FTAs and Export Controls

'How Trade Deals Extend the Frontiers of International Patent Law' (CIGI Papers No. 199 — November 2018) by Jean-Frédéric Morin and Dimitri Thériault for the Centre for International Governance Innovation comments 

Bilateral and regional trade deals frequently include patent provisions that go beyond the minimum requirement of the multilateral Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). They extend the scope of patentability and provide additional rights to patent holders. This paper systematically maps these “TRIPS-plus” agreements. Exploiting a new data set, 52 TRIPS-plus agreements are found to have been concluded between 1990 and 2017. The major proponents of these TRIPS-plus agreements on patents are the United States, followed by the European Union and the European Free Trade Association. Other technology-rich countries, such as Japan and Korea, have surprisingly few TRIPSplus provisions on patent protection in their trade agreements. Few South-South trade agreements include TRIPS-plus provisions, but some include TRIPS-extra provisions on genetic resources and traditional knowledge. Having a clear picture of these TRIPS-plus agreements is essential as they can have important social and economic consequences, including for the development of innovations and access to technologies.

The authors note

This paper is one of the first attempts to systematically map key patent provisions in bilateral and regional preferential trade agreements (PTAs). Some of these provisions have important policy implications, including for the development of innovations and access to technologies. This paper shows their historical evolution and their geographical distribution. 

The available literature has already reported that some PTAs offer a level of patent protection that goes beyond the minimum requirements of TRIPS. However, several questions still need more research and analysis. In particular, the number and scope of TRIPS-plus agreements are uncertain. It is also unclear if their conclusion is more frequent today than it was a decade ago. As well, the practices of several countries remain undocumented, beyond some well-known advocates and opponents of TRIPS-plus agreements. 

This paper fills these gaps by relying on a recent data set of TRIPS-plus agreements (the T+TPA data set) introduced by Jean-Frédéric Morin and Jenny Surbeck. This data set is based on an exhaustive collection of more than 600 PTAs concluded between 1947 and 2017. Among these PTAs, Morin and Surbeck identified 52 PTAs with significant TRIPS-plus provisions on patents. 

The rest of this paper is divided into seven short sections. The first section describes the current state of multilateral negotiations over patent law. The second section describes eight categories of TRIPS-plus provisions on patents, while the third section presents their development over time. The next section identifies the key role played by the United States and by European countries in promoting TRIPS-plus agreements. The fifth section assesses the PTAs involving other technology-rich countries. The sixth section considers developing countries and their role in the diffusion of TRIPSplus provisions on patents. The last section focuses on provisions that are of particular interest for developing countries. The conclusion identifies directions for future policy-oriented research.

They conclude

The proliferation of TRIPS-plus and TRIPS-extra provisions in PTAs requires further research. At least three main areas of research would have clear added value for policy making. The first involves exploring the domestic consequences of TRIPS-plus provisions on patent protection. As yet, it is unclear how far these commitments reflect pre-existing legal standards or whether they require domestic reforms. In the latter case, it would be interesting to study if and how the reforms are being implemented. Developing countries that are compelled to implement TRIPS-plus obligations might take advantage of these legal reforms to include new exceptions and exclusions in their domestic legislation. Case studies might also be useful for investigating the social and economic consequences of implementing TRIPS-plus provisions. 

A second stream of research concerns the global and strategic consequences of TRIPS-plus provisions. These consequences would include processes such as regulatory competition across countries with different standards, norm diffusion driven by the desire to level the playing field and the reverberation from bilateral initiative to multilateral negotiations. The existing literature also tends to portray developed and developing countries as antagonistic actors in international patent law making. It is time to debunk this apparent oversimplification. The pro-patent posture of some developing countries, the nuanced policy of some high-income countries and the rise of emerging countries raise new questions that should be explored. 

A third avenue for future research concerns the potential alternative to existing TRIPS-plus provisions on patents. The current debate on international patent protection has focused on the flexibilities already provided in the TRIPS Agreement and on TRIPS-plus provisions. However, the example of TRIPS-extra provisions on TK and GRs shows that trade negotiators have the capacity to be creative and think outside the TRIPS box. Nothing precludes trade negotiators from addressing issues such as licensing pools, open science and scientific collaboration in their future PTAs. Provisions on these issues might actually do more for technological innovation than TRIPS-plus provisions on patents.

'Strategic Export Controls: A Case Study of Regulation of Executive Power and Parliamentary Accountability in the United Kingdom' by John F McEldowney in Daniel Joyner (ed), Non-Proliferation Export Controls Origins, Challenges, and Proposals for Strengthening (Routledge, 2006) comments 

Export controls received concentrated media attention during the Arms to Iraq saga played out in all its detail before the Scott Inquiry in 1996. The inquiry revealed a complex and detailed regulatory structure overseeing exports that lacked transparency, was of dubious legality and was subject to only weak parliamentary accountability. The focus of this chapter is on the command and control system of regulation over export control within the United Kingdom post the Scott Inquiry and the enactment of the Export Control Act 2002 which came into force on 1 May 2004. In the last annual Report on Strategic Export Controls (United Kingdom 2005; see also Taylor 2003), it was estimated for the year ended 2003, the value of exports of strategically controlled goods was £992.4 million. These exports make a significant contribution to the defence and security of the United Kingdom, as well as contributing to the multi-various international obligations to be met by the armed forces. In considering the regulation of strategic exports, an historical approach is adopted in drawing out the tensions between executive discretion and parliamentary controls. The main question addressed is how accountable is the new regulatory system? The main thesis advanced is that the system of export control is linked to the policy of the government of the day. In its early legal construct, it reflected the legal culture of the UK. Formally legalistic and highly structured in form, the actualité is of a pragmatic system that also reflects many of the strengths and weaknesses of a parliamentary system of ad hoc accountability. Thus the system of control is strongly driven by the government of the day, sustainable through political oversight and pragmatic decision-making subject to market forces. Party political decisionmaking is often interspersed with balancing different shades of multi-nationalism, especially in terms of the influences of the United States and Europe.

