MoH approved Clinical Trial Agreement template in CZ and SK

We would like to inform you that, on 3rd May 2019, the Ministry of Health of the Czech Republic published on its website a Methodological Guideline on the Content of a Clinical Trial Agreement of a clinical trial of medicinal products for human use dated 30th April 2019, which includes a template Clinical Trial Agreement. The Ministry requested all clinical trial sponsors and healthcare providers involved in clinical trials to use such a template agreement as much as possible. The guideline is applicable to all Ministry-directly-managed hospitals (all of the major ones).

The template agreement is designed as a 3-party agreement between a sponsor, a site and an investigator. The agreement is bilingual (Czech and English) and reflects relevant EU and Czech legislation as well as key GDPR aspects.

The main objective of this template agreement is to shorten and simplify the process of executing a clinical trial agreement between sponsors and healthcare providers. The use of a template agreement should also lead an increase in the number of clinical trials performed in the Czech Republic and to the improvement of the Czech Republic’s position in international competition in clinical research. The Ministry’s ideal is that if the agreement will not be amended, it should be automatically accepted by the Ministry directly-managed hospitals.

The Methodological Recommendation in question is available on the website of the Ministry of Health of the Czech Republic, in the section “Legislation” and in the subsection “Clinical trial” (http://www.mzcr.cz/Legislativa/obsah/klinicke-hodnoceni_4016_11.html).

The Ministry of Health of the Slovak Republic approved a similar template Clinical Trial Agreement. The template agreement is a part of the Order of the Minister of Health No. 4/2018 and it is available on the website of the Ministry of Health of the Slovak Republic which is available on the website of the Slovak Ministry of Health (https://www.health.gov.sk/Clanok?Prikaz-4-2018). The Order of the Minister, with respect to the template agreement, is effective from 1st June 2019.

Our office was involved in the preparation of both of the agreements in the Czech Republic and Slovakia.

Please do not hesitate to contact us in case of any questions via our email (info@kastnerpies.cz).

Proposal for emergency distribution channel of pharmaceuticals in Czech Republic

The Czech Ministry of Health (“MoH”) is currently working on a draft legislation implementing an emergency distribution system (inspired by the Slovakia where something similar was introduced in April last year) that should, in the opinion of the MoH, prevent re-export of medicinal products from the Czech Republic and improve availability of the medicinal products on the Czech market. The MoH would like to introduce a specific emergency distribution channel based on which a pharmacy could order a medicinal product directly from the MAH if it cannot be reliably supplied through a standard distribution channel. The whole system is introduced in reaction to repeated complaints from pharmacies regarding unavailability of various medicinal products that are the subject of parallel trade.

The emergency distribution system should work in a way where MAH will have to establish and operate an electronic information emergency system for ordering of Rx products. If a pharmacy cannot procure a medicinal product from a distributor, it will be able to order it through the emergency system. The marketing authorization holder will be obliged, on the basis of this order, to supply the pharmacy with the required medicinal product within two working days of receipt of such order. If the marketing authorization holder fails to comply with this obligation, it will may be subject to significant fines. The draft amendment also provides exemptions from the obligation to supply a medicinal product, for example in case of the reported outage based on objective obstacles.

In relation to the emergency channel, the MoH intends to introduce additional measure that should ensure better availability of medicinal products (only for those with reimbursement) for Czech patients. Specifically, same as in Slovakia, the MoH will introduce a statutory provision based on which reimbursed medicinal products may only be exported to another country with express MAH’s consent. Therefore, the MAH will be fully responsible for assessing the availability of his medicinal product on the Czech market and, if it is not endangered, the medicinal product may be exported abroad with his consent.

The proposal of the Ministry of Health needs to go through the whole legislative process and it is expected to be effective in the course of the next year or beginning of 2020. However, especially the second part (related to consent with export of products) is criticized since it may constitute a competitive issue and violation EU competition law. From our experience in Slovakia, this right of the MAHs is rarely used as there is a potential risk of competition law consequences, even on the EU level.

The concrete text of the statutory amendments is not yet published and the information above is result of information communicated by the MoH’s representatives and thus maybe subject of additional changes.