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Medicinal products for paediatric use

This Regulation seeks to promote the production of medicinal products for paediatric use by increasing research, development and authorisation for this type of medicinal product. The lack of medicinal products specifically designed and developed for treating children* is a Europe-wide problem. Indeed, more than 50% of medicines currently prescribed for children have not been studied and authorised for use in children.

ACT

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on products for paediatric use and amending Regulation (EEC) No 1768/92, Directives 2001/20/EC and 2001/83/EC, and Regulation (EC) No 726/2004 . [See amending acts].

SUMMARY

This European Union (EU) Regulation aims to improve the health and quality of life of children in Europe by ensuring that new medicines for children and medicines already on the market are fully adapted to their specific needs. In order to fill the gaps in research on this type of medicinal product, the Regulation lays down new obligations for the pharmaceutical industry accompanied by rewards and incentives. The Regulation therefore also contributes to the competitiveness of the European pharmaceutical industry.

The aims to be achieved are as follows:

  • to stimulate the development of medicines for use in children;
  • to ensure that medicines used to treat children are subject to high-quality, ethical research;
  • to ensure that these medicines are appropriately authorised for use in children;
  • to improve the information available on the use of medicines in children;
  • to achieve these objectives without subjecting the paediatric population to unnecessary clinical trials and without delaying the authorisation of medicines for other categories of patient.

The Community instruments already in force in the pharmaceutical sector will have a key role to play in achieving these aims. Moreover, as regards the procedure for placing pharmaceutical products on the market, the procedures established by current pharmaceutical legislation have not been altered. However, for every marketing authorisation application, the competent authorities will check compliance with the agreed paediatric investigation plan * or verify the presence of a waiver or deferral.

Paediatric Committee

The Regulation's key feature is the establishment of a Paediatric Committee within the European Medicines Agency (EMEA) *. This committee is made up of five members of the Committee on Medicinal Products for Human Use and their alternates, a member and an alternate appointed by each of the Member States not represented by members of the Committee on Medicinal Products for Human Use, three members and three alternates selected by the Commission to represent the health professions, and three members and their alternates appointed by the Commission to represent patients' associations.

The committee is specifically responsible for advising on questions concerning medicinal products for paediatric use, issuing opinions on the quality, safety and efficacy of medicinal products for paediatric use, assessing and approving companies' paediatric investigation plans * and considering any related requests for waivers and deferrals. The paediatric investigation plan is the document upon which the development and authorisation of medicines for use in children must be based. It should include details of the timing and the measures proposed to demonstrate the quality, safety and efficacy of the medicinal product in a paediatric population. *

In the course of its work, the Paediatric Committee will consider the therapeutic benefits of carrying out studies in children and ensure that unnecessary studies are avoided. It must also ensure that authorisations for medicines for other populations are not delayed by the requirements for studies in children.

Given that certain medicines developed for adults are not suitable for children, the Paediatric Committee will draw up lists of waivers for specific medicines and classes of medicine.

Marketing authorisation procedures and rewards

This Regulation concerns medicines under development which have yet to be authorised, authorised products covered by a supplementary protection certificate or a patent, and authorised products no longer covered by either a supplementary protection certificate or a patent.

A request for marketing authorisation for paediatric * use does not affect the right to apply for authorisation to market the product for other uses.

When all the measures in the paediatric investigation plan * have been complied with, this fact will be recorded in the marketing authorisation. Implementation of these measures will be the basis upon which companies can obtain the rewards for compliance. The provisions differ according to the category of medicine in question, namely:

  • medicinal products no longer covered by a patent: a medicinal product which is no longer covered by a patent may be subject to a new marketing authorisation for paediatric use. It may enjoy a new period of market exclusivity of 10 years. This type of authorisation is called Paediatric Use Marketing Authorisation (PUMA). A medicinal product that has obtained a PUMA can use the existing brand name of the corresponding authorised product in order to take advantage of the latter product's reputation.
  • new medicines and products covered by a patent or aSupplementary Protection Certificate(SPC): if all the measures included in the agreed paediatric investigation plan * are complied with, if the product is authorised in all Member States and if relevant information on the results of studies is included in product information, a six-month SPC extension will be granted.
  • orphan medicinal products*: this category of medicinal products qualifies for ten years of market exclusivity. This period will be extended to twelve years if the requirements for data on use in children are fully met.

European network

The Paediatric Committee must help the EMEA to establish a European network linking together existing national and European networks, researchers and study centres. This network will facilitate cooperation and avoid duplication of studies on the paediatric population.

Information on medicines for children

Increased availability of information facilitates the safe and effective use of medicines for children. Companies are therefore invited to submit all completed studies to the competent authorities. The European database contains information on clinical paediatric studies, whether completed or ongoing, in the Community and non-member countries. By way of derogation the EMEA will reveal to the public some of the information on clinical paediatric studies contained in the European database.

Details of the results of paediatric studies, the status of paediatric investigation plans, and any waivers or deferrals must be included in the product information in order to inform healthcare professionals and patients about the safe and effective use of children's medicines.

Context

This Regulation follows on from a proposal for a European Parliament and Council Regulation of 29 September 2004, which in turn was a response to Council Resolution of 14 December 2000 inviting the Commission to propose measures to address the lack of medicines specifically designed for the paediatric population *. Children today remain exposed to diseases without benefiting from the same technological advances as adults. Market forces have not sufficiently stimulated the development of medicines specifically designed for children, since companies have insufficient income to finance the necessary research. Moreover, attempts to solve the problem at national level have proved ineffective. It is for these reasons that action at Community level has been deemed necessary.

Key terms used in the act
  • Paediatric population: that part of the population aged between 0 and 18 years.
  • European Medicines Agency: created in London on 26 January 1995, it contributes to consumer protection and the establishment of a single market for human and veterinary medicinal products by standardising the sale of certain medicines and improving supervision of their use.
  • Paediatric investigation plan: a research and development programme aimed at ensuring that the necessary data are generated to determine the conditions under which a medicinal product may be authorised to treat the paediatric population.
  • Marketing authorisation for paediatric use: authorisation granted for a medicine for human use that is not protected by a supplementary protection certificate or a patent, covering therapeutic indications for use on the paediatric population, including the dosage, pharmaceutical form or route of administration of the product in question.
  • Orphan medicines: medicines for the treatment of diseases so rare that promoters are reluctant to develop them under normal market conditions. These medicines are designed for the treatment of patients with very serious and even fatal diseases for which there is not yet any treatment, or at least any satisfactory treatment. Many of these diseases affect children and newly-born babies.

REFERENCES

ActEntry into force - Date of expiryDeadline for transposition in the Member StatesOfficial Journal
Regulation (EC) No 1901/200626.1.2007-OJ L 378 of 27.12.2006

Amending act(s)Entry into forceDeadline for transposition in the Member StatesOfficial Journal
Regulation (EC) No 1902/200626.1.2007-OJ L 378 of 27.12.2006

RELATED ACTS

Regulation (EC) No 726/2004of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [Official Journal L136 of 30.4.2004].

Directive 2001/83/ECof the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [Official Journal L 311 of 28.11.2001].

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use [Official Journal L 121 of 1.5.2001].

Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products [Official Journal L 182 of 2.7.1992].

Last updated: 01.10.2007
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