NEWS

Czech Pharma Industry Leaders Meet to Discuss New Legislation

Prague, 20 June 1016 - The Prague office of Baker & McKenzie recently hosted the latest in a series of workshops on hot topics and issues that pharmaceutical companies face when doing business in the Czech and Slovak markets.

As of 1 July 2016, the newly adopted Contracts Registry Act will come into force, which introduces an obligation to publish certain contracts in the publicly-available contracts registry for such contracts to become legally effective. These include private law contracts to which any of the affected public entities is a party, including state contributory organizations (such as public hospitals, etc.), public research organizations and public universities, state or national companies or health insurance companies. However, the Contracts Registry Act makes certain exemptions from the publication duty. For example if a contract has a value of CZK 50,000 (or less (without VAT).

Publication in the online contracts registry means uploading and publishing a contract in a required format in the contracts registry together with the relevant types of metadata. Information that cannot be disclosed/provided under the laws on free access to information, as well as information pertaining to trade secrets, will not be published in the contracts registry. A contract that must be published under the Contracts Registry Act does not become effective until the date of publication. If a contract is not published within three months from its conclusion, it is cancelled ex tunc, i.e. from the beginning.

A detailed presentation and discussion of this topic was delivered and presented by Milena Hoffmanová, head of the Firm's Healthcare group, and associate Martin Lazár, both from the Prague office.

The seminar also dealt with the new act on cross-border cooperation in connection with the posting of employees for performance of work within the framework of the provision of services, which came into force on 18 June 2016. This Act introduces new administrative duties for foreign employers settled in EU member states, posting their employees to the Slovak Republic. Provisions of this Act may also be applied if an employee whose work involves the responsibility for the Czech Republic and the Slovak Republic performs work partly in the Slovak Republic.

In her contribution, Zuzana Ferianc, head of the office's Employment group, focused on what changes the above act will bring, when the new rule is to be applied, what the duties are of the affected entities or what sanctions may be imposed upon them by the National Labor Inspectorate of the Slovak Republic.

The three presenters from the Prague office were joined by Kateřina Schenková, an attorney from the Vienna office specializing in competition law, who addressed issues concerning the distribution of medicinal products from a competition law perspective, such as pricing for resale, collection of information through a distributor, Stock Management Scheme, double prices, exclusive and selective distribution and other topics.

Approximately 20 clients from the Prague office attended this presentation and related discussions, all of them representing major pharmaceutical companies operating in the Czech Republic.

This was yet another successful event organized by our Healthcare practice group, and the eighth in a workshop series aimed at helping clients understand the local regulatory framework and comply with the local legislation affecting their business.

The series started about two years ago and, during this time, has addressed topics such as implementation of the Disclosure Initiative including its tax aspects, the issue of rebates in the pharmaceutical industry from the perspective of competition law, new regulation of parallel exports, control activities of the State Institute for Drug Control (SIDC), as well as other interesting topics.