The petitioner shall: Ministry of Health of the Slovak Republic
Name of the petition:
Petitions for the payment of sensors for the continuous measurement of glycaemic activity from public health

Text: By petitioning, we ask that Sensors for continuous blood glucose monitoring should be fully covered by public health for all diabetics on an intensified insulin regimen.
It's quare: No.
Number of persons supporting the petition: 22 730 who supported the petition electronically
Date of delivery: 1.7.2020
Date of equipment: 2.9.2020
Equipment: § 5 (6) of Law No 85/1990 Coll. on petition law in the wording of subsequent regulations " not evaluated
Reason for equipment:
On 1.7.2020, the submission was delivered to the Slovak Ministry of Health (hereinafter referred to as "the Ministry of Health') on 1.7.2020, undidated and unsigned by the submitter, marked as "Petitions for Diabetes Sensors', accompanied by a non-didated and unsigned submission marked as "Petition for refunding sensors for continuous measurement of glycaemic control from public health'. and a CD with a list of 22 730 persons who supported the petition in question electronically. The Department of Control, Supervision and Complaints (hereinafter referred to as "ÚKDaS') as the organisational unit responsible for handling complaints and petitions in the Ministry's material capacity has accepted the documentation and found the following facts. By means of a non-didated submission designated as -Peticia -Sensors for diabetics, the writer sends the text of petition to the Ministry of Public Health's petition for the payment of sensors for the continuous measurement of glycaemic control. a CD medium with a list of 22,730 persons who supported the petition in question electronically and requests that sensors for continuous blood glucose monitoring be fully covered by the public health system for all diabetics on an intensified insulin regimen. From the website www.peticia.com The ÚKDaS found that the

However, it found that the petition contained certain deficiencies, following an assessment of the content of the undidated and unsigned submission, marked as "Petition for the payment of sensors for the continuous measurement of glycaemic measurements from public health', and sheets containing a list of 22 730 persons who supported the petition in question electronically (hereinafter referred to as "the petition') as well as material and formalities in the context of the provisions of § 3 (3), § 4a (6), § 5 (1) of Law No 85/1990 Coll. on petitioning law as amended (hereinafter referred to as "the Law of Petitions') registered the submission in the Special Report of the Registry kept on the OCD as a petition under sp. zn. Pet 4/2020. Within the meaning of Article 5 (4) of the Law on Petitions, the ÚKDaS called for a specific letter from the petitioner to remedy the deficiencies identified within 30 working days of receipt of the call. The petitioner corrected the shortcomings within the taught deadline and submitted them to MZ SR on 30.7.2020.

After assessing the content of the petition, the ÚKDaS found that the petition was of the nature of the application and the Ministry, as the competent public authority in the matter, is obliged to arrange for the petition in question pursuant to Article 5 (6) of the Law on Petitions, in the sense that the public authority competent to handle the petition containing the application or proposal will assess its content and send a written reply together with the statement of reasons to the representative within the period referred to in paragraph 5, i.e. within 30 working days of the correction of its deficiencies, in conjunction with Section 5d (1) and (4) of the Law on Petitions, in which, if the petition is supported by at least 10 000 persons, it shall be discussed by the competent public authority in charge of the whole territory of the Slovak Republic with the representative and the petition committee. A public authority shall not be obliged to negotiate a petition if it fully complies with its content.
In accordance with Article 5d (1) of the Law on Petitions, a joint meeting between the submitter and the petitioner's representative and the Director-General of the Department of Pharmacy and Drug Policy and the staff of this organisational unit took place at the Ministry on 11.8.2020 with the Director of the ÚKDaS. At the working meeting, the subject of the petition was discussed, while the legitimate procedure for dealing with the petition was outlined, which shows that the persons who supported the petition require the extension of the indication limits for individual subgroups of medical devices to measure diabetes glucose.

The process of extending the indication limit for a subset of medical devices is regulated by Act No. 363/2011 Coll. on the scope and conditions for reimbursement of medicinal products, medical devices and dietetic foods on the basis of public health insurance and on the amendment of certain laws (hereinafter the Act-Law-). Under Paragraph 41 (1) of the Law, the Ministry decides to change the characteristics of the subgroup of medical devices on request or on its own initiative. Pursuant to Paragraph 36 (1) of the Act, a request for a change of characteristics may be made only by a medical device manufacturer or health insurance undertaking. On the basis of the formalities and content of the petition, it can be concluded that the petition is not a request from the manufacturers of the medical devices concerned or from the health insurance companies and does not have the required content of the request to change the characteristics of the subgroup of medical devices. For the above reasons, it can only be seen as a complaint to the Ministry on its own initiative.
Pursuant to Article 91 (1) and (2) of the Cit. of the Act, the Ministry of Categorisation acts in the light of the written recommendations of the advisory bodies, which in this case are the Categorisation Commission for Medical Devices (hereinafter referred to as the According to established standard procedures, any referral to the Ministry for the classification of medical devices shall be subject to an assessment by the CEC, which shall submit written expert advice to the Ministry. On the basis of a technical recommendation, the Ministry shall decide to initiate the procedure on its own initiative. Pursuant to Paragraph 74 (2) in conjunction with Article 76 (2) of the Law, proceedings on the initiative of the Ministry start on the date of publication of the Notice of Initiation on the website of the Ministry. The parties (MP producers and health insurance companies) are entitled to comment on the basis for a first instance decision (i.e. in this case a petition) within 7 days of the opening of the procedure.

All documents relating to the first instance decision are subject to an assessment by the Ministry's advisory bodies. The basis for the first step decision is the review and assessment of the medical expert working group, the working group on the pharmaco-economy and the classification panel. Consequently, taking into account the expert advice of the advisory bodies, the Ministry shall decide to extend or not to extend the indication restriction for the relevant subset of medical devices. Any of the parties may object to this decision. Objections shall be decided by the Minister within a month of the first instance decision. No further objections can be raised to the Minister's decision. The entire process is publicly available on an electronic portal accessible on the Ministry's website at the following electronic address: http://categoryizacia.mzsr.sk/Help/
By sending a written reply to the representative, the Ministry considers the petition to be provided in accordance with Paragraph 5 (6) of the petition law.

Place: Bratislava– Date:7 September 2020