It is a well known fact that little is truly known about any medicinal product prior to its entry to the market and interaction with a more diverse population than that of clinical trial participants. Therefore, drugs continue to be monitored once they are put on the market so as to assure that any aspect which could lead to an adverse reaction is detected, assessed, and necessary measures are taken. Indeed, adverse drug reactions are the 5th most common cause of hospital death in the EU (approx 197,000 deaths per year) and are responsible for 5% of hospital admissions.
Phamacovigilance is defined as the activities that deal with the detection, assessment, understanding and prevention of adverse effects of medicinal products in consumers, simultaneously undertaking the monitoring of counterfeit products and making sure that patients are well-informed about their medicines.
The EU boasts the most advanced and comprehensive pharmacovigilance system in the world, representing a robust and transparent instrument that guarantees a high level of public health protection throughout the EU Member States. The ultimate purpose of this system is to protect public health, thus falling within Article 152 (1) of the Treaty and establishing the European Community referring to an obligation of ensuring a high level of protection for human health.
The legal framework for the development, implementation and sustainability of a strong pharmacovigilance system in the EU has been defined by both a Union-wide Regulation and Directive, since 2004 and 2001 respectively. Regulation (EC) No 726/2004 (for authorization and supervision of medicinal products for human and veterinary use) applies to centrally authorised medicinal products, and Directive 2001/83/EC (for a Community code relating to medicinal products for human use) refers to nationally authorised products.
As a means to update and modernize the legislation, the European Parliament in 2008 adopted the first legal proposal to amend Regulation (EC) No 726/2004 and Directive 2001/83/EC. The amendment of the legislation aimed to further maximize efficiency and strengthen the existing pharmacovigilance system by building on existing structures, procedures, resources, and practices. These two pieces of legislation were further amended in 2010. Hence, as of 31 December 2010 Regulation (EU) No. 1235/2010 and Directive 2010/84/EU have replaced their predecessors.
The new legislation has been officially implemented since 2 July 2012 and has clarified the responsibilities of involved parties (Member States, European Medicines Agency, marketing authorization holders etc.). Furthermore, it has strengthened the reporting system of adverse effects by simplifying procedures. The European Medicines Agency (EMA) in collaboration with Member States is responsible for implementing the new legislation.
To view Regulation (EU) No. 1235/2010, please click here
To view Directive 2010/84/EU, please click here
Important aspects of the legislation:
Regulation (EU) No. 1235/2010 sees the development of two significant bodies for monitoring the safety of medicinal products that are centrally authorised in the EU.
Firstly, the further development of the EudraVigilance database, a web-based information system designed to provide access to information on drug safety. The database, which will collect data from Member States only, will be utilized as a single point of information where Member States, the European Medicines Agency and the European Commission will have simultaneous, permanent and unrestricted access to information available. Marketing authorisation holder and the public will be granted access to certain facets.
The European Medicines Agency first launched EudraVigilance in December 2001.
For more information on EudraVigilance please click here
Secondly, in accordance to Regulation (EU) No. 1235/2010 the European Medicine Agency will act as the coordinating body of the legislation, monitoring its implementation through the creation of a Pharmacovigilance Risk Assessment Advisory Committee (PRAC). The PRAC is responsible for assessing and monitoring safety issues for human medicines by evaluating signals of adverse reactions, and general safety concerns, obtained from the EudraVigilance database, and may recommend regulatory action as a result.
The establishment of the PRAC will make the existing pharmacovigilance system even more robust, as there will now be a dedicated committee responsible for assessing and monitoring safety issues for human medicines.
The PRAC will be composed of members appointed by Member States and patient representatives for a three year term. The composition of the PRAC can be found on the European Medicines Agency’s website. Please click here to access more information on the PRAC.
Directive 2010/84/EU sees the further strengthening of the adverse reactions reporting throughout the EU. Indeed the Directive seeks to improve patient safety and public health through better prevention, detection and assessment of adverse reactions to medicines.
The new legislation has amended the term ‘adverse reaction’ ensuring that it now also covers the unintended effects that result not only from the authorized use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorization.
Furthermore, the Directive obligates Member States to take measures to encourage patients, doctors, pharmacists and other healthcare professionals to report suspected adverse reactions to the national authorities. In addition, patient reporting must be facilitated in ways other than web-based methods. National authorities are required to follow up any reports of adverse reactions by evaluating reports by obtaining accurate scientific facts.
Most importantly the Directive makes special reference to medicinal products that are subject to further monitoring by indicating clearly that these products should include a sentence indicating this status in their information pamphlet in addition to carrying a black symbol on the outer packaging.