. From discussions held to date it would appear that it would be difficult for the relevant interest groups and industry organisations to be prepared to make the hard decisions to rationalise representation. Therefore, hard decisions would have to be made and given the TGA is the body seeking to benefit from effective consultation then appropriately the onus falls back on them to ensure actions are taken to make consultative forums effective.

Recommendation 7 The structure, operation and size of any consultative forums established by the TGA should be such that they enable effective participation by all members. Consultative forums should operate under an agreed set of principles. As a rule, consultative forums should have no more than 10-12 participating members.

Whilst the Productivity Commission recommended that consultative forums should have an independent chair this was not endorsed by the Government and we would not in this case advocate such a position. In the case of the TGA, its primary function is to protect public health and safety and that cannot, and must not, be compromised in any way. An independent chair may not have available to them all the relevant information on critical issues that senior officers of the TGA would have and this may inadvertently create unnecessary tension or conflict or result in a consultative forum providing inappropriate advice. Nor in the end would they be responsible or accountable for decisions taken. Senior TGA Officers, because they can be held accountable and responsible should chair any consultative forums that are established by the TGA so that at all times the TGA’s responsibilities for the safety, quality and efficacy of therapeutic products are paramount.

Recommendation 8 That in order to ensure that the TGA’s primary function, which is to protect the public and ensure the safety, quality and efficacy of therapeutic products, is paramount in any consultations, a senior officer of TGA should chair any consultative forums established by the TGA


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Chapter 6 Possible Models of Consultation

It is worth considering a number of options, including expanding the existing TICC to determine which is the most appropriate model for future TGA consultative arrangements. However, any consultative model that is adopted needs to be capable of addressing the following objetcives:

1. To inform parties as to the TGA’s present and future activities, 2. To facilitate an exchange of views between the TGA and external parties , 3. To provide for a formal process of dialogue between the parties involved in the

provision, regulation and use of therapeutic goods that aims to avoid and/or resolve any conflict over issues,

4. To enable negotiations aimed at reaching agreement about issues, 5. To establish and facilitate ongoing cooperative partnerships to develop agreed

solutions to common problems.

The consultative mechanisms developed also have to be capable of meeting the Government Guidelines for consultation that require,

6. appropriate stakeholder representation;

7. ability to monitor agency efficiency;

8. access to adequate information on agency processes and costs; and

9. transparent reporting processes.

The following is an outline of proposed models for structuring future consultation arrangements and an assessment of their advantages and disadvantages.


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Options for models of Consultation Option 1 Modified Existing Model The existing forum could be modified with an expanded representation, which would include all relevant partners such as the Generic Medicines Industry Association, Australian Health Industries Incorporated, Direct Selling Industry Association, the Pharmacy Guild, Hospital Pharmacists, the Pharmaceutical Society of Australia, the Australian Consumers Association(ACA) as well as the CHF. In order to ensure that those who are not represented by the various industry associations are included, industry representation would need to be boosted by invitations being given to a cross section of industry to ensure that all areas can hear and be heard. A similar argument could be mounted to include patient groups to ensure that consumers are properly represented. The nature of the meeting would have to change and it would become more of an information sharing forum rather than one providing a meaningful consultation forum. This type of forum would be unwieldy and difficult to manage and would be unlikely to afford or provide meaningful input from the various participants. The intermediaries and consumers would probably feel that they were not having a useful input and thus have a lower level of participation, if they participated at all. Advantages and Disadvantages This model would, if it was to have representation from all relevant parties, be very cumbersome and make it difficult to achieve objectives 2, 3, 4 and 5.

