# CE2004078EN.01066601.xml

| 27.3.2004 | EN | Official Journal of the European Union | CE 78/666 |
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27.3.2004

EN

Official Journal of the European Union

CE 78/666

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(2004/C 78 E/0709)

WRITTEN QUESTION E-3878/03

by Johannes Blokland (EDD) to the Commission

(16 December 2003)

Subject:   Research into the effects of medicinal products on children

Subject:

| 1. | Is the Commission aware that the majority — possibly 70 % — of medicinal products prescribed for children have not undergone any research to ascertain their effects on patients of this age group? |
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1.

Is the Commission aware that the majority — possibly 70 % — of medicinal products prescribed for children have not undergone any research to ascertain their effects on patients of this age group?

| 2. | What percentage of medicinal products evaluated by the European Agency for the Evaluation of Medicinal Products (EMEA) have also been found to be suitable for use by children? |
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2.

What percentage of medicinal products evaluated by the European Agency for the Evaluation of Medicinal Products (EMEA) have also been found to be suitable for use by children?

| 3. | What efforts is the Commission making to encourage manufacturers to perform more research into the effects of medicinal products on children? |
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3.

What efforts is the Commission making to encourage manufacturers to perform more research into the effects of medicinal products on children?

| 4. | Is Community funding made available for such research, and if so, what are the relevant appropriations and how are they being used? |
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4.

Is Community funding made available for such research, and if so, what are the relevant appropriations and how are they being used?

Answer given by Mr Liikanen on behalf of the Commission

(30 January 2004)

(30 January 2004)

| 1. | The Commission is fully aware that many medicines used to treat children are not specifically studied nor authorised for such use, and is working to remedy the situation. |
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1.

The Commission is fully aware that many medicines used to treat children are not specifically studied nor authorised for such use, and is working to remedy the situation.

| 2. | In October 2003, the European Medicines Evaluation Agency (EMEA) performed a review of the authorisation status for children of the 191 active substances used in medicines authorised through the Community procedure, on the basis of an EMEA scientific evaluation. Sixty-two (32 %) were appropriately authorised for the use of children. Of the remaining active substances 51 (27 % ) were medicines indicated for diseases not relevant to children (e.g. cancers occurring only in adults). |
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2.

In October 2003, the European Medicines Evaluation Agency (EMEA) performed a review of the authorisation status for children of the 191 active substances used in medicines authorised through the Community procedure, on the basis of an EMEA scientific evaluation. Sixty-two (32 %) were appropriately authorised for the use of children. Of the remaining active substances 51 (27 % ) were medicines indicated for diseases not relevant to children (e.g. cancers occurring only in adults).

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| 3. | Current Community pharmaceutical legislation does not compel industry to study medicines for the use on children. However, the existing regulatory framework already provides incentives to orphan products. Regulation (EC) No 141/2000 of the Parliament and of the Council of 16 December 1999 on orphan medicinal products (1) provides incentives to the pharmaceutical industry to develop and authorise medicinal products for serious, rare diseases where no satisfactory method of treatment exists. This legislation applies equally to diseases affecting children and adults.
  In 2000, following major input from the Union, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline E11: ‘Clinical Investigation of Medicinal Products in the Paediatric Population’ was finalised and implemented in the Union.
  In 2001, the European Medicines Evaluation Agency set up the Paediatric Expert Group of the Committee for Proprietary Medicinal Products. The Paediatric Expert Group provides advice on the study and use of medicines for children and is developing guidance for investigators and the industry on such use.
  Following a resolution of the Council of Ministers, the Commission has been developing and consulting on proposals for a new Regulation that aims specifically to address the need for greater study and authorisation of medicines for children. The Commissions' proposals are currently the subject of an extended impact assessment (EIA) that is due to report in the first quarter of 2004. Following the results of the EIA, it will be possible to finalise the proposals for adoption by the Commission. Pending the results of the EIA, to speed up the legislative process, the Commission has set up an informal ad-hoc working group of the Pharmaceutical Committee (which has representation from all Member States) to advice on its informal draft proposal. In addition, the Commission is continuing its discussions with other stakeholder groups. |
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3.

