OpenLobby.EU
Explore

Evaluation of the legislation on medicines for children and rare diseases (medicines for special populations)

Public health

This joint evaluation covers the legislation on medicines for special purposes, in particular medicines for children and medicines to treat rare diseases. The evaluation will assess to which extent the EU legislation is efficient and effective and considers whether it is fit for purpose in the light of developments in the area of pharmaceuticals. It will look in particular in the impact of the incentives introduced for research, development and marketing, for these specific medicines.

Links

Public consultation

ID: 1248

Lobbying Activity

9 responses

Consultation response

European Federation of Pharmaceutical Industries and Associations, 21 Dec 2017

EFPIA and EuropaBio welcome the opportunity to comment on the European Commission’s roadmap on the evaluation of the legislation on medicines for children and rare diseases (medicines for special populations). It is to note that both the Orphan Medicines and Paediatric Medicines Regulations have…

Consultation response

European Confederation of Pharmaceutical Entrepreneurs, 8 Jan 2018

EUCOPE, the European trade association for innovative pharmaceutical and biotech small to mid-sized and family-owned companies, welcomes the opportunity to provide feedback on the Roadmap published by the EU Commission on 11 December 2017 for the planned evaluation of the legislation on medicines…

Consultation response

European Social Insurance Platform AISBL, 8 Jan 2018

The European Social Insurance Platform, ESIP, strongly welcomes the initiative of the European Commission to evaluate the legal framework concerning paediatric and orphan medicines and the interaction between the two pieces of legislation. In particular, we welcome the intention to carry out a more…

Consultation response

European Society for Paediatric Oncology, 8 Jan 2018

Dear, Please find enclosed the feedback from SIOPE - the European Society for Paediatric Oncology, entitled: "Paediatric Cancers and the 2 Regulations*: a catch-22 situation?" Please also find a summary of the SIOPE recommendations here below: • Explore why pharmaceutical companies use…

Consultation response

Plasma Protein Therapeutics Association Europe, international Association without lucrative purpose, 8 Jan 2018

PPTA, the Plasma Protein Therapeutics Association, welcomes the opportunity to comment on the European Commission Roadmap regarding the Evaluation of the legislation on medicines for children and rare diseases which was published on 11 December 2017. The Plasma Protein Therapeutics Association…

Consultation response

Alliance for Regenerative Medicine, 7 Jan 2018

The Alliance for Regenerative Medicine (ARM) thanks the European Commission for the opportunity to comment on its evaluation roadmap regarding the regulations on medicines for rare diseases and for paediatric medicines. ARM is a global advocacy organisation that promotes legislative, regulatory,…

Consultation response

Verband Forschender Arzneimittelhersteller e.V., 21 Dec 2017

The legislation on medicines for children and rare diseases has been a success story for the patients since meanwhile many medicines have been successfully developed in these fields - and many more are in development. Therefore there is no need to change theses regulations. Yet this does not…

Consultation response

Imagine for Margo - children without cancer, 8 Jan 2018

Cancer is the first cause of death by disease for children over one year of age in Europe. Drug companies have little interest in paediatric cancers, which are perceived as an unattractive commercial market. As a consequence, more that 50% of drugs given to children have never been investigated…

Consultation response

Shire, 8 Jan 2018

Feedback on the Roadmap for the Evaluation of the legislation on medicines for children and rare diseases (medicines for special populations) 8 January 2018 Shire’s registration number on the Transparency Register: 60329985751-43 Shire, as the leading global biotechnology company focused…