A number of measures guaranteed to enhance the safe use by consumers of medicines found on the EU market have finally seen the light of day. The recent vote of approval taken by the European Parliament on a substantial number of amendments to EU laws which seek to protect consumers against the harmful use of medicine has ensured that these new rules will now come into effect by the year 2012.
These new legislative measures are set to ensure that patients will be better informed on how to use their medicines. EU and national web portals will be set up to give information on medicinal products and their proven side effects. National web portals which will be linked to the EU one will include assessment reports, summaries of product characteristics and patient information leaflets.
Consumers will be informed as to how to go about reporting any suspected adverse reactions to certain medicines, either via national web portals or other means. In this way, these websites will also serve as a means of collecting information on dangerous side effects of medicines sold in Europe. The sharing of information from patients across Europe could possibly also leave the desired effect of detecting rare problems with certain medicines, which problems might not have been visible in clinical trials.
High-risk medicines such as medicinal products containing a new active substance will be placed on the market only subject to the condition that they are submitted to additional monitoring. Such products must carry a black symbol together with the statement: “This medicinal product is subject to additional monitoring”, as well as an explanatory sentence. They will also be listed on the EU web site and national web portals.
The EU database “Eudravigilance” will be the single point of contact for information on adverse events associated with medicines. The European Commission, European Medicines Agency and national regulators will have full access to the database, while companies, healthcare professionals and the public will be given “appropriate” access.
These measures have been welcomed by both consumers’ associations and industry alike as a step towards enhancing patient safety and boosting consumers’ trust in the pharmaceutical industry. They are, however, only the first milestone reached in the long journey towards the adoption by the EU institutions of a more comprehensive package of legislative measures dealing with pharmaceuticals, first proposed by the European Commission way back in 2008. Indeed, a number of measures intended to protect the European market from counterfeit medicines and to improve information for patients on prescription medicines are still waiting to see the light of the day.
mariosa@vellacardona.com
Dr Vella Cardona is a practicing lawyer and a freelance consultant in EU, intellectual property, consumer protection and competition law. She is also a visiting lecturer at the University of Malta.