It is estimated that between 50-90% of medicines used to treat children have never been specifically studied in or approved for the paediatric population. Through a combination of obligations and incentives, the proposed regulation aims to ensure that:

- paediatric medicines are subject to high-quality research and clinical development, while avoiding any unnecessary clinical trials in children;
- the resulting products are duly authorised across the EU;
- there is more information on the use of medicines developed specifically for children and more transparency in paediatric clinical trials.

In particular, the new regulations will provide incentives to develop paediatric forms and doses of medicines currently only approved for adults, the main one being a six-month extension to patent protection for innovator companies that test their products on children.

There will also be a separate paediatric marketing authorisation for off-patent medicines that are developed for children and a special fund to encourage research into paediatric forms of such products. The regulation also sets up a paediatric committee at the European Medicines Agency that will agree paediatric investigation plans with companies and determine research priorities.

The R&D-based industry believes the regulation would allow Europe to reclaim a central role in innovative drug development. It is less popular with the generics community. Last minute amendments, negotiated behind the scenes at the European Parliament, mean that during a five-year transition period, innovator companies have up to 6 months before expiry to submit the data and apply for the extension. The original draft suggested a two-year deadline. This change is likely to dramatically affect the timing of generic entry. It is also likely to pose issues for some Eastern European states whose native pharma industry is largely generic and who, since accession, have opposed any measures which have delayed the entry of generic drugs.

Use this new report to:
- Understand and comply with the new legislation
- Profit from the incentives on offer as a result of the new legislation
- Understand how similar legislation has been applied in the US and assess its impact
- Identify key market opportunities for on and off patent drugs