3D Printing and Intellectual Property

3D Printing and Intellectual Property Futures by Thomas Birtchnell, Angela Daly, Thierry Rayna and Ludmila Striukova for the UK Intellectual Property Office comments 

This report contains socio-legal research conducted on the relationship between 3D printing and intellectual property (IP) at the current point in time and in potential future scenarios, through the use of horizon-scanning methods in six countries—China, France, India, Russia, Singapore and the UK - to build a rich picture of this issue, comprising both developed and emerging economies. 

In conducting this research, we take up the baton from previous UK Intellectual Property Office (IPO) reports on 3D printing and IP (Mendis, Secchi and Reeves 2015). As noted in these previous reports, there is very little empirical research on how the relationship between 3D printing and IP is playing out in practice. In addition, there is very little existing literature or research on 3D printing’s trajectory outside of developed Western economies, and how it is interacting with IP in the rest of the world. Our research goes some way to filling this gap, presenting novel insights on developments in Russia and Asia. Furthermore, as the UK reassesses its place in the world post-‘Brexit’ there is a need for greater awareness about future trade partners outside of the European Union (EU) such as the countries we examine. In our project, we have collected valuable information ‘from the ground’ on the past and present of 3D printing and IP in these different countries. Another novelty of our project is the futures projections we led in each place, in order to understand potential trajectories going forward for 3D printing and IP, and to understand the extent to which a harmonised or fragmented global picture can be constructed. Our interdisciplinary, international team, combining legal, business and social scientific regional expertise on 3D printing, has used cutting edge and novel empirical methods in order to pioneer a deeper probing of the ramifications of 3D printing, going further than prior commentary through methodological innovation and an international focus on 3D printing and IP. 

While we have created new research filling - to some extent - the gap on 3D printing and IP outside of Western countries, we also acknowledge one of the limitations of our work. The case of BRICS countries may not be representative of all developments in 3D printing and IP outside of Western countries. Indeed, the use of 3D printing is growing in the Middle East and Africa, but due to limitations of scope we were not able to conduct research in these locations. However, in order to build up a fuller picture of 3D printing’s implementation globally, and the effect this may have on IP, more research is required in locations outside of the North/West.

This Report is structured in three parts: in Part I we present a summary of illustrative existing literature on 3D printing and IP; in Part II we present our empirical research on 3D printing and IP, including potential future scenarios; and in Part III we finish by outlining our findings, recommendations and conclusions drawn from both parts of our research. 

Part I Existing 3D Printing and IP Literature 

There is a blossoming body of literature from the business, legal and social sciences disciplines examining various aspects of 3D printing and/or IP. In the business and social science literature, topics including adoption, industrial applications, prosumerism, IP and future forecasting feature. The legal literature review covers each IP right in turn, proposals for new sui generis rights, enforcement, how different industries have engaged with 3D printing and IP issues, and potential future scenarios. 

Much of this existing scholarship comes from and focuses on 3D printing and IP in the Global North/West, with limited material on emerging economies and the Global South. Furthermore, the IP literature mainly concerns copyright and patents, with literature on other IP rights less developed. 

Part II Empirical 3D Printing and IP Research 

In this project we have aimed to get away from the idea that futures—including for IP—are dependent on, or determined by, technologies or that they are simply derived from the ways in which the present is unfolding (Birtchnell and Urry 2016). In our empirical research we have aimed to better understand the potential future direction(s) of 3D printing technologies and what impact this may have for IP. 

In order to understand more fully the development of 3D printing in different locations, especially in emerging and non-Western economies, its relationship with IP law and practice, and how this relationship may change in the future, we conducted qualitative focus-group style horizon scanning workshops with experts from the 3D printing ecosystem during 2017 and 2018 in six locations: Moscow (Russia), Roorkee (India), Singapore, Shenzhen (China), Paris (France) and London (UK). The workshops comprised between five and fifteen experts in each location who were selected because of their experience in 3D printing and associated industries and/or IP law and practice. Our aim was to get participants comprising a cross-section of different actors in the 3D printing/IP ecosystem, including across a range of industries. 

The horizon scanning format for the workshop was developed by the project team and comprised three parts: the Multi-Level Perspective (MLP) to establish past and present trends and a combination of Ideal Futures scenario constructing and backcasting to scan the horizon. The benefit of the fusion of these methodologies is a multi-dimensional appraisal of foreseeable trends across different countries at different scales. 

