Patent Licensing

The Productivity Commission is to undertake an inquiry into compulsory licensing in the patents system.

The inquiry is promoted by the Assistant Treasurer and the Parliamentary Secretary for Industry & Innovation as examining "whether, and how, to ensure access to patented technology while maintaining the patent incentive to create and protect new technology".

It follows recommendations in Parliamentary Committee reports and the Australian Law Reform Commission Genes & Ingenuity report on gene patents for a review of the operation of compulsory licensing provisions in the Patents Act 1990 (Cth).

The Ministers stated that -

We want to ensure there are no unnecessary delays or impediments to accessing technology. The compulsory licensing provisions are a key protection mechanism to ensure access and an important step in implementing the Government's Response to the Gene Patents Report. 

The Commission will review a range of leading international practices, including the processes under which the current provisions can be used. It will consider any alternative mechanisms, and recommend measures to raise awareness of these safeguard provisions, in particular within the small business and healthcare sector. 

Compulsory licensing is an increasingly sensitive issue internationally, particularly in the context of access to affordable health care. Accurate medical advice relies in part on the identification and use of gene sequences related to human health and disease.

Of concern to government is a perception that patents over genetic technologies, or a perceived lack of licences to use these patents in Australia, unreasonably restricts or delays patient access to medical advice based on the latest diagnostic tests. Other areas of sensitivity include climate change mitigation, food security and alternative energy technologies, and technical standards essential patents (for example, in telecommunication technologies).

The Commission is to provide a final report to the Government in nine months.

Its Terms of Reference are -

The Commission is requested to review the operation of the compulsory licensing provisions in the Patents Act 1990, in particular: 

• Assess whether the current Australian provisions can be invoked efficiently and effectively to deal with circumstances where reasonable requirements of the public are not being met or where the patentee engages in anti-competitive conduct. This includes, but is not limited to, consideration of concerns that gene patents may hinder access to affordable healthcare, including access to medical advice that relies on the identification and use of gene sequences related to human health and disease. 

• Advise on the frequency, and impact, of the issue of compulsory licences in comparable markets and the common features in such compulsory licenses. 

• Recommend any measures that may be required to efficiently and effectively exercise these safeguard provisions and invoke their use in a manner consistent with Australia's international obligations, without limiting access to overseas technologies, technology transfer, research and development investments or substantially reducing the patent incentive for innovation. 

• Recommend any alternative mechanisms deemed necessary to ensure that the balance between incentives to innovate and access to technology best reflect objectives of ensuring reasonable access to health care solutions, maximising economic growth and growing the Australian manufacturing industry. 

• Recommend measures to raise awareness of these provisions and their purpose, including the specific challenges of raising awareness among small businesses and the healthcare sector.

The Commission is to have regard to -

• the importance of incentives for industry and researchers to invest in research and development, and innovation;
• access to and transfer of technology, including climate change mitigation, food security, healthcare and alternative energy technologies, and standard essential patents in telecommunication technologies, particularly where multiple patentees are involved;
• affordable and equitable access to healthcare, including medical treatments and diagnostic tests in Australia; 
• recent changes to the intellectual property system reflected in the Intellectual Property Laws Amendment (Raising the Bar) Act 2012, including the research exemption; 
• other relevant parts of the intellectual property system, such as crown use provisions; and
• the range of international approaches.

Interestingly the inquiry is being undertaken by the Productivity Commission rather than by the Australian Law Reform Commission. There may be two reasons for that choice. The first is simply incapacity at the ALRC, following a succession of funding cuts that have been noted elsewhere in this blog. The second is that the Productivity Commission has particular values, although little experience in dealing with questions about intellectual property and little affinity with the rights of IP holders. Along with the Treasury it is a bastion of what Michael Pusey characterised as 'economic rationalism', embracing a philosophy that government intervention distorts the market and necessarily reduces national economic competitiveness. Would compulsory licensing substantially improve national economic performance, indeed so significantly improve performance as to offset problems such as trade sanctions by the US? The answer is unclear, although my sense is that the answer is no.

Therapeutic Homicide?

