A voice for women's health

Introduction of Fit for Purpose Omics-based Technologies – Think Piece

April 2016

National Health Committee's

The Introduction of Fit for Purpose Omics-based Technologies – Think Piece:

If this feedback is on behalf of an organisation, please name the organisation    Auckland Women’s Health Council

Please provide a brief description of the organisation if applicable    The Auckland Women’s Health Council (AWHC) was formed in 1988. It is an umbrella organisation for individual women and women’s groups in the Auckland region who have a commitment to women’s health issues. The focus of the Council is broad and spans many issues that are of interest to women, particularly those that impact on their health and the health of their families. The Council has a special interest in consumer rights, advocacy, ethics committees, medical ethics, screening programmes, and other issues that arose out of the Cartwright Inquiry. 

One of our members was involved in 'Te Mara Ira: Informing Cultural Guidelines for Biobanking and Genomic Research' as an interviewer and seminar presenter. 

Interest in this topic (eg consumer advocate, health professional, researcher, member of the public)    Consumer advocacy

Please indicate any material you believe should be withheld, if any, under the Official Information Act 1982    

Please indicate if you do not wish any part of your submission to be published on the NHC website    
The AWHC agrees to our submission being published on the NHC website

Consultation questions: The Introduction of Fit for Purpose Omics-based Technologies – Think Piece

1.    Is the description of the risks, issues and opportunities a good reflection of reality? Is anything missing?  
Yes/No   If yes, please provide details of these errors/omissions together with the relevant citations.

The AWHC welcomes the opportunity to comment on this document from a consumer perspective, but believes that consumer input before the document was finalised would have provided a more user-friendly “Think Piece.”

We also need to voice our concerns at the hasty and ill-conceived disbanding of the National Health Committee and its being subsumed into the Ministry of Health. The role of the NHC has been crucial in this area:
•    As a thought leader in the identification of critical issues and as a sponsor of important research 

•    As a mechanism for fostering informed debate in the public sphere 

•    In oversight and planning, and

•    As an important contributor and participant in international debate

We are not confident that these roles are easily transferable or that the Ministry of Health has the competencies and resources available to fulfil the requirements needed for such an important debate. We believe that this was not a wise move and is not in the best interests of New Zealand’s health system or patients.

The description in the document of the risks, issues and opportunities presented by omics-based technologies are heavily weighted in terms of the benefits, particularly the economic benefits. What is missing is the significant impact this will have on individuals and their families, and the need to ensure there is an emphasis on informed consent, on the problems around privacy and security of personal health information, and the lack of protection that New Zealand’s ethics committees currently provide for research participants.

The AWHC believes there is an urgent need for wide consultation with the general public on these issues and that this must be given a high priority. Work on omics-based technologies must not proceed any further until consumers are an ongoing part of the process.        

2.    The proposed approach is for a cross sectoral whole of system collaborative approach. Is this the best approach? What are the critical success factors necessary to make this work, who needs to be involved and how? 
Yes/No    Please provide any feedback in support of your response.

1. The AWHC believes a cross sectoral whole of system collaborative approach is the best way forward.

2. A foundational critical success factor will be whether all elements of the strategy are based on a partnership approach and inclusive of consumers, patients and society. This will require a fundamental shift in engagement - from the current Machiavellian assumption of working in our best interests to working with us to assure our interests are intrinsic and our needs are met.

3.   The 'Introduction of Fit for Purpose Omics -Based Technologies' diagram on Page 15 of the Think Piece document is a comprehensive summary of the important areas to be addressed. We would like consumers and society to underpin the whole structure.

4.    Based on our work and experience within the current system, we have concerns about
building a complex infrastructure on one which we believe is already compromised.  Our particular concerns (detailed below) are in the critical areas of Health Information Technology and the current data infrastructure; the dominant philosophy of practice; privacy and security; ethical oversight in research and practise; and informed consent. These concerns are exacerbated as they operate in a seriously fiscally constrained environment which is complex and short of resources. 

A. Health information technology and the current data infrastructure 
Some of our members are currently active in the Health IT space and have a long involvement with it. Consequently, this could be a very comprehensive answer. However we will restrain ourselves and mention just two areas - consumer access to their own health information and the difficulties and dangers of sharing information in the current system.

The advent of a patient portal is a move in the right direction for allowing consumers to access their own information. However, the current system is mediated by health professionals who choose who, how and what they offer consumers. In working in a number of health IT programmes, it is notable that consumer access to their information is NEVER a top priority. Provision for it is sometimes included at consumers’ insistence. However it is rarely or inconsistently delivered cf  MCIS programme and Shared Care Programme.   

Inter connectivity is a serious problem within the current system. Legacy systems have created an environment where it is difficult to share information across various related parts of the current health system.

The move towards ‘big data’ is encouraging and incentivising the sharing of personal information across the public sector. We are concerned at this development as it is not being accompanied by key features which would ensure that consumers can be confident in the use of their data – elements of transparency, accountability and inclusion.

We note that a ‘Consumer Expectations’ document, developed by the National IT Board consumer panel and setting out some very modest expectations, has not been progressed. This is not indicative of a system which welcomes meaningful consumer input.

We are also mindful of the long history of failure in government IT initiatives.

