A new bill amending the Czech Medicines Act has recently been one of the most debated legislative pieces in the Czech Parliament. For the medicines' distributers and pharmacies, it brings two important changes.
Re-export policy on a straighter line
First of all, the requirements for reexport are envisaged to be stricter. A pharmacy which holds an authorization to distribute medicines shall not use the medicines that were obtained for its “pharmacy” business activities for further redistribution. The authors of the amendment argue that such practices can lead to unpredictability and unexpected market drop-outs of medicines. Also, there is a greater risk that copycats would enter the market due to the non-transparent distribution chain. The authorized pharmacy shall specifically determine which medicines are intended for further redistribution and which to be dispensed directly to the patients. Pharmacists opposing the proposed bill suggested that it will do little to help the situation when dozens of medicines are no longer available in the Czech Republic.
Prescription drugs' obligatory authenticity features
Furthermore, new protective measures for identification of medicines (except for the radiopharmaceuticals) are being introduced which transposes into Czech law the European Directive on the Community Code relating to medicinal products for human use. The new bill aims at fighting counterfeits' spreading in the distribution chain. The obligatory authenticity features on the outer or inner packaging of prescription drugs should help to verify the product's authenticity and identify each package of medicine. The specific technical requirements for the authenticity features (e.g. the common logo) will be adopted by the Commission in the near future. Distributors shall perform a thorough control of these protective features on all received medicinal products and verify their authenticity. Any suspicion that a medicine has been counterfeited must be immediately reported to the Czech State Institute for Drug Control.
The Czech State Institute for Drug Control – extended competence
The Czech State Institute for Drug Control will likely gain more competence. The new bill proposes that the Institute can assess if the product name is appropriate with regard to public health and patients protection. According to travaux préparatoires, for instance the word “rapid” can no longer be used in the name if the product does not have significantly different characteristics from its counterparts and does not provide a faster effect to the patients. Any distributor, producer or importer that would like to have a permanent establishment or a place business in the Czech Republic shall report his intention at least 60 days before he starts his business activities in the country. The Institute will further obtain a competence to impose an obligation to perform post-authorization and safety studies on a marketing authorization holder if it finds it suitable.
Pharmacovigilance – new challenges
Overall, the pharmacovigilance rules will be much stricter. A principal change in the definition of adverse effect of medicinal products for human use is proposed. A mere suspicion that an adverse effect occurred will be sufficient for being reported to the Czech State Institute for Drug Control. At the same time, cases when a medicine was incorrectly used due to prescription mistakes, applications in contrary to the marketing authorization or misuses of the medical products will be also covered by the definition. The Institute is able to block the whole batch of the competitor's medicinal products. Some fear that this can be easily abused in the tough competitive pharmaceutical industry.