(CN) – Europe’s high court rebuked Poland for allowing the sale of unauthorized foreign pharmaceuticals because they are cheaper.
The European Commission brought the action before the Court of Justice in Luxembourg, arguing that the Polish law runs afoul of an EU directive that no medicinal product may be placed on the market without the approval of the European Medicines Agency. The law provides for extenuating circumstances, which it calls “special needs,” provided the drugs are formulated in accordance with health care standards and are prescribed by a medical professional.
Poland has allowed the importation of foreign drugs that are cheaper but formulaically similar to EU-approved pharmaceuticals. The country argued that by focusing solely on price, the commission overlooked the conditions of “special needs,” the purpose of saving lives and safeguarding the health of patients. Poland also argued that its own law is actually more stringent than the EU directive since it requires the same active ingredients and dosing in the imported drugs as are found in EU-approved medicine.
The high court, however, ruled that the directive provides for harmonization of the market, which “enables cost-efficient and non-discriminatory market access, while ensuring that the requirements of safeguarding public health are achieved.”
Any deviation from the directive “must remain exceptional in order to preserve the practical effect of the marketing authorization procedure,” according to the court.
A special need, in the court’s eyes, “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 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 authorized and available on the national market, there cannot in fact be a question of ‘special needs'” under the EU directive, the Thursday decision states.
The financial considerations of patients or state health care providers are not, of themselves, special needs as defined by the directive, according to the court.
Poland’s law on medicinal products does not satisfy the conditions required to meet the special needs derogation, and “none of the other arguments put forward by the Republic of Poland is capable of calling that finding into question,” the court ruled.
The directive does not address national health care systems or their financial stability. Rather, it addresses exceptional cases in which it is appropriate to meet special medical needs, the court said.
All member states are “competent to set the price of medicinal products and the level of reimbursement by the national heath insurance scheme, on the basis of health, economic and social conditions,” according to the decision. They cannot rely on the directive to justify financially based medicinal decisions.