PATIENT SAFETY CANNOT BE COMPROMISED BY SAVING MONEY ON MEDICINES

Europe's highest court has ruled that patient safety cannot be compromised to save money on medicines. The European Court of Justice has found that a Polish law allowing hospitals to import drugs that were not properly authorised violated established EU law.

Under Poland's Law on Medicinal Products, a medicine that was available in any other country but which was not already authorised for use in Poland could be imported into and marketed in Poland if the drug had the same active substances, dosage, and form as a medicine that had already obtained such marketing authorisation, and if the imported medicine was 'competitive in relation to the price of the medicinal product which has obtained authorisation.'

One obvious reason behind the competitiveness provision in the law was cost – to allow the Polish health service to save money on drugs by allowing it to import cheaper medicines than those already available in the country. Despite acknowledging Poland's right to run its health service as it saw fit, the European Commission – which monitors how EU countries adhere to EU law – challenged the Polish law as illegal in June of 2008. The commission requested the country to delete the competitiveness provision from its Law on Medicinal Products to come within the terms of the EU Directive on the Community Code Relating to Medicinal Products for Human Use. After protracted negotiations, the Polish government ultimately refused to back down, and the commission sued the Polish Government in the European Court of Justice in April of 2010 to compel the country to comply with the Medicinal Products Directive.

In its lawsuit, the commission argued that the Polish law conflicted directly with the Medicinal Products Directive because the directive provides that no medicinal product may be placed on the market in an EU country unless a marketing authorisation has been issued either by the medicines agency of that particular EU country or by the European Medicines Agency. The only exception to the directive arises where a doctor made a specific request to prescribe a drug for a particular patient for clinical reasons but where the drug was unavailable in that EU country.

In that regard, the Medicinal Products Directive specifically stated that an EU country may exclude from the provisions of the directive '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 an individual patient under his direct personal responsibility.'

According to the commission, the exception to the Medicinal Products Directive did not include situations where the exception was granted because of the cost of the drug. The commission noted that the Polish law could allow any hospital or wholesaler in Poland to import unlimited quantities of unauthorised drugs on the basis of cost, and without any specific reference to the opinion of a specific doctor to the needs of a particular patient and unavailability of that medicine or other suitable medicine within Poland.

While acknowledging the influence of price on a decision to import and use such a drug, the Polish government was at pains to insist that the national law protected patient safety by including requirements that:

• the intended medicine be certified as necessary for the purpose of saving the life or safeguarding the health of a patient; 
• the intended medicine was already properly marketed under the authorisation of the country from which it was imported; 
•  the intended medicine was approved by a medical specialist in the medical sector concerned; n pharmacies, wholesalers and hospitals engaging in the commercial sale of those medicinal products maintain a register for that purpose; 
• the requirements governing safety of the intended medicine were satisfied like any other drugs authorised in Poland; 
• no intended medicine would be allowed into Poland if its authorisation has already been rejected by Poland's medicines agency. 

In its decision, handed down on March 29, the Court of Justice adopted the arguments of the commission and rejected those of the Polish government. The court wrote that 'to exclude the application of the directive's provisions can be exercised only if that is necessary, taking account of the specific needs of patients. A contrary interpretation would conflict with the aim of protecting public health, which is achieved through the harmonisation of provisions relating to medicinal products, particularly those relating to the marketing authorisation.'

'Special needs'

The court added that the concept of 'special needs' identified in the directive 'applies only to individual situations justified by medical considerations and presupposes that the medicinal product is necessary to meet the needs of the patient. Also, the requirement that medicinal products are supplied in response to a ‘bona fide unsolicited order' means that the medicinal product must have been prescribed by the doctor as a result of an actual examination of his patients and on the basis of purely therapeutic considerations.'

Further, the court ruled that allowing the exception provided for in the Directive relates only to extraordinary situations 'in which the doctor considers that the state of health of his individual patients requires that a medicinal product be administered for which there is no authorised equivalent on the national market or which is unavailable on that market. Where medicinal products having the same active substances, the same dosage and the same form as those which the doctor providing treatment considers that he must prescribe to treat his patients are already authorised and available on the national market, there cannot in fact be a question of ‘special needs.''