NOT RECOMMENDED


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Option 2 Multi-Level Approach. Sector Forums Establish consultation forums for each sector such as prescription medicines, OTC Medicines, Complementary Medicines and Medical Devices including IVD’s. All relevant parties with an interest in the sector would be invited to attend a consultation forum, which would be scheduled as required and at least annually. The forum would be a one-day forum at least annually and potentially biennially. The TGA would convene the meeting and set a initial draft agenda to which suppliers, intermediaries and consumers (broadly defined) would be invited to submit additional agenda items. The sector forums would focus on issues for which the TGA is seeking outcomes. A key issue in these forums will relate to the way in which TGA carries out its statutory functions and the demand for those functions from suppliers that will dictate the level of TGA activity. Suppliers for their part would have to provide on a confidential basis, information on the expected level and nature of applications for marketing approvals that will be made in the forward period (say 2-3 years). The option would also exists to separate off areas if they grow in terms of size and demand e.g. the extent of registration/listing of IVD’s may be of such a quantum that it may warrant being treated as a separate sector. Financial and administrative issues particularly each sector Budget could be dealt with in this forum as it would enable intermediaries and consumers to also have an input into the type, level and standard of services they believe it is appropriate for the TGA to apply. Input from consumers and intermediaries may provide a reasonable balance to the debate, ensuring regulatory standards are maintained. Alternatively if there were biennial meetings, one of these meetings could have a focus on financial and administrative matters which impact on that sector. Again, it would be useful for consumers to be involved to ensure a balance in the views being put forward. Peak Forum/s. There may be issues that are cross sectoral and thus warrant a consultative forum being convened by the TGA that would draw on representation from all the affected sectors. The TGA would invite participation in the forum from relevant parties. The TGA would determine the format and the initial draft agenda of the forum but would also invite participants to suggest matters they would wish to be addressed in such a forum and which are relevant to the parties attending.


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TGA Advisory Committee A committee comprising members drawn from nominations made by relevant stakeholders such as suppliers, industry, health professionals, consumers etc and the organisations representing those groups. The National Manager would select the members of the Advisory Committee from the nominations received, taking into account the need to balance interests. The National Manager would chair the Committee, the function of which would be to provide the management of the TGA with advice on matters such as TGA strategic plan ,performance and service standards, benchmarking, cost recovery, quality improvement, resource requirements and options, proposed management initiatives, issues management etc. The Advisory Committee would meet at least annually but consideration should be given to its meeting six-monthly. The Committee could also be convened on as needed basis as well. Decision making responsibility would at all times remain with the management of the TGA. Annual/ Biennial Conference Another option in this model would be for the TGA to convene a conference to which it would invite all the relevant parties, suppliers, intermediaries and consumers. The TGA would ensure that a cross section of the various stakeholders e.g. small, medium and large pharmaceutical companies, agents, consultants, industry associations, health care professional organisations, consumers, medical practitioners, pharmacists and their respective industry associations. The TGA would determine the format of the conference and the issues to be canvassed. In setting the agenda, the TGA would invite participants to suggest matters they would wish to see canvassed. The TGA could invite selected participants and others to prepare papers and speak on selected topics. The ABARE Annual Outlook conference is a useful model for comparison. (This Conference enables the Government to essentially determine the issues that will be the focus for the agriculture industry in the coming year and guide the debate.) The conference would be of one(1) day and an evenings duration. The forum would be self funding with the participants paying a fee, which meets all costs plus the costs of preparing and conducting the forum. TGA could at its discretion issue complimentary registrations for the forum if it feels it needs to do so in order to achieve balance in attendance. The TGA could contract a conference organiser to run the conference. Advantages and Disadvantages This model would not meet objectives 2, 3, 4, 5, 6 and 7.


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Recommended for consideration Option 3 Multi Forum Model Interest Group forums Another option could be to establish a variety of consultative forum for each of suppliers, intermediaries and consumers. The forums would meet at least annually with the option of more frequent meetings depending on the issues at the time. The suppliers forum could be supplemented by additional forums for each of the industry sectors, prescription medicines, devices and OTC medicines and complementary medicines. Representation should be broadened to include a cross section of industry as well as the various industry associations. Whilst it is expected that industry associations would take a leading role, it is important that those in industry who are not part of the industry organisation have their voices heard. Industry for its part would have to bring to the table information, on a confidential basis, to assist in predicting futures demands on TGA resources. The consumers forum should include representatives of patient groups as well as the peak consumer organisations. The forum would provide a vehicle for the consumers to articulate the standards they expect the TGA to apply which would in all likelihood be higher than industry would propose. The TGA would determine the participation in this forum and the agenda. The intermediaries forum would be held annually and it may be beneficial to combining intermediaries and consumers in some joint sessions as they would have some issues in common. TGA Advisory Committee A committee comprising of members drawn from nominations made by relevant parties such as suppliers, industry, health professionals, consumers etc and the organisations representing those groups. The National Manager would select the members of the Advisory Committee from the nominations received taking into account the need to balance interests.


