ECJ Opinion supports ABPI

An Opinion from the European Court of Justice (ECJ) has supported the Association of the British Pharmaceutical Industry (ABPI) in its claims against the Medicines and Healthcare products Regulatory Agency (MHRA) that prescribing incentive schemes operated by Primary Care Trusts (PCTs) are in fact prohibited under Article 94(1) of European Directive 2001/83.

The Opinion, delivered on February 11, 2010 by Advocate General Jaaskinen, concluded that prescribing incentive schemes, which promote medicines by offering financial incentives to doctors currently prescribing or intending to prescribe specifically named medicine 'A', to start prescribing specifically named medicine 'B', are unlawful. 

Advocate General Jaaskinen continued that the rules on promotion of medicines in Directive 2001/83 apply not just to commercial bodies, but also to public authorities, including PCTs  and that 'promotion' had occurred in these schemes as they "have the deliberate and direct intention of promoting within the NHS certain medicines at the expense of others". 

He said the fact that the aim was to save budgetary resources and improve the provision of public health services is irrelevant, and exemptions did not apply.

While an Opinion is not the final stage in litigation, it plays a part in assisting the full court form its final judgement, which is likely to be in the next three to six months.