18 December 2020

GMP and Cannabis Manufacturing

The TGA consultation paper Potential reforms to medicinal cannabis manufacturing, labelling and packaging requirements states 

 The Therapeutic Goods Administration (TGA) is seeking feedback on proposed reforms to the regulation of medicinal cannabis manufacturing, labelling and packaging. The reforms are principally intended to enhance the quality and safety of medicinal cannabis products by introducing equivalent GMP requirements for imported and domestic medicinal cannabis, introducing labelling requirements for imported medicinal cannabis, clarifying certain matters in the applicable standard, and requiring child-resistant closures to be used on products. ... 

Over recent years, there has been increasing interest in the use of medicinal cannabis. Governments at Commonwealth, State and Territory levels have implemented legislative and policy changes to allow the cultivation, manufacture and supply of medicinal cannabis for patients in Australia. 

Representation of active ingredients, amendments to labelling requirements and reporting of heavy metal results 

Regulation of medicinal cannabis in Australia 

The Department of Health, through the TGA and the Office of Drug Control (ODC), regulates the manufacture, importation, exportation and supply of medicinal cannabis in Australia. 

The Office of Drug Control (ODC) administers the Narcotic Drugs Act 1967. The Narcotic Drugs Act gives effect to Australia’s international obligations under the Single Convention on Narcotic Drugs (1961), and provides controls to prevent the diversion and illicit use of narcotic drugs. Principally, the Narcotic Drugs Act establishes a licensing and permit system for the cultivation, production and manufacture of cannabis (and cannabis resin) for medicinal purposes. 

The ODC also administers the Customs (Prohibited Imports) Regulations 1956 and the Customs (Prohibited Exports) Regulations 1958 to control the importation or exportation of cannabis or cannabis resin. Under these Regulations, importers and exporters require licences and permits. The TGA administers the Therapeutic Goods Act 1989. The Therapeutic Goods Act establishes a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods in Australia. The general rule is that therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) or otherwise subject to an exemption, approval or authority before those goods may be lawfully supplied in, imported into, or exported from Australia. 

Therapeutic goods that are not included in the ARTG are known as ‘unapproved products’. Most medicinal cannabis products are unapproved products, which means that they are not included in the ARTG and have therefore not been evaluated by the TGA for quality, safety, or efficacy. The Therapeutic Goods Act provides a number of mechanisms to enable access to unapproved products, such as medicinal cannabis. These products may be accessed through the following pathways:

• Authorised Prescriber Scheme (AP) 

• Special Access Scheme 

• Clinical trials.

In addition to these controls, the regulation of medicinal cannabis under the Therapeutic Goods Act includes the scheduling of cannabis substances, the application of certain quality standards (most notably, TGO93) and the licensing of manufacturers under Part 3-3. Each of these matters is discussed further below. 

The proposed reforms should not be interpreted to imply that there are concerns with the general quality of medicinal cannabis products currently supplied in Australia. The proposed reforms would extend equivalent manufacturing standards for medicinal cannabis products (applied in Australia to licence holders under Part 3-3 of the Therapeutic Goods Act) to imported medicinal cannabis products. 

The objective would be to provide greater assurance for medical practitioners and patients regarding the quality and safety of medicinal cannabis products that are imported and supplied in Australia. The proposed reforms would also seek to provide clarity to the stated content of active ingredients and further clarity on the quality standard and to introduce the requirement for child-resistant closures in the interest of public safety. 

Quality standard measures 

The TGA is responsible for specifying standards for medicinal cannabis products imported, produced and/or utilised in Australia. Standards are made under section 10 of the Therapeutic Goods Act and may be specified by reference to the quality of the therapeutic goods, or the procedures to be carried out in the manufacture of the therapeutic goods, among other matters. Therapeutic Goods Order (TGO) 93 is a standard for medicinal cannabis products that provides appropriate regulatory controls to enable medicinal cannabis products and the ingredients used in the manufacture of those products to meet minimum quality requirements. 

TGO 93 applies to both domestic and overseas manufacturers to enable all medicinal cannabis products imported, manufactured or supplied in Australia meet the quality controls provided by the standard. In practice, TGO 93 ensures consistency and provides assurance to medical practitioners and patients that medicinal cannabis products manufactured in accordance with the standard meet minimum quality requirements. TGO 93 includes requirements in relation to physical and chromatographic identification, assay tolerances, decontamination treatment, and tests for certain impurities. 

There are criminal offences and civil penalties provisions that apply under the Therapeutic Goods Act to persons who import, export or supply therapeutic goods that do not conform to an applicable standard. Unless the Secretary of the Department of Health has given consent in relation to the importation, exportation or supply of particular medicinal cannabis products, those products must conform to the applicable standard. ... 

Manufacture of medicinal cannabis Domestic manufacture of medicinal cannabis 

To manufacture medicinal cannabis in Australia, a manufacturer must obtain:

• licences and associated permits under the Narcotic Drugs Act from ODC 

• a GMP licence under Part 3-3 of the Therapeutic Goods Act 

• relevant state or territory government licences or approvals.

A manufacturing licence under the Narcotic Drugs Act is granted on the condition that the medicinal cannabis is only supplied in particular circumstances (see current sections 11K and 12L of the Narcotic Drugs Act 1967). 

A GMP licence is granted on the condition that the manufacturer conforms to any applicable standard that applies in relation to the goods (to which the licence is issued). It is also granted on the condition that the manufacturer complies with the manufacturing principles determined by the Minister under the Therapeutic Goods Act. The manufacturing principles provide that applicable procedures and requirements in the Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practices for Medicinal Products (version 14, 1 July 2018) (PIC/S Guide to GMP) must be observed in the manufacture of certain therapeutic goods. 

There are exemptions from the requirement to hold a GMP licence in some circumstances, including in relation to the manufacture of certain starting materials and in relation to certain specified persons, such as medical practitioners and pharmacists (see Schedules 7 and 8 to the Therapeutic Goods Regulations). 

Inspections 

GMP inspections are performed to ensure the manufacturer is conforming to applicable standards and complying with the relevant manufacturing principles (PIC/S Guide to GMP). ... 

GMP clearance and certification for overseas manufacturers of products on the ARTG 

A GMP licence is only required in relation to the manufacture of therapeutic goods at Australian manufacturing sites. 

A GMP licence is not required in relation to the manufacture of therapeutic goods at manufacturing sites outside Australia. In those situations, the sponsor must obtain a GMP clearance for the overseas manufacturing site before the goods may be included in the ARTG. This can be done through three different pathways: 

• Mutual Recognition Agreement (MRA) desktop assessment 

• Compliance Verification (CV) desktop assessment 

• TGA on-site inspection (GMP certification)

GMP certification is usually requested if it is not possible to obtain GMP clearance via the MRA or CV pathways (for example, due to lack of evidence). GMP certification applications are required to be submitted by the Australian sponsor or an agent acting on the Australian sponsor's behalf. 

