Following on from EPTRI’s proposals for amendments to the Pharmaceutical Package legislation, which were shared with some Members of the European Parliament (MEPs), we are pleased to report that most of the points raised by EPTRI have been endorsed and submitted by MEPs from different parties!
EPTRI’s suggestions were all focused on strengthening the paediatric perspective and voice in the new rules. As general concept, EPTRI amendments aimed at:
- Making clearer that the agreement of a Paediatric Investigation Plan should remain mandatory in all the situations already foreseen in the current Paediatric Regulation, regardless it is in the framework of a centralised or national procedure.
- Limiting the impact of changing the status of relevant parts of the paediatric rules from a Regulation to a Directive.
- Avoiding that the scientific and regulatory experience gained at PDCO level is lost.
- Intervening on the matters relevant for the paediatric population, including provisions aimed to improve the outcomes of the Paediatric Regulation in the revised scenario (i.e. more funds for paediatric research, access to PRIME, access to repurposing initiatives, etc).
Concerning the Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, the following EPTRI’s points have been endorsed by MEPs:
- Proposal to set up a Paediatric Working Party at EMA supporting PIP evaluation and other processes involving medicines in paediatric setting.
- Limiting the length of deferrals, to reduce the time for arrival on the market of a paediatric indication/formulation after the Marketing Authorisation of the reference adult product.
- Incentives for research in medicinal products for children to be granted by means of specific research calls at Eu level encompassing the paediatric product’s entire development phase, from discovery to post-marketing.
Concerning the Directive on the Union code relating to medicinal products for human use, the following amendments have been endorsed by MEPs:
- Mentioning ad hoc procedures for paediatric medical devices risk/benefit assessment
- Harmonisation of summary of product characteristics, including harmonization of approved paediatric indications, dosages and ages for which the product is recommended.
- Mentioning the extension of the indication of a medicinal product from adults to one or several paediatric populations as a form of repurposing in the same indication or in different indication. This extension strongly can contribute to reduce the current gaps in the access to medicines of paediatric patients.
In both documents, some key definitions (e.g. paediatric population, medicinal product authorised for a paediatric indication) have been included, where missing.
At this stage, all proposed amendments have been tabled by MEPs and technical meetings are underway at parliamentary level with a view to voting on the legislative texts in March.
Although the final outcome of the proposed amendments is uncertain, we welcome the fact that, in general, a significant number of amendments proposed by MEPs from different parties were aimed at introducing and/or strengthening the paediatric perspective in the legislative documents. EPTRI will continue to actively monitor the legislative process, intervene where possible and provide updates on the outcome!