EU votes for tighter internet drug regulations
pharmafile | May 4, 2010 | News story | Sales and Marketing | EU, counterfeits, viagra
The European Parliament has voted to enact stronger legislation against poor quality medicines available on the internet.
The move comes as a new survey estimates that more than 60% of all drugs purchased on-line are “fake, substandard or illegal”.
The new legislation also confirmed the need for mandatory safety features for all prescription medicines.
To counter the growing numbers of medicinal products that are “falsified in relation to their identity, history or source”, and thus pose a major threat to Europe’s patients and pharmaceutical industry, MEPs on the environment committee advocated the introduction of mandatory safety features, such as seals or serial numbers, for certain medicines.
In principle, these features would be required for prescription medicines, but the European Commission could, subject to an assessment, waive this obligation with generic medicines, for example.
MEPs also want the Commission to assess, after four years, whether this requirement should be extended to non-prescription medicines.
The Commission proposals also aim to improve pharmacovigilance systems in companies and ensure better reporting of adverse reactions.
A report by Linda McAvan from S&D in the UK says that patients, as well as healthcare professionals, should be encouraged to report these reactions.
The report added that in the case of intensively-monitored products, the package leaflet should state the product is “subject to additional safety monitoring” and that suspected adverse reactions should be reported.
Patient safety still at risk from fake, substandard or illegal medicines
A recent survey conducted by independent polling company ICM for the patient safety firm Aegate found that around 9% of consumers have purchased prescription drugs on-line at least once.
Despite 69% of consumers in the survey saying they recognise the danger of such purchases, nearly half did so because it was cheap, and 30% did so because of convenience.
Gary Noon, chief executive of Aegate, said: “Creating effective legislation for patient safety within the online environment is a specific problem.
“Despite the fact that purchasing prescription medicines online is illegal in most European countries, internet pharmacy websites can be registered anywhere in the world and accessed from most computers, making it almost impossible to stem the availability of prescription drugs online.”
One pharma company that has a strong background in lobbying for stronger regulation against illegal drugs entering into the legal supply chain, due mainly to its erectile dysfunction product Viagra being a regular target of counterfeiters, is Pfizer
A survey commissioned by the pharma company in Europe earlier this year echoed ICM’s findings and identified a strong and growing ‘black market’ in falsified medicines.
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