Obtaining GMP Clearance is necessary in the context of an application to include medicines in the ARTG that have been manufactured overseas, as the TGA must evaluate whether the manufacturing and quality control procedures used in the manufacture of such goods are acceptable. GMP clearance assesses requested evidence from a recognised regulatory agency as well as procedure and records from the manufacturer. 

However, GMP clearance is not required where medicinal cannabis products are manufactured overseas and supplied as unapproved products via the SAS B, AP or clinical trial pathways. Therefore, while domestic medicinal cannabis products must be manufactured in accordance with licences issued under the Narcotic Drugs Act and the Therapeutic Goods Act, medicinal cannabis products manufactured overseas and supplied as unapproved products are only required to demonstrate conformity with TGO 93. The options outlined below seek to address this uneven treatment of domestically and overseas manufactured medicinal cannabis products. 

Australian manufacturing licences and overseas GMP certification guidance provides more information about the process for applying for a manufacturing licence or GMP certification. 

Current situation with manufacturing quality (GMP) of imported cannabis 

Under the Customs (Prohibited Imports) Regulations, all forms of cannabis, cannabis resins, extracts (including extracts from hemp) and cannabinoids require a licence and permit to import to Australia. Ordinarily, the importer would apply for an import permit with a declaration of reason of import and product use. The application would include evidence provided to ODC in relation the relevant SAS B approval or authorised prescriber authority. Where the sponsor is a manufacturer, evidence of licensing under the Narcotic Drugs Act is also required. 

Importantly, the import permit process does not require verification as to compliance with the manufacturing principles or equivalent GMP in the manufacture of the imported goods.

AI and EU Intellectual Property Policy

The European Commission report Trends and Developments in Artificial Intelligence: Challenges to the IPR Framework by Christian Hartmann, Jacqueline Allan, P. Bernt Hugenholtz, Joao Pedro Quintais and Daniel Gervais states

This Report examines the state of the art of copyright and patent protection in Europe for AI- assisted outputs in general and in three priority domains: science (in particular meteorology), media (journalism), and pharmaceutical research. “AI-assisted outputs” are meant as including productions or applications generated by or with the assistance of AI systems, tools or techniques. 

As the state of the art reviewed demonstrates, the use of AI systems in the realms of culture, innovation and science has grown spectacularly in recent years and will continue to do so. AI systems have become almost ubiquitous in meteorology and in pharmaceutical research and are making deep inroads into media and journalism. Outside these distinct domains, AI systems are being used to generate diverse literary and artistic content, including translations, poems, scripts, novels, photos, paintings, etc. Likewise, a wide variety of innovative and inventive activity relies on AI systems for its development and deployment, from facial recognition to autonomous driving. 

While AI systems have become – and will become – increasingly sophisticated and autonomous, this Report nonetheless assumes that fully autonomous creation or invention by AI does not exist, and will not exist for the foreseeable future. We therefore view AI systems primarily as tools in the hands of human operators. For this reason, we do not enquire whether AI systems should one day be accorded authorship or inventorship status under future IP Law. We also do not examine the IP protection of AI systems per se; legal issues concerning the input of protected subject matter into AI systems (e.g. for text-and-data mining); nor algorithmic moderation or enforcement of IP subject matter, as these topics are beyond the scope of this analysis. Analysis of legal protection regimes beyond copyright and patent law (e.g. trade secrets, unfair competition and contract law) is also outside the terms of reference. An important trend that does emerge from the state of the art review is that more and more AI capability is being offered “as a service” rather than as “bespoke” (tailored) AI systems. Consequently, the emphasis of our analysis is on the users (operators) of AI systems, rather than on their developers. 

This Report provides an assessment of the state of the art of uses of AI in the three priority domains and a legal analysis of how IP laws currently apply to AI-assisted creative and innovative outputs. The Report concludes with recommendations regarding possible revision of IP law at the European level. 

State of the Art in Uses of AI 

There is no universally accepted definition of AI. At a high level, it can be defined as “computer- based systems that are developed to mimic human behaviour” or a “discipline of computer science that is aimed at developing machines and systems that can carry out tasks considered to require human intelligence, with limited or no human intervention.” 

In pharmaceutical research, AI is finding patterns within large data sets and helping to automate the search process. Based mostly on machine learning, AI is assisting in disease diagnoses, predictions of drug efficacy and identification of drug characteristics (e.g. toxicity). Neural networks enable compound discovery, personalised medicine and drug repurposing. AI is being applied in finding molecular drug targets (e.g. proteins, nucleic acids) by searching through libraries of candidates, accelerating the high throughput screening needed to find a candidate substance for further investigation in drug development. It is helping in repurposing of drugs to meet new or different need, in polypharmacology (where a disease is due to multiple malfunctions of the body) and to find and accelerate the development of vaccines (by both gene sequencing and simulations of vaccines). In these processes, some measure of human intervention is usually required, either at the start or throughout the entire process, with human feedback optimising the steps. 

In recent years, there has been increasing cooperation between the pharmaceutical industry and AI companies. Some companies pursue an active IP strategy and file patents in both the domains of pharmaceutical and AI technology while others sell services confidentially to pharmaceutic companies. 

In the area of science, the Report examines meteorology as one of the main application areas where AI is already routinely used. Meteorology predicts the state of the atmosphere, at a certain time in a certain place or over a specific area, based on historical data and knowledge of climate and the atmosphere. Automated tasks include post-processing of weather data; predictive analytics for future forecasts; bias correction of meteorological observations; parameterisation of models to correct for radiation, turbulence, cloud microphysics, etc.; data assimilation; and local downscaling of model outputs to improve predictions. 

Weather forecasts rely on vast quantities of data. The ability of machine learning to extract knowledge from complex and extensive databases makes it particularly suitable for numerical weather forecasting. Some companies support media companies in weather reporting and forecasting, providing high-precision, precise weather forecasts in multiple formats daily, including recordings, to suit the various reporting media. 

In journalism, AI enables automated aggregation, production and distribution of content (data, text, images, audio or video). Assistive technologies support journalists in the creation of media content, including speech recognition, information extraction, clustering, summarising, and machine translation capabilities for multi-lingual access to sources. Generative technologies produce media content with human intervention limited to inputting the data set, defining output specifications, and quality control. Distributing technologies encompass the publication or other forms of communication (e.g. through chat bots) of automatically created content with the help of algorithms.  

Several companies currently offer technologies for automated content creation for uses in diverse areas including describing product, summarising patient notes in hospitals, reporting on sports events, reporting share prices and customising local information on property markets. Other companies have in-house capabilities for automated news generation. Know-how is commonly protected through licensing models, rather than asserting ownership of IP. It also relies on the tacit knowledge within a company, with the knowledge on how to develop customer-specific systems acting as a high barrier to competitors looking to enter the market. 

