1 June 2012Patents

Polish medicinal legislation contravenes EU directive

The Court of Justice of the EU (CJEU) has ruled that Polish legislation allowing the sale of unauthorised foreign medicines does contravene EU law.

In a decision dated March 29, 2012 the court ruled that approving the goods, which were cheaper than, and similar to, authorised products, breached Directive 2001/83.

Under the directive, medicinal products cannot be sold in EU member states unless they are approved by either the relevant national authorities or the European Medicines Agency. A harmonised policy enables cost-efficient and fair market access, and protects public health, according to the court.

The CJEU stressed that such medicines should be imported only in exceptional cases—such as where patients require them for “special medical needs”. But this should be only when urgent medical care is required and the relevant medicinal product is either unauthorised or its legitimate equivalent is unavailable.

Poland argued that selling cheaper, but unauthorised, products should be allowed owing to financial considerations such as ensuring the financial stability of the national social security system, and allowing patients with limited finances to use the treatment.

But the court rejected the arguments. It said the legislation introduced an exception to the rule—based not on medicine being unavailable, but on unauthorised products being sold at lower prices than their equivalents. The directive does not legislate for the organisation of a national health care system or its financial ability, the court said.

Poland has therefore failed to fulfil its obligations under EU law.

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