March 2016 - From 1 March 2016, the Czech Parliament will start discussing a long-awaited amendment to the Act on Medicinal Products (Act no. 378/2007 Coll., as amended) (the “Bill”). The Bill introduces an entirely new legislative framework for the re-export of medicinal products, intends to amend the regime for conducting clinical trials on medicinal products for human use, and also regulates other related issues. The proposed changes will also be reflected in amendments to the relevant implementing regulations.

Re-export of medicinal products

The main purpose of the Bill is to address the threat of acute unavailability of some medicinal products necessary for the treatment of patients in the Czech Republic. This threat is caused by the parallel trade (re-export) in certain medicinal products, in particular expensive ones that are often less expensive in the Czech Republic than elsewhere. This gives distributors a financial incentive to re-export medicinal products intended for use in the Czech Republic. This practice can greatly increase their profits from the sale of such products. Parallel trade is not in itself an illegal practice; it simply makes use of the free movement of goods within the EU.

The Czech Republic is one of the few countries in the region where the parallel trade in medicinal products is not yet regulated. The Bill seeks to redress this by balancing the individual interests of distributors (and the options they have in this regard under EU law) with the public interest of having medicinal products available for the treatment of patients in the Czech Republic.

The regulation of this issue aims to establish a system to monitor and evaluate the potential risk of a particular medicinal product becoming unavailable. Where such risk exists, the draft legislation would enable the adoption of measures restricting the distribution of such medicinal product outside of the Czech Republic. Under the new legislation, if a distributor intends to distribute a medicinal product abroad that is listed as an “irreplaceable” medicinal product, it notifies the State Institute for Drug Control (the “Institute”). If within 15 days of the notification the Ministry of Health, at the initiative of the Institute, has not issued an order restricting or forbidding the distribution, the distributor would be allowed to re-export the medicinal product in question.

Clinical trials

The Bill further aims to adjust the legal regulation of clinical trials on medicinal products for human use in response to the adoption of the EU Regulation on clinical trials. The purpose of the proposed legislation is to accommodate the procedures for conducting clinical trials established by the EU Regulation. The Bill is intended to simplify the procedures for approval of clinical trials and procedures connected with the clinical trials themselves. In doing this it intends to regulate, in particular:

  • the protection of certain groups of trial subjects (e.g. minors, persons in custody or persons whose capacity is limited),
  • the establishment, composition and activity of an ethical commission, including the issuance of its opinions, and
  • language requirements for clinical-trial documentation.

Other areas

The Bill also sets out to regulate certain issues concerning good manufacturing practice (GMP) for active substances used in medicinal products for human use, which is also covered by the EU Regulation.[3] In this context, it contains measures ensuring the enforcement of the EU Regulation. The Bill also seeks to formulate statutory conditions for effective cooperation between the relevant authorities in identifying counterfeit medicinal products and preventing their handling.

The Bill gives a somewhat mixed impression. On the one hand, it is a welcome step in updating the legal regulation of medicinal products in the Czech Republic and harmonisation of this regulation with EU law. On the other hand, whilst it introduces new regulations covering the re-export of medicinal products, these regulations make no attempt to provide a universal solution to the problem. They rather seek to restrict the re-export of certain medicinal products from the Czech Republic, and thus provide patients with a greater degree of certainty that the medicinal products they need will be available. The Bill also seems to have shortcomings with respect to the vague terminology it employs, and the proposed sanctions are probably too lenient to have a sufficient deterrent effect on all entities concerned (i.e. large as well as small distributors).

Given current progress with the legislative process, it is difficult to predict when the Bill will come into force, or what changes might occur before it is passed into law. In any event, it is clear that the prolonged discussion of the re-export of medicinal products has led to a political will to see the regulation of this issue introduced without undue delay.