With the recent Carter v Canada (Attorney General) 2012 BCSC 886 euthanasia decision in mind it is interesting to see 'Choosing when and how to die: Are we ready to perform therapeutic homicide?', an editorial [PDF] by Ken Flegel & John Fletcher in the Canadian Medical Association Journal regarding the Dying With Dignity report from the Quebec legislature earlier this year.

The authors comment that

the report calls for a change in thinking, arguing that there will still be cases where suffering is great, irreversible and unrelievable, such that the only option is actively helping a person to die. 

The recommendation [regarding physician-assisted death] is based on two legal considerations. First, the civil code recognizes the right of adult patients to make medical decisions concerning their care, even if refusing or stopping treatment may result in their death. Second, both the Quebec and Canadian charters of rights and freedoms enshrine the rights to personal dignity and integrity. These rights imply a respect for self-determination and a person’s physical and psychological well-being. These are powerful arguments and suggest that an individual should be able to make life’s important decisions in a free and unconditional way, including deciding when the struggle to stay alive should end. However, this line of reasoning only supports an individual’s right to end his or her own life. 

Proponents of “dying with medical assistance” must argue that a patient’s rights invoke a corresponding medical duty to provide the means if a patient cannot, and it follows that this should be done in a safe and expert way. Hence, the act of assisting death would need to move from the context of being criminal to being part of the continuum of end-of-life care. 

Many physicians and patients will find this a shocking prospect to consider. If their views are to prevail, they will need to argue why there should be limits to a person’s autonomy. Human dignity may imply certain rights and freedoms, but conflicts among people’s rights are hard to resolve. Frail, dependent patients often feel a burden to their families or caregivers, and the unspoken possibility of a quick resolution to their predicament may complicate an already stressful situation. Removing the legal barrier to ending another’s life may ensure the self-dignity of those who wish to die, but may distress and remove the self-dignity of more people who wish to live.

The salient recommendations of the Quebec report are -

12  The Committee recommends that persons diagnosed with an incurable disease be given an information guide on their rights and the available services and resources. 

13 ... that relevant legislation be amended to recognize medical aid in dying as appropriate end-of-life care if the request made by the person meets the following criteria, as assessed by the physician: 

• the person is a Québec resident according to the Health Insurance Act;
• the person is an adult able to consent to treatment under the law;
• the person himself or herself requests medical aid in dying after making a free and informed decision;
• the person is suffering from a serious, incurable disease;
• the person is in an advanced state of weakening capacities, with no chance of improvement;
• the person has constant and unbearable physical or psychological suffering that cannot be eased under conditions he or she deems tolerable. 

14 ... that relevant legislation be amended to include the following guidelines: 

• all requests for medical aid in dying must be made in writing by way of a signed form;
• the request must be repeated within a reasonable period of time, depending on the type of disease;
• the attending physician must consult with another physician on whether the request meets the eligibility criteria;
• the physician consulted must be independent of the patient and the attending physician, and be competent with respect to the disease in question;
• the attending physician must complete a formal declaration of medical aid in dying. 

15 ... that a body be created to control and evaluate medical aid in dying and whose responsibilities would be to: 

• verify whether acts of medical aid in dying were carried out according to the conditions provided by law;
• publish an annual report, including statistics, on acts of medical aid in dying;
• publish, every five years, a report on the implementation of medical aid in dying provisions. 

16 ... that the appropriate National Assembly committee examine the five-year report of the control and evaluation body. 

17 ...  that relevant legislation be amended to recognize that an adult with the capacity to consent is entitled to give an advance directive for medical aid in dying in the event he or she becomes irreversibly unconscious, based on scientific knowledge. This advance directive for medical aid in dying: 

• must be given in a free and informed manner;
• is legally binding;
• must take the form of a notarized act or an instrument signed by two witnesses, including a commissioner of oaths;
• may mention the name of one or more trusted persons who will ensure the directive is known. 

18 ... that relevant legislation be amended to include the following guidelines: 

• the attending physician must consult another physician to confirm the irreversible nature of the unconsciousness;
• the physician consulted must be independent of the patient and the attending physician. 

19 ... that the ministère de la Santé et des Services sociaux: 

• take the necessary measures to ensure the advance directive for medical aid in dying appears in a person’s medical file and is recorded in a register;
• ensure that physicians check for the existence of such a directive in patient medical files or in the register;
• ensure that each establishment’s service quality and complaints commissioner periodically verifies compliance with advance directives for medical aid in dying. 