Part III Recommendations and Conclusion 

Our main findings from the horizon scanning workshops comprise the following: 

Commonalities across the countries 

1. There are a number of similarities across the countries, in particular government policies to stimulate the creation and take-up of new technologies including 3D printing. 

2. 3D printing does not appear to be posing fundamental threats to IP in any of the countries examined at this moment in time. 

3. IP is far from the only area of law involved with 3D printing, and may not be the most important legal concern for those operating in the 3D printing industry. Medical device regulation, product liability, and health and safety laws may be more important legal considerations for industry actors. 

4. But IP is also not unimportant for 3D printing as can be seen from patenting activities, the expiry of patents leading to greater technology dissemination and the possibility of more IP litigation. 

5. The relationship between 3D printing and other emerging technologies such as automation, Internet of Things (IoT), artificial intelligence and blockchain is one of cross-fertilisation. 

Country-specific issues 

6. In Singapore, an ageing population is influencing government policy, and in turn influencing the implementation of 3D printing in medicine through government investment in this area. 

7. Political and cultural trends especially in the UK and France seems to be leading to renewed interest in re-invigorating manufacturing within the nation-state and 3D printing is imagined as a technology which can fulfil these promises by achieving onshoring— but it is far from clear that this is realistic given competition from Asian and other Western economies. 

8. The projected future outlooks for 3D printing and IP vary quite significantly among the countries examined: the Asian countries and Russia are broadly aligned with a capitalist future outlook, which would likely preserve ‘conventional’ IP laws and practices. The future outlook for the UK and France diverges from this picture by opening more possibilities for commons-based scenarios which may challenges conventional IP. 

9. India remains a possible site for a future large manufacturing paradigm change given pre-existing conditions and significant potential for 3D printing in there. India could be the site of pioneering localised and distributed manufacturing, a model which may be adopted elsewhere especially in other parts of the Global South. 

Our Recommendations 

1. Developments should continue to be monitored, especially:

• the extent to which 3D printing is successful in reinvigorating national manufacturing agendas; 

• the practical opportunities 3D printing offers for localised manufacturing in contrast to the current situation of a ‘World Factory’, containerisation and cyclic consumerism; 

• cultural and political trends; 

• country-to-country and sector-to-sector differences

2. The rise of China, and the potential rise of India into the ranks of developed economies with large middle classes exhibiting a strong showing in innovation, including in 3D printing, should be monitored. 

3. We did not find a pressing need for legal reform from representatives of the industries participating in the horizon scanning workshops, including the creative industries, medicine, law, industrial manufacturing and research. Nevertheless, we recommend legal clarification of existing theoretical IP issues exposed by 3D printing. These issues include the subsistence of IP rights, identifying activities which constitute infringement especially secondary infringement and how some exceptions to infringement operate. The limited litigation so far on 3D printing internationally has not been on these topics and accordingly has not provided this clarification. 

4. The UK should continue to keep track of any next steps in the EU arising from the European Parliament’s Resolution on 3D Printing, and consider aligning any revisions of its own laws with the outcome of this process where this meets domestic objectives. 

5. Companies should not be left alone to the task of business model innovation when faced with new forms of digitised technologies such as 3D printing. Instead, Government should work with industry to create transition ‘champions’ who would help companies understand the arising technological, economic, social and legal issues and rethink their business model to achieve long term competitiveness. Since such issues are only going to become prevalent as 3D printing technologies advance and becomes increasingly adopted, this may well become a critical aspect of industrial policy.

Income, Information and Privacy

'The Salary Taboo: Privacy Norms and the Diffusion of Information' by Zoe Cullen and Ricardo Perez-Truglia comments 

The diffusion of salary information has important implications for labor markets, such as for wage discrimination policies and collective bargaining. Despite the widespread view that transmission of salary information is imperfect and unequal, there is little direct evidence on the magnitude and sources of these frictions. We conduct a field experiment with 752 employees at a multi billion-dollar corporation to address these questions. We provide evidence of significant frictions in how employees search for and share salary information and suggestive evidence that these frictions are due to privacy norms. We do not find any significant differences in information frictions between female and male employees.