Cosmetic Surgery Regulation

The NSW Parliamentary Committee on the state's Health Care Complaints Commission has released its report on Cosmetic Health Service Complaints in New South Wales. The report follows the NSW Health Department's review of the regulation of cosmetic procedures earlier this year, noted here.

The Committee states

The cosmetic health services industry is a growing industry with an increasing demand for services. This inquiry has demonstrated to the Committee that there are a number of complexities that make regulating this area very challenging. There are various State and Commonwealth agencies and entities which play an important role in regulation or complaint handling. There are also a number of different State and Commonwealth laws which may be relevant, depending on the circumstances. Both registered and unregistered practitioners perform, or assist with, different kinds of procedures. In addition, there is no settled definition of what constitutes cosmetic health services. 

The Committee is concerned that complaints about these services may be underreported for a variety of reasons. We are also concerned about the corporate model of practice versus the traditional medical model of patient care and, in particular, the profits before patients focus of some corporate providers. We heard from a wide range of stakeholders that there is a lack of public awareness about various issues associated with this industry.  

The Committee has made 16 recommendations to address these and other issues of concern raised in this inquiry. Our recommendations are intended to ensure that:

• legislative and regulatory frameworks are strengthened to better protect the public from potential harm

• relevant and important information about the cosmetic health services industry is more accessible to the public so individuals can make informed decisions about procedures and practitioners and understand where and how to make a complaint if they are dissatisfied

• the HCCC's powers and functions are robust enough to adequately address the complexities associated with the cosmetic health services industry (and the health services industry more broadly) and assist patients in resolving their concerns.

The Committee's recommendations are not just focused on the HCCC. We found that collaboration between the HCCC and other State and Commonwealth agencies and entities is important to inform the public and protect them from cosmetic health service providers that do not comply with the law or do not have satisfactory practices. Our recommendations will therefore involve work on the part of other NSW government agencies including NSW Health and NSW Fair Trading. We recognise that national cooperation and consistency on many of these issues is preferable. As such, we have recommended that the NSW Minister for Health raise certain issues of concern with the COAG Health Council with a view to achieving reforms that will apply across the country.

The Committee report comments

On 13 February 2018, the Committee resolved to conduct this inquiry into cosmetic health service complaints in New South Wales in response to concerns raised by the Minister for Health, the Health Care Complaints Commission (HCCC), the media and the community. The Committee’s concern was to investigate whether the HCCC and other Government regulatory frameworks could improve outcomes for the public who use cosmetic health services. The terms of reference for the inquiry are in Appendix One.   

A particular case that captured the Committee’s attention was the tragic death of Ms Jean Huang following a breast filler procedure at the Medi Beauty Clinic in 2017. The persons who performed the procedure were allegedly not registered health practitioners in Australia and have been charged with manslaughter. The HCCC is separately investigating the matter. The Committee has also followed matters relating to The Cosmetic Institute, which was investigated by the HCCC after two separate instances where women undergoing breast augmentation suffered cardiac arrest. A class action has also been commenced against The Cosmetic Institute alleging negligence during breast augmentation that left patients with lifethreatening complications. 

Prior to this inquiry, the HCCC issued public warnings in relation to the cosmetic health services industry. The NSW Minister for Health also:

• raised with the Council of Australian Governments (COAG) Health Council the issue of protecting the title ‘cosmetic surgeon’ nationally to restrict its use to appropriately educated, trained and experienced health practitioners 

• introduced regulations to require certain cosmetic surgical procedures, such as breast augmentation, to be carried out in licensed private health facilities  

• requested a review of cosmetic procedures to consider the adequacy of the existing regulatory framework to protect the public.

The NSW Ministry of Health’s report made nine recommendations which have been, or are in the process of being, implemented. 

Complexities of the cosmetic health services industry 

The Committee learnt that the cosmetic health services industry is dynamic and complex. There are a number of issues that present regulatory challenges, such as those outlined below. No agreed definition of what constitutes cosmetic health services While the Medical Board of Australia’s definition of cosmetic medical and surgical procedures provides some guidance, there is no agreed definition of cosmetic health services or cosmetic procedures. The Committee believes that the lack of a clear definition presents regulatory difficulties. However, because new procedures are regularly being developed, the Committee acknowledges that any definition would need to adapt to this ever-changing environment.  

