Medications

The national Health Minister has announced establishment of an Expert Advisory Committee to lead the Review of the National Medicines Policy (NMP) for the Department. 

 The NMP is a statement of principles designed to guide the range of activities encompassing medication management, access and affordability of medicines in Australia through a partnership approach between all sectors. 

 Published in 2000, the NMP is a well-established framework to promote four objectives: timely access to the medicines that Australians need, at a cost individuals and the community can afford; medicines meeting appropriate standards of quality, safety and efficacy; quality use of medicines; and maintaining a responsible and viable medicines industry. The NMP is not prescriptive about the programs and processes used to deliver these four objectives. While the objectives of the NMP continue to resonate today, the landscape in which the policy operates has changed significantly with rapid therapeutic and technological innovations which have expanded treatment options for patients and increased their complexity. 

The NMP has influenced a number of important strategies, frameworks and programs developed since its publication. However, feedback suggests the Review may need to consider modifying and/or including additional objectives such as the centricity of the consumer, transparency and equity, and the relationship with the policy enablers (health literacy, implementation and communication strategies, and performance measures). This feedback has been incorporated into the Terms of Reference for the Review. 

 The Terms of Reference are stated as

This is a high level review aimed at identifying any gaps in the NMP’s objectives, partnership approach and accountabilities. 

The Review of the NMP will:

• Evaluate the current NMP objectives and determine whether these should be modified or additional objectives included. 

• Assess the NMP’s utility in the context of rapidly evolving treatments options, population changes, interconnected relationships and system-wide capacities. 

• Consider the centricity of the consumer within the NMP and whether it captures the diversity of consumers’, and their needs and expectations. 

• Consider the definition of medicines and whether the NMP needs to be expanded to include health technologies. 

• Identify options to improve the NMP’s governance; communications, implementation (including enablers) and evaluation. 

• Review the NMP partners and provide options for building greater accountability including addressing conflicts of interest. 

The Review will be inclusive of the community and supported by a consultation process that ensures the diversity of stakeholders and consumers are captured, including a call for public submissions and a stakeholder forum. 

The review process will begin in August 2021 and is anticipated to take approximately six months. 

 The Committee will be chaired by Deputy Chief Medical Officer, Professor Michael Kidd AM. Members include Professor Lloyd Sansom AO; Mrs Janette Donovan; Dr Sarah Dineen-Griffin and Mr David Herd.

Hacking

The Parliamentary Joint Committee on Intelligence and Security's Advisory report on the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 offers the following recommendations - 

Recommendation 1  The Committee recommends that, in line with the proposed expansion of the Inspector-General of Intelligence and Security’s oversight role, the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020, the Intelligence Oversight and Other Legislation Amendment (Integrity Measures) Bill 2020 and, to the extent necessary, other legislation be amended to expand the oversight remit of the Parliamentary Joint Committee on Intelligence and Security to cover the intelligence functions of the ACIC (including, but not limited to, the use of network activity warrants by the ACIC). 

Recommendation 2  ... the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020, the Intelligence Oversight and Other Legislation Amendment (Integrity Measures) Bill 2020) and, to the extent necessary, other legislation be amended to expand the oversight remit of the Parliamentary Joint Committee on Intelligence and Security to cover the intelligence functions of the AFP (including, but not limited to, the use of network activity warrants by the AFP). 

Recommendation 3  ... the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020, the Intelligence Oversight and Other Legislation Amendment (Integrity Measures) Bill 2020) and, to the extent necessary, other legislation be amended to extend the oversight remit of the Inspector-General of Intelligence and Security’s oversight to include all intelligence functions of the AFP (including, but not limited to, not the use of just network activity warrants). 

Recommendation 4  ... the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 and, to the extent necessary, other legislation be amended to expand the inspection mandate and functions of the Commonwealth Ombudsman to cover – in explicit terms – the propriety of the AFP and ACIC’s actions, practices, policies and activities under these new powers. 

Recommendation 5  ... where a Bill proposes to give operational or intelligence agencies specific new or expanded powers, those agencies should, in addition to providing input to any departmental submission, provide a separate unclassified submission to the Committee which should, at least, outline the necessity and proportionality of the proposed new or expanded powers. Such a submission should include, where appropriate, case studies on the current environment and how the use of any proposed new or expanded powers will assist the agency in the carrying out of its functions. The Committee also recommends that the Department of Home Affairs not make any further submission to the Committee that purports to be authored by, or submitted on behalf of, the “Home Affairs Portfolio”. For the avoidance of doubt this recommendation should not preclude an agency providing a classified submission in addition to any unclassified submission. 

