Supreme Court annuls criterion that allowed Clinical Biochemistry specialization for Pharmacy graduates

The Supreme Court Chamber has upheld as well-founded the lawsuit of the Kosovo Association of Clinical Biochemists, filed against the Ministry of Health (MOH), declaring unlawful and annulling point C of Annex 2 of Administrative Instruction no. 02/2026 on Specialist Education, which had allowed specialization in Clinical Biochemistry for Pharmacy graduates.

The Kosovo Association of Clinical Biochemists had filed an administrative lawsuit at the Supreme Court against the Ministry of Health, challenging the provision of Administrative Instruction no. 02/2026, through which the criteria for specialization in Clinical Biochemistry were changed and application for this specialization was also made possible for candidates who had completed a Master’s in Pharmacy, as “Betimi për Drejtësi” reports.

The Supreme Court announces that after reviewing the lawsuit, the response to the lawsuit, the parties’ statements, the evidence administered during the public judicial review, and the analysis of the relevant constitutional, legal and sub-legal provisions, the Court assessed the plaintiff’s claim as well-founded.

“Point C of Annex 2 of Administrative Instruction no. 02/2026 determined the fields in which persons who have completed a Master’s in Pharmacy may specialize, while the Court assessed that the inclusion of Clinical Biochemistry in this list is unacceptable and that the relevant provision should be annulled,” the announcement says.

In this assessment, the Court compared the academic and professional content of Pharmacy and Clinical Biochemistry and found that they are two tracks with distinct study objectives, professional competencies and professional profiles.

“Pharmacy is oriented mainly toward drugs, medicinal products and their use, while Clinical Biochemistry is oriented toward laboratory analyses and laboratory support of the diagnostic process. Consequently, the two fields have different training objectives, different study program content and different orientation in healthcare practice,” the announcement says.

Thus, the Supreme Court emphasized that specialization cannot be seen detached from the candidate’s prior education.

According to the Court’s reasoning, postgraduate specialization in the field of medicine implies advanced professional training, built on the knowledge and skills previously acquired during university studies.

“In this sense, allowing pharmacists to specialize in Clinical Biochemistry cannot be justified solely by the existence of some common subjects, such as chemistry, biology or physiology, since these two fields have different orientations and professional profiles,” it says further.

The Supreme Court places special emphasis on the distinction between academic ability and professional identity, finding that the fact that the Pharmacy program contains elements of Biochemistry does not turn the pharmacist into a clinical biochemist.

“According to the Court, specialization must also be assessed in relation to the professional consequences it creates after its completion. Allowing persons who have not followed the relevant basic training to subsequently practice in the field of Clinical Biochemistry, including diagnostic laboratory services, would imply that through specialization a professional profile is achieved that was not acquired through basic studies and the master’s,” the announcement says.

The Supreme Court assessed that such an approach could affect the structure of the labor market and the provision of healthcare services, given that Pharmacy and Clinical Biochemistry are equated neither by the relevant legislation nor by the healthcare system.

“In the judgment, the Court also assessed that the Ministry of Health has not proven, neither during the judicial procedure nor during the drafting and issuance of the sub-legal act, that the expansion of the criteria for specialization in Clinical Biochemistry was made due to any defined healthcare need,” the Supreme Court emphasizes.

According to the Court, fulfilling the demands of various professional groups or associations cannot prevail over the needs of the healthcare system and cannot undermine the quality of healthcare services required by law.

The Supreme Court also found that the AI, in the part under review, conflicts with Article 5 of the AI on Standards for Drafting Normative Acts.

“According to the Court’s assessment, in the concrete case no new problem has been defined, nor a justified action that would require the issuance of a new administrative instruction, since the issue of specialization was already regulated by Administrative Instruction no. 01/2023,” the Court announces.

The Supreme Court emphasized that, in case of a need to amend or supplement the existing provisions, this could be done through amending the relevant act, and not through issuing a new instruction, as was done in the concrete case, as “Betimi për Drejtësi” reports.