Legal Analysis under EU Copyright and Patent Laws 

The legal analysis examines whether, and to what extent, AI-assisted outputs are protected by European copyright law, related rights or patent law. For copyright, the analysis is concentrated on the so-called EU copyright acquis and its interpretation by the Court of Justice of the EU (CJEU). The patent analysis concentrates on the European Patent Convention (EPC).

EU Copyright Law 

As our inquiry into EU copyright law reveals, four interrelated criteria are to be met for an AI- assisted output to qualify as a protected “work”: the output is (1) a “production in the literary, scientific or artistic domain”; (2) the product of human intellectual effort; and (3) the result of creative choices that are (4) “expressed” in the output. Whether the first step is established EU law is however uncertain. Since most AI artefacts belong to the “literary, scientific or artistic domain” anyway, and are the result of at least some “human intellectual effort” (however remote), in practice the focus of the copyright analysis is on steps 3 and 4. 

Based on a thorough analysis of the CJEU’s case law, and in light of the findings of two experts workshops, we conclude that the core issue is whether the AI-assisted output is the result of human creative choices that are “expressed” in the output. In line with the CJEU’s reasoning in the Painer case, we distinguish three distinct phases of the creative process in AI-assisted production: “conception” (design and specifications), “execution” (producing draft versions) and “redaction” (editing, finalisation). While AI systems play a dominant role at the execution phase, the role of human authors at the conception stage often remains essential. Moreover, in many instances, human beings will also be in charge of the redaction stage. Depending on the facts of the case, this will allow human beings sufficient creative choice. Assuming these choices are expressed in the final AI-assisted output, the output will then qualify as a copyright- protected work. By contrast, if an AI system is programmed to automatically execute content without the output being conceived or redacted by a person exercising creative choices, there will be no work. 

Due to the “black box” nature of some AI systems, persons in charge of the conception phase will sometimes not be able to precisely predict or explain the outcome of the execution phase. This however need not present an obstacle to the “work” status of the final output, assuming that such output stays within the ambit of the person’s general authorial intent. 

Authorship status will be accorded to the person or persons that have creatively contributed to the output. In most cases, this will be the user of the AI system, not the AI system developer, unless collaboration between the developer and user on a specific AI production indicates co- authorship. If “off-the-shelf” AI systems are used to create content, co-authorship claims by AI developers will also be unlikely for commercial reasons, since AI developers will normally not want to burden customers with downstream copyright claims. 

A problem that might arise is the possibility of falsely claiming authorship in respect of AI productions that do not qualify as “works” for lack of human creativity. Producers or publishers might be tempted to falsely attribute authorship in such productions in order to benefit from the authorship presumptions granted under EU law, which allow the person whose name is mentioned as an author to initiate infringement procedures. 

British and Irish copyright law accord authorship statu s to persons undertaking the arrangements necessary for creating computer-generated works in cases where no (human) author can be identified. These provisions have been criticised as being incompatible with EU copyright standards, since “authorless” works do not meet the EU standard of “the author’s own intellectual creation”. Perhaps, they are therefore better understood as a species of related rights. 

The related rights harmonised under the EU acquis offer various possibilities for protecting AI- assisted outputs that do not qualify for copyright protection. In light of the general absence in related rights’ law of a requirement of human authorship or originality, and its rationale of rewarding economic or entrepreneurial activity, related rights will accommodate AI-assisted output in cases of insufficient human creative input. 

While AI-assisted outputs in the form of aural signals (audio data) may benefit from the phonographic right, audio-visual outputs will qualify for protection under the film producer’s right. Moreover, AI-assisted broadcasts may find protection under the related rights of broadcasters. None of these related rights provide for a threshold requirement, making these regimes available for AI-assisted outputs that are generated without any creative human involvement – even absent significant economic investment. In most cases the user, not the developer, of the AI system will be deemed the owner of the related right, since it is the user that triggers the acts that give rise to these rights through his use of the AI system and output generation. 

Additionally, AI-generated databases will qualify for sui generis protection under the EU Database Directive if the databases are the result of substantive investment. This includes investment in AI technology and know-how applied in producing the database. In light of the broad legal notion of “database”, the sui generis right potentially offers protection to a wide range of AI-assisted productions. However, it is currently uncertain whether investment in machine-generating data – for example, the generation of weather data with the aid of AI – may be factored in. In any case, the prerequisite of a “database” rules out protection of raw data. 

Illustrated via case studies in the Report, it is impossible to make general assessments of the copyright status of AI-assisted outputs in individual cases. In some cases, where the creative role of human beings is evident at various stages of the creative process, such as The Next Rembrandt project, the output will most likely be copyright protected. In other cases, where it is difficult or even impossible to identify creative choices, such as automatically-generated sports reports or AI-assisted weather forecasts, copyright protection will be less likely. Note however that this is the same for sports reports and weather forecasts produced without machine assistance. Nevertheless, producers of “authorless” AI-assisted outputs might still find recourse in related (neighbouring) rights. 

“Authorless” AI-assisted outputs will remain completely unprotected only in cases where no related right or sui generis right is available. Since such rights attach primarily to aural and audio-visual signals, as well as to databases, such cases are most likely to occur if the AI- assisted output is in alphanumerical form. Whether this absence of IP protection might justify regulatory intervention, is primarily an economic question that cannot be addressed in the context of this Report. Such intervention is justified only if no alternative protection (e.g., under trade secret protection, unfair competition or contract law) is available, and solid empirical economic analysis reveals that the absence of protection harms overall economic welfare in the EU. 

Our analysis for EU copyright law and AI leads to the following conclusions and recommendations:  

• Current EU copyright rules are generally sufficiently flexible to deal with the challenges posed by AI-assisted outputs. 

• The absence of (fully) harmonised rules of authorship and copyright ownership has led to divergent solutions in national law of distinct Member States in respect of AI-assisted works, which might justify a harmonisation initiative. 

• Further research into the risks of false authorship attributions by publishers of “work-like” but “authorless” AI productions, seen in the light of the general authorship presumption in art. 5 of the Enforcement Directive, should be considered. 

• Related rights regimes in the EU potentially extend to “authorless” AI productions in a variety of sectors: audio recording, broadcasting, audivisual recording, and news. In addition, the sui generis database right may offer protection to AI-produced databases that are the result of substantial investment. 

• The creation/obtaining distinction in the sui generis right is a cause of legal uncertainty regarding the status of machine-generated data that could justify revision or clarification of the EU Database Directive. 

EU Patent Law 

Our analysis of European patent law – and in particular the EPC – demonstrates that the requirement that an inventor be named on a patent application means that one or several human inventors must be identified. Under the EPC regime, this is essentially a formal requirement. The EPO does not resolve disputes regarding substantive entitlement, which is an issue that is governed by national law. Following this approach, the EPO decided two cases in 2020 (currently under appeal) where it considered that, because AI systems do not have legal personality, they cannot be named inventors on a patent application. 

