Court of Justice Finds Poland’s Low-cost Treatment Law Breaks EU Rules

The EU Court of Justice ruled on Thursday last week that a Polish law which allows the sale of prescription medicine that has not been permitted by the European Medicines Agency (EMA) but is similar and cheaper to drugs which have, breaches European Union (EU) law.

Under European law, no prescription drug can be offered for sale in any EU member state unless it has been accepted by either the European Medicines Agency or the individual member state’s authorities.  There is a “special needs” exemption, which permits the sale of unapproved drugs 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,” notes the legislation.

Poland has been using the “special needs” exception to permit imports of unapproved medicines which contain the same active ingredients, dosage and form as drugs which are currently permitted for sale in the country, as long as they are cheaper.  Poland have therefore been approving the import and sale of unapproved drugs which are not medically essential for a specific patient, and as a result this constitutes failure to obey European law, comments the European Commission.

In the ruling, the European justices agree with the Commission.  First, they note 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 add that the “special needs” exception must remain exceptional, so it is used only when completely essential and is based solely on therapeutic considerations which confirm an individual patient’s requirement for treatment which is unobtainable on the national market or where there is no authorised equivalent.

This means that if medicines with the same active ingredients, dosages and forms are already approved and on the market, there cannot be a requirement for “special needs,” the justice stated, adding that “financial considerations cannot justify the placing on the market of such medicinal products.”

The Court of Justice’s verdict discards the Polish authorities’ argument that allowing the import of such products can be acceptable to guarantee financial stability of the national social security system and to aid patients who have limited financial means access to the treatments they require.

The justice pointed out that while European Union law does not reduce the power of EU member states to organise their own national social security systems or to adopt provisions governing prescription drug intake intended to promote the financial stability of their health insurance schemes, the member states must comply with EU law in exercising that power.

The “special needs” exception is not concerned with the administration of any member state’s health care system or its financial stability; instead, it is a specific provision which must be interpreted rigorously, they emphasised.  Finally, the justices noted that the EU 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 their responsibilities 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 a failure, the member state concerned must comply with the Court’s judgement immediately.  If the Commission considers that the ruling has not been complied with, it can bring a further action against the member state, pursuing financial penalties.


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