On 29 March 2012, the European Court of Justice issued a ruling in a case brought by the European Commission against Poland (Case C-185/10).
The ruling concerns a mechanism of the so-called financial import rule, established in Article 4 of the Law on Medicinal Products 2001, which allows for the importation of drugs not authorised for marketing in Poland where the prices of imported products are competitive - even when there are products with the same active substances, the same dosage and the same form that are authorised in Poland and are accessible. In practice, this rule has been used not for individual patient cases, but for cash-strapped hospitals.
The Commission asked the Court to declare that by adopting and maintaining in force the financial import rule, Poland had failed to fulfil its obligations under Article 6 of Directive 2001/83/EC, as amended (the "Directive"). The Court ruled that the financial import rule is indeed incompatible with Article 6 of the Directive.
As in the previous case brought by the Commission against Poland (C-385/08), the Court stressed that no medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that State in accordance with the Directive or Regulation 726/2004. In other words, placement on the market is, as a rule, dependent on a marketing authorisation issued on the basis of the full records and data required by the law, allowing for the assessment of the safety, efficacy and quality of the product in question.
However, there are exceptions to this rule. Such exceptions are provided for by European law, but they must be interpreted strictly and cannot be freely extended by a Member State, as has happened in Poland. Under Article 5(1) of the Directive, a Member State may exclude from the Directive's scope, in order to fulfil special needs, medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised healthcare professional and for use by a named individual patient under his direct personal responsibility (commonly known as the "named patient specials exception").
The Court emphasised that the concept of "specials" applies only to individual situations justified by medical considerations and presupposes that the medicinal product is necessary to meet the needs of the patient. Where the doctor providing treatment wishes to prescribe a medicinal product but another product with the same active substance, the same dosage and the same form is already authorised and available on the national market, it would not be permissible to use the named patient specials exception. Financial considerations, including the competitive pricing of a foreign product in relation to its national counterpart, cannot justify an exception.
This does not mean that in Poland there are no other options for the "emergency" importation of drugs from abroad. The Commission stressed that its objections concerned only the financial import rule and not the other provisions of Article 4 of the Law on Medicinal Products, which allow for importation of a drug in a situation where it is not registered in Poland or is registered but not available, and where it is required by special considerations, such as natural disaster or another situation where the product is necessary to save a patient's life or health.
This is the second case brought by the Commission against Poland and which Poland has lost before the Court in relation to medicines law in general and authorisation requirements for medicinal products in particular. The first case, covered in a pervious edition of this newsletter, concerned a lack of compliance by the Polish authorisation procedure with the Accession of the Treaty of Poland to the European Union (case C-385/08).