Registered and unregistered practitioners perform cosmetic health services 

Both registered and unregistered health practitioners provide cosmetic health services. Registered practitioners include doctors and nurses and unregistered practitioners could include beauty therapists. This presents challenges because patients do not always understand the distinction; there are differences in the applicable legislative, regulatory and complaint handling frameworks; and there was a perception among some inquiry participants that there is a lack of sufficient oversight of unregistered practitioners. The Committee mostly received evidence from, and about, registered practitioners. As such, the Committee has not made any particular findings or recommendations about unregistered practitioners. However, the Committee considers that the regulation of unregistered health practitioners could be the subject of a separate, dedicated inquiry in the future. 

Licensed facilities versus unlicensed facilities 

The public is also not always aware that some invasive cosmetic surgery procedures, such as breast augmentation, need to be performed in licensed private health facilities, which have more stringent standards with respect to the safety of the premises and patients and the standard of clinical care. Unlicensed facilities may still need to comply with other regulations such as in relation to local council requirements and public health. The Committee believes that raising public awareness about these differences is important. 

Corporate model versus patient model 

The Committee heard that the corporatisation of the cosmetic health services sector has caused some challenges. In particular, the Committee was very concerned to learn that some commercial operators put profits before patients which can conflict with patient interests. Others operate across borders which can cause difficulties for regulation and complaint handling. Some offer low-cost options by using counterfeit products or employing inadequately qualified staff. This can put patients at risk. The Committee acknowledges that State and Commonwealth agencies are collaborating to address these risks. It is essential that this work is continued and that emerging risks are identified and addressed quickly. In contrast, the Committee heard that under a medical or patient-centric model, the medical practitioner owes a duty of care to their patient, which requires them to consider the patient’s best interests including, in some cases, advising them not to proceed with a procedure. 

Under-reporting of complaints 

The HCCC received 94 complaints about cosmetic services in 2016-17. While this was a small number relative to other complaints they received, the overall trend is an increase. In 2017, NSW Fair Trading received 287 complaints about beauty services. Several inquiry participants claimed there may be an under-reporting of complaints because people are not aware that they can complain, feel too embarrassed or believe it would be a waste of time. It is important that the public are made aware that they can complain about these services and are encouraged to do so. Any barriers to making a complaint should be identified and removed. 

Demographics 

The Committee heard from inquiry participants that people who opt for cosmetic procedures are mostly women, often young women and women between 35-55 years of age. However, stakeholders also told the Committee that vulnerable patients from a financial, social and economic perspective are a target market and there has been an increase in men undergoing cosmetic procedures. The Committee also heard that some providers particularly target nonEnglish speaking communities seeking these services by advertising in non-English forums and on social media. The Committee believes that raising public awareness about cosmetic health services should be primarily addressed to these and any other identified groups. 

The Committee’s finding regarding collaboration between State and Commonwealth Governments 

The Committee heard that the legislative and regulatory frameworks in this area are very complex. There are a number of State and Commonwealth agencies and independent bodies that play a key role in regulation, complaint-handling and investigating complaints and offences. These include, but are not limited to, the HCCC, NSW Fair Trading, NSW Health, the Australian Health Practitioner Regulation Agency (AHPRA) and the Therapeutic Goods Administration (TGA). 

The legislative framework is also diverse and deals with issues such as the regulation of registered health practitioners (such as doctors and nurses), unregistered practitioners who provide health services and beauty clinics that carry out procedures involving skin penetration. There are also laws to regulate products such as botulinum toxin (Botox) and dermal fillers and private health facilities where some cosmetic surgery is carried out. Many of these State or Commonwealth laws have recently been amended, or are in the process of being amended or reviewed, to strengthen the legislative framework for cosmetic health services. 

Collaboration between agencies 

The Committee heard that State and Commonwealth agencies are currently collaborating to address risks in this area and inform the public through intergovernmental forums, joint operations, policy development and public education. The Committee supports these efforts and is interested to monitor whether they have the desired impact. 

Because of the complexity of the cosmetic health services industry, and the fact that some providers work across State and Commonwealth borders, the Committee finds that collaboration between the HCCC and other State and Commonwealth agencies and entities is important to inform the public and protect them from cosmetic health service providers that do not comply with the law or do not have satisfactory practices. The Committee considers that it is essential that this collaboration continues (Finding 1). In particular, the Committee believes the following areas of collaboration are important:  strong regulation and laws that focus on public safety and adapt as necessary to changes in the industry  compliance and inspection work of Government  public awareness  consumer and patient complaints are acted upon. 

The Committee’s recommendations 

The Committee has made 16 recommendations to address issues of concern that were identified in this inquiry. Not all of these recommendations are directed to the HCCC. This is because the issues of concern in the cosmetic health services industry require solutions that are broader than the HCCC’s role. 

The recommendations are intended to complement the work that has been done, and is in progress, at State and Commonwealth levels. The Committee believes that its recommendations will lead to a public that is better informed about cosmetic procedures; providers; risk; and options for seeking redress. The Committee’s recommendations will ensure that the HCCC’s powers and functions are robust enough to adequately address the challenges presented by this industry. The recommendations are also intended to further strengthen the legislative and regulatory frameworks to better protect the public. 

Reviewing the powers and functions of the HCCC

The Committee has recommended a review of the HCCC’s powers and functions, in response to stakeholder suggestions, to ensure the HCCC is able to sufficiently protect patients using health services and assist in resolving their concerns. 

