On 25 July 2019 the Czech Senate discussed a draft amendment to Act No. 378/2007 Coll., Pharmaceuticals Act, as amended (the “Amendment”) which was passed by the Chamber of Deputies at the end of June 2019.
The main purpose of the Amendment is to further the digitalisation of healthcare services by setting up detailed rules on the so called “eRecept System”, which enables physicians to access current and historic information about, among others, medication that has been prescribed or dispensed to a patient. The Amendment provides an “opt-out” option under which a patient’s consent for physicians to access such information is deemed to have been granted but can be revoked by the patient at any time.
In addition to the eRecept System, the Amendment specifies the obligation of Marketing Authorisation Holders (“MAH”) to report data on the price of reimbursed pharmaceuticals to the State Institute for Drug Control.
In general, the Senate has accepted the wording of the Amendment, including the eRecept System and the opt-out option but has suggested a few, rather technical, changes. For example, in relation to pharmacists the opt-in (rather than opt-out) option shall apply, i.e. a patient needs to grant consent to a pharmacist to have access to the information.
The Senate rejected part of the Amendment related to the availability of pharmaceuticals for patients in the Czech Republic. Under the rejected part of the Amendment, MAH would no longer be obliged, under certain conditions, to provide distributors with volumes based on their market share. Supplied volumes would correspond to the average two-week demand of the pharmacies ordering from the distributor, and distributors would have to provide a written statement that they would be intended for patients in the Czech Republic only.
It is expected that there will soon be new legislation regulating the distribution of pharmaceuticals. The Ministry of Health is currently preparing new rules regarding the availability of pharmaceuticals in the Czech Republic, the so called “Emergency System”. Under the Emergency System, pharmacies shall have the right, under certain conditions, to order pharmaceuticals directly from the MAH, who must deliver them within two business days.
As a next step, the Amendment, in the wording suggested by the Senate, will be returned to the Chamber of Deputies and will be subject to a new round of voting.