Recommendation 6 ...  in support the proposed expansion of the Parliamentary Joint Committee on Intelligence and Security’s oversight remit (see Recommendations 1 and 2), the AFP and the ACIC provide an unclassified annual report to the Committee which sets out:  to the extent it is possible to do so in an unclassified report, similar information to what is required to be provided under section 3ZZVL of Schedule 3 of the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 (except that information should be provided in respect of all three of the new powers rather than just the account takeover warrants); and  the offences in respect of which the warrants were sought or obtained. This new reporting requirement should be supplemented by classified briefings to the Committee outlining the use of the new powers and their relationship both to each other and other existing powers provided to the AFP and ACIC. 

Recommendation 7 ... the INSLM Act be amended to provide for INSLM review of the data disruption, network activity and account takeover warrants introduced by the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 within three years of the Bill receiving Royal Assent. The Committee further recommends that the INSLM Act be amended to require the INSLM to provide a copy of his or her report to the Committee at the same time the report is provided to the Minister. 

Recommendation 8 ... the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended so that the Parliamentary Joint Committee on Intelligence and Security may conduct a review of the data disruption, network activity and account takeover warrants not less than four years from when the Bill receives Royal Assent to allow the Committee to take into account any report by the INSLM. In addition the Committee recommends that the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended so that each of the new powers sunset five years from the date on which the Bill receives Royal Assent. 

Recommendation 9 ... the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended so that the issuing authority for all of the new powers introduced by the Bill, including emergency authorisations, must be a superior court judge (either of the Federal Court or a State or Territory Supreme Court), except for Account Takeover Warrants which may be granted by an Eligible Judge per Section 12 of the Surveillance Devices Act 2004 (Cth). 

Recommendation 10 ... the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended to provide additional requirements on the considerations of the issuing authority to ensure the offences are reasonably serious and proportionality is maintained. The effect of any changes should be to strengthen the issuing criteria and ensure the powers are being used for the most serious of offending.  This should include specific consideration as to whether the offending relates substantially to: offences against the security of the Commonwealth per Chapter 5 of the Criminal Code; offences against humanity including child exploitation and human trafficking per Chapter 8 of the Criminal Code; serious drug, weapons and criminal association offences per Chapter 9 of the Criminal Code; and money laundering and cybercrime offences per Chapter 10 of the Criminal Code. These examples are not exhaustive, but designed to reflect the intention of the Bill as seen through the Explanatory Memorandum and evidence to this Committee.  This should include the nature of the offending and its relationship to other serious offences. 

Recommendation 11 ...  the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended so that the issuing authority, to the extent known, must consider the following:  consideration to third parties specifically, including their privacy;  specific consideration of privileged and journalistic information; and,  specific consideration of privacy impacts, financial impacts, and the ability of individuals to provide or receive care. 

Recommendation 12 ... the Government commission a review of Commonwealth legislation to determine whether the concepts of “serious offence”, “relevant offence” and other similar concepts:  should be made consistent across different Acts of Parliament (noting that, for example, the definition of “serious offence” in the Telecommunications (Interception and Access) Act 1979 is different to the definition of “relevant offence” in the Surveillance Devices Act 2004; and  whether the threshold for the concept of “serious offence” in all Commonwealth legislation should be – at a minimum – an indictable offence punishable by a maximum penalty of seven years’ imprisonment or more, with a limited number of exceptions. This body of work should inform the eventual electronic surveillance bill being considered by the Department of Home Affairs and other departments. 

Recommendation 13 ...  the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended so that, in order to provide an emergency authorisation for disruption of data held in a computer:  in addition to the matters set out in proposed section 28(1C) of the Surveillance Devices Act 2004, an authorising officer must be satisfied that that there are no alternative means available to prevent or minimise the imminent risk of serious violence to a person or substantial damage to property that are likely to be as effective as data disruption; and  the authorising officer must consider the likely impacts of the proposed data disruption activity on third parties who are using, or are reliant on, the target computer and be satisfied that the likely impacts on third parties are proportionate to the objective of the emergency authorisation. In addition, the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 should be amended so that, where an issuing authority declines to retrospectively approve an emergency data disruption authorisation, the issuing authority may require the AFP or ACIC to take such remedial action as considered appropriate in the circumstances, including financial compensation. 

Recommendation 14 ... the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended so that any post-warrant concealment powers must be exercised within 28 days after the relevant warrant has expired unless the AFP or the ACIC (as applicable) has obtained the approval of a superior court judge to undertake post-concealment activities at a later date. Consistent with the recommendation made by the INSLM, the superior court judge should be required to consider:  how the AFP or the ACIC (as applicable) is proposing to conceal access;  the likely privacy implications at the time and in the place where the concealment activity is proposed to occur; and  whether, in all the circumstances, the concealment activity is appropriate. In addition, and noting that the Committee did not receive evidence on concealment in relation to computer warrants, the Committee recommends that the Government consider whether the same amendment should be made in respect of computer access warrants in the Surveillance Devices Act 2004 consistent with the recommendation made by the INSLM. 

