Summary
The aim of the Paediatric Regulation (European Regulation (EC) No 1901/2006, adopted in 2006) was to encourage the development of medicinal products suitable for children. However, the regulation was constructed less around children’s needs than on incentives for pharmaceutical companies.

• Prescrire has chosen to respond to the consultation on the lessons learnt from the first 5 years of the European Paediatric Regulation by detailing one example in France that illustrates particularly well some of the most lamentable aspects of the application of this regulation: Cozaar° oral suspension, the paediatric form of the antihypertensive drug losartan.
• The packaging of Cozaar° oral suspension is poorly designed and dangerous. Furthermore, the drug is difficult to obtain from retail pharmacies via wholesalers, and the pharmaceutical company MSD France chose not to request its inclusion on France’s list of reimbursable drugs. Cozaar° oral suspension also highlights the failure of the Paediatric Regulation to stimulate the development of the medicines most useful for children.
• Yet MSD France has been granted a 6-month extension to its market exclusivity on losartan in France, even for its non-paediatric indications. In the case of Cozaar° oral suspension, the application of the Paediatric Regulation has resulted in higher health spending in France than if a generic had been used, in order to reward a pharmaceutical company for marketing a paediatric medicinal product that is unsuitably packaged, difficult to obtain, not reimbursable, and not the standard treatment for children with hypertension.  
• The results of the other reward scheme established by the Paediatric Regulation – paediatric-use marketing authorisation (PUMA) – are no more encouraging. PUMAs incentivise companies to develop a product exclusively for paediatric use based on a drug whose patent protection has expired, by making the holder eligible for a 10-year market monopoly and possibilities of exemption from certain fees. However, in the five years since the Paediatric Regulation came into force, the PUMA process has provided very little benefits to children: only one PUMA has been granted, and for a medicinal product that France’s National Authority for Health rated as representing only a minor therapeutic advance over existing therapies.
• As of 2012, the tangible results of the Paediatric Regulation are disappointing. The regulation mainly benefits the pharmaceutical industry and benefit children’s health hardly at all.
• Its implementation must change profoundly to:
  • provide real therapeutic progress for children;
  • reduce the dangers to which children are exposed due to the prevalence of poorly designed packaging.

> Download Prescrire's Response (pdf, 178 Ko)

©Prescrire 28 November 2012

Reference:
1- European Commission "General report on experience acquired as a result of the application of the paediatric Regulation - deadline for public consultation 28 November 2012" 18 September 2012: 13 pages. (‘PCPD/12/01 – Public consultation on paediatric report’ sanco-pharmaceuticals-D5@ec.europa.eu)