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.