Brussels, 19 May 2005
The EU's proposal for a regulation on medicines for paediatric use is expected to receive a boost under the UK's EU Presidency, which begins in July.
The UK's Ministry of Health has made paediatric medicine a priority and hopes the EU proposal, which requires medicine testing on children, could enter into effect in 2006. The move, welcomed by doctors, patients and research-based companies has, however, been criticised by producers of generic drugs.
'Children are not simply small adults, they are physiologically different in many highly significant ways,' Alistair Kent, director of the Genetics Interest Group (GIG), stated at a press briefing. 'No parent wants to see their child treated as a guinea pig [...]. But without appropriate high quality medical research, it is clear that children will continue to suffer,' he added, insisting that regulation of paediatric medicine would protect children's health and could save many lives.
Currently, between 50 and 90 per cent of the medicines given to children may not have been tested on this age group, which means that many drugs are not formulated to suit younger patients. As a result, when treating children, doctors and clinicians lack clear guidelines on the best medicine to use and in which dosage.
In an attempt to address this issue, the European Commission adopted a proposal in September 2004 which would require the development of children-specific medication and, in exchange, would give pharmaceutical companies six months worth of extra patent protection from generics.
The draft law has been welcomed by most doctors. At the press conference, Dr Bruce Morland, who works on childhood cancer at Birmingham Children's Hospital, explained that it would lead to more tailored treatments since at present many cancer drugs tend to be used to treat children on an 'off-label', or unlicensed basis.
Richard Tiner from the Association of the British Pharmaceutical Industry (ABPI), insisted that the proposed new law is a 'win-win' situation for patients and industry.
He explained that in the US, which leads the way in this field, the introduction of paediatric legislation in 1997 led to important new prescription information and label changes on 44 products.
Generic drug manufacturers, however, who feel they could significantly lose out from the extra exclusivity granted to branded medicine firms, argue that the plan for six months of additional patent protection is too generous. Their association, the European Generic Medicines Association (EGMA), has therefore launched a campaign to get the extension reduced to three months.
According to Dr Tiner, however, six months is the minimum required if Europe wishes to remain a centre for medicine research. Reducing the patent extension would entail a loss of drug research to the benefit of the US and Asia, he believes.