Recommendation 15 ... the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended so that:  for the purposes of proposed paragraphs 27KE(7)(b) and 27KE(12) (and any other relevant provision), a data disruption warrant may only authorise the AFP or ACIC to cause material loss or damage to other persons lawfully using a computer if the loss or damage is necessary to do one of the things specified in the warrant (i.e. it is not enough that the loss or damage is “justified and proportionate”); and  the AFP and ACIC must notify the Commonwealth Ombudsman or IGIS (as appropriate) as soon as reasonably practicable if they cause any loss or damage to other persons lawfully using a computer. The notification to the Commonwealth Ombudsman or IGIS (as applicable) must include, among other things, details of the loss or damage caused by the disruption activity and an explanation of why the loss or damage was necessary to do one of the things specified in the warrant. 

Recommendation 16 ... the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended so that the power to temporarily remove computers and other things from premises under a data disruption warrant or a network activity warrant must be returned to the warrant premises as soon as it is reasonably practicable to do so. 

Recommendation 17 ... the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 should be amended to change the reporting requirements from the agencies to the Commonwealth Ombudsman from six-monthly to annually. 

Recommendation 18 ... the Government introduce legislation to implement the Committee’s recommendations in its report on press freedom as soon as possible. In the meantime, the Committee recommends that the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended so that the issuing criteria for each of the proposed new powers requires the applicant, and the issuing authority, to consider the following matters in respect of any warrant that relates to – or may affect – a person working in a professional capacity as a journalist or a media organisation:  the public interest in preserving the confidentiality of journalist sources; and  the public interest in facilitating the exchange of information between journalists and members of the public to facilitate reporting of matters in the public interest. 

Recommendation 19  Consistent with Recommendation 2 of the Committee’s report on press freedom, the Committee recommends that the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended to require that – with respect to an application for a data disruption warrant, a network activity warrant or an account takeover warrant that is being sought in relation to a journalist or media organisation – a “public interest advocate” be appointed. 

Recommendation 20 ...  the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended to make clear the issuing criteria for an assistance orders also requires the issuing authority to be satisfied that:  the order for assistance – and not just the disruption of data – is: − reasonably necessary to frustrate the commission of the offences that are covered by the disruption warrant; and − justifiable and proportionate, having regard to (i) the seriousness of the offences that are covered by the disruption warrant and (ii) the likely impacts of the data disruption activity on the person who is subject to the assistance order and any related parties (including, if relevant, the person’s employer) and (iii) the likely impacts of the data disruption activity on other persons, including lawful computer users or clients of the person subject to the order; and  compliance with the request is practicable and technically feasible (noting that these criteria are to be found in the industry assistance measures introduced by the Assistance and Access Act 2018). 

Recommendation 21 ...  the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended to require consideration by the issuing authority, to the extent that is possible, of whether a person is, or has been, subject to other mandatory assistance orders (including mandatory assistance orders made under other Commonwealth legislation). Having regard to the covert nature of mandatory assistance orders, and the fact that it may not be possible for the issuing authority or applicant to have knowledge of previous (or even concurrent) orders, the Committee further recommends that the Government develop a mechanism to ensure that individuals and companies are not subject to multiple mandatory assistance orders unless specific consideration is given to whether, in all of the circumstances, it is reasonably necessary and proportionate. 

Recommendation 22 ...  the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended to:  impose a maximum period during with a non-emergency mandatory assistance order may be served and executed (and if the order is not served and executed within that period, the order will lapse and a new order must be sought);  require all applications for a non-emergency mandatory assistance order to be made in writing;  require all applications for a non-emergency mandatory assistance order to include, to the extent known key particulars, including the nature of the mandated assistance;  prohibit the AFP and the ACIC, unless absolutely necessary, from seeking a non-emergency mandatory assistance order in respect of an individual employee of a company (i.e. assistance should only ever be sought from the company or business);  set out the process that must be followed in respect of the service of a non-emergency mandatory assistance order on the specified persons, and link the commencement of an order to the date and time of service; and  require that an issuing authority consider whether a person is, or has been subject, to a non-emergency mandatory assistance orders (including mandatory assistance orders made under other Commonwealth legislation). 

Recommendation 23 ... the Government make clear that no mandatory assistance order, including those defined in the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020, can ever be executed in a manner that amounts to the detention of a person. 

Recommendation 24 ...  the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended to introduce good faith immunity provisions for both assisting entities and those employees or officers of assisting entities who are acting in good faith with an assistance order. 

Recommendation 25 ... the Explanatory Memorandum to the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended to make it clear that decisions under the proposed new powers are not excluded from judicial review under the Administrative Decisions (Judicial Review) Act 1977 (ADJR Act). For the avoidance of doubt, the Committee believes that no decision made in relation to data disruption warrants, network activity warrants and account takeover warrants should be exempt from judicial review under the ADJR Act. 

