CLV Partners

CLV-02

pharmaceutics

About the changes of Government Decree 235 of 2009 (X.20.)

In September 2017 Government Decree 250 of 2017. (IX.5.) entered into force, modifying certain healthcare, health insurance and pharmaceutics related government decrees.
On 7 September 2017 Government Decree 250 of 2017. (IX.5.) regarding the modification of certain healthcare, health insurance and pharmaceutics related government decrees entered into force, hereby modifying the Government Decree 235 of 2009. (X.20.) („Government Decree”) regarding the rules of the authorization procedure of medical research, clinical trials of products intended for human use, as well as the clinical trials of medical devices for human use, intended for clinical trials.

The changes of the Government Decree entering into force on 1 January 2018 concern the modification of the research and examination project. In the Hungarian text a slight difference can be found in the wording between the previous version and the one entering into force.

As a new provision entering into force on 1 February 2018 the Government Decree regulates the authorization of research involving ionizing radiation, the serves compliance with EU legal acts (Euratom).

Pharmaceutical news

Act no. CXI. of 2014 on the amendment of certain acts relating to health and health insurance regulations has introduced several changes most of which have become effective as of January 1, 2015. Within the present newsletter we have mainly focused on presenting the changes relating to pharmaceutical law in particular.

1./ Changes made to Act no. XCV. of 2005 on the amendment of regulations relating to medicines for human use and pharmaceutical market (abbreviated in Hungarian: „Gytv.”)

1.1. Amending the rules of permanent or temporary medicine shortage
The rules on the notification of temporary or permanent medicine shortage have been amended. If the holder of the marketing authorization cannot ensure the continuous supply of a certain medicine in Hungary, when making a notification on the temporary or permanent shortage of the medicine has also the obligation to inform its contracting parties i.e. the pharmaceutical wholesalers, the national pharmaceutical authority and in case the medical product is covered by social security reimbursement the health insurance authority as well. The information (in line with the previous regulations applicable in this sense) should cover not only the long-term supply obstacles – but also the duration of the obstacle and as well as the amount of stock available during the shortage. In case of temporary or permanent medicine shortage, the holder of the marketing authorization shall be obliged to cooperate with the national handling company of public health, safety and disaster supply stock and with the national pharmaceutical and health insurance authority (Article 16.§ of Gytv). By this amendment a higher level of cooperation is required from manufacturers and wholesalers dealing with temporary or permanent medicine shortage.

Do not take zopiclone for longer than your doctor advises. It is only recommended for a maximum period of four weeks. This is because your body gets used to this medicine quickly, and after this time it is unlikely to have the same effect. Your body can also become medicament zopiclone 7.5 mg dependent on it when it is taken for longer than this. The tablets will make you sleepy and you could still feel sleepy the next day. Do not drive or use tools or machines on the following day unless your reactions have returned to normal. Do not drink alcohol while you are on zopiclone. It will increase the risk of side-effects such as sleepwalking and doing other things which you are unable to remember when you wake up. When you stop taking zopiclone, your doctor may advise you to reduce the dose slowly to help prevent your sleep problems from returning. Follow any directions you are given. More: somnifere sans ordonnance liste

1.2. New legal instrument against counterfeit medicines
The new legal instrument on imposing temporary inaccessibility of electronic data to public is considered to be an important step in defeating the marketing of counterfeit medicines. The national pharmaceutical authority may order a temporary restriction on the accessibility of a data made publicly available via means of electronic communication (hereinafter: “electronic data”) if the disclosure of the data is connected related to provide counterfeit or unauthorized medical product. The national pharmaceutical body shall impose such restriction in the form of a resolution binding the service provider or the intermediary service provider as defined within the Hungarian act regulating certain questions referring to electronic commercial services and information society- related services. The addressee of the order shall be required to temporarily remove the electronic data within one working day following receipt or such resolution. The national pharmaceutical authority shall resolve on the temporary inaccessibility of electronic data by issuing an order on the temporary removal of such electronic data. The national pharmaceutical authority may impose a fine between HUF 100 000 and up to HUF 1 million to the service provider complying with the resolution. The obligation relating to the temporary inaccessibility of electronic data shall terminate within 90 days as from publication of the order (newly introduced Article 20/A §, of Gytv. contains further details on these rules).

2./ Amendment of Act no. XCVIII of 2006 on the general provisions relating to the reliable and economically feasible supply of medicinal products and medical devices and on the distribution of medicinal products (abbreviated in Hungarian: “Gyftv.”)