In particular, the review is to consider whether the powers of similar bodies in other jurisdictions would be appropriate in New South Wales, including:

•  empowering the HCCC to issue public warnings about specific health service providers and health organisations, in addition to more general warnings 

• authorising the HCCC to make prohibition orders against specific health organisations where they pose a serious risk to public health and safety  

• broader search and entry powers for the HCCC, so it can investigate operators it has concerns about more effectively, and is less reliant on partnering with Commonwealth or State agencies to benefit from their broader, or different, powers (Recommendation 1). 

The Committee did not receive much evidence about whether or not patients or practitioners are satisfied with the outcomes of the HCCC’s complaint-handling, investigation and prosecution functions. This is not surprising given evidence in other areas of the report that complaints may be underreported. However, this will remain an area of interest to the Committee in the future. 

‘Cosmetic surgeon’ and ‘surgeon’ – potentially misleading the public 

The Committee heard from a number of stakeholders that use of the title ‘cosmetic surgeon’ can be misleading to patients by implying that the practitioner has additional qualifications, experience and training. In fact, the title ‘cosmetic surgeon’ is not a protected or restricted title nationally. At present, a range of different kinds of doctors may use this title such as general practitioners, general surgeons and plastic surgeons. 

The Committee heard that defining the scope of practice of the title ‘cosmetic surgeon’ could assist the HCCC, the Nursing and Midwifery Council of NSW and the Medical Council of NSW in their complaint-handling and regulatory work. 

The Committee has recommended that the NSW Minister for Health continues to raise the issue of protecting or restricting the title ‘cosmetic surgeon’ at a national level. Patients could then better inform themselves about whether their ‘cosmetic surgeon’ meets certain minimum criteria in terms of education, training and experience. While the Committee prefers a national approach to this issue, if this cannot be achieved within a reasonable time, the Committee has recommended that the NSW Minister for Health consider whether to introduce legislation in the NSW Parliament to deal with this issue independently. In the Committee’s view, it is essential that this title be clarified to better inform and protect the public. 

The Committee also heard that the title 'surgeon' can be misleading to patients. While the Committee’s consultation has been limited to its terms of reference, the Committee questions whether confusion about this title is only limited to cosmetic health services. The Committee has therefore recommended that the NSW Minister for Health consider whether it would be in the public interest to support protections and restrictions on the use of the title ‘surgeon’, either at a national level or for doctors practising in New South Wales (Recommendations 2 to 4). 

Informing the public 

The Committee heard time and time again from inquiry participants that the public need to be better informed about various issues associated with cosmetic health services. The Committee was told that the public is confused about where and how to make a complaint and the complaints process. Some patients are reluctant to complain for various reasons. The public are also not well-informed about the range of health service providers, procedures and their associated risks, and differences between facilities. The Committee heard that advertising and the normalisation of cosmetic procedures have contributed to some of this lack of public awareness. 

The Committee acknowledges the work of agencies and regulators so far to raise public awareness of these issues. However, because this was an issue that was raised by most inquiry participants, the Committee has made several recommendations. 

In particular, the Committee has recommended that NSW Health and NSW Fair Trading take the lead in developing a targeted public education campaign to raise awareness about cosmetic health services. The HCCC should assist with this campaign, along with other relevant agencies. Various forms of advertising and media should be used, including social media. It is essential that the main demographics seeking these services are well-informed. 

The Committee has also recommended that the Minister for Health pursues with the COAG Health Council the establishment of a national one-stop-shop website and advice service to assist individuals considering making complaints about cosmetic health services. The Committee also considers that it would be beneficial to include information and advice of a more general nature for those persons considering cosmetic procedures. If this cannot be agreed to at a national level, the Committee has recommended that the Minister for Health looks at the NSW Government establishing the service (Recommendations 5 to 8). 

To better inform future policy, regulation and education programs relating to cosmetic health services, the Committee has recommended more research into the behaviours of, and influences on, consumers seeking the services. Inquiry participants provided some insight into this area, such as the potential influence of the media on decisions about cosmetic procedures, especially social media, reality television and celebrities. However, the Committee believes more rigorous research in this area is needed (Recommendation 9). 

Regulation of Laser and IPL devices for cosmetic purposes 

The Committee learnt that there is no specific regulation of laser and IPL (Intense pulsed light) devices for cosmetic use in New South Wales. Some other states regulate this issue and proposed national guidelines have been issued. The Committee heard about patients who have suffered burns or other complications from the incorrect use of these devices. The Committee is concerned about this regulatory gap in New South Wales but would prefer a national regulatory approach so the Committee has recommended that this be pursued. However, if this cannot be achieved, the Minister for Health should consider whether to introduce legislation in New South Wales to provide minimum standards for cosmetic health service providers offering these services. Ensuring that operators have appropriate training and experience to use laser devices and IPL devices for cosmetic procedures will minimise patient complications (Recommendations 10 and 11). 

