In the final weeks of 2007, the World Health Organization (WHO) launched a new campaign in London to raise awareness of the need for more medicines to be designed for children.
The ‘Make medicines child size’ campaign is intended to help plug the significant gap between the availability of drugs tailored specifically for children and the growing demand for them. It will do this by turning up the pressure on pharmaceutical companies and other organisations to carry out more R&D on paediatric medicines and improve access to those drugs already licensed for use in children.
Highlighting the extent of the problem at the campaign launch, Dr Howard Zucker, WHO’s assistant director-general, said more than 50% of children in developed countries take off-label or unlicensed medicines. In developing countries the problem is further accentuated by a higher incidence of illness and poor access to medicines.
“This is not a new crisis, it is a reality we have lived with for many years,” Dr Zucker said. He criticised the current disparities in clinical R&D that allow “one standard for adults and one for children”.
WHO’s campaign calls on all sides of the industry to take up the cause, including: researchers, by identifying and addressing research gaps; pharmaceutical companies, by stepping up research and production of paediatric medicines at affordable prices; and governments, by devising incentives for paediatric R&D, reviewing regulatory requirements and legislation to encourage safe and ethical research in children, and prioritising the supply and procurement of medicines for children.
Model list
The Organization has already set a number wheels in motion, starting with the creation of the first Model List of Essential Medicines for Children and the identification of priority research gaps. It has also begun work on promoting transparency in research into children’s medicines, and is currently building a web portal to clinical trials carried out in children, which will be launched this year.
According to Dr Zucker, WHO also plans to provide some of the funding (with the help of donors) to pay for exploring the need for paediatric treatments for specific diseases, research into appropriate doses, the strengthening of healthcare systems where needed, and the relevant training of health staff.
Harvey Bale, director-general of the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), told delegates he thought industry would help to meet the associated R&D costs. “As an industry we can commit to ensuring that the paediatric medicines issue remains a high priority”, he said, promising that a taskforce would be set up to identify the challenges and opportunities.
The European Medicines Agency also welcomed the new campaign and put its support behind the initiative, which mirrors the aims of the EU regulation on paediatric medicines implemented at the beginning of 2007. But a spokesman for Save the Children, while describing WHO’s campaign as “a necessary step in helping paediatric medicines reach their potential”, said it did not go far enough to address the problem in full.
The introduction of a cross-regulatory approval system is crucial to speeding up access to medicines, he maintained, pointing out that current system constraints inhibit the supply of medicines in many areas of great need. Not the least of these constraints is a crisis in human resources, meaning that, in a number of areas, healthcare professionals are simply not there to provide care.
“The world is on board, but we must act with urgency,” Dr Zucker stressed. “Children under 15 make up over 30% of the world’s population. We have the science, the technology and the financial means to give a third of humanity a better chance.”
The following are the priority disease targets of the ‘Make medicines child size’ campaign :
– Pneumonia and other respiratory infections. Pneumonia alone causes two million deaths every year, which could be prevented with proper access to child medicines.
– HIV/AIDS. Although the virus accounts for “just” 3% of deaths in children under five each year, paediatric HIV is a “growing public health challenge”, with 1,150 new infections every day.
– Malaria. Around one million children die each year from malaria, and although the disease is already considered a priority, issues of access to, and development of, child-specific therapies need urgent attention.
– Diarrhoea. An estimated 1.9 million children under five are killed each year by diarrhoea and its complications, even though these can be treated easily.
– Tuberculosis. Of the 8.8 million new TB cases in 2005, 12% were in children under 14 years of age.
– Lymphatic filariasis and schistosomiasis. The “neglected” tropical diseases filariasis and schistosomiasis make the list because there are significant gaps in either the development or accessibility of suitable medicines.
