At the end of August, the Government submitted to the Chamber of Deputies a draft of amendment to the Act No. 378/2007 Coll., on pharmaceuticals and and on amendments to certain related acts (Act on Pharmaceuticals), as amendedon and the Act No. 48/1997 Coll., on public health insurance and on amendments and supplements to certain related acts, as amended. The main change brought by the amendment is the introduction and subsequent legal regulation of the so-called emergent system of the availability of medicinal products in the Czech Republic.
Introduction and reasons for the adoption of the emergent system
The current wording of the section 77 par. 1 letter h) of the Act on Pharmaceuticals aimed to ensure the delivery of the medicinal product to the pharmacy and to introduce obligations for distributors to deliver the medicinal product ordered by the pharmacy within two working days and further, the obligation of the MA holder to deliver to the distributor who addresses him the required medicinal product to the extent of the market share of that distributor. However, from the legislature´s point of view, this does not fit the context of the Act on Pharmaceuticals and contains several imperfections. The above-mentioned amendment to the Act on Pharmaceuticals focuses on this issue and comes up with a proposal for a solution in the form of introducing a new protective mechanisms, such as the so-called emergent system or the possibility of the State Institute for Drug Control (hereinafter referred to as “SIDC”) to issue operational measures of a general nature on limiting and / or prohibiting the export of a medicinal product abroad or introducing new sanctions for breach of legal obligations.
One of the main reasons why the legislator resorted to the amendment of the Act on Pharmaceuticals is the fact that availability of some medicinal products was limited due to its export (so called reexport) outside the Czech Republic. The new proposed legislation of the Act on Pharmaceuticals aims to ensure the availability of medical products for patients in pharmacies in the Czech Republic, in the sense that the patient should be able to pick up the prescribed medicinal product at any pharmacy of his/her choice. The basic objective of the amendment is therefore to introduce a system enabling the availability of a specific prescription medicinal product presented in a specific pharmacy and its delivery within a specified period if the pharmacy cannot provide the medicinal products by the standard way. The MA holder should then be responsible for the delivery of such a supply. The guiding principle around which the amendment revolves is to ensure that medicinal products placed on the Czech market are primarily used for patients in the Czech Republic and exported abroad only if this does not jeopardize its availability for patients in the Czech Republic.
A similar system of the availability of medicinal products was introduced on 1 April 2017 in Slovakia under the Information system for extraordinary medicines orders by amendment of Slovak Act No. 362/2011 Coll., on medicines and on amendments to certain related acts.
The functionality of the emergent system
The amendment to the Act on Pharmaceuticals will not apply to all groups of medicinal products. It aims to regulate only the supply of reimbursable prescription medicinal products that are not available in the regular distribution network. Over-the-counter medicinal products are widely available on the market, and if they are not available, it is just due to the manufacturing problems, therefore there is no reason to apply the newly introduced system to them. Pursuant to the proposed wording of section 33a para. 3 of the amendment to the Act on Pharmaceuticals, the MA holder will be given a new obligation to ensure delivery of the medicinal product to the pharmacy, which the patient has chosen, within a specified period of two working days from the date of delivery of the order sent via the emergent system, but at the same time the condition that the pharmacy cannot order the medicinal product in the normal distribution network must be met. This results in easier work for pharmacies, which will no longer have to find out at which distributors the medicinal is available.
Furthermore, according to the amendment of the Act on Pharmaceuticals, the MA holder will be obliged to confirm the delivery of an order made through the emergent system electronically to the ordering pharmacy and state the date and time when the order was delivered, otherwise, he commits an offense for which he could be sanctioned.
New obligations for MA holders
New obligations for MA holders are set out in section 32a and section 32b of the proposed amendment to the Act on Pharmaceuticals, some of which are detailed below.
For example, the MA holder will be obliged to ensure the establishment and operation of the emergent system in the event that it is not possible to ensure the availability of the medicinal product to the patient by any other means hereinunder. The MA holder will ensure the operation of the emergent system in the form of automated electronic submission and confirmation of orders via the communication interface and in the event of its failure also in a non-automated form, and in this context will also be obliged to ensure the maintenance of the emergent system in continuous operation.