A human inventor typically has the right to be named on the application. Beyond this, inventorship and co-ownership are mostly a matter for national law. It should be noted, however, that as AI technology stands today, the possibility that an AI system would invent in a way that is not causally related to one or more human inventors (e.g. the programmer, the trainer, the user, or a combination thereof) seems remote. As technology stands, no immediate action appears to be required on the issue of inventorship at EPC level. 

As regards ownership, there are at least three possible (sets of) claimants to an AI-assisted invention: the programmer or developer of the AI system; the owner of the system; and the authorised user of the system (who provided it with training data or otherwise supervised its training). Neither international law nor the EPC provide clear rules on how ownership of patents may be affected by this new type of AI-assisted inventive activity. It is therefore a matter for national laws. However, that might not require harmonisation as there does not seem to be a problem in establishing a sufficient connection between an AI-assisted invention and a patent applicant. 

The granting of a patent requires that, as of the date of filing, the invention must be new (novel) and involve an inventive step. While the increasing use of AI systems for inventive purposes does not require material changes to these core concepts, it may have practical consequences for patent offices. AI systems enable qualitatively or quantitively different novelty (prior art) searches, and the practical application of inventiveness may change as certain claimed inventions may be “obvious” to a person of ordinary skill in the art (“POSITA”) due to the increasing use of AI systems. Any future changes will likely emerge in legal decisions at European (EPO Boards of Appeal) or national levels where patents will either be upheld or not. 

A patent application must also sufficiently disclose the invention. The “black box” nature of some AI systems may present challenges to this requirement. In that regard, it has been suggested that a mechanism to deposit AI algorithms be established, akin to that for microorganisms (the Budapest Treaty). Although it is as yet unclear that a deposit system for AI algorithms would be useful, it seems advisable to at least consider the possibility of requiring applicants to provide this type of information, while maintaining sufficient safeguards to protect all confidential information to the extent it is required under EU or international rules. 

Finally, inventions that might otherwise be patentable might be protectable as trade secrets under the 2016 Trade Secrets Directive, a topic for future study as it is outside the scope of the current work. 

Our analysis for EU patent law and AI leads to the following conclusions and recommendations:

• The EPC is currently suitable to address the challenges posed by AI technologies in the context of AI-assisted inventions or outputs. 

• When assessing novelty, IPOs and the EPO should consider investing in maintaining a level of technical capability that matches the technology available to sophisticated patent applicants. 

• When assessing the inventive step, it may be advisable to update the EPO examination guidelines to adjust the definition of the POSITA and secondary indicia as to track developments in AI-assisted inventions or outputs. 

• When assessing sufficiency of disclosure, it would be useful to study the feasibility and usefulness of a deposit system for AI algorithms and/or training data and models that would require applicants in appropriate cases to provide information that is relevant to meet this legal requirement. 

• For the remaining potential challenges identified in this report arising out of AI-assisted inventions or outputs it may be good policy to wait for cases to emerge to identify actual issues that require a regulatory response, if any. 

• Further study on the role of alternative IP regimes to protect AI-assisted outputs, such as trade secret protection, unfair competition and contract law, should be encouraged.

Secrecy

'Rethinking Cabinet Secrecy by Yan Campagnolo in (2020) 13(3) Journal of Parliamentary and Political Law states 

 This article describes the main shortcomings of the statutory framework regulating Cabinet secrecy in Canada and proposes solutions to address them. The first shortcoming is the indeterminacy of the term “Cabinet confidence” pursuant to sections 39 of the Canada Evidence Act and 69 of the Access to Information Act. Consequently, the executive has broad discretion to delineate the scope of Cabinet immunity. The second shortcoming stems from the absence of meaningful oversight and review mechanisms to prevent and correct possible abuses of this immunity by the executive. Based on the rule of law principle and an analysis of best practices in similar jurisdictions, the author makes recommendations to more clearly circumscribe the scope of Cabinet immunity and to ensure that claims of immunity are subject to meaningful review by an independent and impartial body. To that end, he proposes a narrower immunity, based on a criterion of injury, that could be justified only following an in-depth examination of the public interest. In addition, the author underscores the importance of excluding from the scope of the immunity any factual and contextual information underpinning government decisions that have been made public. Finally, he recommends that judges and the Information Commissioner of Canada be granted the power to examine Cabinet confidences when there is a dispute concerning the validity of a claim of immunity, and that judges be granted the additional power to compel production of those confidences when it is in the public interest.

Pathology

'Can Clinical Genetics Laboratories be Sued for Medical Malpractice?' by Alexandra L. Foulkes, Jessica L Roberts, Paul Appelbaum, Wendy K Chung, Ellen Wright Clayton, Barbara J Evans and Gary E Marchant in (2020) 29 Annals of Health Law & Life Science 153 comments 

 Clinical genetics laboratories are handling more patient information than ever before, including genetic data that has no established clinical significance. Those labs could face legal liability if that previously uncertain information gains clinical significance and a laboratory fails to notify the impacted patients. Should patients choose to sue clinical genetics labs, what body of law will govern: medical malpractice or ordinary negligence? We conducted a fifty-state survey assessing whether clinical laboratories are “health care providers” for the purposes of medical malpractice to answer this question. We found that six states expressly include laboratories or laboratory personnel in their statutory definition of health care provider, fifteen states have judicial opinions that treat laboratories as health care providers, and four states have caselaw concluding that laboratories are not health care providers. Thus, twenty-five states have yet to decide this important threshold matter. We therefore conclude that the legislatures in these states should provide clarity regarding the potential medical malpractice liability of clinical genetics laboratories.

17 December 2020

Scribbles, Daubs and AI

'Thirty-Six Views of Copyright Authorship, by Jackson Pollock' by Dan L Burk in (2020) 58 Houston Law Review comments 

Humans have long used a variety of tools to convey artistic expression. Perhaps the most recent and mysterious artistic tools are machine learning or ‘artificially intelligent’ (AI) computer systems that have captured popular attention. When taken in isolation, these devices seem to operate autonomously, giving the illusion that there is no author behind their output. In fact, there is a rich web of human effort and support behind any AI undertaking. When we pull aside the AI curtain, it becomes apparent that the attribution of authorship for AI-enabled creations is largely an exercise in tracing legal causation. Indeed, the concept of original expression, which is required for copyright authorship, implies a causal chain tracing the origin of fixed expression. In this Article, I show that concepts of causation, volition, and intention that are familiar from other areas of law also inform copyright authorship, and that the machine learning revolution affords us the opportunity to reveal previously hidden assumptions about copyright authorship. While I will begin by illustrating these concepts with examples from the graphic arts, the same principles are readily applied to other authorial works in other media. The result dispels not only the confusion surrounding mechanical creation but a variety of long-standing problems in copyright authorship.

