Safety of Medicines
Currently, almost 200,000 patients die every year in the EU as a result of adverse reactions to medicines, with many thousands more suffering serious side effects.
The most famous case of an adverse reaction was thalidomide in the late 1950s, but adverse reactions can occur with any new drug. Although clinical trials are conducted on all new medicines before they are made publicly available, many less obvious side effects only become evident once a drug is in use among the wider population.
This is why Linda believes we need better systems for picking up on potential problems with medicines and faster action to withdraw medicines when problems occur. At present, the public have no way of knowing whether a drug they have been prescribed is a new product with potentially unidentified side effects. If a patient notices side effects from a drug they are taking, many are unsure what to do and side effects are not reported to the relevant authorities. Furthermore, there is no Europe-wide system for quickly collating all reported side effects meaning side effects detected in one country may not be flagged up elsewhere.
New legislation from the EU on medicine safety, the Pharmacovigilance Directive, which Linda steered through the European Parliament, will change matters. A black triangle symbol will be included in the leaflets accompanying medicines to denote drugs that are new to the market enabling patients to identify them quickly. Patients from across Europe will be able to report side effects they experience directly to a new website and find information on the known side effects of any drug. New drugs will be closely monitored for five years. The information gathered on the website will be collated by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to form a common database that informs regulatory agencies across the EU. And coordination procedures to withdraw a medicine or change its usage are being speeded up across Europe so that if problems occur in one country, action is taken across Europe.