Answer given by Ms Kyriakides on behalf of the European Commission

The Commission would like to inform the Honourable Member that medicines for rare diseases fall already under the mandatory scope of the centralised marketing authorisation in accordance with Regulation (EC) 726/2004[1].

The measures regulating prices and reimbursement of medicines within the EU are a national competence[2] and currently there are no common EU price negotiations.

Still, the Pharmaceutical Strategy for Europe[3] promotes cooperation between national authorities for pricing and reimbursement of medicines through sharing knowledge and exchanging practices, including on public procurement.

The EU Health Programme supported Organisation for Economic Cooperation and Development work on improving performance-based entry agreements[4] and a database for authorities to exchange pricing information[5].

The Commission does not conclude contracts with the industry on orphan medicines. Yet, to strengthen the continuity and security of supply in the EU, a number of initiatives are described in the strategy[6], including the revision of the legislation to introduce stronger obligations for supply and transparency and earlier notification of shortages.

• [1] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32004R0726&from=EN
• [2] Articles 34, 36 and 168(7) Treaty on the Functioning of the EU: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012E/TXT&from=EN
• [3] See Section 2.3 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52020DC0761&from=EN
• [4] https://ec.europa.eu/health/sites/health/files/policies/docs/2019_entryagreements_newmedicines_oecdeu_en.pdf
• [5] https://webgate.ec.europa.eu/chafea_pdb/health/projects/664317/outputs
• [6] See Section 4.1 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52020DC0761&from=EN