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Option 3 (Cont) The National Manager would chair the Committee the function of which would be to provide the management of the TGA with advice on matters such as TGA strategic plan, performance and service standards, benchmarking, cost recovery, quality improvement, resource requirements and options, proposed management initiatives, issues management etc. The Advisory Committee would meet at least annually but consideration should be given to it meeting six-monthly. The Committee could also be convened on and ‘as needed’ basis. Decision making responsibility would at all times remain with the management of the TGA. Advantages and Disadvantages This model would best meet the objectives, as it would provide appropriate stakeholder representation at the appropriate level and with the appropriate interests and thus enable objectives 2, 3, 4, 5, 6 and 7 to be best met. It would also enable the TGA to obtain the most appropriate advice and information across the full spectrum of those it has to interact with and to draw on a wide body of expertise to assist it in its decision making. Parties would also be able to focus on matters of most concern to them and not have to be engaged in forums, which may not be of specific concern or interest to them and thus obtain greater value and benefit in their interaction with TGA. Strongly recommended for consideration.


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Appendix A

Terms of Reference

The TGA Industry Consultative Committee (TICC) is a consultative committee and not a Board of Management for the TGA. The committee does not determine TGA policy in relation to its public health responsibilities. Therefore it is important that industry and consumer representatives have a clear understanding of their role and responsibilities.

The purpose of the consultancy is to review the membership and adequacy of the terms of reference of the TGA Industry Consultative Committee (TICC). Specifically, the consultant will review the membership of TICC to:

• Identify stakeholder interests/interest groups who should be involved as part of the formal consultative process and define possible eligibility criteria for membership;

• Consider the extent to which current membership meets these contemporary

needs and identify the gaps; • Make recommendations on the membership of TICC; and • Define the roles and responsibilities for industry and consumer

representatives on TICC and review the adequacy of the current terms of reference.


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Appendix B

Paper forwarded to various parties re TGA consultation

Points for discussion on Consultation Purpose The TGA is reviewing its consultative mechanisms in order to ensure that they meet contemporary and likely future needs and are as effective as possible. Strategic Consulting Services has been engaged to provide a report on this issue. Background The TGA is a business unit of a Commonwealth Government agency, the Department of Health and Ageing (DO HA). As such, it is not an independent or statutory agency but it does have the significant statutory responsibility to provide a national framework for the regulation of therapeutic goods in Australia and ensure their quality, safety and efficacy. Government policy requires that in carrying out this role it should fully recover the costs of all activities that fall within the scope of the Therapeutic Goods Act 1989. This requirement includes the cost of activities that are directly related to or a direct consequence of that legislation. The TGA does this by charging fees to those who wish to market therapeutic goods in Australia and thus are required to register and/or list their products on the Australian Register of Therapeutic Goods (ARTG). The TGA has, and needs to have, considerable interaction with a quite diverse range of stakeholders including the manufacturers and/or suppliers of therapeutic goods, consumers, medical practitioners and other health professionals, scientific and academic communities and the general public. In doing so the TGA must balance what may be competing interests between the various parties while still fulfilling its statutory obligations and retaining the support and confidence of all. The current situation The TGA has a variety of mechanisms, both formal and informal, that it uses to communicate with and consult the various stakeholders, interest groups and the community with which it interacts. A body such as the TGA Industry


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Consultative Committee (TICC) is an example of a formal mechanism. There are other formal bodies such as the various expert advisory committees that provide scientific advice to the TGA on the quality, safety and efficacy of medicines and medical devices in the Australian marketplace. Consultation for the TGA has many purposes, is multi faceted and takes many forms: • it can simply be about sharing information about present or future activities

to enable the various parties to the consultation to better plan for and carry out their respective functions;

• it can be about exchanging views on issues of common concern so that the parties to the consultation can better understand the factors influencing the other party/parties or the constraints under which the other party/parties may be working;

• it can be about the parties acting in concert to achieve common goals; • it can be about the parties to the consultation working together to develop

better strategic plans for benefit of all parties; • it can be about receiving confidential information which enables them to

better advise their principals on action or activities; and • all of the above. There is a variety of ways in which the TGA consults: • it can be in a very formal structure such as an identified committee or

forum; • it can be in face to face meeting between the various parties both formal

and informal, scheduled and unscheduled; • it can be through the TGA preparing and circulating discussion paper/s on

issues/matters for which it has now, or it is proposed that it may have, responsibility;

