spacer
home > ebr > spring 2007 > child’s play
PUBLICATIONS
European Biopharmaceutical Review

Child’s Play



Dr Duncan Curley of McDermott Will & Emery UK LLP examines the new European law on developing medicines for children

On 26th January 2007, the long-awaited European regulation for encouraging the development of medicines for children entered into force. Since the legislation was first proposed (1), there has been a great deal of debate and discussion about the appropriate rewards and incentives that should be made available in order to encourage clinical trials, both of new medicines for children and of existing medicinal products adapted to their specific needs. This article examines the outcome of that debate and describes the rewards and incentives now available under the Paediatric Regulation: Regulation (EC) No 1901/2006 as amended by Regulation (EC) No 1902/2006. The European Commission (EC) believes that more than 50 per cent of the medicines used to treat children in Europe have not been tested and are not authorised for use in the paediatric population.

The whole purpose of conducting clinical trials and obtaining regulatory approval of a drug for human use is, of course, to make sure that it is safe, efficacious and that it meets adequate standards of quality. However, present doses of medicines for children tend to be worked out with reference to the appropriate doses in adults – usually by reducing the adult dose based upon surface area or body weight – rather than by testing drugs in children beforehand. Yet children may respond differently to drugs that have been trialled and approved for use in adults. For example, reducing the dose of a drug in order to treat children may result in it having no therapeutic effects at all. In addition, the route and frequency of administration of a drug may change its pharmacological effect. Whilst unlicensed and off-label prescription does not necessarily threaten the health of children, there are clearly inherent risks in not properly researching the effect of medicines in the paediatric population before they are widely used. In a worst case scenario, the use of untested medicines could lead to adverse drug reactions, causing illness or even death.

A report commissioned by the EC in 2003 predicted that the costs of adverse drug reactions in children could amount to 0.1 to 0.4 per cent of total healthcare expenditure in Europe by 2015, possibly running as high as two per cent in some cases (2).

THE COST OF PAEDIATRIC CLINICAL TRIALS

The overarching policy objective behind the new legislation is, therefore, to increase the research, development and authorisation of medicines for use in children. The problem is that paediatric drug research has historically been considered expensive, involving difficult issues such as obtaining consent (both from parents and children) and ethical issues arising from uncertain long-term toxic effects.

The cost of conducting a paediatric clinical study was estimated to be between ˆ1 million and ˆ4 million in 2004 (2). The EC therefore needed to address in its legislation the question of how it was going to ensure that potentially expensive clinical trials in children would be carried out, without unduly penalising the research-based pharmaceutical industry with the imposition of a further substantial cost burden.

THE US EXPERIENCE

Fortunately, the European Commission could draw upon the US’ experience of encouraging medicines for paediatric use. By 2004, the Food and Drug Administration Modernization Act of 1997 had had the effect of significantly increasing the number of paediatric investigations of medicines, at an estimated increased cost of $61 million per drug.

The key aspect of this law was a mechanism for improving the reward for carrying out paediatric studies, by means of the intellectual property system. The law rewards drug companies for undertaking clinical studies for new drugs in children by adding an extra six months of exclusivity to the term of patent protection. The incorporation of an equivalent measure into the European law is one of the cornerstones of the new paediatric regulation.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
5
     

There are no comments in regards to this article.

 You must be a member of the site to make a comment.
spacer
Dr Duncan Curley received his BSc and PhD in Chemistry from University College, London. He qualified as a Solicitor in 1995 and joined McDermott Will & Emery in 2000, becoming a Partner in the Intellectual Property, Media & Technology Department in 2003. Duncan practices all aspects of intellectual property dispute resolution, particularly in the life sciences sector. He is the author of the leading textbook on the European technology transfer licensing rules and a special report issued by the Intellectual Property Institute on Supplementary Protection Certificates for pharmaceutical products.
spacer
Dr Duncan Curley
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Innovative Micro-Infusion Pump for Gerresheimer Subsidiary Sensile Medical Developed and Successfully Launched for EVER Pharma

Düsseldorf/Olten, July 03, 2019 – Developed specially by Sensile Medical for EVER Pharma under the brand name D-mine®, this wearable microinfusion pump recently received European CE certification and has already been launched in several European countries. The compact, patient-friendly infusion pump is used for the continuous subcutaneous administration of drugs to treat Parkinson’s disease. The first micro pump from Gerresheimer subsidiary Sensile Medical to be available on the market, it gives Parkinson’s patients greater independence in their day-today lives.
More info >>

White Papers

Microalgae Culture Using the DASGIP® PBR4 Module for Illumination with a New Brunswick™ CelliGen® 310 Stirred-tank Bioreactor

Eppendorf

The number of bioprocess applications for microalgae has increased in recent years, particularly in the fi eld of biofuel production. The combination of the New Brunswick CelliGen 310 stirred-tank bioreactor and the DASGIP LED Illumination System creates a bioreactor setup which is capable of supporting high density microalgal growth. Using the stand-alone Eppendorf DASGIP PBR4 Module, LED illumination spectra and intensities can be controlled for optimal support of all types of chlorophylls and carotenoids. For this study in which high density culture of up to 1.5 x 107 cells/mL was achieved, the unicellular freshwater alga, Dunaliella tertiolecta, was used.
More info >>

 
Industry Events

BioPharm America™ 2019—12th Annual International Partnering Conference

11-12 September 2019, Boston Convention and Exhibition Center (BCEC), Boston, MA 02210 USA

BioPharm America™ is a unique partnering event that forms the nexus of discovery and realization. Startup companies, established biotech and entrepreneurs from academia attend in search of finance, pharma and development partners. The event format highlights innovation and promotes new business relationships by bringing dealmakers from the life science ecosystem together to engage and de-risk the enormous task of drug development. Life science executives from around the world gather to identify, meet and to enter into strategic relationships facilitated by partneringONE®, the world’s leading web-based partnering system. BioPharm America is the only event in North America based on the same reputable formula as EBD Group’s acclaimed European events BIO-Europe® and BIO-Europe Spring®. BioPharm America annually attracts 800+ delegates from over 500 companies who participated in 2,300+ scheduled one-to-one meetings. BioPharm America is now part of Biotech Week Boston, and together they draw a total of over 4,500 life science leaders, scientists and innovators.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement