On Friday, 21 June 2019, within the third reading at the 30th meeting of the Chamber of Deputies of the Parliament of the Czech Republic, the draft amendment to Act No. 378/2007 Coll., Act on Pharmaceuticals, as amended (hereinafter referred to as “Act on Pharmaceuticals”) and some other acts, was approved. The amendment to the legislation affects both patients, marketing authorization holders of medicinal products and distributors.
Among the most important changes which should the amendment bring, can be included:
- introducing a system for keeping a patient record of the patient, which should provide doctors and pharmacists with an overview of the complete pharmacotherapy of the patient, in particular to switch to the planned next step of an e-healthcare in the form of introduction of a patient record and eRecept;
- introducing the obligation of marketing authorization holders to report data on the price of medicated products to the Czech State Institute for Drug Control (hereinafter as “SIDC”);
- changes in the obligation to supply distributors, at their request under certain conditions, with sufficient quantities of medicinal products;
- introducing the obligation of distributors to ensure the supply of medicinal products to operators authorized to dispense medicinal products in quantities and time intervals corresponding to the needs of patients in the Czech Republic under given conditions and, in certain cases, with restrictions on their export; or
- extending the recordkeeping and information obligations of distributors to SIDC on the prices of reimbursed medicinal products.
e-Healthcare
Healthcare has gotten closer to e-healthcare system last January, when the duty of doctors to place recipes on patients electronically was introduced. This fact is continually followed by the amendment to the Act on Pharmaceuticals, which aims to ensure the obligatory e-prescription from the point of detection of possible negative interactions or duplications of used and prescribed medication by the patient via the patient’s medication record.
The main objectives of the proposed amendment to the Act on Pharmaceuticals are primarily to anchor the electronic recipe information system, the eRecept system, as an information system for public administration enabling the implementation and support of electronic prescription of medicinal products. In addition, the scope of SIDC competence as a founder, operator and material and technical administrator of the eRecept system with precisely defined competences and duties is specified in the amendment.
The patient will be able to express his or her disagreement with the view of his or her medication record at any time (so-called opt-out).
New obligations for marketing authorization holders (MAHs) and distributors
As mentioned above, the amendment to the Act on Pharmaceuticals significantly affects marketing authorization holders, distributors and persons authorized to dispense (pharmacies), when legally stipulating the obligation to provide data on the price of the medicinal product to SIDC.
Already, the above-mentioned entities must report to SIDC the volumes of deliveries of medicinal products placed on the market in the Czech Republic, including a more detailed specification to whom the medicinal product was further distributed which, according to the newly proposed wording of Section 33 par. 2 of the Act on Pharmaceuticals, should now be extended to marketing authorization holders by the obligation to provide price information of the medicinal product that has a public health insurance coverage .
The marketing authorization holder will be required, according to the newly proposed wording of the amendment to the Act on Pharmaceuticals, to supply each distributor who makes a written declaration to the marketing authorization holder that the medicinal product is required for patient care in the Czech Republic pursuant to the provision of the Section 77 par. 1 letter h) Act on Pharmaceutical, medicinal products in quantity and time intervals so that this distributor disposes of medicinal products in an amount corresponding at least to the average demand of operators authorized to dispense medicinal products at this distributor for 2 weeks.
The above, followed by the new wording of Section 77 par. 1 letter h) of the Act on Pharmaceuticals, which states to the distributor who has applied for the supply of medicinal products and has made a written declaration to the marketing authorization holder, the obligation to supply the medicinal products thus obtained only to operators authorized to issue medicinal products within 2 working days of receiving a request for the supply of medicinal products. Distributors may not distribute medicinal products thus obtained abroad.
Conclusion
The amendment to the Act on Pharmaceuticals brings significant changes, particularly with regard to next steps of e-healthcare system, and new obligations imposed on marketing authorization holders or distributors.
The amendment adopted by the Chamber of Deputies was passed on 1 July 2019 to the Senate for its hearing. With some exceptions, the effectiveness of the amendment is planned for the first day of the second month following the publication of the approved law in the Collection of Laws – assuming a smooth approval process we can expect it from 1 September 2019 at the earliest, but rather later.
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
08.07.2019