The new act on the limitation of the environmental impact of selected plastic products (the “Act”) is a transposition of the European Directives 2008/98/EC on waste and in particular the 2019/904 on the reduction of the impact of certain plastic products on the environment.
New act on limitation of environmental impact of selected plastic products
The new act on the limitation of the environmental impact of selected plastic products (the “Act”) is a transposition of the European Directives 2008/98/EC on waste and in particular the 2019/904 on the reduction of the impact of certain plastic products on the environment. The Act includes several types of measures - from a complete ban on products, to restrictions on their consumption, to mandatory contributions from producers to clean up municipalities and cities. Only some selected singleuse plastic products (e.g., plastic cotton buds, plastic cutlery, straws, food containers, cups, oxo-degradable plastic products) are directly banned from the market. The Act also introduces new obligations for producers, such as the obligation to inform buyers about the correct handling of waste from certain products, the obligation to educate, i.e., to alert customers to the availability of reusable alternatives to plastic products, and the obligation to label plastic products. The Act also strengthens the so-called extended responsibility of producers of selected plastic waste - producers of, e.g., filter cigarettes will participate in the clean-up of waste from their products in municipalities through financial contributions. Fines of up to CZK 5 million (approx. EUR 205,000) may be imposed for the breach of the Act.
1 October 2022 (effective date of the Act)
New legislation on availability of medicines in crisis situations
This extensive amendment is the legislator's response to the changes in legislation at European level. One of the many areas amended is the purchase of medicines and their availability in crisis situations. In order to prevent disruptions in the supply of medicines to the EU market, the amendment, among other things, provides the Ministry of Health of the Czech Republic (“Ministry of Health”) with considerable powers in the area of purchasing and distribution of medicinal products and setting the prices of medicinal products. The Ministry of Health will have the power to: (i) purchase or distribute medicinal products, (ii) temporarily set the conditions of the reimbursement or the price for the final consumer, (iii) deviate from the Act on Medicinal Products when ensuring the purchase or distribution in a state of emergency or war, (iv) maintain a list of medicinal products which are essential for the needs of the population and whose distribution abroad distributors are obliged to report to the State Agricultural and Food Inspectorate, and (v) restrict or prohibit the redistribution of the medicinal products (listed in the aforementioned list) abroad.
1 December 2022 (effective date of the new legislation)
New act on medical devices and in vitro diagnostic medical devices
The new act on medical devices and in vitro diagnostic medical devices (the “Act”) was adopted to bring national regulation regarding medical devices into line with European Regulations 2017/745 on medical devices and 2017/746 on in vitro diagnostic medical devices (the "Regulations") and repealed the existing Medical Devices Act. The Act supplements the rules set out in the Regulations, regulates the Medical Devices Information System, and regulates the prescription and dispensing of medical devices and in vitro diagnostic medical devices, their use and the conditions for their servicing.
22 December 2022 (effective date of the act)
New price regulations of medicinal products and medical devices
On 30 November 2022, the Ministry of Health published the new price regulations applicable from 1 January 2023: the Price Regulation of Medicinal Products and Foodstuffs for Special Medical Purposes and the Price Regulation of Medical Devices and In Vitro Diagnostic Medical Devices (the “Price Regulation”) which repeals the current regulation of prices of medicinal products and foodstuffs for special medical purposes. The most significant change is the modification of the definition of other persons supplying a medicinal product to the market (the “Definition”). The Pricing Regulation newly establishes, in relation to the Definition, a new requirement that this person must form a concern with the originator, be authorised in writing by the originator to supply such products to the market in the Czech Republic or be authorised to parallel import a mass-produced medicinal product. The Definition is important from the point of view of price regulation, because other persons supplying a medicinal product to the market are (besides the originator of the medicinal product) the first link in the distribution chain to which price regulation under the Price Regulation applies - these persons may sell the medicinal product to local distributors or persons authorised to dispense medicinal products at a maximum price corresponding to the price ceiling set by the State Institute for Drug Control (the so-called originator price). The maximum amount of the trade mark-up is subsequently based on the originator price.
1 January 2023 (effective date of the new price regulations)
By Radek Matous, Partner, Petra Kratochvilova, Counsel and Barbora Bugova, Associate, Eversheds Sutherland