The authors argue

Most employers provide limited information about salaries. Thus, employees’ knowledge about salaries depends largely on their ability to communicate with each other. However, there is a widespread belief that the diffusion of salary information is imperfect and unequal. For example, most employees do not discuss salaries with their coworkers, despite wanting to be better informed about peers’ salaries (Glassdoor, 2016; PayScale, 2018). These information frictions are sometimes attributed to firm efforts that discourage employees from discussing salaries (Gely and Bierman, 2003; Hegewisch et al., 2011). Others argue that the frictions stem from a “salary taboo”: a social norm around salary privacy that discourages coworkers from revealing or inquiring about salary information (Trachtman, 1999; Edwards, 2005). 

These information frictions are important, because they have implications for a broad range of labor market phenomena. For example, information frictions can facilitate workplace discrimination, increase employers’ market power (Danziger and Katz, 1997; Cullen and Pakzad-Hurson, 2017), and hinder collective bargaining and unionization (Corbett, 2002). These supposed information frictions also have inspired several policies, such as those that punish employers when they retaliate against employees who discuss wages with each other (Pender, 2017; Siniscalco et al., 2017). Despite these important implications, there is little direct evidence on the diffusion of salary information. We use a field experiment to provide novel evidence on how individuals search for and share salary information and on the role that privacy concerns play in these decisions. 

Employees can benefit from information about coworkers’ salaries in several scenarios, such as negotiating salary, switching managers, or searching for new jobs. This information has a cost, though: employees must spend time and energy to search for it, and they may face costs for inquiring about sensitive data. We design a novel field experiment to study these costs and benefits. 

To measure employees’ willingness to search for information, we generate an exogenous shock to the benefits of being informed about salaries by allowing employees to partake in a game. In the game, employees guess the average salary of a random sample of five of their peers (e.g., a bank teller guesses the average salary of five other tellers from the same branch). Employees whose guesses fall within 5% of the true average salary receive a monetary reward. After providing their initial guesses, which they must do immediately, respondents are offered the opportunity to acquire an extra week to search for information in the wild and improve their guesses. We elicit the probability of winning the game with and without the additional week, using self-reported and incentive-compatible methods. The degree to which employees expect the extra week to increase their probability of winning the game measures their willingness to search for information in the wild. 

We measure the gross benefits from information by eliciting the willingness to pay for an imperfect but informative signal about the average peer salary, using an incentive-compatible method. In other words, we provide subjects with the opportunity to acquire readily available information from the experimenter instead of searching for information in the wild. Last, we measure the willingness to share information with others. We offer respondents an opportunity to reveal their own salaries to five peers, and we use an incentive-compatible method to elicit the willingness to pay to reveal this information (for subjects who prefer to share the information) or the willingness to pay to conceal this information (for subjects who prefer to conceal the information). 

We cross-randomize two key features of the survey. The first treatment arm allows us to test differences in the diffusion of salary information, relative to other important career information. For this, we randomize subjects into two versions of the survey: salary and seniority. The survey types are identical, except that one asks about the average seniority of peers instead of the average salary. Just like information about peer salary, information about peer seniority can be useful to make important career choices, such as whether to ask for a promotion or search for another job. However, employees may face higher frictions when searching for and sharing information about salary, compared to seniority, for example, because of the salary taboo. 

The second treatment arm aims to test the rational inattention hypothesis, according to which individuals search for and acquire new information when they stand to gain from it (Woodford, 2001; Sims, 2003; Mankiw and Reis, 2002; Reis, 2006). We randomize the size of the rewards of the guessing game using five different values from $13 to $63 (these and all other monetary values reported in this paper are expressed in United States dollars using PPP-adjusted exchange rates from February 2018). This randomization generates exogenous variation in the benefits of being informed. We test two predictions of the rational inattention model: higher rewards should increase the willingness to search for information in the wild and the willingness to acquire readily available information. 

We conduct a field experiment with a sample of 752 employees from a large commercial bank (hereafter referred to as the firm) with thousands of employees, millions of customers, and billions of dollars in revenues. The firm is typical in some relevant respects. The firm does not have open salary policies and discourages employees from discussing salaries with each other. Most employees report that they have limited information about salaries and would prefer the firm to be more transparent. There seems to be a social norm against asking coworkers about their salaries, and employees rarely discuss salaries with their coworkers. A number of studies show that these features are common in firms from several countries, including the United States (Trachtman, 1999; Edwards, 2005; Hegewisch et al., 2011; Glassdoor, 2016; PayScale, 2018). 