Magnitsky Inquiry Report

Last week's Criminality, corruption and impunity: Should Australia join the Global Magnitsky movement? An inquiry into targeted sanctions to address human rights abuses report by the Joint Standing Committee on Foreign Affairs, Defence and Trade - foreshadowed here - features the following recommendations -

1   the Australian Government enact stand alone targeted sanctions legislation to address human rights violations and corruption, similar to the United States’ Magnitsky Act 2012. 

2   the legislation should include a preamble, which would set out the broad purposes and general principles of the Act. 

3  the range of conduct that may be sanctioned should include serious human rights abuse and serious corruption. 

4  the new targeted sanctions legislation should apply to ‘serious human rights abuses’ with further guidance on thresholds and applicable conduct provided in the preamble. 

5   the preamble acknowledge the importance of maintaining journalist and human rights defenders’ human rights and expressly state that systematic extrajudicial actions that intend to limit media freedom can be considered human rights abuses. 

6 the legislation should name the range of conduct which can be sanctioned as ‘Magnitsky conduct’. 

7 sanctions should be applicable to the immediate family and direct beneficiaries of human rights abusers. 

8  sanctions be applicable to all entities, including natural persons, corporate entities and both state and non-state organisations. 

9  sanctions be applicable to associated entities, broadly defined. 

10   the new targeted sanctions legislation should not apply to Australian citizens because they are subject to legislation with similar, if not stronger, consequences. This issue should be re-examined as part of the 3-yearly review. 

11 the new targeted sanctions legislation be applicable to conduct that has occurred prior to enactment of the legislation. 

12  an independent advisory body be constituted to receive nominations for sanctions targets, consider them and make recommendations to the decision maker. 

13  the structure of the independent advisory body should be set out in regulations, and should include the ability to conduct its inquiry in public. 

14   the new legislation should require the decision maker to consider recommendations by the advisory body and give reasons for any decision not to adopt a recommendation by the advisory body. 

15  the decision maker should be able to receive nominations from any source. 

16 the legislation, or regulations under the legislation, set out processes to allow Australian authorities to work with other jurisdictions and their sanctions regimes. 

17   the Minister for Foreign Affairs be the decision maker. 

18  the Minister for Foreign Affairs should be required to consult with the Attorney-General before making a decision. 

19  the legislation include a requirement to give the targeted person a right of reply, and a requirement for the Minister to consider this, before imposing sanctions. 

20  the Minister for Foreign Affairs should have broad discretion as to whether or not to impose sanctions. This would include the ability to remove or vary sanctions. 

21   the legislation allow for a ‘watch list’ of people being considered for sanctioning. Inclusion on a watch list should be for a fixed time period, after which a person must either be sanctioned or removed from the list. The watch list should be public. 

22   the evidentiary standard for a decision should be the balance of probabilities. 

23 the legislation require the publication of the names of sanctioned people and the reasons for their listing. This includes all decisions to remove or vary sanctions. 

24 the legislation require the Foreign Minister to publish an annual report to Parliament advising of sanctions. 

25 the Foreign Minister’s annual report into the sanctions should stand referred to the JSCFADT for inquiry . 

26  there be limited exemptions from including information on the public register, watch list or annual report for reasons of national security or criminal investigations. 

27  the legislation include a right for a sanctioned person to request a review of decision. The Minister should be required to conduct a review on request, although the regulations may limit the obligation to conduct reviews. 

28 argeted sanctions legislation be reviewed by the government three years after commencement. 

29  the sanctions include visa / travel restrictions, limit access to assets, and restrict access to Australia’s financial systems. 

30   the sanctions, to the extent possible, be implemented using existing processes and legislative schemes. 

31 the new sanctions regime be accompanied by a public diplomacy strategy to provide guidance to those affected, including Australian businesses. 

32   the Department of Foreign Affairs and Trade should be given additional resources to implement the sanctions regime. Other departments required to contribute to implementation should also be allocated dedicated resourcing for the task. 

33  the long title of the legislation should include ‘Magnitsky’ to emphasise links with the Global Magnitsky movement.

Persuasion and impersonation

Today's national government media release regarding COVID, offering an insight into public health promotion, states 

An important education campaign will be rolled out to inform Australians ahead of the COVID-19 vaccination program. 

The vaccination roll-out will be a complex task and it will be important that people understand the process with the first vaccinations on track for early next year. 

Minister for Health, Greg Hunt said the Mid-Year Fiscal and Economic Outlook 20-21 (MYEFO) reinforces the Australian Government’s commitment to continue to protect the community and get lives back to normal through this pandemic. 

“The information campaign, with funding of $23.9 million, will work in partnership with the states and medical experts, to explain the regulatory processes, the priority groups, timing and roll-out to assist people to understand how the vaccines work, and to be ready for when they can receive the vaccine,” said Minister Hunt. 

“The vaccines will be voluntary and free, we encourage people to have the vaccine to protect themselves and their family.” 

“It is essential that people understand that Australia’s medical regulatory processes need to occur before the vaccines are approved for use. We are receiving data from overseas and this will assist in finalising the priority groups for the vaccinations, putting our health and aged care workers in the first wave along with elderly Australians who are at most risk from the virus,” Minister Hunt said. 

The COVID-19 vaccine communications will include a national advertising campaign and communication specifically targeting priority groups, culturally and linguistically diverse (CALD) groups and Aboriginal and Torres Strait Islander people. 

Over $40 million in funding is being provided to streamline processes necessary to the approval and distribution, so the clinical information can be assessed in real time. 

The funding for Services Australia, the Australian Digital Health Agency and Therapeutic Goods Administration will allow necessary enhancements aimed at reducing existing manual processes and improving digital integration across these systems. 

The Government is also improving critical capacity requirements for the Australian Immunisation Register, as the Government’s central resource for recording COVID-19 vaccinations so people will have a record of their vaccination. This will be essential as all current vaccines planned for Australia require a two-vaccine process. 

The Government is securing 20 million additional doses of the AstraZeneca COVID-19 vaccine. This brings the total number of doses to 53.8 million – enough for the entire Australian population. 

The extra 20 million doses will be produced in Australia by CSL. 

Additionally, a further 11 million doses of the Novavax vaccine will be purchased, bringing the total for this vaccine to 51 million. This will be an additional whole-of-population vaccine should it be proven to be safe and effective. 

A purchasing agreement is also in place for the Pfizer/BioNTech COVID-19 vaccine, with 10 million doses scheduled for early 2021. 

Building Australia’s vaccine manufacturing capacity 

The Australian Government is investing $1 billion to ensure Australia’s capacity to manufacture vaccines in the future, though its supply agreement with Seqirus. 

