PLASMA DERIVED-PRODUCTS MANUFACTURING PROCESS
PRESS RELEASE
The Italian Competition Authority has submitted an advisory opinion to the Chamber of Deputies and the Government with regards to the distortions to competition in the plasma-derived products market, regulated by Law no. 107/90.
This law provides that for plasma collected in Italy the manufacturing process must be carried out exclusively in the national territory and only by authorized firms who can realise the entire transformation process of plasma in its derived products, which are distributed to the public health service system. At the present time, only one firm presents these characteristics in Italy.
The Authority has verified if the carrying out, on the national territory of all phases of the transformation process could ensure a greater safety of the derived products which utilise plasma collected in Italy. On concluding its inquiry, the Authority found that the obligations provided for by the Article 10 of Law no. 107/90 not only are unnecessary to guarantee a better protection of the public health and a greater safety of the derived products processing, but also restrains the technical progress and the production quality improvement themselves.
The requirements necessary to be licensed and accredited to carry out the manufacturing of medicinal products derived from plasma end up protecting the Italian firms not only from rivals working abroad, but also from potential competitors who could decide to operate in Italy. As a result, in the absence of alternatives in the supply of plasma derived-products, the public health service system, which incurs the costs related to blood collection, is impeded from obtaining better conditions in terms of quality and range of the products derived from plasma collected in Italy, and it has to accept the conditions established by the only authorized firm.
Furthermore, the current regulation concerning the collection and treatment of plasma contributes to hindering new entry, thus inhibiting the creation of competition which could drives the currently working firms to improve their own activity in terms of quality and range of products.
On the basis of these considerations, the Authority points out the opportunity to remove the provision under the Section 10, subsection 3, of the Law no.107/90, in the part establishing that firms whose plants are situated, either in all or partly, abroad, are prohibited to be licensed by the Minister for Health in order to stipulate conventions for the treatment of plasma collected in Italy.