European Commission Report on Ten Years of EU Paediatric Regulation
On 26 October 2017, the European Commission (the “Commission”) published a report (the “Report”) on the application of Regulation 1901/2006 on medicinal products for paediatric use (the “Paediatric Regulation” or “PR”). 2017 marks the tenth anniversary of the PR. The Report provides an account of the PR’s achievements and its shortcomings and feeds into the policy decisions which the Commission is expected to take in 2019.
According to the Report, the PR’s system of obligations on pharmaceutical companies, combined with a set of rewards and incentives, has caused a significant increase in new medicines for use in children (both new marketing authorisations and new indications) in the period between 2007 and 2016. The PR was most successful in the therapeutic areas of rheumatology and infectious diseases.
Conversely, the least progress has been recorded in diseases that are biologically different in adults and children, diseases that only affect children, or diseases whose burden differs depending on whether adults or children are involved. The PR has notably yielded insufficient results when it comes to rare diseases, including childhood cancers.
This is why the Commission will focus its efforts on how to combine the effects of the PR and Regulation 141/2000 on orphan medicinal products (the “Orphans Regulation” or “OR”). The Commission says it will conclude a joint assessment of PR and OR by 2019.
In the meantime, the Commission will seek to ensure speedier completion of Paediatric Investigations Plans (“PIPs”). A PIP is a mandatory part of overall product development requiring firms to screen every new medicinal product for its potential use in children. The Commission will also consider adapting its guidelines for handling PIP applications and promote international cooperation and harmonisation. Lastly, the Commission will give an additional boost to the European Reference Networks for rare and complex diseases which became operational in March 2017.
Please find attached for your perusal the Report as well as two Commission press releases on the subject.