2.1. Amending and refining the rules regarding the supervision of commercial practices
The rules on the supervision of promotional activities and commercial practices have been further clarified, but no fundamental changes were introduced. The national pharmaceutical authority – in order to clarify the facts of the case – is entitled to investigate the contractual relationship between i) the market authorization holder, or the manufacturer or distributor of the medical device and the person authorized for promoting the medical product, between ii) the promoter of the medical product and medical devices and the person entitled to distribute and order such products, and between, iii) the person acting on behalf of the promoter of medicinal product and medical devices and the person entitled to distribute and order such products as well as the activity actually performed on the basis of such contract. In the course of conducting such investigation the parties of the legal relationship concerned shall provide all evidence available, in order to assess whether the activity performed is in line with the content of the relationship established and shall not qualify as unfair commercial practice (Article 20.§ subsection 4) and 4a) of Gyftv.)

The deadline for the procedures regarding inspection and monitoring of the promoting activities and commercial practices is stipulated by the provisions of Gyftv. The deadline shall be 60 days, which in justified cases may be extended once with a maximum of 21 days (Article 20.§ subsection 11 of Gyftv).

The above amendment points to the fact that the national pharmaceutical authority – within its powers for inspection – intends to conduct a more extensive monitoring of the activities relating to commercial practices of healthcare professionals and pharmacies.

2.2. Amendment of rules relating to subsidy volume agreements
The payment obligation stipulated within the subsidy volume agreements may be determined by taking into consideration the cost effectiveness of the dosage, the deviations from the dosage applied and the standard specifications of a certain medicine defined within the contract (Article 26.§ of Gyftv.) Based on the newly implemented regulations, the national health insurance authority may only accept a medicine in the state reimbursement category without an actual supported value (0%), if the annual turnover of the medicine will expectedly not exceed HUF 30 million. This new provision basically refers to medicines which are distributed in hospitals. The insurance authority shall verify the turnover data of the medicine included in this category and if it exceeds the above limit, the national insurance authority may resolve on the termination of the preferential status even before the termination of the five (5) year period (Gyftv. 31./C).

2.3. Amending the rules regarding the approval procedure of therapeutic medical devices. Initiating the setup of a new functional group by the health insurance authority
Once the resolution on the approval of the therapeutic medical devices has become final and binding, if the manufacturer of the therapeutic medical devices or its appointed representative intends to change the price of the approved medical appliance marketed by state subsidy or to change its rental price then it shall be required submit a request or shall make a notification to national insurance authority.

On its own initiative, the national insurance authority may submit a request to the Ministry of Health on setting up a new functional group, provided that the approval of a state subsidy for an otherwise non-reimbursed therapeutic medical devices has been granted on the basis of a request formulated by more than 50 patients for a consecutive period of 12 months and the functional category of the concerned therapeutic medical devices was not yet listed within the Ministry Regulation (Article 34.§ of Gyftv.).

2.4. Changing the rules on the establishment of pharmacies
The rules relating to the establishment of pharmacies and branch pharmacies have been amended and the content of the tender in respect to the independent right of pharmacists has also been clarified (Article 49.§-60.§ of Gyftv).

3./ New regulation relating to healthcare service providers
Pursuant to the amendment of Act no. XI. of 1991 on the authorized official and organizational health care activities (abbreviated in Hungarian: „Ebt.”) the healthcare service provider subject to financing agreement, based on the provisions of law and in the frame of the compulsory health insurance system may not request any compensation fee – except for partial reimbursement fee or additional reimbursement fee – from the patients for the services financed by the National Health Insurance Fund. The above amendment means that in hospitals one may not charge any fee for a service which is subsidized (for e.g. laboratory services) (Ebtv. 9/B. §).

4./ National Medical Supply Center
Based on the amendment of law no CXXXII. of 2006 on the development of health care supply system as from March 1, 2015 the National Medical Supply Center will be established (in Hungarian: „Állami Egészségügyi Ellátó Rendszer”, Hungarian acronym: „ÁEEK”) which will take over the institutional maintenance duties of the National Institute of Quality and Organizational Development in Healthcare and Medicines (Hungarian acronym: „GYEMSZI”)

5./ Change in the amount of the minimum wage
With respect to the amount of inexpensive gift and reasonable support for event, in 2015 the amount of the mandatory minimum wage payable to full-time workers is HUF 105 000, the 5% of which shall be equal to HUF 5250.

The amendments relating to health insurance regulations will be presented in a separate newsletter.

Should you have further queries CLV Partners is ready to answer your questions.

Dr. Csabai Marianna

CLV Partners news