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Questions and Answers in the EU

On 28 October 2008, European Commissioner Ms Vassiliou answered questions put to her by EU member Mr Popa on EU recognition for fibromyalgia, the need for treatments in Europe for fibromyalgia and the need for more data from research.


1. Can the Commission state its position on fibromyalgia, as the WHO did in 1992? Does the Commission think that there is a need for action at European level, in the interests of European citizens, in order to avoid the disparities in diagnoses and treatment which exist in all Member States?

Answer: In accordance with the Treaties, the benefits that Member States provide under their health systems and the conditions applicable are up to Member States to determine, including with regard to the benefits and treatments provided for specific conditions such as fibromyalgia.

2. Can the Commission comment on the lack of availability of approved treatments in the EU for fibromyalgia? Millions of people suffering from fibromyalgia across Europe do not have the same access to medicines to treat fibromyalgia as in the US. Following its October meeting, the Committee for Medicinal Products for Human Use (CHMP) took a negative decision regarding the first medicine for the treatment of fibromyalgia in Europe. Patients across Europe were disappointed to hear that a licence to approve a drug for fibromyalgia had not been granted. Yet the reality is that in Europe patients are taking medicines off-label. What solution does the Commission see for this specific problem?

Answer: The fact that the Committee for Medicinal Products for Human Use (CHMP) proposed a negative decision regarding the market authorisation of a medicine for the treatment of fibromyalgia in Europe does not preclude future authorisation of other proprietary medicines that meet the safety, efficacy and quality requirements laid down in EU legislation.

3. In order to obtain a treatment for fibromyalgia, there is a need to collect EU data. Can the Commission help collect and receive data and also help with the coordination of national expertise?

Answer: The Commission already pointed out that under the current health programme 2008-13 a proposal for surveillance of and information on musculoskeletal diseases including fibromyalgia has been selected and a contract is under negotiation. This project, if the contract can finally be successfully concluded, is expected to contribute to improvement of European data on incidence and prevalence of fibromyalgia as well as information on best practice of diagnosis, treatment and care.

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