Recommendation 26 ... proposed paragraph 27KA(3)(b)ofthe Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended to provide that the statement of facts and grounds accompanying all applications for data disruption warrants must specify the following matters to the extent that is possible:  the acts or types of acts of data disruption that are proposed to be carried out under the warrant;  the anticipated impacts of those specific acts or types of acts of disruption on the commission of the relevant offence (that is, how they are intended to frustrate that offence); and  the likelihood that the relevant acts or types of acts of disruption will achieve that objective. 

Recommendation 27 ... the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended so that only individuals who satisfy the following requirements may apply for a data disruption warrant or an account takeover warrant:  the person is a law enforcement officer in relation to the AFP or ACIC (as applicable) within the meaning of section 6A of the Surveillance Devices Act 2004;  the person has been individually approved, by written instrument made by the AFP Commissioner or ACIC CEO (as applicable) to apply for data disruption warrants; and  the relevant agency head is satisfied that the person possesses the requisite skills, knowledge and experience to make warrant applications, and the person has completed all current internal training requirements for making such applications. 

Recommendation 28 ...  paragraph 27KC of the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended so that, rather than a judge having to be satisfied, that a data disruption warrant would be “justifiable and proportionate”, the judge must be satisfied, to the extent possible at the time an application is made, that a data disruption warrant is:  reasonably necessary to frustrate the commission of the offences referred to in the warrant application; and  proportionate, having regard to: − the specific nature of the proposed disruption activities; − the proportionality of those activities to the suspected offending; − the potential adverse impacts of the disruption activities on non- suspects; and − the steps that are proposed to be taken to avoid or minimize those adverse impacts, and the prospects of those mitigating steps being successful. 

Recommendation 29 ... the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 and the IGIS Act be amended to make it clear that staff members of the Australian Signals Directorate are subject to IGIS oversight if they are seconded to the AFP or ACIC to execute a data disruption warrant for and on behalf of the AFP or ACIC. 

Recommendation 30 ... the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended to strengthen the issuing authority considerations for network activity warrants, including by amending the definition of a “criminal network of individuals” to require there to be a reasonable suspicion of a connection between:  the suspected conduct of the individual group member in committing an offence or facilitating the commission of an offence; and  the actions or intentions of the group as a whole. 

Recommendation 31 ... the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended to clarify that a decision-maker, and the issuing authority, must consider the privacy implications to the extent they are known, of a proposed network activity warrant. To be clear, the committee does not believe that privacy considerations should be determinative in their own right, just that they should be considered. 

Recommendation 32 ... the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020  be amended to require a sworn affidavit setting out the grounds of an application for an account takeover warrant (consistent with the delayed notification search warrants in the Crimes Act). 

Recommendation 33 ... the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be amended to require an issuing authority to consider, to the extent that is possible at the time the application is made, whether a proposed account takeover warrant is likely to have an adverse impact on third parties, including a specific requirement to assess the likely:  impacts on personal privacy;  financial impacts on individuals and businesses;  impacts on a person’s ability to conduct their business or personal affairs; and  impacts on a person’s ability to have contact with family members or provide or receive care. 

Recommendation 34  ... the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020 be passed, subject to the amendments outlined above.

Freedom

'The Meaning of Academic Freedom: The Significance of Ridd v James Cook University' by Adrienne Stone in (2021) 43 Sydney Law Review 241 comments 

The case of Ridd v James Cook University raises important questions as to the content and scope of the principle of academic freedom, and its application to public criticism of academic research and university governance. It presents a rare opportunity for the High Court of Australia to consider the legal content of the principle of academic freedom, and the outcome of the case will likely be very significant for Australian universities. This article provides a principled foundation to suggest that James Cook University’s termination of Professor Ridd contravened critical and widely accepted aspects of the principle of academic freedom. It takes issue with the majority decision of the Full Federal Court of Australia under appeal on two bases. First, it suggests that the majority paid insufficient regard to the principle of academic freedom, which should properly have informed the interpretation of the provisions of the relevant university enterprise agreement relating to ‘intellectual freedom’. Second, given the requirements of the principle of academic freedom and the principle’s centrality to the purposes of a university, the particular provision that protects ‘intellectual freedom’ should have been understood, in some circumstances, to take priority over the code of conduct that Ridd was found to have breached.

ISDS and COVID

'Compulsory licences and ISDS in Covid-19 times: relevance of the new Indian investment treaty practice' by Prabhash Ranjan in (2021) 16(7) Journal of Intellectual Property Law & Practice 748–759 comments 

As the world grapples with the Coronavirus disease (Covid-19)—the worst pandemic in the last 100 years—war-like efforts are being made to find a vaccine or a cure for the disease.  Indeed, a few newly developed Covid-19 vaccines have already been approved for public use.  At the same time, given the concerns of vaccine nationalism—countries pushing to get first access to Covid-19 vaccines —many are filled with consternation about the timely and equitable access to medicines and vaccines. This concern has been outlined by countries like India and South Africa who in their recent proposal to the World Trade Organization (WTO) state: ‘As new diagnostics, therapeutics and vaccines for COVID-19 are developed, there are significant concerns, how these will be made available promptly, in sufficient quantities and at an affordable price to meet global demand.’ 