Issues with therapeutic goods used for cosmetic purposes 

The Committee heard of various issues associated with therapeutic goods used for cosmetic purposes such as botulinum toxin (Botox) and dermal fillers, for example:  illegal importation of these products from overseas  administration of Botox and dermal fillers by unregistered persons when they should be administered by a doctor, or a nurse under the supervision of a doctor  tele-consulting, for example a nurse administers Botox or dermal fillers in one location and is supervised by a doctor from another location via Skype 

The Committee acknowledges the work of State and Commonwealth agencies to identify and seize therapeutic goods which have been illegally imported. NSW Health is working on regulations to better manage therapeutic goods for cosmetic purposes. The Committee looks forward to an assessment of these changes to identify whether further initiatives are required. The Committee notes concerns about the use of teleconsulting to consult on cosmetic procedures. We note that it is a service permitted under the Medical Board of Australia's guidelines and can play a beneficial role in other areas of health care such as reaching people in remote regions. The Committee is concerned that restrictions placed on this service could impact negatively on these communities. 

The Committee is of the view that broader evaluation and consultation on the effectiveness of the current guidelines, beyond the scope of this inquiry, would be required before suggesting any changes to this particular practice in relation to cosmetic procedures. 

Upselling and commissions 

The Committee was surprised to hear that some corporate operators offer nurses or other employees incentives such as commissions to encourage them to sell patients other procedures or more of the same procedure. The Committee acknowledges the detrimental impact such a model could have on patients who may be persuaded to have procedures that are not in their interest and unaware that financial incentives are behind these tactics. 

The Committee has recommended consideration of whether individuals providing these services, or their employees, should be required to disclose any incentives, commissions or other payments they receive for upselling. This would provide more transparency for patients and give them the opportunity to reconsider a procedure (Recommendation 12). 

Increasing the role of General Practitioners in assisting patients with decision-making 

The Committee considers that General Practitioners (GP) can play an important role in providing independent advice to patients considering cosmetic procedures, particularly those that are invasive, as GPs are aware of a patient's broader medical history. The Committee has recommended that the NSW Minister for Health raise with the COAG Health Council whether patients seeking invasive cosmetic surgery be required to consult their GP. The Committee believes that national consultation on this issue will identify potential benefits and impacts. A national approach is also preferred to prevent patients from crossing borders to places with more relaxed standards. The Committee has also recommended that the New South Wales public education campaign about cosmetic health services ensures that patients be encouraged to seek advice from their GP (Recommendations 13 and 14). 

Reviewing the current cooling off periods 

The Committee learnt that Medical Board of Australia guidelines, which apply to doctors, set out cooling off periods for certain cosmetic health services. The Committee believes that cooling off periods are important after a patient had a consultation and been informed of the risks of a procedure. This gives the patient an opportunity to seek further advice or reconsider the procedure. 

The current cooling off period for adult patients is seven days for major cosmetic procedures. There is no cooling off period for adult patients seeking minor cosmetic procedures. There are other specific cooling off periods for young people seeking major or minor procedures. 

Given the concerns raised about cosmetic health service practices as part of this inquiry and in the media more broadly, the Committee has recommended a review of the current cooling off periods in the Medical Board of Australia guidelines to ensure they sufficiently protect consumers in New South Wales. The review will also consider whether it is appropriate to require cooling off periods for some cosmetic procedures provided by unregistered practitioners as the Committee is concerned that this may be a gap in regulation which could put the public at risk (Recommendation 15). 

Revision surgery data collection 

The Committee heard concerns about the costs to, and diversion of resources from, the public health care system when patients are admitted following cosmetic surgery complications. The Committee has recommended that the Minister for Health considers the feasibility of collecting data on cosmetic revision surgery in the public health system to guide future policy and decision-making. The data may also be valuable to the HCCC as adverse outcomes from cosmetic procedures will not always result in complaints to the HCCC (Recommendation 16).

The Committee's Findings and Recommendations are

The current framework to protect the public 

Finding 1 The Committee finds that collaboration between the Health Care Complaints Commission and other State and Commonwealth agencies and entities is important to inform the public and protect them from cosmetic health service providers that do not comply with the law or do not have satisfactory practices. It is essential that this collaboration continues. 

Reforming the HCCC's powers 

Recommendation 1  The Committee recommends that the Minister for Health reviews the powers and functions of the Health Care Complaints Commission to ensure the Commission is able to sufficiently protect patients using health services. In particular, the Committee recommends the Commission should have the powers: a) to issue public warnings about specific health service providers and health organisations; b) to issue prohibition orders in relation to specific health organisations; and c) for search and entry to apply to all complaints and allow authorised persons to enter premises if the premises is a public place and the entry is made when the place is open to the public. 

Titles of medical practitioners 

R2 ...  that the Minister for Health continues to make representations to the COAG Health Council to protect or otherwise restrict the title 'cosmetic surgeon' at a national level under the Health Practitioner Regulation National Law. 

R3 ... that, if the COAG Health Council does not protect or otherwise restrict the title 'cosmetic surgeon' within a reasonable timeframe, the Minister for Health considers whether separate legislation should be introduced in the NSW Parliament to place restrictions on the use of the title 'cosmetic surgeon' in relation to doctors practising in New South Wales. 

R4  ... that the Minister for Health considers whether it is in the public interest to support protections and restrictions on the use of the title 'surgeon' either at a national level or for doctors practising in New South Wales 

Informing the public 

R5  ... that the Minister for Health and the Minister for Innovation and Better Regulation develop a targeted public education campaign to raise awareness about cosmetic health services, the risks involved in procedures and where to get relevant information. 

R6  ... that the public awareness campaign use various forms of advertising, media (especially social media) and other resources to target the main demographics seeking cosmetic health services in terms of age, gender and cultural background. 

