Recommendations

Memorandum to Cabinet Policy Committee: Report Back with Recommendations and Options for Addressing Genetic Material Patents

Hon Annette King, Minister of Health and Hon Judith Tizard, Associate Minister of Commerce

[ Last Updated 25 October 2005 ]

It is recommended that the Committee:

Note that in October 2003 Cabinet directed officials from the Ministry of Health and MED, in consultation with MAF, MoRST, MFAT and Te Puni Kōkiri, to report back to POL with recommendations on the issues and options for addressing genetic material patents (POL Min (03) 26/5).
Note the following issues emerge around genetic material patents:
- Impact on research: while patents are designed to foster research and increase information sharing, there is emerging evidence that patents on genetic material can also discourage research.
- Impact on provision of health services: there has been concern expressed that patents on genetic material may restrict access to or increase the cost of health care.
- Consistency with international obligations and practice: any changes to New Zealand law or policy would need to be consistent with New Zealand's international obligations, in particular, TRIPS.
Note that there are two vehicles for influencing the effects of genetic material patents. The first is to change patent law and the second is to influence how the law is applied. In general, we recommend in the first instance that the focus should be on how the law is applied.

Should Genetic Material Be Patented

Note that we do not support the exclusion of genetic material from patentability because of:
- the large number of genetic material patents that have already been granted;
- the difficulty in defining genetic material;
- the likelihood of inconsistency with New Zealand's international obligations; and
- possible negative effects on the research community.

Note that a genetic material patent only needs to identify one utility to obtain a patent over the gene itself. The patent holder will then hold a broad patent that would cover any subsequent use of that gene (for a period of 20 years) which allows them rights over any subsequent research or use of the patented genetic material.
Note that we have concerns about the breadth of some genetic material patents as patents that are overly broad may impede further research and lead to excessive licensing requests.
Note that more stringent application of the criteria for granting a patent will go some way to addressing concerns around the patenting of genetic material.

Note that IPONZ will develop new guidelines to assist with their interpretation of the amended Patents Act.
Agree that IPONZ consult widely (including the health sector) in the development of its guidelines to ensure a broad perspective in determining the best interpretation of the Patents Act, and in particular the interpretation of the criteria for the granting of a patent.
Agree that MED report back to Cabinet by 30 May 2005, describing:
1. progress on implementing the actions designed to allow more stringent application of the revised Patents Act when it comes into force; and
2. progress made internationally towards finding mechanisms for narrowing the application of patents on genes.

Note that there is emerging evidence that genetic material patents may actually impede and restrict further innovation and research.
Agree that MED, in consultation with MoRST, carry out further policy work on the possibility of adding a research exemption to the Patents Act and report back to Cabinet by the end of December 2004.

Note that inventions whose commercial exploitation would be contrary to morality or ordre public will be excluded from patent protection under changes proposed for the Patents Act.
NoteIPONZ will need to develop the capability necessary to make decisions about public morality. Cabinet has already agreed that there be a requirement for IPONZ to consult externally with relevant bodies (such as the Bioethics Council and the National Ethics Advisory Committee) on issues of public morality.
Agree that IPONZ consult widely when developing guidelines for determining whether a commercial exploitation of a particular invention would be contrary to morality or ordre public.

Note that the amended Patents Act will contain provisions establishing a Māori Consultative Committee for the Intellectual Property Office. The terms of reference have yet to be decided, however they will include advising the Commissioner of Patents on whether the commercial exploitation of inventions that involve traditional knowledge or indigenous plants and animals would be contrary to Māori values.

Agree that the Ministry of Health undertake further policy work on the implications for the public health system of patents over genetic materials and diagnostic tests and how how these are licensed in the health sector, with a report back to Cabinet by 30 May 2005 on:
1. international developments in protecting public access to health care against abuse of monopoly power;
2. fiscal risks in the health sector resulting from the application of patents over genetic material.
Agree that the Ministry of Health, in consultation with MFAT and MED, investigate possible links with Australia, with regards to monitoring the granting of patents over genetic material.
Agree that this paper be released on the MED website as soon as decisions are made, subject to any necessary deletions justified in accordance with the Official Information Act 1982.

Printed: 25/11/2009