B. The dominant philosophy of practise
Within our current health system, the dominant philosophy of practise is still essentially paternalistic. Clinicians do not generally work easily as partners with their patients. This must change. The increasing availability of genomic data and personal health tracking technology mean that consumers as agents in their own health and well-being is inevitable. To unlock the full potential of Omics and free constrained health resources, health professionals must embrace new technologies and discard outdated ways of 'treating' patients. 

C.  Privacy and Security
This is poorly done currently. Audit of access to health information is rudimentary and, while reluctant to share information with the patient, there is very little scrutiny of access by other people within the health system. Certainly, there is very little provision for consumers to see who has accessed their information. Inappropriate access is badly monitored and treatment of breaches is inconsistent. 

D. Ethical oversight in research and practise 
The current system of ethical oversight is designed to facilitate research, not protect patients and research participants. Our real concern here is that recent changes have reflected a call by industry for NZ to be more open to the international pharma and international clinical trials - themes we see echoed in this Think Piece. We believe this has made us a soft touch internationally and has come at the expense of research participants. When things go wrong, participants are not protected by ACC, and find themselves individually battling multinational companies for redress and compensation. 

The line between innovative practise and research is unclear. Work needs to be done to strengthen this. 

A related concern is the Office of the Health and Disability Commissioner which was established to protect patients, but is currently operating in such a way that patient complaint processes are protracted and difficult. It is also poorly equipped to move beyond individual malpractice cases and into consideration of systems based analysis to effect real change. 

E. Informed consent
Informed consent is honoured more in the breach than in practise. Real informed consent is not hard but it does require time and information. Currently both of these are in short supply in our health system.

Consumer Input
The AWHC is aware that given the demise of the National Health Committee as an independent body and the failure of the Ministry of Health to allow time for holding the workshops that the NHC intended to organise that it is very unlikely that there will be many submissions from either individuals or consumer health organisations on this “Think Piece.”

On page 9 of the “Think Piece” is the statement that “the various social and ethical issues will need to be dealt with early on to ensure citizen involvement… Individual values, the right to be involved and the right to choice will need to be honoured.” There must be a commitment to engage with the general public as part of an ongoing process, and that this is undertaken in a manner that is not just about gaining agreement or compliance of health consumers. For example, the change management processes outlined at the bottom of page 10 seems to be more about gaining informed compliance to a vision that consumers may not share. 

It is also essential that consumers are involved at all three levels of the strategic work programme – macro level, meso level, and micro level. 

3.    The think piece proposes the use of a common thinking tool (a principles based framework). Is this a good approach? If not, what else might be a better approach? If it is, are the proposed principles generally appropriate and/or is anything missing?

Yes/No      If yes, please make your proposal(s) (with rationale) below:

The outcome and implementation principles suggested need to be underpinned by three core principles for consumers and NZ society - transparency, accountability and inclusion. This will ensure that they deliver for all our population.

1. Outcome Principles

A. Best outcomes for users, patients, and the country as a whole.
These need to be established by and with them, not for them. Transparent processes will allow an understanding of what is being done and why, accountability mechanisms will allow scrutiny and comment, and inclusion will inform processes to ensure they are fit for purpose and meeting genuine need. At an individual level, inclusion will also inform and empower self-management. 

B.  To safeguard our people, identity and values, we need transparency to enable scrutiny, accountability to ensure equity and inclusion to ensure that our identity and values are reflected in actions and outcomes.

C. The former two outcome principles must always be paramount. While this principle is important, we need transparency to assess the public benefit and ensure it is not outweighed by commercial and research agendas, accountability so that we are aware of the cost/ benefit compromises, and inclusion so that we are able to influence these.

2. Implementation Principles. 
For the most part, the implementation principles are broad and sector wide. They must also consider the specific principles of engagement with consumers and New Zealand society - transparency, accountability and inclusion.

Excellent work has already been done within Aotearoa to inform genomic practise with Te Mata Ira. While these guidelines were developed as cultural guidelines with particular relevance to Maori, the underlying principles are universal and must be incorporated into future practice. 

A. At a societal, patient and population level, the Collective Approach principle needs to be supplemented with a commitment to partnership and inclusion. The shared risk/ shared gain approach needs recognition that risk for individual consumers can be painful and catastrophic and, much like screening, individual gain may be nothing more than a contribution to the greater good and future generations. 

We are encouraged by the development internationally of mechanism which enable ownership and control of databases by patients. 

B. Integration of health, science, education and business
While we support this principle, we are also aware that inclusion of consumers and society is crucial and the challenges this poses are immense. The essential power and resource imbalances for consumers must be addressed and must go beyond ensuring they are well informed. Consumers and New Zealand society must be seen as primary stakeholders - not just as suppliers and buyers of Omics-based products. 

This is one area where the current Machiavellian assumption of doing good for us, but without us, is particularly dangerous and pernicious.

C. Essential infrastructure
The essential infrastructure needs to go beyond engagement with citizens and encompass inclusion. It also needs to provide for transparency and accountability of process and decision-making. 

We have outlined a number of our particular concerns with the current infrastructure in 2.

4.    Is there any other feedback you wish to provide?
Yes/No    Please provide any other feedback.

The AWHC believes a ‘fit for purpose Omics-based technology’ infrastructure must include non-biomedical, non-clinical public interest group to act as educator, conscience and critic to the system as it develops. To offset the power of commercial interests, it needs to be fully resourced and funded. Most importantly, it must be independent – from industry, research, health professional, Ministry and government influence.

Please also note that the AWHC supports the content of the submission made by the Federation of Women’s Health Councils.

April 2016
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