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Parliamentary questions
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20 August 2018
E-003801/2018(ASW)
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: E-003801/2018

The Commission is aware of the epidemiological data of fibromyalgia syndromes including the impact of the disease on employment of affected people.

As regards a marketing authorisation of a medicinal product in the EU, according to the pharmaceutical legislation,(1) it is granted only after the quality, safety and efficacy of the product has been evaluated and a positive benefit-risk balance related to its use has been concluded.

Three medicines (pregabalin, milnacipran, and duloxetine) have been approved in the United States of America for the treatment of fibromyalgia. Applications of these medicines for the indication concerned were also submitted to the European Medicines Agency (EMA).

After careful examination, EMA was of the opinion that the benefits of these medicines in the treatment of fibromyalgia did not outweigh the risks and therefore recommended that the marketing authorisation be refused in this indication(2).

As regards the diagnosis and treatment of fibromyalgia, Article 168 of the Treaty Union on the Functioning of the EU(3) stipulates that organisation and delivery of health services and medical care, including diagnostic services and pain management, fall under the responsibility of Member States.

(1)Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, as amended.
(2)Scientific conclusions and grounds for refusal presented by EMA: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000546/WC500076177.pdf http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/001122/WC500089831.pdf http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000572/WC500076168.pdf
(3)http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012E/TXT&from=EN

Last updated: 22 August 2018Legal notice