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Parliamentary questions
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25 May 2018
E-001858/2018(ASW)
Answer given by Mr Andriukaitis on behalf of the Commission
Question reference: E-001858/2018

The Commission is aware of the Member States concerns related to HIV/AIDS, tuberculosis and hepatitis. A Commission staff working document on ‘Combatting HIV/AIDS, viral hepatitis, sexually transmittable diseases and tuberculosis’ in the EU and neighbouring countries is currently being prepared.

Pre-exposure prophylaxis as an additional prevention option has the potential to reduce HIV transmission(1). According to the pharmaceutical legislation(2) a marketing authorisation is granted for a medicinal product in the applied indication only after its quality, safety and efficacy have been evaluated and a positive benefit-risk balance related to its use has been concluded. Information about a benefit-risk assessment of all EU centrally authorised products including also the product concerned is included in the European Public Assessment Reports(3).

However, the decision of whether to introduce pre-exposure prophylaxis, as well as its price for patients, are the competences of Member States as established in Article 168 of the Treaty on the Functioning of the European Union(4).

(1)http://ecdc.europa.eu/en/publications/_layouts/forms/Publication_DispForm.aspx?List=4f55ad51-4aed-4d32-b960-af70113dbb90&ID=1587
(2)Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, as amended
(3)http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d125
(4)http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012E/TXT&from=EN

Last updated: 28 May 2018Legal notice