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EPC Art. 52(4) states that methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body are not to be regarded as inventions which are susceptible of industrial application. The methods set out in Art. 52(4) are excluded from patentability as a matter of policy. This exclusion is not a new provision under the EPC. Before the EPC came into force, such methods were excluded from patentability under the national laws of many European countries. The policy behind the exclusion of such methods was clearly to ensure that those who carry out such methods as part of the medical treatment of humans or the veterinary treatment of animals should not be inhibited by patents. According to the intention of Art. 52(4) was only to prevent non-commercial and non- industrial medical and veterinary activities from being restrained by patent rights. Like any exclusion clause, Art. 52(4), first sentence, had to be narrowly construed, and should not apply to treatments which were not therapeutic in character or did not constitute a surgical or diagnostic method -a fact underscored by the statement in the second sentence that the exclusion from patentability did not apply to products for use in such methods. Genetic therapy uses purified preparations of a gene or a fraction of a gene to treat a disease. This can be done either by correcting the functioning of a cell in which a single gene does not work properly from birth or sometimes by killing a cell which is out of control. Therefor diseases such as cystic fibrosis, diabetes, Parkinson's, Alzheimer's, heart disease and cancer are all targets for gene therapy. Patents are not granted if the exploitation would be contrary to "ordre public" or "morality". Some patient and public interest groups argue against patenting of human genes on the principle that genes are in every person, belong to all, and their use should not be restricted in any way. However, by establishing an exclusive position, a patent provides an incentive to invest in research and development. Without patent protection, companies would not invest the large amounts of money needed to develop the use of genes and gene products for therapy. Any new discovery can be misused. That ist precisely why we need a set of rules and guidelines which ensure practices are used only according to ethical standards agreed upon after political, scientific and medical discussion. We also need much more public understanding and informed discussion, since in the long term this is the only insurance against misuse.