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Adoption of the Medical Product Policy Reform in Slovakia

With regards to the fact that alianciaadvokátov ak, s.r.o. represents several clients from the pharmaceutical area, we would like to inform you of a new law that has had an impact on our clients. On 13th September 2011 Slovak Parliament adopted a new Act No. 362/2011 Coll. on Medical Products and Medical Devices (hereinafter the „New Law“) which replaced Act No.140/1998 Coll. on Medical Products and Medical Devices, as amended by previous acts. The New Law became valid and effective as of 1st December 2011.

(Source: Courtesy of alianciaadvokátov ak, s.r.o.)

With regards to the fact that alianciaadvokátov ak, s.r.o. represents several clients from the pharmaceutical area, we would like to inform you of a new law that has had an impact on our clients. On 13th September 2011 Slovak Parliament adopted a new Act No. 362/2011 Coll. on Medical Products and Medical Devices (hereinafter the „New Law“) which replaced Act No.140/1998 Coll. on Medical Products and Medical Devices, as amended by previous acts. The New Law became valid and effective as of 1st December 2011.

The proclaimed goal of the New Law is to issue a new wording of the act on medical products and medical devices with regard to numerous amendments to the former law that makes the former law perplexing. However the New Law includes a lot of changes that influence the Pharmaceutical sector in the Slovak Republic.

Extensive parts of the New Law are harmonised with the law of the European Union. The New Law includes harmonised parts concerning requirements on pharmacological tests, toxicological pharmacological tests, clinical trials, registration procedure, manufacture and wholesale distribution of human and veterinary medical products and supervision of medical products for human and veterinary use. In the area of medical devices it includes parts concerning requirements for clinical investigation, conformity assessment procedures, registration of manufacturers of medical devices and control of medical devices.
The areas that are not harmonised with the European Union include pharmacist care and prescription of human and veterinary medical products and medical devices. These areas are the parts of the healthcare and are in the sole scope of authority of a member state.

The main changes introduced by the law are as follows:
The Generic Prescription.

The adoption of the New Law was preceded by a wide discussion between pharmaceutical companies and the Slovak Health Authorities. In principle according to the New Law the physician is responsible for the prescription of an active substance on the basis of the diagnosis, the pharmacist is responsible for the dispense of a medical product on the basis of the prescribed active substance and at the same time the pharmacist is obliged to inform the patient about the options to provide the patient with a cheaper medical product if available.

Physicians are obliged to prescribe the active substance itself instead of a brand name of the medical product. The brand name can be specified on the prescription though it would be upon the decision of the patients as to which medical product they will buy in the pharmacy upon the pharmacist's information on the cheapest available medical product of the same active substance. The Health Authorities expect that patients would choose the generic medical product instead of the original medical product due to the fact that the generic medical product is cheaper. The generic prescription though is limited to medical products that can be taken orally and consists of single component. The New Law includes Annex No. 1 that defines the list of active substances that have to be prescribed only by the name of the active substance, the way of application, medical form, strength of the medical product, size of the packing and amount of packets. The New Law also introduced the liability of the physicians or hospitals towards the health insurance companies in such cases that a physician infringes certain duties imposed by the New Law, mainly ones that relate to generic prescriptions.

Medical products with a different way of application and those that consist of more than one component will be prescribed the same way as before.

The generic prescription shall be applicable only to categorised medical products, in other words, only to medical products that are fully or partially reimbursed by the public health insurance. The process of the categorisation of medical products is defined by Act No. 363/2011 Coll. on the Extent and Conditions of the Reimbursement for Medical Products, Medical Devices and Dietetic Food on the basis of the Public Health Insurance and on change and amendment of certain acts. This act is also a new act that came into effect the same day as the New Law, on 1st December 2011.

Discounts on Medical Products in Pharmacies.
Pharmacies shall be allowed to provide or promise to the patient discounts, benefits or complex of discounts and benefits that the law name as the “fidelity bonus system”. The conditions of the fidelity bonus system have to be available in each pharmacy throughout its application or the pharmacist has to publish it on their website and the pharmacist is obliged to follow these conditions.
The pharmacist may apply the fidelity bonus system on the basis of the precedent (foregoing) written announcement delivered to the all health insurances. In this announcement the fidelity bonus system must be described, otherwise the pharmacist may apply the fidelity bonus system only on the basis of the written agreement concluded in line with the health insurance. If the pharmacist applies the fidelity bonus system on the basis of the precedent (foregoing) written announcement delivered to a health insurance or on the basis of the written agreement concluded with health insurance, the pharmacist has to apply it towards policy holders of all health insurances. It is prohibited the provision of the discounts in perquisites or monetary payments within the framework of the applied conditions of the fidelity bonus system. A voucher for the future monetary discount is not considered as non-monetary fulfilment according to the New Law. The discounts and benefits of the fidelity bonus system may have only the form of discount from the price from the performed purchase or future purchase in the public pharmacy.
The providing of discounts is voluntary and in case a pharmacy decides to provide the discounts to patients the 50 % of the discount provided to the patient must be provided also to a health insurance.
Health insurance companies shall benefit from the discount and due to this public health insurance sources are expected to be saved. This provision re-introduced a possibility of discounts on medical products which were banned in 2010. There was strong pressure from 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 competitive 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. This creates possibilities for the formation of pharmacy networks. This provision was the subject of numerous comments from the side of the Chamber of Pharmacists too.

Anti-Corruption Provisions.
The New Law amends also other laws that are connected to the pharmaceutical sector, especially Act No. 147/2001 Coll. on Advertisement and on the change and amendment of certain acts. The New 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 practitioner 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 Medical Products Shall be Decreased.
The price of medical products should be the second lowest in the European Union. Until the adoption of the New Law the price of medical products 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 medical products but also to the price of medical devices and dietary food. The categorization of the medical products 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 approximately 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 medical products.

Disputable Provisions of the New Law.
The New Law redefines some rules in the pharmaceutical sector. For this reason multiple professional associations of persons and companies participating in the pharmaceutical sector raised a lot of comments to the New Law, some of them were accepted and some not. The most mentioned comments concerned the terminological problems, for example the definitions of medical product and active substance, sponsor, investigator, subject. Pharmaceutical companies complained that these definitions are insufficient and the translation into the Slovak language from the EU directives is problematic. With regard to other problematic content we have to mention the new rights of health insurance companies. The health insurance company became the control body to the clinical trial that is quite unusual; the control bodies are usually Health Authorities (in the Slovak Republic the State Institute for Drug Control and Ministry of Health) and ethical committees. The sponsor of the clinical trial has an information duty towards the health insurance company, this means to submit on request all data and documentation concerning the clinical trials. Further comments were raised by sponsors to the duty of State Institute for Drug Control to publish the financial reward for an investigator, etc. The amendment to the New Law is prepared however the New Law has only been effective for 3 months.


JUDr. Gerta Sámelová Flassiková (flassikova@aliancia.sk),
Mgr. Ján Voloch (voloch@aliancia.sk)

are partners with alianciaadvokatov ak, s.r.o.
This article is of an informative nature only. For
more information go to www.aliancia.sk or contact
alianciaadvokátov ak, s.r.o

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