The Government will extend the current supply agreement with Seqirus, ensuring long-term, onshore manufacturing and supply of products of national significance including pandemic influenza vaccines, Q fever vaccines, and Australian-specific antivenoms from 1 July 2024 through to 2036. Under this agreement, Seqirus will invest more than $800 million in a new state-of-the-art biotech manufacturing facility in Melbourne.

In the United States the House of Representatives Committee on Veterans' Affairs report 'Hijacking Our Heroes: Exploiting Veterans Through Disinformation on Social Media' states 

The threat of foreign individuals and organizations influencing United States (U.S.) elections by manipulating social media has been a persistent and growing issue since before the 2016 election year. The threat was a significant concern during the 2020 elections. 

Recent investigations and analysis document the broad proliferation of online influence campaigns that originate overseas. This includes the use of "spoofing,'' or the act of disguising an electronic communication from an unknown source as being from a known, trusted source. A subset of these operations target the veteran and military service member communities in order to misappropriate their voices, authority and credibility. The pervasiveness of social media, as well as the nature of the specific threat to our election integrity and the sowing of political discord makes this a critical issue affecting both veterans and those who value veterans' voices. As described by Chairman of the House Committee on Veterans' Affairs, Mark Takano (D-CA), "the issue of protecting our elections from foreign influence is one of critical importance to all Americans and preserving the power of veterans' voices should be of equal concern to us all.'' 

VETERANS ARE SPECIFICALLY TARGETED FOR SPOOFING 

On Wednesday, November 13, 2019, the House Committee on Veterans' Affairs held an investigative hearing to examine the nature and scope of threats posed to the veterans' community through "internet spoofing.'' Experts testified that stolen, misappropriated, or fraudulently created social media accounts can be used to target veterans for the purposes of disseminating political propaganda and fake news in order to influence elections. The witnesses also described romance scams and commercial fraud being perpetrated using spoofing techniques. Representatives of three major social media platforms--Facebook, Instagram, and Twitter--discussed how they are addressing this threat, particularly considering the 2020 elections, and described best practices for information sharing, protective measures, and law enforcement cooperation. The Committee later held a briefing on January 14, 2020, with representatives from several components of the Federal Bureau of Investigation (FBI) that handle law enforcement for online crimes. 

Ranking Member Dr. David P. Roe (R-TN) noted during the hearing, "The evidence is clear that veterans have their identity misappropriated and that they, like other social media users, could be targets for propaganda or scams."Although everyone who uses the internet is subject to online scams, spamming, phishing, identity theft, and other such risks, veterans are particularly susceptible to internet spoofing based on their higher propensity for political engagement (including running for office, volunteering, and sharing political opinions and information). For the purposes of disseminating political propaganda or exerting influence on dividing Americans on sensitive political "wedge issues,'' veterans are targeted because of their close identification with strong national security policies, patriotism, personal sacrifice, and honor. Chairman Takano stated during the hearing,  "By impersonating veterans, these foreign actors are effectively eroding the hard-earned power and integrity of veterans'' voices.'' 

Veterans are more likely to be engaged in their communities, be perceived as leaders, and can exert influence on political matters (particularly with respect to defense and national security matters). Therefore, a successful spoofing scam that results in a veteran or Veteran Service Organization (VSO) unknowingly distributing or endorsing a piece of disinformation can yield greatly increased, and sometimes even exponential, results due to the added credibility imparted to that disinformation by virtue of its approval by the veteran or VSO. With each successive endorsement or share, the credibility of the disinformation snowballs. The collective association with actual veterans and VSOs makes it increasingly unlikely that the disinformation will be closely scrutinized, questioned, or eventually exposed as fraudulent or misleading. Moreover, scammers also try to spoof veterans to gain leverage over them. Many veterans move into jobs requiring security clearances or within the federal government after they leave the military--those positions can be jeopardized if the veteran is compromised through financial fraud, identity theft, or otherwise becomes susceptible to blackmail. 

SPOOFING OF VETERANS THREATEN U.S. ELECTIONS 

Internet spoofing became a visible problem in the context of the 2016 U.S. election, when foreign disinformation spread widely across social media, including Facebook, Instagram, Twitter and YouTube, among others. However, disinformation on social media and information operations conducted by sophisticated actors have occurred for far longer. In the past few years, foreign information operations have targeted divisive political issues within American society and have sought to manipulate and divide political and social communities. Unfortunately, our military and veterans' communities are no exception. Moreover, the incidents of foreign spoofing increased following the 2016 election, and industry experts project that these numbers will continue to increase through 2020 and beyond. Russia's Internet Research Agency (IRA), a Russian company which has engaged in online influence operations, more commonly known as a "troll farm,'' dramatically expanded its information operations after the 2016 U.S. Presidential elections, both in terms of volume and intensity. Russia and Iran are the most prominent state actors in this context, but recent work has identified additional state actors, such as China and Saudi Arabia, using information operations to target communities and topics of interests. 

The Senate Select Committee on Intelligence published a five-volume bipartisan report focused on Russia's influence operations. The second volume focused on Russia's use of social media platforms to influence the election, while the third volume focused on the shortcomings of Obama Administration efforts to combat the ongoing attacks. The third volume highlighted the lack of legislative or regulatory action to combat a known threat emanating from Russia and its intelligence services. The Senate Report sheds light on the broader issues of misinformation campaigns and predatory schemes targeting veterans presented in a report prepared by the Vietnam Veterans of America (VVA). 

ACTION BY LAW ENFORCEMENT AND SOCIAL MEDIA PLATFORMS IS INADEQUATE 

Industry analysts, journalists, and law enforcement agree that the problems of internet spoofing and foreign influence exerted through social media continue to grow at an alarming pace. However, neither the major platforms nor the FBI were able to identify an obvious or comprehensive solution to this ongoing problem. Both continue to devote significant resources towards combatting spoofing. However, the foreign entities who perpetrate much of this illicit activity are becoming more sophisticated in their schemes and are targeting broader swaths of internet users to more quickly and efficiently disseminate their fraudulent messaging before they are identified and deactivated. 

Facebook and Twitter note that automated systems can struggle to differentiate authentic images and accounts from fraudulent, unauthorized, or duplicated accounts and thereby risk erroneously flagging and removing legitimate accounts. The platforms have chosen to err on the side of minimizing false negatives by relying upon patterns of suspicious activity and certain tactics or techniques, rather than on other identifying data (e.g., duplicative names or images, geolocation information, or ostensible organizational affiliations). Suspicious activity patterns, such as irregular, repetitive, or voluminous posting, triggers additional layers of review, including an examination of the geolocation data in order to assess where the suspicious activity may be originating. The final review and removal decisions sometimes warrant human examination, but often removals are made without any human review. Although these layered review processes may be effective in protecting legitimate users, they undoubtedly also add a significant gap in removal time for fraudulent accounts, which provides a window within which spoofers can continue to operate. 

