Sunday, 20 December 2015

Taking care of business

The brash banking centre of Canary Wharf, with its gleaming sky-high towers, is the unlikely location for the headquarters of that most decorous of institutions, the European Medicines Agency.  Standing between the murky waters of the Thames and Barclays HQ, the EMA gleams like a beacon for health rather than wealth, right in the heart of London’s bonus-driven business district.

The business I was to witness there, though, was of an altogether different kind. The Paediatric Committee (PDCO) of the EMA had invited me to observe them reviewing investigations into children’s medicines that were being conducted by drug companies. It was illuminating to see the Committee rigourously holding a Pharma company to the conditions that had been set for a trial into a paediatric cancer. What was more interesting, though, was to hear an explanation later of the amendments to regulation the EMA had made in the summer and whether these would, as some members of Pharma had suggested, dramatically change the volume of commercial research into young people’s  cancers.

 In June 2015, an EMA press release announced the revision of some of the class waivers that had allowed companies to avoid obligations to seek cures for childhood illnesses, particularly cancer. Representatives of some drug companies had claimed that this changed the whole research landscape and their employers might even abandon waivers altogether.

The explanation given at the EMA, however, was less dramatic. Removal of some of the broad class waivers would engender more research, particularly for illnesses, such as liver cancer, which occur in both adults and children. However, companies could still apply for product specific waivers. As a recent letter to Lancet Oncology stated ‘ if the company decides to request a waiver because the illness does not exist in children, even though the drug's mechanism of action is relevant for paediatric malignancies, EMA cannot force the company to assess a drug in children.

 This is not something that can be changed by the EMA in London. It can only be resolved in Brussels at the Commission, where the process of European law begins. For this reason, over the autumn, the parents campaign group, Unite2Cure, has been exchanging letters  with the European Health Commissioner, with the support of two MEPs: from Britain, Glenis Wilmott, and from France, Francoise Grosstete.

In January, we will be visiting Ms Wilmott at her surgery in Nottingham at a meeting that will hopefully prepare the ground for the annual Cancer Drugs Development Forum conference on paediatric medicines that will be held later that month. CDDF delegates will be mindful of the 10 year review of the Paediatric Medicines Regulation due in 2017 and for which consultations are already being prepared.

It would be good to think that 2016 will be the opportunity to repair the weaknesses in the Regulation that were identified soon after its introduction. However, the tone of the replies we have received from the Commission suggest they may prefer business as usual to any fundamental change. There is of course no way of telling what the outcome will be in 2016 or 2017, but it would be wise to take the opportunity of January 1st to make some firm resolutions.

Happy New Year.

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