IS THE INDUSTRY NEGLECTING CHILDREN

1
IS THE INDUSTRY NEGLECTING CHILDREN?

• Dr Richard Tiner
• Medical Director, ABPI
• rtiner_at_abpi.org.uk

2
LICENSING MEDICINES FOR CHILDREN

• Joint Report of the BPA and ABPI
• June 1996

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RECOMMENDATION 1

• Medicines are licensed for specific age ranges

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OUTCOME

• ICH E11 recommends five children age groups

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RECOMMENDATION 2

• Networks and departments are established where
  clinical trials on children can be concentrated
  and performed so that necessary expertise may be
  developed.

6
OUTCOME

• ABPI, co-funders with DH and MRC, of Lilleyman
  review of Paediatric Research Network
• Budget 2004 announcement of further funding for
  clinical research in UK. Paediatrics will be one
  of the five new networks
• First meeting of working group 7/6/04

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RECOMMENDATION 3

• The Committee on Proprietary Medicinal Products
  reviews its guidelines.

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OUTCOME

• CPMP guidelines published September 1997

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RECOMMENDATION 4

• Guidance is prepared on what is required for a
  licence to be extended to include infants and
  children.

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RECOMMENDATION 5

• Surveillance at various levels is introduced on
  the use of unlicensed medicines and the
  prescribing of medicines off-label.

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OUTCOME

• MHRA ran yellow card scheme in paediatrics in
  Trent region. Response poor
• DSRU collects some data on prescription event
  monitoring in under 12s
• Industry has legal responsibility to report
  safety issues on all medicines

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RECOMMENDATION 6

• Information on all medicines given to children be
  in forms suitable for children, parents and
  guardians, health professionals and authorities.

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WHAT IS THE PROBLEM?

• Over 90 medicines used in neonatal intensive
  care
• 45 medicines used in general paediatric wards in
  Western Europe
• 10-20 medicines used in children in general
  practice
• ARE USED OFF-LABEL OR UNLICENSED

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INDUSTRY ISSUES

• 75 million children in Europe but market still
  small
• Approx 20 million Euros for paediatric
  development plan
• Poor to moderate return on investment

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WHAT HAS INDUSTRY DONE?

• In America, welcomed the FDA rule which provided
  incentives for doing paediatric research
• In Europe, welcomed all the Commissions actions
  since 2000
• Welcomed Lord Warners statements that
  paediatrics will have a higher profile and be a
  priority issue during the UK Presidency of the EU
  in 2005
• Some companies working with MHRA with regard to
  their American data

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WHAT HAS INDUSTRY DONE? (cont)

• Academy of Medical Sciences Industry Forum
  Conference 14/6/04
• Active participation in Childrens NSF
  consultations
• Financial support for Paediatric Pharmacology
  Research Network review
• Funds 2 specialist registrar posts in Paediatric
  Clinical Pharmacology
• Supports the development of a Childrens BNF
• Has given considerable financial support to the
  School of Pharmacy Pharmacoepidemiology database
  launched in 2003

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CURRENT AMERICAN STATISTICS

• 70 labelling changes
• 247 written requests
• 663 studies involving over 41,000 children

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DRAFT PROPOSAL FROM EC ON MEDICINAL PRODUCTS FOR
PAEDIATRIC USE

• Published March 2004 with four week consultation

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ABPI RESPONSE

• Regret further delays in legislation
• Welcome statement that Regulation will not delay
  authorisation in other populations
• Welcome introduction of incentives to industry
• Disappointed over need for further legislation
  regarding Medicines Investigation for the
  Children of Europe (MICE)
• Regrets lack of independence in appeal procedure
• Believe that it is not the role of the EMEA to
  establish a research network

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GREATEST REGRET

• Lack of a transition period whilst discussions on
  Regulation take place
• Believe that such a transition period will
  benefit the children of Europe and alleviate the
  outcomes of continuing delays

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THE FUTURE

• Continue to lobby for a transition period
• Discuss with Government possible national
  incentives (Article 23) eg tax credits
• Continue to encourage our members to work with
  the MHRA
• Broaden our working party to enhance industrys
  response to the Regulation
• To aid implementation of the Childrens NSF
• Support a UK Paediatric Research Network

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IS THE INDUSTRY NEGLECTING CHILDREN?

• No, but the framework is not
• in place yet for full
• engagement