R7  ... that the Minister for Health pursues with the COAG Health Council the establishment of a national one-stop shop website and advice service relating to cosmetic health services to: a) provide relevant information about procedures, practitioners and facilities to individuals seeking these services, and b) direct individuals who are dissatisfied with a service or provider to appropriate complaint pathways including, for New South Wales, the Health Care Complaints Commission, NSW Fair Trading and NSW Health. 

R8 ... that, if the COAG Health Council does not agree to establishing a one-stop-shop website and advice service for cosmetic health services, the Minister for Health looks at the NSW Government establishing the service. 

R9 ... that NSW Health research behaviours of, and influences on, consumers seeking cosmetic health services to inform future policy, regulation and education programs in this area. The Minister for Health could recommend to the COAG Health Council that it consider this as a priority for research funded through the National Health and Medical Research Council (NHMRC).  

Protecting the public 

R10  ... that the Minister for Health pursues the issue of national regulation of the use of intense pulsed light devices and laser devices for cosmetic health service procedures with the COAG Health Council. 

R11  ... that the Minister for Health examines whether legislation should be introduced in New South Wales to regulate the use of intense pulsed light devices and laser devices used for cosmetic health services. 

R12  ... that the Minister for Health and the Minister for Innovation and Better Regulation consider whether individuals providing cosmetic health services, and employees of those persons, should be required to disclose any commissions, incentives or other payments they receive for encouraging patients to agree to procedures, more of the same procedure or additional procedures. 

R13 ... that the Minister for Health raises with the COAG Health Council the issue of whether patients seeking invasive cosmetic surgery be required to consult their General Practitioner and pursue national consultation on this issue. 

R14 ... that, as part of the New South Wales public education campaign about cosmetic health services, the Minister for Health encourages patients considering invasive cosmetic surgery to seek advice from a General Practitioner. 

R15  .... that the Minister for Health and the Minster for Innovation and Better Regulation review whether the cooling off periods provided for in the Medical Board of Australia's Guidelines for registered medical practitioners who perform cosmetic medical and surgical procedures, 1 October 2016, are sufficient to protect consumers in New South Wales. The Ministers should also consider whether it would be appropriate to require and regulate cooling off periods for some cosmetic health services provided by non-registered practitioners. 

R16  ... that the Minister for Health considers the feasibility of collecting data on revision surgery in the public health system, to correct cosmetic health procedures, to inform future policy and decision-making in this area

Chemical Leasing

Last year's OECD report on Economic Features of Chemical Leasing states

Chemical Leasing (ChL) is a service-oriented business model that aligns the interests of the chemical supplier with those of the chemical user by compensating the service of the chemical rather than the chemical volume sold and used. This creates a strategic partnership between the two parties, in which the common goal is the reduction of chemical consumption, thus achieving enhanced performances, chemical handling and waste management and, therefore, economic and environmental benefits.

Due to the economic and environmental benefits that ChL can achieve, since the early 2000s UNIDO and some European countries, notably, Austria, Germany and Switzerland, have been promoting the business model as a means to achieve sustainability in the chemical industry. This study presents a review of the literature on the economic features of the ChL and of similar business models, focusing on the drivers and barriers and comparing their functioning to traditional contracts.

Advanced chemical legislative frameworks have been and are being established in developed and developing countries with the common objective of providing more information to the public and to further involve the chemical industry in reducing the use of hazardous chemicals. Compliance with chemical policy requires constant innovation at the chemical substance level (search for safer alternatives), at the technical process level (search for more efficient processes and technologies) and at organisational level (search for new business solutions) and an enhanced communication of information through the chemical supply chain. It is therefore a strong driver for the uptake of ChL.

Beside policy, the current characteristics of the chemical market, i.e. increased international competition and declining margins, also constitute a driver for the adoption of business models that help in achieving greater efficiency, in maintaining solid relationships between chemical suppliers and customers and in avoiding price underbidding. Moreover, the increase in the demand for greener consumer products may push large retailers to require higher environmental standards of their suppliers, driving the uptake of innovative business models which demonstrate substantial environmental benefits, such as ChL.

Despite these policies and market drivers and the positive results achieved through the implementation of ChL in different countries, the business model still has a limited penetration. Possible reasons are: strict waste legislation, lack of customer demand, liability risks, fear of losing know-how to the supplier and reluctance of the supplier to take on all the investments. A major external barrier is that prospective ChL users are not completely aware of the life-cycle cost of chemicals.

Another hurdle that could affect the uptake of all business models in which chemical management activities are being outsourced, including ChL, is that, when the chemical management activities are performed by individual staff aside other responsibilities (as it is often the case in small and medium-sized enterprises), the transferability is more problematic and the chemical service provider may not be able to reduce the company direct costs, as the salaries of that staff will have to be paid anyway. On the opposite side of the problem, prospective users may have already invested in in-house capacity for chemical management to ensure compliance to strict environmental and health and safety legislation. Therefore, potential ChL suppliers may find it difficult to improve the chemical management of the users and hence there may be less incentive for such a company to switch to a ChL model. Servicising contracts, such as ChL, can mitigate information asymmetries and transaction costs through the realignment of incentives in the supplier-user relationship. However, these contracts can also lead to new types of transactional hazards, such as bilateral dependence and monopoly. These have been dealt with in ChL with different mitigation strategies, crafted to the peculiarities of the companies involved. On the basis of the identified barriers and of the recommendations provided by different authors, some initiatives are suggested to promote the efficient application of the model, focusing on increasing awareness of ChL and its advantages among stakeholders, offering support in the form of legal advice in drafting contracts and facilitating t

