Re-export of medicinal products
The Amendment addresses the threat of possible unavailability of medicinal products for the treatment of patients in the Czech Republic. This is allegedly caused by the re-export of certain medicinal products, which are often less expensive in the Czech Republic than in other EU countries.
So far, the Czech Republic has been one of the few countries in the region where parallel trade in medicinal products is not regulated. The Amendment now seeks to balance the individual interests of distributors and the options they have in this regard under EU law and the public interest in respect of having medicinal products available for the treatment of patients in the Czech Republic.
The Amendment establishes a system to monitor and evaluate the potential risk of a particular medicinal product becoming unavailable. Where such risk exists, the Amendment enables the adoption of measures restricting or forbidding the distribution of that medicinal product outside of the Czech Republic. If a distributor intends to distribute a medicinal product abroad that is listed as a “potentially unavailable” medicinal product, it shall notify the State Institute for Drug Control (the “Institute”) in advance. At the initiative of the Institute, the Ministry of Health may restrict or forbid the distribution of that medicinal product within 15 days of the notification. If no measure is issued by the Ministry of Health, the distributor may re-export the medicinal product in question.
New measures to ensure appropriate and continued supplies of medicinal products
Following a lengthy discussion in the Czech Parliament, the Amendment also introduces a new provision aimed to ensure appropriate and continued supplies of medicinal products. The Amendment gives pharmacies the right to request any distributor to supply certain medicinal products. The supply has to be provided by the distributor within two working days from receipt of a request. All distributors are then entitled to invite the holder of a marketing authorisation (“MAH”) to supply the medicinal products within the scope of the distributor’s market share.
This new provision is quite controversial and raises a number of practical questions. In particular, the Amendment inappropriately attempts to ensure continued supplies of medicinal products by setting a specific key for allocating supplies of medicinal products to distributors. It is not clear how or who should establish the distributor’s market share for purposes of the allocation. The new provision also seems to purposefully partition the market and foreclose competition in the sense that it effectively blocks any entry of a new distributor into the market. In addition, the regulation does not presume any mechanism based on which MAHs could verify that a particular request from a distributor corresponds to actual patient need.
It seems therefore that the new provision may in fact result in less stability in assuring continued supplies. While it does not explicitly prohibit the “direct-to-pharmacy” (DTP) model in the Czech Republic, it could significantly limit its implementation and possibly erode it. In some cases the number of distributors for a particular medicinal product cannot be managed appropriately, and it could be more difficult to effectively protect the market from re-exports.
The Amendment further modernises the regulation of clinical trials on medicinal products, in response to the adoption of the respective EU Regulation (Regulation No 536/2014). In particular, it accommodates national procedures for conducting clinical trials established by the EU Regulation. The Amendment simplifies the procedures for approval of clinical trials and procedures connected with the clinical trials themselves. This includes (i) the protection of certain groups of trial subjects (e.g. minors, persons in custody or persons whose capacity is limited); (ii) the establishment, composition and activity of an ethics commission, including the issuance of its opinions; and (iii) language requirements for clinical trial documentation.
The Amendment also regulates certain issues concerning the good manufacturing practice (GMP) for active substances used in medicinal products, which is also covered by a respective EU Regulation (Regulation No 1252/2014). In this context, it contains measures ensuring the enforcement of this EU Regulation. The Amendment also seeks to formulate statutory conditions for effective cooperation between the relevant authorities in identifying counterfeit medicinal products and preventing their handling.
The Amendment gives a somewhat mixed impression. On one hand, it modernises Czech pharmaceutical law and ensures that it is harmonised with EU law. On the other hand, the new provisions that aim to ensure appropriate and continued supplies of medicinal products appear to be too experimental and likely insufficiently thought through. Although the purpose is to ensure that medicinal products are available for the treatment of patients in the Czech Republic and not exported, they may create exactly the opposite situation.
The Amendment becomes effective on 1 April 2017. However, the measures aimed to ensure appropriate and continued supplies of medicinal products don’t go into effect until 1 December 2017 while the effectiveness of the new regulation concerning clinical trials is bound to the date of applicability of the respective EU Regulation.