Furthermore, for each reimbursed medicinal product, the MA holder will be obliged to publish, via the emergent system, a list of distributors through which it currently provides its supplies to patients in the Czech Republic. At the same time, the MA holder will have to notify SIDC, on the electronic form published on the SIDC website, of a hyperlink to automated electronic placement and confirmation of orders and data for the execution of non-automated placing of orders and report the change of these data no later than two working days before the change.
Another new obligation for MA holders will be keeping electronic records of distributors and pharmacies, to which he has ensured the delivery of the medicinal product on the basis of an order submitted through the emergent system.
Measures to ensure the availability of medicinal products in the Czech Republic
The amendment to the Act on Pharmaceuticals aims, among the other things, as mentioned above, to increase the control over the dispensing of ordered medicinal products and providing them primarily to the Czech market and Czech patients in order to avoid jeopardizing the availability of medicinal products to meet the needs of patients in the Czech Republic. The pharmacy operator will be obliged to accept and use the medicinal product delivered on the basis of an order made through the emergent system only exclusively for dispensing to the patients on prescription, pursuant to the provisions of the section 33c para. 3 of the amendment to the Act on Pharmaceuticals.
At the same time, provisions limiting unwanted re-export of medicinal products abroad should be put into practice. Only a MA holder who is also the holder of the distribution authorization or the distributor of the given medicinal product will be able to supply a reimbursed medicinal product intended for use in the Czech Republic to another EU member state or a third country, provided that this is in accordance with the valid measure of a general nature issued by SIDC, authorizing the supply of such a medicinal product as mentioned in the section 77c para. 1 of the amendment to the Act on Pharmaceuticals. The measure of a general nature will also include a list of reimbursed medicinal products that have been delivered to pharmacies in the Czech Republic in each of the last three consecutive calendar months and other legal conditions set out in the section 77c para. 2 of the amendment to the Act on Pharmaceuticals, such as medicinal products not ordered via the emergency system by more than five pharmacies in the last three consecutive calendar months.
If it is not a reimbursed medicinal product, SIDC shall issue a measure of a general nature prohibiting or restricting the supply of a medicinal product intended for marketing in the Czech Republic to another EU member state or to a third country if it finds that the supply of a medicinal product to the EU member state or to a third country may jeopardize the availability and effectiveness of the treatment of patients in the Czech Republic with a direct impact on the protection of the health of the population, and the issuance of measures of a general nature is justified by public interest in protecting the health of the population and a less restrictive measure is not possible with regard to the level of threats to the availability and effectiveness of patient treatment in the Czech Republic, which is moreover regulated in detail by the new wording of the section 77d para. 1 of the amendment to the Act on Pharmaceuticals.
Amendment to the Public Health Insurance Act
The amendment to the Public Health Insurance Act focuses mainly on the financial availability of the medicine products. It targets cases where an essential medicine has an outage and a mechanism is in place to ensure its availability or its full replacement, in a situation where the substitute medicine sometimes has no reimbursement from public health insurance.
In such a situation, SIDC will be able to set or increase the maximum price and reimbursement of the medicine from public health insurance by means of a temporary emergency measure.
Conclusion
The draft of the amendment to the Act on Pharmaceuticals, if approved within the legislative process, introduces a new instrument in the form of the emergent system, which is to ensure in particular the availability of medicine products for patients in the Czech Republic and theirs delivery to the pharmacy chosen by the patient and other measures to introduce greater availability of medicines in the Czech Republic.
The emergent system of the availability of medicinal products will bring a number of other new obligations for MA holders, especially in connection with ensuring the operation of the emergent system and keeping it in continuous operation or delivering medicinal products to pharmacies, in the case of their shortage in the normal distribution network at distributors, but only through this emergent system.
There are further new demands placed on MA holders to ensure the availability of medicinal products.
The question is to what extent MA holders can be required to engage and ensure the emergent system itself, including also its establishment, and whether it would be rather preferable to find a compromise solution that will be less burdensome for MA holders.
If you have any questions about the amendment to the Act on Pharmaceuticals or the pharmaceutical law in general, we are at your disposal – please do not hesitate to contact us.
Mgr. Bc. Štěpánka Vajdová, junior lawyer – vajdova@plegal.cz
Mgr. Jakub Málek, partner – malek@plegal.cz
Eliška Vetýšková, legal assistant – vetyskova@plegal.cz
29. 10. 2019