A Polish law allowing the sale of prescription drugs which have not been approved by the European Medicines Agency (EMA) but are similar to those which have, but are cheaper, contravenes European Union (EU) law, the EU Court of Justice has ruled.
Under EU law, no prescription medicine can be offered for sale in any member state unless it has been approved either by the EMA or the individual member state's authorities. There is however a "special needs" exception, which allows the sale of unapproved products in response to a “bona fide unsolicited order,” provided they are “formulated in accordance with the specifications of an authorised health care professional and are for use by an individual patient under his direct personal responsibility," says the legislation.
Poland has been using this "special needs" exception to allows imports of unapproved drugs which have the same active substances, dosage and form as products which are approved for sale in the country, as long as they are cheaper. It has therefore been authorising the import and sale of unapproved medicines which are not medically necessary for a particular patient, and this constitutes a failure to comply with EU law, says the European Commission, in a case against the Polish law which it brought to the Court of Justice.
In their ruling, the European justices agree with the Commission. First, they point out that the EU harmonised marketing authorisation (MA) procedure "enables cost-efficient and non-discriminatory market access, whilst ensuring that the requirements of safeguarding public health are achieved."
They also stress that the "special needs" exemption must remain exceptional, used only when necessary and based purely on therapeutic considerations which confirm an individual patient's need for a treatment which is unavailable on the national market or for which there is no authorised equivalent.
So, if medicines with the same active substances, dosages and forms are already approved and on the national market, there cannot be a question of "special needs," the justices state, adding: "financial considerations cannot justify the placing on the market of such medicinal products."
The Court decision rejects the Polish authorities' argument that allowing the import of such products can be justified to ensure the financial stability of the national social security system and to enable patients with limited financial means access to the treatments they need. The justices point out that while EU law does not detract from the power of member states to organise their national social security systems or, in particular, to adopt provisions governing prescription drug consumption aimed at promoting the financial stability of their health insurance schemes, the states must comply with EU law in exercising that power.
The "special needs" exception is not concerned with the organisation of any member state’s health care system or its financial stability; rather, it is a specific provision which must be interpreted strictly, they emphasise. Finally, the justices point out that the member states "remain competent to set the price of medicinal products and the level of reimbursement by the national health insurance scheme, on the basis of health, economic and social conditions."
- Action against a member state for failure to fulfil obligations under EU law can be brought to the Court of Justice by the Commission or another member state. Should the Court find that there has been such a failure, the member state concerned must comply with the Court's judgement without delay. If the Commission then considers that the judgement has not been complied with, it can bring a further action against the member state, seeking financial penalties.