In connection with the initially drafted draft law, KRIB gave its comprehensive opinion on the contradiction of the introductions restrictive regime of parallel exports of medicinal products with basic European principles and norms.
With the new version of Art. 217a - art. 217d, is confirmed the permissive regime model, in which, for each parallel export of medicinal products, the IAL must give its opinion. It can be a tacit consent, for which you have to wait 30 days, but it can also be an express refusal to carry out the export, based on not unclear criteria.
I. In the newly proposed variants of texts, the following moments are striking:
1. The deadline for giving an opinion from the IAL has been extended from 20 to 30 days. As already justified, the existence of such a waiting period, the opinion of an administrative authority is a direct and factual obstacle to free trade within the Community. The introduction of such restrictions constitutes a gross violation of Art. 35 of the TFEU, according to which they are prohibited the quantitative ones export restrictions between Member Statesas well as all measures of equivalent effect. The increase in the length of the term leads to an even stronger deviation from the European requirements for the freedom of movement of goods and services.
2. In the part concerning the authorization of the IAL to issue prohibitory orders for carrying out exports, texts have been introduced that provide some clarification on how the information on the consumed and imported quantities of medicinal products is collected, but it is still not clear what the quantitative ratio is that can to give grounds to IAL to refuse export.
The new wording of the texts stipulates that the medicinal products available at the time of submission of the export notification are not sufficient to meet the needs of the population. The text thus drafted again does not provide the mechanism for calculating when there is a deficiency, which means that in practice it can be applied in different ways to different entities applying for export. In relation to some subjects, it can be considered that there is a deficiency if there is data that for a given period the imported products are less than those consumed, and in relation to others if there is data that the imported products are equal or even in a larger volume than those consumed.
The lack of clarity allows the administrative body to independently interpret the definition of insufficiency, which, as we have already explained, leads to a violation of the principles openness, predictability и objectivity, provided as basic for the work of the administrative bodies in the Republic of Bulgaria and raised as fundamental in the provision of art. 2, para. 1 of the Law on Administration.
3. In the new texts, it is striking that the conclusions about the available quantities of medicinal products in the country are made on the basis of a comparison of data on the quantities consumed, which are collected by the NHIF and the Ministry of Health, and data on the quantities delivered in the country, which are provided only by the marketing authorization holder.
Thus, the provided mechanism for obtaining information about the quantities of medicinal products that have entered the country only from the holder of the authorization for use, creates prerequisites for the confirmation of the quota regime for the manufacturers, who, at their discretion, determine the quantities of medicinal products that they deliver to the respective countries. In this way, manufacturers restrict the movement of medicinal products supplied in one country to another, in order to limit the possibility of drugs with lower prices in one country being exported to others where their prices are higher. In itself, this represents a limitation of the main European principle of free movement of goods and services, which in this particular case has the consequence and damage to the end users - the patients, who are deprived of the opportunity to receive medicines at lower prices.
It is also reasonable to question whether the data submitted by the MAH will be reliable and how the MAH will verify their veracity. The absence of a verification mechanism would give the holder of the marketing authorization the opportunity to always indicate as imported quantities those that are equal to or smaller than the quantities of drugs consumed in the same period in the country. This would be a prerequisite for the issuance of an order by the IAL to prohibit the export, which would be solely for the benefit of the holder of the marketing authorization, guaranteeing him that drugs with lower prices will not enter a market where the same sell at higher prices and accordingly will not erode the profits generated.
4. An increase in the amount of fines imposed in case of non-compliance with the requirements of the provisions related to parallel export cannot be ignored. Compared to the initial version of the draft law, they have been increased many times and are currently in the range of BGN 50 to BGN 000 for the first violation, and BGN 100 to BGN 000 for repeated violations.
In Bulgarian legislation, there is no analogue of such a high amount of fines for committing an administrative violation. In the current draft law, it is not clear what is the public danger that imposes such a high amount of fines, as well as what are the reasons for their drastic increase compared to the originally proposed ones.
II. In view of the above outstanding issues, we once again propose to consider our proposed texts in the part concerning the regime under which parallel exports take place, as follows:
"Art. 217a. (1) Parallel export of medicinal products from the territory of the Republic of Bulgaria may be carried out by a natural or legal person, holder of a permit for wholesale trade in medicinal products, issued by a regulatory body of a member state in accordance with the procedure provided for by its legislation and registered under Trade Law.
(2) Within a one-month period of carrying out a parallel export of medicinal products from the territory of the Republic of Bulgaria, issued on a doctor's prescription, which are paid for with funds from the budget of the National Health Insurance Fund (NHIF) and the Ministry of Health, the entities that carried out the export notify the IAL .
Art. 217b. The notification under Art. 217a, para. 2 contains the following information:
1. name, pharmaceutical form, quantity of the active substance in a dosage unit of a medicinal product that has been subject to parallel export;
2. number of the authorization for use of the medicinal product being exported;
Art. 217c. (1) In cases where there is a proven shortage of quantities of a medicinal product in the country, which is partially/fully reimbursed by the NHIF and is granted on the basis of protocols for prescribing a medicinal product or quantities of a medicinal product paid for with funds from the republic budget for the treatment of diseases, outside the scope of the mandatory health insurance, the executive director of IAL can issue a reasoned order to limit the parallel export of the medicinal product for a certain period of time.
(2) There is a shortage of quantities of a medicinal product when the available quantities of it in the country are below the average consumption of the same medicinal product in the country for the last three months, calculated on the basis of protocols for prescribing a medicinal product, paid by the NHIF/Regional Health Insurance Fund , respectively, data on prescribed quantities of a medicinal product, paid for with funds from the republican budget for the treatment of diseases, outside the scope of mandatory health insurance.
(3) The Executive Director of IAL ex officio on a quarterly basis collects the information under para. 2 from the NHIF, respectively from the Ministry of Health.
(4) The executive director of the IAL collects the information on the quantities available in the country from the manufacturer and/or importer of the medicinal product, from the wholesalers and the hospitals and pharmacies that distribute it and from the patients who use it, in accordance with the procedure determined by regulation of the Minister of Health.
(5) In the order issued in accordance with paragraph 1, the executive director of IAL gives reasons for limiting the parallel export, indicating its term, which cannot be longer than three months.
Art. 217 Simultaneously with the issuing of an order under Art. 217c, para. 1, the executive director of the IAL notifies the manufacturer and/or importer of the medicinal product for which a shortage has been found and requires him to fulfill his obligation under Art. 208, in connection with Art. . 207, paragraph 1, items 5 and 5a, namely to supply medicinal products to holders of a wholesale trade permit and pharmacies opened in accordance with this law, as well as to supply medical facilities with medicinal products for their own needs. In the notification according to the previous sentence, the executive director of IAL requires actions to be taken within a period of 1 month, in which the causes that led to the shortage will be removed.
The existing Art. 284c. acquires the following revision:
Art. 284c. A holder of a permit for wholesale trade in medicinal products who does not fulfill his obligations under Art. 207, as well as a manufacturer and importer who does not fulfill his obligation under Art. 208, in connection with Art. 207, paragraph 1, items 5 and 5a, shall be punished with a pecuniary sanction of BGN 2000 to 5000, and in case of repeated commission of the same violation – with a pecuniary sanction of BGN 5000 to 10.
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