20 ... that the Attorney General of Québec issue directives (in the form of “guidelines and measures”) to the Director of Criminal and Penal Prosecutions to ensure that a physician who provides medical aid in dying in accordance with the criteria provided by law cannot be prosecuted. 

21 ... that the Collège des médecins du Québec amend its Code of Ethics so that physicians may provide medical aid in dying in accordance with the criteria provided by law while confirming their right to conscientious objection and their obligation, in such a case, to refer their patient to another physician. 

22 ... that the Ordre des infirmières et infirmiers du Québec amend its Code of Ethics to allow its members to help provide medical aid in dying in accordance with the criteria provided by law while, however, confirming their right to conscientious objection.

Jedilicious

After radio interviews and a piece on perceptions of the national population & housing census I was delighted to see some of the dissections of data from that survey.

The ABC's Lateline reports that the number of adherents to the belief system known as Scientology has declined, with a mere 2,163 Australians identifying themselves as Scientologists in 2011, a 13.7% from the 2006 census and of course at odds with promo in 2009 where a Hubbard devotee claimed that there were "tens, if not hundreds of thousands" of Scientologists in Australia and hype about support in connection with last year's employment inquiry.

The number of self-identified Rastafarians is up by 30%. 'Pantheists' increased by 35% and self-identified Jedis reached 65,000. There were a miserable 8,000 Wiccans, one of whom is presumably Ms Eilish De Avalon.

Lateline quotes a "Jedi Master" (no indication of whether he can deliver the goods when asked to do telekinesis or other Jedi tricks) as explaining -

It’s less of a stigma now. Right back in 2001 there was that stigma - that it was a joke religion and that it was just a prank played on the census but I'm finding that I declare myself as Jedi everywhere I go and I'm finding less and less heckling or giggling. ... It is a serious religion; it’s a very serious religion. More than half the population in the world believe in a life force energy. We believe in The Force as our life force energy.

The ABS reports that

In the past decade, the proportion of the population reporting an affiliation to a Christian religion decreased from 68% in 2001 to 61% in 2011. This trend was also seen for the two most commonly reported denominations. In 2001, 27% of the population reported an affiliation to Catholicism. This decreased to 25% of the population in 2011. There was a slightly larger decrease for Anglicans from 21% of the population in 2001 to 17% in 2011. Some of the smaller Christian denominations increased over this period - there was an increase for those identifying with Pentecostal from 1.0% of the population in 2001 to 1.1% in 2011.

There were 529,000 Buddhists and 476,300 adherents of Islam. 22% of the population identified as 'No Religion' (up from 15% of the population in 2001). 28% of people aged 15-34 reporting they had no religious affiliation.

It's too early, of course, for stats on the local branch of The Church of Kopimism (ie Pirate Bay At Prayer)

Archives

The Australian National Audit Office has released its report [PDF] on Records Management in the Australian Public Service (Audit Report No.53 2011–12).

The report centres on electronic records management and archiving, concluding that aspects in selected agencies (including the Treasury Department and Department of Immigration & Citizenship) remain inadequate.

The ANAO comments that

In 2008–09, the estimated annual cost of onsite paper storage of records for 138 Australian Government agencies and bodies was $208 million. The increased use of information technology by agencies has placed pressure on the adequacy of paper‐based records management systems to adequately support the capture, maintenance, access, retention and disposal of records. Australian Government agencies create a substantial amount of electronic information and records as part of their normal operations. However, in 2009 less than 30% of these agencies and bodies managed the majority of their records digitally, even though more than half reported having an Electronic Document and Records Management System (EDRMS) and using other electronic business systems to manage records. Establishing effective records management, particularly digital records management, represents a significant business issue for many agencies. 

To provide impetus and direction for digital records management, in July 2011 the Australian Government announced a policy for agencies to move to electronic records management for efficiency purposes. This policy is referred to as the Digital Transition Policy. It involves agencies’ senior management driving a change to digital records management through an increased focus on resource requirements and records management functionality when purchasing new electronic business systems, and reducing paper stockpiles.