We find that employees have imperfect information about the salaries of their peers: the mean absolute error of the guesses reported in the game is 16%. Indeed, this level of misperception is what we would expect if employees have access only to information about their own salaries. Although employees are overconfident in their guesses, they are aware that their accuracy (i.e., the probability of guessing within 5% of the truth) is far from perfect. 

We provide evidence that misperceptions are partly due to search costs. When presented with financial incentives to do so, most individuals are willing to search for information in the wild. When given an extra week to gather information, the average respondent expects to increase the probability of winning the guessing game by 23 percentage points. The evidence reveals that search costs are unequal: when provided with the additional week, some employees expect to search for information in the wild, but other employees do not expect to search. And consistent with the rational inattention hypotheses, employees who are randomly assigned to higher game rewards expect to search more intensively than employees who are assigned to lower game rewards. 

We find that, much like the search costs, the gross benefits of the salary information are significant and unevenly distributed. The median willingness to pay for the readily available signal of peer salary is about $13. Consistent with rational inattention, this value is higher for individuals who are assigned to a higher game reward and thus stand to gain more from the information. Employees in the bottom half of the distribution, who are willing to pay less than $13 for the information, seem to be misinformed mainly due to a lack of interest. On the other hand, the remaining half of subjects highly value the information: their willingness to pay for the signal has a median of $130 and a mean of $369. These high valuations suggest that these employees do not search for information in the wild because of information frictions. 

We find that individuals also face significant frictions when sharing information with others. The willingness to reveal one’s salary to coworkers is both significant and heterogeneous. Whereas a minority of employees (20%) prefer to share personal salary information with their peers, most (80%) prefer to conceal this information. Moreover, this preference for privacy can be strong: some employees would reveal their salaries for a small sum of money, but roughly half would not be persuaded to reveal the information to five peers even for $125. 

The preference for privacy is consistent with a salary taboo. Individuals are afraid to ask coworkers about their salaries, because they understand that most coworkers prefer to keep their salary information private. Indeed, this interpretation is consistent with our subjective data. Most respondents report that it is socially unacceptable to ask coworkers about their salaries and that they feel uncomfortable doing so. Moreover, 89% of respondents believe that if they ask coworkers about their salaries, they will get asked about their own salaries. Thus, employees may be afraid to ask coworkers about their salaries because that may force them to reveal their own salaries, which they dislike. 

We find that employees are better informed about peer seniority than about peer salaries. When guessing salaries, employees are as accurate as they would be if they just reported their own salaries. This finding indicates that employees do not have access to information beyond their own salaries. In contrast, when guessing seniority, employees are substantially more accurate than they would be if they just reported their own seniority. This finding suggests that employees have access to other information about seniority besides their own seniority. Moreover, our evidence suggests that, at the margin, employees stand to gain more from salary information than from seniority information. This evidence suggests that the difference between salary misperceptions and seniority misperceptions are due to differences in search costs. 

Although it is not the only possible interpretation, the demand for privacy is our favorite interpretation for the differences between salary misperceptions and seniority misperceptions. Two main pieces of evidence support this view. First, the revealed-preference evidence indicates that the topic of salary is substantially more sensitive than that of seniority. The average employee is willing to reveal personal salary information to a sample of five peers for $67 and willing to reveal seniority to peers for just $28. Second, the subjective data also suggest that salary is a more sensitive topic. Whereas 69% of employees find it unacceptable to ask a coworker about salary, only 6% find it unacceptable to ask about seniority; and whereas 53% of employees find it uncomfortable to ask about a coworker’s salary, only 5% find it uncomfortable to ask about seniority. 

We find substantial frictions in information diffusion, even though participation in the game may facilitate this diffusion. For example, the guessing game may provide an excuse to ask peers about their salaries that mitigates the fears of breaking a social norm or breaking the company’s disclosure rules. Thus, if anything, our findings may underestimate the magnitude of information frictions under normal circumstances. 

