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Parliamentary questions
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17 April 2019
E-001938-19
Question for written answer E-001938-19
to the Commission
Rule 130
Damiano Zoffoli (S&D)

 Subject:  Shortage of Sinemet drug
 Answer in writing 

On 7 November 2019, the European Association of Hospital Pharmacists (EAHP) published the findings of its 2018 inquiry into the shortage of medicines (medicines shortages survey), concluding that this was a serious problem.

A ‘shortage’ is taken to refer to a medicine that cannot be obtained in parts of a country as the holder of the marketing authorisation (MA) is provisionally unable to secure an adequate and continuous supply.

The Community code relating to medicinal products for human use, implemented in Italy under Article 105(2) of Legislative Decree 2019 of 24 April 2006, requires manufacturers and distributors of drugs placed on the market to ensure that they are supplied to pharmacies in sufficient quantities to meet the needs of patients.

However, the Sinemet drug, which is used to treat Parkinson's disease, was in seriously short supply in February and October 2018. The pharmaceutical company Merck & Co has recently alerted the US Food and Drug Administration and other drug monitoring agencies around the world to the likelihood of continued shortages of Sinemet and Sinemet Plus in the first quarter of 2019.

Is the Commission aware of this serious problem and what measures is it willing and able to take to resolve it?

Original language of question: IT 
Last updated: 2 May 2019Legal notice