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Parliamentary questions
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27 February 2019
Question for written answer E-001079-19
to the Commission
Rule 130
Soledad Cabezón Ruiz (S&D)

 Subject:  Shortages of medicines
 Answer in writing 

The EU is facing a serious shortage of medicines arising from problems relating to manufacturing, quality issues, products being discontinued and the difficulty in obtaining active ingredients, among other factors. Supply problems put patients at risk as, at times, there is no alternative treatment or medicine available.

Article 81 of Directive 2001/83/EC stipulates measures to prevent shortages of pharmaceutical products by means of a so-called public service obligation, which requires manufacturers and distributors to safeguard supplies to national markets.

The issue of medicine shortages was one of the priorities of the Bulgarian Presidency, although we are unaware if any measures were adopted in this regard.

The 2017 European Parliament report on EU options for improving access to medicines calls for Article 81 to be implemented properly. Medicines on the internal market require coordinated action at European level to avoid competition between Member States.

1. What measures will the Commission take to address shortages of medicines?

2. Is the Commission considering monitoring compliance with Article 81?

3. How does the Commission intend to control production capacity in order to avoid cutting supply?

Original language of question: ES 
Last updated: 11 March 2019Legal notice