Our last result relates to gender differences in information frictions. This analysis is motivated by the widespread view that pay secrecy disproportionately affects women (Babcock and Laschever, 2009) and thus may be one of the factors behind the gender pay gap. Consistent with this view, survey data indicate that women are less confident than men about their salary knowledge (Glassdoor, 2016; Cullen and Pakzad-Hurson, 2017). Consistent with these prior survey findings, our own data indicate that female employees are less confident than male employees about their ability to guess the salaries of their peers. However, we find that those differences in confidence do not correspond with any real differences in accuracy. If anything, female employees are slightly more accurate than their male counterparts. Moreover, we find that other gender differences are small, statistically insignificant, and precisely estimated: female and male employees are equally willing to search for information, equally willing to buy information, and equally willing to share information with peers. 

Our study relates to various strands of literature. A large theoretical literature from economics and management suggests that frictions in the diffusion of salary information can have important implications for labor markets (Akerlof and Yellen, 1990; Kuhn and Gu, 1998, 1999; Ellingsen and Rosén, 2003; Michelacci and Suarez, 2006; Cullen and PakzadHurson, 2017; Moellers, Normann, and Snyder, 2017). Yet, there is little direct evidence on the magnitude and sources of information frictions. This study builds on our previous work documenting significant misperceptions of peer and manager salaries (Cullen and PerezTruglia, 2018).6 This study aims to understand the sources of these misperceptions, with special emphasis on the role of the salary taboo. 

Our study relates to a literature on the diffusion of information in social networks. Several models explain how individuals form beliefs based on peer-to-peer communication (Bass, 1969; Ellison and Fudenberg, 1995). More recent studies measure social learning in the field (Mobius and Rosenblat, 2014). Some of these studies artificially create incentives for information diffusion. For instance, Mobius et al. (2015) recruited college students to play a “treasure hunt” game in which they earned prizes by collecting information from peers. Other studies exploit natural incentives for information diffusion. For example, Beaman et al. (2018) seeded useful information about composting and measured its diffusion in an agricultural network. These papers show evidence that, even in settings where information is mutually beneficial, its diffusion is highly imperfect. Our contribution to this literature is twofold. First, we contribute a new method to measure the willingness to search for information and the willingness to share information with others. Second, we explore the role of privacy norms for the diffusion of information. 

Our paper adds to the literature on the economics of privacy (Acquisti et al., 2016). For example, Goldfarb and Tucker (2012) show that, even in anonymous internet surveys, some respondents refuse to reveal information about their incomes and demographics. Athey et al. (2017) and Adjerid et al. (2013) study the demand for privacy in the crypto-currency market. They show that even individuals who report that they highly value privacy are willing to give away sensitive information for small incentives. We contribute to this literature by measuring preferences for privacy in a context with high stakes (i.e., an employee’s willingness to reveal personal salary information to coworkers). In contrast to those other contexts, we find a high willingness to pay for privacy. Perhaps more surprisingly, we find a large heterogeneity in preferences for privacy, with some individuals willing to pay to reveal their salary to peers rather than conceal it. 

Last, this study relates to literature on wage discrimination. There is a widespread view that pay secrecy hurts minorities, because it helps employers to discriminate against them (Phillips, 2009; Colella et al., 2007). This view has led to various efforts to reduce the gender wage gap, through transparency policies (Colella et al., 2007). However, this argument often assumes that pay secrecy hinders information access more for women and minorities than for others. Our evidence does not support this assumption: women and men face similar frictions and have similar degrees of misperceptions. However, we do find that female employees are less confident than male employees about the accuracy of their beliefs. 

The rest of the paper proceeds as follows. Section 2 presents the conceptual framework. Section 3 presents the survey design. Section 4 discusses the implementation details. Section 5 presents the results. The last section concludes

UK Media Regulation

Echoes of Australia's Finckelstein report in the LSE Commission on Truth Trust And Technology report Tackling The Information Crisis: A Policy Framework for Media Systems Resilience.

The Commission comments

Changes in the UK media system have resulted in an information crisis, with a growing number of leaders in health, defence and politics concerned about system resilience and the new difficulty of achieving informed debate. This report argues that the information crisis is manifested in ‘five giant evils’ among the UK public – confusion, cynicism, fragmentation, irresponsibility and apathy.  

While the media, platforms and public authorities are responding, there are challenges of coordination, a lack of research and information in policy-making, and the potential for conflicts of interest and disputes over media freedom, which are hindering necessary reforms.  

Policy-makers and the public are in the dark: the extent of the problem and whether current policy is addressing it are not clearly understood, and the problems created by a complex media system are ongoing.  