In looking at the chosen agencies for a snapshot of national government records management practice the ANAO goes on to note that -

Each agency maintained a core records management system which supported the management and destruction or transfer of records captured in the system, although there was scope to improve the use and performance of these systems. Many other electronic business systems that were not identified and functioning as ‘records management systems’ were also used by the agencies to create, capture and manage records. These systems did not generally meet legal requirements relating to the management, and destruction or transfer of records. The use of such systems also created a risk that inaccurate or incomplete information could be accessed and used when making decisions, and acquitting legal and policy requirements, such as responding to freedom of information requests. 

The agencies had all experienced delays in transitioning to a digital records management environment that adequately supports business, meets legal and policy requirements, and is easy to use. Implementing digital records management systems and practices is complex, resource intensive and requires significant cultural change. Nevertheless, the need to have robust digital records management is becoming more pressing, particularly given the cost of managing paper records, application of new and changing technologies to improve programs and service delivery, 

It offers several findings at 19 through 29 -

 Assessing records management needs and risks 

Assessing records management needs and risks is an important step in developing an appropriate and effective records management approach. A key action that agencies should take is to develop records authorities to determine the retention, destruction and transfer requirements in accordance with the Archives Act. The three agencies had established, or were in the process of establishing, records authorities for their core business to guide proper disposal of records. The agencies had also completed reviews which identified significant issues and business risks in relation to information and records management or, at the very least, acceptance of records management systems and the application of relevant policy and guidance. These reviews identified a range of treatments to address risks presented by the agency arrangements. However, each agency has experienced delays in progressing effective treatments to information and records management risks, reflecting the relative priority of these issues to other business issues, and the complexity of their treatment. 

A key records management need relates to the development of a digital records management environment. Each of the agencies had identified a need to move to digital records management by implementing an EDRMS and incorporating records management functionality in electronic business systems that contain records. However, despite identifying a need for an EDRMS in 1999, and in subsequent years, Customs’ records management remains paper based. In 2000 and 2004 respectively, DIAC and Treasury had implemented an EDRMS to manage a significant proportion of their records. However, these agencies had further work to do to improve the use, acceptance and/or performance of their EDRMS. 

Other electronic business systems may also be used to create, use, maintain and dispose of records for particular business activities if appropriately managed. To provide for sound management of electronic records in business systems, agencies should consider records management needs during the planning, acquisition, development and implementation of electronic business systems. The agencies generally did not consider the need for records management functionality during these phases, although DIAC had recently changed its IT management arrangements to address this issue.  As a result, some agency systems were being used to maintain records even though they had not been designed to do so. Conversely, some systems could have been used to manage records but no consideration had been given to their potential to fulfil this function. 

It is important for agencies to identify vital electronic and paper records and develop contingency arrangements to enable their timely recovery in the event of a disaster, as part of business continuity planning. Treasury’s records management area had a vital records register which it updated on an ad hoc basis. However, none of the agencies had identified vital records in the context of their business continuity planning processes. Instead, these processes focused on disaster recovery arrangements for electronic systems, thereby providing the agency with the ability to recover information held in an electronic system within specified timeframes. Such approaches do not address the recovery of vital paper records in the event of a disaster. The need to have in place contingency arrangements for paper records was demonstrated following the 2011 Queensland floods, when some Australian Government agencies needed to destroy paper records affected by flood waters.   

Support for records management 

Records management policies and guidance outline an agency’s expectations in relation to information and records management for all staff, including the appropriate creation, capture and storage of records in approved records management systems when undertaking their work. Agencies must first determine the information that needs to be created and received in the context of each of their major business activities. In this respect, Customs and DIAC needed to further develop their guidance on records to create for each major business activity, and Treasury needed to promote the use of its existing guidance. 

Agencies should then identify electronic business systems that are records management systems and specify how all electronic business systems that contain records should be used to manage the records that have been created or received. DIAC and Treasury had adopted a policy to manage a significant proportion of their records electronically by implementing an EDRMS. While this has led to an increase in the volume of records held electronically in the core records management system, further significant changes were required to better support the digital management of records. In particular, the agencies need to discourage unnecessary use of paper files and remove electronic systems, such as shared folders, that provide an alternative place to create, edit and keep records. Customs had a ‘print to paper’ policy that recognised a number of electronic systems were used to create records but required information from those systems to be printed and placed on a paper file. Customs intended to move to an EDRMS as it was recognised that existing arrangements for capturing electronic records were inadequate and inconsistent, and that paper records did not capture all business decisions. More generally, the agencies often had not developed sufficient guidance on the use of other electronic business systems that contain records to help ensure that records are appropriately created or captured, and then transferred to or maintained in approved records management systems, including copying records where appropriate to the core records management system. 

