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Delay in reforming European rules could deny thousands of children access to latest cancer drugs

Thousands of children with cancer across Europe could miss out on the latest targeted treatments because of delays reforming outdated regulations, leading cancer research institutions, charities and expert bodies are warning.

The European Commission has conceded that its Paediatric Regulation has not yet been successful at opening up access for children to the newest precision cancer treatments – but has opted for a further review for up to two years rather than taking immediate action.

Some 24,000 children across Europe – and around 3,600 in the UK alone – will be diagnosed with cancer over the period of a two-year delay.

These children risk missing out on clinical trials of the latest targeted treatments because under the current, flawed rules, pharmaceutical companies are often able to opt out of trialling new drugs in children.

The Institute of Cancer Research, London, Teenage Cancer Trust, CLIC Sargent, the Nuffield Council on Bioethics, Unite2Cure (an umbrella group of parents’ groups) and 11 smaller children’s cancer charities have signed a letter to Jean Claude Juncker, President of the European Commission, setting out their concerns on delays in reforming the EU Paediatric Regulation.

The organisations acknowledge that the Paediatric Regulation has improved children’s access to many types of medicines, but warn that the picture is much less positive for children with cancer.

For several years, children’s cancer researchers and doctors have been warning that nowhere near enough cancer medicines are being trialled in children or licensed for paediatric use.

Together with parents, these experts have been campaigning for reform of the Paediatric Regulation, which governs how children gain access to new medicines.

A loophole in the regulation allows drug companies to opt out of running clinical trials of new cancer drugs in children even where there is good evidence that the drug could work for them.

Companies can be granted a waiver from evaluating a drug in children if the adult cancer for which it has been developed does not occur in children – even though many adult cancer drugs may have a mechanism of action that could be effective against paediatric cancers.

Earlier this year the European Commission launched a consultation as part of a review of the Paediatric Regulation.

The Commission has now responded with a report which admits there are problems with children’s access to new cancer drugs, but has not closed the loophole.

Instead, it has announced a new review of how the Paediatric Regulation works alongside another piece of European legislation governing pharmaceutical agents, known as orphan drugs, which have been developed specifically to treat a rare medical condition.

Commenting on the report, the Commissioner for Health and Food Safety, Vytenis Andriukaitis, conceded that: “When we consider the advances in adult oncology, it upsets me deeply that we have not made the same progress in treating the cancers that affect children.”

In March an analysis by The Institute of Cancer Research (ICR) of European Medicines Agency data showed that over the five years up to 2016, pharmaceutical companies were granted waivers from having to trial cancer drugs in children for 33 of 53 cancer treatments (62 per cent).

With so many drugs not going into clinical trials for children, the group of scientific institutions, charities and parents’ organisations do not believe children should have to wait two years before action is taken.

They are calling for urgent reform, to update the regulation and ensure children and young people have the same access to new cancer drugs as adults.

In their letter to President Juncker, they state that the current Paediatric Regulation could do much more to ensure that children benefit from the dramatic advances in treatment we are seeing for adult cancers.

The group believes a simple change to the waiver system would have a dramatic impact on the number of clinical trials for children with cancer.

Professor Paul Workman, Chief Executive of The Institute of Cancer Research, London, said “There is no scientific reason why children’s cancer treatments have not advanced as quickly as adult treatments. Paediatric cancer researchers are dedicated to finding new ways to treat childhood cancer but the outdated EU Paediatric Regulation is a major road block. The European Commission has missed a golden opportunity to make vital changes to the Paediatric Regulation, which even its own review admits is not delivering for children with cancer. We believe that there is no excuse for another two years of the status quo – and fear that the delays will cost the lives of children and young people. We are urging President Juncker to use his influence to make changes now to the EU Paediatric Regulation, and are keen to work with him to open up children’s access to the latest cancer medicines.”

Source: ICR



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