EMA chief warns against efforts to cut cost of drugs

UK bid to cut drugs spending causes concern.

A UK bid to cut its drugs spending has alarmed Europe’s most senior medicines official, who believes that the European Commission should intervene. 

Thomas Lönngren, the executive director of the European Medicines Agency (EMA), says he is concerned at the possibility that the UK will encourage the use of a bowel-cancer medicine to treat degeneration of the eye.

The drug, Avastin, has not gone through the rigorous testing procedure required for licensed use in ophthalmology, but the UK is now assessing whether it could be an adequate, cost-effective alternative to the much more expensive standard eye treatment.

Lönngren, whose agency has a key role in ensuring that medicines prescribed in the EU have been adequately tested, says he is “unhappy” with the possibility of such “off-label” use. For a member state to encourage the use of a pharmaceutical for an indication for which it is not licensed would be a breach of EU legislation, he said.

More widely, Lönngren warned that member states’ reluctance to pay for new medicines has “broken” the single market in terms of patient access.

Limiting spending

As member states struggle to limit their healthcare spending – in the face of ever-tighter budgets and ever-growing demand – they are increasingly keeping expensive new medicines off the market, or insisting on price cuts. They frequently justify their decisions through the emerging discipline of ‘health-technology assessment’, which incorporates non-medical considerations into appraisals.

But Lönngren said that if a medicine has been approved through the EU’s authorisation procedures, it is fit for purpose.

He believes that if there are problems at member-state level, they should be tackled by the European Commission.

Christina Fasser of Retina International, which represents eye patients, also expressed concern at treatment by an off-label drug in some EU countries in an effort to reduce costs, “despite the availability of a drug that has undergone scrupulous testing”. She said that patient groups in the EU “are concerned that, in times of economic pressure, patient safety may be compromised.”

The European Patients’ Forum also insisted that assessments of health technology “cannot be used as a pretext for tough decisions if public confidence is to be maintained” and called for involvement of patients and their organisations in these processes – which, it said, “is not yet happening in many EU countries”.

No one from the office of John Dalli, the European commissioner for health and consumer affairs, would comment on or respond to Lönngren’s concerns.