Tort

'Apologies as ‘Canaries’ — Tortious Liability in Negligence and Insurance in the Twenty-First Century' by Prue Vines in Kit Barker, Karen Fairweather and Ross Grantham (eds), Private Law in the 21st Century (Hart, 2017) comments

The relationship between tort liability in negligence and insurance is significant, although for most of the twentieth century insurance was ignored in determining liability, despite the massive rise in insurance. Although the determination of liability in negligence typically ignores the existence of insurance, it is there in the background (sometimes driving tort reform) and, if it fails it can be catastrophic for the defendant. The extent to which insurance should be taken into account in considering liability is controversial; this chapter argues that it should only be permissible where the insurance is compulsory or universal, but that it is vital to consider the socio-legal or external power of insurance in relation to tort law because of its importance for access to justice. Insurance contracts typically regulate the relationship between the insured and tortious liability. In most jurisdictions liability insurance contracts contain a provision which makes the contract void if the insured makes an admission against interest. This is traditionally taken to include an apology, hence the commonly repeated advice not to apologise after an accident. The question of whether an apology is an admission is not necessarily clear in the absence of apology-protective legislation. Cases have decided this differently both across and within jurisdictions, although the better view in Australia and the UK is that an apology is not an admission of liability in negligence. This paper attempts to map out the law on apologies and insurance and argues that what is vital is that the liability regime and the insurance regime have some congruence in terms of access to justice and that the apology may serve as a ‘canary’ in the mine of liability – to show whether there is proper congruence or not.

In the US a Californian jury has awarded damages of US$105 million to a cancer patient in a dispute with celebrity naturopath Robert Oldham Young, author of nonsensical but alas bestselling 'pH Miracle' books such as The pH Miracle: Balance Your Diet, Reclaim Your Health.

Dawn Kali sued Young in San Diego County Superior Court, alleging negligence and fraud. She reportedly claimed he had held himself out as a doctor and counseled her to forgo conventional medical treatment, forgoing chemotherapy and accordingly relying on ' alkaline theories' (ie acidity is the cause of all disease and can be addressed through alkaline injections, a 'miracle' diet and so forth). Young spent time in a state prison in 2014 after conviction for practicing medicine without a license, following an investigation by the state medical board and by the District Attorney. At that time he reportedly stated

“I swear to God, from my mouth to God’s ears, that’s the last thing I would do is practice medicine, The reason why is because number one, I don’t believe in it, and number two, the reason I don’t believe in it is because it’s a treatment protocol to deal with symptoms rather than underlying causes.

In his 2014 trial the prosecutor claimed that Young’s degrees came from a correspondence-based diploma mill, with Young progressing from a bachelor’s degree to award of doctorate in about eight months. In 2016, the Osteopathic Medical Board of California charged Johnson with gross negligence, repeated negligence, and general unprofessional conduct in connection with his treatment of four patients at the pH Miracle Center, with his license being revoked the following year alongside an assessment of US$20,000 for the cost of the board's enforcement action.

I am bleakly amused by Young's reported comment that the award is “totally outrageous”, "appalling” and “It’s one-tenth of a billion”. His theories and treatments - at least one of which apparently involved intravenous injections of baking soda and fluid cocktail at US$500 per infusion - might be junk but he can count.

Grannycams

In September one of my pieces in The Conversation commented that 'Hiding ‘grannycams’ in aged care facilities is legally and ethically murky', a response to self-help by loved ones of seniors - and others - in care facilities. (I use the term care with some caution, given a succession of reports indicating that caring someomes limps a long way behind institutional/personal convenience and revenue generation.

There hasn't been a great clarification through the South Australian Supported Residential Facilities (Aged Care Facilities) Amendment Bill 2018, intended to amend the Amendment of Supported Residential Facilities Act 1992 (SA), raises questions about 'grannycams' - undisclosed or evident video surveillance of residents of aged care facilities.

The Bill provides for a new section 29A—Special conditions for aged care facilities -

(1) Each licence under this Act relating to a supported residential facility that is an aged care facility is subject to a condition requiring the proprietor of the facility to comply with this section. 

(2) The proprietor of a supported residential facility that is an aged care facility must ensure that— 

(a) audio-visual recording equipment that complies with any requirements set out in the regulations for the purposes of this paragraph is installed in the bedroom of each resident of the facility; and 

(b) audio-visual recording equipment that complies with any requirements set out in the regulations for the purposes of this paragraph is installed in each common area of the facility. 

