The European Commission (EC) has published its evaluation of the regulations over 2000-2017 (medicines for rare diseases) and 2007-2017 (medicines for children) following several methods of study into their effects.
With the evidence gathered, the EC hopes to produce new legislation and strategy in these areas, potentially affecting swathes of the pharmaceutical and medical device industries. A major finding is the news that the regulations have had positive effects:
“The evaluation found that both regulations have fostered the development and availability of medicines for patients with rare diseases and for children. They have redirected private and public investment towards previously neglected areas through incentives, obligations and rewards. Member States alone could not have achieved this result due to the small number of patients concerned and the fragmentation of the market.”
The evaluation does express concern, however, that development of new treatments is not always targeted at those areas most in need. Development has often been in more profitable areas, into which several therapies emerge in succession.
How to balance positive and negative effects of the regulations will be a key factor in forming new regulations in the coming months.
Find out more about the evaluation in the EC report.