In response to a Times article which was published on Monday 4 February, 'Taxpayers face £500m bill over children’s drug patent loophole', the ABPI has issued the following statement.
Contrary to the claims in your article, the scheme that allows pharmaceutical companies a six-month extension to their patent is not a loophole, but an important initiative to develop children’s medicines. This specialist research is very challenging – it is difficult to recruit sufficient numbers of children into trials, there are ethical questions around their participation and children are a more diverse group compared to adults. The provision of the extension is there to make conducting these trials financially viable for companies and it is important that economic models are in place so effective treatments for children continue to be developed for both new and old medicines.
It is also vital to understand that as of 2007, EMA regulation means companies must provide ‘paediatric investigational plans’ to the regulator for all new medicines they develop, explaining how they intend to develop their adult medicine for use in children. The only exception to this rule is if there are valid clinical reasons why it would not make sense to develop specific medicines for children.
Finally, your article suggests that spending on medicines in the UK is spiralling out of control. It is not. The UK has amongst the lowest prices of medicines in Europe, we spend 0.9 per cent of our GDP on medicines compared with 1.2 per on the continent, and new medicines account for less than 5 per cent of the entire medicines budget, which itself is only around 10 per cent total NHS expenditure. The medicines budget is unfairly targeted as an easy area to cut – it shouldn’t be – our medicines continue to transform people’s lives and helps the NHS reduce the need for expensive hospital care.
ABPI Press OfficeTel: +44 (0) 20 7747 1410 or +44 (0) 20 7747 1441Mobile: +44 (0) 7850 312064 or +44 (0) 7808 641811 Email: [email protected]
The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. Our members supply 90 per cent of all medicines used by the NHS, and are researching and developing over two-thirds of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.
The ABPI is recognised by Government as the industry body negotiating on behalf of the branded pharmaceutical industry, for statutory consultation requirements including the pricing scheme for medicines in the UK.