(3) Subject to this section, the proprietor of a supported residential facility that is an aged care facility must ensure that—

(a) in the case of audio-visual recording equipment installed in the bedroom of a resident—  

(i) the audio-visual recording equipment is operating at all times when any person is in the bedroom; and 

(ii) the audio-visual recording equipment is monitored in accordance with any requirements set out in the regulations for the purposes of this paragraph by a  person or body independent of the aged care facility or the proprietor; and 

(iii) the images recorded by the audio-visual equipment are reviewed, in accordance with any requirements set out in the regulations for the purposes of this  paragraph, by a person authorised in writing by the proprietor; and 

(b) in the case of audio-visual recording equipment installed in a common area of the facility—

 (i) the audio-visual recording equipment is operating at all times when any person is in the common area; and 

(ii) the audio-visual recording equipment is monitored in accordance with any requirements set out in the regulations for the purposes of this paragraph by a person or body independent of the aged care facility or the proprietor; and      

(iii) the images recorded by the audio-visual equipment are reviewed, in accordance with any requirements set out in the regulations for the purposes of this paragraph, by a person authorised in writing by the proprietor.  

(4) The requirements under subsection (3)(a) will only be taken to apply to a proprietor of a facility if each resident in the bedroom in which the audio-visual recording equipment is installed consents in writing to the operation of the audio-visual recording equipment, and the monitoring and review of images recorded by the equipment. 

(5) The proprietor of a supported residential facility that is an aged care facility may recover from a resident the actual costs of— 

a) installing and operating audio-visual recording equipment in the bedroom of the resident; and 

(b) monitoring and reviewing images recorded by the audio-visual equipment in accordance with this section, (however, nothing in this section authorises the recovery of costs in relation to the installation, operation, monitoring or review of audio-visual recording equipment installed in a common area of the facility). 

(6) For the purposes of this section, a reference to the consent of a resident will be taken to include a reference to the consent of a person who is authorised under a law of this State, or of the Commonwealth or another State or Territory, to give consent on behalf of the resident. 

(7) In this section— common area, of an aged care facility, means an area to which all residents of the facility or members of the public (or both) have access

Speech

'Is the ‘Hate’ in Hate Speech the ‘Hate’ in Hate Crime? Waldron and Dworkin on Political Legitimacy' by Rebecca Gould in Jurisprudence) comments 

Among the most persuasive arguments against hate speech bans was made by Ronald Dworkin, who warned of the threat to political legitimacy posed by laws that deny those subject to them adequate opportunity for dissent. In his influential defence of hate speech bans, Jeremy Waldron addresses these objections. Dworkin’s concern with political legitimacy is misplaced, he argues, given the provision speech bans make for substituting permissible modes of expression for impermissible ones. I argue that this defence of speech bans misidentifies the “hate” in hate speech with the “hate” in hate crime. In contesting Dworkin, Waldron fails to contend with the necessarily entangled criminalisation of manner and viewpoint entailed in hate speech bans. By failing to grapple with the way in which every linguistic sign is constituted by both manner and viewpoint, Waldron sidesteps the ways in which hate speech bans undermine political legitimacy within liberal democracies.

Support Animals

Don’t Be Distracted by the Peacock Trying to Board an Airplane: Why Emotional Support Animals Are Service Animals and Should Be Regulated in the Same Manner' by Amanda Foster in (2018) 82 Albany Law Review comments 

Although fifty percent of all Americans are diagnosed with a mental illness or disorder at some point in their lifetime, including one in ten women, and mental illnesses are the third most common cause of hospitalization for adults under forty-four, the ADA’s narrow approach to defining service animals only protects a certain group of people with disabilities using a certain type of animal — dogs who perform tasks associated with the person’s disability. This narrow approach does not consider the thousands of people who use emotional support animals to alleviate or mitigate the symptoms associated with their mental health issues. To provide parity, it is necessary to include emotional support animals within that definition. Despite the prevalence of mental illness, there is a societal backlash against emotional support animals who provide companionship, relieve loneliness, and sometimes help with depression, anxiety, and certain phobias, but do not meet the ADA definition of service animal due to their lack of specialized training. The FHA and ACAA have provided protection and accommodations for people using emotional support animals, but that protection is in jeopardy. In response to uncertainty over the definition of emotional support animals, on April 24, 2018, Senator Burr (R-NC) introduced a bill to amend title 49 of the United States Code, which would make changes to the ACAA such as only allowing service animals as defined by the ADA to be uncaged onboard aircraft's, requiring service animal behavior training for air carrier passengers, and creating a criminal penalty for fraudulently claiming that an animal is a service animal used for disability needs. If Senator Burr’s bill is passed and the ACAA is restrained from allowing emotional support animals to be service animals under the ACAA, then people with mental health issues will once again be stigmatized and treated as second class citizens. Emotional support animals are also on trial in the regulatory realm. The DOT is currently seeking comments on ways to improve the ACAA regulation to ensure nondiscriminatory access for individuals with disabilities to use their service animals onboard airlines while attempting to deter “fraudulent use of other animals not qualified as service animals” and prevent use of “animals that are not trained to behave properly in the public.” Clear regulation is needed to ensure that all people with disabilities can use a service animal, including emotional support animals, if that animal will assist him or her with alleviating or mitigating the symptoms associated with his or her disability. Do not let the peacock trying to board the airplane distract from the real issue at hand. Mental health matters and people who experience mental health issues and need emotional support animals in public places, including on mass transit, to participate in society, should not be denied this accommodation based on fear that some people may fraudulently claim that their pets are emotional support animals. If we legitimize the process of bringing an emotional support animal in public, including on mass transit, then we make steps in continuing to take away the stigma of mental health issues. Parity is essential to accomplishing that goal.