To efficiently manage their records and comply with approved records authorities, agencies need to implement sentencing and disposal programs. Of the three agencies, Treasury had established an annual sentencing program and Customs had commenced development of a sentencing program in July 2011. DIAC had undertaken limited sentencing and disposal work because of a Moratorium on the Destruction of Department Files for several types of records, including client records. 

Systems used to manage records need to be able to preserve the integrity of information, including through quality control procedures to ensure the completeness and trustworthiness of records; and system controls over access and security. However, as indicated ... many electronic systems that were not records management systems, such as shared folders, email, and certain electronic business systems, were being used to store and manage records even though they did not have suitable records management functionality. In some of these systems there were insufficient controls in place to ensure the authenticity and integrity of the records they contained. Delays in filing information from shared folders to the core records management system also exposed records to alteration and deletion, ultimately impacting on the integrity and authenticity of the record. 

It is important to minimise data quality issues in information and records holdings so that the information and records can be considered accurate and reliable. DIAC is aware of data quality issues affecting significant migration processing systems, for example, the creation of multiple records where it cannot be reliably determined that the client records relate to the same person. In June 2011 a review of potential duplicate records in relation to one of the migration processing systems identified there were 653,861 multiple records.  These data quality issues have the potential to increase the risks associated with identity resolution, border operations and departmental reputation. From a policy and guidance perspective DIAC is reviewing the nature and source of data quality issues, and has plans, as part of its information management framework, to implement new data management arrangements to address these issues. 

A significant risk to Australian Government agencies in relation to records management is their ability to access complete and comprehensive information when it is required for business or legal purposes, including responding to freedom of information (FOI) requests in a timely manner. For the three agencies, information and records access was impeded by existing information and records management arrangements. For example, information and records for a business activity were often held in a variety of locations and electronic business systems. Staff did not have access to all locations and systems, and generally had limited understanding of information holdings that fell outside of their day‐to‐day responsibilities. Staff often stored information in a variety of places, but did not have consistent rules about the records that needed to be created and where they would be captured. This means information is captured, managed and accessible on a silo basis. The agencies did not have a widespread culture of consistently using approved records management systems, including the EDRMS and electronic business systems, to support efficient and comprehensive searches for information. 

Where electronic business systems are used to manage records, the retention and destruction of information should be undertaken in accordance with relevant records authorities. With the exception of designated records management systems, none of the electronic business systems examined by ANAO sufficiently provided for sentencing, destruction and transfer in accordance with records authorities. For most of the systems, fields could be overwritten. If this occurred, available audit trails would indicate an edit had occurred but generally did not identify the changes.

Connoisseurship

'Connoisseurship and Its Potential in Matters of Copyright' by Joan Kee in 8(2) Law, Culture and the Humanities (2012) 333-349 comments that -

 Among the most persistent and difficult problems in the field of copyright law is determining whether copying has actually occurred. This article responds to this challenge by proposing that judges and juries consider practices used in disciplines revolving around the close and methodical viewing of visual objects. Of special interest is connoisseurship, long employed by art historians, curators, and collectors to adjudicate the origins, provenance, and authenticity of art. Mindful of law’s emphasis on the spoken and written word, this article focuses especially on the visual analyses of Otto Pächt and Hans Sedlmayr, two art historians whose foundational status in the discipline of art history stems from the extent to which they attempted to systematically translate the experience of looking into words. The article concludes with a brief test case drawn from the high-profile 2005 dispute between architects Thomas Shine and David Childs over the latter’s alleged infringement of the former’s design.

EU Cookies and Transfers

The Article 29 Working Party - the independent advisory body drawn from the EU national data protection authorities, European Data Protection Supervisor and the European Commission - has released a 12 page Opinion (ie formal Guidelines) clarifying exemptions to the Cookie Consent Requirement in the EU 2002 E-Privacy Directive [PDF].

