Thursday, 26 October 2017

European Union celebrates 10 Years of Pediatric Regulation

On the occasion of the 10 years of the Pediatric Regulation of the European Union (EU), the European Commission presented a report prepared by the European Medicines Agency (EMA) to the European Parliament and the European Council where it underlined the progress made with the implementation of the law on research and development of new medicines for children.

More medicines for children, better product information and more pediatric research are the three main objectives of this regulation that allowed the entry of 260 new medicines between 2007 and 2016.


According to the EMA report, in the last 10 years there has been an increase in medicines for children in many therapeutic areas, the most notable being rheumatology and infectious diseases. Regarding clinical research, the proportion of clinical trials including children increased 50% in 2007-2016 from 8.25% to 12.4%.

The number of agreed Pediatric Research Plans (PIPs) has exceeded 1000 in 2017, of which 131 were completed by the end of 2016. There is a clear upward trend in the number of PIPs completed, with more than 60% completed in the last three years.

Currently, the conditions with the largest number of complete PIPs are immunology/rheumatology (14%), infectious diseases (14%), cardiovascular diseases and vaccines (every 10%). However, the oncology, endocrinology and metabolic diseases account for only 7% of completed PIPs. The report also revealed that the regulation works best in areas where the needs of adult and pediatric patients overlap.

However, the report recognizes that more effort is needed to combine the effects of the Pediatric Regulation with those of the Orphan Drug Regulation to correct deficiencies in the treatment of rare diseases in children.

"When we look at advances in adult oncology, it bothers me deeply that we have not made the same progress in treating cancers in children," said European Commissioner for Health and Food Safety Vytenis Andriukaitis in commenting on the report.

Integrated solutions to tackle childhood cancer

The Lithuanian Commissioner has set future goals in order to respond to flaws in the treatment of rare diseases in children. "Over the next ten years we should focus on making similar progress for children by combining incentives under orphans and pediatric regulations and ensuring that European Reference Networks in particular "ERN PaedCan" with a focus on pediatric cancer, reach full capacity, "added Andriukaitis.

The European Reference Networks for rare and complex diseases started work in March 2017 and have the potential to significantly improve diagnosis and treatment as well as influence prescription practices. 

The Commission also said that it will ensure the proper functioning of these networks so that they have access to sustainable resources and the information technology tools needed to reach their full potential.

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