On September 13, 2011 Slovak Parliament adopted a new Act on Drugs and Medical Devices (hereinafter „the Law“) which, replaced Act No.140/1998 Coll. The Law became effective as of 1st December 2011. The adoption of the law was preceded by wide public discussion and quite strong pressure from the side ofpharmaceutical companies. In principle according to the Law the physician are responsible for the prescription of anactive substance on the basis of the diagnosis, the pharmacist is responsible for the administration of the drug on the basis of the prescribed active substance and at the same time he is obliged to inform the patient about the options and to provide the patient with the cheapest drug available.
The main changes introduced by the law are as follows:
The Generic prescription. Physicians are obliged to prescribe the active substance itself instead of a brand name of the drug. The brand name can be specified on the prescription though it would be upon the decision of the patient to which drug they will buy in the pharmacy. The Ministry of Health expects thatpatients would choose the generic drug instead of the original drug due to the fact that the generic drug is cheaper. The generic prescription though is limited to drugs that can be taken orally and consists of single component. The Law also introduced the liability of the physicians or hospitals towards the Health Insurance Companies in case that a physician infringes certain duties imposed by the Law, mainly ones that relate to generic prescriptions
Discounts on drugs in pharmacies. Pharmacies shall be allowed to provide discounts within the fidelity bonus system. Health Insurance Companies shall benefit from a certain part of the discount and due to this public health insurance sources are expected to be saved. This provision re-introduced a possibility of discounts ondrugs which were banned in 2010. There was strong pressure of the Chamber of Pharmacists against the re-introduction of the discounts, as there was a general worry that this provision might have a liquidation effect on smaller pharmacies however, on the other hand it might give a competition advantage to the pharmacy networks.
Pharmacy networks. Creation of the pharmacy networks will become much easier. The law revokes the restriction that enabled the issue of license to only one public pharmacy and one affiliated outlet of public pharmacy, Even this provision was highly critisized form the side of the Chamber of Pharmacists.
Anti-corruption provisions. The Law introduces several provisions which should eliminate the activities of Pharma companies‘ representatives in relation to physicians. A novelty is the prohibition of the pharmaceutical companies representatives to visit the physicians during office hours. Besides that the Law also prohibits reception and donation of any financial donations or material advantages to physicians from pharmaceutical companies‘ representatives. The law also prohibits physicians, pharmacists or any other medical practitionier to participate at an event which is financed, sponsored or otherwise indirectly supported by a pharmaceutical company. The physician, pharmacist or any other medical practitioner may participate only in events with the purpose of which is educational or scientific.
The price of drugs shall be decreased. The price of drugs should be the second lowest in the European Union. Until the adoption of the Law the price of drugs were calculated by the average price of the six lowest prices in the European Union. This change shall apply not only to the price of drugs but also to the price of medical devices and dietary food. The categorization of the drugs shall become more transparent and will be carried out on a monthly basis in contrast to quarterly categorisation , as according to the former law. It is expected that these provisions will bring savings of approx. 75 million Euros in the first year. The pharmaceutical companies on the other hand warn that the above mentioned provisions of the Law might have a negative impact on the availability of drugs.
Gerta Sámelová Flassiková