Human beings as patented GMOs: FOI release

Information requested

How is it recorded on Scottish Government systems that a Human Being cannot be patented as a Genetically Modified Organism (GMO) and that this is enshrined in Scots Law?

As with the earlier Freedom of Information (Scotland) Act 2002 request (now at the Internal Review stage) on the Nuremberg Code, if the Scottish Government do not hold recorded information on this aspect of bioethics then please apply the Section 17(1) exemption.

Response

While our aim is to provide information whenever possible, in this instance the Scottish Government does not have the information you have requested because the topics of human genetics and patents are not devolved to Scotland. Schedule 5 of the Scotland Act 1998 (as amended in 2012 and 2016), lists those matters that are reserved to Westminster.

These are subdivided into two categories, general reservations and specific reservations.

Specific reservations cover particular areas of social and economic policy, listed under 11 “Heads”. Head C specifies 'Intellectual property' (which includes patents and all matters relating to the Patent Office) and Head J specifies genetics (which includes human genetics).

The Explanatory Notes for the Scotland Act confirms here that “All matters relating to human genetics not already reserved by the reservation of the subject-matter of the Human Fertilisation and Embryology Act 1990 will be reserved. This includes research, testing or treatment concerning the human genome or genetic disorders including gene therapy research and all matters relating to the social, ethical and economic consequences of human genetics, such as providing genetic tests for insurance or employment purposes or patenting genetic material.”

This is a formal notice under section 17(1) of FOISA that the Scottish Government does not have the information you have requested.

You may wish to note that Paragraph 3 of Schedule A2 of the Patent Act 1977 (an act of the UK Parliament that covers the whole of the UK, including Scotland) states: “The following are not patentable inventions-

(a) the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene;
(b) processes for cloning human beings;
(c) processes for modifying the germ line genetic identity of human beings;
(d) uses of human embryos for industrial or commercial purposes;
(e) processes for modifying the genetic identity of animals which are likely to cause them sufferingwithout any substantial medical benefit to man or animal, and also animals resulting from such processes;
(f) any variety of animal or plant or any essentially biological process for the production of animals or plants, not being a micro-biological or other technical process or the product of such a process.”

 

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