Law enforcement agencies, such as the FBI, are constrained in their abilities to efficiently identify and eliminate spoofers because the agencies only have limited access to the data held by the social media platforms. Often these agencies do not receive important information until after the platforms have already removed a spoofed account, at which point law enforcement is unable to actively monitor and trace the account in real time. 

The ability of spoofers to operate from overseas, anonymously, or by using fraudulent or concealed identities requires law enforcement to rely upon account identification data and detailed activity patterns in order to accurately identify or locate the potential spoofer. However, Title II of the Electronic Communications Privacy Act (ECPA) (18 U.S.C. Sec. Sec. 2701-2713), known as the Stored Communications Act, requires a government entity to serve a subpoena on social media platforms to compel the production of certain relevant information. Requiring a time-consuming legal process to obtain identification data hampers the ability of law enforcement to respond quickly or to fully understand the scope of a potential spoofing campaign. Therefore, the law enforcement agencies recommend increasing the amount and level of detail that the platforms can easily provide to the authorities. 

Past attempts to address this problem have been piecemeal in nature and have proven ineffective to date. This fragmented approach has prevented any wholesale, systemic efforts to tighten rules or law enforcement protocols. Incremental adjustments have been made by individual platforms, which leaves an irregular landscape where motivated, corrupt actors may still be able to exploit weaknesses among the platforms. 

THE FEDERAL GOVERNMENT AND THE SOCIAL MEDIA PLATFORMS SHOULD TAKE ADDITIONAL ACTION 

Based on discussions with representatives of law enforcement, and considering the issues raised by the social media platforms during the hearing, the Committee believes that there are additional measures needed to address the growing threats posed by spoofing. Our recommendations fall into two broad categories. 

The first category is oriented at users of social media and is defensive in nature, such as teaching users how to be aware of the dangers posed by spoofers on social media and training them how to protect themselves through heightened vigilance, healthy skepticism, and adherence to basic principles of cyber- hygiene. 

1. Improve Awareness through a Public Service Announcement Campaign 

2. Develop Cyber-hygiene Training 

3. Strengthen Partnership Between Social Media Platforms and VSOs 

The second category is aimed at putting the social media platforms and law enforcement on the offensive and developing robust mechanisms to more effectively identify and quickly eliminate foreign-based spoofers. While the first category is likely to be less costly and easier to implement, the second category may ultimately prove to be more effective in bringing the threat under control. 

4. Improve Reviews of Accounts by Social Media Platforms 

5. Consider Legislative Reforms to Facilitate Sharing Information 

6. Increase Data Sharing on Fraudulent Accounts 

7. Improve Identity Verification and Geolocation Identification 

The recommendations in more detail are 

 Recommendations and solutions to the threat of internet spoofing fall into two broad categories. The first category is oriented at users of social media and is defensive in nature, such as teaching users how to be aware of the dangers posed by spoofers on social media and training them how to protect themselves through heightened vigilance, healthy skepticism, and adherence to basic principles of cyber-hygiene. The second category is aimed at putting the social media platforms and law enforcement on the offensive and developing robust mechanisms to more effectively identify and eliminate foreign-based spoofers quickly. While the first category is likely to be less costly and easier to implement, the second category may ultimately prove to be more effective in bringing the threat under control. 

Improve Awareness 

1. Improve Awareness through a Public Service Announcement Campaign--As noted by several Committee Members, FBI representatives, and testifying witnesses, the problem of spoofing is exacerbated by a general lack of public awareness of the issue and unfamiliarity with how to assess online content in order to evaluate authenticity. Warnings of the risk that social media content may not actually be from legitimate sources or be deliberately planted for exploitative purposes can be effectively and efficiently communicated through a public awareness campaign, such as through public service announcements (PSA). These public awareness campaigns can be distributed through the social media platforms themselves, or more comprehensively through other media outlets and agencies, such as VA. 

2. Develop Cyber-hygiene Training--VA and the Department of Defense should develop robust and comprehensive cyber-hygiene training. This would go beyond the basic information provided by public awareness campaigns. For example, agencies could provide training on best practices in protecting personal and financial information, how to read and review content online with an eye towards verification, and how to engage the platforms themselves when needed to remove spoofed accounts, fraudulent posts, or other deceptive content. 

3. Strengthen Partnerships Between Social Media Platforms and VSOs--A strong partnership could include an ongoing process for VSOs to contribute their expertise and familiarity to assist the social media platforms in their efforts to address spoofing. The social media platforms noted that it can be difficult to differentiate legitimate content from veterans or VSOs from spoofed content purporting to be from the veterans' community. There are ample resources within the broader veterans' community to help advise and consult with the platforms on such questions. 

Strengthen Prevention and Enforcement Methods 

4. Improve Reviews of Accounts by Social Media Platforms-- The social media platforms should implement stronger reviews of accounts that pose substantial risk of spoofing. This should include the adoption of industry-developed best practices involving accounts that control groups or pages with very large reach in order to closely scrutinize activity on these groups or pages to quickly identify potential patterns of suspicious behavior. Given the influence and reach, any such groups or pages that meet or exceed certain thresholds of followership should have their controlling accounts be officially verified by the social media platforms, and the details of such verification (ownership, geolocation, moderators, etc.) be publicly available for all users. 

5. Consider Legislative Reforms to Facilitate Sharing Information--Congress should consider appropriate modifications to the federal laws that currently limit the social media platforms' ability to freely share data with law enforcement agencies or other peer platforms in order to detect, prevent, or remove fraudulent or spoofed content in a timely and efficient manner. Federal law is murky on how the privacy rights of users intersect with law enforcement needs with respect to data or identification information in cases of potential illegal activity or fraud. The platforms have generally erred on the side of maintaining user privacy in the absence of a clear legal requirement to provide such data to law enforcement agencies. However, there are certain inconsistencies in the existing laws governing voluntary disclosures to law enforcement which contribute to challenges and delays. Congress could align the scope of voluntary disclosure of information to law enforcement under the respective provisions of Title II of ECPA to facilitate greater transparency and timely information sharing with law enforcement. This would essentially allow holders of electronic communications and records to voluntarily release the data associated with fraudulent, spoofed, or misappropriated accounts to law enforcement agencies and potentially also to their enforcement counterparts at peer platforms, when criminal activity or other imminent harm is reasonably suspected. However, any new legislation in this area or any change to the ECPA statute must be both narrow in scope and include strong safeguards to protect the personal privacy and civil rights concerns of users. 

