this is one of the proposals advanced by the Committee for hygiene and sanità of the Senate – in the draft document released by Aduc – at the conclusion of the fact-finding investigation launched to draw conclusions about the medical abortion and to verify the compatibilityà with the abortion law.
The opinions expressed by the Commission of Palazzo Madama, however, are not binding.
“with Respect to concerns about deaths as a result of taking Ru486 or prostaglandins are associated, and in the face of difficulty; of reliable data – it is stated in the draft final document – it is hoped an arbitration request that reopens the discussion on the risk/benefit ratio and put in place a new appraisal and deliberation by the Emea”.
The so-called arbitration, in accordance with the process of mutual recognition adopted by the company are the manufacturer of Ru486, that will arrive on the Italian market, può be activated when one or more member States, having detected the possible risks to the sanità the public, do not intend to proceed to the recognition of the drug in question.
In this way, the whole matter is referred to the Cpmp (Committee for the evaluation of specialtyà medicinal products of the Emea), the final decision must be transposed by all the member States concerned.
Page published on November 23, 2009