Members of the European Parliament call EU Health Commissioner to place in silico medicine on her policy agenda from 2021 onwards!

On 22 June, a group of five Members of the European Parliament (MEPs) sent a letter to Commissioner for Health, Stella Kyriakides to call for action on computer modelling and simulation (CM&S).

The groups of MEPs representing the main political parties within the European Parliament, MEPs Sean Kelly (European People’s Party, Ireland), Frédérique Ries (Renew Europe, Belgium), Brando Benifei (Socialists & Democrats, Italy), Margrete Auken (Greens/European Free Alliance, Denmark), and Pietro Fiocchi (European Conservatives & Reformists, Italy) co-signed this letter with the aim of outlining why regulatory guidance is urgently needed to make European healthcare systems and patients fully benefit from in silico technologies.

Particularly, the letter addresses how CM&S can initiate major progress in health care, such as in the fields of rare and paediatric diseases and health system sustainability. In that context, it demonstrates by means of tangible examples that the policy frameworks currently in place are not sufficient for these technologies to advance.

That being said, the letter reiterates that clear guidelines and rules must be developed for industries and researchers in the field of CM&S, so as to minimise or even remove any policy barriers now and in the future.

With this, the letter calls upon the Commission to initiate the following actions:

  1. Launch an open consultation on the use of CM&S in healthcare
  2. Include the use of CM&S in any revision of the Paediatrics Regulation to ensure the highest safety standards for children
  3. Encourage the use of “in silico trials” in any revision of the Orphan Medicinal Products Regulation to improve our understanding of rare diseases
  4. Work with the US FDA and other regulatory agencies to develop “Good Simulation Practices” internationally to avoid the creation of unnecessarily differing standards that restrict the growth of this field

The Avicenna Alliance is very pleased with this wide-ranging support received by the Members of the European Parliament to ensure that new technologies in healthcare can thrive, and are looking forward to the Commission’s response!

Please find the letter here.

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