Message 001
Communication from the Commission - TRIS/(2024) 2125
Directive (EU) 2015/1535
Notification: 2024/0445/BG
Notification of a draft text from a Member State
Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt
Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna
MSG: 20242125.EN
1. MSG 001 IND 2024 0445 BG EN 06-08-2024 BG NOTIF
2. Bulgaria
3A. Министерство на икономиката и индустрията,
дирекция "Европейски въпроси и законодателство на ЕС за стоки и услуги",
ул. "Славянска" № 8, 1000 София,
Tel.: +359 2 940 7336, +359 2 940 7565
3B. Министерство на здравеопазването,
дирекция "Лекарствена политика",
пл. "Св. Неделя" № 5, 1000 София,
Tel.: +359 2 930 1298, email: vvasiyanova@mh.government.bg
4. 2024/0445/BG - C10P - Pharmaceuticals
5. Draft Order prohibiting the export of certain medicinal products
6. Medicinal products
7.
8. It shall be prohibited to export, within the meaning of Article 217a(3) of the Law on Medicinal Products for Human Use, the following medicinal products which have received an authorisation pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency, and medicinal products with marketing authorisation issued under Article 26(1) of the Law on Medicinal Products for Human Use, classified according to an anatomical therapeutic chemical classification compliant with the requirements of the World Health Organisation (WHO) into the following pharmacological groups:
1. A10A “Insulins and analogues” – all medicinal products in the group;
2. A10B “Blood sugar lowering medicines excluding insulins” – a medicinal product with ATC code A10BJ06 in injection dosage form;
3. J01 “Anti-infectious medicinal products for systemic use” – all medicinal products in the group in ‘powder for oral suspension’ and ‘granules for oral suspension’ pharmaceutical dose forms.
The prohibition shall apply from 19.8.2024 to 19.9.2024.
9. The reasons for the order are as follows:
Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Insulin is a hormone that regulates blood sugar. Increased blood sugar, hyperglycemia, is the result of uncontrolled diabetes and over time leads to serious damage to many of the body’s systems, especially nerves and blood vessels.
Type 1 diabetes (known as insulin dependent) is characterised by insufficient insulin production and requires daily parenteral insulin administration.
Type 2 diabetes affects the way glucose in the body is absorbed and transformed into energy. This is a pathological condition in which cells either fail to respond normally to the hormone insulin or reduce the number of insulin receptors in response to hyperinsulinaemia.
The main danger in diabetes is its chronic complications. Diabetes leads to the development of damage to the eyes, kidneys, nervous system, cardiovascular diseases, brain strokes, pain in the lower extremities, etc.
In mid-June, by Order No RD-01-537/18.07.2024 of the Minister of Health was prohibited the export of medicinal products classified according to an anatomical therapeutic chemical classification compliant with the requirements of the World Health Organisation (WHO) in the following pharmacological groups:
1. A10A “Insulins and analogues” – all medicinal products in the group;
2. A10B “Blood sugar lowering medicines excluding insulins” – a medicinal product with ATC code A10BJ06 in injection dosage form;
3. J01 “Anti-infectious medicinal products for systemic use” – all medicinal products in the group in dosage forms “powder for oral suspension” and “granules for oral suspension”.
In order to analyse the situation of their availability on the market and patients’ access to them, information was requested from the Bulgarian Drug Agency (BDA) on the available quantities of the medicinal products from the pharmacological groups subject to the prohibition on export to wholesalers and pharmacies, from the Regional Health Inspectorates on checks carried out in community pharmacies on the availability of medicinal products, covering large and smaller settlements. From the website of the National Health Insurance Fund (NHIF), an inquiry was made on the consumption of medicinal products and the number of health insured persons.
Following an analysis of the data received from the above-mentioned institutions, there are indications of irregular deliveries/delays or refusals from wholesalers' warehouses for medicinal products from the following pharmacological groups: A10A “Insulins and analogues”, J01 “Anti-infectious medicinal products for systemic use” (in dosage forms “powder for oral suspension” and “granules for oral suspension”) and A10B “Blood sugar lowering medicines excluding insulins” – a medicinal product with ATC code A10BJ06 in injectable dosage form.
With regard to medicinal products belonging to the pharmacological group A10A “Insulins and analogues”, it is observed that five of the insulins have irregular supply/delay or refusal from the warehouses in more than 50% of all districts in the country.
In relation to other five insulins from this pharmacological group refusals by wholesalers were reported in nearly or more than 30 % of all districts in the country. For the rest of the insulins that were reported to suffer delay/irregular supply or refusal by the wholesaler, problems were observed in single districts.
On the basis of an analysis of the information received from the BDA, comparable with the information on the average monthly consumption of medicinal products by the insured persons, it was found that there is a difficulty in supplying both pharmacies and patients with the medicinal products from the pharmacological group A10A “Insulins and analogues”.
As regards the medicinal product with INN Semaglutide:
The inspections carried out by the Regional Health Inspectorates have found some difficulties in the provision of the medicinal product in pharmacies in the following provinces: Varna, Razgrad, Sofia City, Stara Zagora and Haskovo.
