A number of media have reported that “EU rules are denying children cancer drugs”, based on a press release by the UK’s world-renowned and hugely respected Institute of Cancer Research.
The European Commission and the European Medicines Agency are continuously seeking to do the maximum possible to encourage and stimulate research and development of appropriate medicines for children, in particular for cancer treatment.
This is a complex issue and there is without doubt a real issue for media interest here.
But some reports are a very long way from a fair representation of that issue. Most media– Metro being an honourable exception – did not even ask the Commission to give its point of view.
The EU rules are emphatically not denying children cancer drugs. Indeed they go further than any other jurisdiction in the world to force pharmaceutical companies to ensure that potential drugs are developed and tested for children.
The position of the Institute of Cancer Research and some other organisations – though some other stakeholders do not agree – is that that the rules should be implemented in a yet tougher and more prescriptive way.
So this does not fit easily into the habitual and often misleading narrative of some UK media as far as the EU is concerned.
It is not about removing EU rules that obstruct research or practitioners calling for red tape to be slashed to free up their work.
The Institute is calling for a more prescriptive application of the rules and thus for an increase in the level of EU intervention in pharmaceuticals markets.
The implication being spread by some anti-EU voices on social media that the EU is somehow obstructing the production of cancer drugs for children and that the UK could somehow do more alone than 28 Member States together to compel multinational pharmaceutical companies to perform tests is absurd.
This is the background.
The EU adopted new rules, known as the Paediatric Regulation, in 2007 to increase the number of medicines specifically tested and approved for the use in children.
This was because more than half the cancer drugs being used for children at that stage had not been tested for that purpose and there were high risks and high incidences of ineffective or harmful treatments.
As always, the new rules were not handed down from Brussels but agreed by the European Parliament and Member States, including the UK, based on extensive consultations with experts.
These EU rules were the first ever in the world to force companies to engage in a specific type of medical research and still go further than any other region in the world.
However, as with any obligation a balanced approach is necessary – in order to avoid deterring companies from performing research at all, to avoid wasting valuable research resources on work that cannot lead to a practical medical application and also to avoid unnecessary delay in introducing drugs that could save adult lives but are unsuitable for children.
So the legislation provides for exceptions for products developed for a disease or a condition which does not occur in children, such as lung cancer.
It is experts at the European Medicines Agency who decide whether or not a company can be given an exemption from testing a specific drug for use with children.
In sum, therefore, it is simply not the case that EU rules prevent research into drugs that can be used for child cancers.
The rules concerned never stop pharmaceutical companies from conducting such research: the issue is that in some cases the companies are not legally compelled to do so.
Indeed the EU supports voluntary research by providing incentives under EU rare diseases legislation, all child cancers being classified officially as rare diseases.
The EU invests overall €200 million per year in cancer research, including for child cancers, and provides regulatory incentives for pharmaceutical companies that submit new marketing authorisation applications.
The next report on the Paediatric Regulation is scheduled for 2017 and extensive prior consultation with the Institute of Cancer Research and other stakeholders – who hold a wide range of different views on this – will feed into that.