To ensure timely and equitable access to Covid-19 vaccines, drugs, and diagnostics, India and South Africa have proposed that, following Articles IX.3 and IX.4 of the Marrakesh Agreement establishing the WTO, certain provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement6 be temporarily waived or suspended to allow the prevention, containment, or treatment of Covid-19. Such a temporary suspension of the application of the TRIPS Agreement would give complete regulatory freedom to countries to deal with the production and distribution of Covid-19 vaccines, drugs, diagnostics without being concerned about the enforcement and protection of intellectual property rights. This radical proposal stems from the assumption that intellectual property rights such as patents, in certain circumstances, could act as barriers to accessibility of drugs and medicines. Several least developed and developing countries have endorsed the proposal at the WTO, while developed nations are not in favour. 

Nonetheless, there is a consensus that countries need to collaborate to ensure timely and equitable distribution of drugs, vaccines and diagnostics for the treatment of Covid-19. To accomplish this objective various regulatory tools can be used in a manner that is consistent with the existing international law on intellectual property rights.  This is especially relevant because several patent applications have already been filed for Covid-19 vaccines. 

An important regulatory tool in this regard is a compulsory licence (CL)—the granting of a licence by a government to a third party to use the patent without the consent of the patent holder after paying a government-determined royalty to the patent owner.  The possibility of issuing a CL is significant flexibility in the patent regime, especially in the context of pharmaceutical patents, because it allows governments to address public health needs by ensuring the availability of patented medicines at low-cost prices to those who cannot afford them. 

Some countries have taken steps in this direction by adopting laws to expedite the issuance of CLs.14 Canada enacted a Covid-19 Emergency Response Act,  through which it amended the Patent Act to accelerate the process of issuing CLs for public health purpose.  Likewise, Chile adopted a resolution pronouncing that the Covid pandemic is a strong ground to validate the issuance of CL on Covid-19 related technologies.  Ecuador has also adopted a resolution requiring the national government to establish compulsory licences and adopt other measures to ensure free and inexpensive access to medicines and other medical technologies to combat the Covid-19 pandemic.  Germany, Europe's largest economy, has also passed legislation, the Prevention and Control of Infectious Diseases in Humans Act, which empowers the health ministry to issue government use authorization under the patent law, after the declaration of a national epidemic by Bundestag, German federal legislature’s lower chamber. Israel has already issued a CL for the importation of Kaletra (lopinavir 200 mg/ritonavir 50 mg) for the treatment of Covid-19 patients. 

In India too, several commentators have identified the prominence of CL for realizing public health objectives.  Already demands have been made for the issuance of CL on drugs like remdesivir to augment its accessibility for Covid-19 patients.  The potential use of CL as a regulatory tool in Corona times might go up further as Covid-19 vaccines become available. India, which is often called the pharmacy of the world, might have an important role to play in ensuring supplies of vaccines and drugs to various countries such as in Latin America. 

Given this background of the rising importance of CL, from the perspective of states, it is imperative to understand what kind of legal challenges they can face if they make use of this regulatory tool. This question becomes even more important because patent owners, when it comes to drugs and medicines, in a large number of cases, are pharmaceutical companies who zealously protect their intellectual property. 

One obvious option for these companies will be to challenge the issuance of such CLs under the domestic laws of the country concerned. Another choice that many foreign pharmaceutical companies might like to employ, under international law, is to challenge the issuance of such CLs before investor-State dispute settlement (ISDS) tribunals. These ISDS tribunals derive their authority from bilateral investment treaties (BITs)  or investment chapters of free trade agreements (FTAs). These BITs or investment chapters in FTAs allow foreign investors to directly bring claims against host States for alleged treaty breaches before ISDS tribunals—a three-member ad hoc arbitration tribunal—often without exhausting local remedies.  Intellectual property rights (IPRs) in these treaties are listed as investments.  Consequently, ISDS tribunals have jurisdiction over regulatory measures that impair the investor’s IPRs. This allows pharmaceutical companies to enforce their IPRs through the ISDS mechanism. 

Indeed, in the last few years, foreign investors have employed the ISDS regime to challenge the host State’s regulatory measures relating to IPRs.  For example, Eli Lily, an American pharmaceutical company challenged the invalidation of its patent by a Canadian federal court on the ground of ‘inutility’.  Philip Morris, a tobacco company, challenged Australia’s legislation mandating plain packaging of tobacco products under the Hong Kong–Australia BIT.  Philip Morris also brought a similar claim against Uruguay under the Switzerland–Uruguay BIT. Accordingly, the possibility of pharmaceutical companies challenging the issuance of CL before ISDS tribunals is real, not conjectural. 

