Present: See attendance list

MUDr. Adam Hlôška, Director General of the Pharmacy Section, and drug policy.

Agenda of the meeting:

  1. Amendment to Act No. 362/2011 Coll. on Medicinal Products and Medical Devices and Supplements certain laws, as amended, containing disclosure transfers of values between the pharmaceutical industry and health workers/equipment.

MZ SR pointed out that the draft amendment of the Act prepared in close cooperation with Transparency International, with the Ministry of Finance and Financial Head Office of the Slovak Republic. The aim of this amendment is to increase transparency in Relations between the pharmaceutical industry and healthcare professionals/equipment Slovak Republic and thus contribute to reducing the space for any corruption in this area. The amendment should enter into force on 01.01.2016.

Ms Zuzana Dančíková, Deputy Transparency International, informed about the intention of the proposed changes " reporting obligation on monetary and non-monetary the revenue from the pharmaceutical industry is abolished and the obligation to notify fully it transfers to the pharmaceutical industry.

Slovak Pharmacy Chamber

Asks to delete the obligations for authorisation holders from the amendment to the Act provision of medical care (Art. 23 (7) , (8) and (9)), as it does not exist Real possibility of control by the holder of the authorisation to provide medical, or cash and non-monetary/e.g. in the form of a discount on supplement/ is provided in medical care to a healthcare professional. It is also unacceptable that the Obligation of the holder of a medical care permit uth Health Care Professionals the holder of the authorisation to provide medical care, whether on the basis of employment relationship or similar employment relationship where their holder permissions to provide medical care provided by cash because non-monetary performance, e.g. in connection with an increase in qualifications. Holder permissions to provide medical treatment is not given the amount of the supplement able to affect the patient when choosing the prescribed medicinal product, since the person who dispenses human medicinal product, medical device and dietetic food at dispensation to issue to the patient a medicinal product for human use listed in Annex No. 1 The Law on Medicinal Products and Medical Devices, which is free of charge or with the lowest patient surcharge available, unless the patient chooses otherwise, which in no way affects the quality of the medicine provided care.

At the same time, it calls for any notification obligation to be the proposal submitted relates exclusively to monetary and non-monetary transactions relating to: as in all other cases on normal upstream and downstream business relations, in no way therapy.

Association of Drug Suppliers
They argued that the proposed amendment to the Act did not make a sufficient distinction between commercial transactions from marketing activities that induce increased prescription.

GENAS
They asked for an explanation of § 15 (1) of the draft law No transactions.

AIP
They stated that they had their own code of ethics and proposed measures in the field of transparency is in line with their ethical code and therefore the draft amendment to the Act Support.

Slovak Medical Chamber

They argued that part of the proposed measures were not related to public management resources. Part of the objections covered the latest changes to the legislation in the field withholding tax with an impact on the continuing training of health professionals; which is mandatory. They called for a relationship to the management of public resources to be mentioned in the explanatory memorandum.

Conclusions of the meeting:
The Ministry of Health of the Slovak Republic asked representatives of interested parties to possible comments on the draft amendment of the law sent to MZ SR (e-mail: jozef.slany@health.gov.sk) until the end of May 2015.

She wrote: Mgr. Bronislava Šalková, SFLP - OF