Current Community pharmaceutical legislation does not compel industry to study medicines for the use on children. However, the existing regulatory framework already provides incentives to orphan products. Regulation (EC) No 141/2000 of the Parliament and of the Council of 16 December 1999 on orphan medicinal products (1) provides incentives to the pharmaceutical industry to develop and authorise medicinal products for serious, rare diseases where no satisfactory method of treatment exists. This legislation applies equally to diseases affecting children and adults.

1

In 2000, following major input from the Union, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline E11: ‘Clinical Investigation of Medicinal Products in the Paediatric Population’ was finalised and implemented in the Union.

In 2001, the European Medicines Evaluation Agency set up the Paediatric Expert Group of the Committee for Proprietary Medicinal Products. The Paediatric Expert Group provides advice on the study and use of medicines for children and is developing guidance for investigators and the industry on such use.

Following a resolution of the Council of Ministers, the Commission has been developing and consulting on proposals for a new Regulation that aims specifically to address the need for greater study and authorisation of medicines for children. The Commissions' proposals are currently the subject of an extended impact assessment (EIA) that is due to report in the first quarter of 2004. Following the results of the EIA, it will be possible to finalise the proposals for adoption by the Commission. Pending the results of the EIA, to speed up the legislative process, the Commission has set up an informal ad-hoc working group of the Pharmaceutical Committee (which has representation from all Member States) to advice on its informal draft proposal. In addition, the Commission is continuing its discussions with other stakeholder groups.

| 4. | An emphasis is also put on child health in Priority 1 of the Union's 6th Framework Programme for Research and Technological Development. This thematic priority will stimulate and sustain multi-disciplinary basic research to exploit the full potential of genome information to underpin applications to human health. The specific programme for research, technological development and demonstration: ‘Integrating and strengthening the European Research Area’ (2002-2006) mentions that ‘attention will be paid to childhood diseases and related treatments, whenever appropriate’. Some topics of the Work Programmes of this Priority are clearly devoted to children, for instance ‘Medicines for children’, or ‘Rare autoimmune disorders: from genes to individualised medicine’ including paediatric diseases. Even if topics do not specifically mention children, proposals selected for funding may contain parts referring to, or centred on, children health. It is then to be expected that the results deriving from those projects will directly benefit children, for instance through the better understanding of disease mechanisms, and the development of new diagnostic tools and new therapeutic agents.
  As regards the public health programme, there are possibilities to fund projects on public health aspects of pharmaceuticals. The priorities and the specific research areas are identified in the annual work plans. |
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4.

An emphasis is also put on child health in Priority 1 of the Union's 6th Framework Programme for Research and Technological Development. This thematic priority will stimulate and sustain multi-disciplinary basic research to exploit the full potential of genome information to underpin applications to human health. The specific programme for research, technological development and demonstration: ‘Integrating and strengthening the European Research Area’ (2002-2006) mentions that ‘attention will be paid to childhood diseases and related treatments, whenever appropriate’. Some topics of the Work Programmes of this Priority are clearly devoted to children, for instance ‘Medicines for children’, or ‘Rare autoimmune disorders: from genes to individualised medicine’ including paediatric diseases. Even if topics do not specifically mention children, proposals selected for funding may contain parts referring to, or centred on, children health. It is then to be expected that the results deriving from those projects will directly benefit children, for instance through the better understanding of disease mechanisms, and the development of new diagnostic tools and new therapeutic agents.

As regards the public health programme, there are possibilities to fund projects on public health aspects of pharmaceuticals. The priorities and the specific research areas are identified in the annual work plans.

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(1)  OJ L 18, 22.1.2000.

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