Health Sector Response to Genetic Material Patents
61. Internationally, there have been a number of suggestions regarding possible health sector responses to patents. A report commissioned by the National Health Service (NHS) in the UK, recommended the NHS should take a more active role in the area of IP law and formulate an IP Management Strategy. It recommended that the NHS should have in place mechanisms for assessing whether to:
- make a submission to the patent office during the assessment process that could restrict the scope of the patent approved;
- challenge the validity of a generic patent once it had been granted by opposition proceedings; and/or
- challenge any abuse of monopoly power through competition laws.
62. The Ontario report suggests that the Canadian Federal Government should consider compulsory licensing of patents relating to the provision of genetic diagnostic and screening tests, to be granted by the Commissioner of Patents in return for a reasonable licensing fee. It may often be in the public interest to allow licensing particularly when the invention relates to a disease gene (such as familial breast cancer). In these cases compulsory licensing and crown use provisions could be considered.
63. The ALRC has recommended that the proposed Human Genetics Commission of Australia (HGCA) should monitor the application of intellectual property law to genetic materials and technologies. In particular to:
- provide information to IP Australia about the appropriate scope of some patents;
- liaise with the Australian Health Ministers Advisory Council (AHMAC) about the advisability of opposition, re-examination or revocation of a patent under the Patents Act; and
- liaise with AHMAC about whether access to patented inventions should be obtained under Crown use or compulsory licensing provisions of the Patents Act.
Comment
64. We believe the health sector should further examine whether a publicly funded health system engaged in a broad range of healthcare delivery should be able to make greater use of Crown use provisions to enable wider public access to genetic testing. The public health sector could also take a more active role by screening patent applications. However, this would be very resource intensive and the health sector would need to balance this against other health priorities.
65. There is no system for monitoring licence fees or licence terms in New Zealand and it is left to negotiation between the parties. There will often be inequality of bargaining power for licensing fees. This may create inequalities between royalties paid by different DHBs. The GTG patents have highlighted the need for a national approach when dealing with licensing arrangements for the health sector. The Ministry of Health will need to further investigate options for using government funding and purchasing power to control the cost of goods and services that are used in provision of health care and are subject to gene patenting.
66. We are interested in the recommendation by the ALRC of establishing a Human Genetics Commission. If it is established we would be interested in potential New Zealand involvement in the Commission and recommend that the Ministry of Health discuss this possibility with relevant Australian authorities further, in conjunction with MFAT.
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