International investment lawyers have pointed out that foreign investors can challenge the issuance of CL before an ISDS tribunal on the ground that it amounts to an indirect expropriation of their investments. In other words, foreign investors can argue that the issuance of a CL has led to substantial deprivation of their investment, thus constituting indirect expropriation under international investment law. As Bryan Mercurio argues, the prospect of challenging the issuance of CLs as expropriation before an ISDS tribunal is an attractive proposition for a patent holder for several reasons.  First, it allows the patent holder to directly bring about a claim before an international tribunal bypassing the domestic courts of the host country. Secondly, if the claim were successful, it would provide higher compensation to the patent holder than what the host State would pay to her as remuneration for issuing the CL (see also Section II.2). 

Whether the foreign investor will succeed in such a claim will depend on various factors, such as the duration for which the CL has been issued, whether the royalty paid to the patent owner is satisfactory, what impact the issuance of the CL had on the patent owner’s overall investment in the host State, what is the language of the treaty provision on expropriation in the BIT, whether the treaty permits deviation from the substantive treaty provisions like expropriation for public health purposes etc.36 Nonetheless, since IPRs are recognized as investments in BITs, the critical point is that foreign investors can bring such claims before ISDS tribunals. Thus, ISDS tribunals will enjoy jurisdiction to decide whether the issuance of a CL amounts to indirect expropriation or not. Foreign investors can also contest the issuance of a CL as a violation of the fair and equitable (FET) provision—a ubiquitous clause present in all BITs or other substantive provisions like national treatment. 

The purpose of this article is to closely examine India’s investment treaty practice  to see whether it provides a safe haven for the issuance of CLs from foreign investor's claims for treaty breaches before an ISDS tribunal. In case a BIT or an investment chapter of an FTA exempts the issuance of CLs from the ambit of the substantive treaty standards, it would imply that the host State has greater regulatory autonomy to make use of CLs in the current times without worrying about ISDS claims. A survey of Indian BITs and FTA investment chapters shows that in the bulk of these treaties there is no specific mention of excusing the issuance of CLs from the application of the treaty's substantive standards. In other words, if a foreign investor contests the issuance of a CL as a breach of any of the substantive provisions of the BIT, the outcome of such a challenge will depend on the numerous factors mentioned before. 

However, there are some Indian BITs and FTA investment chapters that exempt the issuance of CLs from the application of the substantive treaty standards. In this article, we study such investment treaties by dividing the discussion into two parts. First, the article, in Section II, discusses those Indian BITs and FTA investment chapters where issuance of CL is outside the ambit of the expropriation provision. Next, the article, in Section III, focuses on the new Indian investment treaty practice, starting from the 2016 Indian model BIT,  which provides that issuance of CL is outside the scope of the entire BIT. Section IV concludes by arguing that India's recent treaty practice provides greater regulatory bandwidth to States in Covid-19 times to pursue public health objectives should countries wish to use CLs as the regulatory tool to increase accessibility of Covid vaccines and drugs. Thus, India’s new investment treaty practice holds some lessons for other countries to deal with ISDS claims challenging the issuance of CLs. However, before discussing the treaty practice, Section I provides an overview of the Indian patent law on the issuance of CLs.

Justice Data

‘Justice system data’: a comparative study (A report examining how Canada, Australia and Ireland manage the data and information that is generated by their justice systems) by Judith Townend and Cassandra Wiener for The Legal Education Foundation (TLEF) analyses 

the ways in which ‘justice system data’ – that is the information generated by the process of justice – is managed in three countries: Australia, Canada and Ireland. It considers how data-sharing methods are perceived to relate to judicial independence, innovation, and public understanding and confidence in the justice system. ... the report builds on previous TLEF work on justice data in England and Wales, and aims to inform UK-based policy making as well as knowledge exchange in international legal and technology networks. 

The research

identified that:

• There is a common understanding and definition of ‘justice system’ data types and access in the three case studies of Australia, Canada and Ireland, though in all contexts justice data management has evolved messily over time (with emergency measures during the COVID-19 period) rather than as the result of purposive design. 

• Improved access to justice data is perceived by legal, academic and NGO stakeholders to help deliver access to justice, and protect important principles of open justice, judicial independence and public understanding of the law, and is part of these countries’ work to meet access to justice policy objectives, including UN Sustainable Development Goal 16. 

• In opening up justice data, challenges and tensions across the jurisdictions were also exposed: the impact of legacy practices; the under-investment and decentralised approach to technological reform; a data deficit for user and case experience; a tension between privacy and transparency in the provision of court records containing personal data; and a lack of accountability measures for the management of justice system data. 

• There is limited robust empirical data with which to measure the impact of justice sharing and access methods against desirable outcomes for a justice system.

In light of the findings, we argue that there is a need for:

• Clearly presented policies, shared publicly, on the differing roles for executive, court service, judiciary and any third-party providers in the management of justice system data. 

