Drug reimbursement is more than just one of many legal issues. This issue determines the health and life of many people. Some medicines are expensive enough to cease to be available. Then the only hope is the refund, which the Minister of Health decides by administrative decision. However, this is not a decision that can be taken entirely freely. Legal provisions need to be properly applied.
The Ombudsman informs the NSA of its judgment (reference no. II GSK 844/18), which solves an extremely important issue – when a health minister may refuse to return the medicine. It needs to be stressed that the NSA's interpretation of the law was a denial of the adverse legal view presented by the Minister of Health and the Provincial Administrative Court.
The Minister of Health will assess the health effects
Key regulation is included in Article 12. The Return Act. According to this provision, the Minister of Health is making a decision to include the medicine in the refund "with a view to achieving the greatest possible health effects within the public funds available."
The following section of the provision refers to the criteria to be taken into account when deciding. The most important of these include drug safety, clinical efficacy and price competitiveness.
When you can refuse a refund
The NSA ruling concerned a patient suffering from chronic illness which significantly impedes normal functioning. It was necessary to purchase a specific medicine based on medical marijuana. The preparation is not available in Poland, the only possibility was its acquisition abroad. The price was not low.
The health minister refused to return the refund. According to his opinion, there is no evidence that the medicine needed has more benefits than risks. The reason for the refusal was also the high price of the preparation. The Minister referred to medical opinions confirming his position.
That decision was contested. The Provincial Administrative Court refused to repeal it. He considered the minister's legal view correct. At the same time, he pointed out that he did not assess the validity of the decision, but merely its legality. The specificity of the administrative judiciary is to examine the legality of the legal act. An administrative decision may be repealed if it is unlawful and not if it is unfair.
Chief Administrative Court of the patient side
The judgment of the WSA was brought before the Supreme Administrative Court. The cassation complaint was supported by the Ombudsman, who in his argument focused on constitutional principles. According to him, the interpretation of the law by the WSA (and the Minister of Health at an earlier stage of the procedure) is contrary to the constitutional principles of health protection and the right to dignity.
In addition, the RPO alleged that the rejection decision was based on unreliable grounds. The Minister of Health referred to general scientific studies and at the same time ignored the opinions of physicians regarding the condition of the patient seeking reimbursement.
The NSA ruling does not, of course, explain all legal doubts about the reimbursement of medicines, but clearly tends towards the patient-friendly argument of the Ombudsman. Refusal of refunds must be justified in a reliable and convincing manner. A negative decision cannot in any case be considered a standard requiring only general justification.