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Law News

Non-swapable biological drugs

A hospital should use biological drugs if the criterion for their replacement with biosimilar drugs is the price. After the last judgment of the Provincial Administrative Court, the discussion on the possibility of substitution of biological drugs has reopened. Producers, service providers and payers participate in the discussion. The Court upheld the decision of the Patients’ Rights Ombudsman. He pointed out, among other things, that the decision to use or change the therapy cannot be dictated solely by the result of the tender. He also emphasized that the specificity of biological drugs justifies caution in swapping.

Stakeholders fear that if the judgment becomes final, they will encounter obstacles to the use of biosimilars. The Polish Association of Pharmaceutical Industry Employers recalls the position of the Ministry of Health and the Office for Registration of Medicinal Products, Medical Devices and Biocides. It says that biological medicines can be substituted. Recall that the association represents manufacturers of generic drugs.

Service providers, on the other hand, are afraid that the cost of therapy will increase. Undoubtedly, the expenses of the National Health Fund will also increase.

Almost at the same time Infarma pointed out that in Poland, innovative drugs still account for only 0.3% of all therapies used. In Europe, they are used five times more often. The members of Infarma are manufacturers of original medicines.

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