Patenting human stem cells – EGE advocates caution

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Patenting human stem cells – EGE advocates caution

On May 7 the European Group on Ethics in Science and New Technologies (EGE) presented to the Commission its latest opinion 'Ethical aspects of patenting involving human stem cells'. The opinion aims to define the conditions and limits of the patenting of stem cells.

The role of the EGE is to advise the Commission on how the ethical values of European societies can be taken into consideration in the scientific and technological developments promoted by EU policies.

The key points of the EGE's opinion are:

  • only human stem cell lines which have been modified by an inventive process to give them new characteristics for specific industrial application should be patentable;

  • stem cells which have been isolated and cultured but are unmodified should not be considered as patentable inventions;

  • recourse to compulsory licences should be encouraged when the access to diagnosis and treatment is blocked by misuse of patent rights;

  • it is the responsibility of the member states to establish the legal framework for the delivery of compulsory licences and to examine if fair access to healthcare justifies such a procedure;

  • it is necessary to secure the right balance between the inventors interests and the interests of European societies;

  • a cautious approach should be adopted when considering patentablility of cloning techniques aimed at obtaining human embryonic stem cells for therapeutic purposes taking into account the exclusion of such inventions from patentability; and

  • patents on stem cells facilitates further research and the EGE calls for the creation of an EU registry of unmodified human stem cell lines. The registry should include both embryonic stem and embryonic germ cells lines.

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Helen Cline

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