As regards medicinal products of the following pharmacological group: J01 “Anti-infectious medicinal products for systemic use” – all medicinal products in the group in pharmaceutical forms “powder for oral suspension” and “granules for oral suspension”:
After a review and analysis of the information received, it was found that the greatest delay, irregularity in supplies, including refusal from the warehouses of wholesalers has been found for medicinal products belonging to INN: Amoxicilline, clavulanic acid – 9 medicinal products out of 20 with reports of bottlenecks in supply. 36% of the districts in the country reported refusal and/or irregular supply of one of these nine medicinal products, while 32% of the districts experienced delay or refusal in supplies of the same medicinal product but in a different concentration of the active substance. In 25 % and 18 % of the districts respectively, there were irregular supplies or refusals of medicinal products containing INN Azithromycin and Cefuroxime. In relation to 10 of the medicinal products belonging to this group, problems related to the supply were observed in single districts.
It should be noted that, according to the aggregated information provided by the Regional Health Inspectorates, shortages, irregularity or refusals by the warehouses were encountered for medicinal products belonging to 7 INNs: Amoxicilline and clavulanic acid, Azithromycin, Cefuroxime, Amoxicilline, Cefpodoxime, Clarithromycin, Cefaclor.
Although the mechanisms laid down in the legislation to restrict the export of medicinal products laid down in Chapter Nine “b” “Export of Medicinal Products”. Specialised electronic system for follow-up and analysis of medicinal products” in the Act on Medicinal Products in Human Medicine, as it could be noted from the analysis of the data received from the above-mentioned institutions, a shortage of medicinal products continues to be observed. Proof of this is the continued receipt of signals of lack in the pharmacy network of these medicines received at the Ministry of Health, and one of the possible reasons for this shortage is that these products are being exported from the territory of the Republic of Bulgaria to other countries in quantities that create conditions for a potential shortage of these medicinal products on the Bulgarian market.
Regardless of the legal nature of the activity carried out, the export of medicinal products used for the treatment of diabetes and of antibacterial medicinal products for systemic use, as well as the observed delays in the supply, disturbs the balance between the medicinal products supplied on the territory of the country and the increased needs thereof to meet the health needs of the population.
Following an in-depth analysis of the current situation with regard to the availability of the above-mentioned groups of medicinal products and the information provided above, the need to introduce an export ban of the aforementioned groups of medicinal products has been identified.
In addition, by setting a time limit for the ban on the export of the medicinal products subject to the export ban, as specified in the Order, a balance will be reached between the aim of the applied measure - to ensure a sufficient quantity of these medicinal products necessary for the treatment of Bulgarian patients, to protect their health and to guarantee the continuity of their drug therapy - on the one hand, and on the other hand, the right of economic operators to carry out the free movement of the goods in which they trade - in this case medicinal products - shall not be infringed for a long period of time.
The objective sought – to provide the Bulgarian pharmaceutical market with sufficient medicinal products to meet the needs of the population, should be proportionate to the potential economic benefits that would accrue to the holders of marketing authorisations for medicinal products if they were able to export the described products during the period in question. The prohibition period introduced does not violate the principle of proportionality laid down in the Administrative Procedure Code, the main purpose of which is that the administrative act and its implementation may not affect rights and legitimate interests to a greater extent than necessary for the purpose for which the act is issued (Article 6(2) of the APC).
The duration of the prohibition, as well as the specific medicinal products, have been determined in strict compliance with the principle of proportionality, in order to protect the health of the population and in compliance with the prohibition of arbitrary discrimination or disguised restriction on trade between Member States referred to in Article 36 of the Treaty on the Functioning of the European Union.
10. References to the basic texts: There is no main text
11. Yes
12. Currently, numerous reports are received for the lack of insulin in pharmacies, which is vital for the treatment of diabetes – including irregular supplies/delays or refusals by the warehouses of wholesalers for these medicines, as well as data from the BDA, comparable to the data on the average monthly consumption of medicinal products by the health insured persons, published by the NHIF, about the difficulty in supplying pharmacies and patients. In relation to the group A10A “Insulins and analogues”, it is observed that four of the insulins have irregular supplies/delays or refusals from the warehouses in more than 50% of all districts in the country. In relation to other five insulins from this pharmacological group refusals by wholesalers were reported in 30 % of all districts in the country. The analysis also shows that the greatest delay exists for medicinal products belonging to INN: Amoxicilline, clavulanic acid – 9 medicinal products out of 20 are reported to have difficulties in supplies. In relation to the other medicinal products of the group there are also delays or refusals. The need for the immediate measure was identified following an in-depth analysis of the current situation concerning the availability of medicines and in the light of the data from the system. The measure will achieve timely and adequate provision of sufficient quantities of these medicinal products for the treatment of the Bulgarian patients, which will ensure the protection of their health and will guarantee the continuity of their drug therapy.
13. No
14. No
15. No
16.
TBT aspects: No
SPS aspects: No
**********
European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu
