Proposal for a regulation
Recital 3 a (new)
(3a) It should also be noted that the continuous expansion of the pharmaceutical industries and the production of generics and biosimilars in certain third countries, in particular China and India, have had two unfortunate consequences: the concentration of effluent pollution from production units, which poses a major threat to global health, in particular by causing antibiotic resistance; and the dependence of EU health systems on imports of raw materials, in particular active ingredients, while these are strategic activities that should be kept on European soil. In order to protect the environment and the health of European citizens – but also global public health – support must be given to the production of generics and biosimilars in the EU.