Changes to the pharmacovigilance system are about to become law.
The Sejm accepted on 27 September 2013 the Senat’s changes to the legislation amending current pharmaceutical law. The Act is now waiting for the President’s signature and it will come into force 30 days following its publication.
The modified system, which belatedly implements an EU pharmacovigilance directive, is intended to be more effective than the current system and contain stronger links to the EU system.
Key changes include:
- improving information-collecting procedures about suspected adverse reactions to medicinal products
- widening the definition of adverse reaction to allow more comprehensive data to be collected. The new definition will include harmful and unintended effects arising from the unauthorised use of pharmaceuticals, such as overdosing, medical errors, and off-label use
- introducing a clearer division and more detailed specification of the duties of regulatory authorities and marketing authorisation holders to collect and assess information about suspected adverse reactions to pharmaceuticals and to cooperate with the European Medicines Agency
- entitling patients to report adverse reactions directly to marketing authorisation holders, or to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- introducing new obligations, where there are safety concerns about a pharmaceutical product, so that marketing authorisation is only granted subject to the holder conducting post-authorisation safety and efficacy studies, and complying with stricter obligations on the recording or reporting of suspected adverse reactions than those provided by the new law
The reporting of adverse reactions by patients generated a lot of controversy as regards data protection. Questions were raised whether, without being given an express right under data protection law, marketing authorisation holders were permitted to process sensitive personal data included in adverse reaction reports.
Law: law of 13 September 2013 amending the Polish Pharmaceutical Law, implementing Directive 2010/84/EU of 15 December 2010 amending Directive 2001/83/EC on the Community Code relating to medicinal products for human use