6. Increase Data Sharing on Fraudulent Accounts--Social media platforms should improve their sharing of identified fraudulent and spoofed accounts with other platforms and law enforcement to the extent permissible under current statutes, both in terms of frequency of sharing and the scope of the data that is shared. Although ECPA protects underlying identifying information, there is other information about spoofed accounts that can still be shared. Increasing the scope and timeliness of shared information pertaining to accounts that have been identified, and likely removed as fraudulent or spoofed, would enhance cross-platform detection. Additionally, consistent protocols could be established around communication between the platforms and law enforcement, and amongst the platforms, to ensure that information is shared on a regular and timely basis, rather than only in response to crises or incidents. This sharing of information should be narrow in scope and include strong safeguards to protect the personal privacy and civil rights concerns of users. 

7. Improve Identity Verification and Geolocation Identification--Social media platforms should improve their verification of identities, affiliations, and geolocation for all accounts. This would create a consistent and more robust version of the verification and checkmark system that was previously employed in various permutations by Twitter and Facebook. This would make it more difficult for foreign actors to disguise or misrepresent their locations and consequently their identities). The geolocation and account ownership information should then be readily available to users and to law enforcement, to increase transparency and foreclose intentional concealment of where an account is based.

Commercialisation

The Australian Health Department has released a consultant's report on The medical research commercialisation landscape. 

The report states that Health 

commissioned Allen + Clarke to undertake qualitative research on the sector’s views regarding the medical research commercialisation landscape since the Strategic Review of Health and Medical Research – Better Health Through Research 2013, also known as the McKeon Review. 

This report includes an overview of public and private funding that supports the development and commercialisation of medical research in Australia, and qualitative research that sought to obtain responses to four research questions:

1. What are the sector’s views regarding existing government funding support and gaps that remain unaddressed or are not sufficiently addressed, particularly in commercialisation and translation of research? 

2. What are the sector’s views regarding the impact of MRFF initiatives to improve the capability and capacity of the medical research and innovation sector to commercialise research outputs, and any perceived gaps? 

3. How have institutions positioned themselves to maximise commercialisation opportunities?   

4. What are the sector’s views regarding other barriers to commercialisation of research outputs in Australia? 

The findings presented in this report were prepared based on desktop research and document review, interviews with informants across the sector, and a sector questionnaire to broaden the perspectives gathered through the research. 

The qualitative research is a representation of the views of people interviewed or surveyed as part of this process. The perspectives represent the views provided by people who participated in the process, and these views have not been validated for accuracy or correctness. 

Overview of public and private funding 

Funding for the development and commercialisation of medical research can come from many different sources, including public, private and non-government organisation (NGO) funding sources. Public funds tend to be used in the early stages of development (particularly for early research), and private sector funding tends to dominate the later stages of commercialisation. 

Funding supports the development and commercialisation of medical research in different ways. For example, funds may be aimed at progressing a specific initiative or idea, they may provide support to an organisation in research and/or development activities, or funding may be directed to improving the capability and capacity within the system to support and facilitate the commercialisation and translation of research outputs. This range of approaches across the life cycle of medical research development and commercialisation is shown in Figure 1. 

As well as providing funds, other support and resources are available to individuals and organisations developing and commercialising medical research. The provision of support and resources may be provided as part of a funding program – for example, mentoring is a feature of many government funding programs, such as the Accelerating Commercialisation program – or it can be provided independently of funding, such as the services and resources provided through TGA’s SME Assist. 

Part 1 of the report further describes funding for the development and commercialisation of medical research, including funding from the Australian Government, state and territory government funding, non-government funding (including philanthropy, private sector investment, and self-financing), and government co-investment. 

Qualitative research findings 

Part 2 of the report presents the key themes for each research question. These key themes are based on the views of people interviewed or surveyed as part of this process. 

In presenting the themes, there are some themes that are strongly held across the sector, while other themes that are of relevance to only specific groups, for example companies involved in the development of digital health innovations. Further, some stakeholders held different views to the themes presented in this report. These divergent views have been included in the report where relevant. The themes presented in this report are not independent items. The development and commercialisation of medical research exists as part of a broader ecosystem, and responding to one theme without responding to others may impact the shape and integrity of this ecosystem. 

Funding 

A summary of the main points that were strongly held by stakeholders follows. 

The medical research commercialisation landscape has improved 

There is strong support from the sector (through the survey and the interviews) that the medical research commercialisation landscape has improved in the last five years. 

Government funding and industry growth has contributed to the improvement 

The funding landscape is difficult to navigate 

Government policy and funding could have a role in further addressing constraints in the commercialisation of medical research Stakeholders had mixed views on the factors that had contributed to the improvement. Government funding (including the MRFF) and the success of companies - such as CSL, ResMed and Cochlear - were seen as factors that had positively contributed to an improved medical research ecosystem. Stakeholders raised concerns about the complexity of the funding landscape and that it was difficult for individuals and applicants to navigate the system to find and obtain funding. 

Stakeholders identified factors that constrain or are a burden to commercialisation. These include access to people with deep skills in commercialisation, access to research infrastructure and access to manufacturing capability. Further, there were systemic factors encumbering the commercialisation of medical research outputs that may be addressed through government policy and/or funding mechanisms, including systemic factors that discourage academic researcher engagement with industry and issues that increase the time and costs associated with the conduct of clinical trials. 

Stakeholders pointed to specific barriers and constraints for clinical researchers to develop and commercialise medical research, including demands of clinical work, access to research infrastructure and support, and access to support or arrangements for progressing the commercialisation of research. 

Funding for early stage medical research commercialisation has improved, but funding is regarded as insufficient and difficult to access 

There remain gaps in existing government support. Stakeholders stated there were now more funds available for medical research commercialisation than previously, but there are still insufficient funds available for the pre-clinical and early clinical stages of medical research development and commercialisation. Stakeholders also noted the difficulty in accessing funds during early stages of medical research commercialisation - with infrequent funding rounds for programs cited as an issue.  

The MRFF is seen as having made a positive impact to the sector 

Stakeholders identified the MRFF as having a positive impact on sector capacity and capability through funding, facilitating and stimulating increased engagement between industry and researchers, and through improving clinical trial infrastructure. 

There are factors that affects the ability of technology transfer offices to position themselves to maximise commercialisation opportunities As well as specific initiatives undertaken by institutions themselves to maximise commercialisation opportunities, stakeholders pointed to factors that they believed underpinned a technology transfer office’s (TTO) success. These factors include the commitment of the university to commercialisation, the TTO’s access to adequate and consistent funding, the skills and experience of the commercialisation and legal officers in the TTO, and the ability of the TTO to cover the vast scope of research within the university. 

Clinical researchers face their own barriers in developing and commercialising research 

Distance to markets and suppliers places Australian organisations at a disadvantage in commercialising research 

Medical research commercialisation occurs within a global market. Stakeholders noted the impact of distance on commercialisation. The effect of distance is experienced most acutely by smaller universities and companies, and western states. The effect of distance is reported as placing Australian organisations at a disadvantage of accessing key industry players. Internet based communication and social media platforms (such as LinkedIn) and networking events and conferences have reduced the impact of this issue in recent years. ;