Other options

A statutory licensing regime

28.97 DP 68 discussed the possibility of introducing a statutory licensing regime for databases of genetic information. Such a regime could give researchers the right to access and use genetic databases for the purpose of research, in exchange for a reasonable royalty. An important difference between statutory licensing and fair dealing is that a statutory licence requires the payment of remuneration for use of the copyright material.

28.98 The Copyright Act contains several statutory licensing schemes that permit third party use of copyright works without prior negotiation or permission, in exchange for a reasonable royalty. These schemes include copying and communication of works and other material by educational institutions or institutions assisting readers with a print disability or persons with an intellectual disability, and the Crown use of copyright material.^[123]

28.99 Justice Sackville raised the possibility of establishing a statutory licensing regime for databases of factual compilations in Desktop Marketing Systems Pty Ltd v Telstra Corporation Ltd. His Honour commented that:

There may be powerful reasons … for requiring the owner of copyright in the compilation to submit to a compulsory licensing regime. Such schemes are established by statute in other areas … A compulsory licensing regime might appropriately reward the monopolist’s labour and expense, yet leave room for innovative competitors who cannot gain access to the basic information required to establish databases of potential commercial value.^[124]

28.100 Several commentators have suggested the desirability of establishing a statutory licensing scheme to facilitate access to factual compilations protected by copyright.^[125] The ALRC also notes that the HUGO Ethics Committee has recommended that provision be made for compulsory licensing of genetic databases in certain circumstances under the EU Database Directive.^[126]

28.101 The Attorney-General’s Department submitted that a statutory licensing regime could potentially be used to provide access to information stored in databases. However, the Department suggested that more analysis would be necessary to determine whether any benefits would be offset by the administrative burden on the parties involved.^[127]

28.102 DP 68 asked whether the Commonwealth should amend the Copyright Act to establish a statutory licensing scheme in relation to genetic databases protected by copyright.^[128] The Department of Industry, Tourism and Resources supported this approach, provided that it is consistent with Australia’s obligations under international agreements.^[129]

28.103 By contrast, most other submissions did not consider that a statutory licensing scheme was necessary at this stage.^[130] The Department of Health and Ageing suggested that, if other measures directed at facilitating reasonable access to genetic databases do not prove feasible, such a scheme should be considered.^[131] The Australian Centre for Intellectual Property in Agriculture (ACIPA) considered that there would be competition concerns involved in the collective licensing of genetic databases.^[132]

Database subscriptions

28.104 Another option is to facilitate access to genetic databases through subscriptions that subsidise or otherwise minimise licence fees for individual researchers and research institutions. This option is of particular relevance in relation to those databases that have been compiled in overseas jurisdictions, and therefore fall largely outside the scope of Australian copyright and contract law.

28.105 In June 2000, the National Health and Medical Research Council (NHMRC) negotiated a three-year agreement between the Australian Government and Celera Genomics. The agreement provided publicly funded researchers in Australia with subsidised access to five of Celera’s databases. Each participating institution paid an annual licence fee based on the number of teams seeking database access and which databases they accessed.^[133] On 1 July 2003, a new three-year academic subscription agreement commenced operation. Under the new agreement, the Applera Corporation administers all subscriptions directly with individual users and institutions.^[134] The NHMRC is no longer involved in the administration of the subscription. Fees under the new agreement have increased to US$2,000 per person per database, and all users requiring access must register individually.^[135]

28.106 IP 27 asked whether the NHMRC’s Celera subscription provides an appropriate model for seeking to increase Australian researchers’ access to information about the human genome.^[136] While few submissions addressed this issue, there was general satisfaction with the NHMRC’s subscription in consultation meetings.

28.107 DP 68 asked whether the new Celera subscription agreement had caused any significant concerns for public research institutions or researchers engaging in publicly funded research.^[137] DP 68 also asked whether the NHMRC, or another Commonwealth body, should have responsibility for monitoring the operation of agreements between genetic database owners and publicly funded research institutions within Australia.^[138]

28.108 Many submissions suggested that the new Celera agreement has not raised any concerns to date.^[139] ACIPA commented that the Celera subscription ‘is an adequate model for seeking to increase Australian researchers’ access to information about the human genome’. In ACIPA’s view, the NHMRC should be responsible for monitoring the operation of agreements between genetic database owners and publicly funded research institutions within Australia. ACIPA also considered that Australian guidelines are necessary to ensure that research is not being withheld from the public domain.^[140]

28.109 It was suggested in consultations that independent monitoring of the operation of genetic database subscriptions would be of value, in particular in relation to the needs of researchers and research institutions.^[141] The NHMRC submitted that a body such as the Human Genetics Commission of Australia (HGCA) should be given responsibility for monitoring and reviewing patent practices generally in relation to genetic materials. It suggested that, as part of this role, the HGCA could monitor the impact—both positive and negative—of any agreements between genetic database owners and publicly funded research institutions.^[142]

28.110 By contrast, several submissions stated that there was no need for such monitoring.^[143] The Queensland Government submitted that monitoring might be of benefit in the future, depending on the practices of the genetic database owners in providing access to their databases.^[144]

28.111 Finally, the Centre for Law and Genetics noted that the NHMRC intends to review the National Statement for Research For Ethical Conduct in Research Involving Humans with a view to including a new set of principles governing human genetic databases.^[145] The Centre suggested that it would be appropriate that:

the new guidelines include a requirement for those responsible for the genetic database to complete reports on databases as part of the annual compliance system for human research ethics committees. In addition, it may be desirable for the proposed HGCA to monitor the operation of genetic databases and their relation with public funded institutions.^[146]

ALRC’s views

28.112 The ALRC does not intend to recommend a statutory licensing scheme for genetic databases, or any reforms in relation to database subscriptions. While several submissions indicated general support for these options, they were generally not considered necessary at this time.

28.113 If the need arises in the future, the ALRC suggests that the Australian Government give consideration to implementing a statutory licensing scheme in relation to databases protected by copyright. This approach would have the benefit of facilitating reasonable access to such databases for research purposes in return for reasonable remuneration.

28.114 The ALRC agrees with suggestions that the HGCA should monitor the application of copyright law to genetic databases used in medical research or human health. Recommendation 19–4 anticipates this role.