This report recommends actions aimed at addressing systemic problems and at creating conditions that will help to sustain democratic processes of deliberation and consensus building in the UK. Whether our longer-term recommendations will need to be implemented will depend on progress in the short term.  

Immediate Actions  

Establish an Independent Platform Agency  

The UK and devolved governments should introduce a new levy on UK online platforms’ revenue, a proportion of which should be ring-fenced to fund a new Independent Platform Agency (IPA). The IPA should be structurally independent of Government but report to Parliament. Its purpose, initially, will not be direct regulation, but rather an ‘observatory and policy advice’ function that will establish a permanent institutional presence to encourage the various initiatives attempting to address problems of information reliability.  

The IPA should be established by legislation and have the following duties:

• Report on trends in news and information sharing according to a methodological framework subject to public consultation. This should include real data on the most shared and read stories, broken down by demographic group.
• Report on the effectiveness of self-regulation of the largest news-carrying social and search platforms. This should include reports on trust marks, credibility signalling, filtering and takedown.
• Mobilise and coordinate all relevant actors to ensure an inclusive and sustained programme in media literacy for both children and adults, and conduct evaluations of initiatives. The IPA should work with Ofcom to ensure sufficient evidence on the public’s critical news and information literacy.
• Report annually to Parliament on the performance of platforms’ self-regulation and the longterm needs for possible regulatory action.
• Provide reports on request to other agencies such as the Electoral Commission, Ofcom and the Information Commissioner’s Office, to support the performance of their duties, according to agreed criteria.
• Work closely with Ofcom and the Competition and Markets Authority to monitor the level of market dominance and the impact of platforms on media plurality and quality.

In order to fulfil these duties, the IPA will need the following powers:

• Powers to request data from all the major platforms (determined by a UK advertising revenue threshold) on the top most shared news and information stories, referrals, news-sharing trends and case studies of particular stories. The types of data should be determined on the basis of public consultation on monitoring methodologies and according to a shared template that applies across different companies above the threshold. These data will be held by the IPA within a tight confidentiality regime to protect privacy and commercial sensitivities.
• Powers to impose fines on platforms if they fail to provide data, and to request additional data when a court order is granted.
• The IPA’s independence from government should be established in law and protected financially and through security of tenure of its governing Board.

The IPA should have close links with civil society and be transparent about how it interprets and performs its remit.

In addition to this new institution, we make further recommendations:  

In the short-term:

• News media should continue their important work to develop quality and innovative revenue and distribution models. They should also continue to work with civil society and the platforms on signalling the credibility of content.
• Platforms should develop annual plans and transparent open mission statements on how they plan to tackle misinformation. They should work with civil society and news providers to develop trust marking.
• Government should mobilise an urgent, integrated, new programme in media literacy. This could also be funded by the digital platform levy and should include digital media literacy training for politicians.
• Parliament should bring forward legislation to introduce a statutory code on political advertising as recommended by the Information Commissioner.

In the medium-term (3 years):

• Standard setting for social media platforms. Until now, standards have been set by platforms themselves. If this fails to improve the UK information environment, the IPA should set these in collaboration with civil society, Parliament and the public.
• The news industry should develop a News Innovation Centre to support journalism innovation and quality news, funded by the levy on digital platform revenue.

In the longer-term (5 years):

• The IPA should provide a permanent forum for monitoring and review of platform behaviours, reporting to Parliament on an annual basis.
• The IPA should be asked to conduct annual reviews of ‘the state of disinformation’ that should include policy recommendations to a parliamentary committee. These should encompass positive interventions such as the funding of journalism.

Possible long term policy actions:  

In the longer term it might be necessary to subject platforms to much more stringent regulation, including making them liable for content they host, obliging them to unbundle or separate internal divisions, or even breaking up their business units or introducing a more comprehensive system of tax incentives. In time, it is possible that the IPA will develop beyond a ‘monitoring and information’ function into a regulatory function, but it is also possible that regulatory needs can be met by a combination of existing bodies, as advised by the IPA.  

The recommendations in this report are aimed at ensuring that the interests of citizens – understood as all of those residing in the UK – are protected alongside the interests of other stakeholders as the media system develops. This is essential if the information crisis is to be tackled successfully and democratic deliberation sustained.

FTAs

'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.

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.