• it can be through circulating a Regulatory Impact Statement; • it can be by circulating regulations or legislation in draft form; • it can be by the TGA participating in conferences and similar type forums

and outlining Government policy or views are on various issues thus giving interested parties a better understanding of factors influencing TGA's activities;


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The future (for discussion) The issues which we would seek to canvass with you and the various interest groups and individuals in preparing our report for the TGA are: • the utility of the present mechanisms which the TGA uses to consult: • the benefit of formal vis-a-vis informal consultation; • the utility of having diverse groups with various interests participating in

the one forum(such as the TICC); , • whether all interest groups or individuals are or have been appropriately

consulted in the past and whether there needs to be changes to ensure they are consulted in the future;

• whether the present mechanisms are the appropriate forum/s for

stakeholders to comment on issues such as Government policies as they are relevant to the role of the TGA;

• whether there are alternate mechanisms which could be used to provide a

mechanism for consultation eg a seminar/conference involving all stakeholders/interest groups to discuss and deliberate on strategic issues;

• whether there is a need to consider smaller and more focussed or

specialised formal or informal forums/committees to consider specific issues or matters;

• whether the TGA needs a dedicated resource/s to ensure all relevant parties are appropriately consulted;

• .what you consider should be the purpose(s) and function of consultation; • the frequency of the different forms of consultation; • what you consider is the appropriate balance that the TGA should seek to

achieve in consulting its partners (too little vis-a-vis over consulting); and • the timing and extent of consultation the TGA should undertake and what,

if any, responsibility the TGA has to ensure the various interests are capable of or able to provide meaningful input into that consultative process.

This is not necessarily an exhaustive list of the various issues surrounding consultation but provides a useful guide to assist in considering the matter of the TGA's consultation.

21 August 2003


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Attachment C

Parties consulted during the project Organisations and Companies • Association of Regulatory and Clinical Scientists • Asthma Australia • AusBiotech • Australian Association of Pathology Practices • Australian Diagnostic Imaging Association • Australian Divisions of General Practice • Australian Consumers Association • Australian Dental Association • Australian Diagnostic Imaging Association • Australian Medical Association • Australian Pharmaceutical Industries • Australian Self Medication Industry • Australian Society of Cardiologists • Bristol Myer Squibb • Catholic Health Australia • Consumers Health Forum • Complementary Healthcare Council • Council of the Ageing and Seniors Australia • Covance • Department of Health & Ageing • Direct Selling Association of Australia • Generic Medicines Association of Australia • Glaxo Smith Kline • Health Industries Association of Australia • Jackson Wells Morris • Kendle • Mayne Health • Medical Industry Association of Australia • Medicines Australia • Merck Sharpe & Dohme • Novartis • Osteoporosis Australia • Roche • Pharmaceutical Research and Manufacturers of America • Pharmaceutical Society of Australia • Pharmacy Guild of Australia • Pfizer • Quintiles • Research Medicines Industry Association of New Zealand


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• Royal Australian College of General Practitioners • Royal Australian College of Pathologists • SANE • Schering Plough • Society of Hospital Pharmacists of Australia • Wyeth


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Attachment D

Civil Aviation Safety Authority-Consultative Arrangements

The Aviation Safety Forum At the invitation of the Director of Aviation Safety, the Aviation Safety Forum (ASF) will provide strategic advice about the Authority's functions, consistent with the following outcomes:

• the provision of up-to-date, simplified regulations aligned with international best practice;

• a consistent approach to enforcement and encouragement of industry to accept its safety responsibility;

• a safety system approach to surveillance audits, where appropriate; • the interpretation of regulations on a nationally consistent basis; • effective safety promotion activities; • the timely and efficient provision of regulatory services; • the appointment of staff with strong industry backgrounds and trained for

regulatory and service delivery roles; • the pro-active management of information.

The ASF will also provide advice to CASA about the following issues: • cultural change within the organisation; • the process of making CASA's cost structure more transparent to the industry,

including an integrated formal consultation process in the organisation's annual budget cycle;

• the development of the public Regulatory Reform Plan; and • the broad policy implications of the regulatory changes developed by the

Standards Consultative Committee. Membership The Director of Aviation Safety will appoint Members for terms of two to three years who:

• as individuals are representative of industry; • are able to work in a two-way partnership with CASA; and • support the organisational and regulatory reforms of CASA.

The records of meetings of the ASF are not publicly available.

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