Intellectual & Industrial Property Industrial Property

Biotechnology: Commissioner Monti welcomes European Parliament Opinion

Single Market Commissioner Mario MONTI has welcomed the transparent, open and in-depth debate which has taken place in the European Parliament on the proposed Directive concerning the legal protection of biotechnological inventions. This debate has made it possible to find the right balance between, on the one hand, the need to ensure that the results of European research can be used throughout the Single Market, in particular for therapeutic purposes and, on the other hand, that ethical aspects to protect the human body are taken into account. The text which results from the Parliament's vote is clear: human cloning is formally prohibited, as are processes for modifying the germ line genetic identity of human beings. The Commission has therefore accepted the amendments proposed by the Parliament to achieve this aim.

"We have found the right balance between economic requirements and sensitivity to ethical issues" commented Commissioner Monti. "We have therefore fulfilled the task that we set ourselves when the original proposal was rejected by the Parliament: to undertake an in-depth reflection with all interested parties with a view to finding the best solution in this sensitive field. The competitiveness of Community industry is at stake, as biotechnology is increasingly important and can give rise to major employment opportunities. If we do not ensure a stable and coherent legislative framework concerning patentability, companies will not be ready to undertake the major investment necessary for the development of these new technologies. I must, however, stress that patent protection does not apply to the use of the invention for teaching or research, but only for commercial use. For this reason, far from constituting an impediment to theoretical research, patent protection makes it possible to develop applications of this research, in particular in the area of health".

During the European Parliament's debate on the proposal for a Directive, Mr Monti announced that the Commission could accept all the amendments aiming to ensure ethical issues are taken into account and to clarify, to this end, the text of the proposed Directive. This involves basically:

• the difference between discovery and invention in connection with the isolated elements of the human body
• the exclusion from patentability of animal races and plant varieties
• the exclusion from patentability of procedures for human reproductive cloning and of processes for modifying the germ line genetic identity of human beings
• the requirement that the ethical dimension must always be taken into account and the possibility that this dimension can be suitably appraised
• the substantial medical usefulness of the inventions in question must be balanced with the suffering that certain inventions could inflict on animals
• a better definition of farmers' privilege concerning the sale of breeding stock animals.

However, there is only one amendement which raises problems concerning the international committments of the Union.

[ Update on the Single Market ] - [ Free Movement of People & Individual Rights ] - [ Free Movement of Goods ] - [ Services & Establishment ] - [ Financial Services ] - [ Company Law, Accounting & Auditing ] - [ Public Procurement ] - [ Media, Information Society & Data Protection ] - [ Intellectual & Industrial Property ] - [ Economic & Monetary Union ] - [ Infringements ]