• Accountability mechanisms for access to justice data: i.e. appropriate routes of application and appeal for accessing justice data that is not readily available in the public domain. 

• Consideration of public and court user views and experiences in the design of justice system data processes (especially with regard to the use of personal data). 

• Detailed measurement of the impact of data sharing practices on outcomes of the justice system.

The authors comment 

 Contemporary justice systems are complex and messy as a result of anachronistic structures and rules that have evolved since the medieval period; they have not been neatly designed to fulfil specific purposes and protect individual or collective interests (even if these purposes and interests are now cemented and protected in national and international law). Inevitably, this means ‘justice system data’ – that is the information generated by the process of justice – is equally complex and messy, with a hybrid of policies and laws governing its collection, storage and dissemination. The transition from analogue and paper-based systems to digital technological methods, with some aspects fast-tracked during the COVID-19 pandemic period, has only further complicated the picture. Despite the importance of reliable data for the purposes of understanding law and legal process, for the development of evidence-based justice policy, and for meeting the objectives of fair and open justice, the theory and practice of justice system data management are rarely the primary focus of academic and policy attention, and often incidental to a broader discussion about an aspect of law. There are, of course, notable exceptions. A previous report on digital justice in England and Wales by The Legal Education Foundation (TLEF) identified data needs within the English justice system and urged the creation of a robust strategy for data collection, analysis and sharing, with 29 specific recommendations, which HM Courts and Tribunals Service (HMCTS) responded to in October 2020. More recently, the Civil Justice Council/TLEF review of the use of remote civil courts during the COVID-19 pandemic highlighted the data gaps on civil justice, and re-iterated the need for the expansion of data collection, and investment in robust data systems. 

In order to further explore this area, we were commissioned by TLEF as part of its ‘Smarter Justice’ programme, which includes developing a Justice Lab UK, to undertake a short-term comparative study considering the ways in which justice system data is managed in different countries, focussing on English-speaking common law jurisdictions. The overall objectives of this study were to consider how current approaches and past experiences can inform the development of justice data systems in other contexts. The research took place from May–August 2020, conducted remotely during the COVID-19 restricted period. 

We contend that while part of a broader agenda on open data and access to administrative data, justice system data deserves its own particular and special treatment, owing to the particular constitutional principles underpinning its generation and use, such as a separation of powers between judiciary and executive. 

Within the scope of this project we cannot promise a complete overview of each of the chosen countries; as we peeled back the layers of the chosen jurisdiction, we discovered further layers of complexity and idiosyncrasy, as we attempted to understand the handling of justice system data within the federal or national level courts, the state or province level courts, and within these, between different court types and jurisdictions (civil, criminal, family, tribunal). Even within a court ‘type’ in a single regional jurisdiction, there may be differences in practice and policy. We have, however, attempted to set out a more thorough comparative review than currently exists in the academic and policy literature. Our review focuses on Australia, Canada and Ireland, with some reference to other global and national initiatives. Our goal is to inform policy development in England and Wales and beyond but as one of our interviewees advised, we do not attempt to set universal recommendations or standards at this point. Instead we focus on evidencing and explaining the principles and practice of existing systems and drawing conclusions on what has and has not worked in the regions we studied, highlighting good practice examples. We hope these conclusions can be drawn upon to inform future justice data governance in England and Wales, where some of the recommendations of ‘Digital Justice: HMCTS Data Strategy and Delivering Access to Justice’ (Byrom, 2019) are already being progressed, as well as to assist initiatives in other countries and at a global comparative level. 

1.2 The brief and our approach 

Our brief asked us to consider: 

1 How other countries define ‘justice system data’. What are the categories they use to describe the different types of data generated by the justice system? This includes information like case files, judgments, management information, tribunal decisions etc. 

2 What arrangements are in place for making this data available to different stakeholders (public/press/researchers/private sector) and how are they financed? To what extent have other countries delegated the function of data dissemination to the private sector? 

3 Where have other countries placed different types of data on the open/shared/closed spectrum? Are these arrangements time limited, e.g. closed until x date? 

4 What have been the benefits and drawbacks of the approaches developed in these countries? We are particularly interested in identifying robust research that is capable of demonstrating a link between the types of sharing practices adopted and: a. judicial independence b. public understanding of the law c. public confidence in the justice system d. innovation e. the attractiveness of the legal system as a forum for resolving disputes. 

In order to answer these questions, via literature review and remote interviews, we have structured our report as follows. Following this introduction, which includes a description of the methodology of the report, Chapter 2 gives more detailed context for the report, providing a definition of ‘justice system data’; details of global initiatives on improving justice data; the risks and safeguards for managing justice data; and an overview of justice system data in England and Wales. Chapters 3, 4 and 5 describe our main case studies, the justice systems in Australia, Canada and Ireland, considering the questions above for selected courts in each jurisdiction, and other relevant issues that emerged in the course of the research. Chapter 6 offers a comparative and critical analysis of all three case studies, with some reference to other jurisdictions, including England and Wales; and makes some general conclusions and recommendations of good practice for policymaking and practice in this area (while not attempting to draft universal standards). The Appendices offer a list of key resources and information about our interviewees. 

