On 23 January 1995, a Conciliation Committee meeting between representatives of the European Parliament and the EU's Council of Ministers agreed a "joint text" on the proposed Directive concerning the legal protection of biotechnological inventions. The Parliament and the Council are expected to adopt the Directive in February 1995. The proposed Directive would harmonize national rules on the application of patent protection to biotechnological inventions. The aim of the Community legislation is to prevent trade barriers within the single market arising from differences between national legislation in this field and to clarify rules across the EU with a view to improving the competitiveness of Community industries using biotechnology. The proposed Directive is the first-ever example of EU law which refers to the "dignity of man". In particular, the Directive will establish a framework of rules on the ethics of particular biotechnology applications, with the consideration of individual cases left strictly to national authorities (such as courts and patent offices). In particular, the Directive will not affect national and Community laws on the monitoring of the applications of research and of the use or commercialization of its results. The Directive specifies that inventions will be considered unpatentable where publication or exploitation would be contrary to public policy or morality. On this basis the following will not be patentable: - The human body or parts of the human body; - Processes for modifying the genetic identity of the human body contrary to the dignity of man; - Processes for modifying the genetic make-up of animals likely to cause them suffering or physical handicaps. The Directive is essential to ensuring a stable intellectual property framework for biotechnological inventions, without which the huge investments necessary in research and development could not take place within the EU. Biotechnology, identified as a key technology by the 1993 White Paper on Employment, Competitiveness and Growth, is increasingly applied in a very wide range of key economic sectors, such as pharmaceuticals, chemicals, plastics, environmental protection and agriculture.
Policy making and guidelines
3 March 1995