Pharmaceutical companies will have less control over how their medicines are used, as the Court of Appeal rubber-stamps a controversial cost-cutting policy for the NHS.
In a recent decision, the Court of Appeal ruled that, where there is adequate clinical evidence, healthcare providers can procure and regularly use medicines « off-label » on grounds of cost, despite authorised alternatives being available. The Court of Appeal also followed the Court of Justice of the European Union (CJEU)’s approach by allowing for compounding (aliquoting) of a medicine when done in a pharmacy on the basis of a prescription, and ruling it does not constitute « placing on the market » nor requires a marketing or a manufacturing authorisation.
Until now, the circumstances in which a medicine might be used outside of its approved indications were thought to be one-off, special cases – eg where there is no known alternative, or that alternative is impossible to procure. UK health providers may now be prepared to do it on a larger scale.