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Speech

'Defamation Actions and Australian Politics' by Michael Douglas in (2021) 5 UNSW Law Journal Forum comments 

 In recent years, politicians have been frequent participants in Australian defamation litigation. Attorney-General Christian Porter’s recent claim against the Australian Broadcasting Corporation and journalist Louise Milligan is a notable example of the weaponisation of defamation in Australian politics. This article reviews prominent examples of where politicians have commenced or threatened defamation proceedings. The article also considers whether the trend of politicians litigating defamation is desirable, and how it will be affected by the amendment of the Uniform Defamation Acts once the Model Defamation Amendment Provisions 2020 are implemented. 

Douglas argues 

In recent years, politicians have been frequent participants in Australian defamation litigation. Attorney-General Christian Porter’s recent claim against the Australian Broadcasting Corporation (‘ABC’) and journalist Louise Milligan  is a notable example of the weaponisation of defamation in Australian politics. This brief article reviews prominent examples of where politicians have commenced or threatened defamation proceedings. The focus is on cases in which politicians are plaintiffs, although some cases mentioned below also involve politician defendants.  The article considers whether the trend of politicians litigating defamation is desirable, and how it will be affected by the amendment of the Uniform Defamation Acts once the Model Defamation Amendment Provisions 2020 are implemented. It begins by considering the value of politicians’ reputations, which defamation law may protect. 

 ‘Reputation’ is a multi-faceted concept at the heart of defamation law.  The value of a person’s is bound up with their honour and dignity, and their standing in society.  Australian defamation law protects the value of a person’s interest in their reputation by providing that publication of matter about a person that damages their reputation, is actionable.  If reputation is what society generally thinks of a person,  then every one of us who is part of the community has a reputation. Politicians are no different. Politicians’ reputations may be different to those of ‘regular people’ in some respects. First, a politician derives an income from their reputation in a way that many (but not all) individuals do not. While impact on a person’s employment may sound in special damages that would be unavailable to a person whose employment was not affected by defamation,  the High Court has confirmed that the general test for defamation applies to professional and non-professional reputations alike. 

Second, politicians’ reputations are bound up with their work in political institutions. We judge politicians by their ability to deliver on promises, their integrity, and how their expressed values align with their lived values.  Our system of representative government depends on politicians’ accountability to the public. Thus, some criticism of public officials is to be expected or even welcomed. Arguably, the public is less likely to take a derogatory comment about a politician to heart; people understand that politicians will be criticised no matter what.  However, insofar that Australian law protects freedom of speech in order to keep leaders accountable, its focus is on the subject matter rather than the person.  The freedom of political communication implied in the Commonwealth Constitution is narrowly confined to certain political speech. The so-called ‘Lange qualified privilege’  underpinned by that freedom is narrow in its operation,  as some of the cases below illustrate. 

Third, putting aside their financial incentives, politicians may have a stronger incentive to sue over defamation than other would-be plaintiffs. Perception is critical to a politician maintaining their standing in the system and grip on power. Several Australian politicians have resigned in the wake of allegations of impropriety.  Although truth provides the foundation of a justification defence for a person publishing an allegation of impropriety,  the mere threat of defamation litigation may be enough to sway some to believe that any allegations were unfounded. The mention of defamation by a politician can signal to the electorate that damaging publications are merely ‘fake news’. The frequency of defamation litigation involving politicians shows that many perceive defamation law as providing a powerful political weapon.

Memory

'Amazon Echo Dot or the Reverberating Secrets of IoT Devices' by Dennis Giesse and Guevara Noubir in Proceedings of Conference on Security and Privacy in Wireless and Mobile Networks, Abu Dhabi, United Arab Emirates, June 28–July 2, 2021 (WiSec ’21),comments 

Smart speakers, such as the Amazon Echo Dot, are very popular and routinely trusted with private and sensitive information. Yet, little is known about their security and potential attack vectors. We develop and synthesize a set of IoT forensics techniques, apply them to reverse engineer the hardware and software of the Ama- zon Echo Dot, and demonstrate its lacking protections of private user data. An adversary with physical access to such devices (e.g., purchasing a used one) can retrieve sensitive information such as Wi-Fi credentials, the physical location of (previous) owners, and cyber-physical devices (e.g., cameras, door locks). We show that such information, including all previous passwords and tokens, remains on the flash memory, even after a factory reset. This is due to the wear-leveling algorithms of the flash memory and lack of encryption. We identify and discuss the design flaws in the storage of sensitive information and the process of de-provisioning used devices. We demonstrate the practical feasibility of such attacks on 86 used devices purchased on eBay and flea markets. Finally, we propose secure design alternatives and mitigation techniques.