Local view for "http://purl.org/linkedpolitics/eu/plenary/2011-02-15-Speech-2-597-000"
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"en.20110215.30.2-597-000"2
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"Allow me to address each of the four component questions in turn.
The third question was: why did the Commission not act until as late as June 2010 when it finally took a clear decision on the marketing of that molecule? The answer: it was only in 2009 that a Member State, namely France, suspended the marketing authorisation of Mediator. Under the new provisions in place since 2004, this automatically triggered a review of the product’s benefit-risk balance, which led to the adoption of a Commission decision requiring all Member States to revoke any national authorisations for benfluorex containing medicinal products.
In this context, it is important to stress that the new pharmacovigilance legislation adopted on 15 December 2010 introduced additional provisions to ensure signal detection by the European Medicines Agency of safety issues for nationally-authorised products and creates new procedures at EU level to assess safety signals for such products, leading to harmonised actions by the Member States.
The fourth and last question was: will the Commission ask the European Medicines Agency to conduct a full retrospective investigation into the ways in which this drug was used over 20 years? The answer: to date, the Commission has not asked the European Medicines Agency to conduct a full retrospective investigation into the ways in which this medicinal product was used over 20 years. The figures and the documentation referred to in the French report clearly indicate that by far the highest use of this medicinal product was in France.
The first question was: can the Commission explain why a decision was not taken in 1998 to ban the marketing of pharmaceuticals containing benfluorex? The answer: benfluorex was discussed in 1998 in the Committee for Proprietary Medicinal Products, now called the Committee for Medical Products for Human Use, of the European Medicines Agency, and subsequently in the Pharmacovigilance Working Party.
The committee considered that benfluorex should not be included in the scope of an ongoing evaluation procedure at European level, concerning certain anorectic agents due to a different mode of action. However, it was agreed that the committee’s pharmacovigilance working party would investigate if there was a safety issue with this compound. In March 1999, the pharmacovigilance working party concluded that there were no major benefit-risk concerns for medicinal products containing benfluorex. Further discussion in the working party did not lead to changes in this conclusion.
The second question: should the Commission not have been alerted and not first by the bans imposed by the authorities in Spain and Italy? The answer: Italy and Spain did not revoke the marketing authorisation for benfluorex. In fact, the first time that a Member State effectively took measures to revoke the national marketing authorisation for Mediator was in 2009, when France suspended its national marketing authorisation.
In Spain, it was the marketing authorisation holder, Servier, that withdrew the marketing authorisation in 2003. Similarly, it was Servier itself that did not request the renewal of the marketing authorisation in 2003 in Italy.
The product remained authorised in France, Portugal, Luxembourg and Greece. Benfluorex was discussed within the pharmacovigilance working party, acting in its role as a forum for Member States to exchange pharmacovigilance data among themselves.
I would like to clarify that monitoring of pharmacovigilance data and the subsequent decision making on national authorisations for medicinal products is the primary responsibility of Member States. Commission intervention in these cases is exceptional and limited to concrete situations foreseen in the legislation.
The Commission can launch a Europe-wide evaluation by the European Medicines Agency in two cases: firstly, when Member States adopt divergent national decisions concerning a marketing authorisation and, secondly, before any decision is reached on the granting, variation, suspension or revocation of a marketing authorisation that appears necessary, in particular, when taking account of pharmacovigilance information in cases where it considers that the interests of the Community are involved.
In this case, no action was triggered at EU level in the light of the conclusions of the pharmacovigilance working party and the fact that no divergent decisions were taken at the time by the Member States in response to the discussions in the working party."@en1
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