Earlier posts have noted the Working Party's concentration on 'consent' in electronic interactions.

This month's Opinion 04/2012 addresses which types of cookies are exempted from the informed user-consent requirement under the European Parliament Directive 2002/58 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy & electronic communications).

Article 5.3 of that Directive requires website operators to obtain informed consent from users prior to storing cookies on the devices of people visiting those sites -

Member States shall ensure that the use of electronic communications networks to store information or to gain access to information stored in the terminal equipment of a subscriber or user is only allowed on condition that the subscriber or user concerned is provided with clear and comprehensive information in accordance with Directive 95/46/EC, inter alia about the purposes of the processing, and is offered the right to refuse such processing by the data controller. This shall not prevent any technical storage or access for the sole purpose of carrying out or facilitating the transmission of a communication over an electronic communications network, or as strictly necessary in order to provide an information society service explicitly requested by the subscriber or user.

There are two exemptions -

•  when the cookie is used for the sole purpose of carrying out the transmission of a communication over an electronic communications network; and 
• when the cookie is strictly necessary in order for an "information society service" provider to provide the service  explicitly requested by the user. 

Where a doubt remains as to whether the cookie falls within an exemption, site operators should seek consent from the user.

The Opinion stresses the narrow scope of the first 'sole purpose' exemption. The words “sole purpose” mean that such cookies will be exempted only if they are strictly necessary for communication to take place over a network between two parties. Three elements should be considered -

• the ability to route information over the network, 
•  the ability to exchange data items, and 
•  the ability to detect transmission errors or data loss. 

The Opinion indicates that the second exemption is necessarily broader. It offers several examples -

• 'user input' cookies (shopping-cart cookies)
• authentication cookies such as those used to identify the user once that person has logged in to an online banking site
• security cookies designed to detect failed login attempts on a website, 
• multimedia player session cookies needed to play audio or video content. 

The Opinion emphasises that storage under the second exemption is restricted to what is strictly necessary for the user rather than the service provider. That has several consequences.

Third-party cookies used for behavioral advertising and third-party tracking cookies used by social network services such as Facebook in the collection of data for behavioral advertising or market research are thus not exempted. The duration of the cookie should reflect the functionality for the user. 'Persistent cookies' - that remain stored in a user’s device after the user closes the browser and potentially linger there for years - are less likely to be exempted.

In emphasising transparency the Opinion notes that "social networks have ample opportunity to collect consent from their members directly on their platform if they wish to conduct such tracking activities, having provided their users with clear and comprehensive information about this activity".

The Working Party has also released guidance [PDF] on Binding Corporate Rules for organisations transferring personal data outside of the European Economic Area on behalf of other bodies. The expectation is that the guidance will allow those data processors to develop internal codes of conduct relating to data privacy and ensure data transfer complies with EU data protection law.

ALRC

The Australian Law Reform Commission (ALRC) has released the Terms of Reference for its inquiry - headed by Professor Jill McKeough - into 'Copyright and the Digital Economy'.

The ALRC is to consider "whether the exceptions and statutory licences in the Copyright Act 1968 (Cth) are adequate and appropriate in the digital environment", having regard to:

• the objective of copyright law in providing an incentive to create and disseminate original copyright materials;
• the general interest of Australians to access, use and interact with content in the advancement of education, research and culture;
• the importance of the digital economy and the opportunities for innovation leading to national economic and cultural development created by the emergence of new digital technologies; and
• Australia’s international obligations, international developments and previous copyright reviews.

The ALRC is to consider - "amongst other things" - "whether existing exceptions are appropriate and whether further exceptions should" -

• recognise fair use of copyright material;
• allow transformative, innovative and collaborative use of copyright materials to create and deliver new products and services of public benefit; and
• allow appropriate access, use, interaction and production of copyright material online for social, private or domestic purposes.

The Commission is to -

• take into account the impact of any proposed legislative solutions on other areas of law and their consistency with Australia’s international obligations;
• take into account recommendations from related reviews, in particular the Government’s Convergence Review; and
• not duplicate work being undertaken on: unauthorised distribution of copyright materials using peer to peer networks; the scope of the safe harbour scheme for ISPs; a review of exceptions in relation to technological protection measures; and increased access to copyright works for persons with a print disability.